bioihbjkbjnl/mcl2 huggingface dataset:
Extended Release Naltrexone for Opioid-Dependent Youth
Condition: Drug Dependence
MeSH terms: Substance-Related Disorders
Intervention: Extended Release Naltrexone; Psychosocial Treatment; Buprenorphine
Intervention description: naltrexone for extended release injectable suspension; Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.; Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
Intervention MeSH terms: Naltrexone; Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 15 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: opioid dependence

Summary:

      The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old
      opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual
      (TAU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic
             subtype;

          -  Within 3 days of admission to MMTC;

          -  Age between 15 and 21, inclusive;

          -  Able and willing to provide informed consent to be randomly assigned to XR- NTX or
             TAU; and for participants under 18 years of age, parental or guardian consent and
             participant assent.

        Exclusion Criteria:

          -  Liver function test levels (Alanine Transaminase, Aspartate Transaminase) four times
             greater than normal;

          -  Unstable medical or psychiatric illness (e.g., schizophrenia) that might make
             participation hazardous;

          -  History of serious suicide attempt in the past 6 months;

          -  History of allergic reaction to naloxone, and/or naltrexone;

          -  Current chronic pain condition for which opioids are deemed necessary for ongoing
             care;

          -  blood coagulation disorder (e.g., hemophilia);

          -  Body Mass Index > 40;

          -  If female, pregnant, lactating, unwilling or unable (due to parental objection) to use
             FDA-approved contraceptive methods;

          -  meeting DSM-IV criteria for benzodiazepine dependence
Synthetic vs Natural Estrogen in Combined Oral Contraception
Condition: Contraception
Intervention: Ethinyl estradiol / dienogest; Estradiol valerate / dienogest; Dienogest
Intervention description: One tablet orally for 9 weeks, continuous use; One tablet orally for 9 weeks, continuous use; One tablet orally for 9 weeks, continuous use
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate; Nandrolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception, oral; Ethinyl Estradiol; Estradiol Valerate; Dienogest; Insulin resistance; Chronic inflammation; Coagulation

Summary:

      The main objective of the study is to compare the metabolic effects of natural estradiol and
      synthetic ethinylestradiol used in combined oral contraception in healthy women. A
      progestin-only preparation will be used in comparison. The main goal is to study the effects
      on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP).
      Our hypothesis is that the natural estradiol preparation will influence blood glucose levels,
      markers of coagulation and chronic inflammation less than the ethinylestradiol preparation.
      The progestin-only preparation will not effect these parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI 19-24.9, regular menstrual cycles (21-35 days), a minimum of 2 months without any
             hormonal contraceptives, no contraindications for use of hormonal contraception

        Exclusion Criteria:

          -  Polycystic ovaries, hypertension, smoking, alcohol abuse, pregnancy, lactation,
             abnormal result in pre-screening 2h oral glucose tolerance test, regular medications
Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin
Condition: Infection
Intervention: Vancomycin CI; Vancomycin II
Intervention description: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin; Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin; Antibiotics, Antitubercular
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: infusion therapy; continuous infusions; nephrotoxicity; outpatient parenteral antibiotic therapy; vancomycin

Summary:

      Evaluate the safety and outcomes associated between the two treatment modalities
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients at least 18 years of age

          -  Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy
             (OPAT) services

          -  Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home
             Infusion Pharmacy

          -  Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in
             duration

          -  Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours
             dosing at the time of enrollment

        Exclusion Criteria:

          -  Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin:
             Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg

          -  Pre-existing leukopenia: White Blood Cell (WBC) < 4,000 x 103 cells/µL
Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Intervention: Teriparatide (FORTEO); Placebos
Intervention description: Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
Intervention MeSH terms: Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteogenesis Imperfecta; Brittle Bone Disease; Fragility Fractures

Summary:

      The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which
      is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in
      adults affected with Osteogenesis Imperfecta (OI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous established diagnosis of Osteogenesis Imperfecta AND

          -  > 2 previous adult fractures, AND/OR

          -  BMD at lumbar spine, femoral neck or total hip T score < -2.0

        Exclusion Criteria:

          -  Open epiphyses.

          -  History of external beam radiation to the skeleton.

          -  Pagets disease.

          -  Bone metastases or skeletal malignancies.

          -  Total lifetime exposure to any antiresorptive medication < 90 days (Primary
             Inclusion).

          -  Treatment with any antiresorptive medication 12 months proceeding enrollment -
             (Secondary Inclusion).

          -  Women with OI who are pregnant or unwilling to use 1 form of contraception.

          -  Vitamin D insufficiency (25-hydroxyvitamin D <15ng/ml)
Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients
Condition: Traumatic Injury; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism; Wounds and Injuries
Intervention: Enoxaparin 40 mg q12h; Enoxaparin 30 mg q8h
Intervention description: Patients receive enoxaparin 40 mg every 12 hours. Dose will be escalated to enoxaparin 50 mg every 12 hours if steady state trough concentration is still subtherapeutic.; Patients receive enoxaparin 30 mg every 8 hours.
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ
      between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed
      on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare two
      enoxaparin dosing strategies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Multi-system trauma

          -  Anticipated length of stay of at least 72 hours

          -  At high risk (risk adjustment profile [RAP] >= 5) and initiated on enoxaparin 30 mg
             every 12 hours per VTE prophylaxis protocol

          -  No counterindication to trauma team VTE prophylaxis protocol (e.g., intracranial
             bleeding, incomplete spinal cord injury with hematoma within 24 hours post injury,
             ongoing hemorrhage, uncorrected coagulopathy, >= grade IV liver or spleen injury,
             intraocular injury)

        Exclusion Criteria:

          -  Renal dysfunction (creatinine clearance < 30 mL/min or on continuous renal replacement
             therapy)

          -  Weight < 50 kg or > 150 kg

          -  Platelet count < 50,000

          -  Allergy to heparin or low molecular weight heparin

          -  On therapeutic anticoagulation on admission or requiring it within 24 hours of
             admission

          -  Isolated intracranial hemorrhage

          -  Known hyperbilirubinemia (serum bilirubin > 6.6 mg/dL)

          -  Pregnancy

          -  Incarceration
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Condition: Constipation; Cancer
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: PEG then Senna; Senna then PEG
Intervention description: Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).; Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
Intervention MeSH terms: Sennosides
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The primary outcome will be treated as a binomial outcome, expressed as the number of successful trials out of a pre-defined number of trials n = 18. Given this, the primary outcome will be analysed via a generalized mixed effects model. The model will include: (i) fixed effects for treatment, treatment period and their interaction, (ii) fixed effects for the baseline characteristics and (iii) a random patient effect. Including the latter effect in the model will help capture the within-patient correlation among the values of the primary outcome collected in Period I and Period II for the same patient.
All statistical analyses will be conducted using the open-source statistical software package R.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind using a dummy alternate treatment.
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Constipation; Opioids; Cancer; Polyethylene glycol; Sennosides; Opioid Therapy

Summary:

      This is a study to compare the efficacy and tolerability of two laxatives for treatment of
      opioid-induced constipation in adult outpatients with cancer treated at the British Columbia
      Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will
      be randomly assigned to one of two treatment groups.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patient (18 years and above) with diagnosis of cancer.

          2. Patient requires treatment or prevention of constipation.

          3. Patient is able to communicate effectively with staff.

          4. Expected prognosis more than 12 weeks.

          5. On or starting opioid therapy

        Exclusion Criteria:

          1. Patient unable to take oral medication.

          2. Allergy or previous intolerance to PEG or sennosides.

          3. Lactose intolerant.

          4. Contraindication to PEG or sennosides.

          5. Known or suspected bowel obstruction or ileus.

          6. Colostomy or ileostomy.

          7. Inflammatory bowel disease.

          8. Hospitalisation expected within the study period.

          9. Patient unable to complete the study diary in English.
Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size
Condition: STEMI - ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Cangrelor
Intervention description: Cangrelor 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion prior to PCI will be given. It will be continued for ≥ 2 hours or for the duration of the procedure, whichever is longer.
Intervention MeSH terms: Cangrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in
      patients with ST-elevation myocardial infarction randomized to receive cangrelor during their
      percutaneous coronary intervention and compares them to patients randomized to not receive
      cangrelor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with an acute STEMI with the University of Kentucky as the institution of
             presentation with plans for PCI

          -  English-speaking

        Exclusion Criteria:

          -  Pregnant patients

          -  Prisoners

          -  Patients who are unable to provide his/her own consent

          -  Patients with a prior history of myocardial infarction

          -  Patients who have received thrombolytics

          -  Patients on systemic anticoagulation

          -  Patients who are hemodynamically unstable with evidence of shock

          -  Patients who are mechanically intubated

          -  Patients with devices not MRI compatible

          -  Patients with chronic kidney disease, glomerular filtration rate less than 30

          -  Patients who are already on dual antiplatelet therapy
Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
Condition: Pain, Postoperative; Cesarean Section
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine; TAP block; QL block; ESP block
Intervention description: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine; Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.; Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.; Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to one of three treatment groups, TAP, QL, or ESP blocks
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this prospective single center, randomized study is to determine if ultrasound
      guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane
      (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.
    

Eligibility criteria:

        Inclusion Criteria:

          1. American Society of Anesthesiologists (ASA) Physical Status 1-3

          2. Age greater than or equal to 18 years

          3. Scheduled for elective cesarean section

          4. English speaking

        Exclusion Criteria:

          1. ASA Physical Status 4-5

          2. Diagnosis of chronic pain

          3. Chronic opioid use (opioid use in the past 3 months)

          4. Preoperative use of SSRIs (Celexa, Lexapro, Prozac, Paxil), SNRIs (Cymbalta, Effexor),
             gabapentin, or pregabalin (Lyrica)

          5. Inability to cooperate with or understand protocol

          6. Inability to communicate pain scores or need for analgesia

          7. Infection at the site of block placement

          8. Intolerance or allergy to local anesthetics

          9. Neurologic deficit or disorder

         10. Blood thinning disorder or taking anticoagulant medication

         11. BMI > 50 kg/m2

         12. Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s),
             or alcohol within the past 2 years

         13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the investigator, may interfere with study assessments or compliance

         14. Current or historical evidence of any clinically significant disease or condition
             that, in the opinion of the investigator, may increase the risk of surgery or
             complicate the subject's postoperative course
Canadian Hemophilia Prophylaxis Study
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS); Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)
Intervention description: escalating dose prophylaxis; escalating dose
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Male
Minimum age: 12 Months
Maximum age: 30 Months
Healthy volunteers: No
Keywords: hemophilia, prophylaxis, cost effectiveness

Summary:

      Primary prophylaxis given less frequently initially, with the infusion frequency increased if
      needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with
      fewer complications than standard prophylaxis while reducing disability to a greater degree
      than intermittent therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A (factor level less than 2%).

          -  Age greater than 1 year and less than or equal to 2.5 years.

          -  Normal joints using the World Federation of Hemophilia orthopedic scale.

          -  Normal radiographs of joints in which bleeding has occurred using the World Federation
             of Hemophilia radiographic scale.

          -  Platelet count of > 150,000.

          -  Informed consent to participate.

        Exclusion Criteria:

          -  Three or more clinically determined bleeds into any single elbow, knee or ankle.

          -  Presence or past history of a circulating inhibitor (level ≥ 0.5 Bethesda Units).

          -  Family judged to be non-compliant by the local hemophilia clinic director.

          -  Competing risk (symptomatic HIV infection, juvenile rheumatoid arthritis, metabolic
             bone disease, or other diseases known to cause or mimic arthritis.)