bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders; Hemorrhage
Intervention: nonacog beta pegol; nonacog beta pegol; nonacog beta pegol
Intervention description: One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience; One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience; Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 74.0
Sex: Male
Minimum age: 13 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this
      trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which
      the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for
      treatment and prophylaxis of bleeding episodes in patients with haemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients with moderately severe or severe congenital haemophilia B with a factor
             IX activity of 2% or below according to medical records

          -  History of at least 150 exposure days to other factor IX products

          -  Patients currently treated on-demand with at least 6 bleeding episodes during the last
             12 months or at least 3 bleeding episodes during the last 6 months, or patients
             currently on prophylaxis

        Exclusion Criteria:

          -  Known history of factor IX inhibitors based on existing medical records, laboratory
             report reviews and patient and legally acceptable representative (LAR) interviews

          -  HIV (Human immunodeficiency virus) positive, with a viral load equal to or above
             400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL

          -  Congenital or acquired coagulation disorders other than haemophilia B

          -  Previous arterial thrombotic events (e.g. myocardial infarction and intracranial
             thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by
             available medical records)

          -  Immune modulating or chemotherapeutic medication
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Intervention: JZP-110
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter
      study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult
      subjects with OSA.
    

Eligibility criteria:

        Major Inclusion Criteria:

          1. Male or female between 18 and 75 years of age, inclusive

          2. Diagnosis of OSA according to ICSD-3 criteria

          3. Body mass index from 18 to <45 kg/m2

          4. Consent to use a medically acceptable method of contraception

          5. Willing and able to provide written informed consent

        Major Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating.

          2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             OSA that is associated with excessive sleepiness

          3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          4. History or presence of any acutely unstable medical condition, behavioral or
             psychiatric disorder (including active suicidal ideation), or surgical history that
             could affect the safety of the subject or interfere with study efficacy or safety
             assessments or the ability of the subject to complete the trial per the judgment of
             the principal investigator

          5. History of bariatric surgery within the past year or a history of any gastric bypass
             procedure

          6. Presence or history of significant cardiovascular disease

          7. Use of any over the counter (OTC) or prescription medications that could affect the
             evaluation of excessive sleepiness

          8. Received an investigational drug in the past 30 days or five half-lives (whichever is
             longer)

          9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05,
             R228060, or YKP10A)

         10. History of phenylketonuria (PKU) or history of hypersensitivity to
             phenylalanine-derived products
Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient
Condition: Gastric Cancer; Obesity
MeSH terms: Stomach Neoplasms; Obesity
Intervention: Sugammadex Sodium
Intervention description: INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.
DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate the impact of muscle relaxation during laparoscopic
      gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary
      endpoint is number of harvested lymph node that is critical point regarding quality of
      surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding,
      surgeons' satisfaction.

      The patients were randomly assigned to two groups using a computer-generated randomization
      table : 196 persons

        -  Deep neuromuscular block group (98persons)

        -  Moderate neuromuscular group (98persons)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gastric cancer patients with laparoscopic subtotal gastrectomy

          -  19-75 years

          -  Body mass index(BMI) > 25kg/m2

          -  American Society of Anesthesiologists I-III

        Exclusion Criteria:

          -  American Society of Anesthesiologists Class IV

          -  End stage renal disease (ESRD) patient

          -  Patients with allergy to muscle relaxants

          -  Patients with diseases that may affect muscle relaxation
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Human cl rhFVIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Male
Healthy volunteers: No
Keywords: Previously untreated patients

Summary:

      Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated
      patients with severe Hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients

          -  Severe Hemophilia A (FVIII:C <1%)

          -  No previous treatment with FVIII concentrates or other blood products containing FVIII

        Exclusion Criteria:

          -  Diagnosis with a coagulation disorder other than Hemophilia A

          -  Severe liver or kidney disease

          -  Concomitant treatment with any systemic immunosuppressive drug
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
Condition: Sclerosis, Systemic
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: Placebo; tocilizumab [RoActemra/Actemra]; tocilizumab [RoActemra/Actemra]
Intervention description: Subcutaneously weekly, Weeks 0-48; 162 mg subcutaneously weekly, Weeks 0-48; 162 mg subcutaneously weekly, Week 48-96
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study
      will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with
      systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162
      mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants
      will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on
      study treatment is 96 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria

          -  Disease duration of </= 60 months (defined as time from first non-Raynaud phenomenon
             manifestation)

          -  >/= 15 and </= 40 mRSS units at screening

          -  Active disease, as defined by protocol

          -  Uninvolved skin at injection sites

          -  Negative pregnancy test for a female subject of childbearing potential

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to and/or during study
             enrollment

          -  Rheumatic autoimmune disease other than systemic sclerosis

          -  Skin thickening (scleroderma) limited to areas distal to the elbows or knees at
             screening

          -  Previous treatment with tocilizumab

          -  History of severe allergic or anaphylactic reactions to human, humanized, or murine
             monoclonal antibodies

          -  Severe cardiopulmonary disease

          -  Known active current or history of recurrent infections

          -  Use of any investigational, biologic, or immunosuppressive therapies including
             intra-articular or parenteral corticosteroids prior to study enrollment as specified
             in the protocol

          -  As specified in the protocol, any current or past medical condition or medical history
             involving but not limited to the nervous, renal, pulmonary, endocrine, and
             gastrointestinal organ systems determined by the Principal Investigator to pose a
             significant safety risk to any subject while participating in the study

          -  Primary or secondary immunodeficiency
A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: placebo to match albiglutide; albiglutide; metformin; glimepiride; pioglitazone; placebo to match pioglitazone
Intervention description: albiglutide matching placebo weekly subcutaneous injection; albiglutide weekly subcutaneous injection; metformin; glimepiride; pioglitazone; pioglitazone matching placebo
Intervention MeSH terms: Metformin; Pioglitazone; Glimepiride; rGLP-1 protein; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 685.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes

Summary:

      The purpose of this study is to determine the safety and efficacy of albiglutide in subjects
      with type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes

          -  BMI 20-45kg/m2 inclusive

        Exclusion Criteria:

          -  females who are pregnant, lactating, or less than 6 weeks post-partum

          -  current symptomatic heart failure (NYHA Class II-IV)
A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Acute Coronary Syndrome; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: dalcetrapib; placebo
Intervention description: Oral doses of 600 mg once daily for 20 weeks; Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
Intervention MeSH terms: Dalcetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This double-blind, randomized, placebo-controlled, multi-center study will evaluate the
      safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome
      (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized
      to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time
      on study treatment is 20 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=45 years of age

          -  Patients admitted to the hospital for acute coronary syndrome (ACS)

          -  Patients receiving guideline-based medical and dietary management of dyslipidemia

        Exclusion Criteria:

          -  Symptomatic congestive heart failure (NYHA Class III or IV)

          -  Clinically significant heart disease requiring coronary artery bypass grafting,
             cardiac transplantation, surgical valve repair/replacement during the study

          -  Uncontrolled hypertension

          -  Uncontrolled diabetes

          -  Severe anemia

          -  Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C;
             eg niacin, fibrates)
Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
Condition: Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile
Intervention: Adalimumab
Intervention description: Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Juvenile Rheumatoid Arthritis

Summary:

      To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with
      Polyarticular Juvenile Rheumatoid Arthritis
    

Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of polyarticular juvenile rheumatoid arthritis (JRA) according to the
             criteria of the American College on Rheumatology (ACR)

          -  Disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs
             (NSAIDs) or methotrexate (MTX)

          -  Presence at screening of at least 5 swollen joints (not due to deformity) and at least
             3 joints with limitation of passive motion with pain by passive motion or/and pain by
             pressure (tenderness)

          -  Stable dosage of MTX for at least 12 weeks prior to the screening visit or
             discontinuation of MTX at least 14 days prior to baseline visit (Day 1)

          -  Discontinuation of disease-modifying antirheumatic drugs (DMARDs) other than MTX at
             least 28 days before screening visit

        Exclusion Criteria

          -  History of inflammatory joint disease other than JRA

          -  Functional class IV JRA by ACR criteria

          -  Clinically significant cardiac disease or laboratory abnormalities

          -  Any subject who is considered by the investigator, for any reason, to be an unsuitable
             candidate for the study
Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon
Condition: Malaria
MeSH terms: Malaria
Intervention: 1. Artemether-Lumefantrine (AL); 2. Amodiaquine-Artesunate (AQ-AS)
Intervention description: Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).; Amodiaquine-Artesunate (0H),D1(24H),D2(48H)= Artesunate 4mg/kg and Amodiaquine at 10mg/kg
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Amodiaquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 816.0
Sex: All
Minimum age: 6 Months
Maximum age: 120 Months
Healthy volunteers: No
Keywords: Efficacy; Safety; Children; Cameroon

Summary:

      This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria
      combination drugs (ACTs) for the treatment of children aged 6-120 months in different
      locations in Cameroon. Randomized clinical trials will provide local data on the safety of
      the test drugs, and on putative marker mutations of the development of resistance to ACT. The
      study will involve three centers, namely, Banso (Guinea-Savannah region), Limbe(Littoral
      Forest), and Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of
      Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be
      determined using a WHO standardized 28-day protocol. Safety will be monitored through
      clinical examination and biochemical and hematological indices. Molecular markers of
      artemisinin resistance will be investigated by molecular sequencing and comparison of
      parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections
      will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on
      generation of gametocytes will be determined from gametocyte carriage rates measured by
      microscopy.
    

Eligibility criteria:

        Inclusion criteria:

          -  children aged 6-120 months;

          -  axillary temperature ≥ 37.5°C and/or history of fever within past 24 hours;

          -  P. falciparum asexual parasitemia between 1000 and 100000/µl;

          -  ability to attend follow-up visits.

        Exclusion criteria:

          -  co-infections;

          -  underlying chronic disease;

          -  severe malaria as indicated by hyperparasitemia, severe anemia (PCV 15%, Hb 5g/ml),
             respiratory distress, inability to drink, persistent vomiting in past 24 hours;

          -  recent history of multiple convulsions;

          -  jaundice;

          -  the inability to stand or sit;

          -  history of allergy to study drugs.
Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide/formoterol pMDI 40/2.25ug + spacer; Budesonide/formoterol pMDI 40/2.25 ug
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Symbicort pMDI; spacer; children

Summary:

      The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of
      steroid potency, improvement of lung function and asthma symptoms in children with asthma
      (6-11 years).
    

Eligibility criteria:

        Inclusion Criteria:

          -  children 6-11 years, diagnosed asthma treated

          -  6 months, PEF

          -  50% of predicted normal value pre-bronchodilator

        Exclusion Criteria:

          -  current systemic glucocorticosteroids usage

          -  current respiratory infection

          -  any significant disease or disorder as judged by investigator