bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Study of Cariprazine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine
Intervention description: Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 752.0
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 long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients and corresponding caregivers who have provided informed consents 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).

          -  Patients with normal physical examination, laboratory, vital signs, and
             electrocardiogram (ECG).

        Exclusion Criteria:

          -  Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform
             disorder, bipolar I or bipolar II disorder, or psychotic disorders other than
             schizophrenia.
A Multinational Phase III Study of CS-8958 (MARVEL)
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: CS-8958; CS-8958; oseltamivir phosphate
Intervention description: CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days; CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days; CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.
Intervention MeSH terms: Oseltamivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1002.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Influenza; Neuraminidase inhibitor

Summary:

      The primary objective of this study is to confirm the efficacy of CS-8958 administered as a
      single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir
      phosphate using the time to alleviation of influenza illness. For safety evaluation,
      between-group comparisons will be made with regard to incidence of adverse events and other
      safety measures.

      In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated
      based on the efficacy and safety of single inhaled low or high dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of influenza

          -  Axillary temperature of > or = to 37.5 degrees C

        Exclusion Criteria:

          -  Infection by bacteria species and/or virus other than influenza virus

          -  Chronic respiratory disease

          -  Renal dysfunction
Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
Condition: Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Canakinumab; Docetaxel; Placebo
Intervention description: Canakinumab, 200 mg, subcutaneous. The initial dose regimen was once every 3 weeks (on Day 1 of each 21-day cycle); Docetaxel 75mg/m^2, intravenous, administered on Day 1 of each 21-day cycle; Placebo, sub-cutaneous, admnistered at the RP3R defined in Part 1-safety run-in.
Intervention MeSH terms: Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ACZ885; canakinumab; docetaxel; NSCLC; Non Small Cell Lung Cancer; Carcinoma; IL-1β; PD-(L)1; CANOPY; CANOPY-2; second or third line therapy; PD-(L)1 inhibitors; platinum-based chemotherapy

Summary:

      This study was designed to evaluate the role of canakinumab in combination with docetaxel in
      subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1
      inhibitors and platinum-based chemotherapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.

          -  Subject had received one prior platinum-based chemotherapy and one prior PD-(L)1
             inhibitor therapy for locally advanced or metastatic disease.

          -  Subject with ECOG performance status (PS) of 0 or 1.

          -  Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1
             in solid tumors criteria.

        Key Exclusion Criteria:

          -  Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor),
             or any systemic therapy for their locally advanced or metastatic NSCLC other than one
             platinum-based chemotherapy and one prior PD-(L)1 inhibitor.

          -  Subject with EGFRor ALK positive tumor.

          -  History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or
             excipients of docetaxel or canakinumab.
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
Condition: HIV
Intervention: Atazanavir Sulphate; Ritonavir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 3 Months
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Pediatric

Summary:

      The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a
      regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse
      transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria:

          -  Confirmed HIV-1 infection diagnosed by protocol criteria

          -  Screening HIV RNA level ≥1000 copies/mL

          -  ≥3 months to <11 years of age at time of first treatment

          -  Antiretroviral-naive or -experienced

          -  At screening, all participants must have genotypic sensitivity to atazanavir and at
             least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved
             for pediatric use at the local country.

          -  Antiretroviral-experienced patients must also have documented phenotypic sensitivity
             at screening to atazanavir (Fold Change in susceptibility <2.2) and to at least 2
             NRTIs that are approved in their country

        Key Exclusion Criteria:

          -  Experienced participants who received atazanavir or atazanavir/ritonavir at any time
             prior to study enrollment or who have a history of 2 or more protease inhibitor
             failures

          -  Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to
             study medications

          -  Cardiac rhythm abnormalities

          -  Need for tenofovir

          -  Weight <5 or ≥35kg

          -  >Grade 2 abnormality in aspartate transaminase/alanine transaminase levels

          -  Coinfection with either hepatitis B or C virus

          -  Any active Centers for Disease Control and Prevention Category C clinical condition
Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin detemir; insulin aspart; insulin detemir
Intervention description: NN304 injected s.c. (under the skin). Given as basal insulin.; Injected s.c. (under the skin). Given as bolus insulin.; NN729 injected s.c. (under the skin). Given as basal insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and
      South Africa. The aim of this trial was to make a safety comparison of insulin detemir
      produced by a new production method (NN729) with insulin detemir made by the previous
      production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks
      at the same total daily dose and frequency of administration as their own pre-trial basal
      insulin . During the trial doses were individualised based on subject's plasma glucose
      measurements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes for at least 12 months

          -  Basal-bolus treatment for at least 3 months

          -  Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

          -  HbA1c (glycosylated haemoglobin) less than or equal to 12.0%

        Exclusion Criteria:

          -  Known or suspected allergy to trial products or related products

          -  Pregnancy, breast-feeding or the intention to become pregnant or not using adequate
             contraceptive measures

          -  Receipt of any trial drug within 1 month prior to this trial

          -  Mental incapacity, unwillingness or language barriers precluding adequate
             understanding or cooperation

          -  Conditions that may interfere with trial participation as judged by Investigator:
             proliferative retinopathy or maculopathy requiring acute treatment within the last six
             months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac
             problems, uncontrolled hypertension (treated and untreated)
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ustekinumab 45 mg; Ustekinumab 90 mg; Placebo
Intervention description: Form = Injection, route = subcutaneous; Form = Injection, route = subcutaneous; Form = Injection, route = subcutaneous
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: 478.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Psoriasis; Ustekinumab; STELARA; Skin disease; Monoclonal

Summary:

      The purpose of the study is to assess the effect of extending maintenance dosing intervals
      beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with
      moderate-to-severe plaque psoriasis.
    

Eligibility criteria:

        Key Eligibility Criteria

          -  Male or female

          -  Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the first
             administration of study agent (subjects with concurrent psoriatic arthritis may be
             enrolled).

          -  Have plaque-type psoriasis covering at least 10% of their total BSA at screening and
             at the time of the first administration of study agent.

          -  Have a PGA score of ≥ 3 at screening and at the time of the first administration of
             study agent.
The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis
Condition: Chronic Kidney Disease; End-Stage Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Intervention: somatropin; placebo
Intervention description: 20 mcg/kg/day, injected s.c. (under the skin); Placebo injected s.c (under the skin)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 712.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.

      The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on
      survival (primary end-point; "time to death" and health related quality of life in adult
      patients on chronic haemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serum albumin as specified in protocol

          -  Malnourished (based on serum albumin value below 40 g/L, assessed centrally)

          -  Stable (for 3 months or more) and adequate haemodialysis treatment three months prior
             to enrolment as defined by Kt/V of more than 1.2

        Exclusion Criteria:

          -  Active malignant disease

          -  Critical illness requiring treatment in an intensive care unit (ICU)

          -  Uncontrolled treated/untreated hypertension

          -  Patients on chronic (more than 3 months) treatment with steroids in doses of more than
             10 mg/day prednisolone (or equivalent)

          -  Patients treated with immunosuppressive agents

          -  Known Growth Hormone Deficiency

          -  Patients suffering from any clinically significant disease history in the opinion of
             the investigator

          -  Severe illness as defined in the protocol (as judged by the investigator)
Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Cytomegalovirus Retinitis; Retinitis
Intervention: Ganciclovir implant and oral ganciclovir; Cidofovir intravenous
Intervention description: oral ganciclovir, 1 gm three times daily; intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate; Cidofovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir
      intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss.

      To compare a treatment regimen that incorporates highly active local therapy (ganciclovir
      device) with a treatment regimen that does not.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age 13 years or older

          -  Diagnosis of AIDS according to current Centers for Disease Control and Prevention
             (CDC) definition

          -  Diagnosis of active CMV retinitis by a SOCA-certified ophthalmologist (involvement of
             any zone or amount of retina is allowed)

          -  Best corrected visual acuity of 20/100 or better in at least one eye

          -  At least one lesion 750 cells/µL or greater

          -  Platelet count 50,000 cells/µL or greater

          -  Willingness and ability, with the assistance of a caregiver if necessary to comply
             with treatment and follow up procedures

          -  Willingness of all men and women of childbearing potential to practice adequate birth
             control to prevent pregnancies during the study and for 3 months afterwards

          -  Collection of all baseline data within 5 days prior to randomization

          -  Signed consent statement

        Exclusion criteria:

          -  Media opacities that preclude visualization of the fundus of all otherwise eligible
             eyes

          -  Treatment for CMV retinitis with the ganciclovir intraocular implant within 9 months
             of study entry

          -  Medical problems or drug or alcohol abuse sufficient to hinder adherence to treatment
             or follow up procedures

          -  Unwillingness to refrain from breast-feeding during the study and for 3 months
             afterwards
Single-Dose Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1
Condition: SMA
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Intervention: Onasemnogene Abeparvovec-xioi
Intervention description: Onasemnogene abeparvovec-xioi is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the human survival motor neuron (SMN) gene under the control of the cytomegalovirus (CMV) enhancer/chicken β-actin-hybrid promoter (CB).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No

Summary:

      Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene
      replacement therapy) in patients with spinal muscular atrophy (SMA) Type 1 who meet
      enrollment criteria and are genetically defined by a biallelic pathogenic mutation of the
      survival motor neuron 1 gene (SMN1) with one or two copies of survival motor neuron 2 gene
      (SMN2). Up to 30 patients < 6 months (< 180 days) of age at the time of gene replacement
      therapy (Day 1) will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with SMA Type 1 as determined by diagnosis of SMA based on gene mutation
             analysis with biallelic SMN1 mutations (deletion or point mutations) and one or two
             copies of SMN2 [inclusive of the known SMN2 gene modifier mutation (c.859G>C)]

          -  Patients must be < 6 months (< 180 days) of age at the time of onasemnogene
             abeparvovec-xioi infusion

          -  Patients must have a swallowing evaluation test performed prior to administration of
             gene replacement therapy

        Exclusion Criteria:

          -  Previous, planned or expected scoliosis repair surgery/procedure prior to 18 months of
             age

          -  Use of invasive ventilatory support (tracheotomy with positive pressure) or pulse
             oximetry < 95% saturation at screening

          -  Use or requirement of non-invasive ventilatory support for 12 or more hours daily in
             the two weeks prior to dosing

          -  Patient with signs of aspiration based on a swallowing test or whose weight-for-age
             falls below the 3rd percentile based on World Health Organization (WHO) Child Growth
             Standards and unwilling to use an alternative method to oral feeding

          -  Participation in recent SMA treatment clinical trial (with the exception of
             observational cohort studies or non-interventional studies) or receipt of an
             investigational or commercial compound, product or therapy administered with the
             intent to treat SMA (eg, nusinersen, valproic acid,) at any time prior to screening
             for this trial.
Efficacy of Esomeprazole in Patients With Frequent Heartburn
Condition: Heartburn
MeSH terms: Heartburn
Intervention: Esomeprazole
Intervention description: Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heartburn

Summary:

      This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of
      frequent heartburn
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-pregnant ,non-lactating females 18 years or older

          -  Experience heartburn at least 2 days a week

          -  Having heartburn that has responded to heartburn medication

          -  Must discontinue any current heartburn medications

        Exclusion Criteria:

          -  Having a history of erosive esophagitis verified by endoscopy

          -  Having a history of GERD which was diagnosed by a physician

          -  Inability to take study medication or complete the study and all study procedures

          -  Subjects that have required more than one 14-day course of PPI treatment within the
             past 4 months
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Pitavastatin; Simvastatin
Intervention description: Pitavastatin once daily; Simvastatin once daily
Intervention MeSH terms: Simvastatin; Pitavastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 857.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hypercholesterolemia; kowa; dyslipidemia; pitavastatin; NK-104; Primary Hypercholesterolemia or Combined Dyslipidemia

Summary:

      The purpose of this study is to compare the efficacy and safety of pitavastatin with that of
      simvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females (18-75 years)

          -  Must have been following a restrictive diet

          -  Diagnosis of primary hypercholesterolemia or combined dyslipidemia

        Exclusion Criteria:

          -  Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;

          -  Conditions which may cause secondary dyslipidemia.

          -  Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)

          -  Abnormal serum creatine kinase (CK) above the pre-specified level

          -  Abnormal pancreatic, liver or renal function

          -  Significant heart disease