bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Study Between Minidose Long Protocol and Microdose Flare Protocol in Controlled Ovarian Hyperstimulation
Condition: Infertility
MeSH terms: Infertility
Intervention: Decapeptyl
Intervention description: half the dose of Gn agonist
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 35 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Low responders; Minidose long protocol; Microdose flare protocol; Oocyte yield

Summary:

      Objective: To compare two stimulation protocols, the minidose long protocol and the microdose
      flare protocol designed for low responders undergoing ICSI.

      Design: Randomized prospective study. Setting: University hospital IVF unit. Patients: 60
      poor responder patients coming for IVF center for ICSI. Interventions: Minidose long protocol
      in which half the dose of agonist was administered from the mid luteal phase until the day of
      HCG administration was compared with microdose flare protocol in which half the dose of GnRH
      was administered from the second day of the cycle until the day of HCG administration. Both
      groups received Gn stimulation from the second day of the cycle (300-450 IU).

      Main outcome measures: Number of oocytes retrieved.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 35 years

          -  Day 3 serum FSH level > 10m IU/ml

          -  Number of antral follicles measuring 4-8mm during the early phase < 6

          -  Small ovarian volume

          -  AMH < 1

          -  Prior poor ovarian response to COH (oocytes < 5)

        Exclusion Criteria:

          -  Polycystic ovarian syndrome patients

          -  Patients with Endometriosis

          -  Normal responders to ovulation induction

          -  Patients having ovarian cyst

          -  Patients receiving ovulation induction in the preceding cycle
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Filgotinib; PTM filgotinib
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1351.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy of filgotinib in the
      induction and maintenance treatment of moderately to severely active ulcerative colitis (UC)
      in participants who are biologic-naive and biologic-experienced.

      Participants who complete the study, or met protocol specified efficacy discontinuation
      criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead
      Study GS-US-418-3899: NCT02914535).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
             the date of the screening visit

          -  Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of
             15 cm from the anal verge. Documentation should include endoscopic and histopathologic
             evidence of UC.

          -  A surveillance colonoscopy is required at screening in individuals with a history of
             UC for 8 or more years, if one was not performed in the prior 24 months

          -  Moderately to severely active UC

          -  Previously demonstrated an inadequate clinical response, loss of response to, or
             intolerance to at least 1 of the following agents (depending on current country
             treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor
             necrosis factor alpha (TNFa) antagonists, or vedolizumab

        Key Exclusion Criteria:

          -  Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant
             colitis, ulcerative proctitis, or toxic mega-colon

          -  Active tuberculosis (TB) or history of latent TB that has not been treated

          -  Use of any concomitant prohibited medications as described in the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The EVARREST® Fibrin Sealant Patch Liver Study
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: EVARREST® Fibrin Sealant Patch; Standard of Care (SoC)
Intervention MeSH terms: Fibrin Tissue Adhesive
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: 18 Years
Healthy volunteers: No
Keywords: Hepatobiliary Surgery

Summary:

      To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch
      (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during
      hepatic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery.

          -  Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as
             identified intra-operatively by the surgeon

          -  Subjects or legally authorized representatives must be willing to participate in the
             study, and provide written informed consent. (Note: This criteria does allow for
             hospital translators to be used where approved by Ethics Committees/Institutional
             Review Boards)

        Exclusion Criteria:

          -  Subjects with any intra-operative findings identified by the surgeon that may preclude
             conduct of the study procedure;

          -  TBS is from large defects in arteries or veins where the injured vascular wall
             requires repair with maintenance of vessel patency and which would result in
             persistent exposure of EVARREST® to blood flow and pressure during healing and
             absorption of the product;

          -  TBS with major arterial bleeding requiring suture or mechanical ligation;

          -  Subjects admitted for trauma surgery;

          -  Subject is a transplant patient for fulminant hepatic failure

          -  Subject with TBS within an actively infected field;

          -  Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony
             confine;

          -  Subjects with known intolerance to blood products or to one of the components of the
             study product or is unwilling to receive blood products;

          -  Subjects who are known, current alcohol and / or drug abusers;

          -  Subjects who have participated in another investigational medical device or
             investigational drug trial within 30 days of surgery or are expected to participate in
             another medical device or investigational drug trial during the course of the study;

          -  Female subjects who are pregnant or nursing.
Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.
Condition: Pre-diabetes; Older Adults
MeSH terms: Diabetes Mellitus; Prediabetic State; Weight Loss
Intervention: liraglutide; Placebo
Intervention description: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.; Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a
      long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead
      to greater weight loss than will a calorie-restricted diet alone in subjects who are older
      (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been
      selected for study because they are at greatly increased risk to develop type 2 diabetes
      (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of
      liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse
      outcomes.

      There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic
      control in patients with manifest 2DM. However, there is relatively little information as to
      the potential utility of these compounds in nondiabetic individual at greatly increased risk
      of 2DM and CVD. This research proposal is aimed at providing some of this information by
      quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin
      secretion, insulin action, and multiple CVD risk factors in a very high risk group-older,
      overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not
      surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be
      possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin
      action.
    

Eligibility criteria:

        Inclusion Criteria:

        IFG, or IGT BMI 27.0-37.0 kg/m2

        Exclusion Criteria:

        DM, CAD, severe anemia, kidney or liver disease, hx of pancreatitis, gallstones, ETOH
        abuse, personnel or family history of medullary thyroid carcinoma or MEN-2
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis
Intervention: SOF/VEL
Intervention description: 400/100 mg tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sofosbuvir; SOF/GS-5816; GS-5816; Hepatitis C; HCV; Cirrhosis; Velpatasvir

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1,
      2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study
      GS-US-342-1138.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

          -  Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Classification as treatment naive or treatment experienced

          -  Males and females of childbearing potential who engage in heterosexual intercourse
             must agree to use protocol specified method(s) of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically-significant illness (other than HCV) or any
             other major medical disorder that may interfere with treatment, assessment, or
             compliance with the protocol; individuals currently under evaluation for a potentially
             clinically-significant illness (other than HCV) are also excluded.

          -  Screening electrocardiogram (ECG) with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at screening

          -  Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A
             inhibitor

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; montelukast sodium; aminophylline hydrate
Intervention description: Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes; Montelukast 14 mg single injection (IV bolus administration) over 5 minutes; Aminophylline 250 mg IV drip infusion over 60 minutes
Intervention MeSH terms: Aminophylline; Theophylline; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 15 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study estimates the efficacy and safety of MK0476 and aminophylline intravenous
      administration in adult participants with acute asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants with acute asthma attacks

        Exclusion Criteria:

          -  Participant has any known or suspected, acute or chronic cause for their pulmonary
             symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).

          -  Participant has a smoking habit (15 cigarettes per day) within a month prior to
             screening period, and/or has a smoking history (20 cigarettes per day) of more than 15
             years.

          -  Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems,
             or other severe disease.
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
Condition: Multiple Sclerosis; Relapsing Multiple Sclerosis; Advancing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Siponimod
Intervention description: Siponimod 2mg tablets taken once daily
Intervention MeSH terms: Siponimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label single arm study
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Relapsing multiple sclerosis; Advancing multiple sclerosis; conversion; siponimod; adult; BAF312; disease modifying therapies; cognitive assessment; open-label

Summary:

      To assess safety and tolerability of patients converting from approved Relapsing Multiple
      Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Signed informed consent.

          2. Male or female aged 18 to 65 years (inclusive).

          3. Patients with advancing RMS as defined by the principal investigator.

          4. Prior history of relapsing MS (RMS), with or without progressive features, according
             to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).

          5. EDSS score of >/= 2.0 to 6.5 (inclusive).

          6. Having been continuously treated with RMS Disease Modifying Therapies.

        Key Exclusion criteria:

          1. Pregnant or nursing (lactating) women.

          2. Patients with any medically unstable condition as determined by the investigator.

          3. Certain cardiac risk factors defined in the protocol

          4. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

        Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Ziprasidone oral capsules; placebo oral capsules
Intervention description: Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.; Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 238.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective
      for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or
      mixed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

        Exclusion Criteria:

          -  Imminent risk of suicide or homicide, as judged by the site investigator; any history
             of serious or unstable medical illness, including risk for QT prolongation
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
Condition: ACL Injury; Postoperative Pain
MeSH terms: Pain, Postoperative; Anterior Cruciate Ligament Injuries
Intervention: Ketorolac; Oxycodone-Acetaminophen
Intervention description: Oral ketorolac for pain control following ACL reconstruction surgery; Oral oxycodone-acetaminophen for post-operative pain control
Intervention MeSH terms: Acetaminophen; Ketorolac; Acetaminophen, hydrocodone drug combination; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ACL reconstruction; Ketorolac; Pain; Narcotic

Summary:

      1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent
           to the standard of care pain protocol for postoperative pain control following ACL
           reconstruction surgery.

        2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the
           standard of care pain protocol will reduce postoperative opioid consumption following
           ACL reconstruction surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 18 and 89 years old

          -  Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

        Exclusion Criteria:

          -  Patients below age 18 or above age 89

          -  Illiterate or non-English speaking individuals

          -  Patients with contraindications to Ketorolac

          -  History of chronic alcohol or drug abuse

          -  Chronic use of psychotropic or analgesic drugs

          -  Known peptic ulcer disease or bleeding diasthesis

          -  Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)

          -  Breastfeeding women

          -  Pregnant women
Prevention of Asthma With Levocetirizine (36 Month Treatment) in Young Children Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and House Dust Mite and Having Completed the Previous EPAAC Trial (NCT00152464)
Condition: Asthma
MeSH terms: Asthma
Intervention: LEVOCETIRIZINE; Placebo
Intervention description: 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months; Oral drops, bid for 18 months
Intervention MeSH terms: Levocetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 30 Months
Maximum age: 42 Months
Healthy volunteers: No
Keywords: Pediatry; EPAAC; atopic Children; prevention of asthma; Levocetirizine; Xyzal

Summary:

      Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic
      Children).

      36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing
      the onset of asthma in young atopic children.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria which must be verified at the end of first 18-months treatment (Visit 9)

          -  Having completed the previous 18-month treatment period of the EPAAC trial -
             NCT00152464

        Exclusion Criteria:

          -  None
Lamotrigine Extended-Release In Elderly Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Lamotrigine
Intervention description: Open-label
Intervention MeSH terms: Lamotrigine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy elderly seizure

Summary:

      This study is being conducted to determine the safety and tolerability of lamotrigine (LTG)
      in elderly patients with epilepsy. This study will be carried out using an extended-release
      formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.
    

Eligibility criteria:

        Inclusion criteria:

          -  Confident diagnosis of epilepsy

          -  Currently treated with one or two antiepileptic medications

          -  Able to complete a seizure diary

        Exclusion criteria:

          -  History of hypersensitivity to lamotrigine

          -  Progressive diseases that would interfere with the study objectives