bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Condition: Esophagitis, Reflux; Esophagitis, Peptic
MeSH terms: Esophagitis; Esophagitis, Peptic
Intervention: Dexlansoprazole MR; Dexlansoprazole MR; Lansoprazole
Intervention description: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.; Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.; Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2054.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erosive Esophagitis

Summary:

      This is a study to assess the efficacy and safety of 8 weeks of treatment with
      Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole
      (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have endoscopically confirmed erosive esophagitis as defined by the Los
             Angeles (LA) Classification Grading System (A-D).

        Exclusion Criteria:

          -  Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.)
             pylori.

          -  Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2)
             receptor antagonists or sucralfate, drugs with significant anticholinergic effects,
             misoprostol or prokinetics

          -  Use of antacids [except for study supplied Gelusil®]

          -  Need for continuous anticoagulant therapy (Blood Thinners)

          -  Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus

          -  History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of
             mucosal tissue near the lower esophageal sphincter)

          -  Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory
             condition

          -  History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer

          -  Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening
             endoscopy
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Condition: Dry Eye; Sjogren Syndrome
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: PRP injection; Standard care Hyaluronic acid eye drops
Intervention description: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90
Intervention MeSH terms: Ophthalmic Solutions; Hyaluronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Dry eye is a chronic condition that decreases function and affect visual function with severe
      discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has
      emerged as a strategy for cellular restoration, the purpose of this study is to evaluate
      their effects in lacrimal production and safety of this intervention in patients with severe
      dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Patients with symptomatic Dry eye

               -  Shirmer ≤10 mm in 5 min

               -  BUT ≤10 seconds

               -  Corneal staining ≥3

               -  Age range: 18 years and older.

               -  Both genders and all ethnic groups comparable with the local community.

               -  Able to understand and willing to sign a written informed consent

               -  Able and willing to cooperate with the investigational plan.

               -  Able and willing to complete all mandatory follow-up visits.

        Exclusion Criteria:

          -  • Patients who are currently engaged in another clinical trial, unwilling or unable to
             give consent, to accept randomization, or to return for scheduled visits.

               -  Children under 18.

               -  Pregnant women or expecting to be pregnant during the study.

               -  Systemic immune deficient conditions such as AIDS or under systemic
                  immunosuppressant.

               -  Concomitant use of systemic antibiotics or steroids.

               -  Contact lens wear

               -  Active ocular infection or allergy

               -  Unable to close eyes or uncontrolled blinking
Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients
Condition: Hypercholesterolemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Intervention: Mipomersen sodium; Placebo
Intervention description: 200 mg/mL; 1 mL matching placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to 1 mL with water).
Intervention MeSH terms: Mipomersen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen
      for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of
      statin and who have a diagnosis that puts them at least at high risk of coronary heart
      disease (CHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hypercholesterolemia (LDL-C ≥ 100 mg/dL)

          -  At high risk of CHD

          -  On stable, maximally tolerated statin therapy for 8 weeks

          -  On stable, low fat diet for 12 weeks

          -  Stable weight for 6 weeks

        Exclusion Criteria:

          -  Significant health problems in the recent past including heart attack, stroke,
             coronary syndrome, unstable angina, heart failure, significant arrhythmia,
             hypertension, liver disease, cancer, type I diabetes.
A Study of Abatacept in Patients With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: abatacept (ABA); placebo; abatacept
Intervention description: Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57 (ABA 30/~10 mg/kg Group).
Induction Period 3 months
Maintenance Period 12 months; Normal saline, IV, 0 mg/kg, every 28 days.
Induction Period 3 months
Maintenance Period 12 months; ~10 mg/kg, once monthly
Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 591.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if abatacept can improve signs and
      symptoms of active ulcerative colitis in patients who have not had an adequate response to
      other therapies. The safety of this treatment will also be studied
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 years or older

          -  Ulcerative colitis for at lease 3 months

          -  Moderate to severe active ulcerative colitis

          -  Inadequate response or intolerance to standard ulcerative colitis treatment
An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Nivolumab; Elotuzumab; Pomalidomide; Dexamethasone
Intervention description: Specified dose on specified days, IV (intravenous); Specified dose on specified days, IV; Specified dose on specified days, PO (by mouth); Specified dose on specified days, PO
Intervention MeSH terms: Dexamethasone; Nivolumab; Pomalidomide; Elotuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of several combination
      therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized
      (assigned by chance) to receive either:

      Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone
      OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone.

      Enrollment is closed for all groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Refractory or relapsed and refractory multiple myeloma

          -  Measurable disease

          -  Have received ≥ 2 lines of prior therapy which must have included an immune modulatory
             drug (IMiD) and a proteasome inhibitor alone or in combination

        Exclusion Criteria:

          -  Solitary bone or extramedullary plasmacytoma disease only

          -  Active plasma cell leukemia

        Other protocol defined inclusion/exclusion criteria apply
Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
Condition: Bacterial Infections; Skin Structures and Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Soft Tissue Infections
Intervention: Omadacycline; Linezolid
Intervention description: Injection for IV dosing; Tablets for oral dosing; Infusion solution for IV dosing; Tablets for oral dosing
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: 655.0
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 treatment and procedures, that require antibacterial treatment for
             greater than 14 days

          -  Evidence of significant immunological disease

          -  Severe sepsis or septic shock

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to
             linezolid

          -  Has received an investigational drug within past 30 days

          -  Women who are pregnant or nursing
Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-120 Gel; IDP-120 Vehicle Gel
Intervention description: IDP-120 Gel, once-daily application; IDP-120 Vehicle Gel, once-daily application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
Enrollment: 585.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120
      Vehicle Gel
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older;

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit);

          3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
             Severity Score (EGSS) assessment at the baseline visit;

          4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20 but no more than 50;

          5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
             less than 25 but no more than 100;

          6. Subjects with two or fewer facial nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
             eczema;

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive;

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments;

          5. Subjects with more than two (2) facial nodules;

          6. Evidence or history of cosmetic-related acne
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: TNX-102 SL; Placebo SL Tablet
Intervention description: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Intervention MeSH terms: Cyclobenzaprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 503.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Sleep; Fibromyalgia; FM

Summary:

      This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week
      study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets)
      taken daily at bedtime for the treatment of fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is male or female 18 to 65 years of age, inclusive.

          -  The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the
             2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology
             Preliminary Diagnostic Criteria)

          -  The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit
             within protocol specified range.

        Exclusion Criteria:

          -  History of or evidence for a diagnosis of borderline personality disorder (BPD).
Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
Condition: Acquired Thrombotic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Intervention: Caplacizumab; Placebo
Intervention description: First day of treatment: 10 mg intravenous (i.v.) injection prior to plasma exchange (PE) followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day.
Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE.
Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.; First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day.
Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE.
Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the
      efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of
      prevention of further microvascular thrombosis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult male or female ≥ 18 years of age at the time of signing the informed consent
             form (ICF).

          2. Clinical diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) (initial or
             recurrent), which included thrombocytopenia and microscopic evidence of red blood cell
             fragmentation (e.g., schistocytes).

          3. Required initiation of daily PE treatment and had received 1 PE treatment prior to
             randomization

          4. Others as defined in the protocol

        Exclusion Criteria:

          1. Platelet count ≥100×10E9/L.

          2. Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L

          3. Known other causes of thrombocytopenia

          4. Congenital TTP (known at the time of study entry).

          5. Pregnancy or breast-feeding.

          6. Subjects who were previously enrolled in a clinical study with caplacizumab and
             received caplacizumab or for whom the assigned treatment arm is unknown

          7. Others as defined in the protocol
Comparison of Intraoperative Warming Devices
Condition: Total Knee Arthroplasty
Intervention: VH2; Bair Hugger
Intervention description: Dynatherm vitalHeat2 (VH2) temperature management system.; Arizant Bair Hugger temperature management system.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post
      anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System
      under general anesthesia for total knee arthroplasty will be equivalent to that of patients
      warmed with the Arizant Bair Hugger System.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Initial total knee arthroplasty.

          -  Expected duration of surgery at least 2 hours.

          -  General anesthesia.

          -  American Society of Anesthesiologists (ASA) classification I-III.

          -  Age >= 18 years.

        Exclusion Criteria:

          -  Skin abrasion at the device application site.

          -  History of peripheral vascular disease.

          -  History of allergic skin conditions of the upper extremities.

          -  History of malignant hyperthermia.
Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
Condition: Cardiovascular Diseases; Depression; Heart Diseases; Myocardial Infarction; Angina, Unstable
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Angina, Unstable; Infarction; Depression; Depressive Disorder
Intervention: Sertraline/omega-3; Sertraline/Corn Oil
Intervention description: Sertraline (50 mgs) plus omega-3 (2 grams); Sertraline (50 mgs) plus corn oil (2 grams) (placebo)
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline
      on depression and cardiac endpoints after myocardial infarction (MI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets the DSM-IV criteria for a current major depressive episode

          -  Score of 15 or higher on the Beck Depression Inventory II

          -  History of acute myocardial infarction, unstable angina, or documented coronary
             disease

        Exclusion Criteria:

          -  Physician or patient refusal

          -  Lives far away from study site

          -  Current alcohol or drug abuse

          -  Psychosis, dementia, or bipolar disorder

          -  Already taking Omega-3

          -  Medically ill or disabled such that patient is unable to participate

          -  Comorbid illness likely to be fatal within 1 year of study entry

          -  Seizure disorder or takes anticonvulsants

          -  Pregnant or breast feeding

          -  Liver or kidney disease

          -  Severe hypertriglyceridemia (greater than 400 mg/dL)

          -  Bleeding or clotting disorder

          -  Type 2 diabetes with a hemoglobin A1c (HbA1c) level greater than 10

          -  Taking lithium or monoamine oxidase inhibitor (MAO-I)