bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
Condition: Pain
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine; Ketorolac; Placebo
Intervention MeSH terms: Ketorolac; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cesarean section

Summary:

      The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine
      (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer
      similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will
      reduce the pain experienced after cesarean section and need for narcotic pain medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiology (ASA) class 1,2, and 3

          -  English speaking women at a gestational age > 37 weeks

          -  scheduled for cesarean delivery under spinal or combined spinal epidural anesthesia

        Exclusion Criteria:

          -  BMI > 50 kg/m2

          -  history of intravenous drug or opioid abuse

          -  previous history of chronic pain syndrome

          -  history of opioid use in the past week

          -  allergy or contraindication to any of the study medications

          -  non-English speaking
Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Dose-matched placebo; Vilazodone
Intervention description: Dose-matched placebo was supplied as tablets.; Vilazodone was supplied as tablets.
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 518.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Depression

Summary:

      The purpose of this study was to further characterize the efficacy, safety, and tolerability
      of a single fixed dose level of vilazodone compared to placebo in patients with major
      depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-70 years of age.

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.

          -  The patient's current major depressive episode must be at least 8 weeks and no longer
             than 12 months in duration.

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women of
             childbearing potential who are not practicing a reliable method of birth control.

          -  Patients with a history of meeting DSM-IV-TR criteria for any:

               -  manic, hypomanic or mixed episode, including bipolar disorder and
                  substance-induced manic, hypomanic, or mixed episode;

               -  any depressive episode with psychotic or catatonic features;

               -  panic disorder with or without agoraphobia;

               -  obsessive-compulsive disorder;

               -  schizophrenia, schizoaffective, or other psychotic disorder;

               -  bulimia or anorexia nervosa;

               -  presence of borderline personality disorder or antisocial personality disorder;

               -  mental retardation, dementia, amnesia, or other cognitive disorders;

               -  patients who are considered a suicide risk.
Post-Operative Therapy for Nausea or Vomiting
Condition: Vomiting; Nausea
MeSH terms: Nausea; Vomiting
Intervention: Acupressure; Ondansetron
Intervention description: Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.
In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team.; Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery.
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PONV; Nausea; Vomiting; Acupressure

Summary:

      This is a single site, prospective, randomized controlled study designed to evaluate the
      impact of acupressure when used as an initial treatment before rescue medications in the
      treatment of post-operative nausea and/or vomiting at UCD.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients scheduled for elective surgery requiring general anesthesia

        Exclusion Criteria:

          -  Age less than 18 years

          -  Adults unable to give primary consent

          -  Pregnancy

          -  Prisoners

          -  Unable to access pericardial 6 acupressure point bilaterally post procedure

          -  Allergy to Ondansetron
Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Syntocinon (Oxytocin); Placebo (Physiological water (solution of sodium chloride (NaCl) in water))
Intervention description: Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray; Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Oxytocin; Autism Spectrum Disorders

Summary:

      The current trial aims to explore the neural and behavioral effects of oxytocin in autism
      spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and
      supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of
      complex social behaviors. Initial studies showed that intranasal administration of oxytocin
      can have a positive effect on social functioning in ASD.

      However, future studies are necessary to explore whether and how oxytocin effects neural
      processes in the brain underlying these behavioral improvements. This trial will not only
      measure behavioral enhancements, but will specifically focus on elucidating the associated
      neurophysiological changes by guiding the administration of oxytocin with regular
      neurophysiological assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Autism Spectrum Disorder, Asperger Syndrome or Autism

          -  Male

          -  Age between 18 and 40 years old

        Exclusion Criteria:

          -  Associated neuro(psycho)logical disorder (i.e. epilepsy, concussion, stroke)

          -  Eye sight worse than + or - 7

          -  Genetic syndrome

          -  Color blindness

          -  Any contraindication to neuroimaging research as assessed with the MRI screening list:

        MRI contraindications:

        pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or implanted
        pump, a neurostimulator or VP shunt, any metallic object in the eyes (metallic fragments)
CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation
Condition: Kidney Transplantation; Kidney Diseases; Kidney Failure
MeSH terms: Kidney Diseases; Renal Insufficiency
Intervention: Campath; Daclizumab
Intervention description: Monoclonal antibody induction therapy; Monoclonal antibody induction therapy
Intervention MeSH terms: Alemtuzumab; Daclizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kidney Transplantation; Kidney Disease; Kidney Failure; Graft Rejection

Summary:

      The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years
      has substantially reduced the risk of rejection after kidney transplantation, has allowed the
      development of immuno-suppressive regimens that do not use long-term steroids (steroid
      avoidance), and has improved transplant success rates both in the short and medium term.

      The main new agents used in these modern regimens are the calcineurin inhibitor (CNI)
      tacrolimus; the anti-proliferative agent mycophenolate; and induction agents which are used
      to provide effective early suppression of the rejection process; these include monoclonal
      antibodies (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and
      daclizumab) and the anti-CD52 antibody Campath-1H (alemtuzumab).

      Although almost all modern immunosuppressive regimens involve one or more of these agents, it
      is not known which is the safest and most effective combination.

      This randomised controlled trial compares two steroid sparing regimens which have been used
      with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit
      over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is
      as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant recipients under the care of the West London Renal and Transplant
             Centre

        Exclusion Criteria:

          -  Patients who are unable to give written informed consent

          -  Simultaneous kidney/pancreas transplant recipients

          -  Non-heart beating deceased donor transplant recipients

          -  Patients who would not be offered Campath-1H induction under our current protocol
             (patients with previous malignancy or with previous exposure to cytotoxic or
             antiproliferative agents)
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Abemaciclib; Fulvestrant; Standard Chemotherapy
Intervention description: Administered orally; Administered IM; Standard chemotherapy of physician's choice administered according to product label.
Intervention MeSH terms: Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel; Capecitabine; Fulvestrant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The reason for this study is to compare the efficacy of abemaciclib, in combination with
      fulvestrant, to that of physician's choice of chemotherapy in women with hormone
      receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic
      breast cancer that has spread to internal organs. Your participation in this trial could last
      up to 31 months, depending on your cancer type and how you and your tumor respond.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be females of post-menopausal status with HR+, HER2- breast cancer
             that has spread to internal organs

          -  Participants must have had at least one endocrine therapy

          -  Participants must be willing to use a device to answer daily questions about how they
             are doing for the duration of their participation in the study

          -  If participant has diarrhea from a previous treatment, they should talk to their
             doctor to ensure they have recovered enough to participate in this study

        Exclusion Criteria:

          -  Participants must not have breast cancer that has spread to the brain if untreated and
             with symptoms

          -  Participants must not have had any systemic treatment after their breast cancer has
             spread unless it is endocrine therapy

          -  Participants must not have certain active infections including HIV or hepatitis

          -  Participants must not be pregnant or breastfeeding

          -  Participants must not have certain types of cancers or certain previous cancer
             treatments

          -  Participants must not have certain serious medical conditions, including heart or lung
             disease, or have had certain types of tissue or organ transplants
Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)
Condition: Critically Ill; Hemodialysis
MeSH terms: Critical Illness
Intervention: Daptomycin
Intervention description: Daptomcyin 8 mg/kg infused intravenously every 48 hours
Intervention MeSH terms: Daptomycin
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: daptomycin; pharmacokinetics; renal replacement therapy; critical illness; intensive care units

Summary:

      Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant
      microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU)
      considering the severity of illness and high risk for infection within this hospital
      environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of
      ICU patients who develop acute renal failure will require some form of renal replacement
      therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most
      common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer
      periods of time. The current data demonstrating the ability of continuous hemodialysis to
      remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is
      to determine the extent of daptomycin removal from critically ill patients receiving
      continuous hemodialysis. Findings from this trial will be used to develop new dosing
      recommendations for daptomycin in continuous hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  =/> 18 years of age

          -  Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary
             physician

          -  Prescribed daptomycin as determined by the primary physician

          -  Informed consent granted

        Exclusion Criteria:

          -  < 18 years of age

          -  Allergy to daptomycin

          -  Patients being primarily treated with daptomycin for diagnosis of osteomyelitis,
             meningitis, or pneumonia without adequate concomitant use of other more effective
             antimicrobial agents as daptomycin is not indicated for primary treatment of these
             types of infections

          -  Inability to complete 48 hours of Continuous Venovenous Hemodialysis (CVVHD)

          -  Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane
             Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis

          -  Inability to obtain informed consent

          -  Pregnant and/or breastfeeding women
Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium; Indacaterol
Intervention description: Tiotropium via Respimat® device once a day; Indacaterol via Breezhaler® device once a day
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Breezhaler; Respimat; Indacaterol; Tiotropium

Summary:

      This study compared the correct use of and patient preference for two drug delivery systems
      (inhalers) in patients with COPD
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male and female adults aged ≥40 years, who have signed an Informed Consent form prior
             to initiation of any study-related procedure.

          2. Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD
             Guidelines 2010 or grade A in GOLD 2011and including:

               -  Smoking history of at least 10 pack years

               -  FEV1/FVC < 70%

        Key Exclusion criteria:

          1. Previous diagnosis of asthma

          2. Pregnant or nursing women

          3. Hospitalization or emergency room attendance due to COPD exacerbation within 3 months
             prior to visit 1
Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod; Standard MS DMT
Intervention description: 0.5 mg/day oral capsule; Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
Intervention MeSH terms: Fingolimod Hydrochloride; Interferon beta-1b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Fingolimod; Disease Modifying Therapy; TSQM-9

Summary:

      The purpose of this study is to evaluate the change in patient-reported treatment
      satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care,
      using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for
      Medication (TSQM-9).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005
             revised McDonald criteria.

          -  Patients who explicitly agree to be assigned to a treatment group that may receive
             fingolimod or DMT after having been informed about their respective benefits and
             possible adverse events by the investigator.

          -  An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.

          -  Must have received continuous treatment with a single approved and indicated MS DMT
             for a minimum of 6 months prior to the screening visit. Patients must continue with
             this MS DMT until the randomization visit.

          -  Naïve to treatment with fingolimod.

        Exclusion Criteria:

          -  A manifestation of MS other than those defined in the inclusion criteria.

          -  A history of chronic disease of the immune system other than MS or a known
             immunodeficiency syndrome.

          -  History of malignancy of any organ system (other than localized basal cell carcinoma
             of the skin), treated or untreated, within the past 5 years, regardless of whether
             there is evidence of local recurrence or metastases.

          -  Patients with uncontrolled diabetes mellitus (HbA1c > 7%).

          -  Diagnosis of macular edema during Screening Phase.

        Other protocol-defined inclusion/exclusion criteria may apply
Prospective Trial of Tranexamic Acid in Cardiac Surgery
Condition: C.Surgical Procedure; Cardiac
Intervention: Tranexamic Acid
Intervention description: The loading doses were given in 15 minutes when incision.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 955.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: tranexamic acid; cardiac surgery; cardiopulmonary bypass

Summary:

      Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease
      perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is
      still unknown. We use three different doses to find which is the optimum dose of tranexamic
      acid in cardiopulmonary bypass cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Noncyanotic congenital heart disease patients requiring cardiac surgeries under
             cardiopulmonary bypass

          -  Rheumatic or recessive valvular disease patients requiring valvular repair or
             replacement under cardiopulmonary bypass

          -  Coronary artery disease patients requiring coronary artery bypass graft under
             cardiopulmonary bypass

        Exclusion Criteria:

          -  Non-primary and emergency cardiac surgery

          -  Disorder in coagulation function before surgery

          -  Anemia before surgery

          -  Definite liver and renal dysfunction

          -  History of stroke

          -  Pregnancy and lactation

          -  Disabled in spirit or law

          -  Fatal conditions such as cancer