bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Exercise on Physical Fitness Among Hemodialysis Patients With Chronic Kidney Disease
Condition: Hemolysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hemolysis
Study type: Interventional

Summary: 
      Regular physical exercise was adapted to the situation of the patient with hemodialysis to
      help improve the quality of life of the patient
    

Detailed description: 
      It has been observed that programs that combine aerobic and resistance exercise can increase
      muscular strength and endurance, functional capacity and quality of life of patients in
      Hemodialysis. Aerobic exercise and muscular endurance during dialysis increase blood flow at
      the muscular level with an increase in capillary surface area, which dynamizes the flow of
      urea and toxins from the tissues to the vascular compartment, which could improve the
      effectiveness of dialysis In addition, moderate regular exercise can modulate the
      inflammatory response, which would be beneficial in patients with chronic kidney disease
    

Intervention name(s): Intradyalisis without exercise programe; Intradyalisis with exercise programe
Intervention type(s): Other; Other
Intervention description(s): patients on hemodialysis are evaluated with all the variables at first (T1) and without intervening in the treatment for 3 months they are evaluated again (T2).; After 3 first month without intervention and also during the time of hemodialysis, the patients star the exercise programe, the first part of the session, an exercise was carried out for cardiovascular work (pedaling on ergometer) and muscle toning, with special attention to the muscular development of the lower limbs (exercises with elastic bands and / or weighted ankles). The session increased in duration and intensity as the physical action program progressed throughout the duration of the permitted period (3 months) and always attending to the individual needs of each subject. In addition, each of the participants will be given a series of recommendations of exercise practice to be carried out during non-hemodialysis days, in order to complement the work done during the sessions.3 month later the investigator evaluated all the variable again (T3)
Intervention model: Single Group Assignment
Intervention model description: One group who perform 3 first month just with normal treatment of hemodialysis and the next 3 month exercise intervention. (6 months in total)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hemodialysis; Klotho Protein; Excercise; Lifestyle condition
A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety of immunization with HIV-1 C4-V3 polyvalent peptide vaccine in
      HIV-infected persons. To determine the proportion of study participants immunized who develop
      new specificities or increased levels of neutralizing and other antibody responses, T-cell
      proliferative responses, and Class I restricted cytotoxic T-lymphocyte ( CTL ) responses.

      HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes
      from four of the most common HIV isolates in the United States and Europe, predicted to
      represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes
      that generate potentially salutary immune responses and deletes epitopes that generate immune
      responses which might contribute to further immunopathogenesis.
    

Detailed description: 
      HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes
      from four of the most common HIV isolates in the United States and Europe, predicted to
      represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes
      that generate potentially salutary immune responses and deletes epitopes that generate immune
      responses which might contribute to further immunopathogenesis.

      Patients are randomized to receive low-dose or high-dose HIV-1 C4-V3 polyvalent peptide
      vaccine in incomplete Freund's adjuvant (IFA), or IFA alone as control. Injections are
      administered on day 0 and at weeks 4, 8, 12, and 24. When patients entered at the lower
      vaccine dose (Cohort A) reach week 6, the data is reviewed and the higher dose cohort (Cohort
      B) will begin. When both cohorts reach week 14, data is evaluated and Cohort C begins vaccine
      administrations at a chosen vaccine dose. Within each cohort, eight patients receive vaccine
      plus IFA and two patients receive IFA alone. Patients are followed to week 52; 18 clinic
      visits and four telephone calls are required.
    

Intervention name(s): HIV-1 C4-V3 Polyvalent Peptide Vaccine
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; AIDS Vaccines; HIV Therapeutic Vaccine
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
Condition: Osteonecrosis of the Femoral Head
MeSH terms: Osteonecrosis; Legg-Calve-Perthes Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to analyze the safety and feasibility of direct administration
      intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients
      with femoral osteonecrosis.
    


Intervention name(s): bone marrow aspirate
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteonecrosis of the femoral head; Stem Cell; Mesenchymal Stem Cells; Femoral Head
Iron Dosing Pilot Study Using Model Predictive Control
Condition: Renal Insufficiency, Chronic; Anemia, Iron Deficiency; Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study to test the utility of an integrated approach in the management of the
      anemia of chronic kidney disease through the administration of both an erythropoietic
      stimulating agent and iron. Subjects will be studied for 6 months during which all iron
      dosing will be recommended using a computer based tool using model predictive control.
      Comparisons will be made to the 6 months prior to enrollment in to the study.
    


Intervention name(s): Model predictive control; Model Predictive Control of Iron Dosing
Intervention type(s): Device; Device
Intervention description(s): Computer aided dose selection for the treatment of iron deficient anemia.; Model Predictive Control of Iron Dosing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Quality of Life After Transanal Endoscopic Microsurgery (TEM)
Condition: Transanal Endoscopic Microsurgery (TEM)
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      This is a observational cohort study to determine the influence of Transanal endoscopic
      microsurgery (TEM) on patients Quality of Life
    

Detailed description: 
      Patients who planning Transanal Endoscopic Microsurgery (TEM) for rectal neoplasms should
      undergoing fecal incontinence quality of life scale and Wexner score before and after surgery
      for measurement their quality of life. For objectification data sphinctrometry will be
      perform.
    

Intervention name(s): sphincterometry
Intervention type(s): Diagnostic Test
Intervention description(s): Sphincterometry is a method of the spincter function examination, which allows to assess the state of the anal sphincter muscle and its function
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with rectal neoplasms with planning transanal endoscopic microsurgery (TEM)
      
Keywords: Transanal endoscopic microsurgery; TEM; QoL; quality of life; rectal cancer; rectal surgery; rectal neoplasm
The Detection of Heat Stress by Assessing Individual Body Responses to Heat (Heat Strain) in Young and Healthy Non-athlete Participants
Condition: Heat Stress
MeSH terms: Heat Stress Disorders
Study type: Observational

Summary: 
      • This study investigates and compares the within and in-between variances of the body
      responses to different heat stressors in a controlled lab-setting. The participants will be
      exposed to different heat sources while a variety of physiological heat strain reactions such
      as heartrate, sweat rate, and core body temperature are recorded using on- and in-body
      devices. For the participant monitoring during the study, medical grade devices such as a
      certified ECG and a swallowable sensor-pill to continuously monitor the core body temperature
      will be applied. A one-for-all wearable device is additionally applied for physiological
      validation. Further, sweat will be collected to assess (i) the local sweat rate and (ii) the
      appearance of different heat stress associated molecular markers in this non-invasively
      collectable biofluid. As a secondary aim, a model will be developed that will enable to
      predict the different heat stress sources out of the heat strain measurements.
    


Intervention name(s): Elevated ambient heat; Elevated relative humidity; Exertion
Intervention type(s): Other; Other; Other
Intervention description(s): Temporary exposure to increased ambient temperature +10°C (the effect of the intervention is fully and spontaneously reversible); Temporary exposure to increased ambient relative humidity +40% (max. 90%) (the effect of the intervention is fully and spontaneously reversible); Temporary exertion on an ergometer (1W/kg body weight) (the effect of the intervention is fully and spontaneously reversible)
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited through Swiss Universities and Swiss Universities of Applied
        Science. The institutions host a broad range of students that are likely to match the
        inclusion criteria.
      
Keywords: Heat Strain; Wearable; Sweat Analysis
Insulin Resistance in Patients With Major Depression
Condition: Depression; Bipolar Disorder; Mood Disorders; Insulin Resistance; Depressive Disorder, Major; Depressive Disorder
MeSH terms: Insulin Resistance; Depression; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major; Mood Disorders
Study type: Observational

Summary: 
      The purpose of this study is to study the relationship between insulin and glucose action and
      neuropsychological functioning (memory, attention, general thinking abilities) in persons
      with depression.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Men and women ages 20 to 65 years of age of any ethnic background, with a diagnosis of
        depression, and whose depressive symptoms are currently in remission
      
Biospecimen description: 
      Optional buffy coat sample
Open-Label Crossover Study Comparing CTP-543 to Jakafi®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the metabolite and pharmacokinetic (PK) profile of a single dose of
      CTP-543 compared to a single dose of Jakafi® in healthy volunteers.
    

Detailed description: 
      The crossover design will assess the safety, tolerability, PK and metabolite profiles of a
      single dose of CTP-543 compared to a single dose of Jakafi. Approximately 12 healthy
      volunteers will be enrolled in this open label study.
    

Intervention name(s): CTP-543, 16 mg (2 x 8 mg tablet); Jakafi 15Mg Tablet
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19
Condition: COVID-19; Delirium; Critical Illness
MeSH terms: COVID-19; Delirium; Critical Illness
Study type: Interventional

Summary: 
      The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or
      sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due
      to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS
      combined with concomitant dexmedetomidine would reduce delirium rates.
    


Intervention name(s): Active HD-tDCS; Sham HD-tDCS
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Brain stimulation using active high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19; Sham high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Healthy Activities Improve Lives
Condition: Physical Activity
Study type: Interventional

Summary: 
      The investigators have developed an online platform to support the 8-week, F&S! exercise
      program called the Healthy Activity Improves Lives (HAIL) online platform. The aims of this
      study are to conduct an open pilot trial with exit interviews (N=30) of the HAIL online
      platform in two racially diverse churches to evaluate its feasibility and acceptability
      (Hypothesis 1) as well as explore its efficacy (Hypothesis 2).
    

Detailed description: 
      This is an open pilot study to evaluate the feasibility and accessibility of the HAIL online
      platform. This study will enroll two cohorts (i.e., at two racially diverse churches) for a
      total number of 30 participants. This study will use a phone screen to assess participants'
      eligibility and explain the study procedures. Eligible individuals will then be given a link
      to complete an e-Consent in REDCap as well as instructions on how to access the HAIL online
      platform to complete assessments as part of the baseline visit. Participants will complete
      the 8-week F&S! exercise program (with access to the adjunct HAIL online platform), which
      will be delivered in-person as well as remote, and then continue to use the HAIL online
      platform during the 3-mo follow-up.
    

Intervention name(s): Fit&Strong Exercise Program
Intervention type(s): Other
Intervention description(s): The Fit and Strong! Program (F&S!) is an exercise program for older adults developed by a study consultant, Dr. Susan Hughes, with funding from the National Institute of Aging. It is tailored for the unique needs of older, underserved adults and targets modifiable factors depicted by the socioecological model is necessary. The F&S! exercise program assists older adults to improve strength and functioning.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared
      to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and
      exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once
      weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
      or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide
      10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once
      weekly). The anticipated time on study treatment is 1 year, and the target sample size is
      100-500 individuals.
    


Intervention name(s): placebo; taspoglutide; taspoglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sc, once weekly; 10mg sc, once weekly; 20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
Intervention MeSH terms: Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The study estimates the efficacy and safety of MK0476 and aminophylline intravenous
      administration in adult participants with acute asthma.
    


Intervention name(s): montelukast sodium; montelukast sodium; aminophylline hydrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes; Montelukast 14 mg single injection (IV bolus administration) over 5 minutes; Aminophylline 250 mg IV drip infusion over 60 minutes
Other intervention name(s): MK-0476; MK-0476; Kyophyllin® Injection 2.5%, FK05
Intervention MeSH terms: Aminophylline; Theophylline; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether bevacizumab and nimustine are effective in
      the treatment of recurrent high grade glioma and to explore whether there is any subgroup
      being sensitive to this therapeutic protocol.
    

Detailed description: 
      Although anti-angiogenesis therapy for glioblastoma(GBM) are showing promise, GBMs often
      develop resistance to treatment within months or weeks after salvage therapy. There are still
      no effective markers to predict the response rate to bevacizumab.

      So the investigators initiate a single-arm Phase II study to evaluate the efficacy and
      tolerability of bevacizumab and nimustine regimen and to explore the predictive markers in
      patients with recurrent high-grade glioma.
    

Intervention name(s): Bevacizumab; Nimustine
Intervention type(s): Drug; Drug
Intervention description(s): Bevacizumab is administered intravenously at 5mg/kg every 3 weeks.; Nimustine is administered intravenously at 90mg/m^2 to 110mg/m^2 every 6 weeks.
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab; Nimustine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bevacizumab; Nimustine; Pathology, Molecular
Epicardial Adipose Tissue Thickness and the Related Factors in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      The aim of this study was to assess the EATT and the related factors in patients with AS and
      to compare the results with that of the healthy controls'
    

Detailed description: 
      The aim of this study was to investigate the epicardial adipose tissue thickness (EATT) and
      the related factors in patients with ankylosing spondylitis (AS) and to compare the results
      with those of the healthy controls. This cross-sectional study comprised thirty patients
      diagnosed with AS based on the modified New York criteria. The control group consisted of 31
      healthy volunteers. Demographic characteristics were recorded. EATT was measured via
      transthoracic echocardiography. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
      Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology
      Index (BASMI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis
      Quality of Life (ASQoL), International Physical Activity Questionnaire Short Form (IPAQ-Short
      Form) were used. Functional capacity assessment was conducted using the six-minute walk test
      (6MWT).
    

Intervention name(s): epicardial adipose tissue thickness
Intervention type(s): Diagnostic Test
Intervention description(s): EATT measured via transthoracic echocardiography
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with AS that came to Istanbul Physical Medicine and Rehabilitation Education and
        Research Hospital outpatient clinic between August 2015 and January 2016
      
Keywords: Ankylosing spondylitis; atherosclerosis; epicardial adipose tissue thickness
Modifying Exercise for the COPD Patient
Condition: Chronic Obstructive Pulmonary Disease; Arthritis; Pain
MeSH terms: Arthritis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the
      chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve
      participation in a pulmonary rehab program compared to the Nustep elliptical. The main
      outcome of participation will be measured by the number of exercise sessions the patient is
      able to complete during their pulmonary rehabilitation program. In addition, distance walked
      in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index
      score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both
      groups. It is believed that the new machine will provide better overall outcomes compared to
      the traditional machine.
    

Detailed description: 
      A Prospective cohort study of 25 COPD patients with osteoarthritis undergoing an exercise
      plan in a pulmonary rehab program. Patient pain level, clinical outcomes, and ultimately,
      quality of life outcomes will be assessed in order to assess whether future compliance for
      COPD arthritic patients will occur in an exercise rehabilitation program.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort of 25 COPD patients (total N = 50) with osteoarthritis undergoing an exercise plan
        in a pulmonary rehab program.
      
Keywords: Chronic Obstructive Pulmonary Disease; Pain; Arthritis; Dyspnea; Exercise; Aerobic