bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Rowachol on Prevention of Postcholecystectomy Syndrome
Condition: Postcholecystectomy Syndrome
MeSH terms: Postcholecystectomy Syndrome; Syndrome
Intervention: Rowachol; Placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: postcholecystectomy syndrome; laparoscopic cholecystectomy; Rowachol

Summary:

      Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually
      manifested by the presence of abdominal symptoms following gallbladder removal. The
      pathogenesis of PCS has not been identified; therefore there is no consensus of medical
      treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric
      acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients
      with cholesterol gallstones, and to promote biliary lipid secretion.

      The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS
      and symptoms change after laparoscopic cholecystectomy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pathologic diseases scheduled for laparoscopic cholecystectomy

        Exclusion Criteria:

          -  Current immunosuppressive therapy

          -  Chemotherapy within 4 weeks before operation

          -  Radiotherapy completed longer than 4 weeks before operation

          -  Inability to follow the instructions given by the investigator

          -  Severe psychiatric or neurologic diseases

          -  Drug- and/or alcohol-abuse according to local standards

          -  Participation in another intervention-trial with interference of a primary or
             secondary endpoint of this study

          -  Lack of compliance

          -  Lack of informed consent
Patient Satisfaction With Propofol for Out Patient Colonoscopy
Condition: Colon Cancer; IBS; Polyps
MeSH terms: Colonic Neoplasms
Intervention: Propofol; Fentanyl Plus Midazolam
Intervention description: The intervention is to use propofol as anesthesia during a colonoscopy.; The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
Intervention MeSH terms: Midazolam; Fentanyl; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: propofol; colonoscopy; patient satisfaction

Summary:

      The primary purpose of this study is to determine if patient satisfaction with propofol is
      better than with non-propofol anesthesia for outpatient colonoscopies.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients having an outpatient colonoscopy

        Exclusion Criteria:

        - High risk patients (ASA IV & V) who are not candidates for colonoscopy in an outpatient
        center will be excluded.
Adult Bipolar Mania
Condition: Acute Mania
MeSH terms: Mania; Bipolar Disorder
Intervention: Quetiapine fumarate XR; Lithium; Placebo
Intervention description: Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.; Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.; Oral treatment twice daily.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute Mania; Mania, Adults; Seroquel; Acute Mania in Adult Patients

Summary:

      The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added
      to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in
      treating acute mania and if so, how it compares with placebo (a non-active capsule, like a
      sugar pill, that looks like lithium).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent before any study procedures are performed.

          -  The patient must have a documented clinical diagnosis for bipolar I disorder,
             including recent episode manic or mixed, and being male of females age 18-65 years,
             inclusive.

          -  Patients may be outpatients or inpatients at enrollment visit, but all patients must
             be inpatients when randomized and remain inpatients until discharged at the discretion
             of the investigator.

        Exclusion Criteria:

          -  The patient can not have had up to 8 mood episodes during the past 12 months and not
             been continuously hospitalized for acute bipolar for up to 3 weeks immediately before
             participating in the study.

          -  The patient can not have a past diagnosis of stroke or medically documented transient
             ischemic attacks (TIA) or a history of seizure disorder, except for febrile
             convulsions.

          -  The patient must not have received electroconvulsive treatment (ECT) within 90 days
             before participating in the study and in the doctors judgement pose a current suicidal
             or homicidal risk.
A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch;
Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h;
One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery.
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rotigotine; NEUPRO®; Parkinson's Disease (PD); perioperative use; anaesthesia,

Summary:

      Evaluation of efficacy and safety on the use of rotigotine in patients suffering from
      Parkinson's Disease during and after surgery requiring general anaesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has idiopathic Parkinson's disease (early- or advanced-stage), as defined by
             the cardinal sign bradykinesia, plus the presence of at least one of the following:
             resting tremor, rigidity, or postural instability and is without any other known or
             suspected cause of Parkinsonism.

          -  Subject is scheduled for an operation requiring general anesthesia.

        Exclusion Criteria:

          -  Subject has previously been treated with rotigotine.

          -  Subject has a history of significant skin hypersensitivity to adhesives or other
             transdermals or recent unresolved contact dermatitis or has a known allergy or
             hypersensitivity to rotigotine or to other components of the patch.

          -  Subject is scheduled for a surgical procedure (surgery per protocol(SPP)) that
             requires magnetic resonance imaging or cardioversion.

          -  Subject has a high probability to require extended postoperative ventilation (> 24
             hours).

          -  Subject has any medical condition that, in the opinion of the investigator, could
             jeopardize or compromise the subject's ability to participate in this trial.
The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Intervention: Elevate Mesh; Anterior Colporrhaphy
Intervention description: Transvaginal mesh repair of anterior vaginal prolapse; Traditional suture repair of anterior vaginal prolapse
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 5.0
Sex: Female
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cystocele; Bladder prolapse; Anterior prolapse; Vaginal prolapse; Uterine prolapse; Urinary incontinence

Summary:

      This study is designed to compare the safety and efficacy of a commercially available mesh
      kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with symptomatic pelvic organ prolapse who opt for a vaginal repair

          -  Require both apical and anterior compartment repairs

          -  Willing to return for follow-up visit

          -  Understand and have signed informed consent to undergo randomization

          -  Need both an apical and anterior repair

          -  All trial participants who have a uterus will require a hysterectomy

        Exclusion Criteria:

          -  Known or suspected vulvodynia

          -  Known or suspected interstitial cystitis

          -  History of chronic pelvic pain

          -  Current pregnancy

          -  Desire to maintain fertility

          -  History of reconstructive pelvic surgery with synthetic mesh

          -  History of radical pelvic surgery

          -  History of pelvic radiation therapy

          -  Currently undergoing treatment for a malignancy

          -  Medically poor candidates for surgery
A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
Condition: Femoro Acetabular Impingement
MeSH terms: Femoracetabular Impingement
Intervention: liposomal bupivicaine; Fascia iliaca blockade
Intervention description: local field infiltration; fascia iliaca compartment blockade
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hip arthroscopy

Summary:

      The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local
      field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and
      falls in the postoperative period following hip arthroscopy
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients (>18 years old)

          -  diagnosed FAI that are indicated for hip arthroscopic labral repair and
             femoroplasty/acetabuloplasty.

        Exclusion Criteria:

          -  patients undergoing revision procedures, bilateral procedures,

          -  advanced osteoarthritis (<2mm joint space on plain radiographs)

          -  frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis
             angle >15 degrees)

          -  diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic
             arthritis, or post traumatic deformity).

          -  allergy to liposomal bupivicaine
Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)
Condition: Premenstrual Dysphoric Disorder
MeSH terms: Premenstrual Dysphoric Disorder
Intervention: Continuous OC (EE/DROS); Intermittent OC (EE/DROS); placebo
Intervention description: Continuous EE(20ug)+DROS(3mg) daily for 3 months; Intermittent EE(20ug)+DROS(3mg) daily for 21 days each month; daily placebo
Intervention MeSH terms: Drospirenone and ethinyl estradiol combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Maximum age: 52 Years
Healthy volunteers: No
Keywords: PMDD; Oral contraceptives; steroid hormones; neurosteroids

Summary:

      The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously
      (every day for three months) with the same low dose oral contraceptive given in an
      interrupted regimen (one week of inactive placebo pills each month) and with continuous
      placebo (inactive placebo given every day for three months). The primary hypothesis is that
      continuous OC will be significantly more effective in reducing premenstrual symptoms compared
      with either the interrupted OC or continuous placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meets prospective criteria for PMDD, AND

          -  English speaking and reading skills.

        Exclusion Criteria:

          -  current psychiatric disorder other than PMDD,

          -  history of venous thromboembolism,

          -  over 35 years of age and obese,

          -  uncontrolled hypertension or end-organ vascular disease,

          -  diabetes,

          -  migraine headache with aura,

          -  breastfeeding or pregnant,

          -  cigarette smoking,

          -  family history of premenopausal breast cancer or breast cancer in more than one first
             degree relative,

          -  elevated serum potassium levels, use of prescription medications (except stable
             thyroid supplementation),

          -  irregular menstrual cycles, OR

          -  history of: endometriosis, hepatic disease, breast carcinoma, pulmonary embolism or
             phlebothrombosis, malignant melanoma, cholecystitis or pancreatitis.
Management of Superficial Thrombophlebitis
Condition: Superficial Thrombophlebitis; Upper Extremity Superficial Thrombophlebitis; Lower Extremity Superficial Thrombophlebitis
MeSH terms: Thrombophlebitis
Intervention: Dalteparin sodium injection
Intervention description: Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneous daily for seven days.
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Superficial Thrombophlebitis; STP; Fragmin; Ibuprofen; Superficial Thrombus; Superficial Phlebitis; phlebitis

Summary:

      The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium)
      subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three
      times daily for 7 days for the treatment of superficial thrombophlebitis (STP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with confirmed upper or lower extremity superficial thrombophlebitis by
             ultrasound imaging

        Exclusion Criteria:

          -  Active, clinically significant bleeding

          -  Known hypersensitivity to NSAIDS, heparin or derivatives

          -  Currently pregnant or < 1 week post-partum

          -  Acquired bleeding diathesis

          -  Known inherited bleeding disorder

          -  Renal failure

          -  Extremes of weight

          -  unable to return for repeat diagnostic testing or follow-up visit

          -  Concurrent deep-vein thrombosis
Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension; Vehicle; Travoprost 0.004% ophthalmic solution
Intervention description: Inactive ingredients used as a placebo comparator
Intervention MeSH terms: Brimonidine Tartrate; Travoprost; Ophthalmic Solutions; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glaucoma; prostaglandin analogue; brinzolamide; brimonidine

Summary:

      The purpose of this study is to demonstrate the additive effect of brinzolamide
      1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or
      ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy (TRAVATAN
      Z®).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open angle glaucoma or ocular hypertension;

          -  Mean IOP measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 8 AM
             while on travoprost monotherapy at 2 consecutive visits (Eligibility 1 and Eligibility
             2);

          -  Able to understand and sign Informed Consent form;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential who are pregnant, breastfeeding, or do not agree to
             use an adequate birth control method throughout the study;

          -  Any form of glaucoma other than open angle glaucoma or ocular hypertension;

          -  Severe central visual field loss;

          -  Chronic, recurrent, or severe inflammatory eye disease;

          -  Ocular trauma within the past 6 months;

          -  Ocular infection or ocular inflammation within the past 3 months;

          -  Best-corrected visual acuity score worse than approximately 20/80 Snellen;

          -  Eye surgery within the past 6 months;

          -  Any condition, including severe illness, which would make the subject unsuitable for
             the study in the opinion of the Investigator;

          -  Use of any additional topical or systemic ocular hypertensive medication during the
             study;

          -  Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering
             ocular medication(s) per the appropriate washout schedule prior to Eligibility 1
             Visit;

          -  Other protocol-defined exclusion criteria may apply.
PR-018: An Open-Label, Safety Extension of Study PR-011
Condition: Cystic Fibrosis; Exocrine Pancreatic Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: EUR-1008 (APT-1008)
Intervention description: EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose will be adjusted based on participants' age and body weight. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment will be up to 12 months.
Intervention MeSH terms: Pancrelipase
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Maximum age: 12 Months
Healthy volunteers: No
Keywords: Exocrine Pancreatic Insufficiency; Infants with CF

Summary:

      A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008)
      3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine
      pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant's parent or guardian signed informed consent form (ICF)

          -  Participants who have completed study PR-011 (NCT01100606)

        Exclusion Criteria:

          -  Participant having any condition that would, in the investigator's opinion, limit the
             participant's ability to complete the study or will result in excess risk to the
             participant that is above the standard of care
Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: olanzapine; risperidone
Intervention description: 5-20 mg, oral, capsules, daily, 12 weeks.; 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
Intervention MeSH terms: Olanzapine; Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will assess whether olanzapine and/or risperidone affect the way the human body
      uses sugar in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years old

          -  Diagnosed with Schizophrenia or Schizoaffective disorder

          -  Ability to visit the doctor's office for scheduled visits

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Have a body mass index (BMI) greater than 40

          -  Have diabetes, heart disease or any other unstable illness

          -  Have known positive human immunodeficiency virus (HIV)

          -  Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable
             antipsychotics