bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Condition: Active Polyarticular Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Abatacept
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin)
      at Day 113 in children and adolescents with pJIA
    

Eligibility criteria:

        Inclusion Criteria:

          -  JIA subjects (male or female), ages 2-17 years with active disease who had an
             insufficient therapeutic response or intolerance to at least one non biologic DMARD or
             Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening

          -  Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30%
             of the population

          -  Subjects must have a history of at least 5 joints with active disease and must have
             currently active articular disease with ≥2 active joints and ≥2 joints with limitation
             of motion.

        Exclusion Criteria:

          -  Subjects with other rheumatic diseases or major chronic inflammatory/immunologic
             diseases, active uveitis, systemic JIA with active systemic features (within a period
             of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more
             TNFα antagonists or other biological DMARDs will be excluded.

          -  Active systemic disease: (ie, extra-articular features of systemic JIA including
             fever, rash, organomegaly) within a period of 6 months prior to randomization.

          -  Subjects who have failed more than two TNFα antagonists or other biologic DMARDs
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Condition: Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone
Intervention: Zandelisib; Rituximab; Bendamustine; CHOP
Intervention description: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3; Rituximab IV 375 mg/m2 for 6 cycles; Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles; Cyclophosphamide, Vindcristine IV, and Prednisone daily orally
Intervention MeSH terms: Prednisone; Cyclophosphamide; Bendamustine Hydrochloride; Rituximab; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1: Rituximab plus Zandelisib
Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with
      rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or
      Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for
             subjects in Japan and Taiwan

          -  Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype
             limited to:

               1. FL Gr 1, Gr 2, or Gr 3a

               2. MZL (splenic, nodal, or extra-nodal)

          -  Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy

          -  Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm

          -  Adequate hematologic parameters at screening unless abnormal values are due to disease

          -  Adequate renal and hepatic function

          -  Adequate cardiac function based on ECG and LVEF assessments

        Exclusion Criteria:

          -  Histologically confirmed diagnosis of FL Gr 3b or transformed disease

          -  Prior therapy with PI3K inhibitors

          -  Ongoing or history of drug-induced pneumonitis

          -  Known lymphomatous involvement of the central nervous system

          -  Tested positive for or active viral infection with hepatitis B or C virus

          -  Tested positive or active infection with human immunodeficiency virus

          -  Tested positive, or active infection with human T-cell leukemia virus type 1

          -  Any uncontrolled clinically significant illness

          -  History of clinically significant cardiovascular abnormalities such as congestive
             heart failure

          -  History of clinically significant gastrointestinal (GI) conditions

          -  Females who are pregnant
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
Condition: Type 1 Diabetes Mellitus (T1DM); High Level of Sugar (Glucose) in the Blood
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sotagliflozin; Placebo
Intervention description: Sotagliflozin, once daily, before the first meal of the day; Placebo, once daily, before the first meal of the day
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus
      placebo in patients with Type 1 Diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants had given written informed consent to participate in the study in
             accordance with local regulations

          -  Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year
             prior to informed consent

          -  Participants were being treated with insulin or insulin analog

          -  Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the
             study diary as required per protocol

          -  At the Screening Visit, A1C was between 7.0% to 11.0%

          -  Females of childbearing potential used an adequate method of contraception and had a
             negative pregnancy test

        Exclusion Criteria:

          -  Use of antidiabetic agent other than insulin or insulin analog at the time of
             screening

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to
             screening

          -  Chronic systemic corticosteroid use

          -  Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the
             Investigator
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin
Condition: Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms
Intervention: Paclitaxel; Carboplatin; Ipilimumab; Placebo
Intervention description: 0.9% sodium chloride injection, USP, or 5% dextrose injection
Intervention MeSH terms: Paclitaxel; Carboplatin; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin
      will extend the life of patients with squamous only non small cell lung cancer more than
      placebo plus Paclitaxel and Carboplatin.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects with NSCLC of predominantly squamous histology documented by histology or
             cytology from brushing, washing or needle aspiration of a defined lesion but not from
             sputum cytology alone

          -  Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of
             Lung Cancer (IASLC) classification)

          -  At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located
             in a previously irradiated area

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1

        Exclusion Criteria:

          -  Brain metastases

          -  Malignant pleural effusion that is recurrent

          -  Documented history of severe autoimmune or immune mediated symptomatic disease that
             required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids)
             treatment
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Plecanatide; Placebo
Intervention MeSH terms: Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1054.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
      parallel-group clinical trial with 12 weeks of study drug therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        •Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS
        based on ROME III diagnostic criteria and meeting criteria for diagnosis of the
        constipation predominant subtype - IBS-C

        Exclusion Criteria:

          -  Refusal or inability to sign informed consent for the trial

          -  Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day
             daily Calls, and/or complete electronic questionnaires

          -  BMI > 35 or < 18

          -  Women of child bearing potential who refuse to use an acceptable method of birth
             control for the duration of the trial

          -  Women who are pregnant or lactating

          -  Diagnosis of IBS-D or IBS-M

          -  Organic or obstructive disease of the small or large intestine

          -  Use of laxatives other than the study-supplied rescue medication (Dulcolax®,
             bisacodyl)

          -  Use of a prohibited concomitant medication within the time frame prior to screening
             outlined in the study protocol for that medication

          -  Unstable medical illness

          -  Bilirubin > 3X ULN in the absence of a conjugation defect

          -  Any laboratory value > 3X ULN unless discussed and approved by the study Medical
             Monitor
Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
Condition: Recurrent Nasopharynx Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Recurrence
Intervention: Etoposide phosphate; Carboplatin; Ifosfamide; Autologous Stem Cell Transplantation
Intervention description: Etoposide is one of three drugs used in the high-dose conditioning phase; Carboplatin is one of the drugs used in the high-dose conditioning phase.; Ifosfamide is one of the drugs used in the high-dose conditioning phase; Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
Intervention MeSH terms: Carboplatin; Etoposide; Ifosfamide; Etoposide phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Recurrent nasopharynx carcinoma

Summary:

      This is a pilot study to evaluate the response rates for patients undergoing high dose
      conditioning chemotherapy using Etoposide, Carboplatin and Ifosfamide followed by autologous
      stem cell transplantation for the treatment of recurrent Nasopharyngeal Cancer (NPC) in
      children, adolescents, and young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Imaging and tissue diagnosis of recurrent or progressive nasopharyngeal carcinoma

          -  Documentation of previous treatment including conventional chemotherapy and/or
             radiation therapy as clinically appropriate

          -  Ages 2 to 30 years of age

          -  Negative serum pregnancy test if applicable

          -  Calculated creatinine clearance of greater than 60 mL/minute, serum creatinine of less
             than 12o micromoles/L, total bilirubin less than 2 mg/dL and aspartate
             aminotransferase (AST) must be less than twice the upper limit of normal

        Exclusion Criteria:

          -  Unsuitable candidate for autologous transplantation due to comorbidities or
             intractable psychosocial issues

          -  Pregnancy

          -  Breast-feeding women
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia
Intervention: Infasurf surfactant (ONY, Inc.); Sham (No Treatment)
Intervention description: Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.; Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
Intervention MeSH terms: Pulmonary Surfactants; Calfactant
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 511.0
Sex: All
Minimum age: 7 Days
Maximum age: 14 Days
Healthy volunteers: No
Keywords: nitric oxide; surfactant; BPD; prematurity; neonates; iNO; pulmonary outcome; neurodevelopmental outcome; Infasurf; lung function; Surfactant Dysfunction; Bronchopulmonary Dysplasia

Summary:

      The purpose of this study is to determine if late doses of Infasurf surfactant given when
      patients are receiving inhaled nitric oxide will interact to improve surfactant function and
      increase survival without BPD in treated infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  <=28 0/7 weeks gestational age

          -  Day of life 7-14

          -  Intubated and mechanically ventilated

          -  Plan to treat with inhaled nitric oxide

        Exclusion Criteria:

          -  Serious congenital malformations or chromosomal abnormalities

          -  Life expectancy <7 days from enrollment

          -  Clinically unstable

          -  Less tha 48 hours since last dose surfactant

          -  Ability to obtain 36 week primary outcome information is unlikely
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: AMG 510; Docetaxel
Intervention description: 21 day cycles; 21 day cycles
Intervention MeSH terms: Docetaxel; Sotorasib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC)
      subjects with KRAS p. G12c mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women greater than or equal to 18 years old.

          -  ECOG ≤ 1

          -  Pathologically documented, previously treated, locally-advanced and unresectable or
             metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have
             documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

        Exclusion Criteria:

          -  Active brain metastases

          -  Myocardial infarction within 6 months of study day 1

          -  Gastrointestinal (GI) tract disease causing the inability to take oral medication
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Intervention: Dasiglucagon; Placebo
Intervention description: Glucagon analogue; Placebo for dasiglucagon
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: glucagon

Summary:

      A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety
      of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes
      mellitus (T1DM) compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined
             by the American Diabetes Association (3).

          -  Treated with insulin for T1DM for at least 1 year and with stable insulin treatment
             (defined as no more than a 10-unit daily variation in total daily insulin dose) 30
             days prior to screening

          -  Hemoglobin A1c <10%.

          -  Aged between 18 and 75 years, both inclusive.

        Exclusion Criteria:

          -  Previous participation in a clinical trial within the dasiglucagon in the rescue
             treatment of hypoglycemia program.

          -  Known or suspected allergy to trial drug(s) or related products.

          -  History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).

          -  Previous participation in this trial. Participation being defined by signing the
             informed consent document.
Diabetic Gastroparesis Study 05
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Relamorelin 10 μg
Intervention description: Relamorelin 10 μg injected subcutaneously twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Gastroparesis

Summary:

      This open-label study is to assess the safety of continued treatment with relamorelin for
      participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146]
      study and to provide treatment for these participants until relamorelin becomes commercially
      available or the Sponsor terminates development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of either Study RLM-MD-03 or Study RLM-MD-04

          -  Ability to provide written informed consent (IC) prior to any study procedures and
             willingness and ability to comply with study procedures

          -  Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or
             RLM-MD-04, in the opinion of the investigator.

        Exclusion Criteria:

          -  Participant is planning to receive an investigational drug (other than study
             intervention) or investigational device at any time during Study 3071-305-020

          -  Participant has an unresolved adverse event (AE) from a lead-in study, ie, a
             clinically significant finding on physical examination, clinical laboratory test, or
             12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the
             participant's ability to participate in or complete the study

          -  Any other reason that, in the investigator's opinion, would confound proper
             interpretation of the study or expose a participant to unacceptable risk, including
             renal, hepatic, or cardiopulmonary disease

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.