bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: efanesoctocog alfa (BIVV001)
Intervention description: Pharmaceutical form: solution for injection Route of administration: IV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      - To evaluate the safety of BIVV001 in previously treated pediatric participants with
      hemophilia A.

      Secondary Objectives:

        -  To evaluate the efficacy of BIVV001 as a prophylaxis treatment.

        -  To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes.

        -  To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes.

        -  To evaluate the effect of BIVV001 prophylaxis on joint health outcomes.

        -  To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes.

        -  To evaluate the efficacy of BIVV001 for perioperative management.

        -  To evaluate the safety and tolerability of BIVV001 treatment.

        -  To assess the pharmacokinetics (PK) of BIVV001.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participant must be younger than 12 years of age, at the time of signing the informed
             consent.

          -  Severe hemophilia A defined as <1 international units per deciliter (IU/dL) (<1
             percent [%]) endogenous Factor VIII (FVIII) as documented either by central laboratory
             testing at Screening or in historical medical records from a clinical laboratory
             demonstrating <1% FVIII coagulant activity (FVIII:C) or a documented genotype known to
             produce severe hemophilia A.

          -  Previous treatment for hemophilia A (prophylaxis or on-demand) with any recombinant
             and/or plasma-derived FVIII, or cryoprecipitate for at least 150 exposure days (EDs)
             for participants aged 6 to <12 years and above 50 EDs for participants aged <6 years.

          -  Weight above or equal to 10 kg.

        Exclusion criteria:

          -  History of hypersensitivity or anaphylaxis associated with any FVIII product.

          -  History of a positive inhibitor (to FVIII) test defined as greater than or equal to
             (>=) 0.6 Bethesda units (BU/mL), or any value greater than or equal to the lower
             sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7
             and 1.0 BU/mL, or clinical signs or symptoms of decreased response to FVIII
             administrations. Family history of inhibitors would not exclude the participant.

          -  Positive inhibitor test result, defined as >=0.6 BU/mL at Screening.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
Condition: Liver Transplantation
Intervention: Sirolimus (Rapamune); Cyclosporine or Tacrolimus
Intervention MeSH terms: Cyclosporine; Sirolimus; Tacrolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 607.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Liver; Transplant

Summary:

      The purpose of this study is to evaluate the sirolimus conversion regimen as compared with
      the calcineurin inhibitor continuation regimen with regards to renal function in stable liver
      transplant subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 13 years (age greater than 18 years as required by some local
             regulations).

          -  Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/-
             corticosteroids +/- antimetabolite.

          -  6 to 144 months after orthotopic liver transplantation.

          -  Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening

        Exclusion Criteria:

          -  History of nonhepatic transplantation

          -  Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).

          -  Known or suspected malignancy < 5 years before random assignment.
Preoperative Gabapentine for Carpal Tunnel
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Intervention: Gabapentine; Sugar pill
Intervention description: Gabapentine 600 mg 01 dose; Sugar pill 01 dose
Intervention MeSH terms: Gabapentin; Anticonvulsants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: gabapentine; postoperative pain

Summary:

      The purpose of this study was to evaluate the postoperative analgesic effect of preoperative
      gabapentine for carpal tunnel syndrome surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  carpal tunnel syndrome

        Exclusion Criteria:

          -  disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia,
             another pain syndrome, drug user, and pregnant
Sleep Apnea and Fetal Growth Restriction
Condition: Obstructive Sleep Apnea; Fetal Growth Restriction; Pregnancy Related
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Fetal Growth Retardation
Intervention: S9 VPAP Adapt
Intervention description: Auto-titrated positive airway pressure
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel group, investigator-blinded, randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: aPAP; OSA; FGR

Summary:

      This study aims to evaluate the association between obstructive sleep apnea (OSA) and fetal
      growth restriction (FGR) and to assess the role of auto-titrated positive airway pressure
      (aPAP) as antenatal therapy in these patients. Pregnant patients with diagnosed FGR will be
      screened for OSA first by screening questionnaire and then by home sleep monitor. Of those
      patients diagnosed with OSA, half will be assigned to use aPAP each night when sleeping and
      half will not (standard care).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 and ≤ 50

          -  Fetal growth restriction (defined as fetal weight <10th percentile based on at least
             one routine 2nd trimester ultrasound without a subsequent increase to >15th percentile
             on any ultrasounds prior to enrollment)

          -  Lower limit of gestational age at enrollment 22+0 weeks.

          -  Upper limit of gestational age at enrollment: adequate time to complete Stages 1 and 2
             and if appropriate to be randomized and receive intervention by no later than 32+0
             weeks.

          -  The absence of 2 minor or 1 major markers of aneuploidy.

        Exclusion Criteria:

          -  Other known cause of fetal growth restriction (including congenital anomalies,
             intrauterine infection, or multiple gestation)

          -  Reversed end-diastolic flow in the umbilical artery

          -  Preexisting diagnosis of OSA being treated with aPAP

          -  Chronic pulmonary disease (cystic fibrosis, moderate persistent asthma)

          -  Hemoglobinopathies (sickle cell anemia, thalassemia)

          -  Maternal craniofacial anomalies

          -  Premature rupture of membranes
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: CC-5013; Dexamethasone
Intervention description: Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.; Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Refractory and Relapsed; Revlimid; CC5013

Summary:

      Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing
      identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will
      participate in a treatment phase and a follow-up phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.

          -  No more than 3 previous anti-myeloma regimens

          -  No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg)
             within 6 months of study randomization.

          -  Measurable levels of myeloma paraprotein in serum or urine (24-hour collection
             sample).

        Exclusion Criteria:

          -  Prior development of disease progression during high-dose dexamethasone containing
             therapy.

          -  Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed

          -  Laboratory abnormalities: Platelet count less than 75,000/mm cubed

          -  Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL

          -  Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate
             transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase
             [ALT])greater than 3.0 x upper limit of normal

          -  Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL

          -  Prior history of malignancies other than multiple myeloma unless the subject has been
             free of the disease for greater than or equal to 5 years.

          -  Known hypersensitivity to thalidomide or dexamethasone.

          -  Development of a desquamating rash while taking thalidomide.
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
Condition: Contraception
Intervention: Radiopaque Etonogestrel Implant
Intervention description: One implant inserted for a 3-year treatment period
Intervention MeSH terms: Etonogestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to evaluate the use of the next generation applicator
      and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives
      include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and
      safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant,
      and to assess participant expectations and satisfaction with the Radiopaque Implant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Woman of at least (>=) 18 but not older than (<= )40 years of age at the time of
             screening;

          -  Good physical and mental health;

          -  Regular cycles with a usual length between 24 and 35 days;

          -  Body mass index >= 18 and <= 35 kg/m^2;

          -  Willing to give informed consent in writing.

        Exclusion Criteria:

          -  Contraindications:

               -  known or suspected pregnancy;

               -  active venous thromboembolic disorder (e.g. deep vein thrombosis,

        pulmonary embolism);

          -  presence or history of severe hepatic disease as long as liver function values have
             not returned to normal;

          -  malignancy or pre-malignancy, if sex-steroid-influenced;

          -  undiagnosed vaginal bleeding;

          -  hypersensitivity to any of the components of Radiopaque Implant.

               -  Hypertension, i.e. systolic blood pressure >140 mmHg and/or diastolic blood
                  pressure > 90 mmHg;

               -  A history during pregnancy or during previous use of sex steroids of: jaundice
                  and/or severe pruritus related to cholestasis, gallstone formation, porphyria,
                  systemic lupus erythematosus, haemolytic uraemic syndrome, Sydenham's chorea,
                  herpes gestationis, otosclerosis-related hearing loss;

               -  Present use or use during 2 months prior to the start of Radiopaque Implant of
                  one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine,
                  rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir,
                  griseofulvin or the herbal remedy St John's wort;

               -  Administration of investigational drugs within 2 months prior to the start of
                  Radiopaque Implant
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 790.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness of nivolumab adjuvant
      immunotherapy compared to placebo in adults and pediatric participants after complete
      resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for
      recurrence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had a negative sentinel lymph node biopsy

          -  Participant has not been previously treated for melanoma

          -  ECOG 0 or 1

          -  Participants must have been diagnosed with histologically confirmed, Resected, Stage
             IIB/C cutaneous melanoma

        Exclusion Criteria:

          -  History of ocular or mucosal melanoma.

          -  Pregnant or nursing women

          -  Participants with active known or suspected autoimmune disease

          -  Known history of allergy or hypersensitivity to study drug components

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4
             antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint
             pathways

        Other protocol defined inclusion/exclusion criteria apply.
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: OPC-34712
Intervention description: Phase A: 1-2 mgs/day by mouth, max of 4 wks.
Phase B: 1-4 mgs/day by mouth, up to 52 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1044.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long-term safety, tolerability and efficacy of
      oral OPC-34712 as monotherapy in adults with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 18 and 65 years of age, with a diagnosis of
             schizophrenia, as defined by DSM-IV-TR criteria

          2. Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231

          3. Willing to discontinue all prohibitive psychotropic medications to meet protocol
             required washouts prior to and during the trial period.

          4. Other protocol specific inclusion criteria may apply.

        Exclusion Criteria:

          1. Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug

          2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

               -  Schizoaffective disorder

               -  MDD

               -  Bipolar disorder

               -  Delirium, dementia, amnestic or other cognitive disorder

               -  Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality
                  disorder

          3. Subjects presenting with a first episode of schizophrenia

          4. Other protocol specific exclusion criteria may apply.
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: bevacizumab [Avastin]; XELOX; bevacizumab [Avastin]; FOLFOX-4
Intervention description: 7.5mg/kg iv on day 1 of each 3 week cycle; As prescribed; 5mg/kg iv on day 1 of each 2 week cycle; As prescribed
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state
      under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or
      FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm
      will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the
      FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated
      time on study treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;

          -  >=1 target lesion.

        Exclusion Criteria:

          -  patients who have previously received systemic treatment for advanced or metastatic
             disease;

          -  patients who have received adjuvant treatment for non-metastatic disease in past 3
             months;

          -  previous therapy with oxaliplatin or Avastin.
Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 1% OPA-15406; Placebos
Intervention description: Twice daily; Twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 364.0
Sex: All
Minimum age: 15 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when
      administered twice daily for 4 weeks using success rate in Investigator's Global Assessment
      (IGA) at Week 4 as the primary endpoint in adult patients with AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AD based on the Japanese Dermatological Association's criteria

          -  History of AD for at least 3 years

          -  Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of
             body surface area (BSA, excluding scalp) at the screening and baseline examinations

          -  IGA score of 2 or 3 at the screening and baseline examinations

        Exclusion Criteria:

          -  Subjects who have an AD or contact dermatitis flare-up defined as a rapid
             intensification of AD, within 28 days prior to the baseline examination
BAX 326 (rFIX) Continuation Study
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: BAX 326 (Recombinant factor IX)
Intervention description: The treatment with BAX 326 will be at the discretion of the investigator and will consist of either twice weekly prophylactic treatment with 50 IU/kg, modified prophylaxis, or on-demand treatment.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery
      over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of
      life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately
      severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric
      study 251101.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Subject and/or legal representative has/have voluntarily provided signed informed
             consent

          -  Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical
             study 251101 (pediatric study)

          -  Subject was 12 to 65 years old at the time of screening for Study 250901 or < 12 years
             old at the time of screening for Study 251101

          -  Subject has severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B
             (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested
             at screening at the central laboratory

          -  Subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study
             250901 or Pediatric Study 251101

        Main Exclusion Criteria:

          -  Subject received factor IX product(s) other than BAX 326 upon completion of Baxter
             Pivotal Study 250901 or Pediatric Study 251101

          -  Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B

          -  For subjects transferring from Pivotal Study 250901: Subject's weight is < 35 kg or >
             120 kg

          -  Subject is planned to take part in any other clinical study, with the exception of BAX
             326 Surgery study as described in this protocol, during the course of the Continuation
             Study