bioihbjkbjnl/mcl2 huggingface dataset:
Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study
Condition: Impaired Glucose Tolerance; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional

Summary: 
      To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on
      general public health recommendations, on glucose tolerance, insulin resistance and metabolic
      cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).
    

Detailed description: 
      Objective To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based
      on general public health recommendations, on glucose tolerance, insulin resistance and
      metabolic cardiovascular risk factors in Dutch subjects with impaired glucose tolerance
      (IGT).

      Research design and methods 147 IGT subjects (75 male, 72 female) were randomized to the
      intervention group (INT) or control group (CON). 106 subjects (52 INT, 54 CON) completed 3
      years of intervention. Annually, glucose, insulin and FFA concentrations were determined
      during fasting and after an oral glucose tolerance test, in addition to measurements of body
      weight, serum lipids, blood pressure and maximal aerobic capacity.
    

Intervention name(s): diet- and exercise intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: impaired glucose tolerance; type 2 diabetes
Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers
Condition: Japanese Encephalitis; Japanese Encephalitis Virus Disease
MeSH terms: Virus Diseases; Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus
      Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine
      [CD.JEVAX™]) after a single dose vaccination to support product registration.

      Primary Objective:

        -  To demonstrate the non-inferiority of the antibody response 28 days after administration
           of one dose of IMOJEV™ compared to the antibody response 28 days after administration of
           one dose of the CD.JEVAX™ control vaccine.

      Secondary Objectives:

        -  To describe the immune response to Japanese encephalitis (JE) in both vaccine groups
           using 50% plaque reduction neutralization assay (PRNT50) assays before and after a
           single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.

        -  To describe the safety of vaccination in all subjects up to 28 days and all serious
           adverse events up to 6-month after vaccination.
    

Detailed description: 
      All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0)
      and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed
      from day of vaccination and up to 6 months post-vaccination.
    

Intervention name(s): Live attenuated Japanese encephalitis chimeric virus vaccine; Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Other intervention name(s): IMOJEV™; CD.JEVAX™
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; Japanese Encephalitis Virus Disease; IMOJEV™; CD.JEVAX™
Safety Study of Probiotics in Adults With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.
    

Detailed description: 
      Recent studies performed outside the U.S. and/or prior to recent FDA requirements suggest
      that the probiotics in VSL#3 may be effective in IBS in adults. Because there is a
      significant unmet need for improved IBS therapies to prevent frequent exacerbations that lead
      to unscheduled health care, we will conduct a safety study of the probiotic VSL#3.
      Preliminary studies suggest that probiotics such as VSL#3 are effective in the treatment of
      adults with IBS but safety studies have not been carried out. A safety study of VSL#3 has
      been carried out in adult asthmatics that demonstrated no significant adverse effects. Before
      a trial of VSL#3 can be performed in children with IBS, the FDA has requested that a safety
      trial be conducted in adults with IBS.

      Consent will be obtained from the subject.

      Adults who meet the criteria for irritable bowel syndrome will be recruited and studied. They
      will have been diagnosed by an adult gastroenterologist.

      During a baseline one week period, the subjects will keep a diary of pain episodes, pain
      severity, pain-induced interference with activity, and stooling pattern (i.e.,
      pain/activity/stool diary).

      Following the baseline period, the subjects will be randomized into either a 4 week or 8 week
      treatment period with the probiotic. The treatment will be open label. During the treatment
      period, subjects will keep the diary for pain and stooling habits and a daily record of
      symptoms (i.e., daily temperature monitoring).

      At the end of the treatment period the pain/stool/activity diary will be repeated. Four weeks
      after the treatment period ends a follow-up phone call will be made to participants to check
      on their pain and stooling patterns.
    

Intervention name(s): Probiotic
Intervention type(s): Biological
Intervention description(s): The subjects will be randomized into either a 4 week or 8 week treatment period with the probiotic. The treatment will be open label. They will take 2 packets once daily.
Other intervention name(s): VSL#3
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS; irritable bowel syndrome; abdominal pain; urgency; bloating; diarrhea
Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether repetitive transcranial magnetic
      stimulation (rTMS) is effective in remediating cognitive deficits while also improving
      functionality in Veterans with schizophrenia.
    

Detailed description: 
      High-frequency, repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral
      prefrontal cortex (DLPFC), the dysfunctional brain region most implicated in cognitive
      deficits in schizophrenia, has recently been shown to improve cognition in non-Veteran
      samples with schizophrenia. The investigators' goal is to confirm the efficacy of this
      treatment modality to remediate cognitive deficits and improve functionality in Veterans with
      schizophrenia, as well as to gain a better understanding of the neural mechanisms responsible
      for cognitive deficits and their remediation. The investigators propose conducting a
      small-scale study to generate pilot data supporting the feasibility of conducting rTMS with
      Veterans and the effectiveness of rTMS in this population. In addition, the investigators
      will conduct neurophysiologic experiments to test whether certain neural maker of abnormal
      brain function improves with rTMS.
    

Intervention name(s): Repetitive transcranial magnetic stimulation; Sham
Intervention type(s): Device; Device
Intervention description(s): rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.; Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.
Other intervention name(s): rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Schizophrenia; Transcranial magnetic stimulation; Electroencephalography
Cerebral Palsy Early Mobility Training
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the optimal treatment duration of a novel early
      mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of
      treatment; and to evaluate the clinical futility of this intervention compared to current
      rehabilitation practice.
    

Detailed description: 
      This study is a single-blind, randomized exploratory clinical trial with repeated assessments
      during a 24-week treatment phase and at three follow-up points over 12 months after treatment
      to track the developmental trajectory of participants' motor function. Gross motor ability
      will be compared to published percentile scores of motor function development in cerebral
      palsy (CP) to determine if the trajectory of predicted motor development is altered, and to
      outcomes of intensity-matched conventional treatment to determine if continued Phase III
      investigation is warranted.
    

Intervention name(s): Dynamic Supported Mobility; Conventional Therapy
Intervention type(s): Other; Other
Intervention description(s): Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance; No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing "typical" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Delay in motor skill development
The Effect of Sorafenib on Portal Pressure
Condition: Clinically Significant Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate) liver
      cancer and for renal cell carcinoma. Sorafenib is a drug that inhibits the growth of cancer
      cells and prevents the formation of new blood vessels that would otherwise help the cancer
      spread.

      Studies in experimental animals have shown that sorafenib may also lower portal vein pressure
      (the pressure of the blood passing from the intestine through the liver.) This study seeks to
      determine if sorafenib lowers the blood pressure in liver blood vessels (portal vein
      pressure) in patients with cirrhosis who have high portal vein pressure. The study will also
      obtain information whether sorafenib is safe in this patient population.

      Half of the patients will be given sorafenib and half will be given a placebo (a pill without
      any medicine in it.) This allows a comparison of the reactions of people who take sorafenib
      to those who do not.
    

Detailed description: 
      This is a pilot proof-of-concept study that investigates the effect of sorafenib on portal
      pressure, as determined by the hepatic venous pressure gradient (HVPG), in patients with
      liver cirrhosis, portal hypertension and unresectable hepatocellular carcinoma (HCC) that has
      successfully responded to radiofrequency ablation and/or transarterial chemoembolization, and
      have obtained a complete response.

      The primary end-point of the study is the change in HVPG observed from baseline to three
      months after starting treatment with sorafenib. Secondary end-point is safety of sorafenib.

      The trial is structured as a randomized double blind placebo controlled study. After a
      three-month period of therapy with sorafenib or placebo (double-blind phase), patients will
      be given open-label sorafenib for an additional 3-month period (open-label phase). A total of
      44 patients will be randomized (in the initial phase) on a 1:1 ratio to sorafenib or placebo.
      Patients will be followed monthly and HCC follow-up will be according to standards of care.
      The study will be sponsored by Onyx, who will also provide the treatment medication
      (sorafenib and placebo)
    

Intervention name(s): Placebo; Sorafenib
Intervention type(s): Drug; Drug
Intervention description(s): Placebo Comparator: Placebo; Sorafenib, 400 mg twice daily
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: portal hypertension; sorafenib
Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      -  To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as
           compared with OHA therapy.

        -  To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA
           therapy.

        -  To evaluate the safety of HMR1964.
    


Intervention name(s): insulin glulisine
Intervention type(s): Drug
Intervention MeSH terms: Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HMR1964, insulin glulisine, Diabetes Mellitus, Type 2
Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®
Condition: Gastrointestinal Neoplasms; Thromboembolic Event
MeSH terms: Gastrointestinal Neoplasms; Digestive System Neoplasms; Thromboembolism
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, monocentric, randomized, parallel group, rater-blinded study using two
      formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events
      (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and
      thromboprophylactic treatment with either Enoxaparin formulations.

      The study has a secondary focus as to evaluate the immunogenicity of the two formulations of
      Enoxaparin through a subgroup analysis.

      Study followup duration is up to 30 days post surgical procedure.
    


Intervention name(s): Enoxaparin 4000 IU
Intervention type(s): Drug
Other intervention name(s): ENOXA®; LOVENOX®
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Enoxaparin; Immunogenicity
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves a single injection of LY2963016 and a single injection of Lantus, on 2
      separate occasions in participants with type I diabetes. Following each dose, participants
      will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7
      days between the two periods, during which time there will be no study treatment, but
      participants will resume their regular therapy. The duration of this study can be up to 9.5
      weeks. The purposes of this study are to understand how the blood sugar lowering effect of
      LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are
      metabolized by participants with type I diabetes.
    


Intervention name(s): LY2963016; Lantus
Intervention type(s): Drug; Drug
Intervention description(s): Single 0.3 U/kg dose administered subcutaneously; Single 0.3 U/kg dose administered subcutaneously
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Relation of Morphine-induced Itch and Pain Processing
Condition: Morphine; Itch
Study type: Interventional

Summary: 
      In This experiment, the investigators would like to test the two following hypotheses
      regarding the mechanisms by which opioids cause itch:

        1. Opioids cause itch by a spinal disinhibition mechanism (central nervous system (CNS)
           effect).

        2. Opioids cause itch through a mast cell-destabilizing effect leading to release of
           histamine and tryptase in the skin where itch is evoked (peripheral mechanism).
    

Detailed description: 
      Intrathecal and orally administered opioids are heavily used for the treatment of several
      acute pain conditions. However, while opioids are effective analgesics for acute pain, they
      are well-known to frequently cause itch (pruritus) as a side effect according with the two
      hypotheses stated above. So far, these two hypotheses have never been tested in humans.The
      present study describes a proposed study design for the purpose of confirming these two
      hypotheses in parallel in human subjects.

      Primary endpoints of the study:

      To evaluate changes itch and pain perception, and superficial perfusion after each itch
      provocations.

      Secondary endpoints of the study:

      To evaluate the existence of a correlation between itch sensitization and analgesic efficacy.
    

Intervention name(s): Morphine; Placebo oral tablet; Histamine; Cowhage (Mucuna Pruriens); isotonic saline; Histamine; Cowhage (Mucuna Pruriens)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A 20 mg tablet of morphine; Matching tablet of placebo; Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.; 25 spicules will be inserted in the centre of the predefined skin area on the forearm. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration; A droplet of saline (0.9%) as vehicle control will be placed on the predetermined area on the forearm and the lancet will be pierced through the droplet.; Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the mandibular area, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.; 25 spicules will be inserted in the centre of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration
Other intervention name(s): saline
Intervention MeSH terms: Morphine; Histamine; Histamine phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
How NAVA Works in Preterm Infants With Irregular Respiratory Efforts
Condition: Premature Infants; Neurally Adjusted Ventilatory Assist; Ventilator Lung; Newborn; Mechanical Ventilation
MeSH terms: Bronchopulmonary Dysplasia
Study type: Observational

Summary: 
      For the infant participating the study, ventilator settings and respiratory variables will be
      recorded every day and exported to a specific computer using the Servo Record Viewer version
      1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value
      for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi,
      measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup
      breaths for each minute. All the ventilator data will be inspected and compared with the
      event logs recorded automatically from the ventilator, which includes all the alarm
      notification, mode and setting changes, cables connection and disconnection data. Data during
      disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded
      from the analysis. The mean values during each day will be computed for each ventilatory
      variables. If there is a change in the ventilatory setting parameters, we will choose the one
      which was applied for longer duration in the 24-hour time period.

      The following clinical characteristics will be collected from medical records: gestational
      age at birth, birth weight, gender, the time and amount of feeding, medication during the
      study days, desaturation events, bradycardia events, suction time and methods.
    


Intervention name(s): Neurally adjusted ventilatory assist ventilation mode
Intervention type(s): Device
Intervention description(s): This technique uses the electrical activity of the diaphragm (Edi) to control respiratory support and the NAVA level as an amplification factor that converts the Edi signal into a proportional pressure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We included preterm infants born before 36 weeks of gestation who received at least 24
        hours of ventilatory support with invasive or non-invasive NAVA using a Servo-i or Servo-n
        ventilator (Getinge, Gothenburg, Sweden).
Apixaban in Hemodialysis
Condition: End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to determine the effects of end-stage renal disease on the pharmacokinetics,
      pharmacodynamics, safety, and tolerability of apixaban. This is a single-center open-label
      pharmacological study. Apixaban will be prescribed at the dose of 2.5 mg twice per day for
      nine days. The concentration of the drug will be measured with repetitive blood tests the
      first and the eighth day of administration (non-dialysis days). The same blood tests will be
      repeated before, during, and after dialysis on dialysis days. If the study shows inadequate
      or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily
      dose.
    


Intervention name(s): apixaban
Intervention type(s): Drug
Intervention MeSH terms: Apixaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Factor Xa Inhibitors; Renal Dialysis