bioihbjkbjnl/mcl2 huggingface dataset:
Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors
Condition: Obesity
MeSH terms: Weight Loss
Intervention: Web-based program
Intervention description: Provided with the web-based program
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Behaviour change; Weight loss; Cardiovascular risk; Diet; Physical activity; Overweight; Obesity; Internet

Summary:

      Web- or internet-based programs have the potential to induce and, possibly, help to sustain,
      significant lifestyle modification. This study will evaluate the effect of a unique
      interactive web-based behaviour change program on weight loss and cardiovascular risk factors
      in people who are overweight or obese and at high risk of cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 18 years old

          -  Have regular access to the internet, telephone and have an e-mail address.

          -  Body mass index (BMI) greater than 27 and less than 40

          -  Sedentary

          -  Have one or more of the following risk factors associated with cardiovascular disease:
             Elevated blood pressure ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic; Elevated total
             cholesterol ≥ 5.0; Type 2 diabetes

          -  Be willing to refrain from participating in another behaviour change program for the
             duration of the study

        Exclusion Criteria:

          -  Major health problems including Type 1 diabetes, established CVD, renal and hepatic
             disease

          -  Psychiatric problems

          -  Pregnancy

          -  Excessive alcohol consumption
Effect of Steroids on Post-tonsillectomy Morbidities
Condition: Postoperative Pain; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: IV dexamethasone; Oral prednisolone; Paracetamol; IV saline
Intervention description: 0.15 mg/kg; 0.25mg/kg/day for 7 days then tapering for next 7 days; acetaminophen 15 mg/kg/dose every 6 hours; IV saline
Intervention MeSH terms: Acetaminophen; Dexamethasone; Prednisolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 5 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dexamethasone; Prednisolone; Tonsillectomy Nausea; Pain, Postoperative; Postoperative Nausea and Vomiting; Randomized controlled trial; Post-tonsillectomy pain; delayed feeding

Summary:

      This study aims to evaluate the effect of postoperative systemic rapid onset and short acting
      dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy
      morbidities. Half of the patients who comply with the inclusion criteria were selected to
      receive a single postoperative dose of intravenous dexamethasone followed by oral steroids;
      the second group received placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients in the waiting list for tonsillectomy under general anesthesia who accepted
             to participate in the study.

        Exclusion Criteria:

          -  Patients who are allergic to steroids or those who have medical conditions which
             contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension
             and those who were on exogenous steroid supplements.
Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)
Condition: Atherosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Intervention: Clopidogrel 75 mg daily; water pill daily
Intervention description: Daily dose of 75 mg Clopidogrel; Daily dose of water pill (placebo)
Intervention MeSH terms: Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Saphenous vein; Intimal hyperplasia; Coronary artery bypass graft surgery; Antiplatelet therapy; Clopidogrel; Saphenous vein graft disease

Summary:

      The purpose of this study is to determine whether the combination of clopidogrel with aspirin
      prevents the development of blockages (atherosclerosis) in vein grafts one year after
      coronary artery bypass surgery (CABG) compared to aspirin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts,
             with or without the use of cardiopulmonary bypass.

        Exclusion Criteria:

          -  Emergency surgery

          -  Valve surgery

          -  Redo CABG

          -  Left ventricle ejection fraction < 25%

          -  Serum creatinine > 130 µmol/L

          -  Preoperative use of clopidogrel (with the exception of the current admission)

          -  Preoperative use of warfarin; allergy to aspirin or clopidogrel.

          -  History of cerebrovascular accident

          -  History of severe liver disease

          -  Morbid obesity

          -  Current malignancy
Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo; Hydrochlorothiazide
Intervention description: Tablets, Oral, 10 mg, once daily, 12 weeks; Tablets, Oral, 0 mg, once daily, 12 weeks; Tablets, Oral, 25 mg, once daily, 12 weeks
Intervention MeSH terms: Dapagliflozin; Hydrochlorothiazide
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as
      assessed by glomerular filtration rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%

          -  Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the
             enrollment visit

          -  Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and < 165
             mmHg, AND/OR diastolic BP (DBP) ≥ 80 and < 105 mmHg

          -  C-peptide ≥ 0.8 ng/mL

          -  Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula > 60
             mL/min/1.73m² and < 150 mL/min/1.73m²

          -  Urine albumin:creatinine ratio (UACR) < 300 mg/g

          -  BMI ≤ 45.0 kg/m2

        Exclusion Criteria:

          -  Administration of diuretics or other medication approved for the treatment of
             hypertension (with the exception of either ACEI or ARB), at any dose during the 12
             weeks prior to the enrollment visit

          -  History of adverse reaction to radio-contrast dye

          -  Allergy or contraindication to use of thiazide diuretics

          -  Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN)

          -  Alanine aminotransferase (ALT) > 3X ULN

          -  Serum Total Bilirubin > 1.5X ULN

          -  Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124
             μmol/l) for women

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematological,
             oncologic, endocrine, psychiatric, or rheumatic diseases
Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Placebo; Dexpramipexole 50 mg/day; Dexpramipexole 150 mg/day; Dexpramipexole 300 mg/day
Intervention description: Placebo: 2 tablets taken orally twice daily; Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily; Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily; Dexpramipexole: 2 x 75 mg tablets taken orally twice daily
Intervention MeSH terms: Pramipexole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Matching placebo during Part 1 and Part 2 placebo washout.
Enrollment: 194.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig; Lou Gehrig's; Lou Gehrig's disease; Motor Neuron Disease; Nervous System Diseases; KNS-760704; BIIB050

Summary:

      This was a 2-part study of dexpramipexole in patients with ALS.

      Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety,
      tolerability, and clinical effects of oral administration of 3 dosage levels of
      dexpramipexole vs. placebo for 12 weeks.

      Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the
      safety, tolerability, and clinical effects of oral administration of 2 dosage levels of
      dexpramipexole for up to 72 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with diagnosis of familial or sporadic ALS, defined as meeting the possible,
             laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS
             according to the World Federation of Neurology El Escorial criteria

          -  Patients with ALS symptom onset < 24 months from randomization

          -  Patients with upright vital capacity (VC) > 65% of predicted for age, height, and
             gender

        Exclusion Criteria:

          -  Patients in whom causes of neuromuscular weakness other than ALS have not been
             excluded

          -  Patients without clinical evidence of upper motor neuron dysfunction

          -  Patients with clinically suspected ALS according to the World Federation of Neurology
             El Escorial criteria

          -  Patients with prior exposure to KNS-760704 or the R(+) enantiomer of pramipexole
             (i.e., R(+)-pramipexole)

          -  Patients taking other investigational agents (including lithium) within 30 days of
             randomization or during the study
A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Bermekimab; Placebo
Intervention description: Participants will receive bermekimab IV.; Participants will receive placebo IV.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of Bermekimab, compared with placebo,
      in participants with moderate-to-severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first
             administration of study intervention as determined by the investigator through
             participant interview and/or review of the medical history

          -  Have a history of inadequate response to treatment for AD with topical medications or
             for whom topical treatments are otherwise medically inadvisable (example, due to
             important side effects or safety risks)

          -  Have an Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16
             at screening and at baseline

          -  Must sign an informed consent form (ICF) indicating that he or she understands the
             purpose of, and procedures required for, the study and is willing to participate in
             the study

          -  Must be willing to undergo 4 skin biopsies

          -  Have an Investigator Global Assessment (IGA) score >=3 at screening and at baseline

          -  Have an involved body surface area (BSA) >=10 percent (%) at screening and at baseline

        Exclusion Criteria:

          -  Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled
             renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
             hematologic, rheumatologic, psychiatric, or metabolic disturbances

          -  Has ever received any Human interleukin-1 (IL-1) antagonist (example, including but
             not limited to anakinra, rilonacept)
Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Intervention: human retinal progenitor cells; Mock injection
Intervention description: live suspension of 3.0 or 6.0 x 10e6 human retinal progenitor cells (hRPC) suspended in clinical grade medium injected intravitreally under local anesthesia; pressing the hub of a syringe with no needle against the eye to mimic intravitreal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Subjects, their family members and clinical staff performing key efficacy assessments will be masked to the randomization assignment of subjects. Due to the nature of some safety assessments and the sham treatment, not all personnel can be masked.
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the changes in visual function at 12 months following a single injection
      of human retinal progenitor cells compared to sham treated controls in a cohort of adult
      subjects with RP.
    

Eligibility criteria:

        Inclusion Criteria:

        Clinical diagnosis of RP confirmed by ERG and willing to consent to mutation typing, if not
        already done Best corrected visual acuity (BCVA) 20/80 or worse and no worse than 20/800
        Adequate organ function and negative infectious disease screen Female of childbearing
        potential must have negative pregnancy test and be willing to use medically accepted
        methods of contraception throughout the study

        Exclusion Criteria:

        Eye disease other than RP that impairs visual function Pseudo-RP, cancer-associated
        retinopathies History of malignancy or other end-stage organ disease, or any chronic
        disease requiring continuous treatment with system steroids, anticoagulants or
        immunosuppressive agents Known allergy to penicillin or streptomycin Treatment with
        corticosteroids or any investigational or neuroprotectant therapy within 90 days of
        enrollment Cataract surgery within 3 months prior to enrollment
Oral Azithromycin Versus Doxycycline in Posterior Blepharitis
Condition: Posterior Blepharitis
MeSH terms: Blepharitis; Meibomian Gland Dysfunction
Intervention: Azithromycin; Doxycycline
Intervention MeSH terms: Azithromycin; Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 100.0
Sex: All
Minimum age: 13 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Azithromycin; Doxycycline; Posterior Blepharitis

Summary:

      One hundred patients with the diagnosis of posterior blepharitis based on history taking and
      proper physical examinations by two experienced ophthalmologists will include in the study.

      Patients will diagnose with posterior blepharitis if they score at least one in two symptoms
      (based on a subjective grading scale) and two signs (based on an objective grading scale) of
      posterior blepharitis according to study criteria. Patients will exclude if they have the
      following criteria: age< 12 years old,history of previous ocular or lacrimal surgery,previous
      usage of contact lenses,any history of ocular allergy,history of systemic diseases with
      ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in
      the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity
      to cyclines.

      Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the
      first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours
      for one month) in a double-blinded fashion. each patients in both treatment groups will
      accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes
      each in the treatment period. Symptoms and signs were recorded for each patient in two
      treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61
      after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients were diagnosed with posterior blepharitis if they scored at least one in two
        symptoms (based on a subjective grading scale) and two signs (based on an objective grading
        scale) of posterior blepharitis according to study criteria

        Exclusion Criteria:

        Patients were excluded if they had the following criteria: age< 12 years old,history of
        previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular
        allergy,history of systemic diseases with ocular involvement (except rosacea), history of
        usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers,
        liver failure and any history of sensitivity to cyclines
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
Condition: Acquired Antithrombin III Deficiency; Coronary Artery Bypass
MeSH terms: Antithrombin III Deficiency
Intervention: Antithrombin III
Intervention description: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%
Intervention MeSH terms: Antithrombins; Antithrombin III
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: antithrombin; ATIII; acquired deficiency; anticoagulants; cardiopulmonary bypass; surgery; complications; postoperative outcomes

Summary:

      The purpose of this trial is to study the effects of preoperative antithrombin
      supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order
      to maintain antithrombin levels in a range greater than 58% of functional activity and,
      eventually, to decrease negative clinical outcomes during the ICU stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  At least 18 years of age

          -  Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart
             transplantation

          -  Subject had a baseline ATIII level of less than 100% and equal to or above 60%

          -  Subject signed the informed consent form

          -  Subject was willing to comply with all aspects of the protocol, including blood
             sampling, for the total duration of the study

        Exclusion Criteria:

          -  Documented congenital ATIII deficiency or ATIII levels below 60%

          -  Subject had a baseline ATIII level of 100% or higher

          -  Subject needed emergency (non-elective) surgery

          -  Subject needed heart transplantation

          -  History of anaphylactic reaction(s) to blood or blood components

          -  Allergies to excipients

          -  Subject was pregnant

          -  Subject had any medical condition that according to the investigators judgment worsens
             the surgical outcome above the expected

          -  Subject had any medical condition which is likely to interfere with the evaluation of
             the study treatment and/or the satisfactory conduct of the trial according to the
             investigators judgment

          -  Subject had participated in any another investigational study within the last 30 days
             previous to the inclusion
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: patiromer
Intervention description: 15 grams/day (5 grams 3 times daily) administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study assessed the pharmacodynamic effects of patiromer on serum potassium in
      participants on hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium
             levels of at least 5.5 mmol/L

          -  Adequately dialyzed (Kt/V ≥ 1.2)

        Exclusion Criteria:

          -  History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders
             or major gastrointestinal surgery.

          -  Severe constipation or irregular bowel habits.

          -  Unable to consume or tolerate the study-specific diet.