bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: The use of low-dose continuous infusion of S(+)-ketamine combined with
      target-controlled intravenous anesthesia with remifentanil and propofol may be related to the
      control of postoperative pain and of opioid-induced hyperalgesia. The present study aimed to
      evaluate the efficacy of continuous infusion of S(+)-ketamine given intraoperatively in the
      control of postoperative pain compared to placebo.
    

Detailed description: 
      Methods: This is a double-blind randomized controlled trial with 48 patients of both genders
      aged from 18 to 65 years who underwent videolaparoscopic cholecystectomy. After venipuncture,
      patients received intravenous parecoxib sodium (40 mg). Target-controlled intravenous
      anesthesia was induced with propofol and remifentanil associated with rocuronium and adjusted
      to maintain the bispectral index between 35 and 50. The S(+)-ketamine group (SG) group
      received a continuous infusion of S(+)-ketamine at a dose of 0.3mg.kg-1.h-1, while the
      placebo group (PG) received a continuous infusion of saline at the same dose. Postoperative
      analgesia was measured by a verbal numerical scale (VNS) from 0 to 10 during 12 hours and
      treated with morphine when VNS score was equal to or higher than 3 at a dose of 0.05 mg.kg-1
      when the patient reported pain for the first time and at a dose of 0.025mg.kg-1 on subsequent
      occasions. Pain scores were recorded in the postoperative care unit (PACU) and at 4 and 12
      hours after the end of the surgery The amount of morphine used during PACU stay, from PACU
      discharge to 4 hours after surgery, and from 4 to 12 hours after surgery, the overall dose of
      morphine used, and possible adverse effects were also assessed
    

Intervention name(s): S(+)-Ketamine
Intervention type(s): Drug
Intervention description(s): S(+)-Ketamine 0,3mg/kg/hr intraoperative
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT
Condition: Opioid-Related Disorders; Heroin Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this project is to study brain functions of 20 heroin addicts (compared to brain
      functions of 20 healthy controls) just before and during a three month extended release
      naltrexone treatment using functional MRI and dopamine transporter SPECT.

      The following hypotheses are tested:

        -  XRNT modulates the fMRI response to drug cues in predetermined brain regions.

        -  The expression of striatal transporters (assessed with SPECT) will decrease after a
           three-month course of extended release naltrexone
    

Detailed description: 
      Heroin dependence is a quintessential international health problem, with a significant
      prevalence. Drug free treatments, including pharmacologically supported interventions using
      oral naltrexone, have not been very successful, mainly due to low compliance. The recent
      introduction of Vivitrol®, consisting of monthly injections, may create new opportunities.
      Vivitrol® is an innovative treatment delivery method that blocks the rewarding effects of
      heroin.
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: opioid dependence; heroin dependence; extended release depot naltrexone; functional Magnetic Resonance Imaging; dopamine transporter; Single Photon Emission Computed Tomography
The Effects of Hot Yoga on Vascular Function
Condition: Hypertension; Elevated Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study will examine the effects of a 12 week hot yoga intervention on vascular health in
      adults between the ages of 20 and 65. The investigators are seeking individuals with slightly
      elevated blood pressure and stage I hypertension who are not currently taking blood pressure
      medications or exercising regularly. Participants will receive 12 weeks of free yoga for
      their participation.
    

Detailed description: 
      This study will examine the effects of a 12 week hot yoga intervention on vascular health by
      assessing changes of pre-intervention and post-intervention measurements in ambulatory blood
      pressure, endothelial function, and arterial stiffness in adults between the ages of 20 and
      65. The investigators are seeking individuals with elevated blood pressure and stage I
      hypertension who are not currently taking blood pressure medications or exercising regularly.
      Participants will receive 12 weeks of free yoga for their participation.
    

Intervention name(s): Hot Yoga
Intervention type(s): Behavioral
Intervention description(s): Bikram or hot yoga is a standardized series of 26 postures with two breathing exercises. Classes will be performed at local yoga studios in Austin, Texas and participants will be required to sign in for each session. All participants will receive 12 weeks of free classes for their participation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Letrozole in Induction of Abortion of Anembryonic Pregnancy
Condition: Anembryonic Pregnancy
Study type: Interventional

Summary: 
      Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol
      for inducing drug abortion. the aim of the study is to compare the effectiveness of various
      regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing
      complete abortion in patients with blighted ovum.
    

Detailed description: 
      Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for
      inducing drug abortion, increases the efficiency of the treatment regimen and also decreases
      the need for surgical interventions. Some conducted studies have mentioned reinforcing the
      impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies,
      so in this study, the investigators will compare the effectiveness of various regimens of
      letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus
      using misoprostol alone in inducing complete abortion in patients with a blighted ovum.
    

Intervention name(s): Letrozole tablets; Misoprostol Tabets; Placebo tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Letrozole is a third-generation non-steroidal aromatase inhibitor; a synthetic prostaglandin medication; Placebo tables with a similar appearance to letrozole
Other intervention name(s): prostaglandin E1
Intervention MeSH terms: Letrozole; Alprostadil; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled trial
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Letrozole; misoprostol; induction of abortion
Modification of Cognitive Processing Therapy (CPT-C) for PTSD and Alcohol Dependence
Condition: Alcohol Dependence; PTSD
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Objective: To develop a detailed treatment manual that modifies the existing CPT-C treatment
      protocol to allow for concurrent treatment of PTSD and AD, and to obtain some pilot data
      regarding its efficacy.

      Hypothesis: We predict that CPT-C will significantly reduce the number of drinking days
      (measured by the Timeline Follow Back Method [TLFB]) and reduce the symptoms of PTSD
      (measured by the [CAPS and PCL] scores).

      Design: This is a non-randomized, prospective study in which all participants will receive
      the modified CPT-C for 12 weeks by trained CPT-C clinicians, with each session lasting
      approximately 1-1.5 hours). Modifications to CPT-C include psychoeducation about alcohol use
      as an avoidance of PTSD symptoms integrated throughout treatment, integration of coping
      skills training for AD, weekly breathalyzer tests to measure blood alcohol level, and use and
      collection of daily dairies of alcohol use.
    


Intervention name(s): modified CPT-C
Intervention type(s): Other
Intervention description(s): modified CPT-C
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol Dependence; PTSD; CPT-C
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study introduces a new optimization immunosuppressive regimen associating tacrolimus at
      a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow
      down renal function worsening and to prevent the progression of chronic allograft
      nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.
    


Intervention name(s): Enteric-coated mycophenolate sodium (EC-MPS); Tacrolimus; Corticosteroids
Intervention type(s): Drug; Drug; Drug
Intervention description(s): At a dose of at least 5 mg/day.
Other intervention name(s): Myfortic; Prograf; Prednisone
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dose optimization; immune suppressive regimen; enteric-coated mycophenolate sodium; EC-MPS; renal transplantation; kidney; transplant; maintenance patients; Renal transplantation in maintenance
Effect of Acetazolamide on Optic Nerve Sheath Diameter in Laparoscopic Donor Nephrectomies
Condition: Intracranial Pressure Increase
MeSH terms: Intracranial Hypertension
Study type: Interventional

Summary: 
      The purpose of the trial is to study the effect of acetazolamide administered via Ryle's tube
      on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.
    

Detailed description: 
      this study was done on 40 American Society of Anaesthesiologist(ASA) I & II live donors of
      either sex in adult age group undergoing laparoscopic live donor nephrectomy. After getting
      approval from institutes ethical committee and written informed consent, Donors were randomly
      allocated to either of two group. Anaesthesia was induced with injection morphine 0.1 mg/kg,
      injection propofol 1-2 mg/kg and vecuronium 0.1 mg/kg. Maintenance of anaesthesia was done
      with isoflurane and oxygen. After induction donors were placed into modified flank position
      with left side upward. Donors in Group A received Acetazolamide 5 mg/kg via orogastric tube
      soon after the induction of anaesthesia. Group S received saline as a placebo. investigator
      and subjects were blinded till the statistical analysis. Optic nerve sheath diameter was
      measured six times during perioperative periods by using high frequency ultrasound probe.
      Intra operative monitoring was done for Heart rate, Blood Pressure, pulse oximetry(Spo2), End
      Tidal Carbon Dioxide(ETCO2), Train Of Four(TOF) and Bi spectral index(BIS). Post operatively
      donors were reversed with injection neostigmine and glycopyrrolate.

      once return of spontaneous ventilation was well established and patient becomes conscious
      oriented trachea was extubated and donors were shifted to post anaesthetic care unit(PACU).
      Postoperatively donors were monitored for Heart rate, Blood Pressure, Spo2, Comfort Score,
      Visual analog score for incisional site pain and shoulder tip pain, and Post operative nausea
      vomiting. Rescue analgesia was given to patients having comfort score less than 6.

      After completion of study Optic nerve sheath diameter, pain scores and comfort scores was
      compared between both groups.
    

Intervention name(s): Acetazolamide; Normal Saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: optic nerve sheath diameter; acetazolamide
Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the
      concomitant administration of Typherix and Havrix, and when compared to the administration of
      monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the
      persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the
      first dose of the study vaccine.
    

Detailed description: 
      Compare the reactogenicity & immunogenicity of GSK Biologicals' combined Vi polysaccharide
      typhoid vaccine & inactivated hepatitis A vaccine, Hepatyrix, to that elicited by GSK
      Biologicals' hepatitis A vaccine, Havrix administered singly or concomitantly with GSK
      Biologicals' Vi polysaccharide vaccine, Typherix, & to that elicited by Aventis Pasteur's
      monovalent Vi polysaccharide vaccine, Typhim Vi, administered intramuscularly to healthy
      subjects aged 18-65 yrs.
    

Intervention name(s): Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix
Intervention type(s): Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A & B; Typhoid
Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, placebo-controlled, dose-escalation, crossover study.
    

Detailed description: 
      Total of 24 health volunteers will be randomized to receive either of Cohort 1,2 or 3. (8
      subjects each)

      [Cohort 1] Subject will fast for at least 10 hours in first treatment, and then be
      administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at
      least 10 hours in second treatment, and then be administrated CG-750 capsule or placebo with
      150 mL of water.

      [Cohort 2] The recommended dose of capsule in cohort 2 will be determined based on the
      bioavailabilty and safety data of cohort 1.

      Subject will fast for at least 10 hours in first treatment, and then be administrated with
      CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in
      second treatment, and then be administrated the determined dose of CG-750 capsules or placebo
      with 150 mL of water.

      After 2-week rest period, subject will take the high fat diet and then be administrated the
      determined dose of CG-750 or placebo with 150 mL of water.

      [Cohort 3] The recommended dose of capsule in cohort 3 will be determined based on the
      bioavailabilty of cohort 1 and 2.

      Subject will fast for at least 10 hours in first treatment, and then be administrated with
      CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in
      second treatment, and then be administrated the determined dose of CG-750 or placebo with 150
      mL of water.
    

Intervention name(s): CG-745 IV Solution; CG-750 125mg capsule; PO Placebo; IV Placebo: 0.9 % normal saline
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): CG-745 IV: Supplied as 125 mg/vial Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion; CG-750 capsule: Supplied as 125 mg/capsule Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3; PO Placebo: Supplied as placebo capsule (same appearance as in CG-750 Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3; IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
Other intervention name(s): CG200745; CG200750
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, double-blind, placebo-controlled, dose-escalation, crossover study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic
      rhinitis symptoms in participants under controlled conditions, to collect well-characterized
      biological samples (urine and blood) before and after they develop these symptoms. The EEU
      provides the ability to control the timing, duration and levels of allergen exposure, and
      also other outside environmental factors, yielding ideal biologic samples for analysis with
      novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic
      rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance
      analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on
      blood samples and compared to spin prick testing and symptoms of allergic rhinitis.
    


Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Healthy males and females 18-55 years old with ragweed induced allergic rhinitis.
      
Biospecimen description: 
      Urine samples will be retained for analysis via nuclear magnetic resonance. Blood samples
      will be retained after separating the mononuclear layer. These samples will be tested for
      epigenetic changes. Blood samples will also be retained for IgE testing.
    
Keywords: Allergic Rhinitis; NMR
Effects of Vaporized Marijuana on Neuropathic Pain
Condition: Neuropathic Pain; Reflex Sympathetic Dystrophy; Peripheral Neuropathy; Post-herpetic Neuralgia; Spinal Cord Injury; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Spinal Cord Injuries; Neuralgia; Peripheral Nervous System Diseases; Neuralgia, Postherpetic; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.
    

Detailed description: 
      We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic
      efficacy of vaporized cannabis in subjects, the majority of whom were experiencing
      neuropathic pain despite traditional treatment. Thirty-nine patients with central and
      peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose
      (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog
      scale pain intensity. Psychoactive side effects and neuropsychological performance were also
      evaluated.
    

Intervention name(s): Mild dose cannabis; Low dose cannabis; Cannabis
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3.53% THC by weight; 1.29% THC by weight; 0.00% THC by weight
Other intervention name(s): marijuana; marijuana; placebo marijuana
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabis; marijuana; neuropathy; antinociception; mood; cognition; neuropathic pain
Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases
Condition: Subarachnoid Hemorrhage, Aneurysmal
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      This prospective observational study will assess the regional cerebral oxygen saturation and
      cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine
      administration for the prevention/management of cerebral vasospasm.
    


Intervention name(s): Nimodipine
Intervention type(s): Drug
Intervention MeSH terms: Nimodipine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        aneurysmal subarachnoid hemorrhage with cerebral vasospasm
      
Keywords: cerebral vasospasm; nimodipine
Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia
Condition: Pulmonary Disease
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence
      will:

        1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death

        2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay
           without increasing adverse effect
    

Detailed description: 
      Bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (NICU) all over
      the world. This multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of
      inhaled nitric oxide (iNO) in the treatment of the preterm infant with developing
      bronchopulmonary dysplasia.

      Infants were followed until death or discharge to home. The trial will compare iNO therapy to
      conventional management strategies (including treatment with nasal continuous positive airway
      pressure (CPAP), surfactant and high frequency ventilation as adjuncts to iNO therapy) as the
      control.

      During the initial dosing, iNO was started at 5 ppm and could be decreased to 1-2 ppm. The
      Infants would inhale NO until weaned. Infants will be monitored for signs of toxicity due to
      cumulated dosage of NO and its metabolites, such as methemoglobin, and nitrite and nitrate in
      blood and urine, and nitrogen dioxide in ventilator circuit to the patient.
    

Intervention name(s): Nitric Oxide; respiratory support
Intervention type(s): Drug; Device
Intervention description(s): The infants in experimental group will receive inhale nitric oxide initiated at 5 ppm for 24 h followed by 2 ppm for 6 days or until weaning off; Routine respiratory support.
Other intervention name(s): Nitrogen Monoxide; Endothelium Derived Relaxing Factor (EDRF); Nasal CPAP; Conventional mechanical ventilation; High frequency Oscillatory ventilation
Intervention MeSH terms: Nitric Oxide; Endothelium-Dependent Relaxing Factors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preterm neonates; Bronchopulmonary dysplasia; Chronic lung disease; Inhaled nitric oxide; Respiratory therapy