bioihbjkbjnl/mcl2 huggingface dataset:
Infiltration Analgesia After Caesarean Section
Condition: Pain, Postoperative; Caesarean Section
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine 0,75%; NaCl 0,9%
Intervention description: Postoperative wound infusion 2 ml/ h/ 48h; Postoperative wound infusion 2 ml/h/48h
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: postoperative pain; infiltration analgesia; ropivacaine; Caesarean Section

Summary:

      Infiltration of a local anesthetic into the surgical wound is a simple method to strive to
      control postoperative pain after surgery. In the investigators institution, this method is
      used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover,
      the cost of the single use elastomeric pump used with this procedure is clearly higher than
      the costs of other routinely used analgesic methods.

      According to the investigators observations, infiltration of a local anesthetic into the
      surgical wound after caesarean section seems to reduce the need for rescue analgesics.
      However, the scientific evidence of the efficacy of this technique is weak. The investigators
      decided to conduct a prospective, controlled, randomised, double blind trial on this topic.

      The hypothesis is that wound infiltration with local anesthetic will reduce postoperative
      pain and opioid consumption after caesarean section without major adverse effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  volunteer

          -  age over 18 years

          -  spinal anesthesia

          -  ASA 1-2

          -  no allergy to used medications

          -  no medications which have effect on pain perception

        Exclusion Criteria:

          -  patient's refusal to participate

          -  marked systemic disease
Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Intervention: Human Rotavirus Vaccine
Intervention description: Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age, 10 & 14 weeks of age, or 6, 10, & 14 weeks of age, depending on study arm assignment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 456.0
Sex: All
Minimum age: 42 Days
Maximum age: 55 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on
      alternate dosing schedules will enhance the immune response to the vaccine in a low-resource,
      high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose
      vaccine schedule at a slightly older age and giving an additional dose of the vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 42 and 55 days of age at the time of enrollment.

          -  Healthy infant free of chronic or serious medical condition as determined by history
             and physical examination at the time of study enrollment.

          -  Parents/guardians of each subject are able to understand and follow study procedures
             and agree to participate in the study by providing parental/guardian permission.

        Exclusion Criteria:

          -  If child has previously had intussusception or abdominal surgery.

          -  Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since
             birth or anticipated during study period.

          -  Current enrollment in any other intervention trial or use of any investigational drug
             or vaccine throughout the study period.

          -  Birthweight less than 2000 grams or gestation < 36 weeks, if this information is
             available.

          -  Any subject who reports plan to leave the study area before the completion of the
             study (i.e., relocation, migration, etc.).

          -  Another child living in the same compound is already enrolled in the trial (i.e., only
             one participant can be enrolled per compound).

          -  After the rotavirus vaccine is introduced into the routine EPI system in Navrongo:
             Another child in the compound is less than 16 weeks of age.

          -  The child has received rotavirus vaccine outside of this study.
Pharmacokinetic Profile of Myfortic in Combination With Tacrolimus in Fed Versus Fasting State
Condition: Kidney Transplantation
Intervention: Myfortic
Intervention description: Myfortic 720 mg orally twice daily
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Literature regarding the effect of food on the pharmacokinetic (PK) profile of enteric-coated
      mycophenolate sodium combined with tacrolimus and corticosteroid withdrawal is lacking. The
      objective of this study is to identify pharmacokinetic variables of mycophenolate sodium
      (Myfortic®) in the fed and fasting state in stable renal transplant patients on tacrolimus in
      combination with a rapid steroid withdrawal protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal transplant recipients greater than 18 years of age, who have given written
             consent

        Exclusion Criteria:

          -  Taking medications that may alter the metabolism of tacrolimus or mycophenolate sodium

          -  Experienced an acute rejection episode prior to the pharmacokinetic profile collection

          -  Serum creatinine >2 mg/dL

          -  Neutropenia (Absolute Neutrophil Count < 1.3x10^3/mL)

          -  Received a previous transplant other than a kidney

          -  Receiving chronic steroids at time of transplant

          -  Known hypersensitivity to tacrolimus, mycophenolate mofetil, mycophenolate sodium,
             mycophenolic acid or any of its excipients
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
Condition: Chronic Kidney Diseases; Iron Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: KRX-0502
Intervention description: Oral ferric citrate with meals
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to assess the long-term efficacy and safety of different
      dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects
      with non-dialysis dependent chronic kidney disease (CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min

          -  Hgb ≥8.5 g/dL and ≤11.5 g/dL

          -  Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%

          -  Serum intact parathyroid hormone ≤600 pg/mL

        Exclusion Criteria:

          -  Serum phosphate <3.0 mg/dL

          -  Intravenous (IV) iron administered within 4 weeks prior to Screening

          -  Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening

          -  Blood transfusion within 4 weeks prior to Screening
A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Bevacizumab; Paclitaxel; Docetaxel
Intervention description: Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.; Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.; Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
Intervention MeSH terms: Paclitaxel; Docetaxel; Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center study will evaluate the safety, tolerability and effect of
      bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on
      disease progression, survival time and Karnofsky performance status in female participants
      with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative
      (triple-negative) breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor
             negative) adenocarcinoma of the breast in pre- or post-menopausal women with
             measurable or non-measurable metastatic disease

          -  Participant who in the Investigator's opinion requires combination therapy for their
             disease

          -  Life expectancy of greater than or equal to (>/=)12 weeks

        Exclusion Criteria:

          -  Previous chemotherapy for metastatic breast cancer

          -  Participants currently undergoing radiation therapy for the treatment of metastatic
             disease (apart from the relief of metastatic bone pain)

          -  Major surgery or significant traumatic injury within 28 days prior to enrollment or
             anticipation of the need for major surgery during study treatment
Improving Post-Operative Pain and Recovery in Gynecologic Surgery
Condition: Postoperative Pain; Opioid Use; Acetaminophen
MeSH terms: Pain, Postoperative
Intervention: Rectal acetaminophen; Intravenous acetaminophen
Intervention description: Rectal 1300mg; Intravenous 1000mg
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative Pain; Minimally-invasive Hysterectomy; Opioid Use; Acetaminophen; Hysterectomy

Summary:

      This is a clinical investigation to determine the efficacy of rectal versus intravenous
      acetaminophen in patients undergoing a minimally invasive hysterectomy. All women will
      receive acetaminophen either rectally or intravenously immediately postoperative, prior to
      extubation. Patient's will be randomly assigned to either the rectal acetaminophen or the
      intravenous acetaminophen group. Patient outcomes will be measured through a Numeric Rating
      Scale (NRS) from 0-10 for pain scores, and total opioid consumption measured in morphine
      milligram equivalent (MME) for the first 24 hours following surgery, or upon discharge,
      whichever comes first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to consent

          -  Amendable to receive either rectal or intravenous acetaminophen

          -  Planned hospital stay for at least 24 hours.

        Exclusion Criteria:

          -  Patients unable to provide informed consent

          -  Patients with a history of regular opioid use prior to surgery based on their current
             home medication list

          -  Patients who have required regular opioid intake for the 7 days preceding surgery

          -  Patients with known hypersensitivity to acetaminophen

          -  Patients with a baseline preoperative liver function enzymes (AST and ALT) that are
             greater than twice the upper limits

          -  Unable to complete procedure as planned.
Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia
Condition: Indication for Modification of Patient Cognitive Status
MeSH terms: Schizophrenia
Intervention: Repyflec cognitive remediation training
Intervention description: Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Cognitive remediation; Group training; Executive function; Social functioning

Summary:

      The purpose of this study was to develop an integrative intervention for schizophrenia taking
      into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of
      our cognitive remediation group training: Problem Solving and Cognitive Flexibility training
      (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We
      hypothesized that training executive function and metacognition would allow us to achieve
      improvements in neurocognition, functioning and psychiatric symptoms of patients with
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia or schizoaffective disorder

          -  More than 2 years illness duration

          -  Literate

          -  Mini Mental Status Examination score over 24

          -  Global Assessment of Functioning scores between 40 and 70

        Exclusion Criteria:

          -  Current acute illness exacerbation

          -  Mental Retardation

          -  Neurological disorder which impairs cognition

          -  Currently participating in social skills training or cognitive remediation

          -  Change of antipsychotic medication one month before the trial or during the 40 study
             weeks

          -  Diagnosis of alcohol or drug dependence within 6 months of trial commencement.
Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: ZOSTAVAX®
Intervention description: One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary objective:

      To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry
      potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by
      glycoprotein Enzyme Linked ImmunoSorbent Assay [gpELISA]) from pre-vaccination to 4 weeks
      post-vaccination.

      Secondary objectives:

      To describe the safety profile of ZOSTAVAX® at minimum release specification approaching
      expiry potency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant of either gender aged ≥50 years

          -  Positive history of varicella or residence for >30 years in a country with endemic VZV
             infection

          -  All females must be postmenopausal or have a negative serum or urine pregnancy test or
             acceptable method of birth control for three months after vaccination

          -  Participant having signed the informed consent form prior to any study procedure

        Exclusion Criteria:

          -  Febrile within 72 hours prior to vaccination

          -  Prior history of Herpes Zoster clinically diagnosed by a physician

          -  Previously received a varicella or zoster vaccine

          -  Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination

          -  Received any other live virus vaccine within 4 weeks prior to vaccination, or is
             expected to receive any other live virus vaccine during the study

          -  Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected
             to receive any inactivated vaccine during the study

          -  Was treated with immunoglobulins or any blood products, other than autologous blood
             transfusion, given during the 5 months prior to vaccination or is expected to be
             treated during the study

          -  Taking any non topical antiviral therapy with activity against herpesviruses.

          -  On immunosuppressive therapy

          -  Known or suspected immune dysfunction caused by a medical condition, or any other
             cause

          -  History of hypersensitivity reaction or anaphylactoid reaction to any vaccine
             component, including gelatin or neomycin

          -  Known active tuberculosis

          -  Significant underlying illness preventing completion of the study
Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: EpiCeram Skin Barrier Emulsion; Desonide Cream 0.05%
Intervention description: topical cream, twice daily, 6 weeks; topical cream, twice daily, 6 weeks
Intervention MeSH terms: Desonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 3 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This study compares the effectiveness of two topical creams for atopic dermatitis in
      pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice
      daily for 6 weeks or until clear.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 3 months of age and less than 13 years of age

          -  atopic dermatitis of moderate severity

        Exclusion Criteria:

          -  pregnant or lactating

          -  treatment of atopic dermatitis with topical product in the 14 days prior to Baseline

          -  treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline

          -  serious or uncontrolled medical condition

          -  active infection

          -  significant use of inhaled, intranasal, or intraocular corticosteroid
Ketamine and Propofol for Upper Endoscopy
Condition: Anesthesia
Intervention: Ketamine; Propofol
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 3 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: Ketamine; Propofol; Children; Pediatrics; Upper endoscopy

Summary:

      The purpose of this study is to examine the dose-response relationship of ketamine in
      combination with propofol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3-13 years

          -  Receiving general anesthesia for upper endoscopy

        Exclusion Criteria:

          -  Known or possible difficult airway

          -  BMI > 35

          -  Weight < 10 kg

          -  Sedative premedication required

          -  Known contraindication to ketamine or propofol
Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: AI-1000 G2; Tocilizumab
Intervention description: Tocilizumab will be administered using the AI-1000 G2.; Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Phase: Phase 4
Study type: Interventional
Primary purpose: Device Feasibility
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate RLHFs concerning administration of the tocilizumab
      autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving
      subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle
      safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be
      assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and
      healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining
      study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with RA for greater than or equal to (>/=6) months receiving 162 mg
             tocilizumab PFS-NSD for >/=8 weeks and who are suitable for continued treatment at
             their currently prescribed dose

          -  CGs and professionally qualified HCPs who are able and willing to administer the
             injection

        Exclusion Criteria:

          -  RA: Functional status Class IV

          -  RA: Neuropathies or other conditions that might interfere with pain evaluation

          -  RA: Pregnant or breastfeeding

          -  RA: Low neutrophil or platelet count at last laboratory assessment

          -  RA: Elevated liver enzymes at last laboratory assessment

          -  Current participation in another interventional clinical trial

          -  Criteria that might give the participant/CG/HCP an advantage in injection tasks such
             as employment in the pharmaceutical industry, etc.