bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Deferiprone Treatment in Patients With Pantothenate Kinase-Associated Neurodegeneration
Condition: Pantothenate Kinase-Associated Neurodegeneration
MeSH terms: Pantothenate Kinase-Associated Neurodegeneration; Nerve Degeneration
Intervention: Deferiprone oral solution
Intervention description: Deferiprone oral solution at a dosage of up to 15 mg per kilogram of body weight, twice a day
Intervention MeSH terms: Deferiprone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants in this study received the same intervention.
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Pantothenate Kinase-Associated Neurodegeneration; PKAN; Neurodegeneration with Brain Iron Accumulation; NBIA; Deferiprone; Ferriprox

Summary:

      Patients with PKAN will be treated with the iron chelator deferiprone for 18 months. Only
      patients who have completed the earlier study TIRCON2012V1 (NCT01741532), a double-blind
      placebo-controlled trial in which participants were randomized to receive either deferiprone
      or placebo for 18 months, are eligible to enroll.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study TIRCON2012V1

        Exclusion Criteria:

          -  Withdrew from the study TIRCON2012V1 for reasons of safety

          -  Plan to participate in another clinical trial at any time from the day of enrolment
             until 30 days post-treatment in the current study
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: GDC-229; Metronidazole Vaginal Gel 0.75%; Placebo
Intervention description: GDC-229 is a vaginal gel.; Metronidazole Vaginal Gel 0.75% is an FDA-approved drug; Inactive arm of the study
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 871.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bacterial vaginosis; vaginal infection; BV

Summary:

      This research study is being done to compare the safety and efficacy of GDC-229 (test drug)
      against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to
      establish that these two drugs work better than placebo in subjects with BV.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Non-pregnant female aged ≥ 18 years who is in good general health

          2. Diagnosis of BV

          3. Willing to refrain from using any intravaginal product (e.g., spermicide, tampon,
             douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom
             with spermicide or insertion into the vagina of any drug or non-drug product during
             treatment), other than study treatment for the duration of the trial

          4. Subjects of childbearing potential who have a negative urine pregnancy test at the
             Entry Visit (Visit 1) and agree to use an acceptable form of birth control throughout
             the study

          5. Able to understand and willing to sign the informed consent form (ICF) and able to
             comply with the requirements of the protocol

        Exclusion Criteria:

          1. History of alcohol or substance abuse

          2. Experienced a clinically significant medical event within 90 days

          3. Abnormal pap or high risk human papillomavirus (HPV)

          4. History or presence of clinically significant central nervous system (CNS),
             cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine,
             immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease

          5. Pregnant, lactating, or planning to become pregnant or breastfeed during the study
             period

          6. Primary or secondary immunodeficiency

          7. Evidence of any vulvovaginitis at screening other than BV

          8. History of hypersensitivity or allergy to metronidazole, parabens, other
             nitroimidazole derivatives, or other ingredients of the GDC 229 (metronidazole 0.75%
             vaginal gel), metronidazole 0.75% vaginal gel (Oceanside Pharmaceuticals), or vehicle
             gel

          9. Participating in another clinical trial
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: RPC1063
Intervention MeSH terms: Ozanimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2494.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: MS; RMS; Multiple Sclerosis; Relapsing Multiple Sclerosis

Summary:

      The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with
      relapsing multiple sclerosis.
    

Eligibility criteria:

        Eligibility Criteria:

        To be eligible to participate in this trial, patients must meet all of the following
        criteria:

          1. Completed one of the parent trials

          2. Does not have a condition that would require withdrawal from one of the parent trials

          3. Has no conditions requiring treatment with a prohibited concomitant medication

          4. Is not receiving treatment with any of the following drugs or interventions within the
             corresponding timeframe:

             At Baseline (Day 1)

               -  CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin)
                  Two weeks prior to Baseline (Day 1)

               -  Monoamine oxidase inhibitors (eg, selegiline, phenelzine)

          5. Ability to provide written informed consent and to be compliant with the schedule of
             protocol assessments

          6. Female patients of childbearing potential:

        Must agree to practice a highly effective method of contraception throughout the study
        until completion of the 90-day Safety Follow-up Visit. Highly effective methods of
        contraception are those that alone or in combination result in a failure rate of a Pearl
        index of less than 1% per year when used consistently and correctly.

        Acceptable methods of birth control in this study are the following:

          -  Combined hormonal (estrogen and progestogen containing) contraception, which may be
             oral, intravaginal, or transdermal

          -  Progestogen-only hormonal contraception associated with inhibition of ovulation, which
             may be oral, injectable, or implantable

          -  Placement of an intrauterine device (IUD)

          -  Placement of an intrauterine hormone-releasing system (IUS)

          -  Bilateral tubal occlusion

          -  Vasectomised partner

          -  Sexual abstinence.

        Exclusion Criteria:
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Condition: Atrial Fibrillation; Stroke
MeSH terms: Atrial Fibrillation
Intervention: WATCHMAN Device; Warfarin
Intervention description: WATCHMAN Left Atrial Appendage Closure Technology; Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Intervention MeSH terms: Warfarin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; stroke; TIA; trans ischemic attack; warfarin; Coumadin

Summary:

      This was a prospective, randomized, multicenter study to provide additional information on
      the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL
      study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study
      and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in
      subjects with non-valvular atrial fibrillation who require anticoagulation therapy for
      potential thrombus formation.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Paroxysmal, persistent or permanent non-valvular AF

          -  Eligible for long-term warfarin therapy

          -  Eligible to come off warfarin therapy

          -  Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be
             included if any of the following apply:

               -  Female age 75 or older

               -  Baseline LVEF ≥ 30 and < 35%

               -  Aged 65-74 and has diabetes or coronary artery disease

               -  Aged 65 or greater and has congestive heart failure

        Key Exclusion Criteria:

          -  Contraindicated/allergic to aspirin

          -  Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to
             enrollment

          -  History of atrial septal repair or has an ASD/PFO device

          -  Implanted mechanical valve prosthesis

          -  NYHA Class IV CHF

          -  Resting heart rate > 110 bpm

          -  Participated previously in the PROTECT AF or CAP Registry studies

        Key Echo Exclusion Criteria:

          -  LVEF < 30%

          -  Existing pericardial effusion > 2mm

          -  High risk PFO

          -  Significant mitral valve stenosis

          -  Complex atheroma with mobile plaque of the descending aorta and/or aortic arch

          -  Cardiac tumor
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
Condition: Acellular Pertussis; Diphtheria; Tetanus
MeSH terms: Diphtheria
Intervention: Fluarix®; Boostrix®
Intervention description: GSK Biologicals' inactivated influenza split virus vaccine.; GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1726.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity,; Influenza; Co-administration,; Tdap,

Summary:

      The current study will provide information for the use of Boostrix concomitantly with
      influenza vaccine in adults aged 19-64 years. This study will also provide safety and
      immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female adults aged between 19 to 64 years, inclusive for the primary
             cohort), or aged 65 years or older (for the exploratory cohort), at the time of
             vaccination.

        Exclusion Criteria:

          -  Administration of an influenza vaccine within six months prior to study entry

          -  Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.

          -  Administration of a Tdap vaccine at any time prior to study entry.

          -  Administration of any investigational or non-registered drug or vaccine other than the
             study vaccines within 30 days preceding vaccination, or planned use during the entire
             study period.

          -  History of diphtheria and/or tetanus and/or pertussis disease.

          -  History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus
             toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any
             component of the study vaccines.
Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
Condition: Covid19
MeSH terms: COVID-19
Intervention: sotrovimab; sotrovimab; sotrovimab; sotrovimab; Sotrovimab; Sotrovimab; Sotrovimab
Intervention description: Sotrovimab 500 mg given by intravenous infusion over 15 min; Sotrovimab 500 mg given by intramuscular injection; Sotrovimab 250 mg given by intramuscular injection; Sotrovimab 2000 mg given by intravenous infusion over 60 min; Sotrovimab 2000 mg given by intravenous infusion over 30 min; Sotrovimab 2000 mg given by intravenous infusion over 15 min; Sotrovimab up to 3000 mg given by intravenous infusion over 90 min
Intervention MeSH terms: Sotrovimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1065.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; coronavirus disease 2019; COVID-19; early treatment; coronavirus

Summary:

      The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab
      versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In
      the safety substudy, the aim is the evaluation of the safety and tolerability of sotrovimab
      across a single ascending dose level and over different infusion times when given for the
      treatment of mild/moderate COVID-19 to participants at high risk of disease progression

      The safety sub-study was discontinued early in the context of ongoing concerns regarding the
      continuous change in the SARS-CoV-2 circulating variants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Main Study participant must be aged 12 years or older AND at high risk of progression
             of COVID-19 or > 55 years old

          -  Sub-Study participants must be aged 18 years or older at time of consent AND at high
             risk of progression of COVID-19 or ≥ 55 years old

          -  Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on
             room air and have COVID-19 symptoms and be less than or equal to 7 days from onset of
             symptoms

        Exclusion Criteria:

          -  Currently hospitalized or judged by the investigator as likely to require
             hospitalization in the next 24 hours

          -  Symptoms consistent with severe COVID-19

          -  Participants who, in the judgement of the investigator are likely to die in the next 7
             days

          -  Known hypersensitivity to any constituent present in the investigational product
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
Condition: Vaginal Dryness
Intervention: Ospemifene; Placebo
Intervention description: 60 mg tablet; Tablet identical to the ospemifene tablet without drug
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 631.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vulvo-vaginal Atrophy; menopause

Summary:

      The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once
      daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause
      in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is postmenopausal.

          -  Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

        Exclusion Criteria:

          -  Subject has clinically significant abnormal findings in the physical examination.

          -  Subject has a body mass index (BMI) equal to or greater than 38 kg/m^2

          -  Subject has uncontrolled hypertension.

          -  Subject has clinically significant abnormal findings in the gynecological examination
             other than signs of vaginal atrophy.

          -  Subject has uterine/vaginal bleeding of unknown origin.

          -  Subject has a vaginal infection requiring medication (may be treated and be eligible
             for study).
Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: lomitapide
Intervention description: 5-60 mg po every day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Homozygous; Familial; Hypercholesterolemia; MTP; Apheresis; lomitapide; Homozygous Familial Hypercholesterolemia (HoFH)

Summary:

      This was a long term follow on study to assess the continued long term safety and efficacy of
      lomitapide in patients with homozygous familial hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed UP1002 or 733-005.

          2. Willing and able to provide consent and comply with the requirements of the study
             protocol.

        Exclusion Criteria:

          1. Met any of the stopping rules for study discontinuation at the final visit of study
             UP1002 or 733-005.
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Androgen Hormonal Suppression and Radiation; Androgen Suppression Therapy and Radiation Therapy
Intervention description: 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.; Total Androgen Ablation and external beam radiation therapy; Total Androgen Ablation and External Beam Radiation Therapy
Intervention MeSH terms: Ascorbic Acid; Docetaxel; Methyltestosterone; Androgens; Estrogens, Conjugated (USP)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 350.0
Sex: Male
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Hormone Refractory; Metastatic; Localized; Locally Advanced; Prostate Cancer - High Risk Localized or Locally Advanced

Summary:

      This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to
      one of the standard treatments (radiation and hormones) for men with high-risk prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven prostate cancer

          -  Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score
             equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible
             patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any
             minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal
             Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive

          -  Negative bone scan

          -  Lymph node assessment by CT or MR

          -  Adequate hematologic function (Blood Counts)

          -  Adequate liver functions (blood tests)

          -  ECOG performance Status 0 or 1

          -  Peripheral neuropathy must be =< grade 1

          -  PSA obtained within 3 months of entry

        Exclusion Criteria:

          -  Prior history of malignancy that are < 5 years except for cancers found to be
             "in-situ" and would not likely impact a patient's life expectancy with appropriate
             medical management.

          -  Prior pelvic radiation therapy

          -  Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)

          -  Individuals unable to tolerate lying still 5 - 10 minutes

          -  Patients with a history of severe hypersensitivity reaction to docetaxel or other
             drugs formulated with polysorbate 90.
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Condition: Asthma
MeSH terms: Asthma
Intervention: Vitamin D 3 cholecalciferol; Vitamin D3
Intervention description: Dosage form oral Dosage 4000IU Vitamin D 3 cholecalciferol; 4000 IU of vitamin D3 administered orally once a day during pregnancy
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 876.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Vitamin D; Randomized Control Trial

Summary:

      Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and
      children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema,
             allergic rhinitis in the biological father of the child

          -  Gestational age between 10 and 18 weeks at the time of randomization

          -  Maternal age between 18 and 39 years

          -  Not a current smoker

          -  English or Spanish speaking

          -  Intent to participate for the full 4 years (through Pregnancy and then until the 3rd
             birthday of the child)

        Exclusion Criteria:

          -  Not meeting inclusion criteria

          -  Gestational age greater than 18 weeks

          -  Presence of chronic medical conditions

          -  Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3

          -  Multiple gestation pregnancy (twins, triplets)

          -  Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF)