bioihbjkbjnl/mcl2 huggingface dataset:
Hip Scope Fascia-iliaca (FI) Block Study
Condition: Hip Dysplasia; Femoroacetabular Impingement; Acetabular Labrum Tear
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Femoracetabular Impingement
Intervention: ropivicaine; clonidine; Epinephrine; Noropin
Intervention MeSH terms: Clonidine; Epinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hip Arthroscopy

Summary:

      Patients undergoing a hip scope procedure will be recruited for this study. They will be
      randomized to either receive a nerve block or no nerve block (pain medicine only). Pain
      levels and clinical outcomes will be assessed through 3 months post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for outpatient hip arthroscopy

          -  American Society of Anesthesiologists (ASA) 1-3

        Exclusion Criteria:

          -  Prior surgery on ipsilateral hip

          -  ASA 4-6

          -  Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine
             per day

          -  Current or prior placement of a spinal cord stimulator or intrathecal pump for pain
             control purposes

          -  Allergy to amide local anesthetics

          -  Contraindication to regional anesthesia

          -  BMI > 40

          -  Females who are pregnant or plan to get pregnant during the course of the study
Immunologic Response to Influenza Vaccination in Children and Adolescents
Condition: Influenza, Human; Immune Response
MeSH terms: Influenza, Human
Intervention: Flucelvax inactivated influenza vaccine; Fluzone inactivated influenza vaccine
Intervention description: Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.); Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 4 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: inactivated; influenza; vaccine

Summary:

      The purpose of this study is to evaluate immunologic response to different types of influenza
      vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized
      controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine
      arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone
      (egg-based inactivated flu shot).
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 4-20 years;

          -  has prior vaccination history available (which can be determined based either on
             medical record review or through state registry review;

          -  plans to receive the current seasonal influenza vaccination at one of the recruiting
             sites

        Exclusion Criteria:

          -  unable or unwilling to completed required study activities, including informed
             consent, randomization to vaccine, and bloodwork;

          -  has already received influenza vaccine for the current season;

          -  has a known immunocompromising condition or is on an immunosuppressing medication
             (e.g., high dose steroids >10 days);

          -  is known to be pregnant;

          -  has a history of severe allergy to eggs or to influenza vaccine or any of its
             components
Obesity, Oral Contraception, and Ovarian Suppression
Condition: Ovarian Suppression
MeSH terms: Vision Disorders
Intervention: Low dose formulation; High dose formulation
Intervention description: Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.
Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet.; Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.
Dose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ovarian Suppression; Oral Contraceptives; Obese and Normal BMI

Summary:

      This study proposes a double blind randomized clinical trial to include normal weight and
      obese women who have normal ovulatory function at baseline; the investigators will randomize
      women to 2 widely used OCs and evaluate ovarian follicle development and circulating
      progesterone to assess ovarian suppression during OC use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-35

          -  Body Mass Index (BMI) 19-24.9 or 30-39.9 kg/m^2

          -  Willing to take birth control pills for 3-4 months

          -  Recent spontaneous pregnancy or cyclic menses

        Exclusion Criteria:

          -  Contraindications to hormonal contraceptives

          -  Oophorectomy/Polycystic ovary syndrome (PCOS)

          -  Taken oral contraceptives to regulate menses recently

          -  Weight reduction surgery

          -  Used Depo-Provera within the last 12 months

          -  Pregnant or currently breastfeeding

          -  Desiring pregnancy within the next 4 months

          -  Unable to make study visit commitment

          -  Previous participation in this study
Nutrition, Physical Performance & Fitness in Indian School Children
Condition: Physical Fitness; Nutritional Status
Intervention: Nutritional supplement; Placebo
Intervention description: Fortified nutritional powder; Un-fortified nutritional powder
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: physical performance; micronutrients; physical fitness; healthy children

Summary:

      The purpose of this study is to evaluate the effect of nutritional supplement on physical
      performance measures of apparently healthy school going children in India.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Boys and girls between ages 7-10.5 years

          -  Z score of height for age and weight for age of 0 to < -3

          -  Good general health at screening

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions

          -  Written informed consent from the parents/ guardians and writtent assent by the study
             participant

        Exclusion Criteria:

          -  Severe anemia (Hb<8 g% )

          -  Cardiovascular disease on clinical examination or history

          -  Any underlying respiratory disease with impairment of lung function

          -  Physical disability Children consuming nutritional supplements (tonics, syrups,
             tablets or chews) and/ or health food drinks on a regular basis

          -  Recent history [3mo] of serious infections, injuries and/ or surgeries

          -  Participation in any nutritional study in the last 1 year

          -  Indication that they are likely to move within the period of study intervention

          -  Any known food allergies like peanut allergy, gluten allergy

          -  Family members of an employee of the Sponsor or the study site.
Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS
Condition: Transplantation; Immunosuppression; Drug Interaction
Intervention: Mycophenolate sodium; Pantoprazole; Mycophenolate mofetil
Intervention description: Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.; Daily dose: 40mg. Application together with CellCept® or Myfortic® .; Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
Intervention MeSH terms: Mycophenolic Acid; Pantoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: immunosuppressive medication; mycophenolic acid; interaction; proton pump inhibitor; pantoprazole; renal transplant patients; pharmacokinetics; pharmacodynamics; bioavailability

Summary:

      The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of
      Pantoprazole on the bioavailability mycophenolic acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients >18 years old

          -  patients who are on stable immunosuppressive therapy for at least one month with
             ciclosporin, EC-MPS or MMF +/- corticosteroids

          -  renal transplantation, at least 6 months prior study inclusion

          -  suitable and willing to switch treatment according to the study plan

          -  women of childbearing potential must have a negative serum pregnancy test before study
             start and effective contraception must be used (method with PEARL index <1%)

        Exclusion Criteria:

          -  patients with renal function <30ml/min (estimated by Cockcroft Gault formula)

          -  patients who are not on stable treatment with enzyme inductors or enzyme inhibitors
             for <1 month before study entry

          -  patients who take medication which is known for interfering with MPA absorption for <1
             month before study entry

          -  known anamnestic hypersensitivity to one of the investigational products or drugs with
             similar chemical structure and to other components of the investigational products,
             respectively

          -  patients on treatment with clopidogrel

          -  acute rejection < 1 month before study inclusion

          -  patients who are HIV positive, hepatitis C virus (HCV) positive, HBsAg positive

          -  patients with gastrointestinal disorders which could affect resorption

          -  pregnancy and/or lactation

          -  drug or alcohol abuse in patient's history

          -  patients with history of psychological illness or condition, which might interfere
             with the ability to understand the requirements, consequences, possible outcome of the
             study and patients who are not willing to give valid informed consent

          -  patients with insufficient co-operation with the clinical investigator (e.g. suspicion
             of non-compliance)
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: iv 0.6 micrograms/kg every 2 weeks
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and
      tolerability of two-weekly intravenous administration of Mircera in dialysis patients with
      chronic renal anemia not currently treated with ESAs. Patients will receive intravenous
      Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last
      treatment visit. The anticipated time on study treatment is 3-12 months, and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients, >=18 years of age;

          -  chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);

          -  no prior erythropoietin stimulating agent (ESA) therapy.

        Exclusion Criteria:

          -  blood transfusion within the previous 4 weeks;

          -  poorly controlled hypertension;

          -  significant acute or chronic bleeding;

          -  active malignant disease;

          -  congestive heart failure (NYHA Class IV).
Effect of Korean Red Ginseng (KRG) on Dry Mouth
Condition: Xerostomia
MeSH terms: Xerostomia
Intervention: Korean Red Ginseng Powder Capsule; Corn-starch powder with ginseng flavor
Intervention description: Generic name: Korean Red Ginseng Powder Capsule Original herb name: Panax ginseng Form and contents: Capsule with powder of steamed root of 6-year Panax ginseng Dosage and frequency: 6 g per day (twice a day), Oral administration Administration duration: 56 days in the study; There is no specific name because this intervention is placebo. This placebo has the same form, color and flavor as Korean Red Ginseng Powder Capsule.
The dosage form, dosage, frequency and duration is also same as experimental intervention (Korean Red Ginseng Powder Capsule).
Main contents: corn-starch with Panax ginseng flavor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 19 Years
Maximum age: 76 Years
Healthy volunteers: No
Keywords: Xerostomia; Panax ginseng(Korean Red Ginseng); Visual Analogue Scale; Salivary Flow Rates

Summary:

      The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth
      (Xerostomia).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dry mouth patients

        Exclusion Criteria:

          -  Sjögren syndrome

          -  Irradiation related xerostomia

          -  Severe psychiatric diseases

          -  pregnancy or breast feeding women
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis, Knee
Intervention: Mobile bearing; Fixed bearing
Intervention description: Mobile bearing in total knee arthroplasty; Fixed bearing in total knee arthroplasty
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Healthy volunteers: No
Keywords: Total knee arthroplasty; Mobile bearing; Fixed bearing; Range of motion; Knee Society Score

Summary:

      The purpose of this study is to compare the clinical and radiological outcomes of
      mobile-bearing with that of fixed-bearing in total knee arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary total knee arthroplasty

        Exclusion Criteria:

          -  infection

          -  severe deformity in knee

          -  revision
Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers
Condition: Transplant Rejection
Intervention: Caffeine; Losartan; Omeprazole; Dextromethorphan; Midazolam; Belatacept
Intervention MeSH terms: Abatacept; Losartan; Midazolam; Dextromethorphan; Caffeine; Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effects of belatacept on the pharmacokinetics
      of caffeine, losartan, omeprazole, dextromethorphan and midazolam
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI 18 to 30 kg/m2

          -  Men and women ages 18 to 45

        Exclusion Criteria:

          -  Active tuberculosis

          -  Any recent infection requiring antibiotic treatment within 4 weeks of dosing

          -  Positive urine screen for drugs of abuse
Memantine for Spasticity in MS Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: placebo; memantine
Intervention description: matched tablets bid; 10 mg bid
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: multiple sclerosis

Summary:

      Participants (n=20) will be identified at routine care visits performed at the Rochester
      Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will
      have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity
      muscle group. Participants will be seen at screening, one, and three months, and will be
      evaluated using the modified Ashworth scale,8 pendulum test,9 toe tapping test,10 manual
      muscle testing,11 timed 25 foot walk,12 and Multiple Sclerosis Functional Composite.13 The
      type and severity of any adverse events will be recorded using standard definitions.
      Participants will be instructed to call between visits to inform the investigators regarding
      any adverse events they experience. Follow-up will continue until all adverse events resolve
      or stabilize.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Multiple sclerosis by McDonald Criteria.

          2. Spasticity. A minimum score of two on the Ashworth spasticity scale in at least one
             lower extremity muscle group and a total score of at least four in the lower extremity
             muscles tested.

          3. Age 18-70.

          4. Normal renal function (estimated CrCl > 50 ml/min).

          5. Women of childbearing potential (i.e., those not postmenopausal or surgically sterile)
             may participate provided that they are using adequate birth control methods (including
             barrier methods, IUD, and oral contraceptives) for the duration of the study.

          6. Willing and able to perform all procedures related to the clinical trial and to
             provide informed consent.

        Exclusion Criteria:

          1. Evidence of clinically significant thyroid, gastrointestinal, cardiovascular, hepatic,
             renal, hematologic, respiratory, neoplastic, endocrine (including diabetes mellitus),
             neurologic (other than MS), or other medical or psychiatric disorder at screening.

          2. Women must not be pregnant or lactating. Serum or urine pregnancy tests will be
             required prior to randomization for women of childbearing potential unless the last
             menstrual period started less than 28 days prior to randomization.
Comparing Naproxen to Sumatriptan for Emergency Headache Patients
Condition: Migraine; Tension-type Headache; Primary Headache Disorder
MeSH terms: Tension-Type Headache; Headache Disorders; Headache Disorders, Primary; Emergencies; Headache
Intervention: Sumatriptan 100 mg; Naproxen
Intervention description: Sumatriptan 100mg tablet; Naproxen 500mg tablet
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Emergency department; headache; migraine

Summary:

      2/3 of patients discharged from an emergency department after treatment for an acute headache
      will still be bothered by headache within 24 hours of emergency department (ED) treatment.
      The goal of this study is to compare two medications, naproxen and sumatriptan, to determine
      which is better for the treatment of recurrent headache within 24 hours of emergency
      department discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated in the emergency department for acute primary headache

        Exclusion Criteria:

          -  Allergy, intolerance, or contra-indication to one of the study medications