bioihbjkbjnl/mcl2 huggingface dataset:
Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Participants will be asked to complete three different tests (standing, stepping and assisted
      walking) and will experience three different experimental conditions during each test. The
      three conditions are types of vibratory plantar cutaneous stimulation, which include no
      vibratory stimulation, submaximal vibratory stimulation and supramaximal vibratory
      stimulation. In the first condition, participants will experience no stimulation applied to
      any part of the body. In the second condition, a submaximal vibratory stimulus will be
      delivered at 90% of the participant's threshold to the surface of the foot. In the third
      condition, a supramaximal vibratory stimulus will be delivered at three times the
      participant's threshold. The hypothesis is that this plantar stimulation (90% threshold and
      supramaximal) will elicit increased muscle activity during these tests. If the hypothesis is
      positive then this protocol will also be presented in incomplete spinal cord injuried
      participants.
    


Intervention name(s): plantar vibration
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep Behavior and Rest-activity Circadian Rhythm (RAR) in Hip/Knee Prosthesis
Condition: Sleep; Pain; Hospitalization; Arthroplasty Complications; RAR
Study type: Observational

Summary: 
      The consequences of chronically insufficient sleep are both behavioral and medical. .
      Patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation
      after hospitalization The aim of the present study is to evaluate the changes inrest-activity
      circadian rhythm (RAR) and objective and subjective sleep quality and perceived pain, untill
      the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.
    

Detailed description: 
      The National Health and Nutrition Examination Survey found that 22% of the US population
      reported 6 h of sleep or less and another 15% registered 5 h of sleep or less per 24 h (1).
      The consequences of chronically insufficient sleep are both behavioral and medical. Quantity
      and quality of sleep represent important factors for the quality of life, which can have
      positive or negative influence on individual health (2-4). Patients who undergo total knee or
      hip arthroplasty commonly complain of sleep fragmentation after hospitalization (5,6) Such
      patients experience acute postsurgical pain and discomfort, including restriction of their
      leg movement to prevent dislocation of the hip implant in the acute stage. The results of
      previous post-surgery studies have shown that REM sleep was severely reduced and awake time
      increased on the first postoperative night compared with the preoperative night (7,8).It is
      necessary for patients to secure the appropriate amount and quality of sleep to facilitate
      recuperation after surgery. Sleep disturbance is also related to the presence of delirium.
      The aim of the present study is to evaluate the changes in objective and subjective sleep
      quality and perceived pain, untill the 10th hospitalization day, in patients who underwent
      total knee or hip arthroplasty.
    

Intervention name(s): Objective sleep evaluation by actigraphy; Pittsburgh Sleep Quality Index (PSQI)
Intervention type(s): Device; Other
Intervention description(s): Each subject will wear a wrist activity monitor (actigraphy) to detect his/her sleep behaviour during hospitalization.; Each subject will fill twice the Pittsburgh Sleep Quality Index (PSQI), before hospitalization and after the 10th day, to evaluate his/her subjective sleep quality.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        20 patients undergoing total knee or hip replacement surgery.
      
Keywords: Sleep; Actigraphy; Pain; Patients; Hospitalization; Hip Replacement; Knee Replacement; Arthroplasty; RAR
Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction
Condition: Chemotherapy-Induced Gut Barrier Damage; Acute Leukemia
MeSH terms: Leukemia; Acute Disease
Study type: Observational

Summary: 
      This is an observational study to collect stool, blood, and urine from acute leukemia
      patients undergoing induction chemotherapy in order to generate preliminary data regarding
      the association between microbiota and chemotherapy-induced gut barrier damage. This study
      consists of inpatient collections of blood, urine, and stool while the patients are
      undergoing inpatient induction therapy. Patients will not be scheduled for any additional
      procedures or testing beyond what is required for clinical care.
    


Intervention name(s): Observational: Stool Sample Collection; Observational: Blood Sample Collection; Observational: Urine Sample Collection
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Observational: Stool Sample Collection
- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.; Observational: Blood Sample Collection
- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.; Observational: Urine Sample Collection
- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Acute leukemia population at the University of Minnesota
      
Keywords: AL
Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle
Condition: Movement Disorders
MeSH terms: Movement Disorders
Study type: Interventional

Summary: 
      This study aims to analyze the changes in plantar support after the technique of deep dry
      puncture in the posterior tibial. The data will be analyzed by a baropodometer which will
      record the possible changes in the footprint. The investigator will perform a
      pre-intervention measurement and 3 post-intervention measurements (immediately after the
      intervention, at 24 hours and at 72 hours)
    


Intervention name(s): Deep dry needling in tibialis posterior; Sham technique in tibialis posterior
Intervention type(s): Procedure; Procedure
Intervention description(s): The inspector, with gloves, disinfects the area to be treated with 70º alcohol. Once the alcohol is applied, the intervenor locates and takes the myofascial trigger point and places the needle with the guide tube resting on the skin of the patient. The inspector holds the guide tube between the index and middle fingers lightly touch the needle with the index finger of the other hand to insert the needle perpendicularly into the skin, directing it towards the inspector's thumb. Once the needle is inserted subcutaneously, the guide tube is removed. The controller deepens the needle to myofascial trigger point, and makes fast inputs and outputs into it. The rapid exit is made to the subcutaneous cellular tissue, outside the muscle, but not outside the skin. Next, hemostasis is performed in the area. Once this hemostasis is completed, the patient is incorporated and dressed.; The patient lies on the stretcher without the trousers. The interventor, with the guide tube, simulates the technique of puncture in the right twin of the subject. The comptroller cleans the area with 70º alcohol. Once the alcohol is applied, he performs the simulated dry needling technique in a plane with his index and middle fingers with the guide tube. It is important that the subject has his head stuck in the hollow of the head of the stretcher throughout the technique to make a correct masking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Tai Chi Chih and Varicella Zoster Immunity
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized control trial testing whether a relaxation response based intervention, Tai Chi
      Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological
      adaptation and health function in the older adult.
    

Detailed description: 
      Both the incidence and severity of Herpes Zoster (HZ) or "Shingles" increase markedly with
      increasing age, is a painful condition, due to a decline in Varicella Zoster Virus (VZV)
      specific immunity. Considerable evidence further shows that psychological stresses salient in
      the older adult correlate with impairments of cellular immunity.

      The investigators have observed that Varicella Zoster Immunity is always decreased in
      individuals with major depression. Moreover, our preliminary data indicates that the presence
      of depressive symptoms in older adults is associated with a decline of VZV responder cell
      frequency (VZV-RCF). Taken together, the untoward effects of age and depressive symptoms on
      VZV immunity raise the question as to whether an alternative medicine intervention might
      augment VZV specific immunity in the older adult. We have preliminarily shown that
      administration of a relaxation-response based intervention, Tai Chi Chih (TCC), results in
      improvements in health functioning and VZV immunity in older adults as compared to controls.
      TCC is a slow moving meditation comprised of twenty separate standardized movements for use
      in elderly populations.

      This proposed controlled clinical trial aims to: 1) determine whether the practice of TCC for
      16 weeks influences Varicella Zoster Virus (VZV) immunity; 2) demonstrate that TCC can
      produce significant changes in psychological adaptation, health behaviors, and health
      functioning and well-being; and 3) assess whether changes in psychological adaptation, health
      behaviors, and health functioning correlate with changes in VZV immunity following TCC in
      older adults.

      We hypothesize that this behavioral intervention that prioritizes treatment of excessive
      physiological arousal can influence one's affective state with effects on cellular immunity.
      By standardization of training and practice schedules, TCC offers an important advantage over
      prior relaxation response based therapies. Focus on older adults at increase risk for HZ and
      assay of VZV specific cellular immunity has implications for understanding the impact of
      behavioral factors and an alternative medicine intervention on a clinically relevant endpoint
      and the ability of the immune system to respond to antigens of infectious pathogens.
    

Intervention name(s): Tai chi chih
Intervention type(s): Behavioral
Allocation: Randomized
Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a 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 examine the effects of onsite and telehealth programs for
      individuals with spinal cord injury. The primary aim of this study is to compare the
      effectiveness of a blended 5-day onsite health promotion program followed by a 12-month
      telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month
      telehealth-only package in individuals with spinal cord injury. The investigators hypothesize
      that the blended onsite and telehealth program will achieve better gains in fitness, dietary
      control, body composition, and pain management scores across a one-year period in comparison
      to the telehealth-only group. The secondary objective of this study is to examine changes in
      psychosocial mediators between the two groups to determine if key social cognitive theory
      constructs were significantly different between the two groups. The investigators hypothesize
      that the blended onsite and telehealth program will achieve better improvements in these
      outcomes compared to the telehealth only group.
    


Intervention name(s): MENTOR + Telehealth; Telehealth Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will live on campus for one week and complete the MENTOR program, which is a course about resilience and how nutrition, exercise and mindfulness help with resilience for individuals with a spinal cord injury. Different experts will cover the three main topics with lectures and application of knowledge through related activities. Participants will then begin a one-year telehealth program at home. The telehealth program will consist of readily available information focusing on nutrition, exercise and mindfulness for individuals with a spinal cord injury and a telehealth coach who will interact on the phone with the participants once every two weeks. This will continue for a total of 26 phone calls until the participant returns for 1-year follow-up testing.; Participants will complete a one-year telehealth program at home. The telehealth program will consist of readily available information focusing on nutrition, exercise and mindfulness for individuals with a spinal cord injury and a telehealth coach who will interact on the phone with the participants once every two weeks. This will continue for a total of 26 phone calls until the participant returns for 1-year follow-up testing.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Spinal Cord Injuries; SCI; Telehealth; Mindfulness; Nutrition; Exercise
Characterization of the Neo-squamous Epithelial Barrier
Condition: Barrett's Esophagus With Dysplasia
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      To prospectively assess the functional aspects of the the esophageal squamous epithelial
      barrier and correlate this with tissue inflammation and intercellular space dilation in
      patients who have successfully completed endoscopic radiofrequency ablation versus balloon
      cryotherapy for Barrett's Esophagus related metaplasia.
    

Detailed description: 
      The investigators will measure and correlate mucosal impedance (measured using a novel
      endoscopic mucosal impedance catheter), intercellular space as measured with transmission
      electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance
      following successful endoscopic therapy (defined as two negative endoscopic surveillance
      histology for intestinal metaplasia).

      Mucosal impedance will be measured by an endoscopic probe. Research biopsies will also be
      obtained for measurement of tissue levels of prostaglandin E2 and intracellular space with
      transmission electron microscopy.

      Volumetric laser endomicroscopy will measure the precise thickness of and area of subsquamous
      structures underneath the neosquamous epithelium.
    

Intervention name(s): Mucosal Impedance; Research Biopsies; Volumetric Laser Endomicroscopy
Intervention type(s): Device; Other; Device
Intervention description(s): Aim 1: Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Mucosal impedance will be measured 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.; Aim 1: Research biopsies will be obtained at 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction, and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Aim 2: Research biopsies will be taken 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.; Aim 2: Volumetric laser endomicroscopy will be done and marked at 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who have successfully completed endoscopic ablation (one endoscopy with no
        evidence of intestinal metaplasia).
      
Biospecimen description: 
      Esophageal biopsies
Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-drug interaction study of Ruzasvir and Bemnifosbuvir
    


Intervention name(s): Cohort 1 BEM + Ruzasvir; Cohort 2 Ruzasvir + BEM
Intervention type(s): Drug; Drug
Intervention description(s): Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions; Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions
Other intervention name(s): AT-527; AT-527
Intervention MeSH terms: Ruzasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations
Condition: Weakness, Muscle
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The purpose of this 12-week, interventional study is to determine the effects of oral
      supplementation with Indus810 (dietary supplement with active ingredient Fenugreek) on body
      composition, muscular performance, and training adaptations
    

Detailed description: 
      This 12-week study is a randomized, parallel-group, placebo-controlled, clinical trial of
      N=66 recreationally, but normal to moderately overweight/obese male subjects to be recruited
      at a single investigational center in Northeast Ohio (i.e. The Center for Applied Health
      Sciences).

      Subjects will attend 4 study visits. At Visit 1, subjects will be screened for participation
      (i.e., medical history, physical exam, routine blood work, background baseline diet). At
      Visits 2 (day 0 - Baseline Testing), and 4 (week 12), measurements of various hemodynamic,
      hematologic & biochemical biomarkers of safety (Total testosterone, CBC, and comprehensive
      metabolic panel) will be made. At Visits 2, 3, and 4, the following efficacy measures will be
      obtained: Body Composition assessment via DEXA, Upper and Lower Body Performance testing on a
      Smith Machine and a TENDO unit utilizing the bench press and squat exercises, and anchored
      100mm VAS scales (for various psychometric indices). In addition, a comprehensive side effect
      profile/ adverse event monitoring will take place throughout the 12-week study duration.
    

Intervention name(s): Placebo; Indus810
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo; Active product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      An extension study of safety and tolerability of SEP-363856 in adult subjects with
      schizophrenia
    

Detailed description: 
      This is a 26 week, multiregional, open-label extension study designed to evaluate the
      long-term safety and tolerability of SEP-363856 for the treatment of subjects with
      schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201
      (NCT02969382) Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and
      then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial.

      No statistical hypothesis tests will be performed.
    

Intervention name(s): SEP-363856
Intervention type(s): Drug
Intervention description(s): One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
Vitamin D Supplementation in CKD - Vascular Function, Structure and Immune Regulation
Condition: Atherosclerosis; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Atherosclerosis
Study type: Interventional

Summary: 
      A pilot study to assess feasibility of methods of an observer-blinded randomised controlled
      trial of the effect of vitamin D supplementation in Chronic Kidney Disease and low vitamin D
      levels on markers of vascular function (Flow Mediated Dilatation of Brachial Artery),
      vascular structure (Carotid Intima Media Thickness) and Immune Regulation (frequencies of
      CD4+CD28null T lymphocytes ad Regulatory T lymphocytes).
    

Detailed description: 
      The study is a single (observer) blinded feasibility pilot randomised study. Study subjects
      will be recruited from clinics run by St George's Hospital Renal Department and randomised to
      treatment arm or no treatment arm.

      In treatment arm, six doses of vitamin D tablets (cholecalciferol 100,000 IU, five capsules
      total) will be administered on weeks 0, 4, 8, 12, 16 and 20. In the no-treatment arm the
      participants receive no cholecalciferol. Participants will have serum calcium levels measured
      at week 12.

      All participants will undergo estimation of endothelial function, carotid intima-media
      thickness, CD4+CD28null and regulatory T cell frequency in week 0 and week 26. The observer
      will be blinded to whether the patient is in the treatment or no-treatment arm whilst the
      following tests are performed:

        1. Measurement of Brachial Artery Flow Mediated Dilatation

        2. Measurement of Carotid Intima Media Thickness

        3. Quantification of CD4+CD28null and regulatory T cell frequency

      The pilot study will assess feasibility of the study methods.
    

Intervention name(s): Vitamin D (cholecalciferol)
Intervention type(s): Dietary Supplement
Intervention description(s): (aviticol) 5x 20,000unit capsules administered monthly over 20 weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Vitamin D; Cholecalciferol; Chronic Kidney Disease; Cardiovascular Disease; Atherosclerosis; Flow Mediated Dilatation; Carotid Intima Media Thickness; CD4+CD28null T lymphocyte; Regulatory T lymphocyte