bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Copaxone®
Intervention description: Subcutaneous Injections
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 861.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to compare patient medication satisfaction as measured
      by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three
      time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women at least 18 years of age or older.

          2. Patients must have a confirmed and documented RRMS diagnosis

          3. Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit.

          4. Patients must be in a stable neurological condition, relapse-free and free of any
             corticosteroid treatment 30 days prior to randomization.

          5. Women of child-bearing potential must have a negative urine pregnancy test at
             screening visit and must practice an acceptable method of birth

          6. Patients must be able to sign and date a written informed consent prior to entering
             the study.

          7. Patients must be willing and able to comply with the protocol requirements for the
             duration of the study.

        Exclusion Criteria

          1. Patient had any contraindication to Copaxone therapy.

          2. Previous use of Copaxone 40 mg/mL three times per week.

          3. Patients with progressive forms of MS.

          4. Patients with neuromyelitis optica.

          5. Use of experimental or investigational drugs, and/or participation in drug clinical
             studies within the 6 months prior to screening.

          6. Patients who have been treated with; immunosuppressive medications, immunoglobulins
             and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or
             mitoxantrone at any time

          7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid
             treatment within 6 months prior to screening visit.

          8. Pregnancy or breastfeeding.

          9. Clinically significant or unstable medical or surgical condition that would preclude
             safe and complete study participation

         10. Employees of the clinical study site or any other individuals involved with the
             conduct of the study, or immediate family members of such individuals

               -  other criteria may apply, please contact the investigator for more information
Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme
Condition: Adverse Effect of Unspecified General Anesthetics
Intervention: Supreme Laryngeal mask airway; Proseal laryngeal mask airway
Intervention description: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant; Proseal is a multiple use, variant of the laryngeal mask airway
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: laryngeal mask, proseal

Summary:

      Laryngeal mask airway is a widely used device in routine anesthesia for airway management
      during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth
      after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal
      mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway
      Supreme is a newer version of the laryngeal mask airway.

      The research is being done to compare two variants of the laryngeal mask airway: the Proseal
      laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the
      newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned
      than the older model, the Proseal laryngeal mask airway. Both models are approved for use by
      the FDA, and are routinely used to assure the airway during general anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 75 years

          -  ASA I and II

          -  Mallampatti class: I and II

          -  Thyromental distance > than 6.5 cm

          -  Interincisor distance > than 3 cm

          -  BMI < 35 Kg/m2

          -  Patients scheduled to undergo anesthesia with an LMA for minor extraperitoneal
             surgical procedures in supine position

        Exclusion Criteria:

          -  Weight < 50 kg

          -  BMI > 35 Kg/m2

          -  Pregnant patients

          -  Known or expected difficult airway

          -  Patients with active, untreated and unresolved gastroesophageal reflux

          -  Esophageal pathology, pulmonary pathology

          -  Laparoscopic procedures

          -  ENT procedures, gastrointestinal procedures, intraperitoneal surgical procedure
Ulcer Prevention Study in Post Gastric Bypass Patients
Condition: Marginal Ulcers
MeSH terms: Peptic Ulcer; Ulcer
Intervention: Omeprazole; Famotidine
Intervention description: 40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.; 40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
Intervention MeSH terms: Omeprazole; Famotidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gastric bypass surgery; anastomosis, Roux-en-Y; Complication, Postoperative

Summary:

      This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or
      Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer
      after gastric bypass surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is age ≥ 18 years

          -  Patient meets the criteria for laparoscopic gastric bypass surgery

          -  Females only: Patient is willing to take a urine pregnancy test

        Exclusion Criteria:

          -  Subject allergic to omeprazole or famotidine

          -  Patient receiving antifungal (i.e. ketoconazole or itraconazole)

          -  Hepatic insufficiency

          -  History of Crohns disease

          -  History of Zollinger-Ellison disease

          -  Patient received an investigational drug within 30 days of enrollment

          -  Patient currently enrolled in another research project

          -  Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks
Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; alpha-glucosidase inhibitors; DPP-4 inhibitors; meglitinides; SGLT-2 inhibitors; sulphonylurea; thiazolidinediones
Intervention description: Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.; Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
Intervention MeSH terms: Liraglutide; 2,4-thiazolidinedione; Meglitinide; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Glycoside Hydrolase Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1991.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate efficacy in
      controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment
      vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects
      with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female at least 18 years of age at the time of signing
        informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above
        90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal
        to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit -
        HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior
        to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or
        intends to become pregnant or is of childbearing potential and not using adequate
        contraceptive methods (adequate contraceptive measures as required by local regulation or
        practice) - Treatment with any medication for the indication of diabetes other than
        metformin in a period of 60 days before the screening visit. An exception is short-term
        treatment (below or equal to 7 days in total) with insulin in connection with intercurrent
        illness - Receipt of any investigational medicinal product within 30 days before the
        screening visit - Any disorder, which in the investigator's opinion might jeopardise
        subject's safety or compliance with the protocol
High Dose Vitamin B1 to Reduce Abusive Alcohol Use
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Benfotiamine; Placebo
Intervention description: Benfotiamine 600 mg; Placebo
Intervention MeSH terms: Benphothiamine
Phase: Phase 4
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
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Alcoholism; Benfotiamine; Thiamine

Summary:

      B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain
      systems damaged by alcohol and help people with alcohol problems control their alcohol use. A
      strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much
      higher levels than can be achieved using normal vitamin supplements. Drinking patterns are
      examined over 6 months of continued supplement use. Men and women with a recent history of
      alcohol problems are eligible to participate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Problem drinking in the last 30 days

        Exclusion Criteria:

          -  Prolonged abstinence

          -  Serious medical problems
Surgical Conditions During Laparoscopic Bariatric Surgery
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Intervention: Rocuronium; Insufflation pressure
Intervention description: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment; The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: morbid obesity; laparoscopic surgery; neuromuscular blockade

Summary:

      Obesity affects more than 78 million adults in the United States and it is estimated that 35%
      of the US population is obese. Currently, more than 179,000 bariatric procedures are
      performed in the US each year with the majority of these surgeries using laparoscopic
      techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but
      there is no evidence that a deep NMB improves surgical conditions and that the surgeons can
      discriminate between a moderate and deep NMB. There is also evidence that maintaining low
      insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal
      of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis
      that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in
      the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize
      lower insufflation pressure and decreases postoperative pain requirements after laparoscopic
      bariatric surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  ASA I-III

          -  BMI ≥ 35

        Exclusion Criteria:

          -  Inability to obtain written informed consent

          -  Pregnancy or breastfeeding

          -  Allergy to rocuronium, sugammadex, or any anesthetic agents used in the protocol

          -  Known or suspected neuromuscular disorders

          -  Significant renal disease with a serum creatinine ≥ 2 mg/dl f. Significant liver
             disease g. A family history of malignant hyperthermia
An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Nivolumab in combination with Ipilimumab
Intervention description: Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1041.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients
      with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or
      non-small cell lung cancer that has come back.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Stage 4 or recurrent non-small cell lung cancer

          -  Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out
             light housework or office work through to being fully active as you were before
             cancer)

          -  No prior systemic anticancer therapy (including EGFR and ALK inhibitors)

          -  Tissue or Programmed death-ligand 1 (PD-L1) results available

        Cohort 1A Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) score 2 or

          -  Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria
             as listed in the protocol

        Cohort C Inclusion Criteria:

          -  High Tumor Mutation Burden

        Exclusion Criteria:

          -  Untreated brain metastases

          -  An active malignancy that requires concurrent intervention

          -  Active, known or suspected autoimmune disease

          -  Carcinomatous meningitis, which means there is inflammation of the covering of the
             brain, caused by cancer

        Other protocol-defined inclusion/exclusion criteria apply
Melancholic Depression and Insomnia as Predictors of Response to Quetiapine in Patients With Major Depression
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Quetiapine 50 MG Extended Release Oral Tablet; Quetiapine Fumarate XR 150-300 mg; Placebos
Intervention description: OD; Dose ranged from 150 to 300mg, XR preparation, OD; Placebo
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1790.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      In essence the researchers are hoping to test two separate hypotheses (described below in the
      form of research questions). Therefore, the proposed analysis has been outlined according to
      each hypothesis.

      Hypothesis 1: Is low-dose quetiapine (50 mg/day) more effective for patients with depression
      who have insomnia at treatment baseline? (Stated differently: is low-dose quetiapine 50
      mg/day effective as monotherapy for patients with depression regardless of whether or not
      they have insomnia at baseline?).

      Hypothesis 2: Is high-dose quetiapine (150 - 300 mg/day) more effective for patients
      presenting with melancholic depression at treatment baseline?
    

Eligibility criteria:

        Inclusion Criteria:

          -  MDD with a HAM-D score of > 21 and > 1 on Item 1

        Exclusion Criteria:

          -  Axis I disorder in last 6 months

          -  Axis II disorder causing significant impact

          -  Current depressive episode > 12 months or < 4 weeks

          -  No response of current episode to > 6 weeks treatment with 2 or more classes of
             antidepressant medication

          -  Substance abuse or dependence in last 6 months

          -  Significant medical illness

          -  Conditions that may alter study drug metabolism

          -  Significant suicide or homicide risk

          -  HAM-D Item 3 score > 2

          -  Suicide attempt in the last 6 months

          -  Lab or physical exam abnormalities

          -  CYP34A inhibitors in last 2 weeks

          -  Active psychotherapy (not supportive) unless ongoing for > 3 months

          -  Antipsychotic, antidepressant, or mood stabilizer in last 7 days (28 days for
             fluoxetine), MAOI or anxiolytic in last 14 days, or deport antipsychotic within 2
             dosing intervals.
Prophylactic Pregabalin to Decrease Pain During Medical Abortion
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Pregabalin; Placebo
Intervention description: Pregabalin 300 mg capsule (over encapsulated to maintain blinding); Matching placebo capsule with excipient to match Pregabalin
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Medical abortion has been associated with significant pain. The objective of this trial is to
      determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to
      the standard of care analgesics, will decrease experienced pain. Investigators will perform a
      randomized, double-blinded, placebo-controlled trial. Participant pain levels and side
      effects will be assessed at multiple time points, along with a measure of satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requested and consented for pregnancy termination by medical abortion

          -  Willing and able to complete multiple electronic surveys

        Exclusion Criteria:

          -  Previous participation in this trial

          -  Current use of pregabalin or gabapentin

          -  Contraindication to medical abortion with mifepristone and misoprostol

          -  Contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin

          -  Unable to understand and sign written informed consents in English
Comparison of Blood Pressure Medications on Metabolism
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: carvedilol; metoprolol
Intervention description: variable; variable
Intervention MeSH terms: Metoprolol; Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: diabetes blood pressure oxidative stress

Summary:

      The purpose of this study is to determine if there are differences, (benefits) between
      carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes.
      Specifically we will be looking at differences in blood pressure and blood sugar control,
      endothelial function, inflammation, oxidative stress and coagulation.

      Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each
      subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done,
      Inflammatory and oxidative stress markers will be measured. Endothelial function will be
      measured using brachial artery ultrasound and laser skin Doppler
    

Eligibility criteria:

        Inclusion Criteria:

          -  not enrolling

        Exclusion Criteria:

          -  not enrolling
Presbyopia-Correcting Intraocular Lenses (IOLs)
Condition: Cataract
MeSH terms: Cataract; Presbyopia
Intervention: ReSTOR +3; Crystalens HD; Crystalens AO
Intervention description: Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.; Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.; Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 132.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: ReSTOR +3

Summary:

      The purpose of this study is to prospectively evaluate postoperative visual and refractive
      parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting
      Intraocular Lenses (IOLs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with bilateral cataracts

          -  candidate for presbyopic lens

        Exclusion Criteria:

          -  > 1 Diopter preoperative astigmatism by Keratometry readings

          -  pre-existing conditions that could skew the results