bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
Condition: Acellular Pertussis; Diphtheria; Tetanus
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Boostrix™; ADACEL®
Intervention description: Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine; Sanofi Pasteur
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2337.0
Sex: All
Minimum age: 19 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis for diphtheria, tetanus, pertussis; Immunogenicity, booster, dTpa

Summary:

      GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug
      Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has
      recently issued provisional recommendations for universal adult Tdap vaccination. The current
      study will provide pivotal data in support of extending the age range for Boostrix vaccine to
      include adults 19-64 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday)
             at the time of study vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding administration of study vaccine, or planned
             use during the active phase of the study.

          -  Chronic administration of immunosuppressants or within six months prior to
             administration of study vaccine.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of administration of study vaccine (with the exception of an influenza
             vaccine).

          -  Administration of a diphtheria-tetanus (Td) booster within previous five years.

          -  Administration of Tdap vaccine at any time prior to study entry. History of serious
             allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria
             toxoid or pertussis-containing vaccine or any component of the study vaccines.
Study of 0417 Ointment in the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 0417; Vehicle of 0417 test product; Tacrolimus Ointment 0.03%
Intervention description: Topical 0417 test product applied twice daily for 4 weeks; Vehicle of 0417 test product applied twice daily for 4 weeks; Reference product for 0417 test product. Apply twice daily for 4 weeks
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 899.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis

Summary:

      The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic
      Dermatitis.

      Treatment medication will be administered as follows: Apply a thin layer of ointment to
      affected skin areas twice daily and rub in gently and completely. Study medication will be
      applied twice a day, approximately 12 hours apart, for approximately 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Atopic Dermatitis

          -  Good health with the exception of Atopic Dermatitis

          -  Percent Body Surface Area minimum requirements

        Exclusion Criteria:

          -  Subjects who are pregnant, nursing, or planning a pregnancy within the study
             participation period.

          -  Subjects who have any systemic or dermatological disorders with the exception of
             Atopic Dermatitis
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Condition: Clostridioides Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Ridinilazole; Vancomycin
Intervention description: Ridinilazole 200mg dosed BID for 10 days.; Vancomycin 125mg dosed QID for 10 days.
Intervention MeSH terms: Vancomycin; Ridinilazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Clostridioides difficile infection (CDI); ridinilazole; Adolescents; vancomycin; C. Diff; Clostridium difficile; Diarrhea; Infection; Pediatric

Summary:

      Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is
      metabolized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is aged 12 to <18 years.

          -  Has signs and symptoms of CDI including diarrhea such that in the Investigator's
             opinion CDI antimicrobial therapy is required, and the subject has tested positive for
             toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed
             bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea
             information is within 24 hours prior to randomization.

        Exclusion Criteria:

          -  Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment
             active against the current episode of CDI prior to randomization.

          -  Has received ridinilazole or an investigational vaccine against C. difficile any time
             in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or
             any other investigational medicinal product for treatment of CDI or fecal microbiota
             replacement therapy within the past 3 months.

          -  Has a clinically relevant positive stool test for pathogens other than C. difficile,
             within 48 hours of randomization.

          -  Has life-threatening or fulminant CDI with evidence of hypotension, septic shock,
             peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus.

          -  Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not
             including appendectomy or cholecystectomy) within past 3 months or has the presence of
             a colostomy or ileostomy or has the likely requirement of an ostomy during the study.

          -  Is receiving treatment that generally is associated with severe diarrhea, intractable
             vomiting, severe nausea, or inability to swallow that cannot be managed with
             antiemetics or antidiarrheals and that limits the ability to take oral medications.
             Cancer treatment that does not comprise ability to take study medication or cause
             severe diarrhea is allowed.
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Intervention description: Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period; Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 354.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; Etrasimod; APD334

Summary:

      The purpose of this study is to assess the efficacy of etrasimod on clinical remission in
      participants with moderately to severely active ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening

          -  Active UC confirmed by endoscopy

        Exclusion Criteria:

          -  Severe extensive colitis

          -  Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history
             of a fistula consistent with CD

          -  Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine
Intervention description: Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 662.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: adolescent; children

Summary:

      Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent
      participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition
      (DSM-5™) diagnosis of MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12
             and ≤18 years in the lead-in study (12709A and 12710A).

          -  The participant must have completed Study 12709A or 12710A (Visit 12, Completion
             Visit) immediately prior to enrolment into this extension study.

          -  The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A,
             diagnosed according to DSM-5™.

          -  The participant is indicated for long-term treatment with vortioxetine according to
             the clinical opinion of the Investigator.

          -  For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able
             to understand the Informed Assent Form, and parent(s)/legal representative(s) are able
             to read and understand the Informed Consent Form.

          -  For participants who turned 18 years during the lead-in study 12710A; the participant
             has signed the Informed Consent Form.

        Exclusion Criteria:

          -  The participant has been diagnosed with another psychiatric disorder (for example
             mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A
             or 12710A.

          -  The participant has an attention-deficit/hyperactivity disorder (ADHD) that requires a
             pharmacological treatment other than a stimulant medication.

        Other protocol-defined inclusion and exclusion criteria may apply
Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Omega -3 fatty acids; Placebo
Intervention description: 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.; Olive Oil capsules
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1516.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; fish oil

Summary:

      This is a large multi-center study to examine whether peri-operative intake of n-3
      polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial
      fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or over

          -  Scheduled for CS on the following day or later, including coronary artery bypass,
             valve surgery, any other open cardiac surgery (i.e., that includes opening of the
             pericardium), or any combination.

          -  Sinus rhythm on current ECG (sinus bradycardia, sinus tachycardia, and ectopy are
             acceptable).

        Exclusion Criteria:

          -  Regular use (3 or more days/week) of fish oil within the past 4 weeks.

          -  Known allergy or intolerance to fish oil or corn oil.

          -  Currently pregnant.

          -  Unable to provide informed written consent.

          -  Current or planned cardiac transplant or LVAD
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
Condition: Herpes Zoster; Shingles
MeSH terms: Herpes Zoster
Intervention: Zoster Vaccine Live
Intervention description: One approximately 0.65 mL injection subcutaneously on Day 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults
      in India.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No fever on day of vaccination

          -  Females have a negative pregnancy test and use an acceptable method of birth control,
             or are postmenopausal

          -  Underlying chronic illnesses must be stable

        Exclusion Criteria:

          -  History of hypersensitivity reaction to any vaccine component

          -  Prior receipt of a varicella or zoster vaccine

          -  Prior history of herpes zoster

          -  Have recently had another vaccination

          -  Have recently received blood products other than autologous blood transfusion

          -  Pregnant or breast feeding

          -  Use of immunosuppressive therapy

          -  Known or suspected immune dysfunction

          -  Use of nontopical antiviral therapy with activity against herpesvirus
Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Overweight; Nutrition Disorders; Body Weight
Intervention: liraglutide; liraglutide; placebo
Intervention description: Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.; Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.; Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 846.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

      The aim of this trial is to investigate the potential of liraglutide to induce and maintain
      weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added
      onto subject's pre-trial background diabetes treatment of either diet and exercise only or
      single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or
      glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration
      of the trial will be 56 weeks followed by a 12 week observational follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained

          -  Subjects diagnosed with type 2 diabetes and treated with either diet and exercise
             alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of
             the previously mentioned compounds

          -  HbA1c 7.0-10.0% (both inclusive)

          -  Body Mass Index (BMI) at least 27.0 kg/m^2

          -  Stable body weight

          -  Preceding failed dietary effort

        Exclusion Criteria:

          -  Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl
             peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months

          -  Known proliferative retinopathy or maculopathy

          -  History of acute or chronic pancreatitis

          -  Obesity induced by drug treatment

          -  Use of approved weight lowering pharmacotherapy

          -  Previous surgical treatment of obesity

          -  History of major depressive disorder or suicide attempt

          -  Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or
             diastolic blood pressure above or equal to 100 mmHg)

          -  Screening calcitonin of 50 ng/L or above

          -  Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
             medullary thyroid carcinoma (FMTC)

          -  Personal history of non-familial medullary thyroid carcinoma
The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery
Condition: Bariatric Surgery Candidate
Intervention: Ropivacaine; Normal Saline
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bariatric surgery; Bariatrics; Local anesthetic; Ropivacaine; Intraperitoneal

Summary:

      This is a pilot study in a randomized, controlled, double-blinded format and will evaluate
      the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass
      surgery. The drug will be administered into the abdomen during a bariatric bypass surgery.
      After surgery, patients who received Ropivacaine will be compared to those without
      Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to
      walk, and quality of life during recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing Roux-en-Y gastric bypass surgery;

          -  Patients who able to tolerate general anesthetic and pneumoperitoneum;

          -  Patients who able to provide informed consent for the surgery;

          -  Patients over the age of 18 years;

        Exclusion Criteria:

          -  Patient undergoing planned Sleeve Gastrectomy (inta-op conversion to Sleeve
             Gastrectomy after delivery of intraperitoneal ropivacaine will be included and
             analyzed using intention-to-treat approach)

          -  Patients with an allergy to local anesthetics

          -  Patients with severe underlying cardiovascular disease (ie: congestive heart failure,
             conduction abnormalities, and ischemic heart disease)

          -  Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than
             60mL/hr (millilitre per hour))

          -  Patients with hepatic dysfunction Child-Pugh Class B or C

          -  Patients with previous foregut surgery including esophageal, gastric, liver, and
             pancreas resections
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Virus Diseases; Hepatitis; Fibrosis
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg FDC tablet administered orally once daily; Capsules administered orally in a divided daily dose
Intervention MeSH terms: Ribavirin; Sofosbuvir-velpatasvir drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Communicable Diseases; Hepatitis; Hepatitis C; Virus Diseases; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Velpatasvir; RNA Virus Infections; Ribavirin; Sofosbuvir; Antiviral Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Decompensated Cirrhosis

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without
      ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and
      decompensated cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV-infected males and non-pregnant/non-lactating females

          -  Treatment naive or treatment experienced individuals

          -  Child-Pugh-Turcotte Score 7-12 at screening

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.