bioihbjkbjnl/mcl2 huggingface dataset:
Preoperative Antibiotics for Carpal Tunnel Release Surgery
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Intervention: Vancomycin; Cefazolin; Saline Solution
Intervention description: Vancomycin - 1-gram dosing; 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater; Placebo
Intervention MeSH terms: Vancomycin; Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Principal investigator, co-investigators, and participants are blinded to study intervention
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Endoscopic Carpal Tunnel Release; Prophylactic Antibiotics

Summary:

      This is a clinical trial to determine how effective antibiotics administered prior to
      endoscopic carpal tunnel release surgery are in preventing surgical site infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High probability (>12 points) on the Carpal Tunnel-6 diagnostic aide

          -  Recommendation for carpal tunnel release

          -  Capable of providing informed consent/LAR to act on subject's behalf

        Exclusion Criteria:

          -  Patients allergic to both penicillin/cephalosporins and vancomycin

          -  Patient immobilized with splint or cast

          -  Unwilling unable to provide informed consent

          -  Children under the age of 18
Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Tazarotene Cream 0.1%; Adapalene
Intervention description: 1 pea-size amount, QD x 16 weeks; 1 pea-size amount, QD x 16 weeks
Intervention MeSH terms: Adapalene; Tazarotene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 165.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel
      0.3% in treating moderate to severe facial acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Facial acne vulgaris characterized by the following: 25-100 facial inflammatory
             lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed
             comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or
             less facial nodules and/or cysts (diameter of 1cm or greater).

          -  Female subjects of childbearing potential must have a negative urine pregnancy test at
             baseline and practice reliable method of contraception throughout the study.

        Exclusion Criteria:

          -  Non-compliance with washout period

          -  Skin disease/disorder that might interfere with diagnosis or evaluation of acne
             vulgaris

          -  Allergy or sensitivity to any component of the test medications

          -  Cosmetic or surgical procedure complementary to the treatment of facial acne within 14
             days of the baseline visit
Effect of Vitamin D Supplementation on Balance in CKD
Condition: Renal Insufficiency, Chronic; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Intervention: Vitamin D
Intervention description: Vitamin D taken in two different dosages daily for six months.
Intervention MeSH terms: Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: dialysis; end stage renal disease

Summary:

      Patients with end-stage renal disease on dialysis (ESRD5D) are 4-5x more likely to suffer
      from a fracture. Fractures can occur spontaneously but typically occur after a fall. Further,
      70-90% of patients with ESRD5D are vitamin D deficient. Vitamin D supplementation has become
      routine care for many in this patient population, but evidence is lacking to support this
      practice. The proposed projects objective is to gather needed preliminary data regarding the
      effects of vitamin D supplementation on balance and muscle strength in patients with ESRD5D.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must be likely to be able to complete the study

          -  must be able to walk without a walking aid

          -  must be able to complete questionnaires interactively research staff

          -  must have been on dialysis for greater than 3 months

          -  all patients must be receiving standard of care per their nephrologist

        Exclusion Criteria:

          -  peritoneal dialysis

          -  an allergy to vitamin D

          -  liver disease

          -  intestinal disorders that would interfere with vitamin D absorption

          -  taking vitamin D supplements >800 IU per day, glucocorticoids, anticonvulsants, or
             other drug therapies for osteoporosis

          -  are pregnant
Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial
Condition: Atrial Fibrillation and Flutter
MeSH terms: Atrial Fibrillation
Intervention: Diltiazem Oral Product; Diltiazem Injectable Product
Intervention description: Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is <60 kg); Diltiazem Continuous Infusion Titrated
Intervention MeSH terms: Diltiazem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diltiazem; Atrial Fibrillation; Atrial Flutter; Emergency Medicine

Summary:

      The primary objective of this study is to compare the incidence of rate control (defined as:
      HR <110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration
      between oral immediate release diltiazem and intravenous continuous infusion diltiazem.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >/= 18 years old

          -  Atrial fibrillation or flutter on electrocardiogram

          -  Heart rate >110 beats/min

          -  Systolic blood pressure >/= 90 mmHg

        Exclusion Criteria:

          -  Limited English proficiency (LEP)

          -  Pregnant

          -  Prisoners

          -  Wolff Parkinson White syndrome

          -  Administration of electrical or chemical cardioversion before screening

          -  Administration of other antiarrhythmics for acute heart rate control (excluding
             adenosine)

          -  History of allergy or idiosyncratic reaction to diltiazem

          -  Unable to take oral medications

          -  Heart rate <60 beats/min
Increased Cefazolin During Cesarean Delivery in Obese Population
Condition: Obesity; Obesity, Morbid; Pregnancy; Infection; Cesarean Section
MeSH terms: Obesity; Obesity, Morbid
Intervention: Cefazolin
Intervention description: Participants who are undergoing an elective cesarean section at term will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision administered through an intravenous line.
Intervention MeSH terms: Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Healthy volunteers: No
Keywords: Antibiotic Prophylaxis; Obesity; Obesity, Morbid; Pregnancy; Infection; Cesarean Section

Summary:

      The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of
      cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the
      current established dosing of 2 grams. The tissue and serum concentration values, when using
      an increased prophylactic dose, can then be compared to our pilot study assays in hopes of
      determining an optimal dosing for the obese and morbidly obese populations undergoing
      cesarean delivery.

      A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial
      Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of
      antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in the
      obese and extremely obese populations. The purpose of this research study is to evaluate
      whether in increased dose of antibiotics given before cesarean delivery (3 grams of
      cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum
      (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an
      effect on the levels of antibiotics in the tissues (a group of similar cells).

      This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index
      (BMI) of 30-40) and morbidly obese (BMI >40) women to receive an increased dose of
      prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC.
      Researchers hope to enroll a total of 35 women overall.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at term (>37 weeks) undergoing a cesarean delivery at Women's Pavilion at
             Miller Children's Hospital and University of California, Irvine.

        Exclusion Criteria:

          -  pre-gestational diabetes

          -  chronic hypertension

          -  collagen vascular disease

          -  renal impairment

          -  multiple gestation

          -  contraindications to Cefazolin administration (known anaphylactic reaction to
             penicillin's or known cephalosporin allergy)

          -  any exposure to cephalosporins in one week prior to cesarean section

          -  need for emergent cesarean delivery or diagnosis of chorioamnionitis
Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)
Condition: Knee Arthropathy
MeSH terms: Joint Diseases
Intervention: Bupivacaine with epinephrine; Methylprednisolone; Cefazolin; 8 MHz. Chiba needle; Bupivacaine with Dexamethasone; Bupivacaine 25cc; Bupivacaine 20cc; Dexamethasone
Intervention description: bupivacaine 0.5% with epinephrine 30cc; 40 mg/ml, 1 ml; 500 mg in 10 ml; 22G/ 4 inches; 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone; 25 cc 0.25% bupivacaine; 20cc 0.25% bupivacaine; 2 mg IV dexamethasone.
Intervention MeSH terms: Cefazolin; Cephalosporins; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: IPACK; PAI

Summary:

      A comparison of two pain control methods - the combination of Adductor Canal Block
      (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal
      artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)
      - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with
      ambulation on postoperative day one (24 hours post-block administration).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with osteoarthritis scheduled for a primary either partial or total knee
             arthroplasty with a participating surgeon

          -  Age 18 to 80 years

          -  Planned use of regional anesthesia

          -  Ability to follow study protocol

          -  English speaking (secondary outcomes include questionnaires validated in English only)

          -  Patients of participating surgeons

        Exclusion Criteria:

          -  Hepatic or renal insufficiency

          -  Younger than 18 years old and older than 80

          -  Patients undergoing general anesthesia

          -  Allergy or intolerance to one of the study medications

          -  BMI > 40

          -  Diabetes

          -  ASA of IV

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine
             equivalent of >5mg/day for one month)

          -  Patients with severe valgus deformity and flexion contracture
Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
Condition: Acute Kidney Injury; Dialysis Hypotension
MeSH terms: Acute Kidney Injury; Hypotension; Wounds and Injuries
Intervention: ORKID Bundled Intervention; Furosemide
Intervention description: During the 90-day study period, participants will be prescribed outpatient hemodialysis with cooled dialysate (35-36°C), high sodium dialysate (145 mmol/L), a high ultrafiltration hold threshold (systolic blood pressure > 110 mmHg; ultrafiltration hold threshold will not be applied in participants with baseline systolic blood pressure < 120 mmHg), and high dose diuretics (160 mg oral furosemide twice daily) to be taken every day at home will also be prescribed. Dialysis will be weaned according to an active weaning protocol.; 160 mg oral furosemide twice daily to be taken every day at home
Intervention MeSH terms: Furosemide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a single-center (multi-clinic), non-randomized pilot study to investigate the feasibility, tolerability, and safety of a bundled intervention (cooled dialysate, high sodium dialysate, high dose diuretics, high ultrafiltration hold threshold, active dialysis weaning) designed to foster recovery from acute kidney injury requiring dialysis.
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dialysis-requiring Acute Kidney Injury; Renal Recovery

Summary:

      There are currently no therapies to improve the chances of recovering enough kidney function
      to come off of dialysis after severe acute kidney injury. It is not known if current routine
      outpatient dialysis treatments are optimized to maximize the chances of recovery. The purpose
      of this pilot study is to see if we can feasibly and safely provide several changes to the
      way that dialysis is provided in outpatient dialysis centers which may improve the chances of
      recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AKI-D (acute kidney injury requiring dialysis), attributed at least in part to acute
             tubular necrosis by clinical nephrology team

          -  Age ≥ 18 years

          -  Pre-hospitalization eGFR ≥ 15 mL/min/1.73m2

          -  Being discharged to a participating outpatient dialysis unit (within 30 miles of UCSF)

        Exclusion Criteria:

          -  Known loop diuretic allergy/intolerance

          -  Dialysis duration > 3 months

          -  Pregnant

          -  Prisoner

          -  Unable to consent

          -  Clinical team declines to allow approach for study
5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
Condition: Major Depressive Disorder
MeSH terms: Hypoxia; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: 5-hydroxytryptophan and Creatine monohydrate
Intervention MeSH terms: 5-Hydroxytryptophan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators hypothesize that the administration of two widely available, naturally
      occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the
      severity of depression in individuals exposed to chronic hypoxia by living at altitude. The
      purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g
      creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms
      measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or
      SNRI-resistant depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female gender, ages 18-64 years inclusive

          -  Current diagnosis of Major Depressive Disorder identified by the SCID-5-CT

          -  Current HAM-D17 score of > 15

          -  Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks

        Exclusion Criteria:

          -  Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified
             by the SCID-5-CT

          -  History of or current diagnosis of renal disease, such as chronic renal failure, acute
             renal failure or end stage renal disease

          -  Diabetes type I or II

          -  Colitis or diverticulitis

          -  History of pulmonary disease

          -  History of fibromyalgia, lupus, eosinophilia myalgia syndrome, dermatomyositis,
             polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue
             disease, ankylosing spondylitis, or other related rheumatological condition

          -  Seizure disorder

          -  Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale

          -  Current treatment with an antipsychotic, mood stabilizer, or non-SSRI antidepressant

          -  Positive pregnancy test

          -  Previous diagnosis of serotonin syndrome

          -  Use of any excluded drugs or medications including serotonergic drugs or medications
Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Quetiapine XR (Seroquel XR)
Intervention description: Tablet, oral, once daily
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute schizophrenia

Summary:

      The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR)
      tablets for 3 weeks will improve their agitation when they have acute psychosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requirement for treatment of acute episode of schizophrenia (according to DSM-IV
             diagnostic criteria)

          -  PANSS total score of ³ 75

          -  CGI > 4

        Exclusion Criteria:

          -  Any DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) Axis I
             disorder not defined in the inclusion criteria

          -  Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
             a danger to self or others

          -  Substance or alcohol dependence at enrollment
A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER
Intervention description: Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone Extended Release (ER)

Summary:

      The purpose of this study is to evaluate the effectiveness of paliperidone ER for the
      treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability,
      detachment from reality, often with delusions and hallucinations, and withdrawal into the
      self) participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are diagnosed with schizophrenia (according to Diagnostic and
             Statistical Manual of Mental Disorders [Edition 4] criteria)

          -  Participants with Clinical Global Impression-Severity (CGI-S) score greater than or
             equal to 4 points (moderately ill) at Screening

          -  Childbearing potential women who consented to the consistent use of the acceptable
             contraception (oral contraceptive, contraceptive injection, intrauterine device,
             double barrier method and contraceptive patch)

          -  Participants who are capable of and willing to fill out the questionnaire for
             themselves

          -  Participants who are compliant with self-medication or can receive consistent help or
             support

        Exclusion Criteria:

          -  Participants with the past history of neuroleptic malignant syndrome (high fever,
             rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or
             blood pressure, or muscle pain or weakness)

          -  Participants with allergy or hypersensitivity to risperidone or paliperidone

          -  Participants who have taken clozapine, or have been exposed to the study drug within
             one month before screening

          -  Participants who have been treated with the long acting antipsychotic injection within
             28 days

          -  Participants with significant risk including suicide or aggressive behavior