bioihbjkbjnl/mcl2 huggingface dataset:
Chronic Effects of Tendon Vibrations on the Neuromechanical Muscular Properties.
Condition: Healthy
Study type: Interventional

Summary: 
      It is a randomized, controlled clinical trial, in healthy volunteers. They are in two groups
      : the test one will perform the vibration training (1h of Vibrasens 3 times a week, 24
      sessions) whereas the control group will not be training. The primary outcome is the maximal
      voluntary strength.
    

Detailed description: 
      These last 10 years, a new idea born: vibrations could have potential effects on muscular
      reconditioning. Researchers have previously demonstrated the effects on plantar ankle
      flexion, with the increase of the strength, on healthy volunteers. Nowadays physicians would
      like to demonstrate the effects on another muscular group: ankle's dorsal flexors. 24
      sessions are programmed on 8 weeks.

      Moreover, the last results showed a modification of the nervous capacities of the cortical
      voluntary activation. Transcranial Magnetic Stimulation (TMS) is a great tool to explore the
      neuromuscular function, at the cortical stage. The use of this tool will allow the
      characterization the effects of the vibration training on the cortical activation state.
    

Intervention name(s): Vibrasens; Usual activities
Intervention type(s): Device; Other
Intervention description(s): Transcutaneous vibrations are used. This device allows vibrations from 25 to 150 Hz with an amplitude of 1 mm. In our study the frequency used is 50 Hz.; The patients will perform their usual activities, to allow the comparison with a vibration programme. They will not have a specific training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD),
      in subjects with gout.
    

Detailed description: 
      A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for
      those with normal renal function and 100 mg for those with impaired renal function) and
      placebo administered once daily in subjects with gout.

      Subjects will receive treatment for 28 weeks.
    

Intervention name(s): Febuxostat; Febuxostat; Febuxostat; Allopurinol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Febuxostat 80 mg, orally, once daily for up to 28 weeks.; Febuxostat 120 mg, orally, once daily for up to 28 weeks.; Febuxostat 240 mg, orally, once daily for up to 28 weeks.; Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.; Placebo, orally, once daily for up to 28 weeks.
Other intervention name(s): TMX-67; Tei-6720; Uloric; TMX-67; Tei-6720; Uloric; TMX-67; Tei-6720; Uloric
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uric Acid, gout, xanthine oxidase, febuxostat, tophi
Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior
      -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and
      the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of
      local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse
      abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal
      wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was
      first described by McDonnell et al. as a landmark technique to provide analgesia for lower
      abdominal surgery.

      Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which
      they named posterior TAP block. The ultrasound allows identification of the external oblique
      abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional
      anesthetic techniques suggest improved block quality and safety, which is primarily due to
      direct visualization of the relevant anatomy, the tip of the needle, and the spread of the
      local anesthetics.

      Clinical trials of the single shot posterior TAP block have shown a significant reduction in
      morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly
      et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic
      cholecystectomy reduced perioperative opioid consumption by more than 50%.

      This is the first study to evaluate the effect of TAP block in the quality of recovery in
      patients undergoing laparoscopic hysterectomy and may help the pathway to make this an
      outpatient procedure.
    


Intervention name(s): Placebo; Drug .5% Ropivacaine; 20 cc of 0.25% ropivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo injection; .5% ropivacaine 20 mls on each side of abdomen; Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine
Other intervention name(s): Sterile normal saline; .5% Ropivacaine; .25% ropivacaine
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Pain; Post Operative; Opioids; Laparoscopic; Surgery; Hysterectomy
Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer
Condition: Cancer of the Esophagus
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this trial is to define the maximum tolerated and/or recommended phase
      II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients
      undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal
      junction. An additional primary objective is to describe the frequency and nature of grade
      III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include
      describing 1-year disease-free survival and overall survival rates as well as to estimate
      clinical and pathologic complete response rates associated with this regimen.
    

Detailed description: 
      This study has a phase I/II design. For this study the administration of panitumumab is
      considered investigational.

      Pretreatment: Part of regular cancer care and disease staging includes Chest/Abdomen CT Scan,
      upper endoscopic ultrasound, PET scan, J-Tube Placement (if clinically indicated),
      bronchoscopy (per clinician judgment), ECG, and baseline laboratory studies.

      During Treatment Weeks 1-5.5 of Radiation Therapy(RT)/Chemotherapy:

        -  RT (180 cGy/fx, Mon-Fri) days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38.

        -  Panitumumab (per dose level) days 1, 15, 29.

        -  Oxaliplatin (per dose level) days 1, 8, 15, 22, 29, 36.

        -  Capecitabine (per dose level M-F) 1-5, 8-12, 15-19, 22-26, 29-33, 36-38.
    

Intervention name(s): Panitumumab; Capecitabine; Oxaliplatin; Radiation Therapy (RT)
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation.; Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation; Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation; Daily for 6 weeks
Other intervention name(s): Xeloda
Intervention MeSH terms: Capecitabine; Oxaliplatin; Panitumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal cancer
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Condition: Epilepsy; Seizures
MeSH terms: Seizures
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of a potential generic 600 mg
      oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet,
      Trileptal, folloiwng a single 600 mg dose administered with food.
    


Intervention name(s): Oxcarbazepine
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PBBT and WBV Effect on Balance and Gait in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the effects of perturbation based balance
      exercises with whole body vibration training in sub-acute stroke patients and to evaluate
      their effects on balance, and gait. The main aim to :

        -  To evaluate their effects on balance, and gait.

        -  Comparison of these rehabilitation protocols and identify the more efficacious
           treatment.

      Participants will perform perturbation based balance training and whole body vibration
      therapy to improve balance and gait.

      If there is a comparison group: Researchers will compare both groups to see both
      interventions effects.
    

Detailed description: 
      Stroke usually causes impairments in a variety of areas, such as cognition, emotion, mobility
      limitation, sensory loss, and there after results in imbalance and gait disability as well as
      impairment of the activities of daily living (ADLs). Poor balance control have a negative
      influence on the recovery of gait and motor function. Many therapeutic interventions, such as
      visual feedback training, robotic devices, mirror therapy, and motor imagery training have
      been performed to improve balance control.

      Reactive balance training (RBT) has emerged as a potential strategy for improving balance and
      participants withstood greater-magnitude perturbations before requiring multiple steps,
      relative to those who completed weight-shifting/gait training in sub-acute and chronic stroke
      patients.

      Whole-body vibration (WBV) therapy used in clinical practice for improving neuro-motor
      performance in various patient populations and this training reduce disability by improving
      balance, gait performance, and mobility in stroke patients.

      According to previous literature there was a lack of comparison of these two studies. In
      previous literature, both of these therapeutic options i.e., Perturbation based balance
      training (PBBT) and whole body vibration (WBV) training were used separately to see the
      effects in stroke population but not in combination. In this study the comparison will be
      done between these two exercise protocols. Consequences will be manipulated for balance, and
      gait by using validated tools.
    

Intervention name(s): Perturbation Exercises; Whole Body Vibration
Intervention type(s): Other; Other
Intervention description(s): Perturbation exercises will be performed 3 times in a week for 6 weeks for 10-15 minutes per session with baseline treatment for total 30 minutes.
Total 18 sessions will be given to the patients.; It will be performed 3 times in a week for 10-15 minutes per session with baseline treatment for total 30 mints.
Total 18 sessions will be given for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Perturbation Exercises; Whole body vibration; Stroke; Balance; Gait
Post Prandial Glucose Control Proof-of-Principle
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the postprandial glycemic response of subjects with
      type 2 diabetes when consuming a meal along with beverages containing various combinations of
      nutritional ingredients and fibers versus control beverage.
    


Intervention name(s): Carbohydrate placebo; Nutritional ingredient; #1 Nutritional ingredient +Fiber; #2 Nutritional ingredient + Fiber; #3 Nutritional ingredient + Fiber
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): dissolve in water and consume with meal; Dissolve in water and consume with meals; Dissolve in water and consume with meal; Dissolve in water and consume with meal; Dissolve in water and consume with meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
Condition: HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598
      when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared
      to placebo + SOC.
    

Detailed description: 
      The safety, tolerability and antiviral activity of ANA598, administered orally at 200 mg BID
      or 400 mg BID for 12 weeks in combination with pegylated interferon and ribavirin (SOC) will
      be compared to placebo + SOC. Treatment-naïve patients with genotype 1 infection will be
      eligible for enrollment. Patients randomized to ANA598 will receive a loading dose of 800 mg
      q 12 hours administered on the first day of dosing. Patients with undetectable HCV RNA at
      week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of SOC
      alone.

      Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort
      will be randomized as 30 active: 15 placebo.
    

Intervention name(s): placebo; ANA598; ANA598; Peginterferon; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral BID; oral 200mg BID; oral 400mg BID; 180 μg dose via subcutaneous injection weekly; oral 1000 mg/day for patients who weighed < 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
UMOX - New Device for Oropharyngeal Preoxygenation
Condition: Preoxygenation
Study type: Observational

Summary: 
      The UMOX is a device that has been designed as an alternative to the conventional face mask
      for preoxygenation to be used when an optimal preoxygenation with a facemask is difficult to
      achieve(i.e: when a leak is present. A previous study in our hospital (unpublished data) has
      shown that the UMOX was only as effective as the conventional mask when a nose clip was used
      to prevent the patients from breathing in some air through the nose, thus preventing the
      dilution/contamination of the 100% oxygen delivered.In that study, the verbal indication
      giving to the subjects to breathe through the mouth was better than no indication at all but
      still yielded unsatisfactory results.

      For this reason, the present study was designed to verify the hypothesis that while using the
      UMOX for preoxygenation, the verbal indication of breathing 8 vital capacity breaths added to
      the indication of breathing through the mouth would bring equivalent results -measured by the
      expired fraction of oxygen- as a preoxygenation of normal tidal breathing through a facemask
      during 3 to 5 minutes.

      Preoxygenation was performed with the 60 volunteers placed in the supine position with 100%
      oxygen. All volunteers went though preoxygenation with two techniques: 1) breathing normal
      tidal volumes at a normal respiratory rate for a period of 5 minutes through a tight fitting
      conventional face mask, and 2) eight deep breaths (i.e. vital capacity breaths) through the
      UMOX device with verbal indication to use only the mouth to breathe.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy Volunteers
      
Keywords: preoxygenation; UMOX
Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
Condition: Major Depression; Bipolar Disorder; Unipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this project is to determine whether concurrent treatment of patients with
      major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead
      to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.
    

Detailed description: 
      AIM: To determine the therapeutic efficacy and adverse effects of triiodothyronine (T3) as a
      supplement to the treatment of bipolar depression (BPD) with a mood stabilizer (MS) (lithium
      - Li, valproic acid - VPA or carbamazepine - CBZ) and the specific serotonin reuptake
      inhibitor (SSRI), sertraline; and as a supplement to the treatment of unipolar depression
      (UPD) with sertraline.

      METHOD: A random assignment, double blind, placebo-controlled trial separately evaluating
      patients with a) BPD who are treated with MS + sertraline + T3 or MS + sertraline + placebo
      and b) UPD who are treated with sertraline + T3 or sertraline + placebo, for up to 8 weeks in
      both cases. The design of the trial will permit both the outcome of treatment and the speed
      of response to be evaluated.
    

Intervention name(s): triiodothyronine; sertraline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: major depression; bipolar disorder; unipolar depression; sertraline; triiodothyronine
The Impact of Dietary Flavanols on the Gut Microflora
Condition: Intestinal Bacteria Growth
Study type: Interventional

Summary: 
      The primary propose of this study is to determine the impact of flavanol-rich cocoa on the
      growth of the human gut microbiota.
    

Detailed description: 
      A randomised, placebo-controlled, double-blind, cross-over human intervention study will be
      conducted in 20 healthy human volunteers to test the impact of a high-flavanol containing
      meal on the growth of the large intestinal bacteria (microflora). The high flavanol test meal
      will contain 495 mg of flavanols and the low flavanol control will contain 23 mg of
      flavanols. The two intervention diets are otherwise matched for macro- and micronutrient
      content. Changes in the gut microbiota will be determined by measuring bacterial population
      levels in human faecal material using 16S rRNA targeted oligonucleotide probes and
      fluorescence in situ hybridization. A number of other biochemical and physiological measures
      will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.
    

Intervention name(s): Low flavanol cocoa beverage; High flavanol cocoa beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 23 mg of total flavanols from cocoa; 495 mg of total flavanols from cocoa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: flavonoids; flavanols; bacteria
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cannabis Use and Cognitive Outcomes in Schizophrenia
Condition: Repetitive Transcranial Magnetic Stimulation (rTMS); Schizophrenia; Cannabis Use Disorder; Cognition
MeSH terms: Marijuana Abuse; Schizophrenia
Study type: Interventional

Summary: 
      The high prevalence of cannabis and other substance use disorders are a major barrier to
      recovery in people with schizophrenia. Moreover, schizophrenia patients have significant
      deficits in cognitive function, which may be exacerbated by cannabis use. Complicating these
      problems is the lack of evidence-based treatments for co-morbid cannabis use disorders (CUDs)
      in schizophrenia; there are no established pharmacotherapies. Therefore, this study is
      investigating the effects of high-frequency (20Hz) repetitive transcranial magnetic
      stimulation (rTMS) on cannabis use disorder and cognitive function in patients with co-morbid
      schizophrenia/schizoaffective disorder. The proposed study would be the first randomized,
      double-blind, sham controlled trial of rTMS in patients with schizophrenia and co-morbid CUD.
      A total of N=40 schizophrenia smokers with co-morbid cannabis use disorder will be assigned
      to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatment
      for four consecutive weeks. All participants will receive weekly behavioral therapy for 4
      weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham
      rTMS for the treatment of CUD in schizophrenia.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS); Sham Repetitive Transcranial Magnetic Stimulation (rTMS); Weekly Counselling Session
Intervention type(s): Device; Device; Behavioral
Intervention description(s): On Day 1, the resting motor threshold (RMT) will be determined according to previous published methods [Cardenas-Morales et al. 2013] and the rTMS will be delivered at an intensity of 90% of the participant's RMT. rTMS will be administered at 20 Hz (25 trains, 30 pulses per train, 30 second intertrain interval).; On Day 1, the resting motor threshold (RMT) will be determined according to previous published methods [Cardenas-Morales et al. 2013] and the Sham rTMS will be delivered at an intensity of 90% of the participant's RMT. rTMS will be administered at 20 Hz with the B65 placebo coil (25 trains, 30 pulses per train, 30 second intertrain interval).; In order to support participants in their abstinence plan, individual weekly sessions of supportive counselling will be administered over the course of the study on 1 time per week over 4 weeks (28 days of abstinence).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sham Repetitive Transcranial Magnetic Stimulation (rTMS); Schizophrenia; Cannabis Use Disorder; Cognitive Function