bioihbjkbjnl/mcl2 huggingface dataset:
Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Patients with incomplete spinal cord injury
    

Detailed description: 
      The objective of this project is to verify the effects of suspended robotic gait training
      (Lokomat) in recovery of functional capacity of the lower limbs patients with incomplete
      spinal cord injury.
    

Intervention name(s): Training sessions; Lokomat system (Hocoma AG Switzerland)
Intervention type(s): Other; Device
Intervention description(s): A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period.; For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Rehabilitation; Walking; Robotics; Neuronal Plasticity
Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia
Condition: Schizophrenia; Neurocognitive Disorders
MeSH terms: Schizophrenia; Neurocognitive Disorders
Study type: Interventional

Summary: 
      About 85% of patients with schizophrenia have cognitive impairments, executive functions
      being particularly affected. Executive dysfunction, and cognitive deficits in general, are
      important predictors of functional outcomes, including social problem solving, activities of
      daily living, life satisfaction, and the ability to return to work or school.The main
      objective of the current study is to examine the efficacy of group-based Goal Management
      Training (GMT) for patients with broad schizophrenia spectrum disorders or high risk
      individuals with executive deficits. The short term goals are to investigate whether GMT can
      improve participants' ability to organize and achieve goals in everyday life in addition to
      improving aspects of emotional health. A long-term goal would be to establish an evidence
      base for nonpharmacological interventions for patients with broad schizophrenia spectrum
      disorders or high risk for schizophrenia. Main research questions: (1) Does a RCT with GMT
      delivered to patients with broad schizophrenia spectrum disorders or high risk for
      schizophrenia result in improved executive functioning, measured by self-reported and/or
      objective measures of executive functions? (2) Does GMT result in improved goal attainment in
      everyday life, social- and real world functioning? (3) Does GMT have a positive impact on the
      patients' emotional health? (4) Are there specific characteristics in patients with broad
      schizophrenia spectrum disorders or high risk for schizophrenia that are associated with
      better treatment benefit from GMT?
    


Intervention name(s): GMT
Intervention type(s): Behavioral
Intervention description(s): Metacognitive strategy training where the primary objective is to stop ongoing behavior to define goal hierarchies and monitor performance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1, double-blind, placebo-controlled crossover study of single, oral
      dose of SAGE-718 using a ketamine challenge, to evaluate the electrophysiology, safety,
      tolerability, and pharmacokinetics in healthy subjects
    


Intervention name(s): SAGE-718; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAGE-718 in combination with Ketamine; Placebo in combination with Ketamine
Other intervention name(s): Ketamine
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6
      weeks is effective and safe in treating asthmatic children aged 6 to <12 years
    

Detailed description: 
      Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study,
      comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in
      children aged 6 to <12 years with asthma
    

Intervention name(s): budesonide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): pMDI, inhalation, bid, 6 weeks; pMDI, inhalation, bid, 6 weeks
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma, children, budesonide pMDI
A Comparison of McGrath, Pentax and Macintosh Laryngoscopes for Nasotracheal Intubation in Pediatrics
Condition: Intubation Time; Intubation Difficulty Scale
Study type: Interventional

Summary: 
      Videolaryngoscope provide better view of the larynx. This better view could improve the
      navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result
      in adult, one previous report using Glidescope in children did not show better performance
      than direct laryngoscope. The aim of this study is to compare the performance of McGrath,
      Pentax and Macintosh laryngoscope for nasotracheal intubation in children.
    


Intervention name(s): Macintosh laryngoscope; McGrath videolaryngoscope; Pentax videolaryngoscope
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
Condition: Infections, Meningococcal; Meningococcal Vaccines
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate
      vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2
      months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be
      co-administered.
    

Detailed description: 
      The study consists of a primary vaccination phase and a booster vaccination phase. The
      Protocol Posting has been updated due to protocol amendment 2.
    

Intervention name(s): Nimenrix™; Menjugate®; NeisVac-CTM; Infanrix™ hexa; Synflorix™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 4- or 3-dose intramuscular injection; 3-dose intramuscular injection; 3-dose intramuscular injection; 4-dose intramuscular injection; 4-dose intramuscular injection
Other intervention name(s): Infanrix hexa™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infants; conjugate vaccine; immunogenicity; meningococcal vaccine; non-inferiority; co-administration
A Clinical Study to Evaluate the Efficacy and Consumer Perception of Lumenato
Condition: Skin
Study type: Interventional

Summary: 
      Subjects will be enrolled in this clinical study to assess the efficacy of an oral supplement
      to change the characteristics of facial skin after 4 and 12 weeks of use and obtain consumer
      perception of the test product through the use of questionnaires.

      Study evaluations will include a comprehensive metabolic panel, Cutometer measurements,
      Canfield's VISIA-CR images, VapoMeter Measurements, and Consumer perception questionnaires.
    


Intervention name(s): Lumenato
Intervention type(s): Dietary Supplement
Intervention description(s): Supplementation of 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Phase I Study to Investigate the Alcohol Interaction of SK3530
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics
      (PKs) and safety.
    

Detailed description: 
      This study was a randomized, open, single-dose, three-treatment, three-period,
      three-sequence, crossover study in which subjects were received, in random order, SK3530
      100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum
      of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water.
      The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma
      samples were collected at pre-scheduled time and the safety was monitored all through the
      study.
    

Intervention name(s): SK3530
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SK3530; alcohol; pharmacokinetics; safety
Effect of Carvedilol on Exercise Performance in Fontan Patients
Condition: Single Ventricle; Fontan
MeSH terms: Univentricular Heart
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart
      operation. All participants will receive carvedilol and placebo for 12 weeks. Exercise tests
      will be performed at the end of each 12 week period.
    

Detailed description: 
      Carvedilol is a well studied heart failure medication in adult heart failure that has been
      shown to improve outcomes. However, it has not been studied in patients who have had a Fontan
      heart operation. Study participants will receive either placebo or carvedilol for 12 weeks,
      at the end of the 12 weeks participants will perform an exercise test. Then study
      participants will receive treatment with placebo or carvedilol for 12 weeks (opposite of what
      participants go the first 12 weeks) and will again perform an exercise test.
    

Intervention name(s): Carvedilol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Carvedilol will be given for 12 weeks and then an exercise test will be performed; Placebo will be given for 12 weeks and then an exercise test will be performed
Other intervention name(s): Coreg; Carvedilol Placebo
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) Versus Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary:

        -  Overall Survival (OS)

      Secondary:

        -  Time to Tumor Progression (TTP)

        -  Response Rate (RR)

        -  Improvement of Quality of Life (QoL)

        -  Safety

        -  Secondary resection rate
    


Intervention name(s): Oxaliplatin + 5-Fluorouracil/Leucovorin; Doxorubicin
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion.
Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion.
Repeated every 2 weeks; Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.
Intervention MeSH terms: Leucovorin; Doxorubicin; Fluorouracil; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
Condition: Advanced Malignancies
MeSH terms: Neoplasms; Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in
      participants With normal hepatic function and participants with hepatic impairment.
    


Intervention name(s): parsaclisib
Intervention type(s): Drug
Intervention description(s): parsaclisib will be administered orally after 8 hours of fasting.
Other intervention name(s): INCB050465
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatic Impairment; parsaclisib
Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis
Condition: Intraoperative Fluid Volume; Hemodynamics; Serum Lactate; Intestinal Edema; Length of the Hospital Stay; First Time to Gastrointestinal Motion; Postoperative Complications
MeSH terms: Colonic Neoplasms; Postoperative Complications
Study type: Interventional

Summary: 
      pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy
      for colonic cancer patients undergoing mass resection and anastomosis for maintaining
      adequate hydration without complications.
    

Detailed description: 
      All Patients will be assigned randomly by using computerized program to one of the two equal
      groups. Patients will be (forty five patients per group):

      Group A ;( control group) Forty five patients will do elective open colonic mass resection
      and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution.

      Group B; Forty five patients will do elective open colonic mass resection and anastomosis.
      Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

      Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be
      measured after induction of anesthesia and every hour till the end of the operation, length
      of the hospital stay, first time to gastrointestinal motion and postoperative complications
      are recorded.
    

Intervention name(s): pulse pressure variation; conventional fluid management
Intervention type(s): Device; Other
Intervention description(s): Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.; Infusion of 6 ml/kg/hr. Ringer's solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Determine the Pharmacokinetics of GSK961081 and Fluticasone Furoate When Administered Alone or in Combination
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK961081 is a novel bifunctional molecule that combines muscarinic antagonism and
      beta2-agonism in a single molecule and is in development for the treatment of chronic
      obstructive pulmonary disease (COPD). This is a randomised, open-label, six-way crossover,
      single dose study. This study evaluates the drug delivery and systemic pharmacokinetics of
      GSK961081 following concurrent administration of GSK961081 and fluticasone furoate via dry
      powder inhaler (DPI) in comparison to GSK961081 DISKUS. There will be six treatment periods
      and 7 days washout period in the study. Subjects will attend the unit in the morning for
      dosing and will be resident until 12 hours post administration. All subjects will receive six
      treatments.
    


Intervention name(s): GSK961081; Fluticasone furoate
Intervention type(s): Drug; Drug
Intervention description(s): Dry white to off white powder; Dry white powder
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Respiratory; GSK961081 (MABA); healthy subjects; pharmacokinetics; GW685698 (fluticasone furoate)
Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy
Condition: Diabetic Neuropathy With Loss of Sensation; Foot and Ankle Muscle Weakness; Foot and Ankle Range of Movement Restriction
MeSH terms: Muscle Weakness; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis is that a physical therapy intervention for foot and ankle of diabetic
      neuropathic individuals would affect positively the way they walk, lowering the harmful
      forces that these segments receive, that are associated mainly with lower range of movement,
      muscle weakness and loss of sensation. The participants will be randomly assigned into
      control group (regular treatment prescribed by their medical group) or into treatment group,
      that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes
      each session. This will aim for increasing foot and ankle range of movement, muscle strength
      and improving sensory inputs.
    

Detailed description: 
      In this study, were included subjects diagnosed with diabetic neuropathy, aged between 45 and
      65 years old. We aimed to assess the effect of a physical therapy program on biomechanics of
      lower limbs during gait.
    

Intervention name(s): Physical Therapy
Intervention type(s): Other
Intervention description(s): strengthening passive and active stretching balance training gait training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Bilateral TAP Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study
Condition: The Main of This Study is to Compare the Nerve Block of the Muscles of the Abdominal Wall Between the Bilateral TAP Block and Curare
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric,
      phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of
      the abdominal wall during laparoscopic digestive surgery.
    


Intervention name(s): Transversus Abdominis Plane; Curare
Intervention type(s): Drug; Drug
Intervention description(s): PIA coelioscopic; IAP coelioscopic
Intervention MeSH terms: Curare
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome
Condition: Xerostomia; Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Xerostomia; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of
      decreased salivary flow associated with primary or secondary Sjögren's syndrome.

      For each patient, the study includes four periods of treatment separated by a washout period
      that may range from 4 - 8 days according to patient and site discretion. Each treatment
      period includes two overnight stays in the clinic. One dose of study drug is taken during
      each treatment period
    


Intervention name(s): NGX267; NGX267; NGX267; NGX267
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 capsules in the am of each treatment period; 2 capsules in the am of each treatment period; 2 capsules in the am of each treatment period; 2 capsules in the am of each treatment period
Intervention MeSH terms: (S)-2-ethyl-8-methyl-1-thia-4,8-diazaspiro(4.5)decan-3-one
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Xerostomia; Sjogren's Syndrome
Multiple-Dose Study of VGX-1027 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile, tolerability and
      pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects
      administered for 5 days.
    

Detailed description: 
      This study will evaluate:

        -  The safety and tolerability of multiple oral doses of VGX 1027 in the range of 40 to
           400mg.

        -  The pharmacokinetics of VGX 1027 in healthy subjects following the first oral dose (Day
           1) and at steady state (Day 5).
    

Intervention name(s): VGX-1027
Intervention type(s): Drug
Intervention description(s): Subjects will
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteers
Comparing Methods to Biopsy Pancreas Mass
Condition: Pancreas Mass Diagnosis
Study type: Interventional

Summary: 
      This study will examine whether there is any difference in number of passes needed to
      diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different
      types of needles.
    


Intervention name(s): FNB
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic