bioihbjkbjnl/mcl2 huggingface dataset:
Interscalene Block Versus Superior Trunk Block
Condition: Joint Disease; Pain; Pain, Acute; Pain, Chronic
MeSH terms: Joint Diseases; Acute Pain; Chronic Pain
Intervention: Bupivacaine; Ultrasound
Intervention description: Anesthetic that will help treat pain and sensation after shoulder arthroscopy; Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block
      (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair,
      stabilization, rotator cuff repair).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who will be undergoing primary unilateral labral repair/stabilization of the
             shoulder

          -  Age 18 to 80 years

          -  Planned use of general anesthesia with LMA and interscalene or superior trunk block

          -  Ability to follow study protocol

          -  English speaking

          -  ASA I - III

        Exclusion Criteria:

        Pre-existing neuropathy of the operative limb

          -  Younger than 18 years old and older than 80

          -  Patients with pulmonary severe respiratory disease

          -  Allergy to one of the study medications

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months)

          -  Contraindication to general anesthesia, interscalene or superior trunk block

          -  Herniated Cervical Disk, Cervical Myelopathy

          -  BMI >35
Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients.
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Topiramate; placebo control group
Intervention description: patients will receive the active drug. The starting dose was 25 mg/day, with weekly increments of 25 mg/day, according to clinical status. The maximum dose considered was 200 mg/day; initial dose 25 mg day, increments of 25 mg each 2 weeks. Up to 100 mg/day Those with no intolerance and no response dose could be up to 200 mg day
Intervention MeSH terms: Topiramate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PTSD,; posttraumatic; stress; disorder,; randomization,; placebo,; controlled

Summary:

      The study is 12-week randomized placebo controlled trial compared to topiramate to treat
      patients with posttraumatic stress disorder, according to DSM-IV criteria.

      Patients will receive topiramate or placebo, the dose will start with 25 mg/day and every
      week 25mg will be increment according to patients tolerance to side effects.

      Patients will be evaluated by blind raters using Clinician-Administered PTSD Scale (CAPS),
      Beck Depression Inventory (BDI) , Beck Anxiety Inventory (BAI), 36-Item Short Form Health
      Survey (SF-36), Social Adjustment Scale (SAS).

      the outcomes will be improvement on Posttraumatic Stress Disorder (PTSD), Depression,
      Anxiety, quality of life and social adjustment scale according to scales above.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient, male and female 18 to 60 yrs old

          -  PTSD diagnostic according to DSM-IV criteria

          -  Patients who agree to receive diagnostic after SCID I application by a trained
             psychiatrist

          -  Sexually active female patients who agree to use contraceptive

          -  Patients who agree to sign the IRB approved informed consent

        Exclusion Criteria:

          -  Patients who have schizophrenic disorder, delusional, psychotic depression,
             schizo-affective, bipolar and dependence to psychoactive substance disorders

          -  Patients who have clinical disorders not compensated, which require clinical treatment
             as priority

          -  Pregnancy

          -  Previous renal calculosis history

          -  Being under antidepressant, or other psychotropic medications

          -  BMI under 20.
Kidney Damage in Patients With Moderate Fall in eGFR
Condition: Coronary Artery Stenosis
MeSH terms: Coronary Stenosis
Intervention: Iopamidol; Iodixanol-320
Intervention description: Iopamidol 370, one time administration for percutaneous coronary intervention; Iodixanol-320 single administration for percutaneous coronary intervention procedure
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil
      Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age and provides informed consent

          -  Scheduled to undergo percutaneous coronary intervention

          -  Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or
             equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Severe congestive heart failure

          -  History of hyperthyroidism;

          -  Unstable renal function

          -  Emergency PCI

          -  History of hypersensitivity to iodinated contrast agents

          -  Receiving diuretics to prevent acute renal injury
Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers
Condition: AOD Use, Abuse, and Dependence
Intervention: Oxytocin; Placebo
Intervention description: Intranasal oxytocin; Intranasal placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, placebo controlled, double blind crossover study of the effects of
      intranasal oxytocin on social cognition, implicit preferences and craving in moderate to
      heavy social alcohol drinkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a volunteer between 18 and 50 years of age.

          -  If female, subject is non-lactating, not pregnant, and using a reliable contraception
             method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier
             method).

          -  Subject is able to read and speak English.

          -  Subject is able and willing to provide written informed consent.

          -  Subject is able to understand and follow the instructions of the investigator and
             understand all screening questionnaires.

          -  Subject is in good health.

        Exclusion Criteria:

          -  Positive urine drug screen (except marijuana).

          -  Using cocaine, stimulants (other than nicotine and caffeine), amphetamines,
             hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other
             psychoactive drugs within 2 weeks of the start of the study (except marijuana) OR more
             than 10 times in the last year (except marijuana).

          -  Marijuana use more than 3 times/week.

          -  Has a current dependence on, or addiction to any psychoactive drug (except nicotine or
             caffeine) including alcohol OR a recent history of substance abuse other than alcohol,
             tobacco or marijuana.

          -  Clinically significant medical or psychiatric illness requiring treatment as
             determined by screening blood tests, medical history, and/or physical exam performed
             or reviewed by the study physician.

          -  BAC level > 0.05% at the beginning of screening visit (within margin of error of
             detection).

          -  Has a neurological dysfunction or psychiatric disorder (confirm with study physician).

          -  Has a history of brain trauma (confirm with study physician).

          -  Has an allergy or intolerance to oxytocin.

          -  Subject has received an investigational drug within 30 days of Screening Visit.

          -  Subject is considered unsuitable for the study in the opinion of the investigator,
             nurse practitioner, or study physician for any other reason.
Simplified Insulin Protocol Using Lantus in Elderly
Condition: Diabetes
Intervention: Glargine
Intervention description: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: simplification; glargine; elderly

Summary:

      The purpose of this study is to find out if simplifying your diabetes treatment by decreasing
      number of insulin injections, with the help of a long acting insulin called glargine, can
      decrease the episodes of low blood glucose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 70 years or older

          -  Diagnosis of diabetes mellitus Type II

          -  At least 2 (short-acting or mixed) insulin injections per day

          -  At least 1 episode of hypoglycemia (glucose value <70) on screening CGM

        Exclusion Criteria:

          -  Patients with the following illnesses in the past 12 months Myocardial infarction
             Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography
             Cerebrovascular event (stroke, TIA)

          -  Active liver disease (history of cirrhosis or LFT > 3 times normal)

          -  On dialysis or with severe renal dysfunction (creatinine clearance <20 ml/min)

          -  Malignancy that limits life span to less than 18 months

          -  Patients seen in the geriatric clinic who already have simplified regimen as proposed
             in the study
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
Condition: Postoperative Ileus
MeSH terms: Ileus
Intervention: Alvimopan; Placebo
Intervention MeSH terms: Alvimopan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ileus; POI

Summary:

      This study is being conducted to determine whether alvimopan can accelerate recovery of
      gastrointestinal function following radical cystectomy when compared with a placebo.
      Secondary objectives of the study are:

        -  to evaluate the effect of alvimopan on hospital length of stay

        -  to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related
           morbidities

        -  to evaluate the overall and cardiovascular safety of alvimopan
    

Eligibility criteria:

        Inclusion Criteria:

          -  are either Male or Female at least 18 years of age

          -  are scheduled for radical cystectomy

          -  are scheduled to receive postoperative pain management with intravenous
             participant-controlled opioid analgesics

        Exclusion Criteria:

          -  are scheduled for a partial cystectomy

          -  have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the
             day of surgery
Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Condition: Retinal Vein Occlusion; Macular Edema
MeSH terms: Macular Edema; Retinal Vein Occlusion
Intervention: dexamethasone intravitreal implant; ranibizumab
Intervention description: Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.; Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Intervention MeSH terms: Dexamethasone; Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of dexamethasone intravitreal implant
      (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion
      (BRVO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of branch retinal vein occlusion in at least one eye

          -  Visual acuity between 20/400 to 20/40

        Exclusion Criteria:

          -  Active eye infection

          -  Ocular hypertension which is not controlled on monotherapy (one medication)

          -  Anticipated need for eye surgery during the study

          -  Cataract surgery in either eye within 3 months

          -  Eye surgery including laser of any type within 6 months

          -  Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic
             anti-VEGF treatment (eg, Avastin) within 6 months

          -  Use of ocular steroids within 3 months

          -  Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use
             during the study
Effects of Nebivolol Versus Carvedilol on Cardiopulmonary Function at High Altitude in Healthy Subjects.
Condition: Hypoxia; Altitude; Heart Failure
MeSH terms: Heart Failure; Hypoxia
Intervention: placebo; Carvedilol; Nebivolol
Intervention description: placebo tablet BID; Carvedilol 25 mg tablets. One tablet twice daily.; nebivolol 5 mg tablets. One nebivolol tablet daily. One placebo tablet daily.
Intervention MeSH terms: Carvedilol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hypoxia; autonomic nervous system; blood pressure; heart rate; exercise; heart failure; receptors, adrenergic, beta.

Summary:

      Exposure of healthy subjects to high altitude hypoxia elicits changes in cardiovascular,
      respiratory and metabolic features as weel as in exercise performance similar, for some
      aspects, to those observed in chronic heart failure. Exposure to high altitude hypoxia
      represents a suitable model to assess different treatments proposed for this pathological
      condition. Our aim was to evaluate the impact of two different third-generation beta-blockers
      used in heart failure (carvedilol and nebivolol) on cardiovascular, respiratory, metabolic
      profile and on exercise performance at high altitude.
    

Eligibility criteria:

        Inclusion Criteria

          -  Men or women of any racial background

          -  healthy

          -  sealevel resident

          -  age >= 18 years, =< 65 years

          -  SBP< 130 mmHg and DBP< 80 mmHg, average of two measures at the sceening visit

          -  FG < 100 mg/dl (5.6 mmol/l)

          -  BMI < 25

          -  written informed consent signed

        Exclusion Criteria

          -  engagement in regular exercise training

          -  smoking habit

          -  being enrolled in another research study

          -  any current or previous cardiovascular, metabolic disease or any other cronic disease

          -  any current treatment for any medical condition

          -  any medical condition preventing or contraindication exposure to altitude hypoxia

          -  any gastrointestinal disorder interfering with drug absorption

          -  known allergy or contraindications to beta-blockers

          -  pregnant or lactating women; women in reproductive age not using recognized
             contraceptive methods.

          -  malignancy within the last 5 years

          -  drug abuse or alcohol abuse within the last 5 years

          -  history of noncompliance to medical regimens

          -  incapacity or unwillingness to sign the informed consent

          -  participation in any investigational clinical trial within the last 3 months
Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir
Intervention description: Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).
Intervention MeSH terms: Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. This trial aims for evaluating the glycaemic control,
      measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to
      oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed more than 12 months ago)

          -  HbA1c greater than 7.0 and less than 12.0% at screening

          -  Currently on any OAD in more than 3 months ago

          -  BMI (Body Mass Index) less than 35kg/m2

        Exclusion Criteria:

          -  Previous treatment with insulin in more than 7 days within the last 3 months

          -  Uncontrolled treated/untreated hypertension (systolic blood pressure greater than
             180mmHg and/or diastolic blood pressure less than 110mmHg)
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will generate safety data on Nivolumab given by itself in treatment of advanced
      Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related
      side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with
      Nivolumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced or Metastatic renal cell carcinoma (RCC)

          -  Predominant clear cell histology:

               1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth
                  factor (anti-VEGF) treatments

               2. No more than 3 total prior systemic treatment regimens in the advanced or
                  metastatic setting

               3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are
                  eligible

          -  Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor

          -  Brain metastases allowed if asymptomatic, without edema, and not receiving
             corticosteroids or radiation

          -  Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)

          -  All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed

        Exclusion Criteria:

          -  Subjects with any active autoimmune disease or a history of known autoimmune disease

          -  History of severe hypersensitivity reaction to other monoclonal antibodies

          -  Prior malignancy, active within the last 3 years, except for locally curable cancers
             which have been apparently cured

          -  Known HIV or AIDS-related illness

          -  Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic
             infection

        Other protocol-defined inclusion/exclusion criteria apply
Sculptra Aesthetic Post-Approval Study
Condition: Nasolabial Fold Contour Deficiencies; Wrinkles
Intervention: injectable poly-L-lactic acid Sculptra Aesthetic
Intervention MeSH terms: Mannitol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 867.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent
      subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and
      other facial wrinkles.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Subjects seeking correction of shallow to deep NLF contour deficiencies.

        Exclusion Criteria:

          1. Subjects seeking, at entry into the study, correction of other facial wrinkles with
             Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines,
             glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower
             lip lines, corner of the mouth lines and/or horizontal neck folds.

          2. Subjects that are less than 18 or greater than 75 years of age.