bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy
Condition: Pain, Postoperative; Analgesics, Opioid; Analgesics, Non-Narcotic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Patient Satisfaction; Return to Work; Activity, Sexual
MeSH terms: Pain, Postoperative
Intervention: Abdominal wall block with liposomal bupivicaine
Intervention description: Abdominal wall block with liposomal bupivicaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: TQL block, TAP block, donor nephrectomy, pain, patient satisfaction

Summary:

      A blinded randomized control trial in living kidney donors. The study group will receive a
      liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general
      anesthesia. The following study variables will be collected postoperatively following arrival
      in the post-anesthesia care unit. Current and maximum intensity pain scores will be
      documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24
      hours will be collected from the EHR and pain diary after discharge. Patient satisfaction
      will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire
      (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing
      notes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing laparoscopic donor nephrectomy

        Exclusion Criteria:

          -  Pregnancy

          -  Systemic or local infection at the potential block site.

          -  Allergy or hypersensitivity to the local anesthetic,

          -  Possible variations in surgical approach to donor nephrectomy other than what is
             defined in this protocol.

          -  Scarring or anatomic abnormality over the proposed injection site
Comparison of Clenpiq vs Golytely Bowel Preparation
Condition: Bowel Preparation Solutions
Intervention: Golytely; Clenpiq
Intervention description: bowel preparation; bowel preparation
Intervention MeSH terms: Picosulfate sodium; Magnesium Oxide; Polyethylene glycol 3350; Citric Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be receive either Golytely or Clenpiq bowel prep solutions. Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the colonoscopy procedure.
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Golytely, Clenpiq, bowel prep

Summary:

      This is a prospective randomized study which will be done at main campus Cleveland Clinic.
      The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale
      in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be
      randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a
      low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and
      anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the
      evening before or as split-dose on the evening before and on the day of the procedure.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will
        be eligible to participate.

        Exclusion Criteria:

          -  Creatinine clearance less than 30 ml/min

          -  History of heart failure with current shortness of breath at rest causing limited
             physical activity, arrhythmia, unstable angina or acute myocardial infarction

          -  Small bowel obstruction, ileus or bowel perforation

          -  Dementia or cognitive dysfunction to an extent that they cannot perform the study
             related documentation or consent to participate in the study.

          -  Gastroparesis

          -  Toxic megacolon or undergoing colonoscopy for decompression

          -  Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin,
             chlorpromazine and penicillamine within 2 hours before or 6 hours after administration
             of Clenpiq or stimulant laxatives within 24 hours

          -  History of prior colorectal surgery

          -  Allergy to any of the ingredients in Clenpiq or golytely

          -  if the procedure is planned in the intensive care unit (ICU)
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
Condition: Paget's Disease of the Bone
MeSH terms: Bone Diseases; Osteitis Deformans
Intervention: Zoledronic Acid
Intervention description: Zoledronic acid 5 mg intravenous infusion once
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Healthy volunteers: No
Keywords: Paget's Disease; Zoledronic acid; Reclast®/Aclasta®; Infusion; Re-treatment; Re-lapse

Summary:

      The purpose of this study was to demonstrate that participants with Paget's disease of the
      bone who had responded to zoledronic acid treatment as participants in the core registration
      studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully
      treated with a 5 milligram (mg) infusion of zoledronic acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written Informed Consent

          -  Participants with Paget's disease randomized to the zoledronic acid arm from the
             CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months

          -  Confirmed relapse of Paget's disease of bone (i.e., serum alkaline phosphatase (SAP)
             above upper limit of normal (ULN), bone scan, worsening clinical symptoms)

        Exclusion Criteria:

          -  A participant previously treated with zoledronic acid who relapsed and was retreated
             with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months

          -  Bisphosphonate Hypersensitivity

          -  Participants with suspected/proven metastases at re-treatment

          -  Calculated creatinine clearance <35 milliliter/minute (mL/min) at screening

          -  Serum calcium level <2.07 millimole/liter (mmol/L) at screening

          -  Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or
             hypothyroidism

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered subcutaneously (SC); Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 159.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of combination therapy
      with dulaglutide and insulin in Japanese participants with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have had a diagnosis of type 2 diabetes mellitus

          -  Participants who have been treated with insulin therapy (basal insulin, premixed
             insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics
             (OADs) at stable dose for at least 3 months before screening

          -  Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant
             is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or
             glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs

          -  Participants who have stable weight (±5%) ≥3 months prior to screening

          -  Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter
             squared (kg/m^2)

        Exclusion Criteria:

          -  Participants who have a diagnosis of type 1 diabetes

          -  Participants who have previously received therapy with a glucagon-like peptide-1
             receptor agonist within 3 months prior to screening

          -  Participants who have been previously treated with dulaglutide prior to screening

          -  Participants who have been treated with 2 of the following at screening: DPP-4
             inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and
             glinide)

          -  Participants who have been treated with continuous subcutaneous insulin infusion
             (CSII) at screening

          -  Participants who have clinically significant gastric emptying abnormality, hepatitis,
             pancreatitis, renal dysfunction, or thyroid abnormalities

          -  Participants who have a history of clinically significant cardiovascular disease,
             transplanted organ, or active or untreated malignancy
Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage
Condition: Miscarriage in First Trimester
MeSH terms: Abortion, Spontaneous
Intervention: Misoprostol 400mcg Tab; Misoprostol 200mcg Tab
Intervention description: 400µg of misoprostol (2 tablets); 200µg of misoprostol (1 tablet)
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Patients, operators and statistical analysis were performed blindly.
Enrollment: 211.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: misoprostol; miscarriage

Summary:

      Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg
      of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been
      recommended by some international guidelines . So far, there are no recent studies comparing
      cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6
      hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not
      inferior to 400µg regimen), costs reductions and lower side effects may be issued without
      losing quality of cervix dilatation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted at the Gynecological emergency Unit at Hospital de Clínicas de
             Porto Alegre scheduled for uterine evacuation with <12 weeks of gestation.

        Exclusion Criteria:

          -  patients who do not wish to participate in the project;

          -  patients with ectopic pregnancy;

          -  patients with comorbidities (heart failure congestive, chronic obstructive pulmonary
             disease);

          -  patients with hypovolemic shock;

          -  patients with cervical incompetence;

          -  patients with infected miscarriage/abortion (presence of fever, pus from the cervix,
             leukocytosis [> 14000]);

          -  patients with twin pregnancy;

          -  patients with Marfan syndrome;

          -  patients allergic to misoprostol;

          -  patients with coagulopathy;

          -  patients with opening of cervical internal os (4 mm of dilatation at the time of
             consultation);

          -  patients with previous surgery of the cervix (conization);

          -  patients with concomitant use of IUDs.
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Condition: Osteoporosis; Atypical Femoral Fracture
MeSH terms: Osteoporosis; Fractures, Bone; Femoral Fractures
Intervention: teriparatide
Intervention description: 20 microgram once-daily subcutaneous injection
Intervention MeSH terms: Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Healthy volunteers: No
Keywords: osteoporosis; atypical femoral fractures; prior bisphosphonate treatment; postmenopausal women; bone loss

Summary:

      This open label comparison study examines the hypothesis that teriparatide given immediately
      following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will
      enhance healing and improve bone mineral density compared to delayed treatment (after six
      months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or
      for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition
      will have greater quality of life measures and less pain compared to those with delayed or no
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal women

          -  with osteoporosis who have been on bisphosphonate therapy for one year or more (all
             bisphosphonates will be included such as alendronate, risdedronate, ibandronate, or
             zoledronic acid).

          -  Patients will also be included if they are on glucocorticoids or other medications
             known to affect bone mineral metabolism as these are often found in patients with
             these types of fractures.

          -  sustain an atypical subtrochanteric or diaphyseal femoral shaft fracture as defined by
             the the 2010 ASBMR task force. An atypical fracture must include all of the following:
             (1) a location in the femur distal to lesser trochanter; (2) no trauma or minimal
             trauma as a fall; (3) transverse or short oblique configuration; (4) noncomminuted;
             and (5) complete fracture extends through both cortices and may be associated with a
             medial spike; incomplete fractures involve only the lateral cortex. Patients who have
             an incomplete fracture can be included if they fall into the 2010 ASBMR task force
             definition.

        Exclusion Criteria:

          -  men

          -  children

          -  those who have had radiation therapy

          -  Paget's disease

          -  treatment with teriparatide for two year in the past

          -  metastatic bone disease

          -  active cancer

          -  hypercalcemia

          -  hyperparathyroidism

          -  metabolic disease other than osteoporosis
Ketamine vs Hydromorphone
Condition: Laparoscopic Gastric Bypass; Obesity; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ketamine; Narcotics; pain scale
Intervention description: Anesthesia of only Ketamine; The narcotic group will receive no ketamine but rather a more standard anesthetic; 0-10 pain scale. 0 = no pain and 10 = worst pain
Intervention MeSH terms: Ketamine; Narcotics
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will help to determine if investigators can minimize narcotic use in laparoscopic
      gastric bypass patients while maintaining adequate pain control. This will allow
      investigators to minimize the negative side effects of narcotics which is a goal in this
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of
             age

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.
Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
Condition: Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
MeSH terms: Neoplasm Metastasis; Inflammatory Bowel Diseases; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Injectafer; Ferrous Sulfate tablets
Intervention description: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg; 325mg (1 tablet) three times a day for 28 days
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the treatment response of Injectafer vs.
      oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric
      Bypass patients may demonstrate to be inappropriate for oral iron therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Male or female subjects ≥ 18 years of age with clinical diagnosis of IDA secondary to
             IBD or Gastric Bypass

          -  Screening Hemoglobin (Hb) ≤ 11g/dL

          -  Screening Ferritin ≤ 100 ng/mL

          -  Female subjects who are of childbearing age must have a negative pregnancy test at
             screening and be practicing an acceptable method of birth control during the study

        Exclusion Criteria:

          -  Hypersensitivity reaction to any component of IV Injectafer or oral iron

          -  Requires dialysis for treatment of chronic kidney disease (CKD)

          -  During the 30 day period prior to screening has been treated with IV iron

          -  No evidence of iron deficiency

          -  During the 30 day period prior to screening has been treated with a red blood cell
             transfusion.

          -  Any non-viral infection

          -  Known positive hepatitis with evidence of active disease

          -  Received an investigational drug within 30 days of screening

          -  Active malignancy within 5 years. Basal or squamous cell skin cancer is not
             exclusionary

          -  Alcohol or drug abuse within the past 6 months

          -  Hemochromatosis or other iron storage disorders

          -  Pregnant

          -  Any other laboratory abnormality, medical condition, or psychiatric disorders which in
             the opinion of the Investigator would put the subject's disease management at risk or
             may result in the subject being unable to comply with the study requirements
Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade
Condition: Laparoscopic Herniotomy
Intervention: Rocuronium and Sugammadex
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromuscular Blockade; Laparoscopy

Summary:

      The purpose of this study is to investigate surgical work space and surgical conditions in
      patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The
      patients will act as their own control with evaluation of surgical work space and surgical
      conditions during both deep NMB and no NMB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients > 18 years old

          -  Elective laparoscopic umbilical herniotomy, incisional herniotomy and linea alba -
             herniotomy

          -  Can read and understand Danish

          -  Informed consent

        Exclusion Criteria:

          -  Known allergy to sugammadex, rocuronium or mivacurium

          -  Known homozygous variants in the butyrylcholinesterase gene

          -  Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or
             hemodialysis)

          -  Neuromuscular disease that may interfere with neuromuscular data

          -  Lactating or pregnant (Women of child bearing potential must take a urine pregnancy
             test at the day of the operation. The test will be provided by the hospital staff).

          -  Indication for rapid sequence induction
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Condition: Insulin Sensitivity; Cardiovascular Risk; Perimenopausal Disorder
MeSH terms: Insulin Resistance; Hypersensitivity
Intervention: Ortho Cyclen®
Intervention description: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)
Masking: None (Open Label)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oral contraceptive; birth control pill; women; healthy volunteer; insulin sensitivity; insulin resistance; cardiovascular risk factors; endothelial function; estrogen metabolism; racial difference; glucose intolerance

Summary:

      Birth control pills are the most commonly used method of birth control. The purpose of this
      research study is to examine whether birth control pills change heart disease risk and how
      the body handles blood sugar when given to different women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal, regular-cycling women 18-35 years

          -  Either African-American or Caucasian (African-American and Caucasian women will be
             BMI-matched)

          -  non-smoker.

        Exclusion Criteria:

          -  Diabetes

          -  Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric,
             infectious, and malignant disease

          -  Contraindications to oral contraceptive use (history of blood clots, heart attacks or
             stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer,
             migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg,
             pregnancy or lactation)

          -  Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic,
             anti-hypertensive or other vasoactive drugs within previous 3 months