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Integrated Clinical Trials is a virtual database currently indexing clinical trials from: EU Clinical Trials Register and ClinicalTrials.gov.
(last updated: Nov 28, 2022)
Clinical Trials Information| Database | Title | Recruitment | Conditions | Intervention | Sponsored By | Gender | |||||
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Clinicaltrials.gov | A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth | Suspended | Obesity, Postpartum Weight Retention, Insulin Sensitivity | Behavioral, Behavioral - Low carbohydrate diet education, Low carbohydrate diet education with behavioral component | The University of Texas Medical Branch, Galveston, Other | Female | 18 Years - 50 Years | N/A | Interventional | The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women. | |
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Clinicaltrials.gov | Church, Extension and Academic Partners Empowering Healthy Families | Suspended | Obesity | Behavioral, Behavioral - Healthy Children, Healthy Families+ (HCHF+), Money Smart | Virginia Polytechnic Institute and State University, Virginia State University, Baptist General Convention of Virginia, Virginia Cooperative Extension, Virginia Family Nutrition Program, Virginia Tech Center for Public Health Practice and Research, Other, Other, Other, Other, Other, Other | 6 Years - N/A | N/A | Interventional | The project will address health disparities via a community-engaged approach in partnership with black churches. The long-term goals of this integrated project are to: 1) prevent and reduce childhood obesity through improved parenting practices and home environment related to obesity; 2) expand Extension capacity for community-engaged research and collaborative programming with faith-based organizations; 3) enhance Extension strategies for recruiting and training community volunteers to extend Extension reach; and 4) train future health professionals to provide culturally appropriate collaborative community-based health programs. The project will target the school-aged subset (ages 6-11, first through fifth grade) of the USDA target age range of ages 2-19. The 14-month randomized control trial design of the research component will generate new knowledge regarding effectiveness of a integrated family-based intervention enhanced with social and environmental (church) support to prevent obesity in school-aged children. The research design with a financial literacy active control condition and the primary nutrition and physical activity intervention being tested meets two needs expressed by the community partner and allows rigorous evaluation of both Extension programs. It is hypothesized that parents in the intervention group will have higher levels of self-efficacy for obesity-prevention behaviors, parenting practices related to food and physical activity, improved home food and physical activity. The long term impact is to reduce the prevalence of childhood obesity. | ||
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Clinicaltrials.gov | Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors | Suspended | Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Cancer Survivor, Inactivity, Obesity, Overweight, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8 | Other, Behavioral, Other, Other - Educational Intervention, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration | Roswell Park Cancer Institute, Other | 65 Years - N/A | N/A | Interventional | This trial studies how well exercise and nutrition education work in improving physical function and quality of life in older breast cancer survivors. Exercise and nutrition education may help to improve the level of fitness, cardiovascular health, and quality of life in breast cancer survivors. | ||
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Clinicaltrials.gov | PsylliumRx Dietary Fiber Study | Suspended | Obesity, Childhood Obesity | Dietary Supplement - Dietary Fiber Supplement | Kaiser Permanente, Other | 12 Years - 21 Years | N/A | Interventional | The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the metabolic effects of the dietary fiber preparation. A study modification will be submitted to add additional study arms for feasibility (strength training, coaching). | ||
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Clinicaltrials.gov | Responses to Appetite and Taste in the Brain Circuits That Control Eating Behaviour | Suspended | Obesity | University College, London, Other | 18 Years - 50 Years | Observational | The aim of this study is to gain insight into brain structure and the neural networks that control taste and eating behaviour in patients with severe obesity undergoing a primary sleeve gastrectomy (SG) or a lifestyle intervention for weight loss compared with normal weight individuals, using functional magnetic resonance imaging (fMRI). | ||||
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Clinicaltrials.gov | Liraglutide for HIV-associated Neurocognitive Disorder | Suspended | HIV Infection, Diabetes Mellitus Type 2, Obesity, Overweight, Metabolic Syndrome | Drug - Liraglutide | Temple University, The Comprehensive NeuroAIDS Center (CNAC) at Temple University, Other, Other | 18 Years - 65 Years | Phase 4 | Interventional | This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes. | ||
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Clinicaltrials.gov | Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation | Suspended | Obesity, Weight Loss, Body Weight, Hepatocellular Carcinoma, HCC, Hepatitis C, Cirrhosis | Device - Embospheres Microspheres | St. Louis University, Other | 18 Years - 65 Years | N/A | Interventional | Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and has a grave prognosis. Obesity is an epidemic in the US.Patients with HCC and obesity are not candidates for liver transplantation, depriving them of the best option for cure from HCC. Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with cirrhosis and HCC who are not transplant candidates due to morbid obesity, leads to clinically significant weight loss with eligibility for liver transplantation. | ||
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Clinicaltrials.gov | Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men | Suspended | Insulin Resistance, Obesity, Metabolic Syndrome | Behavioral - Exercise | University of Glasgow, Other | Male | 18 Years - 40 Years | N/A | Interventional | A number of studies have shown that short duration, high intensity interval training can improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness. However, these often use specialized equipment, such as cycle ergometers, which makes it difficult to roll these interventions out for wide-scale use in the general population. This study aims evaluate the effects of a high intensity shuttle running intervention on insulin sensitivity, fitness and related cardiometabolic risk factors in men who are currently inactive. Participants will be randomized into intervention (4 weeks of shuttle running) and control groups. We hypothesize that the shuttle running programme will result in improved insulin sensitivity, fitness and increased fat oxidation at rest compared with the control group. | |
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Clinicaltrials.gov | Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Bariatric Surgery | Suspended | Obesity, Bariatric Surgery Candidate | Drug, Drug, Drug, Drug - Placebo, Lidocaine 1%, Lidocaine 1.5%, Lidocaine 2% | Mansoura University, Other | 18 Years - 65 Years | Phase 1/Phase 2 | Interventional | Increasing rates of obesity over the last few decades have led to growing demand for bariatric surgery, which may resulted in decreased comorbidities and improved patient outcomes. Laparoscopic bariatric surgery has several clinical benefits in terms of improved quality of analgesia, reduced pulmonary complications, enhanced recovery of bowel function, less immune suppression, and shortened duration of hospital stay than open laparotomies. Some investigators reported delayed return of bowel function for approximately two days after laparoscopic bariatric surgery, despite it occurred one day earlier than after open laparotomy. This potentially can lengthen the duration of hospital stay after bariatric procedures. With the impeding cost of health care in the developing countries, safely reducing length of stay is essential. Other investigators reported early return of bowel movements during the first postoperative day in 65% of patients undergoing laparoscopic gastric bypass surgery due to reduced morphine use with implementation of a multimodal analgesia strategy including ketorolac, and propoxyphene hydrochloride/acetaminophen. Lidocaine was investigated in several studies for its use in multi-modal management strategies to reduce postoperative pain and opioid use and enhance recovery. A recent Cochrane review including 45 trials demonstrated that systemic administration of lidocaine was associated with reduced pain scores at most of 'early time points' in patients undergoing laparoscopic abdominal surgery (MD -1.14, 95% CI -1.51 to -0.78; low-quality evidence), shorter times to first flatus (MD -5.49 hours, 95% CI -7.97 to -3.00; low-quality evidence) and first bowel movement (MD -6.12 hours, 95% CI -7.36 to -4.89; low-quality evidence), and less risk of paralytic ileus (risk ratio (RR) 0.38, 95% CI 0.15 to 0.99; low-quality evidence). However, no evidence of effect was found for lidocaine on shortening the time to first defecation. This low-quality evidence may be related to the heterogeneity between the studies in respect to the optimal dose, timing and duration of the administration of intravenous lidocaine. | ||
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Clinicaltrials.gov | Molecular and Clinical Profile of Diabetes Mellitus and Its Complications | Suspended | Diabetes Mellitus, Type 2, Diabetic Nephropathy, Obesity | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH | 18 Years - N/A | Observational | Background: - Family and twin studies have suggested that genetic factors influence approximately 50 percent of a person's susceptibility to type 2 diabetes. Recently, some of the genes involved in the development of type 2 diabetes have been identified, in large part by genome-wide association studies. Certain risk factors for type 2 diabetes, such as obesity and insulin resistance, are highly inheritable, as are diabetic complications such as diabetes-related eye and kidney disorders. However, few genes associated or linked with diabetes risk factors or complications have been conclusively identified, and more research is needed to study specific genetic factors associated with these aspects of diabetes. Objectives: - To identify and characterize genetic variants associated with type 2 diabetes, its risk factors, and its complications. Eligibility: - Individuals at least 18 years of age who are not pregnant or nursing mothers at the start of the study. Design: - All participants will provide information about family history, ethnicity and ethnic background, occupation, behavioral risk factors, and other data as requested by the researchers. - In addition to a general health history, participants will provide specific information about diabetes history, with particular emphasis on date of diagnosis, symptoms, initiation of insulin therapy, complications, and current medications. - Testing procedures will be different for individuals with and without diabetes. Those without diabetes will have an oral glucose tolerance test, while those with diabetes will be examined for diabetic complications. - Other tests during the study will include the following: - Physical examination with measurements of height and weight, waist circumference, blood pressure, and other tests for individuals who have been diagnosed with diabetes - Glucose tolerance test for those who have not been classified as having diabetes - Retinal photographs - Electrocardiograms - Hepatic Ultrasound - Blood and urine tests - Depending on the results of the examination and laboratory findings, participants may be asked to return to the clinic for supplemental interviews, physical examinations, or blood tests, or to arrange referrals for medical evaluation and treatment. - Participants who have diabetes will be asked to return for yearly follow-up visits. Participants who do not have diabetes at the initial examination will be asked to return for follow-up visits every 2 years. | ||||
Clinicaltrials.gov | A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity | Suspended | Obesity, Insulin Resistance | Drug, Drug - Fenretinide, Placebo | University of California, San Diego, Other | 18 Years - 65 Years | Phase 2 | Interventional | Many metabolic complications of obesity are a consequence of abnormal responses of the liver, muscle, and fat to insulin actions. Fenretinide may improve the effects of insulin, preventing metabolic complications. | ||
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Clinicaltrials.gov | Vitamin D and Type 2 Diabetes Risk in UK Adults | Suspended | Overweight, Obesity | Other - Normal weight and overweight adults | Liverpool Hope University, Other | 18 Years - 50 Years | Observational | This study is exploring the association between vitamin D and Type 2 diabetes risk in normal weight and overweight UK adults. | |||
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Clinicaltrials.gov | Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2 | Suspended | Apnea, Obstructive Sleep, Obesity | Device - Bioelectrical Impedance Analysis (BIA) | Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Other | Female | 16 Years - 50 Years | Observational | Obstructive Sleep apnea (OSA) is a common and underdiagnosed condition in obese pregnant women with serious and life-threatening complications to the mother and baby. The investiators propose that a non-invasive method may be used to detect patients at risk of OSA, giving these women access to the necessary treatment to treat this condition. The method is a estimation of body water, which has been shown to be linked to OSA in the non-pregnant population. Body water is estimated by applying surface electrodes to a participant who is lying down by measuring bioimpedance through body tissues by applying a tiny current between the electrodes. The electrical stimulation is not felt by the participant and has no negative effects on mother or baby. | ||
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Clinicaltrials.gov | A Dissonance-Based Obesity Intervention | Suspended | Obesity | Behavioral - Enhanced Project Health | University of Illinois at Chicago, Other | 18 Years - 25 Years | N/A | Interventional | This project will examine the feasibility and acceptability of Enhanced Project Health, a dissonance-based obesity intervention, and whether this intervention results in significantly greater reductions in weight and improvements in lifestyle behaviors than an assessment only condition. Participants will be young adults enrolled in college. | ||
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Clinicaltrials.gov | Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients | Suspended | Obesity | Drug, Drug - Lorcaserin 10 mg BID, Matching Placebo BID | Kanion & Huawe Medicine Co.,Ltd, Industry | 18 Years - 65 Years | Phase 3 | Interventional | The purpose of this study is to assess the safety and weight loss effect of lorcaserin at the end of the first year of treatment (Week 48) in overweight and Chinese adult obese patients compared to placebo. | ||
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Clinicaltrials.gov | Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy | Suspended | Obesity | Drug - Administration of weight loss drug (Metformin or Topiramate) | Hartford Hospital, Other | 18 Years - 70 Years | Phase 4 | Interventional | The study will investigate the effects of Metformin and Topiramate prescribed at 4 weeks post-surgery on overall weight loss at 6 months post-surgery. The investigators will study patients who, based on current diagnoses and medication regimens, could be expected to benefit the most by taking a medication to facilitate additional post-surgery weight loss. Patients scheduled to undergo laparoscopic sleeve gastrectomy (LSG) at Hartford Hospital's Bariatric and Metabolic Surgery Program will be screened, consented and enrolled in the study. Prior to surgery patients will be randomized to either pharmacotherapy or no pharmacotherapy following LSG. For those randomized to receive pharmacotherapy, medications will be initiated at 4 weeks, as this is the estimated time post-LSG at which patients advance from a liquid diet to soft foods allowing medications to be better tolerated. Once randomly assigned to the medication group, patients will receive Metformin or Topiramate based upon physician judgment and medical history. Dosages will not be adjusted during the course of the study. The primary outcome will be % total body weight loss (%TWL) at 6 months following surgery, as the majority of the weight loss after LSG occurs during the first 6 months. Data collected through up to 12 months will be analyzed. The %TWL for both arms of the study will also be assessed at 8 weeks, 16 weeks, and 9 months and one-year post-LSG. Resolution of comorbidities will be noted. | ||
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Clinicaltrials.gov | Comprehensive Analysis of the Program:Salud Escolar | Suspended | Obesity | Behavioral - World Health Organization Health Promoting Schools | Instituto Nacional de Salud Publica, Mexico, UNICEF, Ministry of Education, Mexico, Ministry of Health, Mexico, Other, Other, Other, Other | 6 Years - 12 Years | N/A | Interventional | The purpose of this study is to comprehensively evaluate Salud Escolar (School Health), a program led by the Mexican Ministries of Health and Education. This comprehensive evaluation considers a design, implementation, results, and impact evaluation of Salud Escolar. | ||
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Clinicaltrials.gov | Ultrasonographic Evaluation of Anovulatory Disorders in Lean and Overweight Women | Suspended | Menstrual Cycle Abnormal, PCOS, Overweight, Obesity | Cornell University, Weill Medical College of Cornell University, Other, Other | Female | 18 Years - 45 Years | Observational | The investigators would like to determine whether ultrasound features of the ovaries can be used to reliably diagnose different types of anovulatory disorders in women across all body types. The study will also try to establish whether ultrasound features of the ovary can reflect the degree of reproductive and metabolic problems that a woman with irregular or absent periods might be experiencing. | |||
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Clinicaltrials.gov | Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant | Suspended | Malnutrition, Obesity | University of Michigan Rogel Cancer Center, Other | 2 Years - 25 Years | Observational | Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies. | ||||
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Clinicaltrials.gov | Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients | Suspended | Polycystic Ovary Syndrome, Obesity | Drug, Dietary Supplement, Dietary Supplement - Metformin, Magnesium, PUFA | Coordinación de Investigación en Salud, Mexico, Other | Female | 18 Years - 38 Years | N/A | Interventional | Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age women. PCOS is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for these patients. Metformin has proven to be useful in IR and is frequently used in PCOS. However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other IR states and may be useful in PCOS. The aim of this study is to asses the efficacy of these alternatives in obese PCOS patients. |
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