bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss
Condition: Alopecia; Baldness
MeSH terms: Alopecia
Intervention: bimatoprost Formulation A; bimatoprost Formulation B; bimatoprost Formulation C; bimatoprost vehicle solution; minoxidil 2% solution
Intervention description: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Intervention MeSH terms: Bimatoprost; Minoxidil; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: Female
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared
      with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern
      hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil
      2% solution which will be provided open-label.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate female pattern hair loss with ongoing hair loss for at least 1 year

          -  Willingness to have micro-dot-tattoo applied to scalp

          -  Willingness to maintain same hair style, length and hair color during study

        Exclusion Criteria:

          -  Drug or alcohol abuse within 12 months

          -  HIV positive

          -  Received hair transplants or had scalp reductions

          -  Use of hair weaves, hair extensions or wigs within 3 months

          -  Oral or topical minoxidil treatment within 6 months

          -  Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to
             scalp within 4 weeks
A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Drug: SHR0302
Intervention description: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel,
      multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment
      for patients with moderate to severe atopic dermatitis.

      The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will
      be compared to placebo and improvement in atopic dermatitis will be assessed using the
      Investigator's Global Score (IGA)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18-75 years of age (inclusive), male or female, at the time of
             informed consent

          -  Moderate to severe atopic dermatitis

          -  Capable of providing a signed and dated informed consent form indicating the subject
             has been informed of all pertinent aspect of the study

        Exclusion Criteria:

          -  Subjects with historical or current evidence of clinically significant cardiovascular,
             neurological, psychiatric, renal, hepatic, immunological, gastrointestinal,
             urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including
             uncontrolled diabetes or thyroid disease) or hematological abnormalities that are
             uncontrolled. Significant is defined as any disease that, in the opinion of the
             Investigator, would put the safety of the subject at risk through participation, or
             which would affect the efficacy or safety analysis if the disease/condition
             exacerbated during the study

          -  Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus
             erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the
             evaluation of atopic dermatitis

          -  Subject has a severe comorbidity that may require systemic steroids therapy or other
             interventions or requires active frequent monitoring (e.g., unstable chronic asthma)
Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: Placebo; Comparator: Sitagliptin
Intervention description: 100 mg once daily (QD), taken orally for 4 weeks; Placebo tablet, QD, taken orally for 4 weeks; 50 mg twice daily (BID), taken orally for 4 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 20 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with
      Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

        Exclusion Criteria:

          -  Patients Have Type 1 Diabetes Mellitus
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Condition: Adult Type Ovarian Granulosa Cell Tumor; Ovarian Gynandroblastoma; Ovarian Sertoli-Leydig Cell Tumor; Ovarian Sex Cord Tumor With Annular Tubules; Ovarian Steroid Cell Tumor
MeSH terms: Neoplasms; Granulosa Cell Tumor; Leydig Cell Tumor; Sertoli-Leydig Cell Tumor; Sex Cord-Gonadal Stromal Tumors
Intervention: Paclitaxel
Intervention description: Given IV
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial studies the effectiveness of paclitaxel in treating patients who have
      ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells
      from dividing so they stop growing or die.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell
             tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma],
             steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex
             cord tumor with annular tubules)

          -  Patients must have recurrent stromal tumor having received no more than one prior
             chemotherapy regimen

          -  Patients must have measurable disease as defined by Gynecological Oncology Group (GOG)
             Response Evaluation Criteria in Solid Tumors (RECIST) criteria

          -  White blood count equal to or greater than 3000/mcl

          -  Granulocyte count equal to or greater than 1500/mcl

          -  Platelet count equal to or greater than 100,000/mcl

          -  Creatinine equal to or less than 2.0 mg%

          -  Bilirubin less than or equal to 1.5 times normal

          -  Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal

          -  Patients with a GOG performance grade of 0, 1 or 2

          -  Patients of child bearing potential must have a negative pregnancy test and must agree
             to practice an effective means of birth control

          -  Patients who have met the pre-entry requirements as specified

          -  Patients must have signed an approved informed consent and Health Insurance
             Portability and Accountability Act (HIPAA) authorization

        Exclusion Criteria:

          -  Patients with GOG performance grade of 3 or 4

          -  Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have
             had any evidence of disease within the last 5 years or whose prior malignancy
             treatment contraindicates the current protocol therapy

          -  Patients having received more than one prior chemotherapy regimen

          -  Patients amenable to cure by surgery

          -  Patients with prior radiation except for those whose recurrent disease is outside the
             radiation port
Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Intervention: Ubiquinol; Ensure
Intervention description: 300 mg Ubiquinol (3 mL liquid Ubiquinol).; 50 mL Ensure
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years)

          -  Cardiac arrest defined by cessation of pulse requiring chest compressions

          -  Not following commands after ROSC

          -  Admission to the ICU

          -  Naso/orogastric tube

          -  Ability to receive enteral medication

        Exclusion Criteria:

          -  Protected populations (pregnant women, prisoners, the intellectual disabled)

          -  Current CoQ10 supplementation

          -  Anticipated death within 24 hours

          -  > 12 hours from ROSC to estimated randomization

          -  Jejunostomy tube (J-tube)
Benefits Counseling to Preserve Function Among Disability Applicants
Condition: Veterans' Disability Claims
Intervention: Benefits Counseling; VA Orientation
Intervention description: Benefits counseling is designed to improve the quality of life of disability applicants by accomplishing two functions: 1) Providing information concerning what vocational rehabilitation services are available and how they will affect receipt of disability payments, 2) Amplifying applicants' existing motivation to engage in work and related-activities, using a Motivational Interviewing approach.; VA Orientation is designed to provide the Veteran with information regarding the services available, how to access the services and where the service is located on the VA campus.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Rehabilitation, Vocational; Compensation and Redress; disability evaluation

Summary:

      This study will address the problem that claimants with psychiatric disabilities who apply
      for and receive disability benefits go on to work less than those whose claims are denied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has never received VBA benefits

          -  Able to provide valid consent

          -  Expresses willingness to discuss benefits with a counselor

          -  Difficulty working as evidenced by a "Yes" to either (a), (b), or (c) of the question
             below about work-related difficulties: During the past 4 weeks, have you had any of
             the following problems (such as feeling depressed and anxious):

               -  Cut down on the amount of time you spent on work or other activities?

               -  Accomplished less than you would like?

               -  Didn't do work or other activities as carefully as usual?

          -  Expresses willingness to try Benefits Counseling if assigned to it

          -  An evaluation by a psychiatrist or psychologist is scheduled

        Exclusion Criteria:

          -  Already receiving VA payments

          -  Already receiving SSI or SSDI payments

          -  Has a conservator
Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia
Condition: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders
Intervention: Bupropion; Contingent reinforcement plus placebo; non-contingent reinforcement plus bupropion; Non-contingent reinforcement plus placebo
Intervention description: Contingent reinforcement plus bupropion (300 mg/day for 3 weeks); contingent reinforcement plus placebo (3 weeks); non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks); Non-contingent reinforcement plus placebo
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco

Summary:

      There is a high prevalence of smoking among people with schizophrenia, and there are few
      smoking treatment programs for these smokers. The aims of this study are to investigate the
      separate and combined effects of bupropion and a voucher incentive program on smoking in
      people with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable
        on antipsychotic and antidepressant medications

        Exclusion Criteria:

        Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical
        conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of
        MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists,
        anorectics, stimulants
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
Condition: Plasmodium Falciparum
MeSH terms: Malaria
Intervention: RTS, S/AS01B; RTS, S/AS02A; Rabipur (Rabies) Vaccine
Intervention description: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.; 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.; 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30%
      efficacy against clinical episodes of malaria and approximately 58% efficacy against severe
      malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine
      RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army
      Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B
      vaccine to the African adults to establish safety and immunogenicity in this population.
      Preliminary indication of vaccine efficacy with this adjuvant will be established by
      monitoring the time to the first infection with Plasmodium falciparum.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male or female volunteers aged between 18 and 35 years at the time of first
             vaccination who have given written consent for their participation in the study were
             included

          -  If the volunteer is female, she must be of non-childbearing potential, i.e. either
             surgically sterilized or one year post-menopausal; or, if of childbearing potential,
             she must be abstinent or have used adequate contraceptive precautions for 30 days
             prior to vaccination, have a negative pregnancy test and must agree to continue such
             precautions for two months after completion of the vaccination series

        Exclusion criteria:

          -  If a subject plans to take vaccine not foreseen by the study protocol within 30 days
             of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded

          -  Volunteers with any confirmed or suspected immunosuppressive or immunodeficient
             conditions

          -  Family history of congenital or hereditary immunodeficiency

          -  History of allergic reactions to previous immunizations

          -  HBsAg positive subjects

          -  History of splenectomy

          -  Pregnant or lactating females will be excluded from the study
Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: Lanraplenib; Filgotinib; Tirabrutinib; Lanraplenib placebo; Filgotinib placebo; Tirabrutinib placebo
Intervention description: 1 x 30 mg tablet administered orally once daily; 1 x 200 mg tablet administered orally once daily; 1 x 40 mg tablet administered orally once daily; 1 x tablet administered orally once daily; 1 x tablet administered orally once daily; 1 x tablet administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and
      tirabrutinib in adults with active Sjogren's Syndrome (SjS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosed with primary or secondary SjS according to the 2002 American European
             Consensus Group (AECG) classification

          -  Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's
             syndrome disease activity index (ESSDAI) ≥ 5

          -  Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or
             anti-SSB)

        Key Exclusion Criteria:

          -  Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD)
             (prior bDMARD treatment allowed with appropriate washout as per study protocol)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Condition: Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Streptococcal Infections; Gram-Positive Bacterial Infections
Intervention: Group B streptococcus vaccine
Intervention description: Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Group B streptococcus; GBS; Vaccine; Prevention of group B streptococcus infection

Summary:

      The study compared the magnitude of the antibody response and safety of a GBS Trivalent
      Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the
      study investigated the maternal to fetal transfer of antibodies induced by the
      investigational vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women 18-40 years of age between 24-35 weeks gestation

          -  Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts >
             50 cells/µL

        Exclusion Criteria:

          -  Women who had CD4+ count ≤ 50 cells/µL

          -  Women who were HIVpos with WHO stage III or IV disease, history of severe allergic
             reactions after previous vaccinations
Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: nab-paclitaxel; Bevacizumab; Trastuzumab
Intervention description: ABI-007; Bevacizumab; Trastuzumab
Intervention MeSH terms: Paclitaxel; Bevacizumab; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and
      carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers
      demonstrating HER2 gene amplification. It is hoped that this novel combination will result in
      increased pathologic response rates that will translate into long term outcome improvements
      in HER2 positive patients with locally advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients with histologically confirmed adenocarcinoma of the breast or
             inflammatory breast cancer

          -  Clinical stage T 1-4, N 0-3, M0

          -  FISH+ HER2 gene amplified breast cancer

          -  18 years or older

          -  Normal cardiac function

          -  Performance status 0-2

          -  Cannot have received any prior chemotherapy for this disease or cannot have received
             chemotherapy for any other cancer in the past 5 years.

          -  Previous diagnosis of noninvasive breast cancer is OK.

          -  Must have adequate bone marrow, renal and liver function.

          -  Pregnant or lactating females not allowed.

          -  Preexisting peripheral neuropathy must be equal to or less than grade 1

          -  Must have archived tumor tissue for tissue testing.

        Exclusion Criteria:

        You cannot be in this study if you any of the following:

          -  History of cardiac disease, with New York Heart Association Class II or greater with
             congestive heart failure

          -  Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias
             needing medication; no bleeding diathesis or coagulopathy.

          -  No prior investigational drug within the last 30 days

          -  No prior trastuzumab or bevacizumab therapy

        There are additional inclusion/exclusion criteria. The study center will determine if you
        meet all of the criteria. If you do not qualify for the trial, study personnel will explain
        the reasons.