bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Risperidone and Olanzapine on Patients With Schizophrenia, Schizoaffective Disorder, Major Depression or Bipolar Disorder
Condition: Schizophrenia; Schizoaffective Disorder; Depressive Disorder, Major; Bipolar Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Bipolar Disorder; Psychotic Disorders; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This twelve month, open-label study considers the effect of Risperdal (risperidone) versus
      Zyprexa (olanzapine) on weight gain, physical health, and outcome in a population of those
      diagnosed with schizophrenia, schizoaffective disorder, major depression or bipolar disorder
      with psychotic features. This study evaluates symptom response as well as general health
      indicators such as body mass index, glucose, prolactin, and cholesterol levels at baseline,
      month (M)1, M3, M6 and M12.
    


Intervention name(s): olanzapine versus risperidone
Intervention type(s): Drug
Intervention description(s): Participants are to be randomized to olanzapine or risperidone. Antipsychotic medication will be given as per package insert daily for the twelve month duration of the trial.
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depression with psychotic features; bipolar disorder with psychotic features
A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will test the hypothesis that CF102 can safely and effectively suppress viral load
      in patients with chronic hepatitis C and high circulating levels of virus. The trial will
      monitor the safety of twice-daily oral dosing with CF102 over a 16-week period; will measure
      changes in viral load during therapy; and will measure blood concentrations of CF102 at
      various time points during dosing.
    

Detailed description: 
      This is a Phase 1/2, randomized, double-blind, placebo-controlled, dose-escalation study of
      subjects with chronic hepatitis C genotype 1. Eligible subjects will be assigned in a 3:1
      ratio (8 subjects in each cohort) to receive qd or bid treatment for 15 days with oral CF-102
      or with placebo. Dose escalation will occur in 2 sequential cohorts.

      The decision to continue dosing within a cohort (eg, Subcohort 1a to Subcohort 1b), or to
      escalate to a new dose level Cohort (eg, Subcohort 1b to Subcohort 2a) will be determined by
      a blinded independent review of safety data. This review will be conducted by a qualified
      Safety Review Committee comprising the medical monitor, the consulting toxicologist, and an
      independent expert clinician.

      For the first 2 cohorts, subjects will return to the study center for follow-up assessments
      on Days 8, 15, and 22. Subjects dosed qd will receive a total of 15 doses of CF-102. Subjects
      dosed bid will receive a total of 29 doses. The 30th dose has been deleted to accommodate PK
      sampling on the morning of Day 16, 24 hours after the last dose of CF-102.

      For the 3rd cohorts, subjects will return to the study center for follow-up assessments on
      weeks 2, 4, 8, 12, 16 and 18.
    

Intervention name(s): CF 102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsules; Matching placebo capsules
Other intervention name(s): Cl-IB-MECA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; Viral hepatitis
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
Condition: PTSD
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of
      30 milligrams (mg) in participants with PTSD.
    

Detailed description: 
      The crossover study consists of two treatment periods of 15 days duration. On Day -1 or Day 1
      of Treatment Period 1, eligible participants will be randomized (1:1) to a sequence of
      treatments (either Lu AG06466-placebo or placebo-Lu AG06466) with 15 participants are planned
      per sequence. Each treatment period will be separated by a washout period of ≥7 and ≤14 days.
    

Intervention name(s): Lu AG06466; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period; Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine
      hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and
      diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration
      under fasted condition in healthy adults subjects.

      To assess the safety and tolerability of the investigational products in terms of advent
      events (AEs) and clinical parameters.
    


Intervention name(s): Naproxen sodium and diphenhydramine hydrochloride soft capsules; Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules); Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)
Intervention MeSH terms: Diphenhydramine; Promethazine; Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers
Condition: Safety in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending-dose study
      of subcutaneously administered XmAb27564 or placebo in healthy male and female subjects.
    

Detailed description: 
      This study will determine the safety and tolerability, pharmacokinetics, and pharmacodynamics
      of single ascending doses of XmAb27564 in normal healthy volunteers. XmAb27564 is an
      engineered IL-2 mutein being developed for autoimmune diseases.
    

Intervention name(s): XmAb27564; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending dose of XmAb27564; Single dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Safety, Pharmacokinetics and Acceptability of PC-1005 for Vaginal Use
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 clinical trial will evaluate MIV-150, a third generation non-nucleoside reverse
      transcriptase inhibitor, co-formulated with a potentially potent agent, zinc acetate for the
      prevention of HIV infection in women. This is the first in-human of PC-1005 (MIV-150/zinc
      acetate in a carrageenan gel), the first study in which females will be exposed to MIV-150,
      the first time MIV-150 will be administered topically, and the first time MIV-150 will be
      administered intravaginally.
    

Detailed description: 
      This study will begin with a safety run-in, which is an open label, single-arm safety run-in
      with 5 women receiving PC-1005 once daily for 3 consecutive days. Safety and pharmacokinetics
      will take place after each dose. the participants from the run-in will not be eligible for
      the main study.

      The main study participants will be randomized 4:1 to the study gels: 24 randomized to
      PC-1005 (active) and 6 randomized to HEC gel (placebo). The study product will be applied
      vaginally once daily for 14 days with clinical and laboratory assessments at baseline
      (enrollment) and after the 1st, 2nd, 8th, 9th, and 14th doses, and a safety follow-up visit 7
      days after the 14th dose.

      Participants in the run-in and main study will be requested to be sexually abstinent starting
      immediately after the Screening Visit until study exit.
    

Intervention name(s): PC-1005; HEC gel
Intervention type(s): Drug; Drug
Intervention description(s): Intravaginal use
Other intervention name(s): MIV-150/zinc acetate in a carrageenan gel; hydroxyethylcellulose gel; placebo gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers
Condition: Coronavirus
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First In Human study designed to assess the safety, tolerability and
      pharmacokinetics of EIDD-2801 in healthy human volunteers.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, First-in-Human study designed to
      evaluate the safety, tolerability, and pharmacokinetics of EIDD-2801 following oral
      administration to healthy volunteers.
    

Intervention name(s): EIDD-2801; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1:
Participants will be randomized to receive a single oral dose of EIDD-2801 or Placebo.
Part 2:
Two single oral doses of EIDD-2801 will be administered to participants, in an open-label manner.
Part 3:
Participants will be randomized to receive twice daily dosing either EIDD-2801 or Placebo.; Part 1:
Participants will be randomized to receive a single oral dose of EIDD-2801 or Placebo.
Part 3:
Participants will be randomized to receive twice daily dosing either EIDD-2801 or Placebo.
Other intervention name(s): Molnupiravir
Intervention MeSH terms: Molnupiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Coronavirus; EIDD-2801; ribonucleoside
Peripheral Metabolic Effects of Ghrelin
Condition: Healthy Controls
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and
      lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that
      ghrelin infusion causes insulin resistance and lipolysis.
    


Intervention name(s): Ghrelin
Intervention type(s): Drug
Intervention description(s): Solvent, cont. infusion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Evaluation on Immunogenicity and Safety Profile of Trivalent OPV (tOPV Bio Farma)
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to compare the antibody response 30 days after two doses of t
      OPV
    

Detailed description: 
      The trial design is phase II, randomized, double blind, prospective intervention study. The
      subject study are 240 healthy, full term, newborn infants.
    

Intervention name(s): tOPV pilot batch; tOPV commercial batch
Intervention type(s): Biological; Biological
Intervention description(s): the tOPV vaccine is given orally; tOPV vaccine is given orally
Other intervention name(s): tOPV (Bio Farma); tOPV (Bio Farma)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: tOPV; Antibody response; Safety
Vitamin D Supplementation in Children
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Prevalence of vitamin D deficiency in children in the northern country during winter season
      is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended
      in Polish children from September till April. However, there is shortage of studies in Polish
      children. The aim of the study is to assess the effectiveness of vitamin D supplementation in
      the prevention of vitamin D deficiency in Polish children (4-10 years of age).
    

Detailed description: 
      Prevalence of vitamin D deficiency in children in the northern country during winter season
      is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended
      in Polish children from September till April. However, there is shortage of studies in Polish
      children.

      Aims:

        1. Assessment of the impact of vitamin D intake at a dose of 1000 IU / day on vitamin D
           status in children aged 4-10 years.

        2. Evaluation of the effectiveness of supply of vitamin D at a dose of 1000 IU / day in
           preventing vitamin D deficiency and maintaining optimal vitamin D status ( 25OHD level
           >30ng/ml)

        3. Evaluation of vitamin D status depending on age, BMI and body composition.

        4. Assessing the safety and tolerability of mel ● tiki vitamin D in children. Material:
           Children aged 4-10 years Study desing: Prospective intervention trial Intervention:
           cholecalciferol at a dose 1000 IU/day for 3 months

      Methods:

        1. Analysis of clinical characteristics (attendance at kindergarten / school, consumption
           of products rich in vitamin D, exposure to sun, use of sunblock's, the overall child's
           health (chronic diseases, medications, vitamins, micronutrients)

        2. Anthropometric measurements (body weight, height, BMI, assessment of body fat content -
           body composition by bioimpedance method- TANITA)

        3. Assessment of vitamin D status (serum total 25OHD concentration in blood serum by
           immunochemiluminescence method)

        4. Collecting data on the tolerability and safety of meliki ● tiki vitamin D including
           possible symptoms of vitamin D overdose
    

Intervention name(s): cholecalciferol
Intervention type(s): Dietary Supplement
Intervention description(s): supplementation at a dose 1000 IU/d
Intervention MeSH terms: Cholecalciferol; Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cholecalciferol; BMI; winter
The Effect of Solifenacin on Post Void Dribbling in Women
Condition: Post-micturition Incontinence; Incontinence
Study type: Interventional

Summary: 
      This is a double-blind, randomized, controlled, parallel design (n=140) study with the
      purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void
      Dribbling.
    

Detailed description: 
      This investigation will have a double-blind, randomized, and controlled, parallel design with
      the % reduction in post void dribbling episodes (events) as the primary endpoint.

      Secondary endpoints will include:

        1. The % of patients with at least a 50% reduction in post void dribbling episodes.

        2. Patient's perspective of the impact of their disease, which will be captured using the
           Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary
           symptoms and quality of life.

      We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects
      in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas
      Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The
      Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo
      group blinding both the subjects and investigators
    

Intervention name(s): solifenacin
Intervention type(s): Drug
Intervention description(s): patient will receive solifenacin 5mg daily or placebo daily
Other intervention name(s): vesicare
Intervention MeSH terms: Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
Condition: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder; Schizophrenia
MeSH terms: Tobacco Use Disorder; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals
      without schizophrenia. While a great deal of research has been focused on smoking cessation
      programs for healthy individuals, little attention has been directed towards developing an
      effective smoking cessation treatment for schizophrenics. This project will evaluate the
      effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine
      withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking
      non-psychiatric control smokers.
    

Detailed description: 
      Nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60
      percent of schizophrenics smoke cigarettes. Nicotine withdrawal may cause a temporary
      worsening of schizophrenia symptoms, making it especially difficult for these individuals to
      quit smoking. Little research has been done on the most effective way to control nicotine use
      in schizophrenic individuals. Transdermal nicotine and bupropion reduce smoking in
      non-psychiatric smokers, but little is known about the effects of these medications in
      smokers with schizophrenia. This project examines the effects of 0, 21 and 42 mg transdermal
      nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine
      withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking
      controls. Participants come to the laboratory at 9 am, at which time placebo or nicotine
      patches are applied. After 5 hrs of smoking abstinence, participants undergo a smoking cue
      reactivity assessment in which craving and withdrawal symptoms are measured after viewing and
      handling neutral cues and smoking cues. This is followed by 90 min period in which
      participants can smoke freely, and smoking topography variables are measured.
    

Intervention name(s): Transdermal Nicotine Patch; 21 mg transdermal nicotine; placebo patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 42 mg transdermal nicotine
Other intervention name(s): nicotine patch; nicotine patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nicotine Dependence; Tobacco Dependence
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
Condition: Peanut Hypersensitivity; Food Hypersensitivity; Immediate Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to explore the safety and efficacy of a sublingual (under the
      tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in
      inducing desensitization and long term tolerance in children with persistent peanut allergy.
    

Detailed description: 
      To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21
      years with: (1) a convincing clinical history of peanut allergy (PA), (2) a serum
      immunoglobulin E (IgE) specific to peanut of >0.35 kilo units per liter (kU/L) and a skin
      prick test (SPT) wheal >3 mm, will be enrolled. Subjects will be recruited from the Johns
      Hopkins Pediatric Allergy Clinic.

      Participants will undergo an initial screening visit that will include a medical history,
      physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At
      the next two visits, 20 participants will complete a double-blind placebo-controlled food
      challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One
      group will receive active SLIT with placebo OIT and the other group will begin active OIT
      with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo
      SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12
      months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those
      patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge
      will be administered at the end of this period.

      Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as
      longitudinal controls for the mechanistic studies. These subjects will follow a modified
      schedule compared to those subjects receiving study treatment and will be evaluated by
      phlebotomy, end point titration prick skin testing, and saliva collection. These patients
      will continue strict avoidance of peanut unless otherwise advised by their personal
      physician.
    

Intervention name(s): Peanut powder; Peanut extract; Placebo extract; Placebo powder
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Delivered orally; Delivered sublingually; Delivered sublingually; Delivered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peanut Allergy
Impact of Three Different Gonadotrophin Regimes on Egg Donation Program
Condition: Ovarian Stimulation
Study type: Interventional
Phase: Phase 4

Summary: 
      Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian
      Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long
      protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group
      II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte
      recipients was compared.
    


Intervention name(s): r-FSH; HP-hMG; r-FSH plus HP-hMG
Intervention type(s): Drug; Drug; Drug