bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Daridorexant; Placebo
Intervention description: Daridorexant will be administered as tablets, orally, once daily in the evening.; Matching placebo will be administered as tablets, orally, once daily in the evening.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 924.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant)
      in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective
      and subjective sleep parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure;

          -  Male or female aged ≥ 18 years;

          -  Insomnia disorder according to DSM-5 criteria;

          -  Insomnia Severity Index score ≥ 15;

          -  Insufficient sleep quantity as collected subjectively in the sleep diary and validated
             objectively by polysomnography;

          -  Women of childbearing potential must have a negative and urine pregnancy test and use
             the contraception scheme up to at least 30 days after last study treatment intake.

        Exclusion Criteria:

          -  Body mass index below 18.5 or above 40.0 kg/m2;

          -  Any lifetime history of of related breathing disorder, periodic limb movement
             disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM)
             behavior disorder, narcolepsy, or apnea/hypopnea;

          -  Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1
             month prior to Visit 3 and the subject agrees to continue this CBT throughout the
             study;

          -  Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;

          -  Acute or unstable psychiatric conditions diagnosed by the Mini International
             Neuropsychiatric Interview;

          -  Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;

          -  For female subjects: pregnant, lactating or planning to become pregnant during
             projected duration of the study;

          -  History or clinical evidence of any disease or medical condition or treatment, which
             may put the subject at risk of participation in the study or may interfere with the
             study assessments.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             the subject's full participation in the study or compliance with the protocol.
A Study of Fibrocaps™ in Surgical Bleeding
Condition: Mild or Moderate Surgical Bleeding
MeSH terms: Hemorrhage
Intervention: Fibrocaps; Gelatin sponge
Intervention description: Human fibrinogen and thrombin powder, for topical administration.; Absorbable gelatin sponge for topical administration.
Intervention MeSH terms: Fibrin Tissue Adhesive; Fibrin Foam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 721.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fibrin sealant; thrombin; fibrinogen; hemostasis

Summary:

      The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as
      compared to gelatin sponge alone, for achieving hemostasis.

      The investigational products were used in participants with mild to moderate surgical
      bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to
      moderate bleeding by standard surgical techniques is ineffective and/or impractical.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has signed an institutional review board/independent ethics committee
             (IRB/IEC)-approved informed consent document

          2. Is undergoing one of the 4 surgical procedures described

          3. Is at least 18 years old at time of consent

          4. If female and of child-bearing potential, has negative pregnancy test during screening
             and is not breast-feeding

          5. If able to reproduce, agrees to use a medically accepted form of contraception from
             the time of consent to completion of all follow-up study visits when engaging in
             heterosexual intercourse

          6. Has not received blood transfusion between screening and study treatment

          7. Has mild to moderate surgical bleeding

          8. Does not have intra-operative complications

          9. Has not used a topical hemostat containing thrombin prior to study treatment

         10. Has an approximate bleeding site surface area of less than or equal to 100 cm^2

        Exclusion Criteria:

          1. Has known antibodies or hypersensitivity to thrombin or other coagulation factors

          2. Has history of heparin-induced thrombocytopenia (only for vascular subjects where
             heparin use is required)

          3. Has known allergy to gelatin sponge

          4. Is unwilling to receive blood products

          5. Has liver enzymes appropriate for the study, considering their disease

          6. Has appropriate level of platelets per liter (PLT/L) during screening

          7. Has any clinically-significant coagulation disorder that may interfere with the
             assessment of efficacy or pose a safety risk to the subject according to the
             Investigator, or baseline abnormalities during screening that are not explained by
             current drug treatment (e.g., warfarin, heparin)
Preemptive Strike With Bortezomib in Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bortezomib
Intervention description: Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks
Intervention MeSH terms: Bortezomib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate whether using the drug bortezomib at the start of remission will prevent relapse
      for a longer period of time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with multiple myeloma currently or previously enrolled on UARK 98-026 and
             currently event-free at the time of the evaluation.

          -  Performance status of 0-2 based of Southwest Oncology Group (SWOG) criteria

          -  Previously documented platelet count > 75,000/ul within a 35 days prior to enrollment

          -  Previously documented peripheral absolute neutrophil count >1,000/ul within 35 days
             prior to enrollment.

          -  Adequate renal function

          -  Signed informed consent

          -  Female subject is post-menopausal or willing to use acceptable birth control

          -  Male subjects agree to use acceptable method of contraceptive

        Exclusion Criteria:

          -  Hypersensitivity to Bortezomib, boron, or mannitol

          -  Female subject is pregnant or breastfeeding

          -  Experienced myocardial infraction within 6 months prior to enrollment

          -  Received other investigational new drugs within 14 days before enrollment

          -  Received any anti-myeloma therapy within 14 days

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study

          -  Diagnosed or treated for another malignancy within 3 years of enrollment
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: Riociguat (Adempas, BAY63-2521); Riociguat (Adempas, BAY63-2521); Placebo
Intervention description: BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks; BAY63-2521: 1.5mg tid orally for 12 weeks; Matching Placebo tid orally for 12 weeks
Intervention MeSH terms: Riociguat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 445.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pulmonary arterial hypertension; PH; Stimulator

Summary:

      The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521
      given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension
      (PAH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH
             due to connective tissue disease, congenital heart disease, portal hypertension with
             liver cirrhosis, or due to anorexigen or amphetamine use)

          -  Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a
             Prostacyclinanalogue (except I.V.).

        Exclusion Criteria:

          -  All types of pulmonary hypertension except subtypes of Venice Group I specified in the
             inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled
             arterial hypertension, left heart failure.
Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: Replagal
Intervention description: Intravenous (IV) infusion for 12 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the safety and effectiveness of various doses of
      Replagal in patients with cardiomyopathy due to Fabry disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years-old;

          -  Male:Fabry disease confirmed by deficiency of alfa galactosidase A activity OR
             Female:Fabry disease confirmed by a mutation of the alfa galactosidase A gene;

          -  ERT-naïve;

          -  LVM/h > 50g/m2.7 for males and >47 g/m2.7 for females;

          -  Negative pregnancy test at enrollment and contraception use required throughout study
             for female patients;

          -  Signed informed consent;

        Exclusion Criteria:

          -  Class IV heart failure;

          -  Clinically significant hypertension;

          -  Hemodynamically significant valvular stenosis or regurgitation;

          -  Morbid obesity;

          -  Known autosomal dominant sarcoplasmic contractile protein gene mutation;

          -  Treatment with any investigational drug or device within the 30 days;

          -  Unable to comply with the protocol as determined by the Investigator;

          -  Positive for hepatitis B, hepatitis C or HIV
Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: Artemether Sublingual Spray; Quinine
Intervention description: Artemether sublingual spray administered at 3 mg/kg (milligrams per kilogram) at specified timepoints; Quinine administered intravenously, 20 mg/kg loading dose followed by 10 mg/kg every eight hours
Intervention MeSH terms: Artemether; Quinine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Healthy volunteers: No
Keywords: Plasmodium infections; Remittent fever; Artemether; Artemesinins; Quinine; Malaria; Protozoan infections; sublingual drug delivery; Parasitic disease; Antiprotozoan agents

Summary:

      The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is
      better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after
      the start of treatment in children with severe malaria, or uncomplicated malaria with
      gastrointestinal complications
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient's legally acceptable representative has provided informed consent and the
             patient has assented (where relevant) to participation in the trial

          2. The patient is a child that weighs between 5.00 kg and 15.00 kg inclusive

          3. The patient has falciparum malaria as evidenced by thick or thin blood smears of ≥ 500
             P Falciparum per mcl (patients with mixed infections may be included provided ≥ 500 P
             Falciparum per mcl)

          4. The patient has either:

               -  severe or complicated falciparum malaria as determined by the investigator based
                  on the WHO criteria for severity, and/or

               -  uncomplicated falciparum malaria but is unable to tolerate oral medication as a
                  result of gastrointestinal complications such as vomiting or diarrhoea.

        Exclusion Criteria:

          1. The patient's legally acceptable representative does not provide informed consent for
             participation, or the child if capable, does not assent to participation in the trial.

          2. Ability to tolerate oral therapy

          3. Patient has received any antimalarial therapy within the 7 days prior to first study
             drug administration.

          4. Patient has evidence of significant co-infections (this does not include mixed
             Plasmodium infections).

          5. Patient has a contraindication, allergy or is otherwise intolerant to either
             artemether or quinine .
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Condition: Epilepsy; Monotherapy
MeSH terms: Epilepsy
Intervention: Lacosamide; Carbamazepine-Controlled Release (CBZ-CR)
Intervention description: 50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years); 200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Intervention MeSH terms: Lacosamide; Carbamazepine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 551.0
Sex: All
Healthy volunteers: No
Keywords: Lacosamide

Summary:

      Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as
      monotherapy in newly or recently newly diagnosed subjects with primary safety variables
      including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs,
      reporting of Serious AEs (SAEs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject/legal representative is considered reliable and capable of adhering to the
             protocol

          -  Subject has remained seizure free and completed the Maintenance Phase of the SP0993;
             or subject has experienced 1 or more seizures on the first or second target dose
             during the SP0993 Maintenance Phase

          -  Subject is expected to benefit from participation in SP0994 in the opinion of the
             investigator

        Exclusion Criteria:

          -  Subject is receiving any investigational drugs or using any experimental devices in
             addition to LCM or CBZ-CR

          -  Subject experienced a seizure at the third target dose during the Evaluation Phase or
             Maintenance Phase of the SP0993 study

          -  Subject is taking benzodiazepines for a non-epilepsy indication

          -  Subject meets a withdrawal criterion from the previous study SP0993

          -  Subject is experiencing an ongoing SAE from the previous study SP0993

          -  Subject has a lifetime history of suicide attempt (including an active attempt,
             interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
             months as indicated by a positive response (Yes) to either Question 4 or Question 5 of
             the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Or subject has a
             positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening
             in the "Since Last Visit" version
Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy.
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Intervention: Best Available Therapy; Ruxolitinib
Intervention description: Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.; Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Polycythemia Vera; Hematologic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Hydroxyurea; INC424; Ruxolitinib

Summary:

      This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in
      patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and
      did not have a palpable spleen.
    

Eligibility criteria:

        Inclusion Criteria:

        Confirmed diagnosis of PV according to the 2008 World Health Organization criteria,
        Non-palpable spleen, Phlebotomy dependent, Resistant to or intolerant of hydroxyurea, ECOG
        performance status of 0, 1 or 2.

        Exclusion Criteria:

        Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral
        infection requiring treatment, Active malignancy within the past 5 years, excluding
        specific skin cancers, Previously received treatment with a JAK inhibitor, Being treated
        with any investigational agent, Women who are pregnant or nursing.

        Other inclusion/exclusion criteria apply.
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Condition: Healthy Subjects
Intervention: 13-valent pneumococcal conjugate vaccine (13vPnC); diphtheria, tetanus, and acellular pertussis vaccine (DTaP); 7-valent pneumococcal conjugate vaccine (7vPnC); DTaP; DTaP
Intervention description: 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 551.0
Sex: All
Minimum age: 3 Months
Maximum age: 6 Months
Healthy volunteers: No
Keywords: vaccine; pneumococcal conjugate

Summary:

      Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group
      1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular
      pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP,
      Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar
      (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be
      open-label. The main purpose of the study is to determine if the immune responses to 13vPnC
      are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given
      with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to
      evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given
      with DTaP in healthy Japanese infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 3 to 6 months of age at the enrollment.

          -  Available for the entire study period and whose parent/legal guardian can be reached
             by telephone.

          -  Healthy infant as determined by medical history, physical examination, and judgement
             of the investigator.

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal, diphtheria,
             tetanus, or pertussis vaccines.

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate any type of injection.

          -  History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis,
             bacteremia, osteomyelitis, arthritis).

          -  Infant who is a direct descendant (child, grandchild) of the study site personnel.