bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate P2X7 Receptor Occupancy by JNJ-54175446 With the Newly Developed P2X7 Receptor Positron Emission Tomography (PET) Tracer 18F-JNJ-64413739
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to measure the whole body distribution and radiation
      dosimetry of 18F-JNJ-64413739 (Part A), to measure the uptake, distribution, and clearance
      (CL) of 18F-JNJ-64413739 in the brain of healthy male subjects by Positron Emission
      Tomography (PET) and to model tissue specific kinetics of 18F-JNJ-64413739 with the
      appropriate input function (IF) (Part B), to measure subject test retest variability in the
      distribution of 18F-JNJ-64413739 in the brain of healthy male subjects by comparing PET scans
      obtained at least 1 week apart (Part C) and following single oral dose administration of
      JNJ-54175446, to measure the blocking of 18F-JNJ-64413739 uptake in the brain at the time to
      reach maximum plasma concentration (tmax) of JNJ-54175446 and model the exposure/receptor
      interaction of JNJ-54175446 in healthy male subjects (Part D).
    


Intervention name(s): JNJ-54175446; 18F-JNJ-64413739
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-54175446 up to 600 mg suspension for oral dose administration.; 18F-JNJ-64413739 fluid for injection administered intravenously.
Intervention MeSH terms: (18)F-JNJ-64413739
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Participants With Limb Girdle and Facioscapulohumeral Muscular Dystrophy (FSHD)
Condition: Facioscapulohumeral Muscular Dystrophy; Limb Girdle Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophies, Limb-Girdle; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      ATYR1940-C-006 is a multi-national, multicenter study being conducted at centers in the
      United States (US) and Europe who participated in Study ATYR1940-C-003 (Stage 1 only) or
      Study ATYR1940-C-004 (that is, the parent studies).
    

Detailed description: 
      Study ATYR1940-C-006 is a multi-national, multi-center, open-label extension study designed
      to evaluate the long-term safety, effects on muscle, and pharmacodynamics of ATYR1940 in
      participants with Limb-girdle muscular dystrophy (LGMD) or FSHD previously treated in the
      Study ATYR1940-C-003 (Stage 1 only) or Study ATYR1940-C-004 that is, the parent studies).
      This study will be conducted at the same study centers at which participants were enrolled in
      the parent studies.

      Participants who completed the treatment period in the parent study and, in the
      Investigator's opinion, demonstrated acceptable tolerability of ATYR1940, are considered by
      the Investigator to be compliant with ATYR1940 and the study procedures, and do not meet any
      criterion for ATYR1940 discontinuation are eligible for participation in the current study,
      contingent upon Investigator and participant agreement to continue ATYR1940 treatment.

      For the first 12 weeks in this extension study, participants will receive ATYR1940 at the
      highest tolerated dose received in the parent study; no dose adjustments are allowed during
      this 12-week period. After 12 weeks, if the participant is demonstrating good tolerability,
      the ATYR1940 dose may be increased on a participant-specific basis at the Investigator's
      discretion, in consultation with the Sponsor and Medical Monitor. ATYR1940 dose increases to
      >3.0 mg/kg are not permissible.

      All participants will receive ATYR1940 on a weekly basis in this study, regardless of the
      frequency of dosing in the parent study. ATYR1940 will be administered via intravenous (IV)
      infusion over 90 minutes. If medically indicated, the infusion duration and volume may be
      adjusted at the Investigator's discretion in consultation with the Medical Monitor and
      Sponsor.
    

Intervention name(s): ATYR1940
Intervention type(s): Drug
Intervention description(s): Concentrate for solution for infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FSHD; LGMD
Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory
      Bowel Disease.
    

Detailed description: 
      Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium
      picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing
      diagnostic or follow-up routine colonoscopy.
    

Intervention name(s): Endoscopy
Intervention type(s): Procedure
Intervention description(s): Colonoscopy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colonoscopy; Inflammatory Bowel Diseases
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to characterize the absorption, metabolism, and excretion of AG-120
      using radiolabeled drug in healthy adult male subjects to support its further development and
      registration.
    

Detailed description: 
      This will be a single-center, open-label, study in healthy adult males. Each subject will
      participate in a screening phase, a baseline phase, a treatment phase, and a follow up
      period. Subjects who have met all inclusion criteria and none of the exclusion criteria at
      screening will return to the clinical site on Day -1 for baseline assessments. Following a 10
      hour overnight fast, subjects will receive a single 500mg dose of AG-120 suspension
      containing a microtracer of [14C] AG-120 (~ 200 μCi) under fasted conditions. The study drug
      will be administered as an oral suspension with approximately 240 mL of room temperature,
      non-carbonated water.

      Blood, urine, and fecal samples (and vomitus, if applicable) will be collected throughout the
      study for pharmacokinetic (PK), mass balance, and/or clinical laboratory assessments. Safety
      will be monitored throughout the study. Subjects will be discharged from the clinical site
      from Day 22 to Day 29, depending on the recovery of eliminated radioactivity.

      Urine and fecal samples will be collected each day until Day 29 (or the point of discharge if
      earlier) for measurement of total [14C] radioactivity. Blood samples for radioanalysis and PK
      assessment, inclusive of metabolite profiling/characterization, will be collected at pre-dose
      and at specified intervals through Day 29. Total [14C]-radioactivity in whole blood, plasma,
      urine, and feces (and vomitus, if applicable ) will be determined.

      Up to 8 subjects will enroll in the study. One to two additional subjects who have been
      confirmed as having poor metabolizer (PM) CYP2D6 genotype may be enrolled.
    

Intervention name(s): [14C]-AG-120
Intervention type(s): Drug
Intervention description(s): Labeled investigational drug
Intervention MeSH terms: Ivosidenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
CAR-GPC3 T Cells in Patients With Refractory Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      This study is designed to determine the safety and efficacy of CAR-GPC3 T cells in patients
      with relapsed or refractory hepatocellular carcinoma. Single or multiple doses of
      GPC3-targeted CAR T cells will be given to subjects with unmet medical needs for which there
      are no effective therapies known at this time.
    

Detailed description: 
      A single arm, open-label pilot study is designed to determine the safety, tolerability and
      engraftment potential of CAR-GPC3 T cells in patients with GPC3-positive hepatocellular
      carcinoma.

      Primary objectives:

      Determine the safety, tolerability and cytokinetics of the autologous T cells transduced with
      the anti- GPC3 lentiviral vector in patients with hepatocellular carcinoma.

      Secondary objectives:

      Make a preliminary evaluation on the efficacy of CAR-GPC3 T cells in patients with
      hepatocellular carcinoma by the following parameters:

      Objective response rate (ORR); Disease Control Rate (DCR); Time of tumor progression (TTP);
      Overall survival (OS).
    

Intervention name(s): CAR-GPC3 T cells
Intervention type(s): Genetic
Intervention description(s): Self-controlled dose escalation will be applied to the first 3 - 6 subjects enrolled.
Classical "3+3" dose escalation will be applied to subsequent subjects based on the self-controlled dose escalation study.
Other intervention name(s): GPC3 Redirected Autologous Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients with previously untreated diffuse large B-cell lymphoma will receive standard
      treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison)
      for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times
      daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment is
      invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD
      20-expression.

      Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels
      are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the MTD.
    


Intervention name(s): Valproate; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Valproate is given in escalating doses to establish maximum tolerable dose when given together with standard treatment in patients with diffuse large B-cell lymphoma; this is the phase I part of the study. When maximum tolerable dose is established, this dose will be given to remaining patients in the phase II part of the study.; Vill be given intravenously, 375 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.; Vill be given intravenously, 750 mg/m2, every second or third week depending on cycle length (14 or 21 days) for a total of 6 cycles.; Vill be given intravenously, 50 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.; Vill be given intravenously, 1.2 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.; Vill be given orally, 50 mg/m2, day 1-5 every cycle, for a total of 6 cycles.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Valproic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; Diffuse large B-cell lymphoma; Valproate; R-CHOP; CD 20
Effect of B-GOS on GI Discomfort in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the effects of a new food supplement which is currently
      available in the market, called Bimuno® (B-GOS), on gastrointestinal discomfort (e.g.
      bloating, abdominal pain/cramp and flatulence) in adults who often experience these symptoms
      but are otherwise healthy.

      About 400 volunteers will take part in this study, which will last 6 weeks (to include 4
      weeks treatment and 2 weeks follow up period).

      Episodes of abdominal pain or discomfort (e.g. bloating, abdominal pain/cramp and
      flatulence), in the absence of diseases, are commonly associated with food or drug intake or
      with alterations of bowel habit and vary between individuals in frequency and severity.

      Some dietary ingredients are known to reduce these symptoms. We have used B-GOS previously in
      trials with healthy younger and older adults and we have observed a trend towards reducing
      abdominal bloating. However, the investigators have not tested B-GOS in healthy adults who
      often experience these symptoms and this is what we will investigate now.
    


Intervention name(s): B-GOS; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Bimuno; corn syrup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional

Summary: 
      The purpose of this study is to describe relationships among whey protein and its hydrolysate
      when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in
      healthy young adults.
    

Detailed description: 
      A randomized, cross-over design study was conducted. Whey protein preloads (5-40 g) and
      hydrolysate whey protein (10 g) were provided in 300 ml water. At 30 min following
      consumption, subjects were fed a preset pizza meal (12 kcal/kg, experiment 2). Satiety,
      insulin and blood glucose were measured at baseline and selected intervals pre- and
      post-meal.
    

Intervention name(s): dietary intervention; water control
Intervention type(s): Other; Other
Intervention description(s): whey protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Whey protein; Hydrolysate whey protein; Blood glucose; Insulin
Acceptance and Commitment Therapy Versus Cognitive Therapy for the Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The study will investigate the effectiveness of Cognitive Therapy and Acceptance and
      Commitment Therapy in a randomized controlled trial among patients with Major Depressive
      Disorder in routine clinical practice. Furthermore, the study will investigate whether each
      specific treatment approach is mediated by its proposed theoretical mechanism.
    

Detailed description: 
      The current study aims at investigating the effectiveness of Cognitive Therapy and Acceptance
      and Commitment Therapy in a randomized controlled trial among patients with MDD in routine
      clinical practice. Further, the study will investigate whether each specific treatment
      approach is mediated by its proposed theoretical mechanism. Patients have to meet diagnostic
      criteria for nonpsychotic MDD as determined by the Structured Interview for DSM-IV. Each
      client will receive either Cognitive Therapy or Acceptance and Commitment Therapy that will
      last between 16 to 20 sessions. Based on previous results, it is expected that both treatment
      forms will prove beneficial for the patients.
    

Intervention name(s): Cognitive Therapy; Acceptance and Commitment Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This interventions will target: (a) behavioral dysfunction, (b) situation-specific negative thinking and cognitive distortions, and (c) underlying dysfunctional beliefs or cognitions assumed to be related to the patient's current depression and risk of future depression. A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.; This interventions will use (a) acceptance, (b) commitment, (c) mindfulness, and (d) behavior change processes to produce reduction of depressive symptoms. A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.
Other intervention name(s): Cognitive behavior therapy; cognitive behaviour therapy.; Mindfulness-based interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to determine the effectiveness of fluoride varnishes in the
      prevention of dental caries lesions in erupting permanent first molars, in high-risk
      patients. Using as reference ICDAS criteria, when the success means that the surface maintain
      an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.

      Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental
      caries.

      Study design: It proposed an experimental design randomized into 3 groups according to the
      frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month;
      Group C: positive control).
    


Intervention name(s): Fluoride Varnish; Control Group
Intervention type(s): Drug; Drug
Intervention description(s): Application of fluoride varnish every 3 and 6 months.; Twice a day brush with fluoride toothpaste.
Other intervention name(s): Duraphat (Colgate); Colgate Total Toothpaste
Intervention MeSH terms: Listerine; Fluorides; Fluorides, Topical; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Dental Caries; Fluoride Varnish; Preschool child; Prevention
Efficacy of Mw Vaccine in Treatment of Severe Sepsis
Condition: Severe Sepsis; Septic Shock; Immune Modulation
MeSH terms: Sepsis; Toxemia; Shock, Septic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is
      likely to increase survival in patients with severe sepsis.

      Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving
      survival and the recovery of organ function in patients with severe sepsis. This will be
      assessed with the help of the following

        -  Mortality in the two arms

        -  Daily SOFA scores

        -  Ventilator free days

        -  Time-to-vasopressor withdrawal

        -  ICU length of stay

        -  Hospital length of stay METHODS This will be a proof of the concept study to assess the
           effect of Mycobacterium w in combination with standard therapy versus standard therapy
           alone on the inflammatory profile in sepsis due to gram negative infection. A total of
           25 patients will be enrolled in each group. The patients will be randomized in balance
           to receive either test drug or its placebo along with the standard of care
    

Detailed description: 
      This will be a proof of the concept study to assess the effect of Mycobacterium w in
      combination with standard therapy versus standard therapy alone on the inflammatory profile
      in sepsis due to gram negative infection. The study will be conducted in the respiratory
      intensive care unit at PGIMER, Chandigarh, over a period of 1 year. A total of 25 patients
      will be enrolled in each group. The patients will be randomized in balance to receive either
      test drug or its placebo along with the standard of care

      In addition to the standard therapy for sepsis, patients randomized to test arm will receive
      single daily dose of 0.3 ml of Mw intra-dermal for 3 consecutive days while patients
      randomized to control arm will receive single daily dose of 0.3 ml of Mw-placebo intra-dermal
      for 3 consecutive days.

      Study Duration Study duration for each patient will be 28 days. Follow up period is included
      in the study duration of 28 days

      Study Outlines and Timing of Visits Eligible patients will be enrolled after due consent and
      randomized to one of the treatment arms. The enrolled patients will be monitored for any
      adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All
      patients will continue to receive standard therapy till considered requisite
    

Intervention name(s): Mw, 0.3ml x three days sc; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mw; Mycobacterium indicum prannii; Mycobacterium w; Severe sepsis; Septic shock
Ibuprofen 4% (w/v) Pivotal Bioequivalence Study
Condition: Bioequivalence of the Test Formulation
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence evaluation of Nurofen for Children® with reference formulation of Algifor®
      Junior by determining and comparing the rate and extent of absorption in both fed and fasted
      states
    


Intervention name(s): Nurofen for Children®; Algifor® Junior
Intervention type(s): Drug; Drug
Intervention description(s): Nurofen for Children® 400 mg/10 ml; Algifor® Junior 400 mg/20 ml
Other intervention name(s): NfC®; Ibuprofen oral suspension
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science