bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: CNTO 148 (Golimumab); Placebo; Methotrexate
Intervention description: Patients will receive subcutaneous (SC) (under the skin) injection of golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 248.; Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive SC injection of placebo every 4 weeks from Week 16 through Week 48.; All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.
Intervention MeSH terms: Golimumab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Juvenile Idiopathic Arthritis; golimumab; juvenile arthritis; GO KIDS; anti TNF alpha medications; juvenile psoriatic arthritis

Summary:

      The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in
      patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with
      active arthritis that have poor response to methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis must have been before the patient's 16th birthday

          -  Disease duration of at least 6 months before study entry

          -  Must have 5 or more joints with active arthritis

          -  Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with
             body surface area [BSA] 1.67 square meter or more must be taking a minimum of 15
             mg/week of methotrexate)

          -  May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may
             take a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks prior to
             entry

          -  Must have qualifying laboratory values at the first visit.

        Exclusion Criteria:

          -  Have known allergies, hypersensitivity, or intolerance to golimumab or similar
             therapeutics

          -  Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6
             months after the last study agent administration

          -  Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study
             initiation
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Condition: Lipodystrophy; HIV Infections
MeSH terms: Lipodystrophy
Intervention: Tesamorelin; Placebo for Tesamorelin
Intervention MeSH terms: Tesamorelin; Growth Hormone-Releasing Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV; Lipodystrophy; Abdominal fat accumulation; Growth hormone releasing hormone; HIV-associated lipodystrophy; Treatment experienced

Summary:

      Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth
      Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011
             study.

          -  Signed informed consent before any trial-related activities.

        Exclusion Criteria:

          -  Fasting blood glucose >8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Efficacy and Safety of Actovegin in Post-stroke Cognitive Impairment (PSCI)
Condition: Post-Stroke Cognitive Impairment (PSCI)
MeSH terms: Stroke; Cognitive Dysfunction
Intervention: Actovegin; Placebo
Intervention description: Actovegin solution for infusion and Actovegin tablets; Actovegin placebo-matching solution for infusion and Actovegin placebo-matching tablets
Intervention MeSH terms: Actovegin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 503.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Post-Stroke Cognitive Impairment (PSCI); Stroke; Actovegin; Cognition disorders

Summary:

      The aim of this trial is to provide evidence that Actovegin has a symptomatic effect in
      subjects with post stroke cognitive impairment (PSCI) during a six month treatment period
      compared to subjects administered placebo. Subjects received IV infusions whilst in hospital,
      and tablets once discharged. Subjects were followed up for a further six months after their
      treatment had been stopped to explore if the cognitive symptoms of the subjects treated with
      Actovegin showed sustained improvement. The trial also explored the possible prevention of
      dementia with Actovegin in patients who had suffered a recent ischaemic stroke, as well as
      the effect of Actovegin on other stroke outcomes. Safety information on Actovegin was
      collected.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Participant has suffered a recent supra-tentorial ischaemic stroke supported by
             computed tomography (CT) scan or magnetic resonance imaging (MRI) findings (in
             accordance with local practice).

          -  Participant is male or female, aged 60 years or above.

          -  Participant has a score on the National Institute of Health Stroke Scale (NIHSS)
             between 3 and 18 (inclusive).

          -  Participant is capable of completing the Montreal Cognitive Assessment (MoCA) and has
             a score of ≤ 25 points with adjustment for level of education (4-9 school years ≤ 23
             points, 10-12 years ≤ 24 points, >12 years ≤ 25 points).

        Main Exclusion Criteria:

          -  Participant has a medical history of dementia.

          -  Participant has a known medical history of major depression or psychotic disorder.

          -  Participant is indicated for treatment with thrombolytics or carotid surgery as the
             current standard of care.

        Randomisation Criteria:

          -  Inclusion Criteria.

          -  Ability to perform Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended
             Version (ADAS-cog+).

          -  Exclusion Criteria.

          -  Clinically there is suspicion of progressive stroke.
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan
Intervention description: Extemporaneous suspension of valsartan, orally.
Intervention MeSH terms: Valsartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Children; pediatrics; High Blood Pressure; Hypertension; Valsartan

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term
      use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
    

Eligibility criteria:

        Inclusion criteria

          -  Participants who qualified and entered the core study.

          -  Participants who participated in the core study, completed Period 1 and were
             re-randomized in Period 2 and continued for at least 3 days in Period 2.

        Exclusion criteria

          -  Participants who did not complete Period 1 of the core study.

          -  Participants who were re-randomized in Period 2 of core study but did not continue for
             => 3 days in Period 2 of the core study.

          -  Participants who experienced any adverse events considered serious or drug related in
             the core study.

          -  Participants excluded from the core study.
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
Condition: Type 2 Diabetes Mellitus; Cardiovascular Disease; Inadequate Glycaemic Control
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: 10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period; matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 964.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: dapagliflozin; diabetes; cardiovascular disease

Summary:

      This study is carried out to assess whether dapagliflozin improves glycemic control,
      decreases fasting plasma glucose levels, body weight and blood pressure when added to
      patient's existing medications and how it compares with their usual treatment without added
      dapagliflozin. Safety data will be collected and analysed to confirm that treatment with
      dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular
      disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus.

          -  Cardiovascular disease

          -  Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment

        Exclusion Criteria:

          -  Patients with type 1 diabetes or diabetes insipidus

          -  Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or
             poorly controlled diabetes

          -  Any clinically significant illness, which would compromise the patient's safety and
             their participation in the study
Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
Condition: Kidney Stones
MeSH terms: Kidney Calculi; Nephrolithiasis
Intervention: cephalosporins; Fluoroquinolones; Clindamycin; Ampicillin/Gentamicin
Intervention description: Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed; If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance; If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.; 5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin
Intervention MeSH terms: Ciprofloxacin; Clindamycin; Gentamicins; Penicillins; Ampicillin; Cephalosporins; Fluoroquinolones; Lincosamides
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Percutaneous Nephrolithotomy; Kidney Stones; Antibiotics

Summary:

      The Investigators objective is to compare the clinical efficacy of a single-day protocol with
      a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly
      unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further
      propagation of resistant microbes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients >18 years old

          -  Negative urine culture within 1 month prior to procedure

          -  Renal Calculi which would optimally require PCNL for treatment.

        Exclusion Criteria:

          -  Patients <18 years old.

          -  Patients who are not able to give consent for study

          -  Patients currently on antibiotics immediately prior to the procedure

          -  Previous history of sepsis or SIRS from stone manipulations

          -  Foley catheter in place for greater than 1 week duration

          -  Patients under going planned, multi-staged procedures

          -  Immunosuppressed patients
A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; methotrexate
Intervention description: 8mg/kg iv, every 4 weeks; 10-25mg oral or parenteral weekly.
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, open-label study will assess the safety and efficacy with regar d to
      reduction of signs and symptoms of treatment with tocilizumab in combinatio n with
      methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will
      receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The
      anticipated time on study treatment is 3-12 months, and th e target sample size is <500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients >=18 years with moderate to severe active RA for at least 6 months;

          -  swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count)
             at screening;

          -  inadequate response to stable dose of MTX;

          -  patients of reproductive potential must be using a reliable means of contraception.

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA;

          -  patients with functional class IV RA;

          -  diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of
             current inflammatory joint disease other than RA;

          -  prior treatment failure with anti-tumor necrosis factor agent;

          -  pregnant or breastfeeding women.
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: fostamatinib; fostamatinib; placebo, fostamatinib
Intervention description: fostamatinib 100 mg twice daily; fostamatinib 100 mg twice daily/150 mg once daily; Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 923.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of the study is to evaluate the effectiveness of two dosing regimens of
      fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking
      methotrexate but not responding. The study will last for 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active rheumatoid arthritis (RA) diagnosed after the age of 16

          -  Currently taking methotrexate

          -  6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and
             either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or
             C-Reactive Protein (CRP) blood result of 10mg/L or more

          -  At least one of the following: documented history of positive rheumatoid factor (blood
             test), current presence of rheumatoid factor (blood test), radiographic erosion within
             12 months prior to study enrolment, presence of serum anti-cyclic citrullinated
             peptide antibodies (blood test)

        Exclusion Criteria:

          -  Females who are pregnant or breast feeding

          -  Poorly controlled hypertension

          -  Liver disease or significant liver function test abnormalities

          -  Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue
             diseases or chronic pain disorders

          -  Recent or significant cardiovascular disease

          -  Significant active or recent infection including tuberculosis

          -  Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment
             with other biological agent

          -  Severe renal impairment

          -  Neutropenia
Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: rFIXFc; FIX
Intervention description: Vials of rFIXFc were combined as needed, based on the actual labeled potency to achieve the participant's calculated dose. Partial vial use was allowed, in order to achieve the calculated dose.; Vials of prestudy FIX (provided by the participants) were combined as needed, based on the nominal labeled potency (e.g., 250 IU, 500 IU, and 1000 IU), to achieve the participant's calculated dose.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation
      Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia
      B. Secondary objectives of this study in this study population are as follows: to evaluate
      the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and
      assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and
      treatment of bleeding episodes
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Severe hemophilia B defined as ≤ 2 IU/dl (≤ 2%) endogenous FIX

          -  Male < 12 years and weight ≥ 13 kg

          -  History of at least 50 documented prior exposure days to FIX

          -  No history of, or currently detectable, inhibitor

        Key Exclusion Criteria:

          -  Other coagulation disorders in addition to Hemophilia B

          -  History of anaphylaxis associated with any FIX or IV immunoglobulin administration

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
Condition: Otitis Media, Serous; Negative Middle Ear Pressure; Rhinitis; Otitis Media With Effusion; Otitis Media, Secretory
MeSH terms: Rhinitis; Otitis; Otitis Media; Otitis Media with Effusion
Intervention: Triamcinolone acetonide nasal spray; Placebo nasal spray
Intervention description: Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms).
Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms).; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily.
Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 6 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      We hypothesize that intranasal steroid application will have a beneficial therapeutic effect
      in adults with regard to resolution of serous otitis media and/or negative middle ear
      pressure, as compared to placebo. We further hypothesize that the rate of spontaneous
      short-term resolution of otitis media wit effusion in adults treated with placebo will be
      relatively low (minority of patients).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 0-18 years

          -  Patients with serous otitis media and/or negative middle ear pressure as documented by
             otoscopic examination and tympanometry will be considered for enrollment

          -  Pregnant

        Exclusion Criteria:

          -  Unwilling to discontinue breast feeding, when applicable

          -  Active upper respiratory infection

          -  Nasopharyngeal mass

          -  Chronic infectious otitis media

          -  Cholesteatoma

          -  Acute infectious otitis media

          -  History of otologic surgery other than placement of a pressure equalizer tube in the
             affected ear

          -  History of radiation therapy to the head and neck region

          -  Neuromuscular disease

          -  Cystic fibrosis

          -  Immunodeficiency

          -  Mucociliary disorders

          -  Craniofacial disorders/syndromes

          -  Cleft palate

          -  Development delay and/or symptoms suggestive of perilymph fistula