bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
Condition: Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Intervention: AZD2927; Placebo
Intervention description: A single dose of AZD2927 administered as an iv infusion; A single dose of placebo administered as an iv infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Atrial refractoriness; cardiac electrophysiology; IKACh

Summary:

      Medical Products Agency
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or postmenopausal female, aged 20 to 80 years inclusive,

          -  clinical indication for catheter ablation of atrial flutter,

          -  history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes
             of persistent atrial flutter or AF requiring cardioversion do not exclude the patient
             from the study,

          -  sinus rhythm at randomisation,

          -  adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010
             or national guideline,

        Exclusion Criteria:

          -  cardioversion within 14 days before randomisation,

          -  history of stroke or transient ischaemic attack (TIA). History of significant head
             trauma, epilepsy or other disorders increasing the risk for seizures,

          -  QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation,

          -  history and/or signs of clinically significant sinus node dysfunction. Sinus
             bradycardia (50 beats per minute or less) at randomisation,

          -  personal or family history of Torsades de Pointes (TdP), any other polymorphic
             ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or
             personal history of sustained (>30 s) monomorphic ventricular tachycardia.
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
Condition: Bronchopulmonary Dysplasia; Encephalomalacia; Premature Birth
MeSH terms: Bronchopulmonary Dysplasia; Encephalomalacia; Premature Birth
Intervention: Hydrocortisone; Placebo
Intervention description: Hydrocortisone 3 mg/kg/d divided q 12h IV/PO tapered over 7 days; Saline
Intervention MeSH terms: Hydrocortisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 1 Week
Maximum age: 3 Weeks
Healthy volunteers: No
Keywords: Bronchopulmonary Dysplasia; Encephalomalacia; Brain injury; Neurosensory impairment; Corticosteroids; Anti-Inflammatory Agents; Extremely Low Birth Weight (ELBW) infants; Premature Birth; Magnetic Resonance Imaging

Summary:

      The purpose of this study is to determine whether treatment of very preterm infants at
      high-risk for lung and brain injury with low dose hydrocortisone results in improved
      pulmonary and neurologic outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient in the Memorial Hermann Children's Hospital (MHCH) neonatal intensive care
             unit with a birth weight ≤ 1000 grams.

          -  Ventilator-dependent between 10 and 21 days of age.

          -  Respiratory index score (RIS: mean airway pressure x fraction of inspired oxygen) of ≥
             2.0 that is increasing or stable for the previous 24 hours or a RIS ≥ 3.0 if
             improvement noted in the past 24 hours.

        Exclusion Criteria:

          -  Prior postnatal steroid treatment.

          -  Evidence of sepsis or necrotizing enterocolitis.

          -  Known major congenital anomalies of the cardiopulmonary or central nervous system.

          -  Infants being treated with indomethacin or those likely to require treatment in the
             next 7 days as judged by the treating physician.

          -  Inability or unwillingness of parent or legal guardian/representative to give written
             informed consent.

          -  Gestational age < 23 weeks.
Cervical Preparation With Mifepristone Prior to Osmotic Dilators
Condition: Second Trimester Abortion
Intervention: Mifepristone 200 MG; Placebo Oral Tablet
Intervention description: Ingestion of study medication vs placebo; Ingestion of study medication vs placebo
Intervention MeSH terms: Mifepristone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators plan to study the role of mifepristone prior to the placement of cervical
      osmotic dilators to evaluate if the medication helps increase the number of dilators. This
      may help improve safety of dilation and evacuation (D&E) procedures.
    

Eligibility criteria:

        Inclusion Criteria:

        A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on
        procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing
        to sign informed consent and follow study protocol

        Exclusion Criteria:

        A. Allergy or known intolerance to mifepristone

        B. Known contraindication to mifepristone for cervical preparation prior to dilation and
        evacuation:

          1. Chronic adrenal failure or insufficiency

          2. Concurrent use of long-term corticosteroid therapy

          3. Inherited porphyrias

        C. Any condition that in the opinion of the investigator could impede study participation
        or collection of study data
A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
Condition: Overweight; Obesity
MeSH terms: Overweight
Intervention: VI-0521; Placebo; Alcohol; alcohol placebo
Intervention description: Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week; Placebo daily for 4 weeks; fruit juice
Intervention MeSH terms: Ethanol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Overweight; Obesity; coordination; psychomotor

Summary:

      The purpose of this study is to determine how VI-0521 affect speed and reaction time on
      specific tasks that require eye and hand coordination, compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written consents;

          -  Adequate contraception from screening through 28 days after the last dose of study
             drug for female subjects;

          -  Healthy obese or overweight subjects with BMI between 27 and 35.

        Exclusion Criteria:

          -  History of glaucoma or any past or present use of medications to treat increased
             intraocular pressure;

          -  Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing
             tobacco, or use within the three months prior to screening;

          -  History of drug abuse during the three years prior to screening;

          -  History of alcohol abuse, or excessive alcohol consumption, or describes themselves as
             non-users of alcohol;

          -  Current depression of moderate or greater severity, or any presence or history of
             suicidal behavior or active suicidal ideation

          -  More than one lifetime episode of major depression;

          -  Currently working night shifts at a job;

          -  On average consumes greater than two cups of coffee or xanthine-containing beverages
             per day (>200 mg/day) within the two weeks prior to screening;

          -  Any use of dietary, herbal, and/or fitness/body-building supplements (with the
             exception of vitamins) within one month prior to screening;

          -  Aspartate aminotransferase or alanine aminotransferase >2.5 x ULN;

          -  Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.
Efficacy and Safety of Itolizumab in COVID-19 Complications
Condition: Acute Respiratory Distress Syndrome; Cytokine Release Syndrome; Covid19
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Cytokine Release Syndrome
Intervention: Itolizumab IV infusion; Best supportive care (BSC)
Intervention description: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.
BSC: similar to Arm B; Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      Randomized, Parallel Group, Active Controlled Trial
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female adults above 18 years (not tested in children yet)

          2. Informed consent for participation in the study

          3. Virological diagnosis of SARS-CoV2 infection (PCR)

          4. Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection

          5. Oxygen saturation at rest in ambient air ≤94%

          6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of < 200

        Key Exclusion Criteria:

          1. Known severe allergic reactions to monoclonal antibodies

          2. Active tuberculosis (TB) infection

          3. History of inadequately treated tuberculosis or latent tuberculosis

          4. In the opinion of the investigator,progression to death is highly probable,
             irrespective of the provision of treatments

          5. Have received oral anti-rejection or immune-suppressive drugs within the past 6 months

          6. Participating in other drug clinical trials (participation in COVID-19 anti-viral
             trials may be permitted if approved by Medical Monitor)

          7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination

          8. Patients with known history of Hepatitis B, Hepatitis C or HIV

          9. Absolute Neutrophils count (ANC) <1000 / mm3

         10. Platelets <50,000 / mm3

         11. Absolute Lymphocyte count (ALC): <500/mm3
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: XmAb5871; Placebo to match XmAb5871
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized (1:1, no stratification), Double-Blinded, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus
      Erythematosus (SLE) disease activity improvement achieved by a brief course of
      disease-suppressing steroid therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of SLE as defined by the ACR criteria

          -  Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented
             within one year prior to randomization

          -  Investigator has assessed the patient and in their judgment, the SLE disease activity
             is not organ threatening

          -  Both investigator and patient agree that it is acceptable to discontinue their current
             immunosuppressant SLE medications and receive a brief course of IM steroid therapy

          -  If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of
             prednisone to enter screening, and must be able to taper to ≤10 mg/day by
             randomization

        Exclusion Criteria:

          -  History or evidence of a clinically unstable/uncontrolled disorder, condition or
             disease, other than SLE that, in the opinion of the investigator would pose a risk to
             patient safety or interfere with the study evaluation, procedures or completion

          -  Patients who have organ threatening manifestations of SLE including active Class 3 or
             4 lupus nephritis requiring induction or maintenance therapy or any other disorder for
             which stopping SLE therapy is contraindicated

          -  Active CNS lupus such as seizures or psychosis that in the opinion of the investigator
             would preclude participation

          -  Unstable hemolytic anemia or thrombocytopenia

          -  Patient is pregnant or breast feeding, or planning to become pregnant while
             participating in the study

          -  Use of any biologic therapy (including belimumab) within 6 months of randomization, or
             prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12
             months of randomization
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; 150 mg PF-04991532; 450 mg PF-04991532; 750 mg PF-04991532; Sitagliptin 100 mg
Intervention description: Tablets (n=6), 0 mg, once daily for 84 days; Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days; Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days; Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days; Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
Intervention MeSH terms: Nicotinic Acids; Sitagliptin Phosphate; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase 2; safety and efficacy study with PF-04991532; Type 2 diabetes

Summary:

      B2611002 is designed to study how safe and effective an investigational medication
      (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5
      treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug,
      and another treatment will be placebo, which does not contain active ingredient.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with type 2 diabetes on stable doses of background medicines for management of
        diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

        Exclusion Criteria:

        Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled
        blood pressure, significant kidney disease.
Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Dronabinol; Placebo
Intervention description: Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects received one dose of either 2.5 mg or 5 mg orally with water.; Placebo will match study drug; taken as one dose orally with water.
Intervention MeSH terms: Dronabinol
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: anandamide; cannabinoid; fatty acid amide hydrolase; gastric; motility; small bowel; sensory; motor

Summary:

      Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no
      effective and safe medications approved for the treatment of abdominal pain associated with
      bowel symptoms in IBS. This study will investigate the effects of an approved medication,
      Dronabinol, on the movement of food through the stomach and colon in subjects with a history
      of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years

          -  Positive for IBS symptoms by Rome III criteria

          -  No prior abdominal surgery (except appendectomy or cholecystectomy

          -  Score of 10 or less on either Anxiety or Depression on the Hospital Anxiety/Depression
             Inventory

        Exclusion Criteria:

          -  Patients with significant depression (score of greater than 10 on Hospital Depression
             Inventory

          -  Patients with anxiety (score of greater than 10 on Hospital Anxiety Inventory.
             However, patients on stable doses of selective serotonin inhibitors (SSRIs) or low
             dose of tricyclic antidepressants will be eligible.
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: Differing doses and frequencies of sc administration
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of different subcutaneous starting doses and
      dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on
      dialysis. The anticipated time on study treatment is 3-12 months and the target sample size
      is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic renal anemia;

          -  not receiving renal replacement therapy.

        Exclusion Criteria:

          -  women who are pregnant, breastfeeding or using unreliable birth control methods;

          -  administration of any investigational drug within 30 days preceding the screening
             visit and during the run-in period.
Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
Condition: Tobacco Use Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Bupropion-SR; Placebo
Intervention description: 150mg tablets taken orally twice daily for 9 weeks.; Matching placebo (to Buproion-SR) twice daily for 9 weeks.
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 12 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: adolescents, cigarettes, smoking, tobacco

Summary:

      Little is known about the best ways to help young people stop smoking. Bupropion (a
      medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The
      purpose of this study is to determine if bupropion is also effective in treating smokers
      between the ages of 12 and 25 years old. This study also compares the effectiveness of
      bupropion used as a supplement to behavioral treatment versus behavioral treatment used
      alone. In addition, the study evaluates whether hormonal response to stress measured prior to
      the start of treatment predicts whether individuals respond well to treatment with
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has smoked at least 10 cigarettes each day for 3 or more months

          -  Weighs at least 90 lbs

          -  Motivated to quit smoking and has had at least one previous failed attempt

          -  Speaks, reads, and writes English

          -  Either diagnosed as depressed OR no history of a psychiatric disorder

        Exclusion Criteria:

          -  History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder,
             autism, or non-nicotine substance use disorder in the 6 months prior to study entry

          -  Currently suicidal or with a history of a suicide attempt in the 6 months prior to
             study entry

          -  Psychotic symptoms

          -  Use of psychotropic medication(s)

          -  Serious medical condition

          -  Prior use of bupropion for smoking cessation

          -  Currently using other smoking cessation treatments