bioihbjkbjnl/mcl2 huggingface dataset:
Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational [Patient Registry]

Summary: 
      The current registry is being undertaken to assess the long-term (12 month) safety and
      tolerability of Venofer in the pediatric population with chronic kidney disease that requires
      intravenous iron maintenance therapy.
    

Detailed description: 
      This will be a multicenter, observational, prospective registry collecting long-term
      (12-month) safety, tolerability, and laboratory data. Subjects will be screened for inclusion
      criteria if on hemodialysis (HD), peritoneal dialysis (PD) or have non-dialysis dependent
      (NDD) chronic kidney disease (CKD).

      Treatment-emergent adverse events (adverse events starting from the time of the 1st dose of
      Venofer administered on study) will be collected via site entry of data into a web-based
      system. Each research investigator will be responsible for entering adverse event information
      on the appropriate clinical research form as well as reporting such events to the sponsor.

      Number of Subjects: 50 evaluable subjects (i.e., took at lease one dose of Venofer and have
      safety data recorded at the 12 month time point).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The current registry is being undertaken to assess the long-term (12 month) safety and
        tolerability of Venofer in the pediatric population with chronic kidney disease (CKD) that
        requries intravenous iron maintenance therapy.
A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Multi-center, randomized, double-blind, vehicle-controlled, parallel group, dose escalation
      study of TDM-180935 following topical administration in healthy male subjects, 18 to 55 years
      old
    

Detailed description: 
      Protocol 239-13851-101 is a planned Phase 1 study entitled "A Randomized, Double-Blind,
      Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety,
      Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy
      Male Subjects". Eligible subjects will be assigned to a sequential treatment cohort and
      randomized to each treatment group (active/placebo vs. placebo/placebo). Subject enrollment
      will continue into the next cohort after review of the dose safety from the previous dose
      cohort.
    

Intervention name(s): TDM-180935; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TDM-180935 topical ointment; Placebo for TDM-180935 topical ointment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
Condition: Visceral Obesity; Tooth Erosion; Insulin Resistance
MeSH terms: Tooth Erosion; Insulin Resistance; Obesity, Abdominal
Study type: Interventional

Summary: 
      The purpose of this study is to test the potential ability of vinegar to significantly
      decrease visceral fat in healthy adults with "central obesity". During the 8-week trial,
      participants will either consume a low-dose vinegar pill (control treatment) or a vinegar
      drink twice per day.

      Research Aim and Hypothesis H1 Daily vinegar consumption will be associated with loss in
      visceral fat (as measured by DXA) after 8 weeks compared to the placebo treatment
      (low-vinegar pill) in a group of healthy adults with "central obesity".

      H2 Daily vinegar consumption will be associated with a decrease in abdominal circumference
      after 8 weeks compared to the placebo treatment (low-vinegar pill) in a group of healthy
      adults with "central obesity".
    

Detailed description: 
      This randomized, placebo-controlled experimental trial will last 8 weeks. At the initial
      visit (consenting visit lasting about 20 minutes) the participant will sign the consent and
      complete a short health questionnaire and a short questionnaire on tooth erosion. Body height
      and weight and waist circumference will also be measured. Qualifying participants will be
      stratified by gender, age, weight, and waist circumference, then randomized into two groups:
      the intervention group, vinegar drinks (VIN) or the control group, vinegar pills (CON). The
      participants will know which treatment they are given but they will not know which group
      (control vs. placebo) they are in. Those who receive the VIN will be instructed to drink 2
      tablespoons of red wine vinegar (provided) mixed with water twice each day for weeks 1 to 8
      of the trial. Those in the CON group will be instructed to take one vinegar pill (provided)
      each day for weeks 1-8 of the trial. Participants will be instructed to maintain their
      current diet and exercise habits during the study.
    

Intervention name(s): liquid vinegar; vinegar pill
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid); Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)
Other intervention name(s): VIN; CON
Intervention MeSH terms: Acetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Qualifying participants will be stratified by gender, age, weight, and waist circumference, then randomized into two groups: the intervention group, vinegar drinks (VIN) or the control group, vinegar pills (CON).
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: randomized clinical trial; vinegar; adiposity; insulin resistance
Dose-Response-Study With a Recombinant Cocktail of Phleum (rPhleum) Allergens
Condition: Type I-Allergy
Study type: Interventional
Phase: Phase 2

Summary: 
      Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen
      (Phleum pratense)
    


Intervention name(s): placebo; rPhleum; rPhleum; rPhleum; rPhleum
Intervention type(s): Drug; Biological; Biological; Biological; Biological
Intervention description(s): Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.; Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg); Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg); Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg); Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
Other intervention name(s): Comparator; Specific Immunotherapy; Specific Immunotherapy; Specific Immunotherapy; Specific Immunotherapy
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ATX-GD-59 in Patients With Graves Disease Not Treated With Anti-thyroid Therapy
Condition: Graves Disease
MeSH terms: Graves Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study to assess the safety and biological activity of ATX-GD-59 in patients with
      Graves Disease not currently treated with anti-thyroid therapy. This will be an open label
      dose titration involving injections on 10 occasions, each two weeks apart. After dosing is
      complete there will be a 12 week follow up period. Blood samples will be drawn throughout the
      study to monitor safety and the body's response to the injections. Thyroid function will be
      measured throughout the trial to monitor Graves disease progression.
    


Intervention name(s): ATX-GD-59
Intervention type(s): Biological
Intervention description(s): Disease specific immune modulating treatment for Graves Disease
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graves Disease; Phase 1
Type 1 Diabetes Data Acquisition and Transfer Adherence Study
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pilot study is to determine if training and support, combined with
      reminders to facilitate glucose data sharing with the diabetes care team in between clinic
      visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have
      HbA1c levels above target.
    


Intervention name(s): Glooko MeterSync
Intervention type(s): Behavioral
Intervention description(s): The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sotagliflozin Bioequivalence Study
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin
      (test) compared to the development tablet of sotagliflozin (reference) under fasting
      conditions in healthy male and female subjects.

      Secondary Objectives:

        -  To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite
           sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test)
           tablet or a single sotagliflozin (reference) table in healthy male and female subjects
           under fasting conditions.

        -  To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet
           compared to a single sotagliflozin (reference) tablet administered under fasted
           conditions in healthy male and female subjects.
    

Detailed description: 
      The study duration per subject will be 36-99 days and will consist of a screening period of 2
      to 21 days, a study period of 7 days for each of four periods, and a washout of 8-21 days
      between each dose administration, and a final follow up visit 10-15 days after final dose
      administration.
    

Intervention name(s): Sotagliflozin (SAR439954)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
In-Use Test With a Cosmetic Product to Treat Pruritus
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the cosmetic features of the product WO 3308 by means of
      a questionnaire in an interview situation after two weeks of product treatment, giving
      special consideration to the cosmetic performance, efficacy and skin compatibility and with
      special focus on the reduction of pruritus. Additionally the tolerance will be evaluated by a
      dermatologist.
    


Intervention name(s): WO 3308 cosmetic product for topical use
Intervention type(s): Other
Intervention description(s): Application on the entire body at least once a day over two weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pruritus; acute pruritus
A Ph 1 Study of Epanova® in Healthy Chineses
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the safety, tolerability, and PK of single and
      multiple doses of Epanova in healthy male and female Chinese subjects and to allow comparison
      of these parameters with the Western population studied to date.
    

Detailed description: 
      This is a single centre, open-label, single- and multiple-dose, PK study in Chinese healthy
      subjects. Approximately 14 subjects will receive a single oral dose of Epanova 4 g followed
      by a 72-hour washout period, and then receive Epanova 4 g orally once daily for 14
      consecutive days. Subjects will undergo screening evaluations to determine eligibility within
      4 weeks (28 days) prior to the first dose of investigational product (IP). Subjects will be
      admitted to the clinical pharmacology unit approximately 48 hours prior to the first dosing
      (Day -2) and will stay at the unit until at least 72 hours (Day 20) after their last dose of
      IP (Day 17). Blood samples will be collected for PK analyses. Subjects will be monitored
      closely for adverse events throughout the study.
    

Intervention name(s): Epanova
Intervention type(s): Drug
Intervention description(s): A single dose of Epanova 4 g will be administered as 4 capsules (each containing 1 g of Epanova) followed by a 72-hour washout period in Chinese healthy subjects. Subsequently, multiple doses of Epanova 4 g will be administered once daily for 14 consecutive days.
Other intervention name(s): Omega-3 carboxylic acids
Intervention model: Single Group Assignment
Intervention model description: Single group
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Safety; Tolerability; Epanova; Omega-3 carboxylic acids; Chinese
Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of
      PF-06473871 in normal healthy adults.
    


Intervention name(s): 80 mg PF-06473871; 160 mg PF-06473871; 320 mg PF-06473871; 480 mg PF-06473871
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 80 mg of PF-06473871 or placebo; 160 mg of PF-06473871 or placebo; 320 mg of PF-06473871 or placebo; 480 mg of PF-06473871 or placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study was to find out how varenicline works to help people quit smoking.
      Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved
      medication that has been shown to help people quit smoking. This study was trying to evaluate
      whether varenicline would change the response to smoking and the desire for cigarettes when
      compared to an inactive placebo control. This was not a quit smoking treatment study, and
      participants were not asked or required to stop smoking while in this study.
    

Detailed description: 
      We proposed the following primary hypotheses:

        1. Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving
           varenicline versus placebo.

        2. Cue-provoked cravings (self-report and physiological responding) would be lower in
           participants receiving varenicline versus placebo. (Secondary indices of craving include
           heart rate and skin conductance.)

        3. The two primary indices of nicotine reward/reinforcement (mCEQ and choice index) would
           be lower in participants receiving varenicline versus placebo. (Secondary indices of
           nicotine reinforcement include smoking topography variables.)

      A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St.
      Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to,
      local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public
      transportation).

      Following the screening session, participants were randomly assigned to receive either
      varenicline or placebo medication.
    

Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants in this group received varenicline according to the schedule in the Arm Description.; Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.
Other intervention name(s): Chantix™
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: tobacco; nicotine; smoking; reward; reinforcement; craving; cues; conditioned stimuli; cue reactivity
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg
      with lanreotide 40mg PR in subjects with active acromegaly.
    


Intervention name(s): Lanreotide Autogel®; Lanreotide Acetate
Intervention type(s): Drug; Drug
Intervention description(s): Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate).; Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection (provided as a sterile injectable lyophilisate of lanreotide acetate).
Intervention MeSH terms: Lanreotide; Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using Social Incentives and Gamification for Weight Loss Promotion
Condition: Weight Loss; Obesity; Physical Activity
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 36-week, three-arm randomized, controlled trial using a team-based model to compare
      two weight loss programs to control. Each intervention will use insights from behavioral
      economics to leverage social incentives and gamification.
    

Detailed description: 
      Obesity is a leading risk factor for morbidity and mortality affecting more than one in three
      adults in the United States. Modifiable health behaviors contribute to this growing epidemic.
      Insights from behavioral economics have shown promise for motivating behavior change through
      the use of financial incentives. However, social incentives or those influences that impact
      individuals to adjust their inherent behaviors based on social ties and connections have not
      been well examined. Social incentives are a more patient-centered approach that leverages and
      enhances the existing connections and influences on the individual. Since one individual's
      behavior change is connected to many others within their network, social incentives have the
      potential to be a scalable intervention that impacts the community. Gamification, or the use
      of game design in non-game situations, is often used in the real world, but its effectiveness
      is unknown. In this study, investigators will conduct a 36-week, three-arm, randomized,
      controlled trial using a team-based model to compare two weight loss programs to control.
      Each intervention will use insights from behavioral economics to leverage social incentives
      and gamification.
    

Intervention name(s): Gamification; Share Data with PCP; Feedback on weight; Feedback on step counts
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): All participants will be entered with their teammate into a game that includes points and levels; Weight and step count data will be shared with the participant's primary care physician; Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.; Participants will use a smartphone application that uses accelerometers within the phone to track step counts and receive feedback on step counts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether fish oils may be of benefit to patients
      with certain heart rhythm disturbances called atrial fibrillation and atrial flutter.

      Atrial fibrillation and atrial flutter are two heart conditions that can be successfully
      treated in the hospital by an ablation (in the case of atrial flutter) or a cardioversion (in
      the case of atrial fibrillation). Ablation involves the application of high frequency energy
      waves to a particular spot in the heart. Cardioversion involves resetting the heart back to a
      normal rhythm with the use of an electric current.

      Fish oil supplements may be of benefit to patients with heart problems. Recent evidence
      suggests that fish oils may benefit those with rhythm disturbances.
    


Intervention name(s): Fish oil
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial mechanical stunning and; atrial electrical remodeling
Improving Driving in Young People With Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the effects of treatment with the anti-anxiety medicine buspirone on
      driving performance (eye tracking) in individuals with high-functioning autism spectrum
      disorder (HF-ASD).

      The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as
      two Driving Simulation visits that will take place at Massachusetts Institute of Technology
      (MIT). Subjects will be given buspirone and asked to take the medication for the two days
      preceding the Driving Simulation Visit.
    


Intervention name(s): Buspirone
Intervention type(s): Drug
Intervention description(s): Buspirone is an atypical anxiolytic medication.
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Autism Spectrum Disorder; ASD; Anxiety