bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating Vitamin D3 Supplement on Post-Op Outcomes
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Vitamin D; Control
Intervention description: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.; Patients randomized to the control will receive a placebo
Intervention MeSH terms: Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The aim of this study is to determine if vitamin D supplementation is associated with
      differences in short-term recovery in patients following total knee arthroplasty compared to
      patients who do not receive supplementation. If so, vitamin D supplementation has the
      potential to become widely incorporated into the routine care for patients undergoing knee
      replacements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient undergoing primary total knee arthroplasty for osteoarthritis

          -  Age ≥ 18 years old

          -  Willingness to undergo randomization and return for all scheduled visits

        Exclusion Criteria:

          -  Age > 80 years old

          -  American Society of Anesthesiologists (ASA) Score ≥ 4

          -  Other supplemental vitamin D or Calcium use including their analogs: ergocalciferol,
             calcitriol, dihydrotachysterol, and paricalcitol

          -  Current cancer

          -  Malabsorption syndromes

          -  Inability to take medications orally

          -  Renal impairment defined as a glomerular filtration rate (GFR) < 30 mL/minute or
             creatinine >1.3 mg/dL

          -  History of hypercalcemia defined as albumin-corrected hypercalcemia >12 mg/dL
Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Intervention: Hybrid regimen; Reverse hybrid regimen; Levofloxacin quadruple regimen
Intervention description: two-step (dual-quadruple) treatment; one-step two-phase (quadruple-dual) treatment; non-Clarithromycin non-Bismuth quadruple therapy
Intervention MeSH terms: Levofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized controlled (interventional) study conducted at Zagazig University Hospital, internal medicine department clinic
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Helicobacter Pylori Infection; Quadruple Therapy; Egypt

Summary:

      The overall prevalence of H. Pylori in the developing countries is 50.8%, with the highest
      one presented in Africa (79.1%). Hybrid therapy is supposed to be more effective as a
      first-line regimen for Helicobacter pylori infection in Egypt than the Reverse hybrid and
      non-bismuth Levofloxacin quadruple therapies. We are aiming here to compare the Hybrid,
      Reverse hybrid, and Levofloxacin quadruple therapies as first-line therapy, trying to reach
      the safest, cost-effective, and compliance-inducing regimen in Egypt. We will conduct a
      randomized controlled (interventional) study at Zagazig University Hospital, internal
      medicine department clinic, on 330 patients. 110 patients will be allocated to each regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive Helicobacter pylori antigen in the stool

          -  Treatment-naive

        Exclusion Criteria:

          -  Previous treatment for Helicobacter pylori

          -  Drug hypersensitivity
Drug Therapy for Generalized Anxiety Disorder Among the Elderly
Condition: Anxiety Disorders; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Escitalopram
Intervention description: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Anxiety; Elderly; Aged; Serotonin Reuptake Inhibitors; SSRI; SERT

Summary:

      This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for
      generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD
      in elderly individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of at least moderately severe generalized anxiety disorder (GAD)

        Exclusion Criteria:

          -  Serious suicide risk or psychiatric instability that would affect study participation

          -  Dementia

          -  Substance abuse, such as alcoholism, within 6 months prior to study entry

          -  Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar
             disorder

          -  Unstable medical conditions that would preclude the use of escitalopram

          -  Use of certain psychotropics that can not be safely tapered or discontinued for at
             least 2 weeks prior to and during the study

          -  Use of neuroleptics that are absorbed over a prolonged period of time within 6 weeks
             prior to study entry
Pharmacogenomics of Antiplatelet Response
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: Aspirin
Intervention description: 2-week aspirin therapy (81mg/day)
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: aspirin, atherosclerosis

Summary:

      This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene
      expression in persons at high-risk of developing heart attacks due to family history of
      early-onset coronary artery disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  45-75 years

          -  GeneSTAR participant

          -  No personal History of Coronary Artery Disease

          -  Women who are post-menopausal

          -  Women who are using a reliable method of contraception, such as history of tubal
             ligation, IUD or taking OCP

        Exclusion Criteria:

          -  Taking aspirin prescribed by physician

          -  weight < 60 kg

          -  History of recent or current bleeding

          -  allergy to aspirin or history of adverse events to aspirin

          -  serious comorbid conditions (such as AIDS, active cancer)

          -  high blood pressure (>160/95)

          -  History of gastrointestinal ulcer/bleeding

          -  Mental incompetence to make decision to participate.
Using Clonidine to Improve Leg Weakness in People With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Clonidine Patch; Matching Placebo Patch
Intervention description: A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.; A matching placebo patch to be worn for a period of 3 months.
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Leg Weakness; Skeletal Myopathy; Sympathetic Nerve Activity

Summary:

      People with heart failure often have weakness in their leg muscles. This study will determine
      whether the leg weakness is due to very high adrenaline levels and whether the medication
      clonidine can improve leg weakness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart failure

        Exclusion Criteria:

          -  Currently on Coumadin therapy

          -  Experienced a heart attack in the 3 months before study entry

          -  Medically unable to receive clonidine

          -  Advanced kidney or liver disease
Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome
Condition: Delayed Sleep Phase Syndrome
MeSH terms: Sleep Disorders, Circadian Rhythm; Syndrome
Intervention: Melatonin; Bright light; Placebo red light; Placebo capsule
Intervention description: Capsules, 3 mg, once every night; Bright light therapy 10.000 lux by Miljølys AS; Red light 400 lux as placebo light; Capsules containing 3 mng rice flour, once every night
Intervention MeSH terms: Melatonin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 16 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      In this study the investigators will examine the effects of melatonin and light therapy on
      delayed sleep phase syndrome in adolescents 16 up to 20 years old. 60 subjects will be
      randomized into four different groups; melatonin + light therapy (N=15), melatonin + placebo
      light (N=15), placebo + light therapy (N=15) and placebo + placebo light. This is a
      double-blinded treatment and the participants will receive this treatment for 2 weeks. Then
      they will be re-randomized into two groups; full treatment with light therapy + melatonin
      (N=30) and no treatment (N=30) for 3 months unblinded. The investigators will test the
      subjects pre-treatment, post 2 week treatment and after 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  16-25 years old

          -  lives in the Bergen area

          -  has Delayed Sleep Phase Disorder

        Exclusion Criteria:

          -  pregnant or nursing women

          -  other sleep disorders (i.e. sleep apnoea or PLMS)

          -  moderate to serious psychiatric disease

          -  use of psychopharmacological medicines

          -  in psychotherapeutic treatment
Fenofibrate in Type 2 Diabetes
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Fenofibrate
Intervention description: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
Intervention MeSH terms: Fenofibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once
      in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in
      diabetic retinopathy offers an important translational research opportunity. The
      investigator's global proteomic study will provide new clues as to how fenofibrate protects
      vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes of at least one year's duration; stable glycemic control (no more than
             1.0% change in HbA1c in the previous six months, but no limit on HbA1c)

          -  Triglycerides >150 mg/dL (in the previous six months)

        Exclusion Criteria:

          -  Previous use of Fenofibrate or other fibrates

          -  Pregnancy

          -  Active malignancy

          -  Recent cardiac event or congestive heart failure

          -  Active liver disease

          -  Significant renal impairment (serum creatinine > 2mg/dl)
Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
Condition: Stress Incontinence
MeSH terms: Infections; Urinary Tract Infections; Urinary Incontinence, Stress
Intervention: Nitrofurantoin; Placebo
Intervention description: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence; 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.
Intervention MeSH terms: Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 161.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Urinary tract infection (UTI); suburethral sling; Prevention; Nitrofurantoin; Prophylaxis

Summary:

      This project will determine whether post-operative prophylaxis with macrobid will decrease
      the incidence of postoperative urinary tract infection in women receiving sub-urethral slings
      for the treatment of urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women over the age of 18 who will undergo the placement of a sub-urethral sling for
             the treatment of stress urinary incontinence

        Exclusion Criteria:

          -  Exclusion criteria are those with a known allergy to macrobid, those with
             glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known
             pregnancy, patients taking medications for gout, and those with known risk factors for
             complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder,
             diabetes, immuno-suppression, etc).
Use of High Cost Monitoring During Letrozole Ovulation Induction
Condition: Infertility
MeSH terms: Infertility
Intervention: Midcycle ultrasound + hCG injection; Urinary LH kits
Intervention description: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.; Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Female
Minimum age: 21 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: letrozole; ovulation monitoring; pregnancy rate

Summary:

      The purpose of this study is to investigate monitoring methods during ovulation induction
      cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction
      cycles with letrozole can be done with a variety of methods, the two most commonly utilized
      are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle
      follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add
      extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ages 21-39 undergoing letrozole ovulation induction (as part of routine clinical
             care) at a single academic-infertility center.

          -  Normal uterus and evidence of at least tubal patency on one side (as assessed by
             saline-infusion sonography or hysterosalpingogram per clinical care).

        Exclusion Criteria:

          -  Current pregnancy

          -  Nursing mothers

          -  Prior hypersensitivity to hCG preparations

          -  Primary ovarian failure or menopausal levels of FSH (>12 mIU/mL)

          -  Patients with abnormal uterine bleeding of undetermined origin or ovarian cyst of
             undetermined origin, sex-hormone dependent tumors, documented bilateral tubal
             obstruction, uncorrected uterine anomalies,

          -  Previous letrozole or gonadotropin use and/or previous treatment with in vitro
             fertilization

          -  Other uncorrected medical condition that would be a contraindication to attempting
             elective ovulation induction (e.g., uncontrolled diabetes, intracranial lesion,
             thyroid or adrenal disease).
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Lumbar Plexus Blockade; Control
Intervention description: The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine; The control group will receive only a combined spinal-epidural.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the use of a lumbar plexus block for
      arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in
      treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the
      total amount of pain medication needed, and therefore reduce the side effects of these
      medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar
      plexus block will significantly reduce patients' postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1-3

          -  Patients aged 18 to 65 years

          -  Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr.
             Coleman, or Dr. Anil Ranawat

          -  Planned use of neuraxial anesthesia

          -  Body Mass Index less than 35

          -  Ability to follow study protocol

        Exclusion Criteria:

          -  Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)

          -  Contraindication to combined spinal-epidural anesthesia including but not limited to
             bleeding disorder, use of clinically relevant anticoagulant or antiplatelet
             medications, and anatomic abnormalities.

          -  Contraindication to lumbar plexus block including but not limited to bleeding
             disorder, use of clinically relevant anticoagulant or antiplatelet medications, and
             anatomic abnormalities.

          -  Infection at the injection site(s)

          -  Allergy to any of the study medications

          -  Contraindication to a short course of NSAIDs (renal failure, intolerance)

          -  ASA Class 4-5

          -  Patient refusal

          -  Patients younger than 18 years old and older than 65

          -  Patients with any known indwelling hardware of the lumbar spine.

          -  Patients with a peripheral neuropathy of the surgical extremity

          -  Non-English speaking patients
Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis
Condition: Hand Dermatosis
MeSH terms: Dermatitis; Skin Diseases; Hand Dermatoses
Intervention: clobetasol propionate
Intervention description: Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment.
Intervention MeSH terms: Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dermatosis, Dermatitis, Dry skin, Irritated skin

Summary:

      The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol
      propionate foam in subjects with chronic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 years of age or older, with diagnosis of chronic dermatitis, able to
             complete the study and comply with study instructions.

          -  Female subjects of childbearing potential must have a negative pregnancy test.
             Sexually active women of childbearing potential participating in the study must have
             been using a medically acceptable form of contraception

        Exclusion Criteria:

          -  Use of systemic corticosteroid and/or other prohibited medications within 4 weeks of
             the baseline visit.

          -  Use of topical corticosteroid therapy and/or other prohibited topical medications
             within 2 weeks prior to the baseline visit