bioihbjkbjnl/mcl2 huggingface dataset:
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
Condition: Idiopathic Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: placebo and pregabalin; pramipexol; pramipexol; Pregabalin; pramipexol; pramipexol
Intervention description: following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
Intervention MeSH terms: Pregabalin; Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 731.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RLS

Summary:

      This purpose of this study is to investigate the efficacy and tolerability of pregabalin in
      treating idiopathic RLS patients for up to 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  idiopathic RLS with the presence of all four clinical manifestations of RLS

          -  RLS symptoms occur predominantly in the evening

          -  RLS history at least 6 months

          -  IRLS => 15 at the beginning and the end of placebo run-in

          -  Have =>15 nights with RLS symptoms in the month prior to screening

        Exclusion Criteria:

          -  Any secondary RLS

          -  Current augmentation due to RLS treatment

          -  Placebo responders identified during the placebo run-in
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
Condition: Kidney Transplantation
Intervention: Tacrolimus Modified Release (MR); Tacrolimus; cyclosporine microemulsion; mycophenolate mofetil
Intervention description: The target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter.; The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 through 90 and 5 to 15 ng/mL thereafter.; The target range for whole blood cyclosporine trough concentrations was 125 to 400 ng/mL for days 0 through 90, and 100 to 300 ng/mL thereafter.; Oral
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Tacrolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 668.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: De Novo Kidney Transplant; cyclosporine; Prograf®; mycophenolate mofetil; tacrolimus

Summary:

      The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate
      mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney
      transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of a primary or retransplanted non-human leukocyte antigen (HLA)-identical
             living or non-HLA-identical cadaveric kidney transplant

          -  Age greater or equal to 12 years

        Exclusion Criteria:

          -  Recipient or donor is known seropositive for human immunodeficiency virus (HIV)

          -  Has current malignancy or history of malignancy

          -  Has significant liver disease

          -  Has uncontrolled concomitant infection or any other unstable medical condition

          -  Is receiving everolimus or enteric coated mycophenolic acid at any time during the
             study

          -  Received kidney with a cold ischemia time of equal or more than 36 hours

          -  Received kidney transplant from a cadaveric donor equal or more than 60 years of age

          -  Received intravenous immunoglobulin (IVIG) therapy prior to randomization
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Condition: Epilepsies, Partial
MeSH terms: Epilepsies, Partial
Intervention: gabapentin
Intervention description: Orally administered gabapentin
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No

Summary:

      Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric
      patients with partial seizures
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of study A9451162 (NCT00603473)

        Exclusion Criteria:

          -  Seizures related to drugs or acute medical illness

          -  History of any serious medical or psychiatric disorder
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: risankizumab; placebo for risankizumab; ustekinumab; placebo for ustekinumab
Intervention description: Risankizumab administered by subcutaneous (SC) injection; Placebo for risankizumab administered by subcutaneous (SC) injection; Ustekinumab administered by subcutaneous (SC) injection; Placebo for ustekinumab administered by subcutaneous (SC) injection
Intervention MeSH terms: Ustekinumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Skin Diseases; Skin Diseases, Papulosquamous; ustekinumab; Dermatologic Agents; ABBV-066; BI 655066; risankizumab

Summary:

      The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066
      (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult
      patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients with age ≥18 years at screening.

          -  Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for
             at least 6 months before the first administration of study drug.

          -  Have stable moderate to severe chronic plaque psoriasis with or without psoriatic
             arthritis at both Screening and Baseline (Randomisation):

               1. Have an involved body surface area (BSA) ≥10% and

               2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and

               3. Have a static Physician Global Assessment (sPGA) score of ≥3.

          -  Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as
             assessed by the investigator.

          -  Must be a candidate for treatment with Stelara® (ustekinumab) according to local
             label.

        Exclusion criteria:

          -  Patients with:

               1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)

               2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta
                  blockers, calcium channel blockers, or lithium)

               3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis
                  that might confound trial evaluations according to investigator's judgment

          -  Previous exposure to BI 655066.

          -  Previous exposure to ustekinumab (Stelara®).
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: SAGE-217 15/20 mg Oral Solution; Placebo; SAGE 217 30 mg Capsules
Intervention description: SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).; SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.; SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Postpartum Care

Summary:

      The primary purpose of this study was to determine if treatment with SAGE-217 reduces
      depressive symptoms in participants with severe postpartum depression (PPD) compared to
      placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for
      Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of
      SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign
      measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the
      Columbia Suicide Severity Rating Scale (C-SSRS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant either must have ceased lactating at screening or, if still lactating or
             actively breastfeeding at screening, must agree to temporarily cease giving breast
             milk to her infant(s)

          -  Participant has had a Major Depressive Episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by the
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders (DSM)-5 Axis I Disorders (SCID-I)

          -  Participant was <=six months postpartum.

        Key Exclusion Criteria:

          -  Active psychosis

          -  Attempted suicide associated with current episode of postpartum depression

          -  Medical history of seizures

          -  Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

        Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion
        criteria might apply.
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Intervention: Macitentan 10 mg; Placebo
Intervention description: film-coated tablet; oral use; film-coated tablet; oral use
Intervention MeSH terms: Macitentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on
      exercise capacity through cardiopulmonary exercise testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent/assent from the subject and/or a legal representative prior
             to initiation of any study-mandated procedures

          -  Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary
             connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery > 1 year before
             Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary
             connection

          -  New York Heart Association (NYHA) functional class (FC) II or III (assessed by the
             investigator using the Specific Activity Scale

          -  Women of childbearing potential must have a negative serum pregnancy test use reliable
             contraception

        Exclusion Criteria:

          -  Pattern of Fontan circulation severity

          -  Deterioration of the Fontan-palliated condition.

          -  Limitations to Cardiopulmonary exercise testing (CPET)

          -  Peak VO2 < 15 mL/kg/min.

          -  Any known factor or disease that may interfere with treatment compliance or full
             participation in the study
Ezetimibe in Patients Hypo-responsive to Statins
Condition: High Cholesterol; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Hypercholesterolemia
Intervention: Ezetimibe; Atorvastatin
Intervention description: 10 mg; Visit 1: (atorvastatin open label challenge): Those who complete the initial screening and washout period will receive open label atorvastatin 10 mg daily for 6 weeks to verify compliance and confirm hyporesponse to statin therapy.
Visit 2: After 6 weeks of therapy repeat baseline fasting cholesterol. Those with LDL-c reduction of 25% or less will be able to proceed to next phase. Patients with greater than 25% LDL-C reduction will be excluded. We expect to randomize 80 patients
Visit 2a: Dispensing of first randomized drug allocation- all patients receive open label atorvastatin 10 mg with additional ezetimibe 10 mg or matching placebo. No blood test during this visit.
Visit 3, 4, 5: Dose titration to atorvastatin to 20 mg, 40 mg, 80 mg, respectively, after fasting blood test
Blood collected in visits 3, 4, and 5 will be stored for additional tests regarding cholesterol metabolism and inflammation.
Visit 6: Final cholesterol panel and conclusion of study period
Intervention MeSH terms: Atorvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Response to statin therapy for elevated low density lipoprotein is variable and may be
      influenced by cholesterol absorption. This study will evaluate whether combination therapy
      with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less
      than 25% LDL reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin
      20 mg daily).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will need to have an LDL-C level of 130 mg/dl or greater without treatment.

          -  They must have demonstrated an initial LDL-C reduction of less than 25% on 10 mg of
             atorvastatin or 20 mg of simvastatin.

          -  Eligible patients will be those deemed by their physicians to be eligible for lipid
             lowering therapy with a statin and to have stable CAD, CAD equivalent per NCEP
             guidelines, or Framingham risk of 10-20%.

        Exclusion Criteria:

          -  Recent (<3 months) diagnosis of Acute Coronary Syndromes due to ethical considerations
             [10].

          -  Pregnant patients, those planning to become pregnant, or those who are breast feeding,
             those with liver disease, history allergic reaction to any agent used in the trial,
             history of myositis, myopathy, pancreatitis, hypertriglyceridemia (TG > 400 mg/dL),
             history of significant alcohol or drug abuse, history of organ transplantation, or
             patient refusal.
Treatment of Patients With Nocturia (Non-PK Study)
Condition: Nocturia
MeSH terms: Nocturia
Intervention: SER120; Placebo
Intervention description: Nasal Spray, once a day; Nasal Spray
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 326.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that
      SER120 will decrease the number of nocturic episodes compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female 50 years or older

          -  Nocturia of 6 or more months duration averaging 2 episodes or more per night

        Exclusion Criteria:

          -  CHF

          -  Diabetes

          -  Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency

          -  Incontinence

          -  Illness requiring steroids

          -  Current or past urologic malignancy

          -  Nephrotic Syndrome

          -  Unexplained pelvic masses

          -  Urinary bladder neurological dysfunction

          -  Urinary bladder surgery or radiotherapy

          -  Sleep Apnea

          -  Pregnant or breast feeding
Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550
Intervention description: 5 mg BID up to 10 mg BID until launch
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 487.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Long term open label study in Japan; CP-690; 550; tofacitinib

Summary:

      The purpose of this study is to determine the long-term effectiveness and safety of
      CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this
      study after they have completed participation in another "qualifying" study of CP-690,550.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed their participation in a randomized "qualifying" study of
             CP-690,550 for the treatment of rheumatoid arthritis

        Exclusion Criteria:

          -  Serious medical conditions that would make treatment with CP-690,550 potentially
             unsafe
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Condition: Antifungal Prophylaxis of Invasive Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Intervention: Itraconazole; Vfend - voriconazole
Intervention description: Prophylaxis; Prophylaxis
Intervention MeSH terms: Itraconazole; Voriconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 489.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who
      have had a Stem Cell Transplant. The success of the end point will be measured using evidence
      of Infection, drug compliance and survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed
             lymphoma therapy or transformation of CML

          -  Male and Female over 12 years or greater

        Exclusion Criteria:

          -  Possible, probable or proven IFI at study entry or at any time in 6 months prior to
             study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)

          -  Previous history of zygomycosis

          -  Anticipated survival less than one month
Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Nivolumab; Cetuximab; Methotrexate; Docetaxel
Intervention MeSH terms: Docetaxel; Nivolumab; Methotrexate; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out whether Nivolumab will significantly improve overall
      survival as compared to therapy of investigator's choice in patients with recurrent or
      metastatic head and neck carcinoma.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG)
             performance status ≤ 1

          -  Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx),
             stage III/IV and not amenable to local therapy with curative intent (surgery or
             radiation therapy with or without chemotherapy)

          -  Tumor progression or recurrence within 6 months of last dose of platinum therapy in
             the adjuvant (ie with radiation after surgery), primary (ie, with radiation),
             recurrent, or metastatic setting

          -  Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per
             Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases are not allowed

          -  Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx,
             squamous cell carcinoma of unknown primary, and salivary gland or non-squamous
             histologies (eg: mucosal melanoma) are not allowed

          -  Subjects with active, known or suspected autoimmune disease