bioihbjkbjnl/mcl2 huggingface dataset:
Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Filgotinib; Placebo to match filgotinib; MTX; Placebo to match MTX
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; Capsule(s) administered orally once weekly; Capsule(s) administered orally once weekly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effects of filgotinib in combination
      with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League
             Against Rheumatism [EULAR] criteria) and are ACR functional class I-III.

          -  Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥
             6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both
             screening and Day 1.

          -  Limited or no prior treatment with MTX

        Key Exclusion Criteria:

          -  Previous treatment with any janus kinase (JAK) inhibitor

          -  Previous therapy for longer than 3 months with conventional synthetic disease
             modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine

          -  Use of any licensed or investigational biologic disease-modifying antirheumatic drugs
             (DMARDs)

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole Ointment; Crisaborole Placebo Vehicle
Intervention description: Crisaborole ointment 2%; Placebo for crisaborole ointment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy
      and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate
      atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized
      in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).
    

Eligibility criteria:

        Inclusion Criteria:

        - Is male or female 2 years and older at the Screening visit/time of informed
        consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and
        Rajka), of at least 5% BSA.

        Exclusion Criteria:

          -  Has any clinically significant medical disorder, condition, or disease (including
             active or potentially recurrent non AD dermatological conditions and known genetic
             dermatological conditions that overlap with AD, such as Netherton syndrome) or
             clinically significant physical examination finding at Screening that in the PI's or
             designee's opinion may interfere with study objectives.

          -  Has participated in a previous crisaborole clinical study.
MabionCD20 Compared to MabThera in Lymphoma Patients
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Rituximab; Doxorubicin; Vincristine; Cyclophosphamide; prednisone
Intervention description: 375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.; 50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle; 1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle; 750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle; 100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20
      (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients
      with CD20-positive diffuse large B-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histological confirmed CD20 (cluster of differentiation 20) positive
             diffuse large B cell lymphoma (DLBCL)

          2. Patients that had been diagnosed according to the WHO classification;

          3. Performance status ≤ 2 on the ECOG (Eastern Cooperative Oncology Group) / WHO (world
             Health Organization) scale, performance status of 3 will be accepted if impairment is
             caused by DLBCL complications and improvement is expected once therapy is initiated;

        Exclusion Criteria:

          1. Life expectance less than 6 months;

          2. Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal
             therapy for treatment of lymphoma within 28 days prior to treatment;

          3. Rituximab, other anti-CD20 mAb (Monoclonal Antibodies) drug treatment, treatment with
             any cell depleting therapies - e.g., anti-CD4 (cluster of differentiation 4) anti-CD5
             (cluster of differentiation 5), anti-CD3 (cluster of differentiation 3), anti-CD19
             (cluster of differentiation 19), anti CD11 (cluster of differentiation 11), anti-CD22
             (cluster of differentiation 11), BLys/BAFF (B Lymphocyte Stimulator/B-cell activating
             factor) within 1,5 years before screening;
Aggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial)
Condition: Saphenous Vein Graft Disease
MeSH terms: Aggression
Intervention: Atorvastatin 80 mg daily; Atorvastatin 10 mg daily
Intervention description: Atorvastatin 80 mg daily for 1 year; Atorvastatin 10 mg daily for 1 year
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Statin,; CABG,; saphenous vein graft,; graft occlusion,; lipids

Summary:

      During coronary artery bypass graft surgery (CABG), saphenous vein from the leg is used to
      bypass the atherosclerotic blockages in the arteries of the heart. Unfortunately, vein
      bypasses themselves develop blockages over time, a process termed saphenous vein graft
      disease. By lowering cholesterol levels in the blood, statin medications are used after
      surgery to prevent the development of atherosclerotic blockages in the vein bypasses.
      Recently, higher doses of statin medications have been introduced, with some studies showing
      that they are more effective than traditional doses when used in heart attack patients.
      Furthermore, laboratory tests have shown that higher doses of statin medications can slow the
      development of atherosclerosis. Despite these benefits, very little is known regarding the
      use of high-dose statin therapy after bypass surgery in humans.

      The goal of this study will be to see if high-dose statin therapy will prevent the
      development of vein graft occlusion during the first year after bypass surgery. Patients will
      be randomized to receive either high-dose statin therapy or conventional moderate-dose statin
      therapy starting within 4 days of surgery and continuing for the duration of one year after
      the operation. The statin medication will be given in capsule form. During the course of this
      study, neither the patient nor the health care team will know which treatment each patient is
      receiving. One year after bypass surgery, a computed tomography (CT) coronary angiogram will
      be performed to evaluate the patency of the vein bypasses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing first-time CABG with at least 1 saphenous vein graft

        Exclusion Criteria:

          -  Redo-CABG

          -  Statin allergy

          -  Severe renal dysfunction

          -  Severe liver disease
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Condition: Weight Gain; Disorder of Bone Density and Structure, Unspecified; Uterine Bleeding
MeSH terms: Bone Diseases; Uterine Hemorrhage; Weight Gain
Intervention: Depot medroxyprogesterone acetate (DMPA)
Intervention description: 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 34.0
Sex: Female
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Birth Control; Contraceptive Methods; Female Contraception; Weight Gain; Bone Density

Summary:

      The investigators are doing this study to look at how different doses of the Depot
      medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens.
      The investigators hope that what the investigators learn from this study will be used to
      develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12-21 years

          2. Healthy, post-menarcheal female

          3. Self-selected to initiate depot medroxyprogesterone acetate (DMPA)

          4. Willingness to use a barrier method of contraception in addition to DMPA

        Exclusion Criteria:

          1. Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes,
             kidney)

          2. Use of medication known to affect weight or BMD (e.g. corticosteroids)

          3. DMPA use within the past 12 months

          4. Pregnancy within the past 6 months

          5. Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined
             estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal
             ring)

          6. Weight exceeding 450 lbs

          7. Need for confidential contraceptive care for individuals < 18 years of age.
A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; Ocrelizumab; Placebo
Intervention description: Oral or parenteral repeating dose; Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).
Ocrelizumab was administered in combination with Methotrexate.; Intravenous repeating dose
Intervention MeSH terms: Methotrexate; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RA

Summary:

      This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in
      patients with active rheumatoid arthritis who have an inadequate response to methotrexate
      therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on
      Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3)
      infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment
      period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a
      single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2
      will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a
      stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated
      time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial
      is 300.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult patients, ≥ 18 years of age

          -  Active rheumatoid arthritis

          -  Inadequate treatment with any DMARD other than methotrexate

        Exclusion criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid
             arthritis

          -  Concurrent treatment with any DMARD other than methotrexate

          -  Previous treatment with any cell-depleting therapies

          -  Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline
A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
Condition: Hodgkin's Disease
MeSH terms: Hodgkin Disease
Intervention: Nivolumab; Brentuximab vedotin
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Brentuximab Vedotin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an investigational immuno-therapy
      combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe
      and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The
      participants of this trial will comprise of patients who have relapsed or did not respond to
      treatment and are not eligible for stem cell transplant
    

Eligibility criteria:

        Inclusion Criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

          -  Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who
             are relapsed or refractory with one of the following:.

             i) Autologous stem cell transplant (ASCT) ineligible patients.

        ii) Patients after failure of ASCT.

        - Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid
        by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan.

        Exclusion Criteria

          -  Known central nervous system lymphoma.

          -  Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL).

          -  Participants with known history of pancreatitis or progressive multifocal
             leukoencephalopathy (PML).

          -  Other protocol-defined Inclusion/Exclusion criteria apply.
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: ALD403; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 898.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess ALD403 in the prevention of migraine headache in
      frequent episodic migraineurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

          -  History of migraine ≥ 12 months with

               -  ≤ 14 headache days of which at least 4 have to be migraine days (migraine days
                  count as headache days) in each 28 day period in the 3 months prior to screening

               -  During the 28 days following the screening visit, the subject experiences ≤ 14
                  headache days of which at least 4 have to be migraine days (migraine days count
                  as headache days) as recorded in the eDiary

          -  No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons
             requiring injections in the head, face, or neck 4 months prior to screening and during
             the 28 day period prior to randomization

          -  Headache eDiary was completed on at least 25 of the 28 days prior to randomization

        Exclusion Criteria:

          -  Confounding pain syndromes, e.g. fibromyalgia, complex regional pain syndrome or any
             pain syndrome that requires regular analgesia

          -  Psychiatric conditions that are uncontrolled and untreated, including conditions that
             are not controlled for a minimum of 6 months prior to screening

          -  History or diagnosis of complicated migraine (ICHD- II, 2004 Section 1), chronic
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
             daily persistent headache, migraine with brainstem aura, sporadic and familial
             hemiplegic migraine

          -  Unable to differentiate migraine from other headaches

          -  Have any clinically significant concurrent medical condition

          -  Receipt of any monoclonal antibody treatment within 6 months of screening (within or
             outside a clinical trial)

          -  Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Macitentan
Intervention description: Tablet, oral administration, 10 mg dose once daily
Intervention MeSH terms: Macitentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 550.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: SERAPHIN; Pulmonary Arterial Hypertension; ACT-064992

Summary:

      The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055
      302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in
      patients with symptomatic PAH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to initiation of any study-mandated procedure.

          -  Patients with pulmonary arterial hypertension and having completed the event-driven
             study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of
             PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this
             study has been obtained from the Sponsor.

          -  Women of childbearing potential must have a negative pre-treatment serum pregnancy
             test and must use a reliable method of contraception during study treatment and for at
             least 28 days after study treatment termination.

        Exclusion Criteria:

          -  Any major violation of protocol AC 055 302/SERAPHIN.

          -  Pregnancy or breast-feeding.

          -  AST and/or ALT > 3 times the upper limit of the normal range.

          -  Any known factor or disease that might interfere with treatment compliance, study
             conduct or interpretation of the results, such as drug or alcohol dependence or
             psychiatric disease.

          -  Known hypersensitivity to ACT 064992 or any of the excipients.
Sleep Apnea and Fetal Growth Restriction
Condition: Obstructive Sleep Apnea; Fetal Growth Restriction; Pregnancy Related
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Fetal Growth Retardation
Intervention: S9 VPAP Adapt
Intervention description: Auto-titrated positive airway pressure
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel group, investigator-blinded, randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: aPAP; OSA; FGR

Summary:

      This study aims to evaluate the association between obstructive sleep apnea (OSA) and fetal
      growth restriction (FGR) and to assess the role of auto-titrated positive airway pressure
      (aPAP) as antenatal therapy in these patients. Pregnant patients with diagnosed FGR will be
      screened for OSA first by screening questionnaire and then by home sleep monitor. Of those
      patients diagnosed with OSA, half will be assigned to use aPAP each night when sleeping and
      half will not (standard care).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 and ≤ 50

          -  Fetal growth restriction (defined as fetal weight <10th percentile based on at least
             one routine 2nd trimester ultrasound without a subsequent increase to >15th percentile
             on any ultrasounds prior to enrollment)

          -  Lower limit of gestational age at enrollment 22+0 weeks.

          -  Upper limit of gestational age at enrollment: adequate time to complete Stages 1 and 2
             and if appropriate to be randomized and receive intervention by no later than 32+0
             weeks.

          -  The absence of 2 minor or 1 major markers of aneuploidy.

        Exclusion Criteria:

          -  Other known cause of fetal growth restriction (including congenital anomalies,
             intrauterine infection, or multiple gestation)

          -  Reversed end-diastolic flow in the umbilical artery

          -  Preexisting diagnosis of OSA being treated with aPAP

          -  Chronic pulmonary disease (cystic fibrosis, moderate persistent asthma)

          -  Hemoglobinopathies (sickle cell anemia, thalassemia)

          -  Maternal craniofacial anomalies

          -  Premature rupture of membranes