bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: YKP3089; Placebo
Intervention description: Capsule, dose to be titrated Tablet, dose to be titrated; Placebo capsule Placebo tablet
Intervention MeSH terms: Cenobamate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: partial onset seizures; treatment resistant; partial epilepsy

Summary:

      This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared
      to baseline in subjects with partial onset seizures not fully controlled despite their
      treatment with 1 to 3 concomitant anti-epileptic drugs.

      Also to evaluate the safety and tolerability of YKP3089.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of treatment resistant partial epilepsy;

          -  History of epilepsy for at least 2 years;

          -  Have at least 3 simple partial with motor component, complex partial or secondarily
             generalized seizures per month with no consecutive 21 day seizure free period.

          -  Currently treated on a stable dose of :

               -  1 - 3 AED's for at least 12 weeks prior to randomization.

               -  VNS will not be counted as AED; however the parameters must remain stable for at
                  least 4 weeks prior to baseline.

               -  Benzodiazepines taken at least once per week for epilepsy, or for anxiety or
                  sleep disorder, will be counted as 1 AED. Therefore only a maximum of two
                  additional approved AEDs will be allowed.

        Exclusion Criteria:

          1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years.

          2. Subject has had status epilepticus within past 1 year.

          3. Subject has had greater than 2 allergic reactions to an AED or one serious
             hypersensitivity reaction to an AED.

          4. Subjects taking felbamate with less than 18 months continuous exposure.

          5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.

          6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months.

          7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide
             attempt.

          8. Subject meets criteria for current major depressive episode (within 6 months).

          9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a
             24-hour period is considered one rescue) in the one month period prior to Visit 1.
Study of Tremelimumab in Patients With Advanced Solid Tumors
Condition: Urothelial Bladder Cancer; Triple-negative Breast Cancer; Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma; Urinary Bladder Neoplasms; Triple Negative Breast Neoplasms
Intervention: Tremelimumab monotherapy; MEDI4736 monotherapy; MEDI4736 + tremelimumab combination therapy
Intervention description: IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 150 Years
Healthy volunteers: No
Keywords: Urothelial bladder cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Advanced Solid Tumors, Tremelimumab, MEDI4736, ORR

Summary:

      A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with
      Advanced Solid Tumors
    

Eligibility criteria:

        Inclusion Criteria:

        1. histologically or cytologically documented solid tumor malignancies, including but not
        limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible
        for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not
        previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest
        diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography
        (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for
        accurate repeated measurements.

        Exclusion criteria:

        1. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2.
        History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or
        inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic
        or treated and stable off steroids and anti-convulsants for at least 14 days prior to study
        treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF)
        ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: PF-06700841; Vehicle (Placebo)
Intervention description: PF-06700841 topical cream; Vehicle topical cream
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 292.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Mild-to-Moderate Atopic Dermatitis; topical

Summary:

      This study is being conducted to provide data on efficacy, safety, tolerability and PK of
      multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of
      mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the
      dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future
      clinical development of topical PF-06700841.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Atopic Dermatitis for at least 3 months

          -  Investigator's Global Assessment (IGA) Score of 2 or 3

          -  Eczema Area Severity Index (EASI) score of 3-21

          -  Body Surface Area (BSA) of 2-20%

          -  Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

        Exclusion Criteria:

          -  Other forms of dermatological diseases (other than atopic dermatitis)

          -  Fitzpatrick skin type score greater than 5

          -  Clinically significant abnormal ECG, vital signs, and laboratory values

          -  Infection with HBV, HCV, herpes zoster or tuberculosis
A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: GLPG2222 50 mg; GLPG2222 100 mg; Placebo; GLPG2222 200 mg; GLPG2222 400 mg
Intervention description: Oral tablet(s) containing GLPG2222; Oral tablet(s) containing GLPG2222; Matching oral tablet(s) containing placebo; Oral tablet(s) containing GLPG2222; Oral tablet(s) containing GLPG2222
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled,
      parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to
      adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic
      Fibrosis Transmembrane conductance Regulator (CFTR) mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject ≥ 18 years of age, on the day of signing the Informed Consent
             Form (ICF).

          2. A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation

          3. Weight ≥ 40 kg.

          4. Stable concomitant treatment for at least 4 weeks (28 days) prior to baseline

          5. Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted normal for age, gender
             and height at screening

        Exclusion Criteria:

          1. History of clinically meaningful unstable or uncontrolled chronic disease that makes
             the subject unsuitable for inclusion in the study in the opinion of the investigator.

          2. Unstable pulmonary status or respiratory tract infection requiring a change in therapy
             within 4 weeks of baseline.

          3. Need for supplemental oxygen during the day, and >2 liters per minute (LPM) while
             sleeping.

          4. Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to
             the first study drug administration.

          5. History of hepatic cirrhosis with portal hypertension.

          6. Abnormal liver function test at screening; defined as aspartate aminotransferase (AST)
             and/or alanine aminotransferase (ALT) and/ or alkaline phosphatase and/or
             gamma-glutamyl transferase (GGT) ≥ 3x the upper limit of normal (ULN); and/or total
             bilirubin (>1.5 times ULN)

          7. Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula at
             screening.
A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Condition: Raynaud's Phenomenon Secondary to Systemic Sclerosis
MeSH terms: Neoplasm Metastasis; Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: Temanogrel; Placebo
Intervention description: Participants will receive a single oral dose of temanogrel during the treatment visit.; Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.
Intervention MeSH terms: APD791
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Raynaud's phenomenon; SSc-RP; Systemic sclerosis; SSc; Digital cold sensitivity; Digital blood flow; APD791; Temanogrel

Summary:

      The purpose of this study is to determine whether oral temanogrel improves digital blood flow
      in participants with Raynaud's phenomenon secondary to systemic sclerosis (SSc-RP) as a
      potential safe and effective treatment for symptoms associated with SSc-RP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Raynaud's phenomenon (defined as a history of digital cold sensitivity associated with
             color changes of cyanosis and pallor, with on average at least 5 attacks per week
             during the winter period) secondary to systemic sclerosis (SSc)

          -  Both men and women participants agree to use a highly effective method of birth
             control if the possibility of conception exists

          -  Body mass index 18.0 to 40.0 kilograms per square meter (kg/m^2), inclusive

        Exclusion Criteria:

          -  Active digital ulcer(s), recent history (within 3 months of Screening) of digital
             ulcers, or history of recurrent digital ulcerations that in the opinion of the
             Investigator increase the likelihood of developing a digital ulcer during the course
             of the study. Any history of gangrene, amputations, or other critical digital ischemic
             event

          -  Raynaud's phenomenon due to any cause other than SSc

          -  Severe gastrointestinal complications related to SSc that in the opinion of the
             Investigator could significantly affect study drug absorption

          -  History of gastrointestinal bleeding or active gastric or duodenal ulcers
Dapagliflozin (DAPA) Effects in HFpEF
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Intervention: Dapagliflozin; Placebo
Intervention description: 10 mg orally once a day; Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
Intervention MeSH terms: Dapagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6
      months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart
      failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study specific procedures.

          -  Male or female.

          -  Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation.

          -  EF ≥ 50% + BMI ≥ 30 kg/m^2

          -  Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg)
             ascertained at Visit 1. Patients that have consented to study procedures but do not
             meet this invasive criterion will be considered as screen failures and will not be
             randomized .

        Exclusion Criteria:

          -  Type I diabetes.

          -  Type II diabetes with poor control (HgbA1C ≥ 10%).

          -  Recent hospitalization (< 30 days) or revascularization (< 90 days).

          -  Primary cardiomyopathy (such as amyloid).

          -  Constrictive pericarditis.

          -  Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the
             investigator.

          -  Severe anemia (hemoglobin < 9gm/dl.

          -  Significant left-sided valvular heart disease (> mild stenosis, > moderate
             regurgitation),

          -  Severe kidney disease (estimated glomerular filtration rate (GFR) < 30) or liver
             disease,
A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111
Condition: Choroideremia
MeSH terms: Choroideremia
Intervention: BIIB111
Intervention description: Administered as specified in the treatment arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NightstaRx; NSR-REP1; CHM; Gene Therapy; AAV; REP1; Timrepigene Emparvovec

Summary:

      The objective of the study is to evaluate the safety of bilateral, sequential sub-retinal
      administration of a single dose of BIIB111 in adult male participants with Choroideremia
      (CHM).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Are willing and able to give informed consent for participation in the study to have
             both eyes treated.

          2. Have documentation of a genetically-confirmed diagnosis of CHM.

          3. Have active disease clinically visible within the macular region of both eyes.

          4. Have a BCVA of ≥34 ETDRS letters (20/200 or better Snellen acuity) in both eyes, or in
             the untreated eye, if the other eye was previously treated with BIIB111*

             *If previously treated with BIIB111 in an antecedent study, participants may be
             eligible for participation following Sponsor approval.

          5. For participants who received treatment with BIIB111 in an antecedent study, have
             biological samples available to complete an adequate immunology profile.

        Key Exclusion Criteria:

          1. Have a history of amblyopia or inflammatory disorder in either eye.

          2. Are unwilling to use barrier contraception methods or abstain from sexual intercourse
             for a period of 3 months following treatment with BIIB111 in either eye.

          3. Have had previous intraocular surgery performed within 3 months of the Screening Visit
             in either eye.

          4. Have any other significant ocular or non-ocular disease/disorder which, in the opinion
             of the investigator, may either put the participants at risk because of participation
             in the study, or may influence the results of the study or the participant's ability
             to participate in the study. This includes but is not limited to a potential
             participants:

               -  with a contraindication to oral corticosteroid (e.g., prednisolone/prednisone)

               -  with clinically significant cataract in either eye

               -  who, in the clinical opinion of the Investigator, is not an appropriate candidate
                  for sub-retinal surgery.

          5. Have participated in another research study involving an investigational product in
             the past 12 weeks or received a gene/cell-based therapy at any time previously, except
             if treated within an antecedent study with BIIB111.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: NYX-2925; Placebo
Intervention description: NYX-2925 administered orally; Placebo administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed consent

          -  Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening
             and reports at least moderate pain over the last week

          -  Stable protocol allowed medication and other therapies during the study

          -  Agrees to use highly effective birth control during the study

          -  Has not participated in an interventional study for at least 30 days and agrees not to
             participate in another interventional study during the study

        Exclusion Criteria:

          -  Pain due to other conditions or diseases that would complicate participation in the
             study or pain reporting

          -  Current or historical serious medical conditions

          -  Prior participation in NYX-2925 clinical trial
Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)
Condition: Advanced or Metastatic Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Ipilimumab
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of a sequential combination
      therapy of Nivolumab and Ipilimumab
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically confirmed unresectable Stage III or IV melanoma

          -  Treatment-naive or experienced disease recurrence or progression during or after one
             prior systemic regimen for advanced disease

          -  Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Known BRAF V600 mutation status or consent to BRAF V600 mutation testing

          -  Sufficient tumor tissue accessible for baseline and post-treatment biopsies.

        Exclusion Criteria:

          -  Active central nervous system (CNS) metastases

          -  Carcinomatous meningitis

          -  Active, known or suspected autoimmune disease

          -  Condition requiring systemic treatment with either corticosteroids (>10 mg daily
             prednisone equivalent) or other immunosuppressive medications within 14 days of
             randomization

          -  Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1
             (PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4)
             antibody

          -  Prior treatment with other immunotherapies

          -  Prior therapy with BRAF inhibitor within 6 weeks of enrollment