bioihbjkbjnl/mcl2 huggingface dataset:
Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study will evaluate the impact a behavioral intervention can have on BMI. The
      researchers anticipate the intervention group will experience a decrease in BMI of
      approximately five points. The intervention group will be compared to a control group. This
      is a long term, randomized, controlled study. The behavioral intervention is conducted during
      a four hour monthly session. The behavioral intervention includes: exercise, education on
      medical aspects and nutrition, and empowerment.
    

Detailed description: 
      This is a long term randomized controlled trial, looking at the impact of a behavioral
      intervention on BMI,in participants ages 10-20 with a BMI > 85%.

      The intervention group will:

        -  have baseline and follow up blood work (fasting insulin, glucose, lipid panel)

        -  have baseline and follow up BMI, blood pressure measurements

        -  see a dietician-minimum of three visits during study

        -  attend monthly, four hour sessions. These sessions include:

             1. registration-monitoring of choices of liquid intake using standardized models,
                monitoring of sedentary behaviors-hours watching television, computer, video games,
                monitoring of heart rate at baseline and after exercise, monitoring of METs
                (metabolic equivalents), motivational interviewing, monitoring of exercise
                abilities (endurance, agility, curl ups, balance, power)

             2. one hour of exercise (including strength training)

             3. educational lectures on nutrition and the medical aspects of obesity and Type 2
                diabetes epidemic

             4. projects/games

             5. empowerment tools such as leading exercises and presenting food labels for
                discussion

      The control group will have:

        1. baseline and follow up blood work (fasting insulin, glucose, lipid panel)

        2. baseline and follow up BMI and blood pressure measurements

        3. visits to dietician (minimum of three visits during study)

        4. standard education on nutrition and exercise given during office visit with primary care
           doctor
    

Intervention name(s): Behavioral education program
Intervention type(s): Behavioral
Intervention description(s): Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BMI; obesity; behavioral intervention; longterm randomized controlled trial; exercise; empowerment; nutrition
Philippine Child Health and Policy Experiment
Condition: Childhood Illness
Study type: Interventional

Summary: 
      The long-term consequences of poverty on child health, including cognitive development, are
      one of the world's great tragedies. In the Philippines, diarrhea, acute lower respiratory
      infections, and the attendant problems of malnutrition, are the leading causes of childhood
      illness. The Philippine government plans to launch a broad national Health Sector Reform
      Agenda (HSRA) that will address the problems of poverty and illness in children. The
      introduction of these reforms provides an exceptional opportunity to conduct a social
      experiment. Four institutions, already involved in the design and implementation of the HSRA,
      plus leading experts in international health, government, and health measurement will
      collaborate on this project to collect longitudinal data and measure the impact of HSRA
      reforms on child health outcomes in a population. We will measure the health impacts of two
      experimental interventions: (1) expansion of health insurance coverage, and (2) capitation of
      providers. Our research will measure the impact of health reforms on the physical and
      cognitive health outcomes of children age 0-4. We will use a block design of 21 sites
      throughout the Philippines: seven for each of the two interventions, and seven matched
      controls. We will measure the quality of clinical practice using vignettes and will measure
      health outcomes using objective clinical tests. We will also use an advanced sampling
      strategy and panel data to link clinical practice with population health outcomes. This
      unparalleled research opportunity will yield significant insights about specific, unanswered
      questions of tremendous importance: Does health care serve as a social intervention that
      ameliorates the effects of morbidity and malnutrition on cognitive development? How effective
      are government policies at creating incentives to improve the quality of clinical practice?
      Do financial and organizational policies actually lead to better health and developmental
      outcomes? The results from this study will provide insights into the linkages between
      increased access, high quality care, and health outcomes in children.
    


Intervention name(s): Access Intervention; Bonus/Pay-for-Performance Intervention
Intervention type(s): Other; Other
Primary purpose: Health Services Research
Keywords: Quality of care; Access to care; Health Outcomes
Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial
Condition: Glycogen Storage Disorder Type 1; Hypoglycemia; Cornstarch; Glycosade
MeSH terms: Glycogen Storage Disease; Glycogen Storage Disease Type I; Hypoglycemia
Study type: Interventional

Summary: 
      The objective of this demonstration project is to compare a novel long-acting starch,
      Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy
      tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade
      has been reported to increase the duration of euglycaemia. Its slow release and longer
      periods of normal blood sugar achieved would preclude the need for the overnight dextrose
      infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this
      purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus
      potentially improving compliance to therapy. The investigators intend to evaluate Glycosade
      in our patients and determine its efficacy on glucose control, on the length of normoglycemia
      achieved and to determine if there are reduced side effects in our patients with GSD-I. This
      will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the
      protocol.
    


Intervention name(s): Glycosade
Intervention type(s): Dietary Supplement
Other intervention name(s): Modified starch
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The objective of this study is to evaluate the effects of 2 intravitreal injections with
      Ranibizumab or Avastin on endothelial function in subjects with neovascular macular
      degeneration compared to patients with dry AMD.
    


Intervention name(s): Ranibizumab; Bevacizumab; No treatment
Intervention type(s): Drug; Drug; Other
Intervention description(s): ranibizumab (0.5 mg) will be injected intraocular; Bevacizumab (1.25 mg) will be injected intraocular; No treatment
Other intervention name(s): Lucentis; Avastin
Intervention MeSH terms: Bevacizumab; Ranibizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        See eleigibility criteria
      
Keywords: Macular Degeneration; Age-Related Maculopathies
Clinical Observation of the Performance of Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line in Treatments of Patients With End-Stage Renal Disease (ESRD)
Condition: End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The incidence and prevalence of chronic kidney disease are increasing worldwide, as is the
      number of patients progressing to End-Stage Renal Disease (ESRD). China has experienced an
      increased accessibility and affordability of dialysis treatment, which in turn has brought
      about an increase in the number of patients receiving Renal Replacement Therapy (RRT).Without
      RRT, either in the form of maintenance dialysis or transplantation, ESRD is fatal.

      The scope of the trial is to observe the performance of Artis Dialysis System, ArtiSet
      PrePost and Ultra HDF Line versus AK 200 Ultra S, extracorporeal circulation conduct of blood
      purification apparatus and Ultra Steriset as the comparator devices in treatment of patients
      using hemodialysis (HD) or hemodiafiltration (HDF) for ESRD.
    


Intervention name(s): Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line; AK200 Ultra S, extracorporeal circulation conduct of blood purification
Intervention type(s): Device; Device
Intervention description(s): The HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.; The HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      In order to study the effect of anthocyanins on the improvement of glucose and lipid
      metabolism, randomized intervention trials were conducted to compare the effects of
      anthocyanins on the improvement of glucose and lipid metabolism in different dose groups.To
      explore the best dose of anthocyanins for the prevention and treatment of anthocyanin
      metabolic diseases provide an important scientific basis.
    

Detailed description: 
      In order to study the effect of anthocyanins on the improvement of glucose and lipid
      metabolism, randomized controlled trials were conducted to enrolled 300 patients with
      dyslipidemia. The subjects were divided into 0 mg / d, 40 mg / d, 80 mg / d, 320 mg/ d five
      dose groups, intervention for 12 weeks, comparing different doses of anthocyanins on glucose
      and lipid metabolism.To explore the best dose of anthocyanins for the prevention and
      treatment of anthocyanin metabolic diseases provide an important scientific basis.
    

Intervention name(s): Medox® Anthocyanin capsules
Intervention type(s): Drug
Intervention description(s): Subjects were orally administered Medox® capsules daily for 12 weeks.
Other intervention name(s): Medox® Placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: anthocyanins; dyslipidemias; dose response
A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Thorough QT study intended to estimate the effect of glasdegib at therapeutic
      exposure and at supra-therapeutic exposure on cardiac repolarization in healthy subjects.
      This is a randomized, double blind, positive and placebo controlled study with a 6 day
      washout between successive periods.
    


Intervention name(s): Glasdegib Therapeutic Exposure; Glasdegib Supra-therapeutic Exposure; Positive Control (Moxifloxacin); Placebo Control
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Subjects Receive a single 150 mg dose of Glasdegib followed by ECG and PK assessments.; Subjects receive a single 300 mg dose of glasdegib followed by ECG and PK assessments.; Subjects will receive a single 400 mg dose of moxifloxacin followed by ECG and PK assessments.; Subjects will receive placebo dose followed by ECG and PK assessments.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Glasdegib; PF-04449913; Pharmacokinetics; QTc; TQT
Tissue Collection From People With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study will examine the relationship between bacterial products in lung infections in
      cystic fibrosis and disease severity. It will examine plasma and lung tissue from cystic
      fibrosis patients.

      Patients with cystic fibrosis and having certain genetic characteristics, who are between 9
      and 65 years of age and any cystic fibrosis patient undergoing lung transplantation at INOVA
      Fairfax Hospital in Fairfax, Virginia, may be eligible for this study.

      Patients who cannot undergo apheresis may be asked to provide up to an additional 100 cc (7
      tablespoons) of blood for research to look at bacterial products.

      Lung specimens of participating transplant patients will be collected at INOVA Fairfax
      Hospital. Patients who participate in the apheresis portion of the study will be admitted to
      the NIH Clinical Center for 2 to 3 days. Apheresis is a procedure for collecting large
      quantities of specific blood components. For this study, plasma-the liquid part of the
      blood-will be collected. For the procedure, whole blood is collected through a needle in an
      arm vein, similar to donating blood. The blood is separated into its components by
      centrifugation (spinning), the plasma and white cells are extracted and collected in a bag,
      and the red cells are returned to the body, either through the same needle or through another
      needle in the other arm.

      During the hospital stay, patients may also be asked to participate in other cystic fibrosis
      studies involving blood tests, an echocardiogram (ultrasound test of the heart), urine
      pregnancy test, and pulmonary function (breathing) tests.
    

Detailed description: 
      Lungs of individuals with cystic fibrosis (CF) are frequently colonized with a number of
      bacterial pathogens. One of the most common organisms is Pseudomonas aeruginosa. Previous
      studies have shown the presence of the type III-secretion pathway within P. aeruginosa,
      implicating these cytotoxins as virulence factors for this organism. To evaluate further the
      effect of these cytotoxins on lung cells, we would like to collect plasma and tissue from
      individuals with CF. Because larger quantities of plasma than can safely be obtained by
      simple phlebotomy will be required, apheresis procedures performed in the Clinical Center
      Apheresis Unit will be used. To obtain lung cells from patients with CF infected with P.
      aeruginosa, tissue from explanted lungs will be collected in collaboration with INOVA Fairfax
      Hospital. We intend to look for expression of the type- III proteins of P. aeruginosa by
      measuring the immune response against components of the type- III pathway and their presence
      in lung cells.
    

Keywords: Apheresis; Transplantation; Type III Secretion Pathway; Exotoxins; Pseudomonas Aeruginosa; Cystic Fibrosis; CF
Micronutrients and Child Health Study
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine to what extent supplementation with zinc and other
      micronutrients are efficacious in preventing malaria in young Tanzanian children.
    

Detailed description: 
      Zinc is essential for the functioning of the immune system. Supplementation trials in Asia,
      Latin America, the Pacific and developed countries have shown that increasing zinc intake has
      great potential to control common infections in children, but the response to supplementation
      may be different in Africa, where the primary environmental challenge to children's health is
      malaria. Simultaneous supplementation with other potentially limiting nutrients may be
      required to overcome a lack of response when zinc is given alone. The project aims at
      measuring effects of daily oral supplementation with zinc and other micronutrients, given
      either alone or in combination, on malaria incidence and nutritional status, and on
      indicators of immunity.
    

Intervention name(s): Zinc; Vitamins and minerals other than zinc; Vitamins plus zinc and other minerals; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks; Daily supplementation with vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks; Daily oral supplementation with zinc, vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks; Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks
Intervention MeSH terms: Vitamins; Zinc
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Micronutrients; Zinc; Vitamins; Trace elements; Minerals; Vitamin A; Vitamin B1; Vitamin B2; Niacin; Vitamin B6; Folic acid; Vitamin B12; Vitamin C; Vitamin D; Vitamin E; Vitamin K; Iron; Iodine; Copper; Selenium; Magnesium; Calcium; Malaria; Immunity; Anthropometry
Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
Condition: Inflammatory Bowel Disease; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Both ulcerative colitis and Crohn's colitis are associated with an increased risk of
      developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is
      well established, several studies show that the risk varies widely between patients,
      depending on the presence of risk factors. Recently, several of these risk factors were
      implemented in the updated British guidelines for surveillance which are now used to
      determine surveillance intervals in our center. The new guideline recommends stratification
      of patients in a high, medium or low risk group depending on the presence of clinical and
      endoscopic risk factors and to adjust the surveillance interval accordingly. Although these
      guidelines provide a first step towards an individualized surveillance regimen, current data
      regarding risk factors for IBD (inflammatory bowel disease) -associated CRC are solely based
      on retrospective studies. Prospective data on the phenotype and genotype reliably predicting
      the risk of CRC is needed to further optimize surveillance in the future.

      Objectives:

        1. To confirm established and identify new predictive factors for colorectal cancer in a
           prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or
           colorectal cancer will be the primary outcome.

        2. To provide evidence that mucosal healing results in a significant reduction of
           colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA
           (5-aminosalicylic acid) or anti-TNF (tumor necrosis factor) maintenance therapy.

        3. Study the expression of several tumor markers in biopsies, blood and faeces at baseline
           and determine whether expression of these markers can predict dysplasia or colorectal
           cancer development during follow-up.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with a diagnosis of ulcerative colitis, Crohn's colitis or indeterminate colitis
        between 18 and 70 years of age. Patients should have an indication for surveillance
        according to the current guidelines, which means a disease duration of at least 8 years and
        involvement of at least 30% of the colon.
      
Biospecimen description: 
      biopsies, blood, stool
    
Keywords: IBD; colitis; dysplasia; colorectal cancer
Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients
Condition: Transcutaneous Electrical Acupoint Stimulation; Hemifacial Spasm; Dizziness
MeSH terms: Hemifacial Spasm; Vertigo; Spasm; Dizziness
Study type: Interventional

Summary: 
      To observe the prevention and treatment effect of transcutaneous electrical acupoint
      stimulation (TEAS) on postoperative dizziness in patients with hemifacial spasm undergoing
      microvascular decompression surgery, and its possible mechanisms.
    

Detailed description: 
      Hemifacial spasm (HFS) is mainly caused by vascular compression on the roots of the VII
      cranial nerves from the brain stem. Microvascular decompression (MVD) is the exact surgical
      method for the treatment of HFS, but the incidence of dizziness and postoperative nausea and
      vomiting (PONV) after MVD is extremely high. Despite the use of dual antiemetic therapy
      during the operation, the incidence of PONV within 24 hours after MVD is still as high as
      66.7%. Medication alone has limited effects on dizziness and PONV treatment after MVD.
      Meta-analysis shows that transcutaneous electrical acupoint stimulation (TEAS) is associated
      with the reduction of post-emetic remedies and the incidence of dizziness after general
      anesthesia, and it can be integrated into the multi-modal therapy of PONV. Therefore, the
      purpose of our study is to observe the prevention and treatment effect of TEAS on
      postoperative dizziness in patients with hemifacial spasm undergoing microvascular
      decompression surgery, and explore its possible mechanisms.
    

Intervention name(s): HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)
Intervention type(s): Device
Intervention description(s): Stimulation sites: Mastoid area on the contralateral side of the operation, Fengchi acupoint on the contralateral side of the operation, and Neiguan acupoints on both sides.
Timing of stimulation: In postanesthesia care unit (PACU) after extubation, 6 hours, 24 hours, 48 hours, and 72 hours after returning to the ward. 30-minutes treatment for each time-point.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment