bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Condition: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; High Grade Serous Carcinoma; Endometrioid Adenocarcinoma
MeSH terms: Carcinoma; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Endometrioid; Cystadenocarcinoma, Serous
Intervention: Rucaparib; Nivolumab
Intervention description: Oral rucaparib will be administered twice daily; IV nivolumab will be administered once every 4 weeks
Intervention MeSH terms: Nivolumab; Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PARP; PARPi; PARP inhibitor; ARIES; Opdivo; Rucaparib; Nivolumab; PD-1; BRCA; LOH; CO-338; Immunotherapy; BMS-936558; Clovis; Clovis Oncology; Rubraca

Summary:

      This is an open label Phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination
      with nivolumab in patients with high-grade serous or endometroid ovarian cancer.

      Patients entering the following cohorts must have BRCA mutational status confirmed by a
      central lab:

        -  Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)

        -  Cohort A2: BRCA mutation in tumor
    

Eligibility criteria:

        General Inclusion Criteria:

          -  ≥ 18 years of age

          -  Adequate organ function

          -  Life expectancy ≥ 16 weeks

          -  Women of childbearing potential must have a negative serum pregnancy test

          -  High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary
             peritoneal cancer

          -  Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have
             platinum-sensitive disease

          -  Relapsed/progressive disease (confirmed by radiologic assessment)

          -  Willing and able to have a biopsy of tumor at screening and after 4 weeks of
             treatment.

          -  Measurable disease (RECIST v1.1)- Cohort A1 only

          -  ECOG performance status of 0 to 1

        General Exclusion Criteria

          -  Active second malignancy

          -  Central nervous system brain metastases

          -  Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of
             myocarditis.

          -  Active, known or suspected autoimmune disease (eg, autoimmune hepatitis).

          -  Condition requiring systemic treatment with either corticosteroids

          -  Prior treatment with a PARP inhibitor or immune checkpoint inhibitor.

          -  Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential
             (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are
             allowed.
Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis
Condition: Vitamin D Deficiency
MeSH terms: Cystic Fibrosis; Vitamin D Deficiency
Intervention: Treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 36 Months
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than
      or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to
      participate in this study. Upon consent, they will be given oral cholecalciferol
      supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed
      by measuring a serum calcium level within 1 week of supplementation. Efficacy will be
      assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be
      assessed with the previous two measures as well as a brief questionnaire administered via
      telephone within 1 week of supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with Cystic Fibrosis >36 months of age

          -  Serum/blood 25OHD level < 30 ng/dL

          -  Ability to provide valid informed consent to be a part of the study

        Exclusion Criteria:

          -  Any history of kidney disease, kidney stones or on dialysis

          -  Any history of hypercalcemia

          -  Any history of hypercalciuria

          -  Pregnancy at time of enrollment

          -  Any history of parathyroid disorders

          -  Inability to swallow pills by mouth
Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: Bortezomib; Rituximab
Intervention description: Once weekly for 3 weeks; Intravenously once a week for the first and fourth weeks of a cycle
Intervention MeSH terms: Rituximab; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: relapsed Waldenstrom's macroglobulinemia; refractory Waldenstrom's macroglobulinemia; Velcade; WM

Summary:

      In this study, we are trying to find out if the combination of these two drugs is effective
      in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not
      been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and
      Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a
      cancer that is closely related to Waldenstrom's macroglobulinemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Patients with previously untreated WM and those who have received prior therapy are
             eligible

          -  Must have received prior therapy for their WM and have relapsed or refractory WM.

          -  CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow
             cytometric analysis performed up to 3 months prior to enrollment.

          -  Measurable disease

          -  ECOG Performance Status 0,1, or 2

          -  Total bilirubin < 2.0 mg/dl

          -  AST < 3 x ULN

          -  Life expectancy of greater than 12 weeks

        Exclusion Criteria:

          -  Uncontrolled infection

          -  Other active malignancies

          -  Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or
             corticosteroids less than 2 weeks, prior to registration.

          -  Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
             considered investigational

          -  Known to be HIV positive or HEP B positive

          -  Radiation therapy less than 2 weeks prior to registration

          -  Grade 2 or greater peripheral neuropathy

          -  Myocardial infarction within 6 months rior to enrollment or has NYHA Class III or IV
             heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
             electrocardiographic evidence of acute ischemia or active conduction system
             abnormalities.

          -  Hypersensitivity to bortezomib, boron, or mannitol

          -  Pregnant or breast feeding women

          -  Other investigational drugs within 14 days of enrollment

          -  Serious medical or psychiatric illness likely to interfere with participation
Safety Study of Zimura™in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Zimura; Avastin; Lucentis; Eylea
Intervention description: Zimura 2 mg, administered by intravitreal injection; Avastin 1.25 mg, administered by intravitreal injection; Lucentis 0.5 mg, administered by intravitreal injection; Eylea 2 mg, administered by intravitreal injection
Intervention MeSH terms: Bevacizumab; Ranibizumab; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Neovascular age-related macular degeneration (NVAMD)

Summary:

      The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in
      combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment
      experienced subjects with neovascular age-related macular degeneration (AMD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment experienced subjects defined as subjects with 1 prior dose of same
             intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular
             age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters
             of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start
             of anti-VEGF treatment.

          -  Presence of subfoveal active choroidal neovascularization (CNV)

        Exclusion Criteria:

          -  Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of
             indication, with the exception of the 1 prior anti-VEGF injections.

          -  Presence of other causes of choroidal neovascularization, including pathologic myopia,
             ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal
             choroiditis.

          -  Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months
             of trial entry.

          -  Prior thermal laser in the macular region, regardless of indication.

          -  Ocular or periocular infection in the past twelve weeks.

          -  History of any of the following conditions or procedures in the study eye:
             rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma
             drainage device, or corneal transplant.

          -  Previous therapeutic radiation in the region of the study eye.

          -  Evidence of diabetic retinopathy
Weight-based Dosing in Hemophilia A
Condition: Hemophilia
MeSH terms: Hemophilia A
Intervention: rFVIII
Intervention description: Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)].
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which
      promotes blood clotting is missing or does not work properly. Individuals with hemophilia A
      are at risk for bleeding. Bleeding is prevented and/or treated with recombinant factor VIII
      (rFVIII), which is an FDA-approved treatment for Hemophilia A. Obesity is common among
      patients with hemophilia. Some studies have shown that obese hemophilia patients may be able
      to prevent bleeding with a lower dose of clotting factor than the dose they are currently
      receiving. The lower dose is calculated based on what a patient should weigh rather than what
      he does weigh. This is a clinical research study to test whether calculating rFVIII dosing
      based on lean body mass and ideal body weight (what a person should weigh based on his
      height) in overweight and obese patients with hemophilia is more accurate than calculating
      rFVIII dosing based on what a person actually weighs.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult males age 18 or older.

          2. Hemophilia A (FVIII activity 40% or less).

          3. Overweight or obesity defined as a BMI of 25.0-29.9 and ≥ 30 mg/m2, respectively.

        Exclusion Criteria:

          1. Prior history of, or currently detectable, FVIII inhibitor defined as greater than or
             equal to 0.6 Bethesda Units (BU); however, a subject with a past low-level
             non-responding inhibitor defined as less than 5 BU, with no increase in titer
             following FVIII exposure, and not detectable within 12 months of the study, despite
             FVIII exposure during that period, will be allowed to enroll on study.

          2. Allergy to FVIII products.

          3. Current rFVIII requirements do not include at least a 72-hour period without rFVIII
             administration.
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF
Intervention description: 90/400 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal transplant

Summary:

      This study will evaluate the safety, tolerability, and antiviral efficacy of
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults
      with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney
      transplant.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genotype 1 or 4 chronic HCV infection

          -  Have received a kidney transplant more than 6 months before the Baseline visit

          -  Cirrhosis determination

          -  Screening laboratory parameters within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain
             -resolved skin cancers)

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Planned or anticipated second kidney transplant

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS1411; Placebo
Intervention description: DSXS (Taro Pharmaceuticals Inc.); Placebo (vehicle) (Taro Pharmaceuticals Inc.)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and
      a Placebo in patients with moderate to severe scalp psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females age 12 and older.

          -  Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's
             Global Assessment score of at least 3 at screening.

        Exclusion Criteria:

          -  Under 12 years of age.

          -  Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other
             concomitant topical therapies during the study.

          -  Has a scalp skin condition that would interfere with the diagnosis or assessment of
             plaque psoriasis of the scalp.
Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Cabergoline; Norethindrone acetate
Intervention MeSH terms: Cabergoline; Norethindrone; Norethindrone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Female
Minimum age: 15 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent,
      cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of
      endometriosis-associated pain in young women with endometriosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Surgically confirmed endometriosis

          -  Age between 15-40 y, and premenopausal

          -  Pelvic pain score ≥3 on a Visual Analog Scaleover the last month

        Exclusion Criteria:

          -  Use of other concurrent hormone medications (such as birth control pills)

          -  Impaired liver function (ALT > 2x normal) or liver disease (cirrhosis, hepatitis)

          -  Pregnancy

          -  Breast cancer

          -  Active thromboembolic disease

          -  Uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic
             disorders
Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors
Condition: Hemophilia A and B
MeSH terms: Hemophilia A
Intervention: Befovacimab (BAY1093884)
Intervention description: Once weekly doses until premature termination of the study, subcutaneous injection
Intervention MeSH terms: Lipoprotein-associated coagulation inhibitor; Immunoglobulins; Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subcutaneous; Prophylaxis; Non-Inhibitors; Inhibitors

Summary:

      The purpose of this study was to assess the safety and tolerability of multiple doses of a
      human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or
      B. This antibody was intended to protect from bleeds by inhibiting a substance (Tissue Factor
      Pathway Inhibitor, TFPI) that reduces the ability of the body to form blood clots.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male severe hemophilic patients with undetectable FVIII activity <1% or FIX activity
             <2%, with or without inhibitors (any titer) are eligible.

          -  Subjects with a past history of inhibitors (any inhibitor titer) are eligible.

          -  Age ≥18 years.

          -  Documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not)
             within the 6 months prior to screening.

          -  For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.

          -  For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing
             ITI.

        Exclusion Criteria:

          -  History of any other coagulation disorder (particularly disseminated intravascular
             coagulopathy or combined FVIII/FV deficiency) or platelet disorder.

          -  History of diseases related to venous thromboembolic events (e.g., pulmonary embolism,
             deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.

          -  Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension,
             uncontrolled diabetes).

          -  History of cardiac, coronary and/or arterial peripheral atherosclerotic disease

          -  Platelet count <100,000/μL.

          -  Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4
             (CD4+) lymphocyte count of <200/mm^3
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis; Anemia, Sickle Cell
Intervention: LDV/SOF
Intervention description: 90/400 mg fixed dose combination (FDC) tablet administered orally once daily
Intervention MeSH terms: 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: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Gilead; Hepatitis C

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for
      12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle
      cell disease (SCD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic genotype 1 or 4 infected patients with sickle cell disease

          -  HCV RNA ≥ 1,000 IU/mL at screening

          -  Cirrhosis determination by transient elastography

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
             skin cancers)

          -  History of clinically significant illness or any other medical disorder that may
             interfere with treatment, assessment or compliance with the protocol

        Note: Other protocol defined inclusion/Exclusion criteria may apply.
Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP
Condition: Molybdenum Cofactor Deficiency, Type A
MeSH terms: Metal Metabolism, Inborn Errors
Intervention: ORGN001 (formerly ALXN1101)
Intervention description: IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Healthy volunteers: No
Keywords: Molybdenum cofactor deficiency (MoCD); molybdenum cofactor (MoCo) biosynthesis; sulfite oxidase (SO); xanthine dehydrogenase; aldehyde oxidase; S sulfocysteine (SSC)

Summary:

      This study will include a screening period, a 6-month treatment period, followed by long-term
      extension period expected to last approximately 72 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with a genetically confirmed diagnosis of MoCD Type A (MOCS1
             mutation)

          -  Currently treated with rcPMP infusions

        Exclusion Criteria:

        - Current or planned treatment with another investigational drug or device, with the
        exception rcPMP treatment through Day -1.