bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)
Condition: Prostatectomy; Pain
Intervention: Acetaminophen (Ofirmev); Placebo
Intervention description: The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.; The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: Male
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acetaminophen

Summary:

      To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its
      potential to improve hospital efficiency and patient outcomes. The investigators compare the
      addition of IV acetaminophen versus placebo on postoperative anesthesia care unit recovery
      times, inpatient hospital length of stay (LOS), postoperative pain scores, consumption of
      opiates as rescue agents and side effects among patients undergoing robotic-assisted
      laparoscopic prostatectomy (RALP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing robotic-assisted laparoscopic prostatectomy

          -  ≥18 years old males

          -  American Society of Anesthesiologists class 1-4

        Exclusion Criteria:

          -  Chronic opiate use

          -  Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic
             steatohepatitis, history of alcoholism, liver function test results greater than 3
             times upper limit of normal in the past 3 months)

          -  Allergy/hypersensitivity to acetaminophen

          -  Patients with baseline dementia

          -  Chronic diathesis

          -  Chronic kidney disease
An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Metformin Small Pack; Metformin Large Pack
Intervention description: A single small pack of metformin will consist of a blister package containing 10 pills with a patient information leaflet in local language. The small packs will be available at each site in the following doses: 500 mg, 850 mg, and 1000 mg. The small pack size of metformin is not yet marketed. Small pack metformin will be provided by GSK as GSK brand metformin.; The large pack will consist of 1 month's supply of metformin.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Socioeconomic category; Medication compliance; Metformin; small pack

Summary:

      MTF116086 is an open-label, randomised, parallel-design study in subjects with type II
      diabetes. The study is site-based, with local pharmacies serving as the sites and pharmacists
      as principal investigators for the sites. All subjects will enter an initial 8-week
      observational phase during which purchase behaviour and compliance with usual metformin use
      will be observed and recorded. At the end of the observational phase, subjects will be
      randomised to one of the two arms (metformin small pack vs. metformin large pack) for a
      20-week interventional phase. The medication in the interventional phase is provided to the
      subjects free of charge. HbA1c will be collected for all subjects during Week 0, Week 8, and
      Week 28. Subjects will be asked questions about their tablet compliance, their satisfaction
      with the pack size they received and reasons for missing doses throughout the interventional
      phase by the pharmacist. The pharmacy visit on Week 28 will be end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females of age >=18 years

          -  Diagnosis of type II diabetes

          -  HbA1c value no higher than 9.0%

          -  Evidence of physician-supplied prescription for metformin use

          -  Stable dose of metformin for 3 months prior to enrolment

          -  Written informed consent from the subject

        Exclusion Criteria:

          -  Current use of any anti-diabetic medication other than metformin
Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
Condition: Pain
Intervention: IV ibuprofen; Ketorolac
Intervention MeSH terms: Ibuprofen; Ketorolac; Ketorolac Tromethamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post Operative Pain,; Pail relief

Summary:

      The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to
      ketorolac for the treatment of postoperative pain as measured by patient pain intensity
      (Visual Analog Scale, VAS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for knee arthroscopy

        Exclusion Criteria:

          -  Inadequate IV access.

          -  History of allergy or hypersensitivity to any component of ibuprofen, ketorolac,
             aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs),
             opioids or cyclooxygenase-2 (COX-2) inhibitors.

          -  Less than 18 years of age.

          -  Use of analgesics less than 8 hours prior to surgery.

          -  Patients with active, clinically significant anemia.

          -  History or evidence of asthma or heart failure.

          -  Pregnant.

          -  Recent history of chronic opioid use.

          -  Concomitant use of probenecid.

          -  Inability to understand the requirements of the study, be willing to provide written
             informed consent (as evidenced by signature on an informed consent document approved
             by an Institutional Review Board [IRB]), and agree to abide by the study restrictions
             and to return for the required assessments.

          -  Refusal to provide written authorization for use and disclosure of protected health
             information.
Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Risperidone prolonged release
Intervention description: Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Schizophrenia; Risperidone; Risperdal consta

Summary:

      The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting
      risperidone when switching from oral antipsychotics in participants with schizophrenia
      (psychiatric disorder with symptoms of emotional instability, detachment from reality, often
      with delusions and hallucinations, and withdrawal into the self).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders,
             fourth edition (DSM-IV)

          -  Be on treatment with oral antipsychotic of first or second generation, for a minimum
             time of 12 months

          -  Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months

          -  Total Positive and Negative Syndrome Scale score less than or equal to 90, the
             conceptual disorganization, hallucinatory behavior, suspicion and not usual content of
             thought must be less than or equal to 4

          -  Be not pregnant as showed on negative pregnancy serum test

        Exclusion Criteria:

          -  Contraindication or known hypersensitivity to risperidone

          -  Previous history of unsatisfactory response to risperidone

          -  Previous history of refractivity to the other second generation antipsychotics

          -  Use of antipsychotic of intramuscular deposit in the last 12 months

          -  Other mental disturbances of DSM-IV axis
Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
Condition: Epilepsy
MeSH terms: Seizures
Intervention: Pregabalin
Intervention description: Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID).
Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID).
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregabalin for partial seizures

Summary:

      The objective of study is to assess the clinical improvement (change in seizure frequency),
      safety, and tolerability of subjects with partial seizures following adjunctive therapy of
      pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with
             partial seizures having minimum of two partial seizures during a two month period
             before the baseline visit

          -  Having a clinical history of epilepsy and AED treatment at least 1 year prior to
             inclusion

        Exclusion Criteria:

          -  AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures

          -  Having absences seizures

          -  Having had status epileptics within the year prior to inclusion

          -  Having a progressive neurological or systematic disorder

          -  Having known significant renal or hepatic dysfunction
Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Metformin
Intervention description: 5 mg, oral tablet, once daily; 500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 286.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Saxagliptin; Randomised; Double-blind

Summary:

      The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration
      of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a
      submaximal dose of metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent

          -  Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of
             metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.

          -  HbA1c ≥7.0% and ≤10.0%

        Exclusion Criteria:

          -  Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.

          -  Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2

          -  Individuals who, in the opinion of the investigator, in which participation in this
             study may pose a significant risk to the patient and could render the patient unable
             to successfully complete the study
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
Condition: Idiopathic Focal Segmental Glomerulosclerosis
MeSH terms: Proteinuria; Glomerulosclerosis, Focal Segmental
Intervention: Acthar Gel
Intervention description: Acthar Gel 80 U/mL solution for subcutaneous injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FSGS; primary FSGS; idiopathic FSGS

Summary:

      Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that
      remove waste from the blood. Proteins are supposed to stay in the blood. Damaged "filters"
      let protein get into the kidney.

      FSGS is a serious condition that can lead to kidney failure. The only treatment for kidney
      failure is dialysis or kidney transplant.

      Proteinuria means too much protein came through the kidneys into the urine.

      If the doctor cannot figure out what is causing the problem, it is primary (idiopathic) FSGS.
      This kind of FSGS is very hard to treat.

      This study will test Acthar in patients with this condition who have not responded to other
      treatments. It primarily investigates how well the therapy is tolerated by the patients and
      how well they respond to this treatment.
    

Eligibility criteria:

        Inclusion Criteria

        Potential participants must meet the following summary criteria for inclusion in the study:

          -  Is male or non-pregnant, non-lactating female

          -  Has primary FSGS, is nephrotic and did not achieve at least partial proteinuria
             response with prior therapy

          -  Has been treated with an angiotensin converting enzyme inhibitor or receptor blocker
             (or have documented intolerance), for at least 4 weeks before screening

          -  Has blood pressure no higher than 150/90 mmHg

          -  Meets all other inclusion criteria detailed in the protocol

        Exclusion Criteria

        Potential participants will not be eligible for the the study if they meet the following
        summary criteria:

          -  Has hepatitis B or C, tuberculosis, or other contraindication listed on the United
             States (US) Prescribing Information for Acthar

          -  Has Type 1 or Type 2 diabetes mellitus or any clinically significant infection

          -  Has received specific treatments at exclusionary time points per protocol

          -  Has been involved in a therapeutic drug/device trial (other than for FSGS) within 4
             weeks before screening

          -  Meets any other exclusion criteria detailed in the protocol

          -  Has any other condition that might, per protocol or in the opinion of the
             investigator, compromise:

               1. the safety and well-being of the participant or their offspring

               2. the safety of study staff

               3. analysis of results
Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy
Condition: Hypoxemia
MeSH terms: Hypoxia
Intervention: Alfentanil; Normal saline; Targeted controlled infusion; Propofol
Intervention description: Give Alfentanil before TCI Propofol sedative bronchoscope; Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.; The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model; The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
Intervention MeSH terms: Alfentanil; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sedative bronchoscope; Alfentanil doses; Propofol; Targeted controlled infusion; Hypoxemia

Summary:

      Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many
      other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic
      onset and quick recovery, synergic sedative effect and unwanted side effects too. However,
      the amount of Alf needed in combination with Pro for induction and the timing of
      administration was no standardized. The investigators designed this study to evaluate the
      optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for
      flexible bronchoscopy sedation, and also to evaluate the influence of variable regimen of Alf
      and Pro on hypoxemia, hypotension, cough severity, and Pro injection related pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who required elective sedative bronchoscopy

        Exclusion Criteria:

          -  any physical, psychiatric, social problem that avoid from conscious level evaluation,

          -  hypersensitivity or allergy to Propofol, Alfentanil

          -  severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of
             predicted value, or requirement for oxygen therapy)

          -  unstable haemodynamic status (defined as a heart rate < 60 or ≧ 120 bpm and/or

          -  a systolic blood pressure (SBP) < 100 or ≧ 180 mmHg)

          -  predictable difficult upper airways (Mallampati classification score of IV)

          -  severe obstructive sleep apnea with apnea hypopnea index (AHI) > 45

          -  Body mass index (BMI) more than 42 in male and 35 in female

          -  renal insufficiency

          -  liver cirrhosis
Deep Neuromuscular Block for Laparoscopic Surgery
Condition: Laparoscopy; Anesthesia Recovery Period
Intervention: Sugammadex; Neostigmine
Intervention description: Reversal of neuromuscular block Sugammadex dosage will be adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. Dosage will be 4mg/kg if TOF = 0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.; Neostigmine 50 micrograms/kg coupled with atropine 20 micrograms/kg or glycopyrrolate 5 micrograms/kg, to a maximum dose of neostigmine of 5.0 mg. The neostigmine should not be administered until the TOF has at least 3 twitches present.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Trial summary: deep neuromuscular block is proposed as a technique to improve operative
      conditions for laparoscopy. Early clinical data would suggest that there may also be patient
      benefits beyond the operative period related to lower intra-abdominal pressure, and improved
      surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential to
      use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide
      moderate neuromuscular block and reverse with neostigmine. It is not possible to safely
      reverse deep neuromuscular block using neostogmine, as the majority of block must have worn
      off for neostigmine to be effective. in order to identify whether deep neuromuscular block
      improves quality of recovery after surgery, the investigators will conduct a randomised trial
      of deep versus moderate neuromuscular block, whilst minimising variance in other anaesthetic
      techniques and drugs used. the outcome measured will be the post-operative quality of
      recovery over multiple time periods using the Postoperative Quality of Recovery Scale
      (PostopQRS). 350 patients will be enrolled over 4 centres.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult participants

          2. operative gynecological or abdominal surgery

          3. receiving general anesthesia

          4. Operation expected to exceed1 hour duration

          5. Participants must speak sufficient English to answer the survey questions

        Exclusion Criteria:

          1. Participants undergoing diagnostic laparoscopy only

          2. Participants <18 years of age

          3. Current pregnancy

          4. Known allergy to rocuronium, neostigmine or sugammadex, or desflurane
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
Condition: Idiopathic Growth Hormone Deficiency; Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Intervention: Blood sampling
Intervention description: Subjects with pre-established diagnosis of IGHD and TS and were treated with r-hGH therapy for 1 year, will be observed in this retrospective cohort study wherein blood sampling will performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 458.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Growth Hormone Deficiency; Turner syndrome; Pharmacogenetics; Recombinant Human Growth Hormone therapy

Summary:

      PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to
      confirm that some genes can be used to predict how well a subject diagnosed with idiopathic
      growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with
      recombinant human growth hormone (r-hGH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-established diagnosis of IGHD or TS based on classical criteria with at least 1
             year of r-hGH therapy and with Tanner stage 1 at treatment start

          -  Retrospective availability of a complete set of clinical, auxological and biological
             parameters necessary for building the predictive model

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Acquired growth hormone deficiency (GHD)

          -  Any drug or disease that could affect growth during the first year of r-hGH treatment

          -  Other protocol defined exclusion criteria could apply