bioihbjkbjnl/mcl2 huggingface dataset:
Normative Data of Dynamic Gait Index and 5 Time Sit to Stand Test Among Elderly Population
Condition: Fall; Old Age; Debility
MeSH terms: Frailty
Study type: Observational [Patient Registry]

Summary: 
      The goal of this observational study is to measure the normative data for dynamic gait index
      and 5 time sit to stand test in elderly population. This study aimed for to take normative
      measurement of dynamic gait index and five time sit to stand test among elderly population
      and to compare the preliminary values of above mentioned tests with age.
    

Detailed description: 
      Anthropometric factors affect the stability limits of the individual and can affect the motor
      strategies relating to balance control. The core elements of anthropometry are height,
      weight, body mass index (BMI), body circumferences (waist, hip, and limbs), and skin-fold
      thickness. Some anthropometric variables, such as body mass, are directly related to postural
      balance. Due to lack of normative data for dynamic gait index and five times sit to stand
      test in elderly population, this study aimed to formulate normative values for dynamic gait
      index and five times sit to stand test among elderly and correlation with anthropometric
      measures. Objectives: The objective of this study was to take normative measurement of
      dynamic gait index and five times sit to stand test among elderly population and to compare
      the preliminary values of above mentioned tests with age. All possible elder population was
      taken in current study to calculate the normative values of these two tests, five times STS
      to measure the ability to get up from a chair and DGI to record dynamic gait tasks in elder
      people
    

Intervention name(s): Dynamic gait index and 5 time sit to stand test
Intervention type(s): Other
Intervention description(s): dynamic gait index and 5 time sit to stand test was administered to all sample size of 400
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Data was collected from old age home in Lahore. Sample size of 400 subjects was chosen.

        Group 1: 45-50 years Group 2: 50-55 years Group 3: 55-60 years
      
Keywords: Anthropometrics; DGI; Five time sit to stand test
Brain Function and Decision-Making
Condition: Behavior, Social; Psychology, Social; Social Interaction; Interpersonal Relations
Study type: Interventional

Summary: 
      This study is about how brain function and structure is different between two universities.
      Participant in this project will contribute to a better understanding of how universities
      affect the brain.
    

Detailed description: 
      Some study details are purposely omitted at this time to preserve scientific integrity. Now
      that the study is completed, full details are included below.

      The true purpose of this study was to investigate the psychometric properties of the two
      computer tasks that participants completed. Specifically, researchers wanted to know if they
      would be able to accurately measure motivated empathy. To better understand this,
      participants were asked to rate images of people expressing pain and were told that these
      were either students from their university or students from a different university. This was
      not the case. The faces shown were random images produced for a research study.

      Researchers also wanted to know if they could accurately measure moral decision making and
      how those judgments relate to aggression. To examine this, participants were asked whether
      various scenarios were immoral and then asked about aggressive tendencies.
    

Intervention name(s): Psychological task
Intervention type(s): Behavioral
Intervention description(s): Participants will complete a psychological task that evokes antisocially- and prosocially-motivated empathic responding
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study is aimed to investigate the effects of upper extremity manual lymphatic drainage,
      which is applied to remove edema from the carpal tunnel region in addition to conventional
      exercise therapy in Carpal tunnel syndrome patients on findings of clinical,
      ultrasonographic, and electrophysiological.
    

Detailed description: 
      Thirtyfour volunteer participants between aged 40 and 60 years, who met the inclusion
      criteria, will be included in the study. Participants will be randomly divided into two
      groups experimental and control groups. While the control group will receive only
      conventional exercises, the experimental group will receive both conventional exercises and
      upper extremity manual lymphatic drainage. A total of 3 measurements will be made before the
      treatment, after the treatment and 1 month after the end of the treatment. Symptom severity
      will be evaluated via Boston carpal tunnel syndrome questionnaire, grip strength via hand
      dynamometer, pressure pain threshold via digital algometer device, cross-sectional area of
      the median nerve via ultrasound, and median nerve conduction velocity via superficial EMG
      device.
    

Intervention name(s): manual lymphatic drainage (MLD)
Intervention type(s): Other
Intervention description(s): MLD is a manual technique that is applied to the lymphatic system with a pressure of approximately 40-50mmHg and increases the working speed of lymphatic nodules/collectors. Its main purpose is to support microcirculation by accelerating lymphatic flow and to prevent/remove interstitial fluid accumulation that may cause fascial adhesions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: carpal tunnel syndrome; manual lymphatic drainage; surface electromyography
Continue Glucose Monitoring Before Insulin Pump
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to learn more about blood glucose control when people with Type 1
      Diabetes switch to an insulin pump. The investigators hope to learn whether using a
      continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to
      stable blood glucoses and less frequent insulin pump dose changes during the transition to an
      insulin pump.
    

Detailed description: 
      This is a prospective, randomized controlled study. Participants will be asked to wear a
      Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump
      therapy. Depending on randomization groups, participants will either have CGM data used
      inform starting insulin pump doses (treatment group), or to standard of care for starting on
      insulin pump (control group). Participants will wear the CGM again during the first 5 days of
      pump start and at approximately 6 weeks after pump start, in order to collect blood glucose
      data. Each time the CGM is worn, blood glucoses must be checked 6-8 times daily, and a
      written log must be completed. Baseline medical information also will be collected at the
      start of participation. Participants will also be asked to complete a questionnaire at
      approximately 6 weeks after pump start. Participation in the study will be complete after a
      standard of care follow up visit approximately 3 months after pump start.
    

Intervention name(s): CGM Informed
Intervention type(s): Device
Other intervention name(s): iPro2 Professional Continuous Glucose Monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CGM
The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      the objective of this study is to evaluate the impact of vacuum-compression effects of
      Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri's
      principle in diabetic patients.
    

Detailed description: 
      Diabetic foot ulcers are common and serious complications of chronic diabetes mellitus. The
      prevalence of foot ulcers among patients with diabetes is 15%. The length of hospital stay is
      approximately 60% longer among patients with foot ulcers, as compared with those without
      ulcers. Diabetic foot ulcers accounts for >50% of all nontraumatic lower-leg
      amputations.Although, current preventive methods and treatment modalities have been effective
      in healing foot ulcers, statistics show high incidence of foot ulcers and amputations in
      individuals with diabetes.On the other hand, only a few studies were performed on the effects
      of Vasotrain in healing diabetic foot ulcers. The use of the machine enhances the delivery of
      oxygen and nutrients to the area, which in turn, facilitate wound healing
    

Intervention name(s): Vasotrain-447
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Diabetic Foot Ulcer; Vacuum compression therapy; Stereology; Ulcer Area; Vasotrain; Random Controlled Trial.
Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding
Condition: Gastrointestinal Bleeding; Cirrhosis
MeSH terms: Liver Cirrhosis; Gastrointestinal Hemorrhage; Hemorrhage; Fibrosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main objective is to evaluate the effectiveness of the experimental drug to reduce plasma
      ammonia concentration at a dose that is safe and well tolerated. Ammonia usually rises
      significantly in the hours after gastrointestinal bleeding in patients with cirrhosis of the
      liver. This increase in the concentration of ammonia facilitates the development of hepatic
      encephalopathy.

      The study will be divided in two parts:

      Part A: Open-label, dose-escalating, single cohort study. The goal of this phase is to
      confirm the tolerance and safety of the dose of OP that is being proposed for the study
      according to the results of phase I and phase II studies in healthy subjects and stable
      outpatients with cirrhosis.

      Part B: Multi-center (2 University Hospitals), double-blind, randomized, parallel-group
      trial. Assignment of treatment will be done according to a list (one at each study site) of
      random numbers in blocks that will be concealed until the end of the study. The control group
      will be assigned to placebo on a 1:1 ratio. The placebo and treatment will be masked.
    


Intervention name(s): Ornithine-phenylacetate
Intervention type(s): Drug
Intervention description(s): Phase A: Open-label scalating dose of OP. Treatment will be initiated at 1/3 of the final dose and will be scalated every 12 hours up to the full dose, except if there are problems of tolerance. Duration of the infusion 5 days.
Phase B: Comparative study of experimental drug vs placebo for 5 days OP (OCR-002) at a dose of 10 g diluted in 150 ml of water for injection administered as a continuous i.v. infusion for 24 hours (8.3 ml/h)during 5 days.
Other intervention name(s): OCR-002
Intervention MeSH terms: Phenylacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cirrhosis, gastrointestinal bleeding
Blood Pressure Change and Outcome
Condition: Renal Disease; High Blood Pressure
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal
      disease) population. In dialysis patients, however, it has been shown that higher blood
      pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure
      evolution over time has not been previously studied in dialysis population. The investigators
      aim to understand how both blood pressure levels and blood pressure changes over time predict
      patient survival.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Renal Research Institute hemodialysis patients
HBV Virions Bound Proteins
Condition: Hepatitis B Virus Infection
MeSH terms: Hepatitis B; Herpesviridae Infections; Hepatitis
Study type: Interventional

Summary: 
      The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough
      understanding of the biology of one of its major causative agents, the hepatitis B virus
      (HBV). HBV particles acquire via budding and encapsidation cellular proteins. There is
      mounting evidence on several viral species that virion-bound proteins are prone to be
      involved either at the replication, budding/egress or entry/release steps of the viral cycle.

      Identifying such targets may yield ideal candidates for gaining insight on the dependence of
      HBV upon a restricted subset of host proteins, therefore providing refined sets of
      genetically stable targets for therapy. This project's goals are to set up adequate
      conditions for robust and reproducible purification of HBV virions in clinical samples,
      followed by the identification of their HBV-bound host proteins and the characterization of
      their functions. Proteomics profiling of HBV particles purified from clinical samples will be
      overlaid with proteins identified and characterized in cell culture grown HBV particles,
      using clinical biomarker discovery grade criteria. Targets identified in both samples sets
      will be subjected to in vitro investigations using HBV-replicating cells. Conventional
      biochemical and imaging methods will be used in order to: (i) ascertain their physical
      association with HBV virions; (ii) define the modalities of their interaction with HBV
      proteins; (iii) decipher the topology and subcellular localization of their association with
      HBV proteins and virions; (iv) quantitatively assess their functional involvement in particle
      budding, egress or secretion and infectivity. A candidate that yielded satisfactory results
      in these experiments will be disclosed and further investigated at the level of structural
      biology, in collaborative research programs.
    


Intervention name(s): blood draw
Intervention type(s): Other
Intervention description(s): blood draw of 150ml, twice
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: HBV; liver
An Open Label Study of LMI070 (Branaplam) in Type 1 Spinal Muscular Atrophy (SMA)
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An open-label, multi-part, first-in-human study of oral branaplam in infants with Type 1
      spinal muscular atrophy. The purpose of this study is to evaluate the safety, tolerability,
      pharmacokinetics (PK), pharmacodynamics (PD) and efficacy after 13 weeks; and to estimate the
      Maximum Tolerated Dose (MTD) of orally administered branaplam; and to identify the dose that
      is safe for long term use as well as that can provide durable efficacy optimal dosing regimen
      in patients with Type 1 SMA.
    

Detailed description: 
      This is an open-label, multi-part, first-in-human, proof of concept study in infants with
      Type 1 spinal muscular atrophy who have exactly 2 copies of SMN2, to evaluate safety,
      tolerability, PK, PD and efficacy of oral branaplam after 13 weeks treatment.

      Parts 1 and 2 are intended to be non-confirmatory. In Part 1 of the study, patients will be
      dosed once weekly with branaplam. The branaplam dose will be escalated in subsequent cohorts
      until MTD is determined or when sufficient PK results confirm that the MTD cannot be reached
      due to a potential pharmacokinetic plateau at higher doses. A decision to dose escalate the
      next cohort will be made after safety data have been collected for 14 days following the
      first dose (14-day DLT window). PK will be used to confirm that there is no accumulation of
      the compound.

      Part 2 of the study will enroll new patients into one of up to 3 dose cohorts with once
      weekly dosing for 52 weeks. The branaplam dose will be escalated in subsequent cohorts after
      6 patients have been enrolled and at least 3 patients from the previous cohort will have
      completed 13 weeks of treatment. After 52 weeks, patients may continue treatment if Novartis,
      the investigator and the independent DMC agree that this is in the best interest of the
      patient.

      In all cases continuation of the treatment will be done at a dose selected as optimum,
      considering existing safety as well as efficacy data
    

Intervention name(s): branaplam
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Spinal Muscular Atrophy
Observational Study to Evaluate Efficacy and Remission Status for Schizophrenia Patients Under Atypical Treatment
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The objective of this study is to evaluate under routine clinical setting the efficacy and
      remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute
      episode or not achieving remission under regular treatment from schizophrenia/schizoaffective
      disorder. This study will collect in real-life practice the severity of schizophrenia by
      Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission
      applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group,
      the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of
      Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced
      Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by
      documenting spontaneous reports on adverse events as well as change in body weight.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute episode (first or relapse), or upon revisit and identified not
        achieving remission of schizophrenia or schizoaffective disorder (according to remission
        criteria of schizophrenia)
      
Keywords: Schizophrenia remission status by 8-item PANSS
Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      A single-center, single-blind, randomized study to investigate the effectiveness of a
      hemodynamic-guided treatment strategy to improve blood pressure control
    

Detailed description: 
      Hypertension is a hemodynamic-related disorder characterized by abnormalities of the cardiac
      output (CO) and/or systemic vascular resistance (SVR). It is hypothesized that selecting
      antihypertensive therapy based on patients' hemodynamic profile could lead to more effective
      blood pressure (BP) control than standard care in a real-world population of hypertensive
      patients in outpatient setting. A single-center, randomized trial was conducted to include
      adults with uncontrolled hypertension who seek outpatient care at Peking University People's
      Hospital between December 2018 and December 2019 in Beijing, China.

      Participants were randomly assigned to the standard care group or the hemodynamic group in a
      1:1 ratio. Impedance cardiography (ICG) was performed with all participants to measure
      hemodynamic parameters. Only physicians in the hemodynamic group were provided with patients'
      ICG findings and a computerized clinical decision support of recommended treatment choices
      based on patients' hemodynamic profiles. The primary outcomes were the reductions in systolic
      BP (SBP) and diastolic BP (DBP) levels at the follow-up visit 8(±4) weeks after baseline.
      Secondary outcomes included achievement of BP goal of <140/ 90 mmHg and the reductions in BP
      by baseline BP, age, sex, and BMI.

      The ICG device used (HDproTM CHM T3002/P3005, designed by Beijing Li-Heng Medical
      Technologies, Ltd, manufactured by Shandong Baolihao Medical Appliances, Ltd.) was developed
      based on improved hardware and advanced digital filtering algorithms, and has been validated
      versus both invasive thermodilution and non-invasive echocardiography in different settings.
    

Intervention name(s): ICG-guided drug selection; empirical drug selection
Intervention type(s): Other; Other
Intervention description(s): anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience; anti-hypertensive drug selection based on physician's experience only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; ICG-guided; Hemodynamic profiling; Impedance cardiography
A Study of MG1111 in Healthy Children
Condition: Healthy Children
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus
      comparator
    


Intervention name(s): Varicella Vaccine
Intervention type(s): Drug
Intervention description(s): The subject will receive investigational product or comparator.
Other intervention name(s): vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention