bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Condition: Anovulation
MeSH terms: Anovulation
Intervention: Anastrozole 1 mg; Anastrozole 5 mg; Anastrozole 10 mg; Clomiphene Citrate 50 mg; Clomiphene Citrate 100 mg
Intervention description: Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).; Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).; Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).; Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).; Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).
Intervention MeSH terms: Anastrozole; Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 271.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate and compare the safety and efficacy of various
      doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating
      follicular growth and ovulation in infertile women with ovulatory dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-40 years

          -  Ovulatory dysfunction characterized by irregular and/or extended cycles

          -  Non-smoker

        Exclusion Criteria:

          -  No previous gonadotropin treatment

          -  No more than 6 previous clomiphene treatment cycles
Efficacy Of A PVP-I Fluoride Varnish
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Test varnish; Standard varnish
Intervention description: Topical application of test varnish to the teeth 4 times per year.; Topical application of test varnish to the teeth 4 times per year
Intervention MeSH terms: Fluorides; Sodium Fluoride; Fluorides, Topical
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All study personnel except for designated personnel in the data center will be blinded to the participant treatment assignment. In order to maintain blinding, the caries scoring examinations will precede the application of test varnishes at baseline. The staff member applying these varnishes will not perform the caries scoring exams in order to eliminate examiner bias and ensure blinding to treatment assignment. Test drug and comparator are packaged identically.
Enrollment: 284.0
Sex: All
Minimum age: 60 Months
Maximum age: 84 Months
Healthy volunteers: No
Keywords: sodium fluoride; povidone iodine; varnish

Summary:

      The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish.
      Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
      Subjects will be stratified by early childhood education center and then randomized to
      receive either test varnish or control varnish topically to the teeth. Treatment will be
      administered quarterly for up to 24 months. The primary outcome is surface-level primary
      molar caries increment (d2-4mfs) at 24- months post baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject's parent or legal guardian must provide signed and dated informed consent
             (parent permission form).

          2. The subject's parent or legal guardian of the subject must be willing and able to
             comply with study requirements.

          3. The subject is aged 60-84 months at the time of enrollment.

          4. The subject must be in good general health as evidenced by parent report.

        Exclusion Criteria:

          1. Known allergy to iodine

          2. Known allergy to seafood

          3. Known hypersensitivity to fluoride varnish

          4. Diagnosis of thyroid disease

          5. Chronic, prophylactic use of antibiotics

          6. Treatment with another investigational drug or other intervention within 30 days
             preceding the Baseline Visit.
A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.
Condition: Treatment for Prevention of Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab
Intervention description: Administered by subcutaneous injection once a month
Intervention MeSH terms: Erenumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 609.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: No
Keywords: Chronic Migraine

Summary:

      To assess the long-term safety and efficacy of erenumab.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has provided informed consent prior to initiation of any study-specific
             activities/procedures

          2. Completed the 12-week study visit and did not end IP early during the double-blind
             treatment period of the AMG 334 20120295 (NCT02066415) parent study, and is
             appropriate for continued treatment.

        Exclusion Criteria:

          1. Development of any unstable or clinically significant medical condition, laboratory or
             electrocardiogram (ECG) abnormality following randomization into the parent study,
             that in the opinion of the investigator, would pose a risk to subject safety or
             interfere with the study evaluation, procedures or completion.

          2. Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at
             screening/Day 1.

          3. Subject who used excluded concomitant medications between week 8 and week 12 of the
             parent study
Reduced Intensity Conditioning Using CD3+/CD19+ Depletion for Non Malignant Transplantable Diseases
Condition: Bone Marrow Failure Syndromes; Immunodeficiencies; Immune Dysregulation Syndromes
MeSH terms: Bone Marrow Failure Disorders; Pancytopenia; Syndrome
Intervention: CliniMACs device
Intervention description: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells.
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Maximum age: 22 Years
Healthy volunteers: No
Keywords: Transplant related mortality; Graft versus host disease; Bone marrow transplant

Summary:

      This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen
      to allow successful engraftment with CD3+ /CD19+ depleted peripheral stem cell grafts from
      mismatched donors. There are two conditioning regimens depending upon patient diagnosis and
      age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bone marrow failure syndromes for which SCT is indicated, including severe aplastic
             anemia refractory to non transplant therapies congenital neutropenia, congenital
             thrombocytopenia, congenital red cell aplasia

          -  Immunodeficiencies for which allogeneic hematopoietic stem cell transplant is
             indicated, including severe combined immunodeficiencies, Wiskott-Aldrich syndrome,
             IPEX syndrome, X-linked lymphoproliferative disease

          -  Immune dysregulation syndromes, including refractory or recurrent hemophagocytic
             lymphohistiocytosis, HLH with genetic mutations, refractory multisystemic Langerhans
             cell histiocytosis, other MAS refractory to standard therapy

          -  Organ function clearance

        Exclusion Criteria:

          -  Uncontrolled bacterial, viral or fungal infections

          -  HLA matched related or unrelated donor able to donate mobilized peripheral stem cells.

          -  Fanconi's syndrome, dyskeratosis congenita or other chromosomal fragility syndromes

          -  Pregnant Females
Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
Condition: Onychomycosis
MeSH terms: Mycoses; Onychomycosis
Intervention: NVXT Solution; Vehicle of test product
Intervention description: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.; Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in
      patients with mild-to-moderate fungal infection of the toe nail.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically diagnosed onychomycosis

          -  Presence of dermatophyte fungal infection with no current topical or systemic
             antifungal therapy

          -  Clinical diagnosis of mild-to-moderate fungal infection of at least one toe involving
             10-50% of the nail area, without involvement of one of the lunular proximal regions

          -  Positive potassium hydroxide mount preparation

          -  Positive fungal culture for a dermatophyte

        Exclusion Criteria:

          -  Nail or anatomical abnormalities of the toe that may interfere with evaluations or
             dosing compliance
Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Intervention: Esomeprazole; Placebo
Intervention description: Sugar pill
Intervention MeSH terms: Esomeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: CF

Summary:

      Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may
      lead to worsening lung function and more respiratory infections for a person with CF. This
      study will look at treating GERD with a medication, esomeprazole. The medication stops
      stomach acid from being made. The study will see if there are fewer respiratory infections
      and improved lung function in patients with CF when taking esomeprazole.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cystic fibrosis

          2. Age > 18 years

          3. Stable maintenance medical regimen during the previous 6 weeks.

          4. Negative pregnancy test (women of childbearing potential) at both screening and
             baseline visits.

          5. Women of childbearing potential must be using medically acceptable contraception.

          6. At least two respiratory exacerbations per year requiring oral and/or intravenous
             antibiotics for each of the two years prior to study entry, but no more than 4
             exacerbations requiring intravenous antibiotics during either of those years.

        Exclusion Criteria:

          1. Previous anti-reflux or peptic ulcer surgery,

          2. Use of proton pump inhibitor (PPI) within the past two weeks

          3. Pulmonary exacerbation requiring antibiotics within the previous 2 weeks

          4. Parenteral hyperalimentation

          5. Cigarette smoking

          6. Treatment with azoles, iron, anti-coagulants, digitalis

          7. Use of any investigative drugs within the previous month.

          8. Use of over the counter acid suppressor agents (not including acid neutralizers)
ELITE: Early Versus Late Intervention Trial With Estradiol
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: 17B-estradiol; Placebo
Intervention description: Oral 17B-estradiol 1 mg daily; Matching oral 17B-estradiol placebo daily
Intervention MeSH terms: Hormones; Estradiol; Estrogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 643.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: atherosclerosis; CAD; cardiac computed tomography; cardiovascular disease; carotid artery intima-media thickness; cognitive function; computed tomography; coronary artery calcium; coronary artery disease; coronary artery lesions; CVD; estrogen; estrogen therapy; hormone therapy; postmenopausal; subclinical vascular disease; timing hypothesis; ultrasonography; menopausal hormone replacement therapy; menopause; prevention; intervention

Summary:

      The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the
      progression of early (subclinical) atherosclerosis and cognitive decline in healthy
      postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with a serum estradiol level 25 pg/ml or less

          -  No period for 6 months or more

          -  Postmenopausal less than 6 years, OR 10 years or longer

        Exclusion Criteria:

          -  Clinical signs, symptoms, or personal history of cardiovascular disease

          -  Women who have had a hysterectomy only and no oophorectomy (since time from menopause
             cannot be determined)

          -  Diabetes mellitus or fasting serum glucose 140 mg/dL or greater

          -  Uncontrolled hypertension (diastolic blood pressure 110 mmHg or greater)

          -  Thyroid disease (untreated)

          -  Serum creatinine greater than 2.0 mg/dL

          -  Plasma triglyceride levels greater than 500 mg/dL

          -  Life threatening disease with prognosis less than 5 years

          -  Cirrhosis or liver disease

          -  History of deep vein thrombosis or pulmonary embolism

          -  History of breast cancer

          -  Current hormone replacement therapy (HRT)
Safety Evaluation of 3K3A-APC in Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: 3K3A-APC; Placebo
Intervention description: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion; Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Intervention MeSH terms: Protein C
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: ischemic stroke; stroke; APC; 3K3A; 3K3A-APC; activated protein C; RHAPSODY

Summary:

      The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary
      efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human
      activated protein C (APC), in in the treatment of acute ischemic stroke following treatment
      with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute ischemic stroke

          -  Able to receive IV tPA, mechanical thrombectomy or both

          -  National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5

          -  Signed informed consent

          -  Mechanical thrombectomy subjects only: onset time to arterial puncture time < 6 hours

        Exclusion Criteria:

          -  History of stroke or penetrating head injury within 90 days prior to enrollment

          -  History of previous or current diagnosis of intracranial hemorrhage that represents a
             potential for re-hemorrhage if subjected to thrombolytic therapy or mechanical
             thrombectomy

          -  Moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm
             requiring intervention during the acute study period

          -  Presence of other neurological or non-neurological co-morbidities that may lead,
             independently of the current stroke, to further deterioration in the subject's
             neurological status during the trial period

          -  Presence of premorbid neurological deficits and functional limitations assessed by a
             retrospective Modified Rankin Scale (mRS) score of ≥ 2

          -  Mechanical thrombectomy subjects only: baseline non-contrast CT scan revealing a large
             core occlusion as defined by local protocol

          -  Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT)

          -  Severe hypertension or hypotension

          -  Glomerular filtration rate (GFR) <35 mL/min

          -  Blood glucose concentration < 50 mg/dL

          -  Prior exposure to any exogenous form of APC
Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: AFQ056; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Fragile X Syndrome; Martin-Bell Syndrome; Genetic Diseases; X-Linked; Escalante's syndrome

Summary:

      This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective
      in treating the behavioral symptoms of Fragile X Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Fragile X Syndrome, who are at least moderately ill based on a Clinical
             Global Impression Severity score of at least 4 and have qualifying scores on the ABC-C
             and IQ test at Visit 1

        Exclusion Criteria:

          -  Advanced, severe or unstable disease that may interfere with the study outcome
             evaluations

          -  Cancer within the past 5 years, other than localized skin cancer

          -  Current treatment with more than two psychoactive medications, excluding
             anti-epileptics

          -  History of severe self-injurious behavior

          -  Weigh less than 32 kg

          -  Females who are sexually active

        Other protocol-defined inclusion/exclusion criteria may apply
Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Ketamine infusion; Saline
Intervention description: 0.5mg/kg IV over 40 minutes; saline infusion
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: OCD

Summary:

      In this study investigators are studying the effects of a drug called ketamine on the
      symptoms of Obsessive-compulsive disorder (OCD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-55

          -  Physically healthy and not currently pregnant

          -  Primary Diagnosis of OCD

          -  Sufficient severity of symptoms

          -  Able to provide consent

        Exclusion Criteria:

          -  Psychiatric conditions that make participation unsafe

          -  Currently on psychotropic medication

          -  Medical conditions that make participation unsafe

          -  Allergy to ketamine

          -  Any metal in the body