bioihbjkbjnl/mcl2 huggingface dataset:
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome
Condition: Myelofibrosis
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Primary Myelofibrosis
Intervention: Busulfan; Fludarabine; Thymoglobulin (ATG)
Intervention description: Test dose = 32 mg/m^2 by vein x 1 day; 100 mg/m^2 by vein daily over 3 hours x 4 days; 40 mg/m^2 by vein daily over 1 hour x 4 days; 2.5 mg/kg by vein over 6 hours x 3 days if there is an unrelated or a mismatched donor
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Busulfan; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Idiopathic Myelofibrosis; Myelofibrosis; Essential Thrombocythemia; Polycythemia Vera; Busulfan; Antithymocyte Globulin; ATG; Fludarabine; Thymoglobulin

Summary:

      The goal of this clinical research study is to learn if using a combination of fludarabine,
      busulfan, and antithymocyte globulin (ATG) can help to control myelofibrosis or
      myelodysplastic syndrome in patients receiving a bone marrow or blood stem cell transplant.
      The safety of these drugs will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera
             or Essential Thrombocythemia or Myelodysplastic syndrome with or without fibrosis.

          2. Patients 75 years or younger

          3. Patients must have an HLA matched or at least a 9/10 antigen (A, B, C, DQ or DR)
             matched related or unrelated donor.

          4. Patients must have a Zubrod PS 2 or less.

          5. Creatinine < 1.6 mg/dl

          6. Ejection fraction >/= 40%, unless cleared by cardiology

          7. Serum direct bilirubin < 2 mg/dl (unless due to Gilbert's syndrome), serum glutamate
             pyruvate transaminase (SGPT) </= 4 x normal values

          8. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), or
             diffusing capacity of lung for carbon monoxide (DLCO) >/= 40% of expected.

          9. Negative Beta human chorionic gonadotropin (HCG) test in a woman with child bearing
             potential defined as not post-menopausal for 12 months or no previous surgical
             sterilization.

        Exclusion Criteria:

          1. Uncontrolled life-threatening infections

          2. HIV positive

          3. Patients with Active viral hepatitis
Sildenafil After the Fontan Operation
Condition: Hypoplastic Left Heart Syndrome; Tricuspid Atresia
MeSH terms: Hypoplastic Left Heart Syndrome; Tricuspid Atresia
Intervention: Sildenafil; Placebo
Intervention description: One 20 mg capsule of sildenafil will be taken by mouth three times-a-day.; One placebo capsule will be taken by mouth three times-a-day.
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 8 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Other Single Ventricle Anatomy; Hypoplastic Left Heart Syndrome; Tricuspid Atresia

Summary:

      In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance
      in patients with a single cardiac ventricle who have undergone the Fontan operation. The
      investigators will also evaluate echocardiographic measures of ventricular function and
      measure quality of life changes using two validated quality of life measures. The hypothesis
      is that sildenafil will result in increased exercise tolerance in patients who have had the
      Fontan operation as compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  8 years of age or older

          -  All participants must have had Fontan completion

        Exclusion Criteria:

          -  Height less than 132 cm

          -  Unable to participate in exercise testing due to medical restrictions or physical
             limitations

          -  Fontan baffle obstruction or single lung physiology

          -  Coarctation of the aorta or neo-aorta (BP gradient > 20 mmHg)

          -  Severe ventricular dysfunction assessed qualitatively by echocardiography

          -  Severe atrioventricular valvar regurgitation assessed qualitatively by
             echocardiography

          -  Presence of electronic pacemaker

          -  History of treatment with sildenafil in the six weeks prior to enrollment in study

          -  Patients with severe renal impairment

          -  Patients with severe hepatic impairment

          -  Patients taking medications that inhibit or induce Cytochrome P450 3A4 (CYP3A4)
             (including grapefruit juice and St. John's Wort)

          -  Patients taking alpha-blockers and nitrates

          -  Parents/guardians or subjects who, in the opinion of the investigator, may be
             non-compliant with study schedules or procedures
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Intervention: AZD9668; Placebo
Intervention description: 2 x 30 mg, oral tablet, twice daily for 28 days; 2 x Matched placebo, oral tablet, twice daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: bronchiectasis; Phase II

Summary:

      The purpose of this study is to investigate if treatment with AZD9668 for 28 days is
      effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance
      which does not have any action).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female of non child bearing potential

          -  Clinical diagnosis of bronchiectasis

          -  Be sputum producers, with history of chronic expectoration on most days

        Exclusion Criteria:

          -  Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD

          -  FEV1 of <30% of predicted normal
Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer; Ulcer
Intervention: esomeprazole
Intervention description: esomeprazole 20 mg qd for 6 months
Intervention MeSH terms: Esomeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Healthy volunteers: No
Keywords: proton pump inhibitor; peptic ulcer; clopidogrel; prevention

Summary:

      Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at
             initial endoscopy. The patients will be randomly assigned to receive either (1)
             esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6
             months.

        Exclusion Criteria:

          -  1.serious disease 2.refuse informed consent
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Intervention: LDV/SOF
Intervention description: Tablet(s) administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: HCV genotype 1 or 4 (GT-1 or GT-4); Direct Acting Antiviral; Combination Therapy; Hepatitis C, Chronic; Liver Diseases; Virus Diseases

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric
      participants who are undergoing cancer chemotherapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Aged 12 to <18 years

          -  Parent or legal guardian must provide written informed consent

          -  Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on
             a maintenance cancer chemotherapy regimen

          -  Receiving a protocol-approved maintenance chemotherapy regimen for a hematological
             malignancy

          -  Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy

          -  Screening laboratory values within defined thresholds

          -  No History of solid organ or bone marrow transplantation

          -  No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy,
             variceal hemorrhage)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin 50 mg; Placebo; Canagliflozin 150 mg; Metformin
Intervention description: One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks; 1 placebo capsule taken orally twice daily with a meal for 18 weeks; 1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks; The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Intervention MeSH terms: Metformin; Canagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 279.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Canagliflozin; Placebo; Metformin; Hemoglobin A1c; Type 2 diabetes mellitus

Summary:

      The purpose of this study is to evaluate the efficacy and safety of 2 different doses of
      canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are
      receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have
      inadequate glycemic (blood sugar) control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of T2DM and be currently treated with metformin

          -  Patients in the study must have a HbA1c between >=7 and <=10.5%

          -  Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a
             severe hypoglycemic episode within 6 months before screening
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF; RBV
Intervention description: LDV/SOF FDC administered orally once daily; Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
Intervention MeSH terms: Ribavirin; Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state
      pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose
      combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in
      Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of
      dosing of LDV/SOF FDC in HCV-infected pediatric participants.

      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate
      LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover
      into the Treatment Phase with no interruption of study drug administration. The primary
      objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and
      tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants
      with HCV.

      During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to
      swallow tablets.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Consent of parent or legal guardian required

          -  Chronic HCV infection

          -  Screening laboratory values within defined thresholds

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment, assessment or compliance with the protocol.

          -  Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus

          -  Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)

          -  Pregnant or nursing females

          -  Known hypersensitivity to study medication

          -  Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Topical NVN1000 for the Treatment of External Genital and Perianal Warts
Condition: Genital Warts; Perianal Warts
MeSH terms: Warts; Condylomata Acuminata
Intervention: NVN1000 8% Gel; NVN1000 16%; Vehicle; NVN1000 24%
Intervention description: once and twice daily; once daily; placebo comparator; once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: genital warts; perianal warts

Summary:

      A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study
      Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External
      Genital Warts and Perianal Warts
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 2 but not more than 20 genital/perianal warts with a maximum total wart
             surface area no more than 1% body surface area

          -  If a woman of child-bearing potential, have a negative pregnancy test and use
             effective contraception

          -  If currently receiving wart treatment, be willing to stop all treatment for 28 days
             prior to randomization and during the study

        Exclusion Criteria:

          -  Immunocompromised patients including those with HIV, receiving radiation, or drugs
             that suppress the immune system

          -  Pregnant, planning to become pregnant, or nursing

          -  History of cancer (including cervical cancer) within 5 years, with exception of
             non-melanoma skin cancer in non-genital skin

          -  Recent history of other genital skin infections

          -  Active HSV and frequent HSV recurrences unless receiving suppression therapy

          -  Have hemoglobin < 10 G/dl or methemoglobin > 3%

          -  Known allergy to any component of the gel including excipients

          -  Previously participated in any study with NVN1000 or SB204
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Atacicept 75 milligram (mg); Atacicept 150 mg; Placebo
Intervention description: Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.; Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.; Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atacicept; Placebo

Summary:

      This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of
      atacicept in subjects with systemic lupus erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible male and female subjects, aged 18 years or older

          -  Must have at least moderately active SLE, as defined as SLE Disease Activity
             Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit

          -  At least 4 of the 11 American college of rheumatology (ACR) classification criteria
             for SLE (diagnosed >= 6 months prior to the screening visit)

          -  Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded
             deoxyribonucleic acid (anti-dsDNA) antibodies

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Subjects have demyelinating disorder

          -  Severe central nervous system SLE

          -  Use of cyclophosphamide within 3 months of the screening visit

          -  Urine protein:creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day

          -  Other protocol defined exclusion criteria could apply
Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes
Condition: MELAS Syndrome
MeSH terms: MELAS Syndrome; Brain Diseases; Acidosis; Acidosis, Lactic
Intervention: Idebenone; Idebenone; Placebo
Intervention description: 900 mg/day for 1 month; 2250 mg/day for 1 month; Placebo - No idebenone
Intervention MeSH terms: Ubiquinone; Idebenone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 8 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy of two (2) different doses of idebenone
      with that of a placebo over a one month period on cerebral lactate concentration as measured
      by magnetic resonance spectroscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of MELAS with confirmed A3243G mtDNA mutation, or evidence of central
             nervous system involvement (cognitive problems, migraines, memory loss)

          -  Cerebral lactate level equal to or greater than 5.0 i.u. at baseline

          -  Patients at least 8 and < 65 years of age at baseline

          -  Patients with a body weight > 37 kg/82 lbs at baseline

          -  Stable co-medication/vitamins/supplements within 1 month prior to baseline

          -  Patients who in the opinion of the investigator are able to comply with the
             requirements of the study, including swallowing the study medication

          -  Negative urine pregnancy test at screening and baseline (female patients of
             childbearing potential)

        Exclusion Criteria:

          -  Contraindication to MRS (e.g. metal implant, claustrophobia)

          -  Stroke like event within 2 months prior to baseline

          -  Treatment with idebenone at any dose, or coenzyme Q10 at doses above 100mg/d within 1
             month prior to baseline

          -  Inadequate contraception use

          -  Pregnancy and/or breast-feeding

          -  Clinically significant abnormalities of clinical hematology or biochemistry including,
             but not limited to, elevations greater than 1.5 times the upper limit of normal of
             aspartate aminotransferase (AST), alanine aminotransferase (ALT) or creatinine

          -  Current abuse of drugs or alcohol

          -  Participation in a trial of another investigational drug within the last month

          -  Other factor that, in the investigator's opinion, excludes the patient from entering
             the study
A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: 5-fluorouracil; Epidoxorubicin; Cyclophosphamide; Paclitaxel; Bevacizumab
Intervention description: 600 milligrams per meter squared (mg/m^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.; 90 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.; 600 mg/m^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.; Paclitaxel was administered at 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.; Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Bevacizumab; Fluorouracil; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of sequential neoadjuvant
      chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants
      with inflammatory or locally advanced operable breast cancer. Participants will receive
      5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given
      concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and
      the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female participants, >=18 years of age;

          -  stage III, or inflammatory breast cancer;

          -  estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human
             epidermal growth factor receptor 2 (HER-2) negative;

          -  normal left ventricular ejection fraction (LVEF).

        Exclusion Criteria:

          -  previous chemotherapy/endocrine therapy;

          -  evidence of distant metastatic disease;

          -  other primary tumors in last 5 years (except for adequately treated cancer in situ of
             the cervix, or basal cell skin cancer);

          -  chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day
             clopidogrel.