bioihbjkbjnl/mcl2 huggingface dataset:
Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Semaglutide; Placebo (Semaglutide)
Intervention description: Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks; S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Healthy volunteers: No

Summary:

      This study will look at the change in body weight from the start to the end of the study.
      Researchers will compare the weight loss in people taking semaglutide (a new medicine) to
      people taking "dummy" medicine. In addition to taking the medicine, participants will also
      have talks with study staff about healthy food choices, how the participant can be more
      physically active and what participants can do to lose weight. Participants will either get
      semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance.
      Participants will need to take 1 injection once a week. The study medicine is injected with a
      thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about
      2 years. The participants will have 19 clinic visits and 15 phone calls with the study
      doctor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age more than or equal to 18 years at the time of signing informed
             consent

          -  Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27
             kg/m^2 with the presence of at least one of the following weight-related comorbidities
             (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or
             cardiovascular disease

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

        Exclusion criteria:

          -  HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory
             at screening

          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: TEV-48125; TEV-48125
Intervention description: TEV-48125 will be administered subcutaneously once every 4 weeks.; TEV-48125 will be administered subcutaneously once every 12 weeks.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of
      TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at
      675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine
      patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of migraine (according to The International Classification of
             Headache Disorders, third edition [beta version] criteria) or clinical judgment
             suggests a migraine diagnosis

          -  Patient fulfills the criteria for Chronic migraine or Episodic migraine in baseline
             information collected during the 28 day screening period

          -  Not using preventive migraine medications for migraine or other medical conditions or
             using no more than 2 preventive migraine medication for migraine or other medical
             conditions if the dose and regimen have been stable for at least 2 months prior to
             giving informed consent.

          -  Patient demonstrates compliance with the electronic headache diary during the
             screening period by entry of headache data on a minimum of 24 of 28 days and the
             entered data is judged appropriate by the investigator.

        Exclusion Criteria:

        - Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary,
        neurologic, hepatic, or ocular disease considered clinically significant in the judgment of
        the investigator
A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
Condition: Avian Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: aH5N1c; Placebo
Intervention description: Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).; Placebo: Saline injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3196.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Vaccine; Flu; Avian; Pandemic; H5N1; MF59

Summary:

      This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots
      of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18
      years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were
      randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was
      stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate safety
      assessment of the entire age spectrum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 18 years of age, mentally competent, in good health as determined by
             medical history, physical examination and clinical judgment by the Investigator; able
             to comply with all study procedures, to be contacted, and to be available for study
             visits according to the protocol.

        Exclusion Criteria:

          -  Individuals who are pregnant or breastfeeding. Female subjects of childbearing
             potential must have a negative pregnancy test prior to study vaccines being
             administered.

          -  Females of childbearing potential who refuse to use an acceptable method of birth
             control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination,
             and, if sexually active, who have not used a reliable birth control method for at
             least two months prior to study entry.

          -  Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3
             days of intended study vaccination.

          -  Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7
             days prior to enrolment in this study or who are planning to receive any type of
             influenza vaccine within 7 days (before or after) from the study vaccines.

          -  Individuals who received any other licensed vaccines within 14 days (for inactivated
             vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are
             planning to receive any (non-influenza) vaccine within 28 days (before or after) from
             the study vaccines.

          -  Individuals with known or suspected impairment of the immune system.
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Placebo; Ruxolitinib
Intervention description: Placebo administered BID approximately 12 hours apart; Ruxolitinb administered BID approximately 12 hours apart
Intervention MeSH terms: Janus Kinase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blinded
Enrollment: 211.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Cytokine storm; COVID-19; ARDS; SARS-CoV-2; ruxolitinib; pneumonia

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the
      treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS)
      who require mechanical ventilation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant or guardian health proxy must provide informed consent before any study
             assessment is performed.

          -  Male or female participants aged ≥ 12 years.

          -  Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to
             randomization by any test with local regulatory approval.

          -  Participants who are intubated and receiving mechanical ventilation due to
             COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of
             randomization.

        Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest
        x-ray or CT scan.

        Exclusion Criteria:

          -  Known history of hypersensitivity to any drugs or metabolites of similar chemical
             classes as ruxolitinib.

          -  Presence of severely impaired renal function defined by estimated creatinine clearance
             < 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the
             updated bedside Schwartz equation. Participants must not be receiving CRRT or
             intermittent hemodialysis at screening.

          -  In the opinion of the investigator, unlikely to survive for > 24 hours from
             randomization.

          -  Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides
             COVID-19).

          -  Currently receiving ECMO.

          -  Participant may not be sharing a ventilator, or co-ventilating, with any other
             patient.

          -  Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK
             inhibitor, within 7 days of randomization.

          -  Treatment with a JAK inhibitor within 30 days of randomization.

          -  Participants who are on long-term use of antirejection or immunomodulatory drugs.

          -  Pregnant or nursing (lactating) women.
Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery
Condition: Intraoperative Complication; Malignant Female Reproductive System Neoplasm; Pain
MeSH terms: Genital Neoplasms, Female; Intraoperative Complications
Intervention: Epidural analgesia; Intraoperative Complication Management and Prevention; Pain Therapy
Intervention description: Receive epidural placement. Standard epidural medications and dosage are as follows:
0.1% ropivicaine + 10 mcg/mL hydromorphone at 6 mL/hr continuous rate
3 mL/hr RN bolus, to be used as needed based on pain ratings
3 mL/30 minutes patient bolus, which is available on patient demand.; Undergo ERP; Undergo ERP
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized clinical trial studies epidural anesthesia within an enhanced recovery
      pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural
      analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and
      stops the feeling of pain. It stays in place for several days after surgery and may be
      helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of
      specific steps used before, during, and after surgery by health care providers to care for
      patients after surgery. ERPs include patient education, not using laxatives before surgery,
      increasing activity after surgery, and scheduled use of medications for pain and nausea.
      Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing
      gynecologic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing gynecologic surgery via midline vertical laparotomy at University
             of Wisconsin Hospital and Clinics (UWHC)

          -  Patients must be English speaking

          -  Patients must have the ability to understand visual and verbal pain scales

          -  Patients must be eligible for epidural placement

        Exclusion Criteria:

          -  Known allergy to local anesthetics

          -  Known history of chronic pain disorders and/or chronic opioid use defined as > 10 mg
             of oral (PO) morphine or equivalent used daily for at least 30 days prior to
             enrollment

          -  Patient is a prisoner or incarcerated

          -  Significant liver disease that would inhibit prescription of opioids

          -  Significant kidney disease that would inhibit administration of gabapentin

          -  Patient has a history of opioid dependence requiring rehabilitation or the use of
             opioid antagonists

          -  Patient is pregnant

          -  Patients with a planned exploration with biopsies (no organs removed) will be excluded
             from the study
TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Combination Product (sumatriptan succinate / naproxen sodium); RELPAX(eletriptan) 40mg Tablet
Intervention description: sumatriptan/naproxen sodium; eletriptan tablets
Intervention MeSH terms: Naproxen; Sumatriptan; Eletriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Combination product, sumatriptan succinate, naproxen sodium, absorption, pharmacokinetics, disintegration, gastric transit, gastric scintigraphy

Summary:

      An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and
      naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consented males and nonpregnant females using adequate contraception, between 18 and
             55 years of age, with at least 1-6 migraines per month for past 6 months. Subjects
             will be excluded for confirmed or suspected ischemic heart disease, uncontrolled
             hypertension at screening; a history of epilepsy or structural brain lesions which
             lowered the convulsive threshold; confirmed or suspected cardiovascular,
             cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel
             disease; impaired hepatic or renal function; basilar or hemiplegic migraine. Other
             exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before
             screening; ergot prophylactics in past 3 months; anticoagulants; smoking more than 10
             cigarettes/day, evidence of alcohol or substance abuse; GI bleeding disorders,
             inflammatory bowel disease; or any concurrent medical or psychiatric condition that in
             the investigator's opinion could affect interpretation of efficacy or safety
             information or which otherwise contraindicated participation in the study.
Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study
Condition: Cirrhosis; Congenital Heart Disease
MeSH terms: Liver Diseases; Heart Diseases; Heart Defects, Congenital
Intervention: Sildenafil; Placebo
Intervention description: Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months.; Placebo capsules matching study drug
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double-blind Placebo-control study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Both the treatment arm (sildenafil) and the placebo arm will receive monthly package of similar pills. Equal number of patients will be randomly assigned to each arm.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the medication, sildenafil (also known as
      Revatio), can slow or stop the progression of liver disease in patients who previously had a
      Fontan operation.
    

Eligibility criteria:

        Inclusion criteria:

          -  All adult Fontan patients who have no contraindications for magnetic resonance imaging
             (MRI) will be eligible for the study.

        Exclusion criteria:

          -  Subjects with implantable pacemakers

          -  Residual cardiac lesions (severe ventricular dysfunction, severe atrioventricular
             valve regurgitation, Fontan baffle or conduit obstruction)

          -  Viral hepatitis

          -  Severe renal dysfunction

          -  History of sildenafil use in the six months prior to study enrollment

          -  Ongoing sildenafil therapy

          -  Patients currently taking nitrates

          -  Hypotension at baseline (BP <90/50 mmHg)

          -  Pulmonary veno-occlusive disease

          -  Hearing/vision impairment

          -  Pulmonary hypertension due to sickle cell disease

          -  Women of child-bearing potential with a positive pregnancy test will additionally be
             excluded
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ofatumumab subcutaneous injection; Teriflunomide-matching placebo capsules; Teriflunomide capsule; Matching placebo of ofatumumab subcutaneous injections
Intervention description: Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter; Placebo capsule, matching in appearance to teriflunomide, taken orally once daily; Teriflunomide 14 mg oral capsule taken once daily; Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
Intervention MeSH terms: Teriflunomide; Ofatumumab; 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: 930.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; Ofatumumab; adult; OMB157; multiple sclerosis; T1 lesions; T2 lesions; relapse; GD-enhancing MRI; McDonald criteria; RRMS; SPMS

Summary:

      To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4
      weeks versus teriflunomide administered orally once daily in patients with relapsing multiple
      sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 55 years of age

          -  Diagnosis of multiple sclerosis (MS)

          -  Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)

          -  At least 1 relapse during the previous 1 year or 2 relapses during the previous 2
             years or a positive gadolinium-enhancing MRI scan in previous year

          -  Expanded disability status scale (EDSS) score of 0 to 5.5

        Exclusion Criteria:

          -  Primary progressive MS

          -  Disease duration of more than 10 years in patients with an EDSS score of 2 or less

          -  Patients with an active chronic disease of the immune system other than MS

          -  Patients at risk of developing or having reactivation of hepatitis

          -  Patients with active systemic infections or with neurological findings consistent with
             PML
Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
Condition: Bacterial Infections; Skin Structures and Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Soft Tissue Infections
Intervention: Omadacycline; Linezolid
Intervention description: po tablets; po tablets
Intervention MeSH terms: Linezolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 735.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared
      to linezolid in the treatment of adults with acute bacterial skin and skin structure
      infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, ages 18 years or older who have signed the informed consent

          -  Has a qualifying skin and skin structure infection

          -  Female patients must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

        Exclusion Criteria:

          -  Infections where the outcome is strongly influenced by factors other than
             protocol-defined treatments and procedures, or that require antibacterial treatment
             for greater than 14 days

          -  Evidence of significant immunological disease

          -  Severe renal disease or requirement for dialysis

          -  Evidence of septic shock

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to
             linezolid

          -  Has received an investigational drug within the past 30 days

          -  Women who are pregnant or nursing