bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion
Condition: Healthy
Intervention: ertapenem; ertapenem
Intervention description: 1 gram IV bolus every 24 hours (q24h) for 3 days; 1 gram 30 minute infusion q24h for 3 days
Intervention MeSH terms: Ertapenem
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics; Safety

Summary:

      The purpose of this study is to characterize and compare the concentration-time profiles and
      multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily
      versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and
      pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and
      compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults (18 years of age or older)

        Exclusion Criteria:

          -  Ertapenem or other beta-lactam allergy

          -  Pregnant or breast feeding females

          -  Body Mass Index (BMI) greater than or equal to 30

          -  Abnormal lab values at baseline

          -  Hypertension

          -  Significant medical abnormality

          -  Regular alcohol consumption

          -  Significant nicotine use
Study of Dual Trigger Ovulation in Oocyte Donors
Condition: Infertility
MeSH terms: Infertility
Intervention: HCG; Lupron Trigger; Dual Trigger
Intervention description: hCG Trigger; leuprolide acetate 2 mg SQ; a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oocyte donor; oocyte recipient; ovulation trigger

Summary:

      The project is a randomized, controlled, prospective study of oocyte donors comparing the
      safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and
      very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard
      GnRH trigger alone.
    

Eligibility criteria:

        Inclusion Criteria:

        Donors

          -  Young women, age 21 to 34, presenting to our facility with the desire to donate
             oocytes and meeting FDA and program requirements for donation.

        Recipients

          -  Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and
             meeting FDA and program requirements to be recipients of donated eggs.

        Exclusion Criteria:

        Donors

          -  Less than 2 ovaries or any other significant ovarian abnormality

          -  Does not meet current FDA or program requirements for donation.

          -  A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
             undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)

          -  A contraindication for the use of oral contraceptive pills (h/o thromboembolism,
             breast cancer, undiagnosed vaginal bleeding)

          -  Known gene defects, genetic abnormalities or abnormal karyotype

          -  Contraindication or hypersensitivity to any of the concomitant medication prescribed
             as part of the treatment regimen in this protocol

          -  Inability to give informed consent

          -  Donors who, because of their place of residence or personal situation, would not be
             able to commit to all required time points including the one extra visit required by
             study participation.

          -  The subject has a recent history of/or current epilepsy, thrombophilia, diabetes,
             cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease
A Smoking Cessation Intervention for Yale Dining Employees
Condition: Smoking Cessation
Intervention: Contingency management; Nicotine replacement therapy; Varenicline; Additional behavioral support
Intervention description: Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.; Participants have the option of using nicotine patch in combination with nicotine gum or lozenge; Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative; Based on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate a smoking cessation program for employees at the
      Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3
      control sites) will be offered a contingency management/pharmacotherapy smoking cessation
      intervention at the work site.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current smoker

          -  Interested in receiving treatment for quitting smoking.

          -  Employed for more than 20 hours per week by one of the 7 residential college dining
             halls selected for inclusion in this study.

          -  English speaker.

        Exclusion Criteria:

          -  None specified, other than failure to meet all inclusion criteria listed above.
Evaluation of Diaphragm Movement After an Interscalene Block
Condition: Phrenic Nerve Paralysis
MeSH terms: Paralysis
Intervention: liposomal bupivacaine; bupivacaine
Intervention description: Experimental; Active comparator
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the movement of the diaphragm after an interscalene
      block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine.
      This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using
      liposome bupivacaine in an interscalene block, using ultrasound.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients age 18 years and older who are scheduled for shoulder surgery with
             interscalene block and remain in the hospital for more than 24 hours that are being
             randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.

        Exclusion Criteria:

          -  Non English speaking patients.
A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Pneumovax 23- pneumococcal polysaccharide; Blood draw
Intervention description: PPSV23 is a vaccine to help protect against serious infection due to the Streptococcus pneumoniae bacteria. One dose administered intramuscularly or subcutaneously.; 6 ml blood draw at baseline and 6 months post immunization
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Will study immunological response to vaccination
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if children with type 1 diabetes have adequate
      immune response to PPSV23 vaccination and to assess factors affecting immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children ages 3-18 years old.

          -  Clinical diagnosis of Type 1 diabetes.

        Exclusion Criteria:

          -  Newly diagnosed with Type 1 diabetes with in the past month of study date.

          -  Contraindications to receiving 23 valent pneumococcal vaccines.

          -  Other conditions associated with compromised immunity and vaccine response.

          -  Primary or Secondary Immune deficiency.

          -  Previous receipt of PPSV-23 vaccination.
Two Dose Epidural Morphine for Post-cesarean Analgesia
Condition: Pain; Morphine Adverse Reaction
Intervention: Epidural Morphine; Epidural Saline
Intervention description: Patients will be given 3mg epidural morphine, 24 hours after the initial dose.; Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Post-cesarean analgesia; Second dose of epidural morphine after surgery; Post-operative analgesia; Self-administered epidural morphine; Pain management after cesarean

Summary:

      The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen
      for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes
      scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that
      administration of a second dose of epidural morphine 3 mg, 24 hours after an initial
      intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours
      after surgery, compared to a single epidural morphine dose regimen. The primary outcome will
      be the amount of intravenous morphine patients self-administer during the 2nd 24 hours
      post-surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing cesarean section under epidural anesthesia.

        Exclusion Criteria:

          -  Emergent cesarean section

          -  Coagulopathy

          -  Failed epidural anesthesia or patchy block

          -  General anesthesia

          -  Use of epidural chloroprocaine

          -  Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)

          -  Severe opioid side effects

          -  History of chronic opioid use

          -  History of chronic pain

          -  History of obstructive sleep apnea

          -  Morbid obesity (Body Mass Index (BMI)>45 kg/m2)

          -  Height under 4' 10" (147 cm)

          -  Documented dural puncture by the epidural (Tuohy) needle

          -  Preeclampsia

          -  Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or
             more).
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
Condition: Patient Adherence
Intervention: Vitamin D Supplement
Intervention description: Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks.
Intervention MeSH terms: Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PrEP; Pre exposure Prophylaxis; Truvada; CCTG; 595; Vitamin D; Bone mineral density

Summary:

      CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs.
      standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection
      (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control
      substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In
      CCTG 595, plasma from participants are being collected and stored at entry and every 12
      weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in
      both cases and controls at entry, week 24, and week 48.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must meet CCTG 595 inclusion criteria.

        Exclusion Criteria:

          -  All subjects must meet CCTG 595 exclusion criteria.

          -  Current or prior use of bisphosphonate therapy.

          -  Current use of Vitamin D supplements greater than 400 IU/day.

          -  Current use of androgenic hormones or growth hormones.

          -  History of nephrolithiasis (kidney stones).

          -  History of fragility fracture.

          -  No use of tenofovir prior to entry into CCTG 595
Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
Condition: Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Ondansetron; Placebo
Intervention description: The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos.; The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study is a randomized placebo controlled trial to determine whether repeated
      postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative
      and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy.
      Ondansetron will be administered in the intra- and post-operative period. These individuals
      will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of
      postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative
      prophylactic administration of multiple doses of ondansetron (Zofran).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients of Dr. Coleman or Dr. Kelly ages 18 to 65 undergoing arthroscopic hip
             surgery

          -  Planned use of neuraxial anesthesia

          -  Ability to follow study protocol

          -  Willing to complete daily diary and be interviewed daily for three days after
             discharge

        Exclusion Criteria:

          -  Patients younger than 18 years old and older than 65

          -  Patients unable to undergo a spinal or epidural anesthetic

          -  Having nausea or vomiting within 24 hours of the surgery

          -  Receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g
             Zofran, Compazine, Phenergan, Reglan)

          -  Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)

          -  Hypersensitivity and/or allergy to ondansetron

          -  Intraoperative use of any volatile anesthetic

          -  Contraindication to a short course of NSAIDs (renal failure, intolerance)

          -  Allergy or intolerance to Vicodin
Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Ramelteon; Placebo
Intervention description: one 8 mg tablet at bedtime for up to 6 months; one tablet at bedtime for up to 6 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether treating sleep difficulties in patients
      with bipolar disorder also improves their mood stability.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of written informed consent before initiation of any study-related
             procedures

          2. Men and women aged 18 to 65 years.

          3. A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical
             Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.4x
             Bipolar I disorder, most recent episode manic, 296.6x Bipolar I disorder, most recent
             episode mixed, or 296.5x Bipolar I disorder, most recent episode depressed.

          4. PSQI total score of >=5.

          5. MADRS total score of <=12.

          6. YMRS total score of <= 12

          7. Female patients of childbearing potential must have a negative urine pregnancy test at
             enrollment and be willing to use a reliable method of birth control, i.e.,
             double-barrier method, oral contraceptive, implant, dermal contraception, long-term
             injectable contraceptive, intrauterine device or tubal ligation, during the study.

          8. Be able to understand and comply with the requirements of the study, as judged by the
             investigator.

          9. Outpatient status at enrollment.

        Exclusion Criteria:

          1. Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the
             patient's current psychiatric status.

          2. Presence of prohibited medications of antidepressants (including MAOI's) and systemic
             corticosteroids.

          3. Patients with a diagnosis of primary insomnia disorders

          4. Patients with a diagnosis of severe chronic obstructive pulmonary disease

          5. A clinical finding that is untreated (eg, hypertension, poorly controlled diabetes,
             angina) or that, in the opinion of the investigator, would be negatively affected by
             the study medication or that would affect the study medication.

          6. Patients with active substance abuse diagnoses (except tobacco abuse).

          7. Known history of intolerance or hypersensitivity to ramelteon or to any other
             component in the tablet.
An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
Condition: Neoplasms
Intervention: Bevacizumab
Intervention description: Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants were assigned the same treatment. The Number of Arms represent the reporting groups of all subjects according to disease.
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm, open-label, multicenter extension study will provide continued bevacizumab
      therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech
      sponsored study and who derived benefit from the bevacizumab therapy. Participants will
      receive the same dose and regimen of bevacizumab as used in the previous parent trial and
      continue this treatment until progression of disease or unacceptable toxicity, withdrawal of
      consent or death whichever occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored
             parent trial and continues to have benefit as judged by the investigator

          -  Eligible for continuation of bevacizumab treatment at the end of a parent trial,
             according to parent trial protocol

          -  Able to comply with this extension study protocol (MO25757)

        Exclusion Criteria:

          -  Evidence of disease progression assessed according to parent trial protocol during the
             screening phase for this extension study

          -  Evidence of any adverse event potentially attributable to bevacizumab, for which the
             local label recommends permanent discontinuation

          -  A treatment interruption with bevacizumab of more than 42 days since the last
             administration of bevacizumab in the parent trial

          -  Evidence of any other disease that would put the participant at high risk for
             treatment-related complications
Residual Curarization and Its Incidence at Tracheal Extubation (P08194)
Condition: Observation of Neuromuscular Block
Intervention: TOF-Watch SX® Monitoring of NMB
Intervention description: Participants will have the extent of NMB monitored by a TOF-Watch SX®.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios
      at tracheal extubation when anesthesiologists have determined that full recovery of
      neuromuscular function has occurred using standard clinical criteria for participants whose
      non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase
      inhibitor administered as per standard routine care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be American Society of Anesthesia (ASA) class 1-3.

          -  Participant must be scheduled for elective open or laparoscopic abdominal surgery that
             is anticipated to last less than 4 hours.

          -  Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular
             blockers for endotracheal intubation or maintenance of neuromuscular blockade.

          -  Extubation must occur in the operating room (OR).

        Exclusion Criteria:

          -  Surgery re-admission on the same hospital admission.

          -  Pre-established need for or expected to require post-operative mechanical ventilation.

          -  Conditions, surgical procedures or position that may interfere with the TOF-Watch SX®
             operation, calibration or accuracy.

          -  Administration of sugammadex (Bridion®) for reversal of neuromuscular blockade.

          -  Participation in any other clinical trial.

          -  Member or a family member of the personnel of the investigational or Sponsor staff
             directly involved with this trial.

          -  Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g.
             mechanomyography, electromyography or related method).