bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Infertility in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Infertility; Pregnancy
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women.
      The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair,
      acne, and infertility. This study will test a combination of medications in women with PCOS
      to determine which works best to overcome infertility.
    

Detailed description: 
      PCOS is characterized by excess circulating androgen levels and chronic anovulation. The
      fundamental pathophysiologic defect is unknown, but PCOS is characterized by insulin
      resistance and compensatory hyperinsulinemia. Improvements in insulin sensitivity in PCOS
      women, either through lifestyle changes or through pharmaceutical intervention, have
      consistently resulted in a marked improvement in the reproductive and metabolic abnormalities
      in PCOS. Resumption of ovulation occurs in up to 70% of women treated for PCOS. This study
      will evaluate the safety and effectiveness of clomiphene citrate and metformin XR in
      achieving a successful pregnancy in infertile PCOS women.

      Women with PCOS who are seeking pregnancy will be enrolled in this study. Women will be
      randomized to one of three different treatment arms: A) metformin XR 1000 mg twice/day; B)
      clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle); or C) metformin XR 1000 mg
      twice/day with clomiphene citrate 50 mg/day for 5 days (day 3-7 of cycle). Women will
      continue on study medications for 30 weeks, 6 treatment cycles, or until they become
      pregnant. Progesterone levels will be drawn weekly to monitor ovulation.
    

Intervention name(s): metformin XR; clomiphene citrate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to
      antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an
      inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo
      + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study
      consisted of approximately 2 weeks of screening and washout followed by 8 weeks of
      double-blind treatment followed by a 1 week safety follow-up.
    


Intervention name(s): Placebo; Cariprazine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo was supplied in capsules; Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder; Depression
Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and the acceptability of low-residue
      diet package (Enimaclin®) as diet control before colonoscopy.
    

Detailed description: 
      In this study, we investigate a randomized, single-blinded, comparative study to evaluate the
      efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control
      before colonoscopy.
    

Intervention name(s): Enimaclin®; Self-controlled diet; 2L PEG-ELS; low volume 1.5L PEG-ELS
Intervention type(s): Dietary Supplement; Other; Drug; Drug
Intervention description(s): Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal.
The duration of study is one day before colonoscopy.; Self-controlled low residue diet.; Normal volume of PEG-ELS; Low volume PEG-ELS
Other intervention name(s): Enimaclin Colomil ®,a low-residue diet package; Self-controlled low residue diet.; Taiwan name: Niflec powder; Taiwan name: Niflec powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Diet Control before Colonoscopy
Photocil (Topical) for the Treatment of Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional

Summary: 
      Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B
      (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from
      non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light
      in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the
      safety and efficacy of Photocil in the treatment of vitiligo.
    

Detailed description: 
      NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported
      to be safe and effective in numerous clinical trials. Clinical trials have reported
      achievement of Vitiligo Area Severity Index (VASI)-75 in 50-70% of patients after 4-6 weeks
      of NB-UVB treatment.

      Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB
      phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks
      or more) performed at a specialized phototherapy clinic combined with high cost and low or no
      reimbursement make compliance and access a major drawback.

      In order to address the drawbacks of phototherapy, we developed a novel topical cream -
      Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with
      natural sunlight, Photocil provides a convenient alternative to traditional clinic based
      phototherapy; thus, has the potential to dramatically increase patient compliance and
      treatment outcome.
    

Intervention name(s): Photocil for Vitiligo; Placebo - Sunscreen (SPF 2)
Intervention type(s): Drug; Other
Intervention description(s): Photocil for Vitiligo; Placebo - Sunscreen (SPF 2)
Other intervention name(s): Photocil for Vitiligo (U.S. FDA NDC: 54841-001-01)
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
Condition: Alcohol Consumption
MeSH terms: Emergencies; Alcohol Drinking
Study type: Interventional

Summary: 
      Alcohol misuse amongst youth is a significant clinical and public health problem. The
      Emergency Department (ED) is an important setting for the treatment of alcohol-related
      problems as it is often the first point of contact between youth, their families, and the
      healthcare system. This pilot study will assess the feasibility and acceptability of a
      computer-based intervention in the ED for youth with alcohol-related presentations. The
      investigators research team will: (1) evaluate the methodological and operational processes
      involved in study recruitment and intervention implementation, (2) determine recruitment and
      retention rates, and (3) obtain preliminary data on the difference in alcohol consumption at
      different time points. The clinical and health service implications of this research will be
      used to plan further investigations designed to improve the standard of ED care among youth
      aged 12 to 16 with alcohol-related presentations. This research will also help optimize the
      planning and development of a full-scale randomized controlled clinical trial of a
      computer-based intervention designed to reduce higher-risk alcohol consumption and
      alcohol-related health and social problems in this target population.
    


Intervention name(s): Computer-based PAF; Computer-based Sham
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention includes standard medical care followed by receipt of computer-based Personalized Assessment Feedback (PAF). PAF is a type of brief intervention that targets norm misperceptions, for example summarizing a person's drinking in comparison to the average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.; This intervention includes standard medical care followed by receipt of a computer-based sham. The sham is similar in format and duration as the computer-based Personalized Assessment Feedback but will engage youth in nutrition and exercise-related questions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol consumption; personalized assessment feedback; youth; emergency department
Duration of Use of Highly Effective Reversible Contraception
Condition: Pregnancy
Study type: Observational

Summary: 
      To assess the proportion of women who use HERC for ≥2 years of duration
    


Intervention name(s): Mirena (Levonorgestrel IUS, BAY86-5028); ParaGard; Implanon/Nexplanon
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Levonorgestrel-releasing intrauterine device 20 mcg/day; Copper T380A; Etonorgestrel contraceptive implant
Intervention MeSH terms: Levonorgestrel; Etonogestrel
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who had an IUD or contraceptive implant inserted at the University of Utah healthcare
        system
Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate how safe Budigalimab is and how it moves within the body in adult
      participants with HIV-1 infection.

      Budigalimab is an investigational drug being evaluated for the treatment of Human
      Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups
      and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous
      (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will
      be enrolled in the study in approximately 9 sites worldwide.

      Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1
      and will be followed for 24 weeks.

      Participants will attend weekly to every two and every four weeks visits during the study at
      a hospital. The effect of the treatment will be checked by medical assessments, blood tests
      and checking for side effects. There may be higher treatment burden for participants in this
      trial.
    


Intervention name(s): Budigalimab; Placebo; Budigalimab; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous (SC); Subcutaneous (SC); Intravenous (IV); Intravenous (IV)
Other intervention name(s): ABBV-181; ABBV-181
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus (HIV); Budigalimab; ABBV-181
A SAD, MAD, and FE Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of FM101 in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This a double blind, randomized, placebo controlled, single and multiple ascending dose
      (SAD/MAD) study in healthy subjects. Safety evaluation will include adverse events (TEAEs),
      clinical laboratory values, vital signs, ECGs, and physical examinations.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study in healthy volunteers designed
      to assess the safety, tolerability and PK of FM101. This study will consist of 3 parts: a SAD
      part, a single dose FE part and a MAD part. Each subject is to participate in only 1 part of
      the study.
    

Intervention name(s): Single ascending doses of FM101; Multiple ascending doses of FM101; Food effects of FM101
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The study drug (FM101 and placebo comparator) will be administered orally as SAD doses; The study drug (FM101 and placebo comparator) will be administered orally as MAD doses; The study drug (FM101) will be administered orally under fasted condition and fed condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Post-marketing Study to Evaluate the Efficacy of Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      As a result of the recent supply shortages in the U.S., as well as an anticipated increase in
      demand during the coming years, GSK Biologicals is pursuing licensure of Fluarix in the U.S.
      under the accelerated approval process; marketing approval most likely will be granted before
      the start of this clinical trial. GSK proposes to support U.S. licensure of Fluarix with this
      confirmatory post-marketing study. The purpose of the study is to evaluate the efficacy of a
      single dose of Fluarix in preventing influenza in adults during the 2005/2006 Influenza
      season.
    


Intervention name(s): Influenza vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of
      RPC1063 in RMS.
    

Detailed description: 
      The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics
      profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following
      multiple-dose administration of the two different dosing regimens that are being evaluated in
      the Phase 3 RMS studies.
    

Intervention name(s): RPC1063
Intervention type(s): Drug
Intervention description(s): Oral capsule daily
Intervention MeSH terms: Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: MS; RMS; Multiple Sclerosis; Relapsing Multiple Sclerosis
Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly
      Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a
      complication of diabetes.
    

Detailed description: 
      Primary objective: To Evaluate the Safety and Tolerability of G-Pen™ (Glucagon Injection) 1
      mg

      Secondary objective (1): To Evaluate the pharmacodynamics (Efficacy) of G-Pen™ (Glucagon
      Injection) 1 mg

      Secondary objective (2):To compare the pharmacokinetics of G-Pen™ (glucagon injection) 1mg
      [test] administered as 0.5 mg and 1 mg injections, versus Lilly Glucagon™ (glucagon for
      injection [rDNA origin]) 1 mg (reference)
    

Intervention name(s): G-Pen(TM) 1 mg; Lilly Glucagon(TM) 1 mg; G-Pen(TM) 0.5 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypoglycemia; Glucagon
ReShape Intragastric Balloon for the Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      A prospective, non-randomized, open-label, multi-center study designed to implant up to
      twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index
      (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within
      their labeled indications and as per their instructions for use. Enrolled patients will be
      followed for seven months. The patient will be prescribed a controlled diet, exercise and
      counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to
      900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of
      placement and removal required).
    


Intervention name(s): ReShape Duo Balloon
Intervention type(s): Device
Intervention description(s): ReShape Duo Balloon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; intragastric balloon
Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      This multi-center, post-marketing, observational study evaluates the real world safety and
      effectiveness of glecaprevir plus pibrentasvir use in participants infected with the
      hepatitis C virus genotype 1 - 6.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Japan patients infected with hepatitis C virus and treating with glecaprevir plus
        pibrentasvir per approved Japan label.
      
Keywords: chronic hepatitis C virus (HCV); Genotype; glecaprevir; pibrentasvir; sustained virologic response; chronic hepatitis C virus genotype 1; chronic hepatitis C virus genotype 2; chronic hepatitis C virus genotype 3; chronic hepatitis C virus genotype 4; chronic hepatitis C virus genotype 5; chronic hepatitis C virus genotype 6
Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent
      of patients don't respond to current treatments. MBS2320, the drug being tested in this
      trial, represents a new approach to treating RA, with the potential not only to reduce levels
      of inflammation but to also directly inhibit bone damage.The aim of this study is to test the
      safety of MBS2320 in healthy volunteers, to find out how MBS2320 levels change in the blood
      with dose, and to test the safety and compatibility of giving MBS2320 to patients with RA in
      combination with an existing treatment, methotrexate.
    

Detailed description: 
      The study will be conducted in 4 parts (parts A to D). The principal aim of this study is to
      obtain safety and tolerability data when MBS2320 is administered orally as single and
      multiple doses to healthy subjects (parts A to C). The effect of MBS2320 on the
      pharmacokinetics (PK) of the first-line rheumatoid arthritis (RA) therapy, methotrexate
      (MTX), and the effect of MTX on the PK of MBS2320, will also be evaluated in a cohort
      consisting of subjects with RA (Part D).
    

Intervention name(s): MBS2320; Placebo; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): As described in the arm descriptions; As described in the arm descriptions; Background therapy as described in the arm descriptions
Other intervention name(s): Rheumatrex; Trexall; Amethoperin; Mexate
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Osteoclastogenesis inhibitor; Anti-Inflammatory Agent; Musculoskeletal Diseases; Joint Diseases
A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, Open-Label, Multi-Center, Randomized Study to Investigate the Efficacy and Safety
      of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus
      Platinum-Pemetrexed Alone as First-line Treatment for Participants With Stage IIIB or IV
      Non-Squamous Non-Small Cell Lung Cancer. 45 sites will be involved in China, 320 subjects
      will be enrolled.
    


Intervention name(s): Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed; Cisplatin or Carboplatin,Pemetrexed
Intervention type(s): Drug; Drug
Intervention description(s): Treatment for advanced NSCLC; Treatment for advanced NSCLC
Intervention MeSH terms: Cisplatin; Carboplatin; Pemetrexed; Tislelizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment