bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor
Condition: Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma
MeSH terms: Glioblastoma; Astrocytoma; Oligodendroglioma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter study evaluating the safety and tolerability of increasing doses of
      Toca 511, a retroviral replicating vector, injected into the resection cavity of patients
      with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their
      tumor. Approximately 6 weeks after injection of Toca 511, patients will begin an oral courses
      of Toca FC, an antifungal agent. These one week courses of Toca FC will be repeated during
      the approximately 30 week study. Two separate cohorts of patients treated with Toca 511 and
      Toca FC will also be evaluated with either of the following standard treatments for glioma:
      lomustine or bevacizumab. After completion of this study, all patients will be eligible for
      enrollment and encouraged to enter a long-term continuation protocol that enables additional
      Toca FC treatment cycles to be given, as well as permits the collection of long-term safety
      and survival data.
    


Intervention name(s): Toca 511 vector; Toca FC
Intervention type(s): Biological; Drug
Intervention description(s): All patients will receive Toca 511, a retroviral replicating vector that expresses the cytosine deaminase (CD) gene. CD converts the antifungal 5-FC to the anti-cancer drug 5-FU in cells that have been infected by the Toca 511 vector. Beginning approximately 6 weeks after administration of Toca 511, patients will begin courses of oral Toca FC at pre-specified intervals, depending on cohort, during the approximately 30 week study.
Other intervention name(s): Toca 511, RRV, retroviral replicating vector; 5-FC, flucytosine, 5-fluorocytosine, Toca FC; flucytosine, 5-FC, 5-FC XR, Toca FC
Intervention MeSH terms: Flucytosine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GBM; HGG; High grade glioma; Malignant glioma; Grade III glioma; Grad IV glioma; glioma; glioblastoma; Grade IV astrocytoma; brain cancer; recurrent glioblastoma; AA; AOD; anaplastic astrocytoma; Anaplastic oligodendroglioma; Anaplastic oligoastrocytoma
The Benefits of Hemp Protein Supplementation During Resistance Training
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Forty physically active men and women aged 18-45y will take part in an 8-week resistance
      training program, randomized (double blind) 1:1 into each of two groups. Twenty participants
      will be randomized to receive 60 g/d of hemp powder (containing approximately 40 g protein
      and 9 g oil) supplementation and 20 randomized to receive 60 g/d of soy supplementation
      (matched to the hemp for macronutrients and calories) during eight weeks of training. Each
      participant will complete testing before and after the intervention for assessment of body
      composition (lean tissue, fat, and bone mass), strength, central fatigue, markers of
      inflammation, and bone resorption. Over the 8-weeks of training, participants will train
      four-five days per week for 1-1.5 hours per session with exercises targeting all major muscle
      groups. The training will involve a "two day split" where different muscle groups are trained
      on two consecutive days (day 1 involves chest, back, and arms; day 2 legs, shoulders, and
      abdominals). Resistance training will provide the necessary stimulus for protein synthesis to
      optimize the effect of a protein-containing nutritional supplement. The hemp or soy powder
      will be consumed in two doses (i.e. 30 g powder containing 20 g protein per dose) immediately
      after exercise sessions and one hour after exercise. This dosing regimen is optimal for
      stimulating muscle protein synthesis and building muscle mass . On the one non-training day
      per week the two doses will be consumed with meals.
    


Intervention name(s): Hemp powder; Soy Powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Hemp powder supplement; Soy powder supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional

Summary: 
      Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the
      area of executive functioning. Relatively limited research has focused on interventions for
      improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for
      cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from
      conventional cognitive remediation approaches in that it directly stimulates specific brain
      regions responsible for cognitive processes and activates functional networks similar to
      those activated during cognitive training.

      Primary Objective

      To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired
      with remote cognitive training on direct testing of executive function in survivors of ALL.

      Secondary Objectives

        -  To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS)
           paired with remote cognitive training on patient-reported symptoms of executive
           dysfunction in survivors of ALL.

        -  To examine the effects of home-based tDCS paired with remote cognitive training on
           patterns of regional brain activation as measured by functional magnetic resonance
           imaging.

        -  To examine the effects of home-based tDCS paired with remote cognitive training on white
           matter integrity and structure as measured by diffusion tensor imaging.
    

Detailed description: 
      Eligible participants will be randomized to receive 1 mA direct current stimulation over the
      left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will
      receive home-based computerized cognitive training. Participants will complete tDCS paired
      with cognitive training 2 times per week for 6-months.
    

Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Participants will receive active 1mA direct current stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.; Participants will receive sham (no direct current) stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Acute Lymphoblastic Leukemia; Neurocognitive impairment; Executive dysfunction; Survivorship
Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease
Condition: Stable Coronary Artery Disease; Obesity; Impaired Glucose Tolerance
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Glucose Intolerance
Study type: Interventional

Summary: 
      Chronic inflammatory activation in fat tissue can be the link between adiposity and an
      increased risk for atherosclerosis. Aim of the study is to investigate how molecular
      alterations in fat tissue can be influenced by regular physical exercise training alone or in
      combination with a medical therapy (Glitazon or Metformin) in obese patients with stable CAD
      and impaired glucose tolerance.
    


Intervention name(s): training; training + metformin; training + glitazon
Intervention type(s): Other; Other; Other
Intervention description(s): regular physical exercise training for 6 months; regular physical exercise training in combination with metformin for 6 months; regular physical exercise training in combination with a glitazon for 6 months
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: adiposity
A Clinical Study in Healthy Subjects Which Aims to Investigate the Safety, the Tolerability and the Effects of GRT0151Y and How the Compound is Taken up and Excreted From the Body
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this clinical study in healthy participants is to investigate the safety and
      tolerability of GRT0151Y after multiple oral intake of different increasing doses and to
      evaluate the pharmacological effects (action of the compound) by means of pupillometry
      (measuring the pupil size of the eye) and Cold Presser Test (measuring the pain when
      immersing the hand in 2 degree Celsius cold water). An additional aim of the study is to
      investigate the pharmacokinetics of GRT0151Y (how it is taken up into the body and how it is
      excreted from the body)."
    


Intervention name(s): 100 mg GRT0151Y; 125 mg GRT0151Y; 150 mg GRT0151Y; 225 mg GRT0151Y; Matching placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100 mg capsule (1 x 100 mg capsule); 125 mg (1 x 100 mg capsule and 1 x 25 mg capsule); 150 mg (1 x 100 mg capsule and 1 x 50 mg capsule); Day 1: 150 mg (1 x 100 mg capsule and 1 x 50 mg capsule) Day 2 - 5: 225 mg (2 x 100 mg capsules and 1 x 25 mg capsule); Matching placebo capsules using the same dosing regimen as defined in the treatment groups.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Twelve volunteers (6 males and 6 females) per dose group will be randomly assigned to two treatment sequences (placebo-verum and verum-placebo, within dose-group randomized) in a ratio of 1:1. There will be a washout period of 7 to 11 days between the treatment sequences.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dermacyd Tina Gel Tangerina Mix - Photo Evaluation
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the absence of photo irritation and photo sensitivity
      potential of the product Dermacyd Tina Gel Tangerina Mix.
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hygiene
Prevalence of Nocturnal Hypoglycemia in Children on a Type 1 Diabetes (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS)
Condition: Nocturnal Hypoglycemia; Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Observational

Summary: 
      This study will help determine the frequency and magnitude of nocturnal hypoglycemia (low
      blood sugar at night during sleep), in children with type 1 diabetes who are on a standard
      insulin regimen, by using a Continuous Glucose Monitoring System (CGMS). Secondary objectives
      include the establishment of a definition of nocturnal hypoglycemia for the CGMS and for the
      calculation of sample size needed for future studies using CGMS. Nocturnal hypoglycemia (NH)
      can be associated with significant morbidity including seizure and coma. The investigators
      intend to use the CGMS in a future study investigating the use of a new insulin combination
      aimed to decrease the frequency of NH in the pediatric population.

      Thirty pediatric subjects with established type 1 diabetes mellitus will be asked to wear a
      CGMS for 3 days. During this time the participants will be required to test and record
      self-monitored blood glucose readings at designated time periods and if they have symptoms of
      hypoglycemia. The comparison of these values with each other and with different previously
      defined values of NH will allow for a clear definition of NH to be made. A survey has also
      been designed to assess participant satisfaction with the CGMS.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with type 1 diabetes
      
Keywords: Nocturnal Hypoglycemia; Type 1 diabetes; Children; Adolescents; CGMS
Gabapentin Treatment of Cannabis Dependence
Condition: Cannabis Dependence; Cannabis Withdrawal; Cognitive Deficits
MeSH terms: Marijuana Abuse; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical study to evaluate the efficacy of the medication gabapentin in treating
      persons with cannabis dependence.
    

Detailed description: 
      This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of
      gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a
      comprehensive screening visit is scheduled to determine eligibility. Upon enrollment,
      counseling, medication dispensation and research assessments occur 1 time per week for 3
      months.
    

Intervention name(s): gabapentin 1200mg/day; Placebo; Manual-guided behavioral counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): gabapentin 1200mg/day for 12 weeks; 1200mg/day of placebo for 12 weeks; Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
Other intervention name(s): Neurontin; Manual-guided therapy
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabis Treatment; Cannabis Use; Cannabis Dependence; Executive Functioning; Cognitive Deficits
Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to
      netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%
    


Intervention name(s): PG324 Ophthalmic Solution 0.02%/0.005%; Netarsudil (AR-13324) ophthalmic solution 0.02%; Latanoprost ophthalmic solution 0.005%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 drop daily in the evening (PM) in both eyes (OU); 1 drop daily in the evening (PM) in both eyes (OU); 1 drop daily in the evening (PM) in both eyes (OU)
Intervention MeSH terms: Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a controlled study designed to evaluate the efficacy of UFT on survival compared with
      surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery
      followed by UFT within 6 weeks after curative resection. To assess treatment response, data
      on recurrence and survival will be collected for 5 years after enrollment of the last
      patient. To evaluate safety, data on adverse events will be collected for 16 months after the
      start of treatment.
    


Intervention name(s): UFT (uracil, tegafur); Surgery alone
Intervention type(s): Drug; Procedure
Intervention description(s): uracil-tegafur 360 mg per square meter per day orally 16 months; Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.
Intervention MeSH terms: Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach Cancer
Measurement of Maximal Oxygen Uptake (VO2max) Using Mankato Submaximal Exercise Test in Young Adults
Condition: Healthy
Study type: Observational

Summary: 
      -  To measure the maximal oxygen uptake (VO2max) using Mankato Submaximal Exercise test.

        -  To correlate 'true' VO2max with Modified Bruce protocol and Mankato Submaximal Exercise
           Test.
    

Detailed description: 
      First of all, 'true' VO2max of all subjects was calculated using non-exercise regression
      equation and one mile walk test. Variables used for the VO2max regression equation included
      BMI, age (years), gender (Male=1, Female=0) and physical activity rating scale. On the same
      visit, the subjects also performed one mile walk test. After the completion of test, pulse
      rate of subjects was calculated in beats per minute. The VO2max after the test was measured
      using the VO2max aerobic capacity calculator. Variables required were age, gender, weight,
      total time taken to complete test and pulse rate at test completion.

      'True' VO2max accepted was the highest value obtained from non-exercise regression equation
      and one mile walk test On the 2nd visit, the participants performed Modified Bruce Submaximal
      Exercise test depending upon their fitness level and Mankato Submaximal Exercise test in
      counter balanced order with 30 minutes rest in between
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        study design was Analytical (Correlational) study design. During the first visit, First of
        all, 'true' VO2max of all subjects was calculated using non-exercise regression equation
        and one mile walk test.

        On the 2nd visit, the participants performed Modified Bruce Submaximal Exercise test
        depending upon their fitness level and Mankato Submaximal Exercise test in counter balanced
        order with 30 minutes rest in between.
Dysphagia Handicap Index: A Structured Translation From English to German
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      Establishment of a questionnaire in German to determine in a structured and quantifiable
      manner the quality of life of patients with dysphagia.
    


Intervention name(s): Pretest and validation of a translated questionnaire
Intervention type(s): Procedure
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from dysphagia
Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement
Condition: Total Knee Replacement; Total Knee Arthroplasty
Study type: Interventional

Summary: 
      Despite best efforts to provide standardized and effective rehabilitation sessions post-total
      knee replacement (TKR), there are a few factors that may result in sub-optimal recovery in
      this group of patients. There is a need to develop innovative rehabilitation strategies that
      (i) provide patients with accurate cues allowing for better compliance and exercise
      performance, (ii) allow for therapists to ensure continuity of care, monitor compliance, and
      identify deviation from recovery trajectories post-discharge, prior to their first outpatient
      appointment, and (iii) reduce reliance on manpower and variability during rehabilitation
      sessions.

      Technological solutions that empower patients and allow home-based rehabilitation to take
      place without the need for real-time human supervision could be the key to improving
      effectiveness and lowering costs. A mobile application which detects key landmarks on the
      body for human pose estimation will allow patients to perform their rehabilitation exercises
      with real-time feedback allowing for proper execution of the exercises. Physiotherapists will
      be able to access the data generated from the exercise session via a command centre to
      monitor patients' recovery progress and compliance.

      The primary aim of this pilot study is to evaluate the feasibility of using a mobile
      application during rehabilitation in patients after a TKR surgery. The secondary aim is to
      study the effects of using a mobile application during rehabilitation on knee functional
      status, exercise self-efficacy, and treatment satisfaction after TKR surgery.
    


Intervention name(s): Mobile application; Standard rehabilitation program
Intervention type(s): Device; Other
Intervention description(s): Participants will be instructed on the installation and use of the mobile application on their personal mobile phones. Participants will then have to perform the assigned exercises using the mobile application 3 times daily. Physiotherapists will still perform the required assessment/review, education, and intervention.; All participants will be seen by physiotherapists in the ward post-TKR surgery and undergo standard inpatient rehabilitation. Patients will be given instructions to perform assigned exercises 3 times daily. Physiotherapists will perform the required assessment/review, education, and intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients
Condition: Renal Transplant Recipients
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the effects of tacrolimus sustained-release
      capsules replacing cyclosporin on kidney function of renal transplant recipients.
    


Intervention name(s): Tacrolimus sustained-release capsule
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): FK506
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FK506; Renal transplant recipients; cyclosporin