bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: IVA
Intervention description: Granules in sachet for oral administration.
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: 57.0
Sex: All
Minimum age: 1 Month
Maximum age: 24 Months
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of
      ivacaftor and metabolites in participants with cystic fibrosis (CF) who are <24 months of age
      at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance
      regulator (CFTR) gene mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF by sweat chloride value or CF mutation criteria.

          -  Have 1 of the following 10 CFTR mutations on at least 1 allele: G551D, G178R, S549N,
             S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H (eligible in regions where
             ivacaftor is approved for use). Part A/B group may also have other
             ivacaftor-responsive mutations.

          -  Hematology, serum chemistry, and vital signs results at screening with no clinically
             significant abnormalities that would interfere with the study assessments, as judged
             by the investigator.

        Exclusion Criteria:

          -  History of any illness or condition 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

          -  Colonization with organisms associated with a more rapid decline in pulmonary status
             at screening (Only for Parts A and B)

          -  History of abnormal liver function or abnormal liver function at screening

          -  History of solid organ or hematological transplantation

          -  Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A
             within 2 weeks before Day 1

          -  Participation in a clinical study involving administration of either an
             investigational or a marketed drug within 30 days or 5 terminal half-lives before
             screening

          -  Hemoglobin (Hgb) <9.5 g/dL at screening

          -  Chronic kidney disease of Stage 3 or above

          -  Presence of a non-congenital or progressive lens opacity or cataract at Screening

        Other protocol defined Inclusion/Exclusion Criteria may apply.
An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide; Syringe; Needle; Vial Adapter for Device
Intervention description: Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.; Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.; Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.; Vial adapter for device is approved for use in Japan by PMDA.
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to evaluate the long-term safety and efficacy of
      teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent
      SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the
      TED-C14-004 (NCT02340819) study.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants who meet all of the following criteria will be enrolled in this study:

          1. Ability to voluntarily provide written, signed, and informed consent to participate in
             the study.

          2. Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage
             3 or Stage 4.

          3. Females of childbearing potential must agree to comply with the contraceptive
             requirements of the protocol.

          4. An understanding, ability, and willingness to fully comply with study procedures and
             restrictions.

        Exclusion Criteria:

        There are no exclusion criteria for this study.
Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.
Condition: Myelofibrosis With High Molecular Risk Mutations
MeSH terms: Primary Myelofibrosis
Intervention: Ruxolitinib; Ruxolitinib Placebo
Intervention description: 5 mg tablet for oral use; 5 mg placebo tablet for oral use
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Early Myelofibrosis; high molecular risk mutations.; Ruxolitinib; INC424; High molecular risk mutations; HMR

Summary:

      Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive
      disease with increased risk of leukemic transformation and reduced overall survival. As there
      are no therapies currently established in the subset of high molecular risk patients with
      early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of MF with bone marrow fibrosis of at least Grade 1; irrespective
             of JAK2 mutational status

          -  Patients with at least one mutation in one of the five HMR genes (ASXL1, EZH2, SRSF2
             and IDH1/2)

          -  Patients with non-palpable spleen or spleen palpable ≤ 5 cm from the left costal
             margin to the point of greatest splenic protrusion

          -  Patients with MF-7 score of ≤ 15, with each individual symptom score of ≤ 3

        Exclusion Criteria:

          -  Patients with prior treatment with ruxolitinib or other JAK inhibitors.
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: XP13512 600MG; XP13512 1200MG; PLACEBO
Intervention description: XP13512 600MG ONCE DAILY; XP13512 1200MG ONCE DAILY; PLACEBO ONCE DAILY
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to assess the efficacy of XP13512 taken once daily
      compared to placebo for the treatment of patients suffering from Restless Legs Syndrome
      (RLS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.

        Exclusion Criteria:

          -  A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of
             RLS;

          -  Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's
             Disease, Multiple Sclerosis, dyskinesias, and dystonias);

          -  Abnormal laboratory results, electrocardiogram (ECG) or physical findings;

          -  Pregnant or lactating women;

          -  Women of childbearing potential who are not practicing an acceptable method of birth
             control.
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram; Placebo
Intervention description: Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks; Placebo once daily for up to 8 weeks
Intervention MeSH terms: Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Adolescents; Escitalopram; Pediatrics

Summary:

      Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the
      S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake
      inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to
      provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment
      of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be
      eligible to enter an open-label extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV)
             diagnostic criteria for Major Depressive Disorder.

          -  Patient's current depressive episode must be at least 12 weeks in duration

          -  Patient must have a parent or caregiver who must agree to accompany the patient to all
             clinic visits.

        Exclusion Criteria:

          -  Patients who currently meet DSM-IV criteria for:

               1. attention deficit-hyperactivity disorder

               2. obsessive-compulsive disorder

               3. posttraumatic stress disorder

               4. bipolar disorder

               5. pervasive developmental disorder

               6. mental retardation

               7. conduct disorder

               8. oppositional defiant disorder

          -  Patients who are considered a suicide risk (have active suicidal ideation), who have
             made a suicide attempt, or who have ever been hospitalized because of a suicide
             attempt.
Local Anesthetic Treatments for Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: alkalinized xylocaine; placebo
Intervention description: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks; normal saline
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Administration, Intravesical; Anesthetics, Local

Summary:

      The purpose of this study is to determine whether alkalized lidocaine instilled into the
      bladder is effective in the treatment of overactive bladder (OAB).
    

Eligibility criteria:

        Inclusion criteria:

          -  Female patient, 18 years of age and older

          -  Overactive bladder defined as:

               -  Urinary frequency defined as eight or more voids in a 24 hour period > 50% of
                  days of the week

               -  Symptoms of urgency

               -  Symptoms of at least three months duration

        Exclusion criteria:

          -  Positive urine culture in the past month, or more than 3 episodes of bladder infection
             in the last 2 months

          -  Stress or overflow urinary incontinence (determined by clinician) if more than 14
             episodes of urinary incontinence per week; also insensate incontinence

          -  Pregnancy

          -  Seizure disorder or clinically significant renal disease, allergy to lidocaine,
             uninvestigated hematuria, or history of urinary/reproductive tract malignancy

          -  Post-void residual more than 200 cc
Testosterone Treatment for Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone (T) Gel 1.62%; Placebo
Intervention description: Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.; Placebo Control
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 274.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypogonadism; Testosterone Deficiency

Summary:

      Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal
      men
    

Eligibility criteria:

        Inclusion Criteria:

          -  Low T males 18 - 80 years of age

        Exclusion Criteria:

          -  Normal T levels

          -  Elevated Prostatic Specific Antigen (PSA)
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: fostamatinib; fostamatinib; placebo, fostamatinib
Intervention description: fostamatinib 100 mg twice daily; fostamatinib 100 mg twice daily/ 150 mg once daily; Placebo for 24 weeks followed by fostamatinib 100 mg twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 913.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of the study is to evaluate the effectiveness of two dosing regimens of
      fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking
      disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1
      year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active rheumatoid arthritis (RA) diagnosed after the age of 16

          -  Treatment with one the following disease modifying anti-rheumatic drug: methotrexate,
             sulfasalazine, hydroxychloroquine or chloroquine

          -  4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and
             either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or
             C-Reactive Protein (CRP) blood result of 10mg/L or more

          -  At least one of the following: documented history of positive rheumatoid factor (blood
             test), current presence of rheumatoid factor (blood test), radiographic erosion within
             12 months prior to study enrolment, presence of serum anti-cyclic citrullinated
             peptide antibodies (blood test)

        Exclusion Criteria:

          -  Females who are pregnant or breast feeding

          -  Poorly controlled hypertension

          -  Liver disease or significant liver function test abnormalities

          -  Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue
             diseases or chronic pain disorders

          -  Recent or significant cardiovascular disease

          -  Significant active or recent infection including tuberculosis

          -  Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment
             with other biological agent

          -  Severe renal impairment

          -  Neutropenia
A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
Condition: Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Aspergillosis
Intervention: caspofungin acetate; Comparator: Micafungin sodium
Intervention description: Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.; Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
Intervention MeSH terms: Caspofungin; Micafungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and efficacy of MK0991 in patients
      with deep-seated mycoses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The
             Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To
             Candida species (Spp.) Or Aspergillus Spp.

        Exclusion Criteria:

          -  Patients With Mycoses Other Than Ones Due To Candida Spp. Or Aspergillus Spp.

          -  Patients Who Will Receive Other Systemic Antifungal Agents For The First Time In
             Screening Period.
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Condition: Organ Transplantation, Renal Transplantation
Intervention: Everolimus (Certican); Cyclosporine (Neoral); Steroid; Basiliximab (Simulect)
Intervention description: Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
Intervention MeSH terms: Cyclosporine; Prednisone; Everolimus; Cyclosporins; Basiliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Renal transplantation,; everolimus,; immunosuppressants,; basiliximab,; cyclosporine microemulsion discontinuation, cyclosporine microemulsion minimization

Summary:

      The purpose of this study is to evaluate the safety and efficacy of everolimus in combination
      with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney
      transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipients of a first renal transplant from a primary cadaveric or non-HLA identical
             living related donor.

          -  Renal cold ischemic time < 36 hours.

          -  Age of donor < 65 years.

        Exclusion Criteria:

          -  Patients who have received an investigational drug within 4 weeks of baseline period.

          -  Patients who are recipients of multiple organ transplants, including any organ other
             than kidney.

          -  Recipients of non-heart beating donor organs.

        Other protocol-defined exclusion criteria may apply.
Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenic Disorders; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Intramuscular olanzapine depot
Intervention description: 45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 931.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No

Summary:

      This is a long-term, open-label clinical study designed to enable longer-term treatment of
      patients completing other clinical studies with intramuscular olanzapine depot.

      Key objectives of the study are to:

        -  Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,

        -  Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,

        -  Determine the blood levels of IM olanzapine depot in patients during long-term treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have schizophrenia

          -  Female patients of childbearing potential must be using a medically accepted means of
             contraception

          -  Patients must have completed (within 10 days) another IM olanzapine depot study if
             permitted by that study's protocol.

        Exclusion Criteria:

          -  Patients must not have participated in a clinical trial of another investigational
             drug, including olanzapine, within 1 month (30 days) prior to study entry

          -  Female patients must not be pregnant or breast-feeding

          -  Patients must not be experiencing acute, serious or unstable medical conditions other
             than schizophrenia or schizoaffective disorder

          -  Patients must not have a substance (except nicotine or caffeine) dependence within the
             past 30 days