bioihbjkbjnl/mcl2 huggingface dataset:
Ankle Tracking Training in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the improvement in ankle control and brain activation
      in subjects with stroke resulting from two different forms of telerehabilitation: tracking
      training, emphasizing accurate movements, versus movement training, involving simple
      movements.

      Hypotheses:

        1. The Track group will show greater improvement in ankle range of motion compared to the
           Move group.

        2. The Track group will show greater improvement in ankle tracking accuracy and greater
           changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor
           cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent
           (BOLD) signal intensity index) compared to Move group.

        3. The Track group will show greater improvement in tracking accuracy at an untrained joint
           (knee) compared to the Move group.

        4. The Track group will show greater improvement in standing balance.

        5. The Track group will show greater improvement in walking speed and ankle dorsiflexion
           during gait compared to the Move group.
    


Intervention name(s): ankle tracking training
Intervention type(s): Behavioral
Intervention description(s): one group will use the ankle for tracking, the other group will use the ankle for simple movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Smoking Cessation Intervention for Women Living With HIV
Condition: AIDS/HIV
Study type: Interventional

Summary: 
      As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as
      cardiovascular diseases and cancers on these people have consistently increased. Smoking is
      one of the major contributing factors to these health problems and rates of cigarette smoking
      in this group are substantially higher than those of the general population: 40-70% vs.
      17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the negative
      consequence of smoking than their male counterparts. They are also less likely to see tobacco
      dependence treatment for dual stigma associated with both conditions: HIV infection and
      nicotine addiction. This is a pilot study to develop smoking cessation intervention for these
      women.
    

Detailed description: 
      Women are at high risk of becoming HIV positive due to biological vulnerabilities, low
      socioeconomic status, dominant sexual practices of males and epidemiological factors. For
      example, the risk of being infected with HIV during unprotected sex is two to four times
      greater for women than for men. With the use of combined antiretroviral therapies, these
      women now live longer than ever before which now faces the healthcare community with the need
      for evolving understanding of HIV and aging. However, the burden of non-AIDS related health
      problems such as cardiovascular diseases and cancers on people living with HIV/AIDS while
      aging has considerably increased. Smoking is one of the major contributing factors to these
      health problems. Rates of current cigarette smoking are substantially higher among people
      living with HIV/AIDS than the general population: 40-75% versus 19%. Women smokers living
      with HIV have a 36% higher risk for developing AIDS and 53% higher mortality when compared to
      non-smoking women with HIV. This study is a pilot randomized controlled trial (RCT) testing
      the feasibility and acceptability of a videoconferencing smoking cessation intervention
      (video arm) for women with HIV in comparison with a telephone-based smoking cessation
      intervention (telephone arm). Both arms will receive 8, 30-minute weekly cessation counseling
      sessions plus 8-week nicotine replacement therapy. Participants will be followed up at 1, 3
      and 6 months from the target quit day. Self-reported abstinence will be verified with a
      saliva cotinine test using an Nicotine Alert test strip and the testing process will be
      monitored via mobile-phone video call.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Received 8 weekly individualized counseling sessions of cognitive behavioral therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps
Condition: Colonic Polyps
MeSH terms: Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      This clinical trial is being conducted to compare the efficacy and safety of two standard
      methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater
      Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.
    


Intervention name(s): Underwater EMR
Intervention type(s): Behavioral
Intervention description(s): Polypectomy is performed under full water emersion without the use of submucosal injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial was to quantify the effect of oral single-dose (480 mg) and
      steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and
      P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. The AUCs for
      the probe drugs caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin were
      assessed.
    


Intervention name(s): BI 201335 NA; Caffeine; Warfarin sodium; Vitamin K; Omeprazole; Dextromethorphan hydrobromide; Midazolam HCl solution; Midazolam HCl oral syrup; Digoxin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 480 mg BI 201335 NA in the morning, 240 mg BI 201335 NA in the evening of day 10
240 mg BI 201335 NA bid from day 11 to 23; days 1, 10 and 19; days 1, 10 and 19; days 1, 10 and 19; days 1, 10 and 19; days 1, 10 and 19; Days 3 and 21; days 1, 10 and 19; Days 2 and 20
Intervention MeSH terms: Vitamin K; Digoxin; Midazolam; Dextromethorphan; Caffeine; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.
Condition: Baro-reflex Sensitivity; Heart Rate Variability; EEG, Microstates; Cerebral Blood Flow Regulation; Cerebral Oxygenation; Oxygen Saturation; Concentration Performance
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg,
      for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and
      other physiological variables in different normobaric and hypobaric hypoxic conditions.
    

Detailed description: 
      Subjects will bike at 1W/kg for 6 minutes at different simulated altitude level in the
      hypobaric chamber at the FAI in Dübendorf. Concentration performance also will be measured to
      better understand how hypobaric and hypoxia conditions may affect physiological responses,
      cerebral and cognitive functions.
    

Intervention name(s): Hypoxia
Intervention type(s): Other
Intervention description(s): Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.
Other intervention name(s): Low-intensity cycling exercise
Intervention model: Single Group Assignment
Intervention model description: Crossover randomized study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hypoxia; Baro-reflex sensitivity; Low-intensity exercise; Hear rate variability; EEG; Concentration performance
An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression
Condition: Depression; Adolescent
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium
      (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action
      (like the Tipepidine Hibenzate) is expected as a new curative medicine of adolescent
      depression.

      The purpose of this research is to confirm the effect by carrying out the additional dosage
      of the Tipepidine Hibenzate to the adolescent patients with depression.

      If suggestion is obtained by this research about the effect on adolescent patients with
      depression of Tipepidine Hibenzate, it can contribute to development of the medical treatment
      of adolescent patients with depression.
    


Intervention name(s): Tipepidine Hibenzate
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Observational

Summary: 
      The purpose of this project is to study the pharmacokinetics of a once-daily antiretroviral
      medication used to treat adolescents and young adults with HIV infection.
    

Detailed description: 
      Once-daily antiretroviral therapy is being used to treat adolescents and young adults with
      HIV-1 infection. When new antiretrovirals (ARVs) are developed, information on kinetics is
      collected in adults, and then in children, but often the adolescent age group is
      under-represented in initial or even later pharmacokinetics studies, so specific data on
      appropriate drug doses to use in adolescents may be lacking; it is assumed that they should
      receive the adult dose. Furthermore, as newer drugs are used in combination regimens, more
      information becomes available on drug interactions that might not have been initially
      anticipated. This information is usually generated in studies of adults, with little or no
      specific information in children or adolescents. This is an open-label, 24-hour, single-dose
      pharmacokinetic study.
    

Intervention name(s): blood draw
Intervention type(s): Procedure
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Persons with HIV-1 infection between the ages of 18 years, 0 days and 24 years, 364 days
        currently on a stable combination antiretroviral regimen (> 28 days) with FDA-approved
        antiretroviral combination regimens that include tenofovir plus atazanavir/ritonavir and at
        least one other active antiretroviral drug.
      
Keywords: HIV; Atazanavir; ritonavir; tenofovir; Adolescent; Treatment Experienced
CareLink Connect - Technical Evaluation Study
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the performance, patient satisfaction and safety of
      connectivity gateway device CareLink Connect, transferring CGM (Continuous Glucose
      Monitoring) data from a VEO insulin pump to CareLink online (every 5th minute) and thereby
      making it available for patients or Care Partners individual web connected devices such as
      smartphones, tablets and PCs.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinic patients
      
Keywords: Sensor-Augmented Pump Therapy; Connected Care
Relationship of Balance, Functional Capacity and Fear of Movement With Lower Extremity Muscle Strength in Elderly
Condition: Elderly
Study type: Observational

Summary: 
      Aging is a period in which the morphological, physiological and pathological changes progress
      negatively, accompanied by various diseases and regression of physical and mental abilities.
      In this period, the individual experiences biological and physiological losses as well as
      social problems in his/her life. From the age of 65, approximately 80% decrease in muscle
      strength can be observed and this decrease is especially noticeable in the leg and trunk
      muscles. Decreases in the strength of the muscles in the lower extremities may cause
      deterioration in physical function, decrease in mobility, increase in falling related
      accidents, also can cause osteoporosis and physical deficiencies. Determining the structures
      with which the lower extremity muscle strength is related will facilitate the precautionary
      measures for the inadequacies that will arise in the later stages of aging.

      This study was performed to analyze the relationship of lower extremity muscle strength with
      balance, functional capacity, fear of movement and quality of life in elderly individuals
      living in nursing homes.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects aged between 65-88 years who are a minimum score of 24 on the Mini-Mental State
        Examination, no cognitive impairment, and are independent of daily life activities will be
        included in the study.
      
Keywords: Balance; elderly; fear of movement; functional capacity; lower extremity muscle strength; quality of life
Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin
Condition: Deep Vein Thrombosis; Venous Thrombosis; Adverse Effect of Anticoagulants
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of the study are:

      o Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing
      ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA

      o Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these
      patients compared with the original drug Lovenox ®.
    


Intervention name(s): Enoxaparin
Intervention type(s): Drug
Intervention description(s): enoxaparin 4000 IU 1 injection/day in subcutaneous.
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: deep veinous thrombosis; enoxaparin
Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)
Condition: Renal Failure; Nutrition Disorders
MeSH terms: Acute Kidney Injury; Nutrition Disorders
Study type: Observational

Summary: 
      -  To investigate the etiology, epidemiology and prognostic factors of acute kidney injury.

        -  To find out risk factors that relate with the prognosis of acute kidney injury,focusing
           on inflammation, oxidative stress and nutritional status.

        -  To study on the relationship between gene polymorphism and prognosis of acute kidney
           injury.
    

Detailed description: 
      1. to investigate the relationship between preexisting malnutrition and adverse outcomes in
           patients with AKI

           - Several nutritional assessment methods such as anthropometric, clinical and
           biochemical evaluations have been used; however, no single indicator is considered to be
           a "gold standard."

        2. to evaluate the association of serum nutritional variables and prognosis of acute kidney
           injury

        3. Given the different half-lives of serum nutritional markers, we hypothesized that the
           utility of serum nutritional variables as prognostic predictors may differ in early
           death (<7 days) and late death (>7 days, <28 days) patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients selected from a university-affiliated hospital in Shanghai, China.
      
Biospecimen description: 
      1ml whole blood and 1ml serum will obtained within 24 hour after AKI for hematological and
      biochemistry analyze.
    
Keywords: acute kidney disease; prognosis; oxidative stress; inflammation; gene polymorphism
Clinical Trial in Constitutional Thinness
Condition: Individuals With Constitutional Thinness
MeSH terms: Thinness
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the molecular differences between a group of
      Constitutionally Thin (CT) subjects and a group of controls.
    


Intervention name(s): Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days.
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Registry Study for Talimogene Laherparepvec
Condition: Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial
Study type: Observational [Patient Registry]

Summary: 
      A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously
      Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials
    

Detailed description: 
      A registry study is to evaluate the overall survival, use of subsequent anti-cancer therapy,
      and the long-term safety of subjects who have received at least one dose of talimogene
      laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type. Follow-Up
      will occur every 3 months.
    

Intervention name(s): Information collection
Intervention type(s): Other
Intervention description(s): Q3M Information collection
Other intervention name(s): Q3M Information collection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have received at least one dose of talimogene laherparepvec in an Amgen or
        BioVEX-sponsored clinical trial.
      
Keywords: Melanoma; talimogene laherparepvec
A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after
      administration of two different formulations in healthy participants.
    


Intervention name(s): JNJ 64304500; JNJ 64304500
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single subcutaneous dose of JNJ-64304500 reference formulation.; Participants will receive a single subcutaneous dose of JNJ-64304500 test formulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being performed to investigate the potential for AZD5672 to affect the
      electrical conduction pathways in the heart. AZD5672 will be compared against a drug
      (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the
      electrical conduction of the heart.
    


Intervention name(s): AZD5672; Moxifloxacin; placebo; AZD5672; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 12 x 50mg tablet, oral, single dose; 1 x 400mg capsule, oral, single dose; 12 x matched to AZD5672 50 mg tablet; 3 x 50mg tablet, oral. single dose; 9 x matched to AZD5672 50mg tablet; 1 x matched to Moxifloxacin capsule
Other intervention name(s): Avelox
Intervention MeSH terms: Moxifloxacin; N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: QTcF; Crossover; ICH E14; QT/QTc prolongation; Moxifloxacin; QT/QTc Interval
Comparison of Prophylaxis and On-demand Treatment in Children With Moderate to Severe Hemophilia A
Condition: Prophylaxis; Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional

Summary: 
      Comparison of prophylaxis and on-demand treatment in children with moderate to severe
      hemophilia A.

      This study determines to compare the efficacy of prophylaxis and on-demand treatment in
      moderate to severe hemophilia A children in King Chulalongkorn Memorial Hospital, Bangkok,
      Thailand
    


Intervention name(s): prophylaxis treatment, on demand treatment
Intervention type(s): Other
Other intervention name(s): Hemofil M
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prophylaxis treatment; On demand treatment; Severe hemophilia A; Moderate hemophilia A
Monocyte Activation in Preclinical Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Observational

Summary: 
      The study of proinflammatory and anti-inflammatory cytokines and chemokines expression
      profiles in human monocytes to identify new effective biomarkers that have the best
      diagnostic potential in asymptomatic atherosclerosis.
    

Detailed description: 
      This project is the first step in creating a method for assessing an individual activity of
      macrophages. The problems addressed in the project are socially significant because of the
      high incidence of life-threatening diseases and their effects in the population. The method
      of evaluation of monocyte-macrophages activity in human blood will be based on the analysis
      of expression of cytokines and chemokines - markers of inflammatory and anti-inflammatory
      activity of macrophages. The most informative panel of cytokines and chemokines obtained
      during the project can be further used to create effective diagnostic tests.
    

Intervention name(s): In vitro estimation of individual reactivity of monocytes
Intervention type(s): Other
Intervention description(s): Technique for isolation/separation of monocytes with culture purity more than 95 % CD14-positive cells according to flow cytometry, the share of viable cells at least 98% by trypan blue vital staining, capable of producing TNFa at concentration of at least 50 pg/ml when stimulated with 100 ng/ml IFN-gamma, and CCL18 at concentration at least 30 pg/ml when stimulated with 10 ng/ml interleukin.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The inclusion of healthy individuals, of apparently healthy persons with a predisposition
        to atherosclerosis, and subjects with subclinical atherosclerosis, according to the results
        of ultrasonographic examination of carotids, to achieve 80% statistical power (up to 50
        study participants per group).

        Conducting experiments on obtaining the individual cultures of blood monocytes and
        stimulation of cells by proinflammatory and anti-inflammatory stimuli
      
Biospecimen description: 
      Whole blood taken with anticoagulants for immediate monocyte isolation to be seeded in cell
      culture, and for preparation of plasma samples to be frozen for lipid analysis.
    
Keywords: proinflammatory cytokines; anti-inflammatory cytokines; human monocytes; activation; biomarkers; asymptomatic atherosclerosis