bioihbjkbjnl/mcl2 huggingface dataset:
Oral DS107 in Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Oral DS107; Placebo
Intervention MeSH terms: Evening primrose oil; Mineral Oil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients
      with moderate to severe atopic dermatitis.

      Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against
      placebo.

      This study will enroll approximately 100 adult patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject aged 18 years and older.

          -  Moderate to severe atopic dermatitis.

        Exclusion Criteria:

          -  Clinically significant impairment of renal or hepatic function.

          -  History of hypersensitivity to any substance in Oral DS107 or placebo capsules.

          -  Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).

          -  Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources
             and/or is planning a trip to sunny climate.
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Recombinant human erythropoietin alfa (drug); Placebo
Intervention description: 200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days; Normal saline to match active drug (rHuEpo)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Platelet function tests; Erythropoietin; Myocardial infarction

Summary:

      The purpose of this study is to see if a naturally-occurring hormone called erythropoietin
      changes the action of platelets in the blood. Patients with heart attacks are treated with
      medicines to reduce the clotting action of platelets. This study is trying to determine
      whether erythropoietin alters the clotting action of platelets in patients receiving
      anti-platelet medicines. It is important to understand the effects of erythropoietin on
      platelets since preliminary studies in animals suggest that erythropoietin may protect the
      heart from damage during a heart attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21-75 years

          -  Clinical evidence of acute myocardial infarction (MI) with total or sub-total
             occlusion on angiogram

          -  Status post percutaneous revascularization procedure for acute MI with TIMI 3 flow

          -  Ongoing clinically-indicated treatment with aspirin, thienopyridines

        Exclusion Criteria:

          -  Hemodynamic instability/shock or severe congestive heart failure

          -  Time from onset of chest pain to revascularization procedure > 16 hours

          -  Use of intravenous thrombolytic agents for treatment of MI

          -  Known need for additional revascularization procedures
An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Condition: Smoking Cessation
Intervention: varenicline; placebo
Intervention description: variable dosing schedule; placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking cessation; varenicline; smoking cessation treatment

Summary:

      The purpose of this study is to explore the use of an prolonged alternative dosing schedule
      using varenicline for smoking cessation leading to greater quit rates and higher rates of
      continuous abstinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  currently smoking at least 15 cigarettes daily

          -  in good health

          -  able to read and speak English fluently

          -  have a home telephone and plan to reside in Western New York for 6 months

          -  willing to make quit attempt

          -  signed informed consent

          -  who planned quit attempt.

        Exclusion Criteria:

          -  serious medical condition

          -  depression or mental health condition requiring treatment in the past year

          -  history of panic disorder, psychosis, bipolar disorder

          -  alcohol or drug abuse in the past year

          -  use of tobacco products other than cigarettes

          -  current use of other cessation pharmacotherapies

          -  pregnancy/planned pregnancy.
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: ALX-0061; 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: 312.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Primary objective:

      To assess the efficacy and safety of different dose regimens of ALX-0061 administered
      subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus
      erythematosus (SLE) compared to placebo.

      Secondary objectives:

      To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate,
      steroid reduction and health-related quality of life, with different dose regimens of
      ALX-0061.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Man or woman ≥ 18 years and < 65 years of age

          2. Have a diagnosis of SLE for at least 6 months prior to screening and fulfill the 1997
             American College of Rheumatology (ACR) or 2012 Systemic Lupus International
             Collaborating Clinics (SLICC) classification criteria

          3. Have moderate to severe active SLE

          4. Have seropositive disease at screening

          5. Subject must be at least on one or more of the treatments for SLE as listed in the
             protocol

          6. Others as defined in the protocol

        Exclusion Criteria:

          1. Have an A score on the revised BILAG-2004 other than in the mucocutaneous and/or
             musculoskeletal system at screening and at baseline for the organ systems that can be
             clinically assessed

          2. Have a systemic inflammatory disease other than SLE

          3. Clinically significant infection treated or needing treatment

          4. Any active or recurrent viral infection that based on the Investigator´s clinical
             assessment makes the subject unsuitable for the study

          5. Have received prior therapy blocking the interleukin-6 (IL-6) pathway

          6. Others as defined in the protocol
Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Trizivir; Lamivudine/Zidovudine; Lopinavir/Ritonavir; Nevirapine
Intervention description: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily; 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily; 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily; 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
Intervention MeSH terms: Ritonavir; Lopinavir; Lamivudine; Zidovudine; Nevirapine; Lamivudine, zidovudine drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 730.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Treatment Naive; MTCT; HIV Seronegativity

Summary:

      Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child
      transmission (MTCT) of HIV in developed countries. However, little is known of the
      effectiveness of such regimens in developing countries, such as Botswana. This study will
      determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and
      zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV)
      is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected
      pregnant women in Botswana.
    

Eligibility criteria:

        Inclusion Criteria for Mothers:

          -  HIV-infected

          -  At least at 26th week of pregnancy (treatment group) or 18th week of pregnancy
             (observational group) but not beyond the 34th week of pregnancy

          -  Able to complete study visits until at least 6 months postpartum

          -  Citizen of Botswana

        Exclusion Criteria for Mothers:

          -  Taken ARVs for more than 1 week, other than ZDV, during current or prior pregnancy.
             Women who have received single-dose NVP in a prior pregnancy are not excluded.

          -  Certain abnormal laboratory values

          -  Plan to formula feed

          -  Known fetal abnormalities that suggest the fetus will not survive to 6 months of
             gestational age

          -  Known allergy or medical contraindication to any of the study drugs

          -  Require certain medications

          -  Previous participation in the "Prevention of Milk-Borne Transmission of HIV-1C in
             Botswana" (Mashi) study

          -  Currently incarcerated
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: sunitinib malate dose escalation; sunitinib malate
Intervention description: sunitinib starting dose will be 15mg/m^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).; sunitinib 50mg daily on Schedule 4/2
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 6 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Children and young adults with GIST; sunitinib malate; pharmacokinetics; tumor response; overall survival; tumor KIT mutation status

Summary:

      Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with
      sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be
      studied in these patients. In addition, tumor responses and overall survival will be
      assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological diagnosis of GIST.

          -  Patients must have demonstrated either disease progression or intolerance to imatinib
             mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain
             imatinib in their country

          -  Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable
             disease.

        Exclusion Criteria:

          -  Current treatment with another investigational agent.

          -  Prior sunitinib treatment.

          -  Prior therapy with known risk for cardiovascular complications.
A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: Ruxolitinib cream; Vehicle Cream
Intervention description: Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitiligo; depigmenting disorder; topical JAK inhibitor

Summary:

      The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in
      vitiligo by assessing the change in biomarkers.
    

Eligibility criteria:

        Inclusion Criteria

          -  A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5%
             BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body
             vitiligo area (facial and nonfacial) should not exceed 50% BSA.

          -  At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance,
             pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.

          -  Agree to discontinue all agents used to treat vitiligo from screening through the
             final safety follow-up visit. Over-the-counter preparations deemed acceptable by the
             investigator and camouflage makeups are permitted.

        Exclusion Criteria

          -  No pigmented hair within any of the vitiligo areas on the face.

          -  Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or
             other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy,
             postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus,
             chemical leukoderma, and tinea versicolor).

          -  Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or
             other pigmented areas except hydroquinone.

          -  Any other skin disease that, in the opinion of the investigator, would interfere with
             the study medication application or study assessments.

          -  Conditions at baseline that would interfere with evaluation of vitiligo.

          -  Use of any protocol-defined treatments within the indicated washout period before
             baseline.
High Dose Vitamin D vs Standard Dose Vitamin D Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: 800 IU Vitamin D Supplement; 50,000 IU Vitamin D supplement
Intervention description: Standard Dose; High Dose
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Hormone Receptor Positive; Vitamin D

Summary:

      This study is being done to look at the difference, if there is a difference between two
      different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is
      caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients.
      The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent
      aromatase inhibitor arthralgia (AIA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All participants must be female and at least 21 years of age

          -  Signed informed consent

          -  Patients must have had histologically confirmed stage I-III breast carcinoma that is
             positive for Estrogen Receptor (ER) and/or Progesterone Receptor (PR).

          -  Post-menopausal

          -  Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6
             weeks

          -  Bisphosphonates are allowed at the treating investigator¡¦s discretion

          -  Performance status (WHO/ECOG scale) 0-2.

        Exclusion Criteria:

          -  History of kidney stones

          -  Hypercalcemia at baseline, defined as any corrected calcium greater than the
             laboratory's normal parameters

          -  History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating
             investigator's discretion

          -  Baseline Vitamin D level greater than 50 ng/mL

          -  Inability or unwillingness to comply with, or follow study procedures.

          -  Currently taking Phenytoin or phenobarbital -7 Currently taking cholestyramine or
             orlistat

          -  Malabsorption syndrome, such as Crohn's disease

        Prohibited Therapies: Patients may not take additional Calcium and Vitamin D aside from the
        study medications. Patients who are on cholestyramine or orlistat will not be allowed on
        the trial. Also, patients who are taking phenytoin or phenobarbital are not allowed on the
        trial either because of interaction between Vitamin D and anti-epileptic medications.
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Nasobol®; Androderm® (Positive Control)
Intervention description: Intra-nasal Testosterone (2 syringes), b.i.d.; QD administration
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Primary Hypogonadism; Secondary Hypogonadism

Summary:

      This clinical trial is being performed to compare the pharmacokinetic profile of testosterone
      after repeated intra-nasal administration of products of different strengths in subjects with
      hypogonadism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes)
             testosterone levels >100 ng/dl and ≤ 300 ng/dL.

          -  Normal Otolaryngological nasal endoscopy examination.

          -  Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.

        Exclusion Criteria:

          -  Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex
             hormones

          -  Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12
             months

          -  History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or
             sinus surgery.

          -  History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per
             month, abuse of nasal decongestants) or sleep apnea.
Metformin as an Upstream Therapy in Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Metformin
Intervention description: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if the study drug metformin will help patients who are
      overweight and have atrial fibrillation. This study aims to see if metformin helps patients
      stay in normal sinus rhythm after a catheter ablation.

      Metformin is investigational for use in patients with atrial fibrillation. Metformin is
      approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes
      Mellitus. Metformin is used with a proper diet and exercise program to control high blood
      sugar, and has been shown to help people lose weight. This study aims to look at the effects
      of metformin on weight loss and heart rhythm in patients with atrial fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm
             control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the
             study. All subjects must be able to understand and willing to sign a written informed
             consent document.

        Exclusion Criteria:

          -  Individuals who are already taking metformin or other antidiabetic medications
             including insulin, have a diagnosis of diabetes, have a known allergy or FDA-labeled
             contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other
             clinical diagnosis of advanced renal disease,, have acute or chronic metabolic
             acidosis (serum bicarbonate <22 mEq/L), have a history of significant alcohol use (>2
             drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X
             greater than the upper limit of normal), have a history of New York Heart Association
             (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.