SIRIS-Lab/grant-classification-train · Datasets at Hugging Face

id stringlengths 36 36	title stringlengths 0 391	funder stringclasses 125 values	beneficiary stringlengths 3 1.44k	source_id stringlengths 0 41	abstract stringlengths 6 4.76k	funding_scheme stringclasses 411 values	label class label 8 classes
gen_319400789f36e14f943645377a9ea342	Erlotinib Study for Myelodysplastic Syndrome (MDS)	Genentech, Inc.	H. Lee Moffitt Cancer Center and Research Institute	NCT00977548	The purpose of this research study is to find out what effects, good and/or bad, erlotinib has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib use in this study is considered investigational as the FDA has not approved it for the treatment of myelodysplastic syndrome.	Drug	4other_research_funding
gen_987ebce3c515381f60d4ce0833dc7f2c	Tomosynthesis Versus Digital Mammography in a Population-based Screening Program	im3D S.p.A.	SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino	NCT02590315	Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime. This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.	Other	4other_research_funding
gen_3657caa9dc6f1068b88c52adef8a37cd	Azithromycin - Ivermectin Mass Drug Administration for Skin Disease	Murdoch Childrens Research Institute	London School of Hygiene and Tropical Medicine	NCT02775617	This is an open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections. Communities will be randomised to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2). Treatment of yaws: Single dose of Azithromycin (30mg/kg, max 2G). Treatment of scabies: Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses 7-14 days apart. Investigators will complete a clinical and microbiological assessment of bacterial skin disease at baseline and at 12 months to assess the impact of treatment on the prevalence of bacterial infection and the emergence of antimicrobial resistance. Primary Outcome 1. Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms. Secondary Outcomes 2. Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms 3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms	Drug	4other_research_funding
gen_78c9a575ced9413ecc785a01dbcc7bb0	Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)	Merck Sharp & Dohme Corp.	Hopital de Fann, Dakar	NCT00573001	The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.	Drug	4other_research_funding
gen_889975a7b33189315c7ed6285cd32c62	Antiarrhythmics or Ablation for Ventricular Tachycardia Pilot	St. Jude Medical	Nova Scotia Health Authoriry	NCT02830360	This is a pilot study to determine the feasibility of a larger scale multicenter trial comparing first line catheter ablation to antiarrhythmic drug therapy for patients with prior MI, an ICD and VT.	Drug	4other_research_funding
gen_c905972bed428ccc3c6d0a317b8dd9cb	INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study	National Institute of Mental Health (NIMH)	Dr Mohan's Diabetes Specialities Clinic	NCT02022111	To provide better care and preventive services for people with both depression and diabetes, the investigators propose to develop and test whether interventions to reduce depressive symptoms can be integrated into routine diabetes clinics in India. The investigators will gather feedback from patients in India through focus group discussions and individual interviews so they can culturally-adapt a model of combined depression and diabetes care. The investigators will then evaluate the effectiveness and costs of this care model in a trial at three diabetes clinics in India. It is expected that results from this study can guide how to incorporate mental health care into routine diabetes clinics in low-resource settings.	Other	4other_research_funding
gen_8f3aff4316d8464a3e9039f6723db1aa	Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)	FDA Office of Orphan Products Development	Children's Hospital of Philadelphia	NCT00529191	The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).	Drug	4other_research_funding
gen_192796cbefa55e578aeeb1cacdcbc744	Primary Tube Versus Trabeculectomy Study	Research to Prevent Blindness	Bascom Palmer Eye Institute	NCT00666237	The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.	Procedure	4other_research_funding
gen_807075b2ae303368b8158fdea01d9ca6	A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)	Clinical Associates Research, Maryland	Yale University	NCT00809523	This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.	Device	4other_research_funding
gen_e1687248fafc1deb55f80f038b4897e3	PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma	National Cancer Institute (NCI)	Gundersen Lutheran Center for Cancer and Blood	NCT00049530	RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.	Biological	4other_research_funding
gen_72b809c8bc8150b6a0ebc7cd1927131a	Task Shifting and Blood Pressure Control in Ghana	National Heart, Lung, and Blood Institute (NHLBI)	NYU Langone Medical Center	NCT01802372	The goal of this study is to evaluate the comparative effectiveness of the World Health Organization Package targeted at Cardiovascular (CV) risk assessment and hypertension control, delivered by Community Health Nurses as part of Ghana's Community based Health Planning and Services program, versus provision of health insurance coverage, on blood pressure reduction. Findings from this study will provide policy makers and other stakeholders needed information to recommend efficient cost-effective policy with regards to comprehensive CV risk reduction in patients with hypertension in low resource settings.	Behavioral	4other_research_funding
gen_b240e0cd88f2c928908b4fd7c687e689	Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients	Sintesi Research Srl	Centro Emofilia e Trombosi Angela Bianchi Bonomi, IRCCS Fondazione Ospedale Maggiore Policlinico	NCT02479087	The purpose of this study is to assess the role of a FVIII/VWF complex concentrate (Emoclot) in successfully inducing immune tolerance (I.T.I.) in patients with Haemophilia A with inhibitors, including patients at high risk of failure.	Drug	4other_research_funding
gen_b3d178e83a83b628e041daa836db604c	The Safety and Efficacy of Low and High Carbohydrate Diets	National Center for Complementary and Integrative Health (NCCIH)	University of Pennsylvania	NCT00143936	This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).	Behavioral	4other_research_funding
gen_63a78b3e0a96b063e2205a8015df3160	Self-Management Program Based on Physical Exercises in People With Multiple Sclerosis	CHU de Reims	UCL	NCT02607020	Fatigue is the most chronic and disabling symptom in multiple sclerosis patients. Self-management physical exercise programs seem promising to allow patients to improve their fatigue and their deconditioning. However, the effectiveness of such programs has been poorly assessed until now. The objectives of the present study are to evaluate the relationships between fatigue and physical capacity among slightly affected MS patients, and to carry on a large trial to assess the effectiveness of a self-management exercise program in the same patients. Sixty-four patients will be included and will be asked, after an educational period, to perform at least three exercise sessions of more than 30 minutes each week, over a period of three months. Patients will be splitted in two groups : one group will perform endurance and resistance physical exercises, and the other one will perform relaxation exercises with the help of soothing music. A regular coaching will adapt the exercises and motivate the patients to continue the treatment. Assessors won't be informed of patients' treatment. Four evaluations will be done, and will notably assess muscle strength, endurance, fatigue and social participation.	Other	4other_research_funding
gen_6d140173c85ab7ea415deababdc9c179	AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies	Massachusetts General Hospital	Dana-Farber Cancer Institute	NCT01065662	The purpose of this research study is to determine the safety of the combination of the two drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop cancer cells from growing. These drugs have been used in other research studies in ovarian and kidney cancer and these studies suggest that these drugs may help to keep cancer from growing in this research study.	Drug	4other_research_funding
gen_8f698e459e6126c143532c96a018312a	OSTPRE-Fracture Prevention Study	Academy of Finland	Department of Gynecology and Obstetrics, University Hospital of Kuopio	NCT00592917	The purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-D3 800 IU/d divided in two daily doses on the incidence of falls and fractures, bone mineral density and bone metabolism in postmenopausal women 65-71 years of age.	Dietary Supplement	4other_research_funding
gen_8daaec2b4bacaa9e1cd913b0c514473e	Beat AML Core Study	Cellworks Group Inc.	University of Florida	NCT02927106	In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity assays will be utilized to define clinically relevant gene mutations and identify potential therapeutics for patients with acute myeloid leukemia (AML).	Genetic	4other_research_funding
gen_396bed29a83599f50836cde73c12448f	The Medicines Optimisation Review Toolkit Evaluation in HIV Outpatients	Merck Sharp & Dohme Corp.	University of Sussex	NCT03340077	Multicentre, randomised (1:1), controlled, open (not blinded) comparison of MOR toolkit (intervention) with standard pharmaceutical care (control)	Other	4other_research_funding
gen_2907d6bf09c3ba5d65e0d5f71b752c37	Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma	Jiangxi Provincial Cancer Hospital	Sun Yat-sen University	NCT01245959	The purpose of this study is to compare induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy in NPC patients.	Radiation	4other_research_funding
gen_3ecbd378ac88fef9c8a4a0dd22c18c64	Progressive Goal Attainment Program for Veterans	Michael Debakey Veterans Affairs Medical Center	MDRC	NCT01565863	The purpose of this study is to test the effectiveness of the Progressive Goal Attainment Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans with disabilities.	Behavioral	4other_research_funding
gen_46a9a29b684478ef1cf9441111a2d48d	Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis	National Center for Research Resources (NCRR)	Stanford University	NCT01029353	This trial will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.	Procedure	4other_research_funding
gen_463beaa30a40cd522ab7ef14788d9383	Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder	North Carolina Translational and Clinical Sciences Institute	University of North Carolina, Chapel Hill	NCT01799291	The primary aim is to test the efficacy of a new intervention to improve clinical judgment. The investigators focus on the assessment of pediatric bipolar disorder (PBD), a controversial diagnosis with frequent diagnostic errors, by educating mental health professionals in common cognitive pitfalls and training them in recommended de-biasing strategies. The investigators hypothesize that the Treatment group will show higher diagnostic accuracy than the Control condition: Participants receiving the cognitive de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity bias. Secondary aims include soliciting feedback about whether the skills were useful when diagnosing the vignettes, and whether skills and cases seem clinically realistic.	Behavioral	4other_research_funding
gen_b35bd00d942fc230bed640996ede34e3	AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL)	Cancer Research UK	Burton Hospitals NHS Foundation Trust	NCT01791985	This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks" proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug. The investigators will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547. (Stage 1 only)	Drug	4other_research_funding
gen_bd93d2e39ad04b7c0cedf75571905084	Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death	Ontario Ministry of Health and Long Term Care	St. Michael's Hospital, Toronto	NCT00524862	Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.	Drug	4other_research_funding
gen_bf5a7c56d1b5dc2f8f18de068046a3fa	IRIS : Use of Implantable Defibrillator in High-Risk Patients Early After Acute Myocardial Infarction	AstraZeneca	Herzzentrum Ludwigshafen, Germany	NCT00157768	Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.	Device	4other_research_funding
gen_57eb6850fe8591225571812767a5bbaa	Brain Response to Single Dose of Pregabalin in Fibromyalgia	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.	HCPA	NCT02639533	Fibromyalgia syndrome represents a "spectrum disorder" characterized by widespread chronic pain, fatigue, sleep disturbances, mood and cognitive alterations. The most accepted models explaining the causes of the disease have focused on the reduced pain inhibitory systems activity, that allow low intensity stimuli to be processed easier, and that finally amplify pain stimuli. One of the interventions approved for Fibromyalgia is Pregabalin, which demonstrated to be effective reducing pain. Different studies in animals have shown that it works reducing the liberation of neuronal messengers, which slow the conduction of pain signals. Although studies in humans have confirmed Pregabalin clinical benefits, there are still few studies aiming to explain how it actually works in patients with fibromyalgia, though. A better understanding of the mechanisms by which Pregabalin reduces pain in patients with fibromyalgia would allow designing new interventions to enhance its clinical effects. Thus, the investigators propose to study in real-time the electrical, vascular and hormonal response of the brain of patients with fibromyalgia who receive a single dose of Pregabalin. The vascular response will be assessed using functional near infrared spectroscopy (fNIRS) neuroimaging techniques. The electrical response will be assessed using Transcranial Magnetic Stimulation (TMS). The hormonal response will be assessed in blood, measuring neurotrophins (Brain Derived Neurotrophic Factor) and inflammatory mediators (Tumor Necrosis Factor). These responses will be studied in consideration of the patients' characteristics that will be assessed using validated scales. Taken into account the above considerations, a crossover, double-blinded randomized clinical trial is proposed. In the investigators' study, patients and healthy volunteers will be asked to visit the investigators' laboratory in three opportunities: one for a baseline assessment, and the other two to test the effects of either Pregabalin 150 mg PO or Placebo. All participants will eventually receive both, Pregabalin and Placebo. In each visit a brain hemodynamic, electrical, hormonal and clinical evaluation will be performed.	Drug	4other_research_funding
gen_826fc3ed446e81a9ff58d19a7d7274a1	Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass	Society of American Gastrointestinal and Endoscopic Surgeons	Duke University	NCT02288351	The purpose of this study is to investigate small intestinal remodeling and reprogramming of glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major mechanism for the remission of T2DM following RYGB. The two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control observed in T2DM patients undergoing RYGB.	Other	4other_research_funding
gen_424254aa7a102f122f94a54aa3d1cd3c	Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.	Mena, Raul, M.D.	East Valley Hematology and Oncology Group	NCT00131313	This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.	Drug	4other_research_funding
gen_e4c6cacc873ab83900cec09d16edace5	BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer	ImClone LLC	M.D. Anderson Cancer Center	NCT01263782	The goal of this clinical research study is to learn if knowing biomarker status can help researchers find better treatment combinations for patients with advanced NSCLC. Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab) to give in combination with carboplatin and pemetrexed. The safety of these drug combinations will also be studied.	Drug	4other_research_funding
gen_d5e48c4eabfcb5570e12fc644de53002	A Phase II Study of Spinal Radiosurgery	The Kirklin Clinic at Acton Road	University of Alabama at Birmingham	NCT00573872	Phase I of the study (motion and quality assurance [QA] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.	Radiation	4other_research_funding
gen_c21581f87e6a87739e77a5948d844c3d	Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions	Mayo Clinic	Global Blood Therapeutics	NCT03051711	To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline.	Drug	4other_research_funding
gen_6b4a7c0787e993e21cbb782610fb61f6	Feeding the Critically Ill During Phases of Altered Redox Status	American Society for Parenteral and Enteral Nutrition	University of Illinois at Chicago	NCT03085615	The FEDOX trial is a prospective randomized clinical trial exploring oxidative stress as a mechanism of harm to explain the negative outcomes found in feeding trials that achieved caloric exposure commensurate with the nationally recommended guidelines. Due to its impact on energy metabolism, we will also explore low T3 syndrome's relationship to this mechanism. Finally, we will explore circadian patterns of diurnal/nocturnal TSH fluctuation as a potential biomarker to indicate this mechanism of harm has subsided. This 7-day prospective randomized clinical trial is designed to address the following specific aims (SA) in ICU patients (n=40) with systemic inflammatory response syndrome. SA1) Determine whether provision of enteral nutrition (EN) at 100% of levels in Nationally Recommended Guidelines NRG (25-30 kcals/kg, 100%NRG) early in critical illness increases reactive oxygen species (ROS) production compared to EN at 40% of NRG levels (10-12 kcals/kg, 40%NRG). Subjects will be fasted overnight and randomized to receive either 100% NRG or 40%NRG for 7 days. Plasma F2-isoprostanes will be measured daily and compared between groups through repeated measures analysis. SA2) Determine if EN at 100%NRG interrupts the critical illness induced low T3 syndrome and subsequently further increases the ROS production compared to 40%NRG. Serum thyroid parameters (T3, T4, rT3, TSH) with be measured daily and compared between groups as above. Mediation analysis will be used to determine the proportion of the effect of nutrition group on F2-isoprostane production explained by each thyroid parameter. SA3) Determine if the return of diurnal/noctural fluctuations in TSH is associated with decreased nutrition-induced ROS production. Plasma TSH will be measured twice per day at 0300 and 1800hrs to determine TSH fluctuation. The interaction effect between TSH fluctuation and nutrition group on F2-isoprostane production will be assessed through repeated measures analysis. This study provides vital mechanistic insight into the impact of feeding on oxidative stress during the first week of critical illness, represents an important first step in determining the safest timing and dosage of nutrition support, and sets the foundation for future larger clinical trials on these topics.	Other	4other_research_funding
gen_dbc7049325efeab5cd71fe1b8029b626	Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)	Sunshine Coast Hospital and Health Service	Sunshine Coast University Hospital	NCT03267628	The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.	Procedure	4other_research_funding
gen_8579417862b193ced69ee50862c284bf	Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects	Chinese Academy of Sciences	Shuguang Hospital affiliated with Shanghai University of TCM	NCT02622230	The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in healthy adult subjects.	Drug	4other_research_funding
gen_8c48f4a8cb03b415bbdb3303bdbda575	Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer	National Cancer Institute (NCI)	CHUM Hospital Notre Dame	NCT00047008	RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.	Radiation	4other_research_funding
gen_9be3b6ecb0891715462c857dfc07f00d	Cadiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH	ElsassFonden	Copenhagen University, Denmark	NCT01699646	Hypothesis: STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia and reduce the number of newborns with metabolic acidosis. Primary endpoint: 1) Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery < 7.05 and standard base excess <-10. Secondary endpoints: 1. Number of intervention (VE and caesarean section) in the two groups 2. Number of pH measurements in the two groups 3. Number of neonates admitted to the neonatal department because of suspected asphyxia in the two groups The aim of fetal surveillance is to identify those fetuses at risk for developing damage in newborn to term or long term damage caused by lack of oxygen during birth process. Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is believed to be caused by lack of oxygen during birth. These can be avoided if the investigators intervene actively in the birth before damage occurs. CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in CTG interpretation may therefore lead to increase in the number of deliveries with vacuum suction and caesarean section. Interpretation of CTG can be improved by analyzing the acidity of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analysis shows indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and requires repeated measurements if the abnormal heart rate pattern persists. This method is the normal routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital. The problem seems to be partially alleviated by using a newly developed method for fetal surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes a portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The technique is easy to use, since it only requires one electrode on the fetal scalp that is placed in the same way as in ordinary CTG registration.	Procedure	4other_research_funding
gen_fabea028caca02fa747d2033486ba4bf	A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment	National Institute on Drug Abuse (NIDA)	Professor, Johns Hopkins University School of Medicine	NCT01416584	The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment injection heroine users.	Behavioral	4other_research_funding
gen_3396634acfe826a0f42f9998f64c71ac	Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design	Medical Research Council	Klinikum of the University of Munich	NCT01785186	This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized, controlled clinical trial that will compare the efficacy and safety of four experimental four drug regimens with a standard control regimen in patients with smear positive, pulmonary tuberculosis (TB). Patients will be randomly allocated to the control or one of the four experimental regimens in the ratio 2:1:1:1:1. Experimental regimens will be given for 12 weeks. Thereafter, participants in the experimental arms will receive continuation phase treatment for 14 weeks containing standard-dose rifampicin and isoniazid. All participants will receive 25 mg of vitamin B6 (pyridoxine) with every dose of INH to prevent INH‐related neuropathy. Interim analyses will be conducted during the trial for efficacy, with the aim of identifying experimental arms that perform below a pre‐specified efficacy threshold; these arms will then be stopped from further recruitment. Following the first scheduled interim analysis on March 3rd, the Trial Steering Committee (TSC) followed a recommendation of the independent data monitoring committee (IDMC) and has stopped the enrolment into two of the arms in the MAMS-TB trial: HRZQ and HR20ZQ, based on these arms not meeting the pre-specified gain in efficacy over control. Importantly, there was no safety concern that prompted stopping recruitment to these arms. They recommended that recruitment to arm 2 (HRZQ) and 3 (HR20ZQ) be terminated as there was insufficient evidence that these regimens could shorten treatment. Importantly, there was no evidence that either arm was inferior to standard treatment (the control arm) with regards to efficacy. There was, however, sufficient evidence that the other intervention arms HR35ZE and HR20ZM could shorten treatment to continue enrolling patients.	Drug	4other_research_funding
gen_227371bf2ad0bda2a4de4c276ac7dafb	DGB-01 Effects on Endurance Exercise	Immunotec Inc.	University of Kentucky, Dept of Physiology	NCT01424904	The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40‐km time trial in trained male cyclists. The investigators believe that DGB-01 will improve performance on the time trial as measured by a reduction in the amount of time required to complete the distance, using a computerized cycle ergometer.	Dietary Supplement	4other_research_funding
gen_c858d95de61dfbdd4fcb2dd6bcac61f3	Meta-analyses of the Effect of Sucrose Versus High Fructose Corn Syrup on Cardiometabolic Risk	The Physicians' Services Incorporated Foundation	University of Toronto	NCT02702479	The rise in high fructose corn syrup (HFCS) consumption over the past 40 years since its introduction as a popular sweetener in the United States has led to much concern regarding its contribution to the rise in obesity (1), diabetes (2) and related cardiometabolic disorders (3).Unlike sucrose which contains equal proportions of fructose and glucose bound by an α-glycosidic bond, HFCS contains 42-55% of fructose to glucose in a free (unbound) form (4). Despite these differences in composition, both sugars possess identical energy contribution on a gram to gram basis (4). However, the higher ratio of fructose to glucose in HFCS has led to the hypothesis that HFCS may uniquely contribute to cardiometabolic risk, more so than sucrose, through proposed differences in fructose metabolism, endocrine and hedonic properties (5). We will conduct a series of systematic reviews and meta-analyses to assess the role of HFCS versus sucrose under energy matched (isocaloric) conditions on cardiometabolic risk.	Other	4other_research_funding
gen_55dbbd69a9b59b4d1fe600969027b3f7	Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension	Corporación Bonima S.A. de C.V.	Bayer	NCT01073540	A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.	Drug	4other_research_funding
gen_cc333bbbf8bdf9e9e417fdc90a3453e8	A Trial of Levodopa in Angelman Syndrome	Children's Hospital Medical Center, Cincinnati	Baylor College of Medicine	NCT01281475	This study is designed to determine whether levodopa will lead to an improvement in the development and tremor in children with Angelman syndrome (AS). It has been suggested that levodopa, a medication that is usually used to treat Parkinson disease in adults, may help children with AS in their overall development and reduce the tremor that some of them have. If levodopa is found to be beneficial for children with AS, this could lead to a new treatment for AS. Funding Source - FDA-OOPD	Drug	4other_research_funding
gen_a2adca541895672ba44e65f98f150799	Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)	National Institute of Neurological Disorders and Stroke (NINDS)	Clinical Coordinating Center, Department of Neurology, University of Virginia Health System	NCT00252239	The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available treatment with tissue plasminogen activator (tPA).	Drug	4other_research_funding
gen_b31a9a8536000be938483f8fdb1b16ed	GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Professor of Internal Medicine	NCT01257802	The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater ovarian protection than placebo.	Drug	4other_research_funding
gen_09a3b7e071f160592d0bcdaa0110c79e	ICU Family Communication Study	National Institute of Nursing Research (NINR)	University of Washington, Division of Pulmonary and Critical Care Medicine	NCT00720200	The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.	Behavioral	4other_research_funding
gen_8f989005cf92cf14e1cc959840b9ae28	The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients	International Antiviral Therapy Evaluation Center	The HIV Netherlands Australia Thailand Research Collaboration	NCT00400738	Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.	Drug	4other_research_funding
gen_4c438a7884fbebe5f47c3980d3ab9843	Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement	Medical Specialist Heinrich Kopp's Grant	Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University	NCT01410409	The purpose of this study is to test whether surgical insertion of total knee replacement provides further improvement in quality of life, pain and function in addition to an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive). The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment results in a greater increase in quality of life and functional capacity and greater reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up 12months after the start of the treatment. See statistical analysis plan available under "Links" for further description of the study.	Behavioral	4other_research_funding
gen_0dc1ea055df9878bba4d9721b3a313bd	Resource Sparing Curative Radiotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck: The HYPNO Trial	Institute Rotary Cancer Hospital, New Delhi, India	University of Maryland	NCT02765503	The aim of the study is to test whether a resource-sparing 4-week, 20-fraction course of accelerated hypofractionated radiotherapy is non-inferior to accelerated radiotherapy delivering 33 fractions over 5.5 weeks in the treatment of patients with Stage I-IV squamous cell carcinoma of the pharynx, larynx and oral cavity with the exception of paranasal sinus, nasopharyngeal and stage I-II glottic carcinomas.	Radiation	4other_research_funding
gen_633f6167a208d03fe53c892b9c6cb00c	Blood Pressure in Dialysis Patients	The Cleveland Clinic	Medical University of South Carolina	NCT01421771	Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.	Other	4other_research_funding
gen_d1c83c273f2f4d1f262599a316e4d81e	Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis	Dutch Heart Foundation	Hôpital Lariboisière, Paris, France	NCT01204333	Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a poor prognosis despite treatment with heparin. Published experience with ET is promising, but only based on case series and not on controlled trials. Objective: The main objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Study population: Patients are eligible if they have a radiologically proven CVT, a high probability of poor outcome (defined by presence of one or more of the following risk factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the deep cerebral venous system) and the responsible physician is uncertain if ET or standard anti-coagulant treatment is better. Intervention: Patients will be randomized to receive either ET or standard therapy (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke scale and relevant laboratory parameters will be assessed at baseline. Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most important secondary outcomes are the mRS, mortality and recanalization rate at 6 months. Major intra- and extracranial hemorrhagic complications within one week following the intervention are the principal safety outcome. Results will be analyzed according to the "intention-to-treat" principle. Assessment of study endpoints will be carried out according to standardized questionnaires by a blinded neurologist or research nurse who is not involved in the treatment of the patient. Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82 in each treatment arm) have to be included (two-sided alpha, 80% power). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients may benefit directly from ET. Complications of ET, most notably intracranial hemorrhages, constitute the most important risk of the study.	Drug	4other_research_funding
gen_bad7e18d965da4f11ba582c046067a89	Active Bathing to Eliminate Infection (ABATE Infection) Trial	John H. Stroger Hospital	University of Massachusetts, Amherst	NCT02063867	The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units. The two strategies to be evaluated are: - Arm 1: Routine Care Routine policy for showering/bathing - Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen Note that enrolled "subjects" represents 53 individual HCA Hospitals (representing ~190 non-critical care units) that have been randomized.	Drug	4other_research_funding
gen_856b47edc46414f43f9364df304f7c88	Diabetes Prevention Program Outcomes Study	Office of Research on Women's Health (ORWH)	University of Tennessee Health Science Center	NCT00038727	The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest IFG/IGT population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.	Behavioral	4other_research_funding
gen_cbac9f7fc3ff241507dd37c88c769543	Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter	Ministry of Health, France	CHU de Saint-Etienne	NCT00736294	Atrial Flutter [AFL] is a relatively frequent arrhythmia, considered as benign, but associated with both invalidating symptoms and thromboembolic risk. The objective of the treatment consists to on the one hand the sinus rhythm [SR] restoration and on the other hand the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency ablation [RFA] became the first line therapy due to its both high effectiveness and safety. The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation [AFib] close to 25% at 1 year. This risk of subsequent AFib is related to the common substrate between both arrhythmias. When AFib occurs, the interest to maintain the SR is still required, even if recent studies did not show a significant difference in term of total mortality between rate or rhythm control strategies [AFFIRM, RACE and PIAF studies]. The studies published underlined the anti-arrhythmic drugs limits in patients with both arrhythmias [AFib and AFL]. After years centered on the mechanisms and the electric treatments of AFib, researchers are nowadays focusing on the study's evaluation of the atrial tissue substrate. Accordingly, the renin-angiotensin system role was investigated in many works. Indeed, angiotensin II plays a role in the modification of atrial pressure and in the fibers stretching ["stretch"], conditions required for the development of AFib. Angiotensin II is also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen alteration. These mechanisms lead to atria cells conduction disorders and refractory periods modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors deterioration were observed in patients with AFib. This brings to the concept of AFib treatment while interfering on tissue remodeling by the way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition [ACEI] may reduce AFib in patients with heart failure. No randomized study so far has compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA area. On the basis of experimental and clinical study, the investigators seek to evaluate the ACEI use in the prevention of AFib in an AFL post RFA ablation.	Drug	4other_research_funding
gen_e00d3b72229a7d63a3ce993623c2999e	Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms	National Cancer Institute (NCI)	University of Pittsburgh	NCT01640522	The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.	Other	4other_research_funding
gen_63b87be94045b46913aa882a401e01be	Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant	National Cancer Institute (NCI)	Fred Hutch/University of Washington Cancer Consortium	NCT01812252	This randomized clinical trial studies different chemotherapies in treating patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.	Drug	4other_research_funding
gen_9178191a56aebf671b77f8dd01ea832b	The Respiratory Protection Effectiveness Clinical Trial	Washington D.C. Veterans Affairs Medical Center	Johns Hopkins University School of Medicine/Johns Hopkins Hospital	NCT01249625	Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.	Device	4other_research_funding
gen_3d4a2a1fb1223ab06da98ab3901ec5fa	2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery	Bausch & Lomb Incorporated	Ophthalmology Associates	NCT01455233	The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.	Drug	4other_research_funding
gen_63de1bb75dae82bdb08bc6fe89cb3982	Remote Monitoring of Patients With CHF in Central Greece	Institute of Biomedical Research & Technology, Larissa, Greece	Cardiology Department - Regional University Hospital of Larisa	NCT01503463	The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.	Procedure	4other_research_funding

gen_319400789f36e14f943645377a9ea342

Erlotinib Study for Myelodysplastic Syndrome (MDS)

Genentech, Inc.

H. Lee Moffitt Cancer Center and Research Institute

NCT00977548

The purpose of this research study is to find out what effects, good and/or bad, erlotinib has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib use in this study is considered investigational as the FDA has not approved it for the treatment of myelodysplastic syndrome.

Drug

4other_research_funding

gen_987ebce3c515381f60d4ce0833dc7f2c

Tomosynthesis Versus Digital Mammography in a Population-based Screening Program

im3D S.p.A.

SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino

NCT02590315

Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime. This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.

Other

4other_research_funding

gen_3657caa9dc6f1068b88c52adef8a37cd

Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

Murdoch Childrens Research Institute

London School of Hygiene and Tropical Medicine

NCT02775617

This is an open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections. Communities will be randomised to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2). Treatment of yaws: Single dose of Azithromycin (30mg/kg, max 2G). Treatment of scabies: Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses 7-14 days apart. Investigators will complete a clinical and microbiological assessment of bacterial skin disease at baseline and at 12 months to assess the impact of treatment on the prevalence of bacterial infection and the emergence of antimicrobial resistance. Primary Outcome 1. Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms. Secondary Outcomes 2. Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms 3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms

Drug

4other_research_funding

gen_78c9a575ced9413ecc785a01dbcc7bb0

Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)

Merck Sharp & Dohme Corp.

Hopital de Fann, Dakar

NCT00573001

The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.

Drug

4other_research_funding

gen_889975a7b33189315c7ed6285cd32c62

Antiarrhythmics or Ablation for Ventricular Tachycardia Pilot

St. Jude Medical

Nova Scotia Health Authoriry

NCT02830360

This is a pilot study to determine the feasibility of a larger scale multicenter trial comparing first line catheter ablation to antiarrhythmic drug therapy for patients with prior MI, an ICD and VT.

Drug

4other_research_funding

gen_c905972bed428ccc3c6d0a317b8dd9cb

INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study

National Institute of Mental Health (NIMH)

Dr Mohan's Diabetes Specialities Clinic

NCT02022111

To provide better care and preventive services for people with both depression and diabetes, the investigators propose to develop and test whether interventions to reduce depressive symptoms can be integrated into routine diabetes clinics in India. The investigators will gather feedback from patients in India through focus group discussions and individual interviews so they can culturally-adapt a model of combined depression and diabetes care. The investigators will then evaluate the effectiveness and costs of this care model in a trial at three diabetes clinics in India. It is expected that results from this study can guide how to incorporate mental health care into routine diabetes clinics in low-resource settings.

Other

4other_research_funding

gen_8f3aff4316d8464a3e9039f6723db1aa

Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)

FDA Office of Orphan Products Development

Children's Hospital of Philadelphia

NCT00529191

The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).

Drug

4other_research_funding

gen_192796cbefa55e578aeeb1cacdcbc744

Primary Tube Versus Trabeculectomy Study

Research to Prevent Blindness

Bascom Palmer Eye Institute

NCT00666237

The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.

Procedure

4other_research_funding

gen_807075b2ae303368b8158fdea01d9ca6

A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)

Clinical Associates Research, Maryland

Yale University

NCT00809523

This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.

Device

4other_research_funding

gen_e1687248fafc1deb55f80f038b4897e3

PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma

National Cancer Institute (NCI)

Gundersen Lutheran Center for Cancer and Blood

NCT00049530

RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.

Biological

4other_research_funding

gen_72b809c8bc8150b6a0ebc7cd1927131a

Task Shifting and Blood Pressure Control in Ghana

National Heart, Lung, and Blood Institute (NHLBI)

NYU Langone Medical Center

NCT01802372

The goal of this study is to evaluate the comparative effectiveness of the World Health Organization Package targeted at Cardiovascular (CV) risk assessment and hypertension control, delivered by Community Health Nurses as part of Ghana's Community based Health Planning and Services program, versus provision of health insurance coverage, on blood pressure reduction. Findings from this study will provide policy makers and other stakeholders needed information to recommend efficient cost-effective policy with regards to comprehensive CV risk reduction in patients with hypertension in low resource settings.

Behavioral

4other_research_funding

gen_b240e0cd88f2c928908b4fd7c687e689

Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients

Sintesi Research Srl

Centro Emofilia e Trombosi Angela Bianchi Bonomi, IRCCS Fondazione Ospedale Maggiore Policlinico

NCT02479087

The purpose of this study is to assess the role of a FVIII/VWF complex concentrate (Emoclot) in successfully inducing immune tolerance (I.T.I.) in patients with Haemophilia A with inhibitors, including patients at high risk of failure.

Drug

4other_research_funding

gen_b3d178e83a83b628e041daa836db604c

The Safety and Efficacy of Low and High Carbohydrate Diets

National Center for Complementary and Integrative Health (NCCIH)

University of Pennsylvania

NCT00143936

This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).

Behavioral

4other_research_funding

gen_63a78b3e0a96b063e2205a8015df3160

Self-Management Program Based on Physical Exercises in People With Multiple Sclerosis

CHU de Reims

UCL

NCT02607020

Fatigue is the most chronic and disabling symptom in multiple sclerosis patients. Self-management physical exercise programs seem promising to allow patients to improve their fatigue and their deconditioning. However, the effectiveness of such programs has been poorly assessed until now. The objectives of the present study are to evaluate the relationships between fatigue and physical capacity among slightly affected MS patients, and to carry on a large trial to assess the effectiveness of a self-management exercise program in the same patients. Sixty-four patients will be included and will be asked, after an educational period, to perform at least three exercise sessions of more than 30 minutes each week, over a period of three months. Patients will be splitted in two groups : one group will perform endurance and resistance physical exercises, and the other one will perform relaxation exercises with the help of soothing music. A regular coaching will adapt the exercises and motivate the patients to continue the treatment. Assessors won't be informed of patients' treatment. Four evaluations will be done, and will notably assess muscle strength, endurance, fatigue and social participation.

Other

4other_research_funding

gen_6d140173c85ab7ea415deababdc9c179

AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies

Massachusetts General Hospital

Dana-Farber Cancer Institute

NCT01065662

The purpose of this research study is to determine the safety of the combination of the two drugs cediranib and temsirolimus and the highest doses of these two drugs that can be given in combination to people safely. Cediranib is a drug that may stop blood supply to the tumor and therefore help keep cancer cells from growing. Temsirolimus is a drug that may stop cancer cells from growing. These drugs have been used in other research studies in ovarian and kidney cancer and these studies suggest that these drugs may help to keep cancer from growing in this research study.

Drug

4other_research_funding

gen_8f698e459e6126c143532c96a018312a

OSTPRE-Fracture Prevention Study

Academy of Finland

Department of Gynecology and Obstetrics, University Hospital of Kuopio

NCT00592917

The purpose of this study is to determine the effect of calcium 1000 mg/d and vitamin-D3 800 IU/d divided in two daily doses on the incidence of falls and fractures, bone mineral density and bone metabolism in postmenopausal women 65-71 years of age.

Dietary Supplement

4other_research_funding

gen_8daaec2b4bacaa9e1cd913b0c514473e

Beat AML Core Study

Cellworks Group Inc.

University of Florida

NCT02927106

In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity assays will be utilized to define clinically relevant gene mutations and identify potential therapeutics for patients with acute myeloid leukemia (AML).

Genetic

4other_research_funding

gen_396bed29a83599f50836cde73c12448f

The Medicines Optimisation Review Toolkit Evaluation in HIV Outpatients

Merck Sharp & Dohme Corp.

University of Sussex

NCT03340077

Multicentre, randomised (1:1), controlled, open (not blinded) comparison of MOR toolkit (intervention) with standard pharmaceutical care (control)

Other

4other_research_funding

gen_2907d6bf09c3ba5d65e0d5f71b752c37

Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Jiangxi Provincial Cancer Hospital

Sun Yat-sen University

NCT01245959

The purpose of this study is to compare induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy in NPC patients.

Radiation

4other_research_funding

gen_3ecbd378ac88fef9c8a4a0dd22c18c64

Progressive Goal Attainment Program for Veterans

Michael Debakey Veterans Affairs Medical Center

MDRC

NCT01565863

The purpose of this study is to test the effectiveness of the Progressive Goal Attainment Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans with disabilities.

Behavioral

4other_research_funding

gen_46a9a29b684478ef1cf9441111a2d48d

Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

National Center for Research Resources (NCRR)

Stanford University

NCT01029353

This trial will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.

Procedure

4other_research_funding

gen_463beaa30a40cd522ab7ef14788d9383

Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder

North Carolina Translational and Clinical Sciences Institute

University of North Carolina, Chapel Hill

NCT01799291

The primary aim is to test the efficacy of a new intervention to improve clinical judgment. The investigators focus on the assessment of pediatric bipolar disorder (PBD), a controversial diagnosis with frequent diagnostic errors, by educating mental health professionals in common cognitive pitfalls and training them in recommended de-biasing strategies. The investigators hypothesize that the Treatment group will show higher diagnostic accuracy than the Control condition: Participants receiving the cognitive de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity bias. Secondary aims include soliciting feedback about whether the skills were useful when diagnosing the vignettes, and whether skills and cases seem clinically realistic.

Behavioral

4other_research_funding

gen_b35bd00d942fc230bed640996ede34e3

AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL)

Cancer Research UK

Burton Hospitals NHS Foundation Trust

NCT01791985

This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks" proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug. The investigators will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547. (Stage 1 only)

Drug

4other_research_funding

gen_bd93d2e39ad04b7c0cedf75571905084

Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death

Ontario Ministry of Health and Long Term Care

St. Michael's Hospital, Toronto

NCT00524862

Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.

Drug

4other_research_funding

gen_bf5a7c56d1b5dc2f8f18de068046a3fa

IRIS : Use of Implantable Defibrillator in High-Risk Patients Early After Acute Myocardial Infarction

AstraZeneca

Herzzentrum Ludwigshafen, Germany

NCT00157768

Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.

Device

4other_research_funding

gen_57eb6850fe8591225571812767a5bbaa

Brain Response to Single Dose of Pregabalin in Fibromyalgia

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

HCPA

NCT02639533

Fibromyalgia syndrome represents a "spectrum disorder" characterized by widespread chronic pain, fatigue, sleep disturbances, mood and cognitive alterations. The most accepted models explaining the causes of the disease have focused on the reduced pain inhibitory systems activity, that allow low intensity stimuli to be processed easier, and that finally amplify pain stimuli. One of the interventions approved for Fibromyalgia is Pregabalin, which demonstrated to be effective reducing pain. Different studies in animals have shown that it works reducing the liberation of neuronal messengers, which slow the conduction of pain signals. Although studies in humans have confirmed Pregabalin clinical benefits, there are still few studies aiming to explain how it actually works in patients with fibromyalgia, though. A better understanding of the mechanisms by which Pregabalin reduces pain in patients with fibromyalgia would allow designing new interventions to enhance its clinical effects. Thus, the investigators propose to study in real-time the electrical, vascular and hormonal response of the brain of patients with fibromyalgia who receive a single dose of Pregabalin. The vascular response will be assessed using functional near infrared spectroscopy (fNIRS) neuroimaging techniques. The electrical response will be assessed using Transcranial Magnetic Stimulation (TMS). The hormonal response will be assessed in blood, measuring neurotrophins (Brain Derived Neurotrophic Factor) and inflammatory mediators (Tumor Necrosis Factor). These responses will be studied in consideration of the patients' characteristics that will be assessed using validated scales. Taken into account the above considerations, a crossover, double-blinded randomized clinical trial is proposed. In the investigators' study, patients and healthy volunteers will be asked to visit the investigators' laboratory in three opportunities: one for a baseline assessment, and the other two to test the effects of either Pregabalin 150 mg PO or Placebo. All participants will eventually receive both, Pregabalin and Placebo. In each visit a brain hemodynamic, electrical, hormonal and clinical evaluation will be performed.

Drug

4other_research_funding

gen_826fc3ed446e81a9ff58d19a7d7274a1

Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass

Society of American Gastrointestinal and Endoscopic Surgeons

Duke University

NCT02288351

The purpose of this study is to investigate small intestinal remodeling and reprogramming of glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major mechanism for the remission of T2DM following RYGB. The two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control observed in T2DM patients undergoing RYGB.

Other

4other_research_funding

gen_424254aa7a102f122f94a54aa3d1cd3c

Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.

Mena, Raul, M.D.

East Valley Hematology and Oncology Group

NCT00131313

This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.

Drug

4other_research_funding

gen_e4c6cacc873ab83900cec09d16edace5

BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer

ImClone LLC

M.D. Anderson Cancer Center

NCT01263782

The goal of this clinical research study is to learn if knowing biomarker status can help researchers find better treatment combinations for patients with advanced NSCLC. Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab) to give in combination with carboplatin and pemetrexed. The safety of these drug combinations will also be studied.

Drug

4other_research_funding

gen_d5e48c4eabfcb5570e12fc644de53002

A Phase II Study of Spinal Radiosurgery

The Kirklin Clinic at Acton Road

University of Alabama at Birmingham

NCT00573872

Phase I of the study (motion and quality assurance [QA] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.

Radiation

4other_research_funding

gen_c21581f87e6a87739e77a5948d844c3d

Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions

Mayo Clinic

Global Blood Therapeutics

NCT03051711

To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline.

Drug

4other_research_funding

gen_6b4a7c0787e993e21cbb782610fb61f6

Feeding the Critically Ill During Phases of Altered Redox Status

American Society for Parenteral and Enteral Nutrition

University of Illinois at Chicago

NCT03085615

The FEDOX trial is a prospective randomized clinical trial exploring oxidative stress as a mechanism of harm to explain the negative outcomes found in feeding trials that achieved caloric exposure commensurate with the nationally recommended guidelines. Due to its impact on energy metabolism, we will also explore low T3 syndrome's relationship to this mechanism. Finally, we will explore circadian patterns of diurnal/nocturnal TSH fluctuation as a potential biomarker to indicate this mechanism of harm has subsided. This 7-day prospective randomized clinical trial is designed to address the following specific aims (SA) in ICU patients (n=40) with systemic inflammatory response syndrome. SA1) Determine whether provision of enteral nutrition (EN) at 100% of levels in Nationally Recommended Guidelines NRG (25-30 kcals/kg, 100%NRG) early in critical illness increases reactive oxygen species (ROS) production compared to EN at 40% of NRG levels (10-12 kcals/kg, 40%NRG). Subjects will be fasted overnight and randomized to receive either 100% NRG or 40%NRG for 7 days. Plasma F2-isoprostanes will be measured daily and compared between groups through repeated measures analysis. SA2) Determine if EN at 100%NRG interrupts the critical illness induced low T3 syndrome and subsequently further increases the ROS production compared to 40%NRG. Serum thyroid parameters (T3, T4, rT3, TSH) with be measured daily and compared between groups as above. Mediation analysis will be used to determine the proportion of the effect of nutrition group on F2-isoprostane production explained by each thyroid parameter. SA3) Determine if the return of diurnal/noctural fluctuations in TSH is associated with decreased nutrition-induced ROS production. Plasma TSH will be measured twice per day at 0300 and 1800hrs to determine TSH fluctuation. The interaction effect between TSH fluctuation and nutrition group on F2-isoprostane production will be assessed through repeated measures analysis. This study provides vital mechanistic insight into the impact of feeding on oxidative stress during the first week of critical illness, represents an important first step in determining the safest timing and dosage of nutrition support, and sets the foundation for future larger clinical trials on these topics.

Other

4other_research_funding

gen_dbc7049325efeab5cd71fe1b8029b626

Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)

Sunshine Coast Hospital and Health Service

Sunshine Coast University Hospital

NCT03267628

The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.

Procedure

4other_research_funding

gen_8579417862b193ced69ee50862c284bf

Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects

Chinese Academy of Sciences

Shuguang Hospital affiliated with Shanghai University of TCM

NCT02622230

The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in healthy adult subjects.

Drug

4other_research_funding

gen_8c48f4a8cb03b415bbdb3303bdbda575

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

National Cancer Institute (NCI)

CHUM Hospital Notre Dame

NCT00047008

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.

Radiation

4other_research_funding

gen_9be3b6ecb0891715462c857dfc07f00d

Cadiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH

ElsassFonden

Copenhagen University, Denmark

NCT01699646

Hypothesis: STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia and reduce the number of newborns with metabolic acidosis. Primary endpoint: 1) Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery < 7.05 and standard base excess <-10. Secondary endpoints: 1. Number of intervention (VE and caesarean section) in the two groups 2. Number of pH measurements in the two groups 3. Number of neonates admitted to the neonatal department because of suspected asphyxia in the two groups The aim of fetal surveillance is to identify those fetuses at risk for developing damage in newborn to term or long term damage caused by lack of oxygen during birth process. Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is believed to be caused by lack of oxygen during birth. These can be avoided if the investigators intervene actively in the birth before damage occurs. CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in CTG interpretation may therefore lead to increase in the number of deliveries with vacuum suction and caesarean section. Interpretation of CTG can be improved by analyzing the acidity of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analysis shows indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and requires repeated measurements if the abnormal heart rate pattern persists. This method is the normal routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital. The problem seems to be partially alleviated by using a newly developed method for fetal surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes a portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The technique is easy to use, since it only requires one electrode on the fetal scalp that is placed in the same way as in ordinary CTG registration.

Procedure

4other_research_funding

gen_fabea028caca02fa747d2033486ba4bf

A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

National Institute on Drug Abuse (NIDA)

Professor, Johns Hopkins University School of Medicine

NCT01416584

The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment injection heroine users.

Behavioral

4other_research_funding

gen_3396634acfe826a0f42f9998f64c71ac

Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design

Medical Research Council

Klinikum of the University of Munich

NCT01785186

This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized, controlled clinical trial that will compare the efficacy and safety of four experimental four drug regimens with a standard control regimen in patients with smear positive, pulmonary tuberculosis (TB). Patients will be randomly allocated to the control or one of the four experimental regimens in the ratio 2:1:1:1:1. Experimental regimens will be given for 12 weeks. Thereafter, participants in the experimental arms will receive continuation phase treatment for 14 weeks containing standard-dose rifampicin and isoniazid. All participants will receive 25 mg of vitamin B6 (pyridoxine) with every dose of INH to prevent INH‐related neuropathy. Interim analyses will be conducted during the trial for efficacy, with the aim of identifying experimental arms that perform below a pre‐specified efficacy threshold; these arms will then be stopped from further recruitment. Following the first scheduled interim analysis on March 3rd, the Trial Steering Committee (TSC) followed a recommendation of the independent data monitoring committee (IDMC) and has stopped the enrolment into two of the arms in the MAMS-TB trial: HRZQ and HR20ZQ, based on these arms not meeting the pre-specified gain in efficacy over control. Importantly, there was no safety concern that prompted stopping recruitment to these arms. They recommended that recruitment to arm 2 (HRZQ) and 3 (HR20ZQ) be terminated as there was insufficient evidence that these regimens could shorten treatment. Importantly, there was no evidence that either arm was inferior to standard treatment (the control arm) with regards to efficacy. There was, however, sufficient evidence that the other intervention arms HR35ZE and HR20ZM could shorten treatment to continue enrolling patients.

Drug

4other_research_funding

gen_227371bf2ad0bda2a4de4c276ac7dafb

DGB-01 Effects on Endurance Exercise

Immunotec Inc.

University of Kentucky, Dept of Physiology

NCT01424904

The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40‐km time trial in trained male cyclists. The investigators believe that DGB-01 will improve performance on the time trial as measured by a reduction in the amount of time required to complete the distance, using a computerized cycle ergometer.

Dietary Supplement

4other_research_funding

gen_c858d95de61dfbdd4fcb2dd6bcac61f3

Meta-analyses of the Effect of Sucrose Versus High Fructose Corn Syrup on Cardiometabolic Risk

The Physicians' Services Incorporated Foundation

University of Toronto

NCT02702479

The rise in high fructose corn syrup (HFCS) consumption over the past 40 years since its introduction as a popular sweetener in the United States has led to much concern regarding its contribution to the rise in obesity (1), diabetes (2) and related cardiometabolic disorders (3).Unlike sucrose which contains equal proportions of fructose and glucose bound by an α-glycosidic bond, HFCS contains 42-55% of fructose to glucose in a free (unbound) form (4). Despite these differences in composition, both sugars possess identical energy contribution on a gram to gram basis (4). However, the higher ratio of fructose to glucose in HFCS has led to the hypothesis that HFCS may uniquely contribute to cardiometabolic risk, more so than sucrose, through proposed differences in fructose metabolism, endocrine and hedonic properties (5). We will conduct a series of systematic reviews and meta-analyses to assess the role of HFCS versus sucrose under energy matched (isocaloric) conditions on cardiometabolic risk.

Other

4other_research_funding

gen_55dbbd69a9b59b4d1fe600969027b3f7

Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

Corporación Bonima S.A. de C.V.

Bayer

NCT01073540

A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.

Drug

4other_research_funding

gen_cc333bbbf8bdf9e9e417fdc90a3453e8

A Trial of Levodopa in Angelman Syndrome

Children's Hospital Medical Center, Cincinnati

Baylor College of Medicine

NCT01281475

This study is designed to determine whether levodopa will lead to an improvement in the development and tremor in children with Angelman syndrome (AS). It has been suggested that levodopa, a medication that is usually used to treat Parkinson disease in adults, may help children with AS in their overall development and reduce the tremor that some of them have. If levodopa is found to be beneficial for children with AS, this could lead to a new treatment for AS. Funding Source - FDA-OOPD

Drug

4other_research_funding

gen_a2adca541895672ba44e65f98f150799

Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)

National Institute of Neurological Disorders and Stroke (NINDS)

Clinical Coordinating Center, Department of Neurology, University of Virginia Health System

NCT00252239

The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available treatment with tissue plasminogen activator (tPA).

Drug

4other_research_funding

gen_b31a9a8536000be938483f8fdb1b16ed

GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Professor of Internal Medicine

NCT01257802

The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater ovarian protection than placebo.

Drug

4other_research_funding

gen_09a3b7e071f160592d0bcdaa0110c79e

ICU Family Communication Study

National Institute of Nursing Research (NINR)

University of Washington, Division of Pulmonary and Critical Care Medicine

NCT00720200

The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.

Behavioral

4other_research_funding

gen_8f989005cf92cf14e1cc959840b9ae28

The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients

International Antiviral Therapy Evaluation Center

The HIV Netherlands Australia Thailand Research Collaboration

NCT00400738

Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.

Drug

4other_research_funding

gen_4c438a7884fbebe5f47c3980d3ab9843

Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement

Medical Specialist Heinrich Kopp's Grant

Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University

NCT01410409

The purpose of this study is to test whether surgical insertion of total knee replacement provides further improvement in quality of life, pain and function in addition to an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive). The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment results in a greater increase in quality of life and functional capacity and greater reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up 12months after the start of the treatment. See statistical analysis plan available under "Links" for further description of the study.

Behavioral

4other_research_funding

gen_0dc1ea055df9878bba4d9721b3a313bd

Resource Sparing Curative Radiotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck: The HYPNO Trial

Institute Rotary Cancer Hospital, New Delhi, India

University of Maryland

NCT02765503

The aim of the study is to test whether a resource-sparing 4-week, 20-fraction course of accelerated hypofractionated radiotherapy is non-inferior to accelerated radiotherapy delivering 33 fractions over 5.5 weeks in the treatment of patients with Stage I-IV squamous cell carcinoma of the pharynx, larynx and oral cavity with the exception of paranasal sinus, nasopharyngeal and stage I-II glottic carcinomas.

Radiation

4other_research_funding

gen_633f6167a208d03fe53c892b9c6cb00c

Blood Pressure in Dialysis Patients

The Cleveland Clinic

Medical University of South Carolina

NCT01421771

Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.

Other

4other_research_funding

gen_d1c83c273f2f4d1f262599a316e4d81e

Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis

Dutch Heart Foundation

Hôpital Lariboisière, Paris, France

NCT01204333

Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a poor prognosis despite treatment with heparin. Published experience with ET is promising, but only based on case series and not on controlled trials. Objective: The main objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Study population: Patients are eligible if they have a radiologically proven CVT, a high probability of poor outcome (defined by presence of one or more of the following risk factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the deep cerebral venous system) and the responsible physician is uncertain if ET or standard anti-coagulant treatment is better. Intervention: Patients will be randomized to receive either ET or standard therapy (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke scale and relevant laboratory parameters will be assessed at baseline. Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most important secondary outcomes are the mRS, mortality and recanalization rate at 6 months. Major intra- and extracranial hemorrhagic complications within one week following the intervention are the principal safety outcome. Results will be analyzed according to the "intention-to-treat" principle. Assessment of study endpoints will be carried out according to standardized questionnaires by a blinded neurologist or research nurse who is not involved in the treatment of the patient. Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82 in each treatment arm) have to be included (two-sided alpha, 80% power). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients may benefit directly from ET. Complications of ET, most notably intracranial hemorrhages, constitute the most important risk of the study.

Drug

4other_research_funding

gen_bad7e18d965da4f11ba582c046067a89

Active Bathing to Eliminate Infection (ABATE Infection) Trial

John H. Stroger Hospital

University of Massachusetts, Amherst

NCT02063867

The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units. The two strategies to be evaluated are: - Arm 1: Routine Care Routine policy for showering/bathing - Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen Note that enrolled "subjects" represents 53 individual HCA Hospitals (representing ~190 non-critical care units) that have been randomized.

Drug

4other_research_funding

gen_856b47edc46414f43f9364df304f7c88

Diabetes Prevention Program Outcomes Study

Office of Research on Women's Health (ORWH)

University of Tennessee Health Science Center

NCT00038727

The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest IFG/IGT population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.

Behavioral

4other_research_funding

gen_cbac9f7fc3ff241507dd37c88c769543

Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter

Ministry of Health, France

CHU de Saint-Etienne

NCT00736294

Atrial Flutter [AFL] is a relatively frequent arrhythmia, considered as benign, but associated with both invalidating symptoms and thromboembolic risk. The objective of the treatment consists to on the one hand the sinus rhythm [SR] restoration and on the other hand the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency ablation [RFA] became the first line therapy due to its both high effectiveness and safety. The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation [AFib] close to 25% at 1 year. This risk of subsequent AFib is related to the common substrate between both arrhythmias. When AFib occurs, the interest to maintain the SR is still required, even if recent studies did not show a significant difference in term of total mortality between rate or rhythm control strategies [AFFIRM, RACE and PIAF studies]. The studies published underlined the anti-arrhythmic drugs limits in patients with both arrhythmias [AFib and AFL]. After years centered on the mechanisms and the electric treatments of AFib, researchers are nowadays focusing on the study's evaluation of the atrial tissue substrate. Accordingly, the renin-angiotensin system role was investigated in many works. Indeed, angiotensin II plays a role in the modification of atrial pressure and in the fibers stretching ["stretch"], conditions required for the development of AFib. Angiotensin II is also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen alteration. These mechanisms lead to atria cells conduction disorders and refractory periods modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors deterioration were observed in patients with AFib. This brings to the concept of AFib treatment while interfering on tissue remodeling by the way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition [ACEI] may reduce AFib in patients with heart failure. No randomized study so far has compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA area. On the basis of experimental and clinical study, the investigators seek to evaluate the ACEI use in the prevention of AFib in an AFL post RFA ablation.

Drug

4other_research_funding

gen_e00d3b72229a7d63a3ce993623c2999e

Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms

National Cancer Institute (NCI)

University of Pittsburgh

NCT01640522

The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.

Other

4other_research_funding

gen_63b87be94045b46913aa882a401e01be

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant

National Cancer Institute (NCI)

Fred Hutch/University of Washington Cancer Consortium

NCT01812252

This randomized clinical trial studies different chemotherapies in treating patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Drug

4other_research_funding

gen_9178191a56aebf671b77f8dd01ea832b

The Respiratory Protection Effectiveness Clinical Trial

Washington D.C. Veterans Affairs Medical Center

Johns Hopkins University School of Medicine/Johns Hopkins Hospital

NCT01249625

Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.

Device

4other_research_funding

gen_3d4a2a1fb1223ab06da98ab3901ec5fa

2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery

Bausch & Lomb Incorporated

Ophthalmology Associates

NCT01455233

The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.

Drug

4other_research_funding

gen_63de1bb75dae82bdb08bc6fe89cb3982

Remote Monitoring of Patients With CHF in Central Greece

Institute of Biomedical Research & Technology, Larissa, Greece

Cardiology Department - Regional University Hospital of Larisa

NCT01503463

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

Procedure

4other_research_funding