bioihbjkbjnl/mcl2 huggingface dataset:
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Condition: Liver Transplant; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Liver Cirrhosis; Fibrosis
Intervention: Cyclosporine A; Tacrolimus
Intervention description: Initial dose of 10-15mg/kg/day either orally, via a nasogastric (NG) tube or intravenously (i.v.) within the first 24 hours post-transplantation.; Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses either orally or via a nasogastric (NG) tube or intravenously (i.v).
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Liver transplant, adults, hepatitis C, liver fibrosis, cyclosporine microemulsion, tacrolimus

Summary:

      Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases
      and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this
      study was to see if the frequency of liver fibrosis was different with cyclosporine
      microemulsion than tacrolimus
    

Eligibility criteria:

        Inclusion criteria

          -  Reason for transplant is end-stage liver disease due to hepatitis C cirrhosis

          -  Patients receiving a first liver transplant from a deceased or living donor

          -  Patients in whom biopsies will be possible

        Exclusion criteria

          -  Recipients of a liver from an hepatitis C virus positive (HCV+), human
             immunodeficiency virus positive (HIV+) or hepatitis B virus positive (HBV+) donor

          -  Patients with any severe coexisting disease or suffering any unstable medical
             condition or co-infected with HBV or HIV

          -  Patients with co-existing alcoholic disease who have not been abstinent for at least 6
             months

          -  Transplanted for liver cancer exceeding a pre-defined size

          -  Pregnant or nursing women

        Other protocol-defined inclusion/exclusion criteria may apply
Neuromuscular Blockade During Transurethral Resection of Bladder Cancer
Condition: Neuromuscular Blockade
MeSH terms: Urinary Bladder Neoplasms
Intervention: Rocuronium; Sugammadex
Intervention description: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.; Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the
      mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia
      for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the
      use of sugammadex as a reversal agent may be associated with better endoscopic surgical
      condition and recovery profile compared with moderate NMB during TURB.

      This study was designed to compare patients with deep neuromuscular blockade (NMB) with
      moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical
      condition and postoperative recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged more than 18 years

          -  American Society of Anesthesiologists (ASA) physical status I and II

          -  scheduled to undergo elective Transurethral resection of the bladder tumor (TURB)

        Exclusion Criteria:

          -  history of neuromuscular, renal, or hepatic disease

          -  a body mass index (BMI) of < 18.5 or > C 30.0 kg/m2

          -  treatment with drugs known to interfere with neuromuscular function
COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
Condition: Colorectal Surgery
Intervention: ColonRing (Colorectal anastomosis)
Intervention description: Creation of a colorectal compression anastomosis
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colon Anastomosis; Rectum Anastomosis; Intestine; Colorectal Surgery; Colorectal Anastomosis

Summary:

      The performance of the ColonRing™ will be comparable to or better than the reported
      performance of staplers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is ≥ 18 years old.

          2. BMI < 34.

          3. Subject is planned to undergo a non-emergency (i.e., elective) operation with the
             creation of an anastomosis using the ColonRing™.

          4. Subject signs and dates a written informed consent form (ICF) and indicates an
             understanding of the study procedures.

        Exclusion Criteria:

          1. Subject has a known allergy to nickel.

          2. Subject is planned to undergo an emergency procedure or has a diagnosis of bowel
             strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic
             bowel,carcinomatosis.

          3. Subject has participated in another clinical study which may affect this study's
             outcomes within the last 30 days.

          4. Subject's ASA (American Society of Anesthesiology) score 4 or 5.

          5. Subject has a concurrent or previous invasive pelvic malignancy.

          6. Subject has a systemic or incapacitating disease.

          7. Subject has extensive local disease in the pelvis.

          8. Subject requires more than one anastomosis during the surgery.

          9. Women who are known to be pregnant.
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution; latanoprost 0.005% ophthalmic solution
Intervention description: Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.; Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Intervention MeSH terms: Timolol; Bimatoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination
      (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never
      been previously treated and are at high risk for progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary open-angle glaucoma that has never been treated

          -  Visual Acuity 20/60 or better in each eye

        Exclusion Criteria:

          -  Eye surgery within 3 months

          -  Any refractive eye surgery

          -  Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive
             pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of
             severe myocardial infarction [heart attack])

          -  Eye inflammation or eye infection within 3 months

          -  Eye trauma within 6 months

          -  Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use
             during study
NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial
Condition: Epistaxis
MeSH terms: Epistaxis
Intervention: Doxycycline; Placebo
Intervention description: Doxycycline, 100 mg twice a day for 2 months; Matching placebo, twice a day for 2 months
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epistaxis; Hereditary Hemorrhagic Telangiectasia; HHT; Doxycycline; Nosebleed

Summary:

      The purpose of this research study is to determine whether Doxycycline can be used to control
      nosebleeds (epistaxis) for patients with Hereditary Hemorrhagic Telangiectasia (HHT).
      Patients with HHT will be randomized to one of 2 study arms: Doxycycline or Placebo for a
      period of 2 months followed by a 1-month washout period before switching treatments for a
      further 2 months period. Observation and evaluation will continue for a period of one month
      after treatment is completed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of definite HHT by the Curacao criteria or genetic diagnosis of HHT

          -  Epistaxis severity during observation month at least moderate by Epistaxis Severity
             Score (ESS) evaluation

          -  For female participants, a negative pregnancy test at Day -1 and agree to use birth
             control during treatment and for 28 days following cessation of Doxycycline

        Exclusion Criteria:

          -  Use of medication(s) contraindicated with doxycycline use within 14 days prior to the
             study (including barbiturates, tegretol, dilantin, warfarin, isotretinoin)
Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: High blood pressure, hypertension, aliskiren, low sodium diet

Summary:

      This study will compare the effects of high and low level sodium (salt) diets on blood
      pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients 18-60 years old

          -  Patients with systolic hypertension who met the 24 hour Ambulatory Blood Pressure
             Monitoring (ABPM) criteria (ABPM mean daytime Systolic Blood Pressure (SBP) >= 135
             mmHg and < 160 mmHg)

        Exclusion Criteria:

          -  Overt heart failure (HF) or a history of heart failure within preceding 6 months.

          -  Unstable angina pectoris.

          -  Type 1 or Type 2 diabetes mellitus or abnormal hemoglobin A1c(HbA1c)

          -  Body mass index (BMI) > 30 kg/m2

          -  Subjects taking more than 2 antihypertensive medications.

          -  Use of other investigational drugs within 30 days of the time of enrollment

          -  Use of Tamsulosin hydrochloride and other alpha blockers.

          -  Use of Antiarrhythmic drugs, including digoxin.

          -  History of MI or cardiovascular attack (CVA) within the preceding 6 months.

          -  History of malignancy of any organ system, treated or untreated, within the past 5
             years with the exception of localized basal cell carcinoma of the skin

          -  Pregnant or nursing (lactating) women
Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
Condition: Laceration; Anxiety
MeSH terms: Lacerations
Intervention: Dexmedetomidine; Midazolam
Intervention MeSH terms: Midazolam; Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Midazolam

Summary:

      The objective of this research study is to show superiority of intranasal dexmedetomidine to
      intranasal midazolam as anxiolysis prior to pediatric laceration repairs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical
             Center

          -  Laceration <5 cm in total length

          -  Require simple suture laceration repair

        Exclusion Criteria:

          -  Allergies/intolerance/contraindication to the study drugs

          -  Lacerations requiring complex (multilayer) repair or total laceration length>5cm
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Condition: Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome; Premenstrual Dysphoric Disorder
Intervention: Flutamide; Placebo
Intervention description: Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.; Participants will take a lactose capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
Intervention MeSH terms: Flutamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 115.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Premenstrual Dysphoric Disorder; PMDD; PMS

Summary:

      This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual
      dysphoric disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for PMDD by history

          -  Regular menstrual cycles that are 25 to 35 days in length during the year prior to
             study entry

          -  Willing to use barrier methods of birth control during the study if sexually active

          -  If engaged in psychotherapy for at least 3 months before study entry, participation
             will be allowed if the intensity of psychotherapy remains the same during the study

          -  Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study
             entry

        Exclusion Criteria:

          -  Use of oral contraceptives or other exogenous hormone preparations within the 3 months
             prior to study entry

          -  Suicide attempt or severe suicidal ideation within the 2 years prior to study entry

          -  History of any psychotic disorder or bipolar disorder

          -  Substance abuse, except nicotine, within the 6 months prior to study entry

          -  Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones,
             gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations,
             diuretics) within the 3 months prior to study entry

          -  Daily use of psychotropic or anticonvulsant medications within the 3 months prior to
             study entry

          -  Use of sleeping pills more than once per week

          -  Consumption of more than 50 ounces of alcohol per week

          -  Pregnant or breastfeeding

          -  Hepatic, renal, autoimmune, or chronic inflammatory disease

          -  Seizure disorder

          -  Inability to read or follow instructions in English
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
Condition: Malaria
MeSH terms: Malaria
Intervention: chloroquine; Artemether-lumefantrine combination; Primaquine; Primaquine
Intervention description: standard dose; standard dose; single dose; 14 days
Intervention MeSH terms: Chloroquine; Lumefantrine; Artemether; Primaquine; Artemether, Lumefantrine Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 12 Months
Healthy volunteers: No

Summary:

      This is a study assessing safety and efficacy of current national guidelines for the
      treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among
      the enrolled patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 12 months

          -  P. vivax or P. falciparum monoinfection or P.v. / P.f. mixed infection

          -  Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs

          -  Ability to swallow oral medication.

          -  Ability and willingness to comply with the study protocol for the duration of the
             study

          -  Informed consent/assent from the patient or from a parent or guardian in the case of
             children.

        Exclusion Criteria:

          -  Presence of general danger signs in children aged under 5 years or signs of severe
             malaria according to the definitions of WHO

          -  Presence of severe malnutrition

          -  Acute anaemia <8g/dL

          -  Regular medication, which may interfere with antimalarial pharmacokinetics

          -  History of hypersensitivity reactions or contraindications to any of the drug(s)
             tested or used as alternative treatment(s)

          -  A positive pregnancy test or lactating
Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Condition: Femoroacetabular Impingement
MeSH terms: Femoracetabular Impingement
Intervention: platelet-rich plasma injection; Kenalog 10 MG/ML Injectable Suspension
Intervention description: platelet-rich plasma injection; 4 mL corticosteroid injection
Intervention MeSH terms: Triamcinolone Acetonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the clinical response of intra-articular platelet
      rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular
      impingement (FAI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic FAI

          -  Clinical and radiographic evidence of FAI

          -  Patients able to provide consent to study participation

          -  Completion of 6 weeks of physical therapy program

        Exclusion Criteria:

          -  Established Osteoarthritis (Kellgren-Lawrence > 3)

          -  Minimum joint space > 2 mm as measured on AP radiograph

          -  Hip dysplasia (center edge angle < 20° on AP radiograph)

          -  Patients with clinically significant cardiovascular, renal, hepatic, endocrine
             disease, cancer or diabetes

          -  Patients with ongoing infection including HIV and Hepatitis

          -  Patient with history of osteomyelitis/septic arthritis

          -  Anticoagulation therapy

          -  Patients who are pregnant or breast feeding

          -  Patients with systemic, rheumatic or inflammatory disease of the knee or
             chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee
             associated with juxta-articular Paget's disease of the femur or tibia, hemophilic
             arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and
             synovial chondromatosis

          -  Patients taking immunosuppressant medication

          -  Patients with abnormal hematology or serum chemistry lab results

          -  Patients receiving injection to treatment knee within 2 months of study enrollment

          -  BMI greater than 35 or less than 20
Safety Study Looking at the Effects of Stendra on Vision
Condition: Vision
Intervention: Stendra 200 mg; Placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vision; Stendra; avanafil; PDE5 inhibitor; visual acuity; intraocular pressure; pupillometry; color vision discrimination; healthy males

Summary:

      The purpose of this study is to see if Stendra causes any changes in vision, eye pressure,
      pupil dilation, and color vision in healthy males.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult males 18 to 45 years of age, inclusive

          -  Non-tobacco user for at least 6 months prior to first dose

        Exclusion Criteria:

          -  History or presence of retinal disease or any vision defects including color vision

          -  Intraocular pressure value ≥ 22mm Hg

          -  Resting heart rate < 45 or > 90 beats per minute (3 rechecks)

          -  Systolic blood pressure < 90 or > 140 mm Hg or Diastolic blood pressure < 50 or >90 mm
             Hg (3 rechecks)

          -  Initiation or change in dose of any α-blockers 14 days prior to randomization