bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating
      Painful DPN.
    


Intervention name(s): VX-548; Pregabalin; Placebo (matched to VX-548); Placebo (matched to pregabalin)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration.; Capsules for oral administration.; Placebo matched to VX-548 for oral administration.; Placebo matched to pregabalin for oral administration.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Testing the Effect of the InsuPad Device in Daily Life Conditions
Condition: Diabetics Mellitus Type 1; Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is the test protocol for the InsuPad device. The aim of the study is to show economical
      benefit when using the InsuPad device, by testing the effect of the InsuPad device on
      reducing injected insulin dose while keeping the same overall glycaemic control.
    


Intervention name(s): InsuPad
Intervention type(s): Device
Intervention description(s): Use of the InsuPad for at least 3 times a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DM; insulin; injections
Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Tadalafil is an effective oral therapy in erectile dysfunction. L-arginine is a pro drug that
      increase the level of nitrous oxide in the smooth muscles so can increase the strength and
      duration of erection. this clinical trials compare the daily oral L-arginine plus tadalafil
      in treatment of erectile dysfunction in diabetic patients.
    


Intervention name(s): L-arginine 5 gm oral caps; Tadalafil 10 MG; serum testosterone level; HbA1C; penile doppler
Intervention type(s): Drug; Drug; Diagnostic Test; Diagnostic Test; Device
Intervention description(s): oral L-arginine 5 gm daily for 8 weeks; oral daily tadalafil 10mg for 8 weeks; measurement of serum testosterone level; measurement of HbA1C levels; penile doppler to measure the degree of erection and penile vasculature
Intervention MeSH terms: Tadalafil; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erectile dysfunction; Diabetes; Tadaladil; L-arginine
Enteroendocrine Cells Before and After Sleeve Gastrectomy
Condition: Obesity
Study type: Interventional

Summary: 
      Morbidly obese patients exhibit impaired secretion of satiation hormones which may contribute
      to the development of obesity. Bariatric surgery is associated with weight loss and dramatic
      increase in the secretion of satiation hormones, but the underlying mechanism remains
      unknown. The investigator's goal is therefore to examine patients before and after sleeve
      gastrectomy and compare findings to lean controls.
    

Detailed description: 
      Morbidly obese patients exhibit impaired secretion of satiation hormones cholecystokinin
      (CCK), glucagon-like peptide 1 (GLP-1) and peptide YY (PYY), which may contribute to the
      development of obesity. Bariatric surgery is associated with weight loss and dramatic
      increase in the secretion of satiation hormones, but the underlying mechanism remains
      unknown. A better understanding of mechanisms involved will assist in development of
      non-invasive therapeutic strategies. The investigator's goal is therefore to examine patients
      before and after sleeve gastrectomy and compare findings to lean controls. Gastric and
      intestinal mucosa will be collected by endoscopy from morbidly obese subjects before and 3
      months after sleeve gastrectomy. In Addition, lean controls will be examined. Expression of
      various gut peptides will be assessed by immunohistochemistry and quantitative polymerase
      chain reaction (PCR).
    

Intervention name(s): sleeve gastrectomy; no intervention
Intervention type(s): Procedure; Other
Intervention description(s): Sleeve gastrectomy is an established form of bariatric (weight reducing) surgery, where the greater curvature of the stomach is removed.; lean control group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study
Condition: Dietary Exposure
Study type: Observational

Summary: 
      This proposal aims at identifying new biomarkers of dietary exposure using metabolomic
      approaches. This project is based on the European Prospective Investigation on Cancer and
      Nutrition (EPIC) Calibration Study and more particularly upon a subset of 494 men and women
      from 4 European countries (Germany, Greece, Italy and France). Urine and blood samples are
      analyzed by untargeted metabolomics.
    

Detailed description: 
      Subjects participating in the study are characterized by the availability of one 24-hr urine
      sample, blood serum, 24-hr dietary recall (24HDR) and food frequency questionnaire (FFQ)
      data.

      The main objectives of the proposal are:

        1. To collect a set of high-quality metabolomic data containing rich information on the
           food-derived metabolome.

        2. To mine this data in different Metabolome-Wide Association Studies in order to identify
           food-derived metabolites discriminating consumers and non-consumers of various foods,
           nutrients and dietary patterns.

        3. To identify the food-derived metabolites characteristic of the consumption of the
           different foods/nutrients and dietary patterns.
    

Intervention name(s): Identify Biomarkers of Dietary Intake in Healthy Subjects
Intervention type(s): Other
Intervention description(s): Observational study. No intervention.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        494 men and women from 4 European countries (Germany, Greece, Italy and France) selected
        from the EPIC Calibration study. Different settings by centre; mostly general population
        with some exceptions: women of a health insurance company for teachers and school workers
        (France), women attending breast cancer screening (Florence-Italy), mainly blood donors
        (most centers in Italy) and a cohort consisting predominantly of vegetarians (the
        'health-conscious' group in Oxford, UK).
      
Biospecimen description: 
      24-hour urine samples Plasma samples
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)
Condition: Oropharynx Cancer
MeSH terms: Oropharyngeal Neoplasms; Xerostomia
Study type: Observational

Summary: 
      Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only
      one planification before treatment. Adaptative radiotherapy integrates one or several
      planifications during treatment radiotherapy in order to take into account anatomic
      modifications that occurs.

      Adaptative radiotherapy is very expensive, complex and is consuming human resources as well
      as equipment.

      ARTIX study (NCT01874587) entitled "Phase III trial testing the benefit of
      intensity-modulated radiotherapy with weekly replanifications versus intensity modulated
      radiotherapy with only one planification in locally advanced oropharynx carcinoma for
      decreasing xerostomia" is completed and clinical data from this study are used to analyse if
      xerostomia is decreased when adaptative radiotherapy is used.

      ARTOME study will assess cost-efficiency and cost utility between standard treatment (one
      pretherapeutic planification) and experimental treatment (weekly replanifications during
      treatment). Clinical data from ARTIX study will be used for ARTOME study.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients treated for oropharynx cancer in specialized hospitals
      
Keywords: adaptative radiotherapy; xerostomia; medico-economic assessment
Evaluation of an Early Screener to Identify Long-term Problems With Regard to Metabolic Control and Treatment Adherence Among Children and Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Background: Type 1 diabetes is one of the most common chronic illnesses among children and
      adolescents. Although, intensive medical care is provided for these patients, some of them
      have poor metabolic control. For example, only 21% of adolescents with type 1 diabetes in the
      USA achieve the recommended average blood sugar concentration (HbA1c<7.5%). This is a major
      problem, since chronic hyperglycemia is the primary cause of morbidity and mortality in type
      1 diabetes and causes several serious complications, for example kidney failure, blindness,
      and stroke. Therefore, the International Society for Pediatric and Adolescent Diabetes
      (ISPAD) declared psychosocial factors, to be the most important risk factors of poor type 1
      diabetes Management. Therefore, an instrument is needed to identify children and adolescents
      with poor metabolic control in their course of disease as soon as possible. With an early
      identification of such risk patients, better support can be provided. However, there is no
      such instrument yet for pediatric patients with type 1 diabetes. To fill this gap, a
      questionnaire (FEPB) based on the PAT 2.0© (Psychosocial Assessment Tool; an instrument used
      in oncology) was developed for this project.

      Aim: The aim of this project is to evaluate and validate a new instrument (FEPB) for an early
      identification of children and adolescents with poor metabolic control in their course of
      disease in a longitudinal design.

      Method: The sample consists of children and adolescents (age: 5-18 years), who were newly
      diagnosed with type 1 diabetes (2-4 weeks ago), and who are in care at the University
      Children's Hospital of Zurich. Structured interviews are conducted with the patients and the
      parents are asked to fill out some questionnaires at two times: first, 2-4 weeks after the
      diagnosis (T1) and second 6 month later (T2). With the new instrument (FEPB) a risk score can
      be calculated for each patient at T1. Statistical analysis will be performed to determine
      whether that risk score can predict which patients have poor metabolic control (HbA1c > 7.5%)
      at T2.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic - University Children's Hospital Zurich
      
Keywords: type 1 diabetes; metabolic control; psychosocial risk factors; FEPB; children; adolescents
Cognitive Remediation in 22q11DS
Condition: 22q11.2 Deletion Syndrome; Velo-Cardio-Facial Syndrome
MeSH terms: DiGeorge Syndrome; Syndrome
Study type: Interventional

Summary: 
      The goal of this study is to collect preliminary data on the efficacy of a cognitive
      remediation program in improving the neurocognitive deficits in children with chromosome
      22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a
      computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a
      Social Cognitive Training (SCT) program. The computer-based training program has shown
      encouraging results in improving learning deficits in individuals with schizophrenia and we
      now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ
      and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group
      intervention program based on cognitive enhancement therapy, which has been shown to improve
      social cognition and functionality in adults with schizophrenia. A preliminary study will be
      performed using this two-pronged approach, to establish the feasibility and gather
      preliminary data on neurocognition before and after the intervention in these children; these
      data would enable a larger randomized controlled study to assess the efficacy of this
      approach.
    


Intervention name(s): Cognitive remediation program; Small group social skills training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subject plays for 30 minutes, 4 times per week, for 12 weeks.; Meet once per week for duration of 40 weeks.
Other intervention name(s): Posit Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Cognitive remediation; Social Cognition
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing
      clinical remission in patients with moderate to severe Crohn's disease as compared with
      placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
    


Intervention name(s): certolizumab pegol (CDP870, CZP); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4; Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
Other intervention name(s): CIMZIA ®; CDP870; CZP
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CDP 870; Certolizumab Pegol; CIMZIA ®; Crohn's disease; Induction; Clinical remission; Clinical response
Role of Flavanols in Exercise and Aging
Condition: Aging
Study type: Interventional

Summary: 
      It has well known that diets rich in fruits, vegetables and cocoa products are associated
      with positive health benefits and these positive effects have been shown to be due to
      compounds they contain called flavanols. Flavanols have been shown to exert their positive
      effects by indirectly increasing nitric oxide (NO) bioavailability. NO is a potent
      vasodilator that is believed to play a role in increasing blood flow to active muscle during
      exercise. This regulatory process is impaired with healthy aging. The underlying premise to
      this study is that if NO bioavailability can be increased following flavanol ingestion, will
      there be a restoration of blood flow during exercise in older individuals? Accordingly, the
      first part of this research project will compare the acute vascular effects of flavanol
      ingestion between a young and old group. The investigators have hypothesized that both groups
      will show an improvement in blood flow to active muscle during exercise, though the magnitude
      of the change will be greater in the older group. The second part of this project will look
      at the effects of 4 weeks of daily flavanol ingestion in the old group. The investigators
      hypothesize that subjects will demonstrate an improvement in blood flow to active muscle
      during exercise after the 4 week intervention and that the magnitude of the change will be
      greater than the acute effects. Findings from this proposal will provide evidence for the
      efficacy of flavanols to be used (as a simple and safe lifestyle intervention) to reverse or
      combat impaired blood flow regulation in older individuals.
    


Intervention name(s): High Flavanol Trial; Low Flavanol Trial; High Flavanol Trial; long-term; Low Flavanol Trial; long-term effects
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The experimental trial (high flavanol content) will involve the consumption of a beverage containing about 1000mg of cocoa flavanols.; The placebo trial (low flavanol content) will involve the consumption of a beverage containing 75 mg of cocoa flavanols.; The experimental trial (high flavanol content) will involve the daily consumption of a beverage containing about 1000mg of cocoa flavanols for 4 weeks. Subjects will be provided with 28 packets of the beverage to take home with them.; The placebo trial (low flavanol content) will involve the daily consumption of a beverage containing 75 mg of cocoa flavanols for 4 weeks. Subjects will be provided with 28 packets to take home with them.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Exercise; Blood Flow; Nitric Oxide; Aging; Antioxidant; Flavanol; Young (18-30 yrs); Aging (60 - 80 yrs)
The Effects of Exercise on Dietary Intake
Condition: Active Lifestyle Males; Inactive Lifestyle Males
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not energy and macronutrient intake
      changes when comparing habitually active and habitually sedentary college-aged males in two
      different sessions of one resting and one exercise.
    

Detailed description: 
      Obesity is a consequence of positive energy balance, in which more energy is consumed than
      expended. It is hypothesized that regular amounts of physical activity may be important in
      helping individuals more accurately regulate energy balance. More research is needed to
      understand the impact of a physically active lifestyle on energy regulation capabilities
      Therefore, this study looks at sedentary college aged males compared to active college aged
      males when looking at two different sessions of energy expenditure, one exercise session and
      one resting session, and their energy and macronutrient intake after these sessions. The
      sessions will take place in the morning where each participant will exercise or rest and then
      be allowed to eat from a buffet ad libitum, where acute energy and macronutrient intake will
      be assessed.

      The following hypotheses are proposed:

        -  Individuals who regularly engage in physical activity will more accurately respond to an
           energy deficit caused by an acute period of physical activity by increasing intake at a
           subsequent meal.

        -  Individuals who do not regularly engage in physical activity (sedentary individuals)
           will be less sensitive to accurately regulate energy balance and will not respond to an
           energy deficit caused by a period of acute physical activity.
    

Intervention name(s): Exercise Session; Rest Session
Intervention type(s): Other; Other
Intervention description(s): This study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The "Exercise Session" will consist of the participant coming into the lab and completing 45 min bout of exercise on an exercise bike, followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum.; This study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The "Rest Session" will consist of the participant coming into the lab and completing a 45 min period of reading followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise; Sedentary; Energy Expenditure; Energy Balance; Macronutrient Intake; Energy and Macronutrient intake; Exercise and Energy Balance
Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy
Condition: Family Planning
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      The goal of this pilot study is to assess both implementation outcomes (acceptability,
      feasibility and adoption) and clinical efficacy (contraceptive method uptake by women wishing
      to avoid pregnancy) using a Hybrid Type 2 study design of a family planning program being
      piloted by the Cervical Cancer Prevention Program in Gabarone, Botswana.
    


Intervention name(s): WHO Decision-Making Tool for Family Planning Clients and Providers
Intervention type(s): Other
Intervention description(s): Contraception decision-making tool
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Conjunctival Rebound After Scleral Lens Wear
Condition: Conjunctival Diseases
MeSH terms: Conjunctival Diseases
Study type: Interventional

Summary: 
      Scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival
      tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. The
      purpose of the study is to determine the amount of conjunctival compression caused by the
      devices and the length of time required for the shape to recover from compression.
    

Detailed description: 
      The purpose of this study is to determine the interval required for the conjunctival tissue
      to return to its natural shape after scleral lens wear. All study visits will take place at
      the University of Houston College of Optometry (UHCO). Subjects will be recruited and fitted
      with scleral lenses to wear during the experimental days. Once the proper fit has been
      achieved, subjects will wear the scleral lens for 4 days total, returning after the 1st and
      4th day of lens wear for approximately 2 hours of testing. The subjects will then return
      every 24-hours for measurements until their conjunctival shape has returned to the original
      shape. The testing will be done using the sMap scleral topographer, which measures the
      elevation of the conjunctiva. Testing is non-invasive although it requires instillation of
      Fluress eye drops, a sodium fluorescein dye with anesthetic that allows for imaging. The
      total number of visits is 9-14 and the length of visit ranges from 10 minutes to 2.5 hours.
    

Intervention name(s): Scleral lens
Intervention type(s): Device
Intervention description(s): Scleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use.
Intervention model: Single Group Assignment
Intervention model description: Prospective observational study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: scleral lenses