bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
Condition: Moderate to Severe Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: secukinumab 150 mg; placebo to secukinumab 150 mg
Intervention description: secukinumab (AIN457) 150mg or 300mg subcutaneous; Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; plaque; plaque-type psoriasis; IL-17 blocker; subcutaneous; psoriatic arthritis; injection; AIN457; AIN457A; secukinumab

Summary:

      This study will assess the safety and efficacy of secukinumab compared to placebo in patients
      that have moderate to severe, chronic, plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

          -  Severity of psoriasis disease meeting all of the following three criteria:

          -  Psoriasis Area and Severity Index (PASI) score of 12 or greater,

          -  Investigator's Global Assessment (IGA) score of 3 or greater,

          -  Total body surface area (BSA) affected of 10% or greater.

          -  Inadequate control by prior use of topical treatment, phototherapy and/or systemic
             therapy.

        Exclusion criteria:

          -  Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
             pustular, erythrodermic, guttate).

          -  Current drug-induced psoriasis.

          -  Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.

          -  Significant medical problems such as uncontrolled hypertension, congestive heart
             failure or a condition that significantly immunocompromises the subject.

          -  Hematological abnormalities.

          -  History of an ongoing, chronic or recurrent infectious disease, or evidence of
             untreated tuberculosis.

          -  History of lymphoproliferative disease or history of malignancy of any organ system
             within the past 5 years.

          -  Pregnant or nursing (lactating) women.

          -  Subjects not willing to limit UV light exposure during the study Other
             protocol-defined inclusion/exclusion criteria may apply.
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Polycystic Kidney Disease, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Tolvaptan; Placebo
Intervention description: Tolvaptan was supplied as tablets.; Placebo was supplied as tablets.
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1445.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: ADPKD; Polycystic; kidney; ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Summary:

      This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus
      placebo in patients with ADPKD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Legal adult age and able to give Informed Consent.

          -  Adult subjects with a diagnosis of ADPKD. A diagnosis of ADPKD (age 18 or 20-50)
             required several cysts in each kidney (3 if by sonography, 5 if by CT or MRI) in those
             with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney
             and exclusion of other cystic kidney diseases if there was no family history.

          -  Willingness to comply with reproductive precautions, if female.

          -  Estimated creatinine clearance ≥ 60 mL/min. Estimated from serum creatinine during
             screening using Cockcroft-Gault with correction for gender and race, where possible.

          -  Rapidly progressive kidney growth (total volume ≥ 750 cc) by magnetic resonance
             imaging (MRI) at randomization.

        Exclusion Criteria:

          -  Prior exposure to tolvaptan or other experimental PKD therapies.

          -  Currently taking medication for purpose of affecting PKD cysts.

          -  Women who are breast feeding and females of childbearing potential who are not using
             acceptable contraceptive methods.

          -  In the opinion of the study investigator or sponsor may present a safety risk or
             confound study objectives.

          -  Patients who are unlikely to adequately comply with study procedures.

          -  Patients having contraindications to MRI.

          -  Patients taking medications or having any illnesses likely to affect ADPKD outcomes.
Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
Condition: Peripheral Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis
Intervention: Adalimumab; Placebo
Intervention description: Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.; Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: peripheral spondyloarthritis; adalimumab; humira

Summary:

      The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg
      administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks
      followed by open label (OL) safety and efficacy assessments in participants with
      non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral
      spondyloarthritis (SpA) who have had an inadequate response to >= 2 non-steroidal
      anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for,
      NSAIDs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants who had inadequate response to >= 2 non-steroidal
             anti-inflammatories (NSAIDs)

          -  Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis
             clinical criteria

          -  Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline
             Visit were Negative

          -  Ability to administer subcutaneous injections

          -  General good health

        Exclusion Criteria:

          -  Prior anti-tumor necrosis factor (TNF) therapy

          -  Psoriasis or Psoriatic Arthritis

          -  Fulfillment of modified New York criteria for Ankylosing Spondylitis

          -  Recent infection requiring treatment

          -  Significant medical events or conditions that had put patients at risk for
             participation

          -  Female participants who were pregnant or breast-feeding or considering becoming
             pregnant during the study

          -  History of cancer, except successfully treated skin cancer

          -  Recent history of drug or alcohol abuse
Albuterol HFA MDI in Pediatric Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Albuterol; Placebo; Proventil® HFA
Intervention description: Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days.; Placebo HFA MDI four times a day (q.i.d) for 21 days.; Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Pediatric, asthma, albuterol-HFA and Placebo

Summary:

      The primary objective of this study is to evaluate the chronic-dose and efficacy of
      Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months
             duration that has been stable for at least four weeks prior to screening.

        Exclusion Criteria:

          -  Hospitalization for acute asthma exacerbation greater than two years in 12 months
             prior to screening and/or received ER treatment or hospitalization for asthma
             exacerbation.
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Intervention: V503; Comparator: Menactra™ (Concomitant); Comparator: Adacel™ (Concomitant); Comparator: Menactra™ (Non-Concomitant); Comparator: Adacel™ (Non-concomitant)
Intervention description: V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6; Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.; Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.; Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.; Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1241.0
Sex: All
Minimum age: 11 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the tolerability and immunogenicity of administration of the first
      dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one
      month prior to administration of Menactra™ and Adacel™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health

          -  Subject's parent/legal guardian can read, understand, and complete the vaccine report
             card

          -  Subject is not sexually active and does not plan on becoming sexually active during
             the study

          -  Subject has received a documented full primary immunization series against diphtheria,
             tetanus, and pertussis (not in the last 5 years)

        Exclusion Criteria:

          -  Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™

          -  Subject has a condition that is a contraindication to vaccination with Menactra™ or
             Adacel™

          -  Subject has any coagulation disorder

          -  Female subject is pregnant

          -  Subject is immunocompromised or immunodeficient

          -  Subject has had a splenectomy

          -  Subject has received immunosuppressive therapies in the prior year

          -  Subject has received any immune globulin product or blood-derived product in the last
             3 months

          -  Subject has received inactivated vaccines within 14 days or live vaccines within 21
             days of the first study vaccination

          -  Subject has received a marketed HPV vaccine or has participation in an HPV vaccine
             trial

          -  Subject has received a meningococcal vaccine

          -  Subject has a fever >= 100F within 24 hours of vaccination

          -  Subject has a history of HPV
Telmisartan+Amlodipine Fixed Dose Combination in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: telmisartan+amlodipine fixed dose combination
Intervention description: after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in
      the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic
      blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan
      80mg/Amlodipine 5mg in patients with moderate to severe hypertension
    

Eligibility criteria:

        Inclusion criteria:

          1. Aged at least 18 years at the date of signing the consent form

          2. For treatment-naïve patients: hypertension defined by a mean seated diastolic blood
             pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at
             visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated
             diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than
             100 mmHg at visit 2 measured by manual cuff sphygmomanometry

          3. 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline
             Ambulatory Blood Pressure Monitoring

        Exclusion criteria:

          1. mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated
             diastolic blood pressure equal or more than 120 mmHg

          2. any clinically significant hepatic impairment

          3. severe renal impairment

          4. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or
             post-renal transplant

          5. current treatment with any antihypertensive agents, whether or not prescribed for this
             indication, that cannot be safely stopped

          6. other conditions or situations that could put potential participants at unacceptable
             risk due to participation in this study
Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Interferon beta-1b (Betaseron, BAY86-5046)
Intervention description: Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 16 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: MS

Summary:

      The purpose of this study is to determine if the study drug is effective and safe in the
      treatment of Multiple Sclerosis (MS) in patients of Chinese origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese origin

          -  diagnosis of Relapsing remitting multiple sclerosis or secondary progressive multiple
             sclerosis

        Exclusion Criteria:

          -  Any disease other than Multiple Sclerosis (MS) that could better explain the patients
             signs and symptoms

          -  HIV (human immunodeficiency virus) infections

          -  Hepatitis A

          -  Syphilis

          -  immunodeficiency

          -  rheumatic disease or Sjogren syndrome

          -  heart disease

          -  severe depression

          -  pregnancy or lactation

          -  conditions interfering with Magnetic Resonance Imaging (MRI)

          -  Gadolinium DTPA (Gadovist, contrast agent) allergy

          -  allergy against human proteins, paracetamol, acetaminophen and ibuprofen intolerance

          -  participation in other trial
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
Condition: Autism Spectrum Disorder (ASD)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: BUMETANIDE (S95008) for week 0 - 26; PLACEBO for week 0 - 26; Open-Label BUMETANIDE (S95008) for weeks 26 - 52
Intervention description: Oral solution dosed at 0.5 mg/mL Taken twice daily.; Oral solution Taken twice daily.; Oral solution dosed at 0.5 mg/mL Taken twice daily.
Intervention MeSH terms: Bumetanide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 6-month, randomized, double-blind, placebo-controlled, parallel groups followed by an open label active 6-month treatment period with bumetanide.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 211.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008
      in the improvement of Autism Spectrum Disorder core symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients from 2 to less than 7

          -  Primary diagnosis of ASD as per Diagnostic and Statistical Manual of Mental Disorders
             - Fifth Edition (DSM-5) criteria

          -  Criteria met for ASD on Autism Diagnostic Observation Schedule-Generic (ADOS-2) and
             Autism Diagnosis Interview Revised (ADI-R)

          -  CGI (Clinical Global Impression) - Severity rating Score ≥ 4

          -  Childhood Autism Rating Scale second edition (CARS2-ST or HF) total raw score ≥ 34

          -  Social responsiveness Scale second edition (SRS-2) total score ≥ 66 T-Score

          -  Absence of diagnosis of Fragile X or Rett Syndrome

          -  Absence of any clinically significant abnormality likely to interfere with the conduct
             of the study according to the judgment of the investigator.

        Exclusion Criteria:

          -  Patients not able to follow the study assessments defined by the protocol, with the
             exception of self-rating questionnaires which will be assessed by parent/legal
             representative/caregiver for those patients unable to complete them

          -  Patients having a high suicidal risk according to the investigator judgement

          -  Chronic renal dysfunction

          -  Chronic cardiac dysfunction

          -  Patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural
             therapy

          -  Severe electrolyte imbalance that is likely to interfere with the study conduct or
             evaluation
An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
Condition: Brain Cancer
MeSH terms: Glioblastoma; Brain Neoplasms
Intervention: Nivolumab; Temozolomide; Radiotherapy
Intervention MeSH terms: Nivolumab; Temozolomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated
      (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every
      two weeks in addition to radiation therapy, and then every four weeks. They will be compared
      to patients receiving standard therapy with temozolomide in addition to radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females, age ≥ 18 years old

          -  Newly-diagnosed brain cancer or tumor called glioblastoma or GBM

          -  Tumor test result shows MGMT unmethylated type

          -  Karnofsky performance status of ≥ 70 (able to care for self)

        Exclusion Criteria:

          -  Prior treatment for GBM (other than surgical resection)

          -  Any known tumor outside of the brain

          -  Recurrent or secondary GBM

          -  Active known or suspected autoimmune disease

          -  Biopsy with less than 20% of tumor removed

        Other protocol-defined inclusion/exclusion criteria apply
Hypocaloric Nutrition in Critically Ill Patients
Condition: Critically Ill
MeSH terms: Critical Illness
Intervention: Hypocaloric hyperproteic nutrition; Standard care
Intervention description: 15 kcal per kg of body weight and 1.7 grams of protein per kg.; 25 kcal per kg of body weight
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adults

Summary:

      The aim of this study is to compare two nutritional regimes in critically ill patients.
      Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15
      kcal per kg). The main outcome will be the SOFA (sequential organ failure assessment) score.
      The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic
      failure in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years

          -  estimated fasting period of at least 96 hours

        Exclusion Criteria:

          -  parenteral nutrition

          -  pregnancy

          -  diabetes

          -  liver or renal failure

          -  transplantation

          -  admitted from another hospital