bioihbjkbjnl/mcl2 huggingface dataset:
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.
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Cariprazine; Antidepressant Therapy (ADT)
Intervention description: Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.; ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 442.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression

Summary:

      The objective of this study is to evaluate the long-term safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major
      Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided consent prior to any study specific procedures

          -  Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text
             Revision (DSM-IV-TR) criteria for MDD

          -  New patients must have ongoing inadequate response to protocol allowed ADTs as
             reported in Antidepressant Treatment Response Questionnaire (ATRQ)

          -  For rollover patients from RGH-MD-72 [NCT01715805], completion of Study RGH-MD-72
             (either double-blind or single-blind treatment periods) with continued ADT treatment.

        Exclusion Criteria:

          -  Patients who do not meet the DSM-IV-TR criteria for MDD.
A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; placebo
Intervention description: For oral use once daily.; For oral use once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3183.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate the cardiovascular
      safety of oral semaglutide in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female diagnosed with type 2 diabetes

          -  Age at least 50 years at screening and presence of cardiovascular disease, or age at
             least 60 years at screening and presence of at least one cardiovascular risk factor

        Exclusion Criteria:

          -  Current or previous (within 90 days prior to screening) treatment with any GLP-1
             (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor
             or pramlintide

          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary
             thyroid carcinoma (MTC)

          -  History of pancreatitis (acute or chronic)

          -  History of major surgical procedures involving the stomach potentially affecting
             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
             gastric bypass surgery)

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV
             heart failure

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  Any of the following: myocardial infarction, stroke or hospitalisation for unstable
             angina or transient ischaemic attack within the past 60 days prior to screening

          -  Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment
             (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73
             m^2)

          -  History or presence of malignant neoplasms within the last 5 years (except basal and
             squamous cell skin cancer and carcinoma in situ)
A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Glecaprevir/Pibrentasvir
Intervention description: Film-coated tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Virus (HCV); Genotype 1 - 6; Metavir System Fibrosis Score; Glecaprevir; Pibrentasvir; Treatment naïve; Cirrhosis; Compensated cirrhosis

Summary:

      This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of
      glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in
      Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without
      cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic
             acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit.

          -  Participant must have been documented as without cirrhosis with METAVIR equivalent
             fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a
             liver biopsy, or FibroScan, or FibroTest score.

          -  Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected
             may have been enrolled if they had a positive test result for anti-HIV antibody at
             Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a
             stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline.

          -  Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma
             (HCC) within 3 months prior to Screening or a negative ultrasound at Screening.

        Exclusion Criteria:

          -  Current hepatitis B virus (HBV) infection on screening tests.

          -  Any current or past clinical evidence of Child-Pugh B or C classification (score of >
             6) or clinical history of liver decompensation including ascites on physical exam,
             including hepatic encephalopathy or variceal bleeding.

          -  Receipt of any investigational or commercially available anti-HCV agents.
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
Condition: Cryptococcal Meningitis; Fungal Meningitis
MeSH terms: Meningitis, Cryptococcal; Meningitis, Fungal; Meningitis
Intervention: Sertraline
Intervention description: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks.
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cryptococcal meningitis; cryptococcus; meningitis; yeast; fungus

Summary:

      This is a phase III trial to determine whether adjunctive sertraline will lead to improved
      survival 18-week survival.

      There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF
      concentrations in 172 persons conducted from August 2013 to August 2014. See NCT03002012.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)

          -  HIV-1 infection

          -  Ability and willingness of the participant or legal guardian/representative to provide
             informed consent

          -  Willing to receive protocol-specified lumbar punctures

        Exclusion Criteria:

          -  Age < 18 years

          -  Receipt of >=3 doses of amphotericin therapy

          -  Cannot or unlikely to attend regular clinic visits

          -  History of known liver cirrhosis

          -  Presence of jaundice

          -  Pregnancy

          -  Current breastfeeding
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Nivolumab; Ipilimumab; Cetuximab/Erbitux; Cisplatin/Platinol; Carboplatin/Paraplatin; Fluorouracil/Adrucil
Intervention MeSH terms: Cisplatin; Carboplatin; Fluorouracil; Nivolumab; Cetuximab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 947.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare nivolumab and ipilimumab with the extreme
      regimen as first line treatment in patients with recurrent or metastatic squamous cell of the
      head and neck cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head
             and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to
             curative therapy.

          -  No prior systemic cancer therapy for recurrent or metastatic disease (except if
             chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).

          -  Measurable disease detected by imaging exam (CT or MRI).

          -  Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have
             results from testing of HPV p16 status.

        Exclusion Criteria:

          -  Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of
             unknown primary, squamous cell carcinoma originating from skin and salivary glands or
             non squamous histologies (eg. mucosal melanoma).

          -  No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other
             antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab
             or EGFR inhibitors in any treatment setting.

          -  Participants with certain diseases such as active autoimmune disease, type I diabetes,
             hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.

          -  Inadequate hematologic, renal or hepatic function.

        Other protocol defined inclusion/exclusion criteria could apply
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
Condition: Crohn's Disease; Colitis; IBD; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Colitis; Inflammatory Bowel Diseases
Intervention: Placebo SC; Placebo IV; Ustekinumab 90 mg SC q8w; Ustekinumab 130 mg IV; Ustekinumab 90 mg SC q12w
Intervention description: Placebo will be administered subcutaneously.; Placebo will be administered as a single Intravenous infusion at week 0.; Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.; Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.; Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1282.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ustekinumab; Stelara, Moderately to severely active Crohn's Disease; IBD, Crohn's; UNITI; colitis; IL-12; IL-23

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance
      regimens of ustekinumab administered subcutaneously to patients with moderately to severely
      active Crohn's disease who responded to treatment with intravenous ustekinumab in studies
      CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who received study agent at the start of study CNTO1275CRD3001 or
             CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:

          -  Patients who underwent a Crohn's disease-related surgery since the start of induction
             study CNTO1275CRD3001 or CNTO1275CRD3002

          -  Patients who started a protocol prohibited medication since the start of studies
             CNTO1275CRD3001 and CNTO1275CRD3002

          -  Patients with protocol-specified changes to their concomitant medications due to
             Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001
             and CNTO1275CRD3002
Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Ubrogepant; Placebo-matching Ubrogepant
Intervention description: Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1686.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25
      and 50 mg) compared to placebo for the acute treatment of a single migraine attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis
             according to the International Classification of Headache Disorders, 3rd edition, beta
             version

          -  Migraine onset before age 50

          -  History of migraines typically lasting between 4 and 72 hours if untreated or treated
             unsuccessfully and migraine episodes are separated by at least 48 hours of headache
             pain freedom

          -  History of 2 to 8 migraine attacks per month with moderate to severe headache pain in
             each of the previous 3 months.

        Exclusion Criteria:

          -  Difficulty distinguishing migraine headache from tension-type other headaches

          -  Has taken medication for acute treatment of headache (including acetaminophen,
             nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or
             combination analgesics) on 10 or more days per month in the previous 3 months

          -  Has a history of migraine aura with diplopia or impairment of level of consciousness,
             hemiplegic migraine, or retinal migraine

          -  Has a current diagnosis of new persistent daily headache, trigeminal autonomic
             cephalgia (eg, cluster headache), or painful cranial neuropathy

          -  Required hospital treatment of a migraine attack 3 or more times in the previous 6
             months

          -  Has a chronic non-headache pain condition requiring daily pain medication

          -  Has a history of malignancy in the prior 5 years, except for adequately treated basal
             cell or squamous cell skin cancer, or in situ cervical cancer

          -  Has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes,
             inflammatory bowel disease) that may affect the absorption or metabolism of
             investigational product; participants with prior gastric bariatric interventions which
             have been reversed are not excluded

          -  Has a history of hepatitis within previous 6 months.
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: FMX-101, 4% minocycline foam; Vehicle Foam
Intervention description: FMX-101, 4% minocycline foam applied topically once daily for 12 weeks; Vehicle foam applied topically once daily for 12 weeks
Intervention MeSH terms: Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 495.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: acne

Summary:

      This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical
      administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne
      vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has facial acne vulgaris with:

               -  20 to 50 inflammatory lesions (papules, pustules, and nodules)

               -  25 to 100 noninflammatory lesions (open and closed comedones)

               -  No more than 2 nodules on the face

               -  IGA score of moderate (3) to severe (4)

          -  Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin
             Cleanser) and to refrain from use of any other acne medication, medicated cleanser,
             excessive sun exposure, and tanning booths for the duration of the study

        Exclusion Criteria:

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
             that could interfere with the clinical evaluations

          -  Sunburn on the face
A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Fostamatinib disodium; Placebo
Intervention description: Fostamatinib (100 mg PO bid or 150 mg PO bid); Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Persistent Immune Thrombocytopenic Purpura; Chronic Immune Thrombocytopenic Purpura

Summary:

      The purpose of this study is to determine whether fostamatinib is safe and effective in the
      treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of persistent/chronic ITP for at least 3 months.

          -  Average platelet count < 30,000/µL (and none > 35,000 unless as a result of rescue
             therapy) from at least 3 qualifying counts

        Exclusion Criteria:

          -  Clinical diagnosis of autoimmune hemolytic anemia

          -  Uncontrolled or poorly controlled hypertension

          -  History of coagulopathy including prothrombotic conditions