bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients
Condition: Visual Impairment
MeSH terms: Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      Our study aims to validate the relevance of a virtual reality tool (VIRARE: VIrtual REality
      Assisted Rehabilitation) in the assessment and rehabilitation of visually impaired subjects.
    


Intervention name(s): Virtual reality tests
Intervention type(s): Device
Intervention description(s): The patient will complete 3 self-questionnaires and pass 3 exploratory tests of virtual reality:
10 minutes sitting test: detection of 5 targets in a 360 ° field of vision
10-minute stand-up motionless test: detection of 5 targets in a 360 ° field of view and placing ingredients of a recipe
Standing 10-minute test: the patient moves to the site of his mission, detection of 5 targets in a 360 ° field of vision and preparing a recipe
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Minimal-Dose Resistance Training for Improving sIgA and Cortisol
Condition: Resistance Training; Immune System
Study type: Interventional

Summary: 
      Whereas the role of endurance training on immune function has been widely studied, little is
      known about the role of resistance training (RT). In this cross-over randomized controlled
      study, it will be analysed the effects of three RT protocols which only differs in volume in
      improving secretory immunoglobulin A (sIgA) and cortisol in saliva among young, health and
      sedentary people
    


Intervention name(s): Resistance training
Intervention type(s): Behavioral
Intervention description(s): Resistance circuit training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: resistance training; immune system; cortisol
Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell
      Implantation in Patients with CP
    

Detailed description: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with
      Cerebral Palsy(CP)
    

Intervention name(s): ASTROSTEM
Intervention type(s): Biological
Intervention description(s): Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10^7cells/5mL 15kg ~ 25kg : 1x10^8cells/10mL 25kg over : 1.5x10^8cells/15mL
Other intervention name(s): Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Brain Stem Glioma
Condition: Brain Tumors; Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation
      therapy in treating patients with newly diagnosed brain stem glioma.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of vincristine
      given as an IV push dose in combination with continuous infusion cyclosporine and oral
      etoposide concurrent with and prior to radiotherapy in children with newly diagnosed primary
      intrinsic brain stem glioma. II. Determine the incidence and severity of other toxicities of
      vincristine in this regimen in these patients. III. Determine a safe and tolerable dose of
      vincristine under these conditions to be used in phase II studies. IV. Seek preliminary
      evidence of antitumor activity in this setting in these patients.

      OUTLINE: This is dose escalation study of vincristine. Patients receive radiotherapy daily
      for 6 weeks with concurrent induction chemotherapy. Induction chemotherapy consists of
      vincristine IV push weekly for 6 weeks, oral etoposide daily on days 1-21 and 29-49 and
      cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion.
      Cohorts of 3-6 patients receive escalating doses of vincristine. If dose limiting toxicity
      (DLT) occurs in 2 or more of 3-6 patients, the maximum tolerated dose (MTD) has been exceeded
      and the preceding dose is declared the MTD. Maintenance therapy consists of 6 monthly courses
      of cyclosporine IV over 36 hours beginning on day 1, vincristine IV push on day 1, and oral
      etoposide daily for days 1-21. Patients are followed every 6 months for 4 years and then
      annually thereafter.

      PROJECTED ACCRUAL: At least 6 patients will be accrued into this study at a rate of 12
      patients per year.
    

Intervention name(s): cyclosporine; etoposide; vincristine sulfate; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Other intervention name(s): CSA; NSC # 290193; VP-16; VePesid; NSC # 141540; VCR; Oncovin; NSC # 067574
Intervention MeSH terms: Cyclosporine; Etoposide; Vincristine; Cyclosporins
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: untreated childhood brain stem glioma
Clinical Characterization of Symptomatic Populations
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of
      symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study
      lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear
      for 1 week.
    


Intervention name(s): senofilcon A contact lenses
Intervention type(s): Device
Intervention description(s): Senofilcon A Daily Disposable Contact Lenses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effect of a High Fat Meal on Surufatinib in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a 2-period study conducted with 26 healthy male or female subjects.
      Subjects will be randomly assigned to either receive a single dose of surufatinib with food
      in period 1, then without food in period 2, or vice-versa.
    

Detailed description: 
      This study will be a single center, open label, randomized crossover, 2-period study
      conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to 1 of
      the 2 possible treatment sequences as follows:

        -  Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8

        -  Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8
    

Intervention name(s): surufatinib
Intervention type(s): Drug
Intervention description(s): Surufatinib: 300 mg as a single dose on Days 1 and 8 with or without food
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows:
Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8
Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8
Masking: None (Open Label)
Primary purpose: Basic Science
Ondansetron for the Treatment of Methamphetamine Dependence - 1
Condition: Amphetamine-Related Disorders
MeSH terms: Amphetamine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess ondansetron for the treatment of methamphetamine
      dependence.
    

Detailed description: 
      This study was designed to be a preliminary assessment of the efficacy and safety of 3-wide
      range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce
      methamphetamine use in subjects with methamphetamine dependence and to determine the optimal
      dose of ondansetron.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: amphetamine dependence
Real-Time Support for Exercise Persistence in COPD
Condition: Pulmonary Disease, Chronic Obstructive; COPD; Emphysema; Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive; Emphysema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this exploratory study is to determine the feasibility, acceptability, and
      efficacy of an exercise persistence intervention for patients with chronic obstructive
      pulmonary disease (COPD) following pulmonary rehabilitation (PR).
    

Detailed description: 
      Exercise, a cornerstone of PR, is effective in improving dyspnea, functioning, and health
      related quality of life (HRQL) in patients with COPD. However, these improvements gradually
      dissipate following program completion. There are currently few successful interventions that
      support patients' persistence with community-based exercise after PR and that have closely
      monitored the potentially negative impact that COPD exacerbations have on exercise behaviors.
      Emerging technologies such as wirelessly enabled personal digital assistants (PDA) may
      provide an innovative means to support exercise persistence through real-time collaborative
      monitoring of exercise and signs and symptoms of COPD exacerbations and reinforcement to
      enhance exercise self-efficacy. Patient graduates of two PR programs who have COPD (n=20)
      will first undergo a 2-week run-in prior to being randomized to either the MOBILE (Mobilizing
      Support for Long-term Exercise) intervention or attention control for 6 months.
    

Intervention name(s): Coached exercise persistence intervention; Self-Monitored exercise persistence intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Collaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone.; Self-monitoring of symptoms and exercise using a mobile device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Exercise; Physical Activity; Adherence
Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children
Condition: Pneumonia, Pneumocystis Carinii; HIV Infections
MeSH terms: Pneumonia; Pneumonia, Pneumocystis
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate
      suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94
      amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally
      exposed (per 8/9/95 amendment) infants and children who are at risk of developing
      Pneumocystis carinii pneumonia (PCP).

      Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly
      absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has
      been prepared as a microparticulate suspension. Since studies in adults have demonstrated
      substantial safety of this drug, evaluation in children is being pursued.
    

Detailed description: 
      Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly
      absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has
      been prepared as a microparticulate suspension. Since studies in adults have demonstrated
      substantial safety of this drug, evaluation in children is being pursued.

      Three cohorts of four patients each (ages 2-12 years, 3 months to less than 2 years, and 1
      month to less than 3 months) receive atovaquone daily for 12 days. The oldest age group is
      treated first. In the absence of unacceptable toxicity, the dose of atovaquone is escalated
      in subsequent 4-patient cohorts representing each of the age stratifications and (per 9/30/94
      amendment) in a separate 4-patient cohort aged 3 months to less than 2 years. If two of four
      patients in a given cohort experience unacceptable toxicity at the initial dose, two
      additional patients in the same age range are entered. Blood samples are drawn for
      pharmacokinetic evaluation. Patients are followed to day 24. Per 9/30/94 amendment, patients
      aged 3 months to less than 2 years of age who received one of the lower doses may re-enroll
      in the higher dose cohort after a 1-month washout.
    

Intervention name(s): Atovaquone
Intervention type(s): Drug
Intervention MeSH terms: Atovaquone
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumonia, Pneumocystis carinii; Antifungal Agents; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Biological Availability; atovaquone
Staccato Loxapine PK in Smokers and Nonsmokers
Condition: Smoking, Cigarette
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg
      Staccato Loxapine administered to smokers compared to nonsmokers.
    

Detailed description: 
      Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were
      studied in male and female adult subjects (nonsmokers and smokers) following a single dose of
      10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30,
      and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were
      analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.
    

Intervention name(s): Inhaled Loxapine 10 mg
Intervention type(s): Drug
Intervention description(s): Staccato Loxapine 10 mg, single dose
Other intervention name(s): Staccato Loxapine 10 mg
Intervention MeSH terms: Loxapine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Staccato Loxapine; pharmacokinetics; smokers; non-smokers
Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional

Summary: 
      Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to
      be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen
      with rabies immunoglobulin have never been studied in the aspect that the immunity level
      would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This
      study would access this subject.
    

Detailed description: 
      -  Controlled trial study

        -  All 75 volunteers who had never had rabies immunization would be enrolled and designated
           into 3 groups.

      group 1 : 25 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed
      to rabies and had WHO category III exposure, all receive standard post - exposure rabies
      treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of equine
      rabies immune globulin (ERIG).

      group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on
      day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG).

      group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on
      day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

      5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and
      360 for rabies neutralizing antibody titers (RNab).

      The GMTs of RNab among both groups would be analyzed and compared.
    

Intervention name(s): rabies vaccine
Intervention type(s): Biological
Intervention description(s): Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.
Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.
Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Other intervention name(s): Equine rabies immunoglobulin produced by Thai Red Cross
Intervention MeSH terms: Immunoglobulins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: rabies; rabies immunoglobulin
Comparison of Three Different Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to compare three assisting devices to propel personal
      wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual
      wheelchair in patients with spinal cord injury.
    

Detailed description: 
      The objective of the study is to compare three assisting devices to propel personal
      wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual
      wheelchair in patients with spinal cord injury.

      The study consists of three distinct and independent phases:

        -  Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy
           expenditure and kinetic characteristics in comparable situations with regard to speed
           and workload imposed to the wheelchair-patient couple.

        -  Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor
           and indoor paths with standardised obstacles. Trajectories are to be recorded in order
           to allow analysis by independent experts.

        -  Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the
           patient's ability to transfer from wheelchair to car seat and from car seat to
           wheelchair, as well as ease of wheelchair packing in car, in the context of a standard
           city transport involving a car and the wheelchair.

      The three phases are to be performed using the standard manual wheelchair and the three
      assisting devices in a randomized order.

      Three different groups of patients are included in the three phases of the study.
    

Intervention name(s): Servomatic™ assisting device; E.Motion© assisting device; Standard manual Wheelchair
Intervention type(s): Device; Device; Device
Intervention description(s): Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .; E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .; Standard manual Wheelchair
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device
Quality of Recovery Awake Versus Asleep Craniotomy
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      Awake craniotomy (AC) is an anesthetic and surgical technique commonly used to resect tumors
      involving or adjacent to the eloquent or motor cortices, those portions of the brain that are
      responsible for language and motor skills, respectively. By mapping those areas of the brain
      that are necessary for such functions, the neurosurgeon is able to avoid resection of
      cortical tissue that might compromise the patient's abilities to speak or move, hence
      preserving neurologic function. AC is often accomplished by direct cortical stimulation or
      inhibition, while maintaining the patient's ability to interact with the operative team. The
      anesthetic technique often involves a regional (scalp) block combined with intraoperative
      intravenous mild sedation. In some reported instances of AC, no cortical mapping is
      performed, and the technique is performed solely because it is thought that AC leads to a
      better recovery profile (less pain, better neurologic outcome, and shorter hospital stay)
      than craniotomy performed under general anesthesia.

      The Quality of Recovery Score (QoR-40) is a validated, multi-parameter instrument that has
      been used in various postoperative populations to assess the overall satisfaction and
      well-being of patients having undergone anesthesia and surgery. Leslie et al. have reported
      that the QoR-40 is a valid tool in assessing neurosurgical patients, but a direct comparison
      between AC patients and general anesthesia craniotomy (GAC) patients using this tool has
      never been performed.

      AC may also be associated with better 30 and 90 day multi-parameter outcomes than GAC. The
      well-validated Acute Short Form (SF-12) health survey, an abbreviated version of the SF-36,
      consists of 12 items. It measures two domains, including mental and physical component
      summaries (mental component summary and physical composite score, respectively).

      Hypothesis:

      Awake craniotomy for tumor resection is associated with a better multi-parameter quality of
      recovery in the immediate postoperative period, and better 30 and 90 day quality of life
      outcomes, than craniotomy performed under general anesthesia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult non-pregnant patients (age ≥ 18 years) undergoing Awake Craniotomy or General
        Anesthesia Craniotomy for elective supratentorial tumor resection.
A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of LX4211 and metformin on each other
      when given at the same time as single doses to healthy human subjects.
    


Intervention name(s): 400 mg LX4211; 1000 mg metformin
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg of LX4211 given as a solid oral dose form; 1000 mg metformin given as a solid oral dose form
Intervention MeSH terms: Metformin; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment