bioihbjkbjnl/mcl2 huggingface dataset:
Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms
Condition: Glioma; Glioblastoma
MeSH terms: Glioblastoma; Glioma
Study type: Observational

Summary: 
      This pilot study will assess feasibility and to obtain initial estimates of efficacy of Sleep
      Activity and Task Effectiveness (SAFTE) model, which can accurately estimate the impact of
      scheduling factors and sleep history on both safety and productivity. The SAFTE model will be
      used to asses cancer-related fatigue and study potential associations of change in sleep
      patterns to tumor recurrence in patients with high grade glioma. Data will be collected using
      the Readiband™ Sleep Tracker (https://www.fatiguescience.com/sleep-science-technology/). The
      Readiband device captures high-resolution sleep data, validated against the clinical gold
      standard of polysomnography with 92% accuracy. Sleep data is transmitted to the cloud
      automatically for SAFTE Fatigue Model analysis. We will correlate clinical progression data
      obtained from the patient's electronic medical record with SAFTE data.
    


Intervention name(s): Readiband Sleep Tracking
Intervention type(s): Device
Intervention description(s): Once a patient has consented to study progression, a Readiband™ Sleep Tracker device will be provided to the patient, along with necessary instructions. Patients will return home with the device and fatigue data will be obtained from the device at subsequent standard care follow-up visits. In addition, surveys related to fatigue and quality of life will be administered via secure electronic survey to participants.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Grade IV gliomas treated at Abbott Northwestern Hospital's Givens Brain Tumor
        Center will comprise the study population. Patients enrolled in this study must intend to
        complete post-surgery chemoradiation as part of their standard treatment. Twenty-five
        patients will prospectively be included in the study. Aggregate fatigue data and sleep
        patterns for a group of 30 healthy controls will be procured from FatigueScience in a
        de-identified manner for data analysis purposes.
Acute Effect of Whole Body Vibration on Reaction Speed and Proprioception
Condition: Whole Body Vibration
Study type: Interventional

Summary: 
      It will be determined whether the application of whole body vibration has an immediate effect
      on upper extremity reaction speed and proprioception.
    

Detailed description: 
      Muscles and tendons are among the mechanisms affected by whole body vibration. In this way,
      it is thought that TVV indirectly affects the reaction speed of individuals. In the light of
      this information, this study was planned to investigate how whole body vibration application
      affects proprioception and reaction speed. The reaction rate and instantaneous effect of the
      virion given at 30 Hz and 2 mm amplitude in the push-up position on proprioception will be
      investigated. The aim of this study is to investigate the instantaneous effect of whole body
      vibration on reaction speed and proprioception in the upper extremity in healthy individuals.
    

Intervention name(s): whole body vibration
Intervention type(s): Other
Intervention description(s): A total of 5 sets of vibration will be given at 30 Hz, 2 mm amplitude, 1 minute of application and 1 minute of rest.
Intervention model: Single Group Assignment
Intervention model description: A total of 5 sets of vibration will be given at 30 Hz, 2 mm amplitude, 1 minute of application and 1 minute of rest.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: whole body vibration; healthy subject; reaction time; proprioception; Upper Extremity
Physical Activity Choices Everyday
Condition: Obesity
Study type: Interventional

Summary: 
      This study aims to test two strategies for weight loss maintenance. It involves two phases, a
      weight loss phase and a maintenance phase. During Phase I (the weight loss phase),
      participants will receive a 16-week, Web-based behavioral weight loss program that involves
      access to weekly weight loss information and weekly personalized feedback on diet, activity,
      and weight loss goals. Individuals who lose at least 5% of their initial body weight during
      this program, will be invited to participate in Phase II. During Phase II, two 4-month
      treatments for weight loss maintenance will be tested. At the beginning of Phase II,
      participants will be randomly assigned to one of the two maintenance programs: (1) a
      behavioral maintenance program that involves in-person group meetings plus daily exercises in
      which information about a healthy lifestyle is reviewed or (2) a behavioral maintenance
      program that involves in-person group meetings plus daily exercises in which descriptions of
      positive future events are reviewed. Throughout the study, participants will complete
      assessments that examine the effects of the interventions on delay discounting, physical
      activity, weight, and other important health and psychosocial outcomes.
    


Intervention name(s): Weight Loss Maintenance + Healthy Thinking; Weight Loss Maintenance Treatment + Future Thinking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.; Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight Loss Maintenance
Protein Before Night Sleep to Improve Recovery and Performance in Runners
Condition: Healthy
Study type: Interventional

Summary: 
      32 runners will be randomized into two groups. The duration of the intervention is one week
      including a strenuous endurance training program. Group 1 receive a protein beverage before
      each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test
      before and after the intervention and blood sampling before and during the intervention to
      check for markers for muscle damage.
    


Intervention name(s): Sport beverages Protein; Sport beverages Carbohydrate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Beverage ingested before each night sleep during the intervention; Beverage ingested before each night sleep during the intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and Asia. The aim of the trial is to investigate the
      influence of semaglutide on pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of warfarin and
      pharmacokinetics of metformin in healthy subjects.
    


Intervention name(s): semaglutide; placebo; metformin; warfarin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will initiate treatment with 0.25 mg for the first four weeks followed by dose doubling every four weeks up to a dose of 1.0 mg.; Semaglutide placebo will be administered s.c.; For oral administration twice daily, in two periods, each of 3.5 days duration. The first period is initiated before semaglutide treatment and the second period is initiated at the end of semaglutide treatment.; For oral administration, given as a single dose. The first dose is given before semaglutide treatment and the second dose is given at the end of semaglutide treatment.
Intervention MeSH terms: Metformin; Warfarin
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Quality of Life in Individuals With Parkinson's Disease
Condition: Parkinson Disease; Tremor; Functionality
MeSH terms: Parkinson Disease; Tremor
Study type: Observational

Summary: 
      This study aimed to examine the relationship of quality of life with tremor severity and
      upper limb functionality in individuals with Parkinson's Disease. The differences between
      Parkinson's Disease Quality of Life Questionnaire, Nine-Hole Peg Test, grip and pinch
      strength values in the individuals with and without tremor in the study were investigated.
    

Detailed description: 
      Evaluating the relationship between Quality of Life and tremor is needed to determine the
      best physiotherapy and rehabilitation approaches for individuals with Parkinson's Disease.
      This study aimed to examine the relationship of quality of life with tremor severity and
      upper limb functionality in individuals with Parkinson's Disease. Fifty-two individuals with
      Parkinson's Disease participated in the study. Quality of Life, tremor amplitude, upper limb
      functionality, grip and pinch strength were evaluated. The relationship of quality of life
      with tremor severity and upper limb functionality was examined in individuals with
      Parkinson's Disease. The results of individuals with and without tremor were compared.
    

Intervention name(s): Quality of life; Upper limb functionality; Grip and pinch strength; Tremor amplitude; Depression and anxiety levels; Clinical manifestations
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Parkinson's Disease Quality of Life Questionnaire (PDQ-39); Nine-Hole Peg Test; Dynamometer; Electromyography; Hospital Anxiety and Depression Scale; The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals with Parkinson Disease were included in the study
      
Keywords: Quality of Life; Upper Limb Functionality; Tremor; Electromyography; Parkinson's Disease
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia
Condition: Insomnia; Sleep Disturbance
MeSH terms: Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Insomnia is known to be one of the most common health concerns in in the general population
      and has been associated with several health consequences. Medications are known to be
      effective, and currently serve as the primary treatment for insomnia but their use is limited
      due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown
      to be effective and safer in the treatment of insomnia but presents its own limitations such
      as the time, cost, and training required. The relationship between vestibular stimulation and
      sleep continues to be explored, however its usefulness in the treatment of insomnia is still
      unknown. Vestibular stimulation itself has been shown to be safe across multiple populations.
      If vestibular stimulation is shown to be effective in the treatment of insomnia, it could
      serve as a safer alternative to medications. It could also require less cost, time, and
      training than CBT-1, providing a treatment option that is not only safe and effective, but
      broadly available to the general population. Consequently this trial seeks to evaluate the
      efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving
      sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with
      insomnia.
    


Intervention name(s): VeNS
Intervention type(s): Device
Intervention description(s): The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
WALK Study: Women's Active Living for Koreans Study
Condition: Physical Activity; Metabolic Syndrome; Lifestyle, Sedentary
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing
      evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic
      Whites, but a culturally and linguistically appropriate lifestyle intervention has not been
      developed for Korean American middle-aged and older women. Thus, the investigators propose to
      develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to
      increase physical activity (PA) and reduce sedentary behavior for Korean American women.
    

Detailed description: 
      The purpose of this pilot study is to develop a 4-week lifestyle intervention (Women's Active
      Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary
      behavior for Korean American women. The investigators will assess feasibility and
      acceptability of the WALK Study and potential efficacy of the WALK Study on outcomes
      including sedentary behavior and PA.
    

Intervention name(s): WALK
Intervention type(s): Behavioral
Intervention description(s): Walking program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
N Acetyl Cysteine for Cystinosis Patients
Condition: Renal Disease; Cystinosis
MeSH terms: Kidney Diseases; Cystinosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study intends to verify the interference of N acetyl cysteine in the progression of
      chronic kidney disease in patients with Nephropathic Cystinosis.
    

Detailed description: 
      Patients with Nephropathic Cystinosis have an increased oxidative stress and go to end-stage
      renal disease, even when all steps of the treatment are done. Therefore, this study is
      conducted to verify the interference of the stress oxidative in the progression of the renal
      disease with the use of an oxidant drug, N acetyl cysteine (NAC). The investigators selected
      patients with good compliance of the treatment. In these patients the investigators evaluate
      the serum creatinine, creatinine clearance estimated by Schwartz Formula, cystatin C and a
      marker of oxidative stress, TBARS ( thiobarbituric acid substances). The variables are
      analyzed 6 months before the introduction of NAC and the three months after NAC.
    

Intervention name(s): N acetyl cysteine; N acetyl cysteine
Intervention type(s): Drug; Drug
Intervention description(s): N acetyl cysteine to cystinosis patients with CKD stages 1 to 4; N acetyl cysteine for cystinosis patients CKD stages 1 to 4
Other intervention name(s): N acety cysteine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal function; before and after N acetyl cysteine; Cystinosis patients
PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma
Condition: Sarcoma; Refractory Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first study to evaluate the safety and clinical activity of the combination of
      oral pazopanib, intravenous or oral irinotecan, and oral temozolomide in pediatric and young
      adult patients with relapsed or refractory sarcomas. This study will use a 3 + 3 design for
      dose escalation (Part 1), followed by an expansion cohort (Part 2) at the recommended phase 2
      dose level.
    

Detailed description: 
      The combination of irinotecan and temozolomide is well-tolerated and provides an active
      therapy option for heavily pre-treated patients with sarcoma. The toxicity profile and
      activity level suggest that this combination will provide a useful platform onto which novel
      compounds may be added. Pazopanib has been shown to demonstrate single-agent activity in
      sarcomas in the preclinical and clinical settings. Pazopanib has also been shown to have
      additive or synergistic effects in preclinical models of sarcomas when combined with
      cytotoxic chemotherapy. Pharmacokinetic studies of pazopanib and irinotecan as well as
      pharmacodynamic studies of pazopanib to assess anti-angiogenesis will be performed.
      Exploratory studies to assess non-invasive methods of monitoring tumor response [circulating
      tumor DNA and functional imaging by positron emission tomography (PET)/magnetic resonance
      imaging (MRI) will be performed].
    

Intervention name(s): Pazopanib; Irinotecan; Temozolomide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pazopanib will be administered orally as a tablet according to an assigned dose level per protocol. A cycle will be defined as 21 days. Drug dosing for the tablet formulation will be determined using a study-specific nomogram.; Patients will be given irinotecan at a dose of 25 mg/m2/dose IV on days 1-5 of a 21-day cycle during Cycle 1. In subsequent cycles, irinotecan may be given intravenously at a dose of 25 to 37.5 mg/m2/dose or orally at a dose of 45 to 67.5 mg/m2/dose on days 1-5 of a 21-day cycle.
Note that some patients enrolled on an earlier protocol version received 50 mg/m2/dose IV on days 1-5 of the first 21-day cycle and then either 50 mg/m2/dose IV or 90 mg/m2/dose orally for subsequent 21-day cycles. This higher dose level is no longer being given to newly enrolled subjects.; Temozolomide will be given at a dose of 100 mg/m2/dose orally on days 1-5 of each 21-day cycle.
Intervention MeSH terms: Irinotecan; Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Livedoid Vasculopathy: Strong Association With Smoking, Weak Association With Thrombophilia
Condition: Livedoid Vasculitis
MeSH terms: Vasculitis; Livedoid Vasculopathy; Thrombophilia
Study type: Observational

Summary: 
      A screening of patient histories at the clinics of Dermatology of the universities of Zurich,
      Basel and Bern is performed in order to identify patients with a history of Livedoid
      vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in
      the study. After reading the patient information and if the informed consent is signed
      patients are included in the study. Patients are questioned about their smoking history and
      blood is drawn in order to perform a screening for thrombophilia.
    

Detailed description: 
      A screening of patient histories at the clinics of Dermatology of the universities of Zurich,
      Basel and Bern is performed in order to identify patients with a history of Livedoid
      vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in
      the study. The presence of Livedoid vasculopathy must be confirmed by a histologic specimen.
      After reading the patient information and if the informed consent is signed patients are
      included in the study. Patients are questioned about their smoking history and blood is drawn
      in order to perform a screening for thrombophilia. The presence of a history of smoking and
      thrombophilia is compared to the general Swiss population.
    

Intervention name(s): Thrombophilia screening
Intervention type(s): Other
Intervention description(s): No intervention. Blood is drawn for analysis.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated for livedoid vasculopathy at the clinics of Dermatology of the University
        hospitals of Zurich, Basel and Bern.
      
Biospecimen description: 
      Blood samples for thrombophilia screen.
    
Keywords: Livedoid Vasculitis; smoking; thrombophilia
A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine
Condition: HIV Infections
MeSH terms: Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to make didanosine (ddI) available to children with AIDS who are
      clinically deteriorating on zidovudine (AZT) or intolerant to AZT and cannot enter the Phase
      II ddI programs due to protocol exclusion or geographic location.
    


Intervention name(s): Didanosine
Intervention type(s): Drug
Intervention MeSH terms: Didanosine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Didanosine; Drugs, Investigational; Acquired Immunodeficiency Syndrome; Zidovudine
Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence
      study in 18 healthy male and female subjects.
    

Detailed description: 
      Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence
      study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a
      washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of
      eslicarbazepine acetate following a standard meal in one period, and following at least 10
      hours of fasting in two periods.
    

Intervention name(s): BIA 2-093
Intervention type(s): Drug
Other intervention name(s): ESL, Eslicarbazepine acetate
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment