bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Cariprazine in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine; Placebo
Intervention description: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 446.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Acute Schizophrenia; Psychotropic Drugs; Antipsychotic Agents; Mental Disorders; Dopamine Agents; Central Nervous System Agents

Summary:

      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided informed consent prior to any study specific procedures

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,
             disorganized type, catatonic type or undifferentiated type), as confirmed by the
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (SCID)

          -  Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS)
             total score ≥ 80 and ≤ 120

          -  Diagnosis of schizophrenia for a minimum of 1 year before Visit 1

          -  Patients with normal physical examination, laboratory, vital signs,and/ or
             electrocardiogram (ECG)

        Exclusion Criteria:

          -  Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform
             disorder, other psychotic disorders other than schizophrenia, or bipolar I or II
             disorder

          -  Patients in their first episode of psychosis

          -  Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during
             the study

          -  Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and
             other cognitive disorders

          -  Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR
             axis II disorder of sufficient severity to interfere with participation in this study

          -  Substance abuse or dependence within the prior 3 months
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661 Plus Ivacaftor Combination; Ivacaftor; VX-661 Plus Ivacaftor Combination Placebo; Ivacaftor placebo
Intervention description: FDC tablet, oral use; Tablet, oral use; FDC tablet, oral use; Tablet, oral use
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 510.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Homozygous for the F508del CFTR Mutation

Summary:

      This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter
      study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane
      conductance regulator (CFTR) gene mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del CFTR mutation, genotype to be confirmed at the Screening
             Visit

          -  Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative
             pilocarpine iontophoresis

          -  Forced expiratory volume at one second (FEV1) ≥40% and ≤90% of predicted normal for
             age, sex, and height during screening

          -  Stable CF disease as judged by the investigator

          -  Willing to remain on a stable CF medication regimen through Week 24 or, if applicable,
             the Safety Follow up Visit

        Exclusion Criteria:

          -  History of any comorbidity 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
             participant.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
             (first dose of study drug)

          -  Pregnant or nursing females (females of childbearing potential must have a negative
             pregnancy test at Screening and Day 1)

          -  Sexually active participants of reproductive potential who are not willing to follow
             the contraception requirements
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
Condition: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Intervention: Eculizumab; Placebo
Intervention description: Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks; Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Devic's disease, Transverse Myelitis; Optic Neuritis; relapse; eculizumab; soliris; NMO-IgG; CNS Autoimmune Disorders; Demyelinating Disorders; NMO; NMOSD

Summary:

      The objectives of this time-to-event study were to assess the efficacy and safety of
      eculizumab as compared with placebo in participants with neuromyelitis optica spectrum
      disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female participants ≥ 18 years old.

          2. Diagnosis of NMO or NMOSD.

          3. AQP4 antibody seropositive.

          4. Historical relapse of at least 2 relapses in the last 12 months or 3 relapses in the
             last 24 months with at least 1 relapse in the 12 months prior to the screening.

          5. Expanded Disability Status Scale score ≤ 7.

          6. If a participant entered the study receiving immunosuppressive therapy (IST) for
             relapse prevention, the participant must have been on a stable maintenance dose of
             IST(s), as defined by the treating physician, prior to Screening and must have
             remained on that dose for the duration of the study, unless the participant
             experienced a relapse.

          7. Female participants of childbearing potential were to have a negative pregnancy test
             (serum human chorionic gonadotropin). Participants were required to practice an
             effective, reliable, and medically approved contraceptive regimen during the study and
             for up to 5 months following discontinuation of treatment.

        Key Exclusion Criteria:

          1. Use of rituximab within 3 months prior to Screening.

          2. Use of mitoxantrone within 3 months prior to Screening.

          3. Use of intravenous immunoglobulin within 3 weeks prior to Screening.
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
Condition: Spinal Metastases
MeSH terms: Neoplasm Metastasis
Intervention: single-fraction SRS; high-dose hypofractionated SRS; Quality of Life Measures
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stereotactic Radiosurgery (SRS); Single-Fraction; Hypofractionated; Spinal surgery; 14-233

Summary:

      The purpose of this study is to find out whether giving one higher dose of radiation is as
      good at treating the tumor in the patient's spine after surgery as giving three lower doses
      of radiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically diagnosed metastatic cancer (Diagnosis made or confirmed at MSKCC for
             MSKCC participants. Institutional pathologic determination accepted from participating
             multicenter sites.)

          -  Age ≥18 years

          -  Life expectancy ≥3 months

          -  ECOG ≤ 3

          -  Spinal surgery carried out with the goal of spinal cord decompression and spinal
             stabilization within 8 weeks

          -  Post-operative CT myelogram or MRI perfusion with evidence of separation of tumor and
             the spinal cord It should be noted that patients with multiple lesions will be
             eligible as long as there are no overlapping fields of radiation, including at various
             time frames.

        Exclusion Criteria:

          -  Primary spine tumor

          -  Age < 18

          -  Pregnancy

          -  Lack of adequate (≥ 2 mm) separation between the spinal cord and the tumor on
             post-operative CT myelogram or MRI perfusion

          -  Radiosensitizing chemotherapy (taxol, taxotere, cisplatin, gemcitabine,
             5-fluorouracil) given within one week of radiation treatment
Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone
Condition: Opioid-Induced Bowel Dysfunction
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Opioid-Induced Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 24 mcg capsules twice daily (BID); 0 mcg capsules twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone
      administration in patients with Opioid-induced Bowel Dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid
             for at least 30 days prior to screening.

          -  Diagnosis of opioid-induced bowel dysfunction (OBD) as confirmed during the screening
             period.

          -  If patient has a history of chronic constipation, condition must have been exacerbated
             by initiation of opioid treatment.

          -  Use of prescribed or Over-the-Counter (OTC) medication that affects gastrointestinal
             motility (other than opioid therapy) must be discontinued during the study.

          -  If treated for clinical depression with Selective serotonin reuptake inhibitor
             (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase
             inhibitor (MAO) inhibitors, treatment must have been at a stable dose for at least 30
             days prior to screening.

          -  Use of laxative and stool softeners (with the exception of approved rescue
             medications) must be discontinued while on study.

        Exclusion Criteria:

          -  Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma,
             and/or for the management of drug addiction.

          -  Patient has been treated for cancer in the past 5 years (with the exception of
             localized basal cell, squamous cell skin cancer, or in situ cancer that has been
             resected).

          -  Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of
             administration within 30 days of screening.

          -  Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.

          -  Non-ambulatory patients, or those who are unable to eat/drink, take oral medications,
             or to hold down oral medications due to vomiting.

          -  Female patients of childbearing potential who are unable/unwilling to use
             protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to
             become pregnant or nurse during the study.

          -  Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: UT-15C (treprostinil diolamine)
Intervention description: UT-15C extended release oral tablet three times daily
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 471.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PAH; PH; FREEDOM; 6 minute walk test; treprostinil; open label

Summary:

      This study is an international, multi-center, open-label study designed to provide oral
      treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have
      completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety
      of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participated in United Therapeutics Study TDE-PH-310

          -  All women of childbearing potential (WOCBP) must have practiced true abstinence from
             intercourse when it was in line with their preferred and usual lifestyle or used 2
             different forms of highly effective contraception for the duration of the study and
             for at least 30 days after discontinuing study medication.

          -  Males who participated in the study must have used a condom during the length of the
             study and for at least 48 hours after their last dose of study medication.

        Exclusion Criteria:

          -  The subject was pregnant or lactating.

          -  The subject had received infused or inhaled prostacyclin therapy for 29 days or more.

          -  The subject was prematurely discontinued from TDE-PH-310 for reasons other than a
             clinical worsening event.

          -  The subject developed a concurrent illness or condition during the conduct of
             TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their
             overall health if they enrolled in this study.
A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Intervention description: Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when
      administered for the maintenance of hemoglobin levels in participants with chronic renal
      anemia, not on dialysis. Participants currently receiving maintenance treatment with
      subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A.,
      with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from
      the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study
      start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic renal anemia

          -  Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 8 weeks

          -  Poorly controlled hypertension requiring interruption of epoetin treatment in previous
             6 months

          -  Acute or chronic bleeding requiring therapy within previous 8 weeks
Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
Condition: Atrial Fibrillation; Persistent Common Pulmonary Vein
MeSH terms: Atrial Fibrillation
Intervention: Adenosine arm
Intervention description: After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Intervention MeSH terms: Adenosine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 378.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary Vein Isolation; Adenosin effect; Atrial fibrillation ablation

Summary:

      The investigators studied the effects of adenosine on the reconnection rate after successful
      pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant
      atrial fibrillation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed atrial fibrillation

          -  recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use

          -  written informed consent

        Exclusion Criteria:

          -  intracardiac thrombus

          -  pregnancy
Esomeprazole (NEXIUM) vs. Surgery
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: esomeprazole; Laparoscopic fundoplication (surgery)
Intervention description: 40 mg oral tablet administered daily; Surgery
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 626.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Acid reflux disease; Gastroesophageal Reflux Disease

Summary:

      The study investigates the efficacy of long-term treatment of esomeprazole compared to
      anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to
      treatment failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects considered suitable for surgical treatment and long-term management of
             esomeprazole.

          -  History of chronic reflux esophagitis or symptomatic GERD

        Exclusion Criteria:

          -  History of esophageal, gastric, or duodenal surgery predicted to influence negatively
             on subsequent treatment within the study.

          -  Contraindication to the study drug.

          -  Pregnancy, lactating or of child-bearing potential.
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Intervention: Rifaximin; Placebo
Intervention description: Oral; Oral
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 299.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the study drug is safe and effective in
      preventing hepatic encephalopathy (HE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must sign an Informed Consent Form

          -  In remission from past HE

          -  Uses appropriate birth control measures

          -  More than or equal to 18 years of age

          -  Must have potential to benefit from treatment

          -  Recent prior HE episodes

          -  Capable and willing to comply with all study procedures

          -  Participant has personal support available

          -  Has a certain Model End Stage Liver Disease (MELD) score

          -  Recent transjugular intrahepatic portosystemic shunt (TIPS) placement or revision

        Exclusion Criteria:

          -  Significant medical conditions, medical conditions that may impact study
             participation, or Investigator decision not to include

          -  Allergies to the study drug or similar drugs

          -  Laboratory abnormalities

          -  Recent participation in another clinical trial

          -  History of non-compliance

          -  Pregnant or at risk of pregnancy, or is lactating

          -  Recent alcohol consumption

          -  Active bacterial or viral Infections

          -  Bowel issues

          -  Active malignancy

          -  On a prohibited medication

          -  Liver transplant expected in near term

          -  Lactulose intolerance

          -  Participant shows presence of intestinal obstruction or has inflammatory bowel disease

          -  Ongoing or recent GI bleed