bioihbjkbjnl/mcl2 huggingface dataset:
Self-Management Addressing Heart Disease Risk Trial
Condition: Bipolar Disorder; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Bipolar Disorder
Intervention: Chronic care model for Bipolar Disorder
Intervention description: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Illness; Disease management; Health Behaviors; Mood Disorders-Bipolar

Summary:

      The purpose of this research study is to learn whether or not people with bipolar disorder
      can reduce their risk of heart disease and related conditions by having a Care Manager
      provide self management and care management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bipolar disorder (I, II, not otherwise specified, or
             schizoaffective-bipolar subtype)

          -  Have a diagnosis or be at risk for arteriosclerotic cardiovascular disease (ASCVD).

        We define this as a patient having a current diagnosis of or receiving treatment for at
        least one of the following medical conditions:

          -  hyperlipidemia or dyslipidemia (documented diagnosis or low-density lipoprotein >=160,
             or receiving statin or other treatment)

          -  hypertension (documented diagnosis or blood pressure of >=140/90 on 2 occasions)

          -  diabetes mellitus (documented diagnosis or HbA1C >=7%, or receiving treatment)

          -  obesity (documented diagnosis or BMI >30), based on medical record review of current
             problems

          -  current ASCVD diagnosis

        Exclusion Criteria:

          -  Have unresolved substance intoxication or withdrawal, such as appearing to be
             intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms
             from substance abuse at the time of enrollment.

          -  Are already enrolled in a mental health program with a mobile outreach component in
             which clinical caregivers deliver services to the patient in the community (e.g.,
             assertive community treatment or intensive case management). These patients may be
             receiving similar services to those offered in the intervention.

          -  Are unwilling or unable to provide informed consent or comply with study requirements
             at the time of enrollment (e.g., unable to complete forms or attend scheduled sessions
             due to serious illness or substantial functional limitations).
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM/IVA; LUM/IVA
Intervention description: Lumacaftor (LUM) 200 mg every 12 hours (q12h)/ivacaftor (IVA) 250 mg q12h (for 6 through 11 years of age).
LUM 400 mg q12h/IVA 250 mg q12h (for 12 years and older).; LUM 200 mg q12h/IVA 250 mg q12h (for 6 through 11 years of age).
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic
      fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator
      (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233).
      Study 110 is designed to evaluate the safety and efficacy of long term treatment of
      lumacaftor in combination with ivacaftor.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects entering the Treatment Cohort must meet both of the following criteria:

          -  Completed study visits up to Week 24 of Study 109 or Week 26 of Study 011B and did not
             permanently discontinue treatment

          -  Willing to remain on a stable CF medication through the Safety Follow-up Visit.

        Subjects entering the Observational Cohort must meet 1 of the following criteria:

          -  Completed 24 weeks of study drug treatment in Study 109 or completed 24 weeks of study
             drug treatment and the Week 26 Safety Follow up in Study 011B.

          -  Received at least 4 weeks of study drug and completed visits up to Week 24 of Study
             109 or Week 26 of Study 011B.

        Exclusion Criteria (Treatment Cohort Only):

          -  History of any comorbidity or laboratory abnormality that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject (e.g., cirrhosis with portal hypertension).

          -  Pregnant and nursing females.

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements.

          -  History of drug intolerance in the prior study that would pose an additional risk to
             the subject in the opinion of investigator

          -  History of poor compliance with study drug and/or procedure in the previous study as
             deemed by the investigator.

          -  Participation in an investigational drug trial (including studies investigating
             lumacaftor and/or ivacaftor).
RESCUE and REVERSE Long-term Follow-up
Condition: Leber Hereditary Optic Neuropathy
MeSH terms: Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber
Intervention: GS010; Sham Intravitreal Injection
Intervention description: Lenadogene nolparvovec Intravitreal ocular unilateral Injection; Lenadogene nolparvovec Intravitreal ocular unilateral Injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intra patient comparaison
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Heredity Optic Atrophy; Leber Hereditary Optic Atrophy; Leber Hereditary Optic Neuropathy; LHON; Eye Diseases; Hereditary Eye Diseases; Inborn Genetic Disease; Gene Therapy; Intravitreal Injections; Mitochondrial Disease; AAV2 Vectors; Nervous System Diseases; Neurodegenerative Disease; Heredodegenerative Disorders of the Nervous System

Summary:

      The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a
      gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4
      mitochondrial mutation and who were treated in the Rescue or Reverse studies.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject was treated with GS010 IVT injection in either of the RESCUE or REVERSE Phase
             III clinical studies

          -  Subject of legal consent age has provided informed consent; subjects that are not of
             legal consent age have undergone their country-approved clinical trial enrollment
             consent process

        Non-Inclusion Criteria

          -  Subject is unwilling or unable to comply with the protocol requirements

          -  Subject has any medical or psychological condition that, in the opinion of the
             Investigator, may compromise his or her safe participation in the study

          -  Subject is taking or intending to take idebenone during the long-term follow-up study
             period
Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Sulfonylurea; Metformin
Intervention description: One 100 mg tablet taken orally once daily; Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.; Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 870.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glucose metabolism disorders Metabolic diseases Peptidase inhibitors

Summary:

      This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment
      versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who
      regularly take an SU drug, and choose to fast during the month of Ramadan. The primary
      hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or
      without metformin) compared to SU treatment (with or without metformin) results in a lower
      incidence of hypoglycemia in participants with T2DM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Muslim, with type 2 diabetes mellitus

          -  Intends to fast during the month of Ramadan

          -  Hemoglobin A1c (HbA1c) ≤10% at screening

          -  On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at
             least three months, with or without metformin therapy at a stable dose

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Pregnant or breast feeding or with gestational diabetes

          -  Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment

          -  Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)

          -  History of severe hypoglycemia (defined as a hypoglycemic event requiring the
             assistance of another individual, and/or resulting in a emergency department
             admission, physician office visit and/or hospitalization)

          -  Any use of insulin (prior to or during Ramadan)

          -  Use of any class of oral antidiabetic therapy other than an SU or metformin

          -  Current participation in another interventional study
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost SR; Sham: Applicator Without Needle; Active Comparator: Timolol 0.5%; Timolol Vehicle (placebo)
Intervention description: Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.; Sham administered on Day 1, Week 16, and Week 32.; Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.; Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Intervention MeSH terms: Timolol; Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in
      patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month
      treatment period with an 8-month extended follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes
        require IOP-lowering treatment.

        Exclusion Criteria:

          -  Previous enrollment in another Allergan Bimatoprost SR Study

          -  Eye surgery (including cataract surgery) and/or any eye laser surgery within the past
             6 months in the study eye

          -  Anticipated need for laser eye surgery within the first 52 weeks of the study duration

          -  History of glaucoma surgery
Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: bapineuzumab; placebo
Intervention description: Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.; Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1100.0
Sex: All
Minimum age: 50 Years
Maximum age: 88 Years
Healthy volunteers: No
Keywords: antibody; immunotherapy

Summary:

      This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in
      patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab
      or placebo. Each patient's participation will last approximately 1.5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable AD, with MMSE score of 16-26, and brain MRI consistent with the
             diagnosis of AD

          -  Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.

          -  Caregiver will participate and be able to attend clinic visits with patient.

        Exclusion Criteria:

          -  Significant neurological disease other than AD, or a major psychiatric disorder

          -  Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal
             objects in the body)

          -  Woman of childbearing potential
Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
Condition: Obesity; Type 2 Diabetes
MeSH terms: Obesity; Diabetes Mellitus, Type 2
Intervention: VI-0521; VI-0521; VI-0521
Intervention description: phentermine 15 mg and topiramate 92 mg, po once daily; phentermine 7.5 mg and topiramate 46 mg, po once daily; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2487.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Obesity, Type 2 diabetes

Summary:

      The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to
      placebo in treatment of obesity in an adult population with obesity related co-morbid
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent

          -  BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)

          -  70 years of age or less

          -  Have 2 or more of the following obesity-related co-morbid conditions:

               -  Systolic blood pressure 140-160 mmHg (130-160 if diabetic);

               -  Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);

               -  Requirement for 2 or more medications to achieve control (<140/90 mmHg)

          -  Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to
             achieve control (<200 mg/dL)

          -  At lease one of the following metabolic criteria:

               -  Fasting blood glucose level > 100 mg/dL

               -  Glucose level > 140 mg/dL

               -  Diagnosis of type 2 diabetes

          -  Waist circumference ≥ 102 cm for men or ≥88 cm for women

        Exclusion Criteria:

          -  Stroke/MI/unstable cardiovascular disease within 6 months

          -  Clinically significant renal, hepatic or psychiatric disease

          -  Unstable thyroid disease or replacement therapy

          -  Nephrolithiasis

          -  Obesity of known genetic or endocrine origin

          -  Participation in a formal weight loss program or lifestyle intervention

          -  Glaucoma or intraocular pressure

          -  Pregnancy or breastfeeding

          -  Drug or Alcohol abuse

          -  Smoking cessation within previous 3 months or plans to quit smoking during study

          -  Eating disorders

          -  Cholelithiasis within past 6 months

          -  Excluded medications

          -  Type 1 diabetes or use of any antidiabetic medication other than metformin

          -  Previous bariatric surgery

          -  Bipolar disorder or psychosis

          -  Steroid hormone therapy

          -  Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg

          -  Creatinine clearance < 60 mL/minute
Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: autologous hematopoietic stem cell transplantation; leukapheresis
Intervention description: Patients undergo autologous stem cell transplantation; Stem cells collected
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; recurrent adult diffuse large cell lymphoma

Summary:

      RATIONALE: It is not yet known which method of stem cell collection is best for patients
      undergoing an autologous stem cell transplant.

      PURPOSE: This randomized phase III trial is comparing two different methods of collecting
      stem cells in patients undergoing stem cell transplant for diffuse large cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of diffuse large cell lymphoma

               -  Low-grade non-Hodgkin lymphoma transformed to diffuse large cell lymphoma allowed

          -  Candidate for with autologous peripheral blood stem cell transplantation

               -  Not requiring bone marrow harvest to collect stem cells

               -  No chemotherapy with filgrastim ( G-CSF) or mobilization study drug (i.e.,
                  AMD3100) needed for mobilization of stem cells

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Cardiac and pulmonary status sufficient to undergo apheresis and stem cell
             transplantation

          -  Negative pregnancy test

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No active uncontrolled infection requiring antibiotic treatment

          -  No comorbid condition which, in view of the investigators, renders the patient at high
             risk from treatment complications

          -  Willing to provide all research blood samples as required by the protocol

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior chemotherapy (rituxan is not considered chemotherapy for
             the purpose of this study)

          -  More than 4 weeks since prior experimental therapy

          -  No concurrent enrollment on another experimental protocol during the mobilization
             phase

          -  No concurrent participation in any autologous stem cell transplantation study that is
             not using the standard conditioning regimens for lymphomas
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