bioihbjkbjnl/mcl2 huggingface dataset:
GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients
Condition: Corneal Epithelium Defect
Intervention: 0.3% hypromellose
Intervention description: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LASIK; Ocular Lubricants; Corneal Epithelium; Wound Healing

Summary:

      GenTeal gel is an artificial tear gel used to lubricate the surface of the eye. This study
      will evaluate the effect of GenTeal gel on comfort following LASIK surgery. Participants will
      be asked to come to the clinic for three regularly scheduled visits after LASIK surgery: Day
      1 (one day after LASIK surgery), Day 7 (one week follow-up), and Day 30 (one month
      follow-up). Participants will be asked to complete a questionnaire regarding eye comfort
      during each follow up visit. Participants will be randomly assigned to one of two groups, one
      of which will receive Genteal Gel four times a day for five days prior to surgery. The other
      group will receive no preoperative gel or lubricant, which has been our standard approach for
      many years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 - 60

          2. Both sexes

          3. Any race

          4. Seeking LASIK surgery at the Medical College of Georgia (MCG)/Eye Care One

          5. Meeting all established criteria for appropriateness for LASIK established by MCG/Eye
             Care One

        Exclusion Criteria:

          1. Any corneal pathology including scars, prior herpes keratitis, prior corneal
             transplant

          2. Any immunocompromised state including diabetes mellitus, cancer, HIV infection, or
             Hepatitis B or C.

          3. Failure to meet all established criteria for appropriateness for LASIK established by
             MCG/Eye Care One
The Treatment of Insomnia in Patients With HIV Disease
Condition: HIV Infections; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Doxepin; Temazepam; Placebo
Intervention description: Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length; Temazepam capsule 15 mg po nightly x duration of study; Placebo capsule nightly for duration of study
Intervention MeSH terms: Doxepin; Temazepam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: HIV; Insomnia; Cytokines; Adherence

Summary:

      This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use
      in patients who are HIV positive and suffer from insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Insomnia

          -  HIV Seropositive

          -  Stable HIV Disease

        Exclusion Criteria:

          -  Other psychiatric illnesses

          -  Unstable HIV disease
Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
Condition: Impotence
MeSH terms: Erectile Dysfunction
Intervention: Viagra (Sildenafil citrate)
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 183.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the
      same extent as it is by moderate and severe ED. This study will provide controlled clinical
      data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated
      with Viagra versus those treated with a placebo. With an open-label extension, this study
      will also provide all study subjects the opportunity to receive the active drug treatment for
      6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men above age of majority

          -  Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or
             less)

        Exclusion Criteria:

          -  Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any
             PDE5 inhibitor in the past 4 weeks

          -  Subjects currently taking any other commercially available drug or non-drug treatment
             for ED
Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery
Condition: Blood Pressure
Intervention: Gabapentin1200 mg; bisoprolol 2.5mg; placebo
Intervention description: patients received 1200mg gabapentin 2 hrs preoperative; patients received 2.5mg bisoprolol 2 hrs preoperative; patients received oral placebo 2 hrs preoperative
Intervention MeSH terms: Bisoprolol; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: gabapentin; bisoprolol; hemodynamic; surgical field

Summary:

      the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of
      intraoperative bleeding, improving the operative's field visibility and increase the surgeon
      satisfaction via optimization of blood pressure and heart rate .

      A prospective randomized double blinded controlled study. Eligible patients were randomized
      according to random list generated software and allocated into 3 equal and matched groups (15
      patients in each group):-

        -  Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200
           mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of
           anesthesia.

        -  Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5
           mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of
           anesthesia.

        -  Group C: control group in which Patients were premedicated with oral placebo with sips
           of water, 2 hours before induction of anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who underwent functional endoscopic sinus surgery

          -  ability to swallow tablets

        Exclusion Criteria:

          -  suspected difficult airway

          -  basal HR <60/min.

          -  chronic cardiovascular or cerebrovascular disease

          -  bronchial asthma or COPD

          -  DM

          -  bleeding disorders

          -  anemia (Hb level< 10 gm/dl)

          -  renal or hepatic insufficiency

          -  psychiatric disorders

          -  chronic treatment by BBs, gabapentin or drugs that affect coagulation

          -  acute nasal infection

          -  allergy/contraindications to any of the study's drugs.
Optimizing Body Composition for Function in Older Adults
Condition: Obesity; Overweight With Indications for Weight Loss
MeSH terms: Overweight; Weight Loss
Intervention: Pioglitazone; Resistance exercise training to maximize muscle power; Hypocaloric diet; Placebo
Intervention MeSH terms: Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Enrollment: 88.0
Sex: All
Minimum age: 65 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Body Composition; Sarcopenia; Weight loss trials; Intervention studies; Elderly

Summary:

      The purpose of this pilot study is to compare two strategies intended to improve the health
      of overweight older adults by improving body composition. One strategy, resistance training,
      is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ
      agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These
      strategies will be used in conjunction with a hypocaloric diet and will be compared to a
      hypocaloric diet alone to determine if either of these strategies are superior in reducing
      visceral fat and preserving muscle mass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weight Stable, Indication for weight loss per NIH guidelines, Performance on the short
             physical performance battery score 3-10

        Exclusion Criteria:

          -  Diabetes, weight > 136 kg, Medical condition that limits exercise participation,
             Congestive heart failure, abnormal kidney function, higher ALT than normal, currently
             involved in a weight loss or exercise program, current smoking, alcohol or drug abuse,
             taking anti-inflammatory steroids, taking protein supplements, taking PPAR-gamma
             agonist, edema, anemia
Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Implantable Cardioverter-Defibrillator (subject's pre-existing ICD); Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)
Intervention description: Pacing parameters set to AAI 90; Pacing parameters set to DDD 90-100
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventricular assist device

Summary:

      Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left
      ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart
      failure. However, little is known about RV pacing in patients with advanced heart failure
      treated with an implantable left ventricular assist device (LVAD). The univentricular support
      provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart
      failure patients, yet the incidence of RV failure in the early post-operative period
      following implantation is associated with significantly reduced survival and increased length
      of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size
      that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing
      may counteract these adverse mechanical alterations, improving RV systolic function and
      ultimately LVAD function.

      The investigators will recruit all patients referred for an implantable, continuous flow LVAD
      at Duke University Medical Center who have an existing implantable dual-chamber
      cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to
      compare continuous right ventricular pacing vs. native ventricular conduction at equivalent
      heart rates. Multiple clinical outcomes will be examined over a two week period
      post-operatively including invasive hemodynamics, vasoactive medication use, end-organ
      function, RV function by Echocardiography as well as patient symptoms and functional status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years old, both men and women

          -  Existing implantable cardioverter-defibrillator (ICD)

          -  Referred for implantation of a continuous flow LVAD

        Exclusion Criteria:

          -  Permanent left ventricular epicardial defibrillator in place

          -  Congenital heart disease with single ventricle physiology

          -  Right ventricular assist device (RVAD) in place

          -  Existing pacing indication
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Condition: Kidney Transplantation
Intervention: mycophenolate mofetil; tacrolimus, standard dose; tacrolimus, low dose; corticosteroids
Intervention description: 0.75-1 g PO BID from Day 0 through Month 12; Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.; Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.; According to center's practice
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of CellCept, combined with low or
      standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients
      will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid +
      tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or
      2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3
      followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study
      treatment is 1 year, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, <=75 years of age;

          -  single organ recipients of renal allograft;

          -  negative pregnancy test for women of childbearing potential; reliable contraception
             must be used before starting drug therapy, until 6 weeks after the last dose of study
             medication.

        Exclusion Criteria:

          -  severe gastrointestinal disease which may influence the absorption of oral drug
             therapy;

          -  severe infection, HIV or active hepatitis;

          -  active gastric ulcers;

          -  malignancy other than cured skin cancer;

          -  severe anemia, leucopenia or thrombocytopenia.
PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Sertraline; Placebo oral capsule
Intervention description: < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.; Matched encapsulated placebo from 1-4 capsules daily
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Posttraumatic stress disorder; PTSD; Sertraline; Burns

Summary:

      This is a randomized, double-blind, placebo-controlled study to determine whether
      administration of sertraline to patients who exhibit acute stress disorder secondary to
      severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Victim of a traumatic event leading to personal injury

          -  Patient experienced a feeling of intense fear, hopelessness, or horror during the
             course of the event or immediately afterward

          -  Positive screen on the ASDS (for inclusion in the randomization phase); a total ASDS
             score of ≥ 37 (including a dissociative score of ≥ 9) will be counted as a positive
             screen.

        Exclusion Criteria:

          -  Age < 18

          -  Pregnant women, lactating women, or women not using acceptable form of birth control

          -  Epilepsy or head trauma resulting in seizures

          -  Current or historical schizophrenia, bipolar disorder, mental retardation, OCD, eating
             disorders, dementia, delirium, or self-injurious behavior

          -  Current/previously diagnosed PTSD

          -  History of hypersensitivity to sertraline

          -  Trauma occurring > 7 days prior to likely first treatment in the randomization phase
             of the trial.

          -  Unable to provide informed consent for participation in the study protocol.

          -  Patient at high risk of recurrent bleeding despite surgical stabilization

          -  Patient with a history of serotonin syndrome

          -  Patient non-fluent in English

          -  Patient currently prescribed an antidepressant (any SSRI, SNRI, TCA, MAOI,
             mirtazapine, or trazodone in excess of 100mg per day)
A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Injections of tildrakizumab
Intervention description: given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of
      10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40,
      Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week
      16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks,
      excluding a screening period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects are non-immunocompromised males or females 18 years of age or older.

          2. Subjects have ≥3% total body surface area plaque psoriasis.

          3. Subjects are candidates for phototherapy or systemic therapy.

          4. Subject must be diagnosed at least 6 months prior to entering the study.

          5. Females must be surgically sterile, postmenopausal for >5 years, or using a highly
             effective form of birth control (<1% failure rate), for at least 30 days prior to test
             article exposure, with a negative serum pregnancy test.

        Exclusion Criteria:

          1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

          2. Subject is younger than 18 years of age.

          3. Subjects with uncontrolled mental illness or active suicidal ideations based on
             baseline mental health questionnaire of choice.

          4. Subject is known, or suspected of being unable to comply with the study protocol, in
             the opinion of the investigator.

          5. Subject is currently enrolled in an investigational drug or device study.
Does Ultrasound Improve Procedural Time in the Lateral Popliteal Approach to the Sciatic Nerve in Obese Patients
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ultrasound; Nerve stimulation
Intervention description: Using ultrasound for nerve localization when performing a sciatic nerve block via the lateral popliteal approach; Using nerve stimulation for nerve localization in sciatic nerve blocks via the lateral popliteal approach
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nerve stimulation; ultrasound; sciatic nerve block; popliteal block; obese

Summary:

      Ultrasound have been shown to improve the time needed to locate and block nerves in the non
      obese population. However, its utility is still unknown in the obese population. Ultrasound
      is known to produce poorer quality images in the obese population. This study aims to find
      out if it is a better tool for nerve localization compared to the traditional nerve
      stimulation technique.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA 1-3

          -  Age 18 and above

          -  BMI >30

          -  Operations requiring lateral popliteal approach to the sciatic nerve block

        Exclusion Criteria:

          -  Diabetes

          -  Injection site deformities

          -  infection at the injection site

          -  existing peripheral neuropathy

          -  allergy to LA agents

          -  Dementia or communication problems

          -  Inability to understand or discern temperature difference

          -  Any other contraindication to lower limb peripheral nerve block