bioihbjkbjnl/mcl2 huggingface dataset:
Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity
Condition: Vagus Nerve Stimulation
Study type: Interventional

Summary: 
      Transcutaneous Auricular Vagus nerve stimulation may be successful in cardiac modulation
      because of the cardiac connections of the vagal nerve. Therefore, in order to observe the
      cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood
      pressure after transcutaneous auricular vagus nerve stimulation application.
    

Detailed description: 
      Participants were divided into four groups (Figure 1) according to PNS and SNS indexes as
      Group 1 (PNS index <-2, SNS index >+2), Group 2 (PNS index <-2, SNS index <+2), Group 3 (PNS
      index >-2, SNS index >+2), Group 4 (PNS index >-2, SNS index <+2). Participants were assessed
      with blood pressure, pulse rate and HRV before and after taVNS stimulation. Sympathetic
      nervous system (SNS) index and parasympathetic nervous system (PNS) index values were assumed
      to be between -2 and +2 (95%) in the normal population according to Kubios software, and the
      grouping method was based on this situation.
    

Intervention name(s): Transcutaneous Auricular Vagus Nerve Stimulation
Intervention type(s): Device
Intervention description(s): Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: After the participants were included in the study, heart rate variability was measured and divided into 4 groups according to PNS and SNS indexes.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vagus Nerve Stimulations; Diastolic Pressure; Pulse Rate; Systolic Pressure
GrafixPL PRIME Evaluation Case Study
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40)
      that receive optimal treatment including serial wound debridement and off-loading with total
      contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data
      on other potential confounding factors that could affect healing such as medications,
      tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity.
      Wound healing, including wound size and adverse events will be evaluated. The objective of
      this study is to understand the use of this product to evaluate wound healing in 40 patients.
    

Detailed description: 
      Screening and Enrollment:

        -  Review and sign the Informed Consent and HIPAA Authorization

        -  Review the inclusion and exclusion criteria

      If the subject qualifies for the study, they will participate in the following procedures
      (weekly visits, +/-4 days):

      Visit 0:

        -  Demographics (such as age, gender, race or ethnicity)

        -  Medical/Surgical and Social History, Current Antibiotics.

        -  Laboratory Results

        -  Vascular - ABI

        -  Neurological evaluation - Monofilament and VPT

        -  Vitals - Sitting blood pressure and Pulse rate, Height/Weight, and BMI

        -  Wound debridement

        -  eKare - Wound imaging measurement

        -  Application of GrafixPL PRIME

        -  Current Antibiotics

        -  Offloading

        -  Adverse Events

        -  Source documentation

      Visits 1 - 11:

        -  Wound debridement

        -  eKare - Wound imaging measurement

        -  Application of GrafixPL PRIME

        -  Current Antibiotics

        -  Offloading

        -  Adverse Events

        -  Source documentation

      Visit 12/End of Study (EOS) Visit:

        -  Wound debridement

        -  eKare - Wound imaging measurement

        -  Current Antibiotics

        -  Offloading

        -  Adverse Events

        -  Source documentation (End of Study will occur on the date the subject is healed)
    

Intervention name(s): GrafixPL PRIME
Intervention type(s): Biological
Intervention description(s): GrafixPL PRIME
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Gene Therapy for Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy; Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of bilateral intramuscular
      injections of VM202 versus placebo in the treatment of painful diabetic peripheral
      neuropathy.

      A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two
      treatment groups. Note that 500 participants received IP treatment, whereas 7 participants
      did not receive IP treatment.

      Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants

      Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants

      Randomization were stratified by current use of gabapentin and/or pregabalin.
    

Detailed description: 
      Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries
      a high risk of pain, trophic changes, and autonomic dysfunction. Current treatments of
      diabetic peripheral neuropathy (DPN) are based on either pathogenetic mechanisms or
      symptomatic relief. A number of clinical trials have established symptomatic treatment but
      for pathogenetic mechanisms, the only proven treatment strategy is strict glycemic control.
      Clearly, it would be desirable to prevent, impede, or reverse the disrupting and often
      life-threatening manifestations of peripheral neuropathy by stimulating growth or
      regeneration of peripheral nerve axons.
    

Intervention name(s): Engensis (VM202); placebo
Intervention type(s): Biological; Other
Intervention description(s): gene therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetic; peripheral neuropathy; shooting pain; burning pain; pins and needles pain; foot pain; ViroMed
KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia
Condition: Low Birth-weight
MeSH terms: Birth Weight
Study type: Observational [Patient Registry]

Summary: 
      The main objective is to implement Kangaroo Mother Care (KMC) at selected facilities in Addis
      Ababa and Oromia Regions to achieve high effective coverage in the catchment population.
    

Detailed description: 
      To achieve the objective summarized above, the investigators will engage in an iterative
      process using program learning and quantitative data to continuously improve models in order
      to enhance uptake of KMC in two phases.

      In phase 1, the model will undergo an iterative process whereby every three months, the
      investigators will analyze the data collected and improve the model until it is reached at a
      model that achieves effective KMC coverage of at least 80%.

      In phase 2, we will scale the successful model to all selected facilities.

      The investigators' primary outcomes will be effective coverage of KMC at 7 days of age, and
      effective coverage of KMC at 7 days after discharge from the facility. Effective coverage
      will be defined as adoption of skin to skin care for at 8 least hours and exclusive
      breastfeeding in the 24 hours prior to assessment
    

Intervention name(s): Kangaroo mother care (KMC)
Intervention type(s): Other
Intervention description(s): Skin to skin contact of newborns with mothers and exclusive breast feeding
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be low birth weight babies (less than 2000 gm) within the study
        sites. The study sites are one primary hospital in Addis Ababa Region and two primary and
        one referral hospital in Oromia Region.
Posture and Pulmonary Function of Mouth-breathing Children
Condition: Mouth Breathing
MeSH terms: Respiratory Aspiration; Mouth Breathing
Study type: Observational

Summary: 
      The purpose of this study is to characterize the posture and respiratory function of
      mouth-breathing children.
    

Detailed description: 
      Mouth-breathing children presents changes in stomatognathic system, which results in head
      projection, tension augment in scapular belt muscles and postural adaptations. Although
      thoracic shape and posture can influence ventilatory dynamics, we didn't find studies
      addressing pulmonary function of mouth-breathing children. This was a transversal study,
      designed to analyze the posture of mouth-breathing children, and verify the existence of
      correlation between posture and pulmonary volumes.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Mouth-breathing children were referred by Pediatrics Service (Federal University of Rio de
        Janeiro) and by School of Dentistry (Federal University of Rio de Janeiro), after the
        diagnosis of mouth breathing was confirmed.

        Nasal breathing children were recruited from Tia Ciata Municipal School (Praça Onze-Rio de
        Janeiro, Brazil).
      
Keywords: respiration; respiratory disorders; Otolaryngology; Otorhinolaryngology; Posture
Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence
Condition: Nicotine; Vaping; Nicotine Vaping
Study type: Interventional

Summary: 
      To demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected harmful and
      potentially harmful constituents (HPHC) in smokers switching from cigarette (CIG) to P4M3, an
      Electronic Nicotine Delivery System (ENDS), compared to continuing cigarette smoking for 5
      days.
    

Detailed description: 
      This clinical study aims to demonstrate the reduction of BoExp to selected HPHC in smokers
      switching from CIG to two flavor variants of P4M3 as compared to smokers continuing smoking
      CIG, or to smoking abstinence (SA).

      A reduction of exposure to HPHC from CIG smoke is expected to diminish the health risk of
      nicotine consumption if switching completely to ENDS.

      The data collected in this study in confinement will provide information on exposure
      reductions achievable in a well-controlled environment with full control on daily P4M3/CIG
      consumption and compared to SA.
    

Intervention name(s): P4M3 CA35; P4M3 CM35; CIG; Smoking Abstinence
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Ad libitum use of P4M3 with CA35 cartridges; Ad libitum use of P4M3 with CM35 cartridges; Ad libitum use of subject's own preferred brand of cigarettes; Abstention from cigarette smoking
Other intervention name(s): P4M3 "Classic Auburn" 3.5% nicotine (CA35); P4M3 "Classic Menthol" 3.5% nicotine (CM35); Cigarette
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nicotine; Smoking; Cigarette; E-Cigarette; Electronic Nicotine Delivery System; Vaping
Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes
Condition: Hypertension; Obesity; Diabetes
MeSH terms: Hypertension; Diabetes Mellitus; Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Recent studies have shown that obese people are more prone to high blood pressure. With the
      co-existence of obesity, hypertension and diabetes, patients were more susceptible to
      hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease.
      Abdominal obesity has often accompanied by substantial accumulation of visceral fat, which
      increased secretion of many inflammatory mediators, cytokines and adipocytokines and played
      an important role in cardiovascular and metabolic disease. Some reports had shown that
      angiotensin II receptor blockers (ARB) may improve metabolic profiles in patients with
      diabetes or metabolic syndrome, in addition to its hypotensive effect. It has been reported
      that some ARB, such as telmisartan and candesartan, can prevent weight gain and
      high-fat-induced obesity in experimental animals. However, whether telmisartan intervention
      on improvement of fat deposition and other related metabolic profiles is better than a CCB
      drugs (amlodipine) in those obese hypertensive patients with diabetes, was still unknown.
    


Intervention name(s): Temisartan; Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): Temisartan, initial dose: 40 mg per day, Max dose: 160 mg per day; Amlodipine, initial dose: 5 mg per day, Max dose: 10 mg per day
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Abdominal obesity; Diabetes; Treatment
Study to Assess the Effect of the Aerobika Device in Addition to Standard of Care Treatment in Sputum Producing COPD Patients Using FRI
Condition: Pulmonary Disease, Chronic Obstructive; COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary:

      The primary objective of this study is to evaluate the effect of the Aerobika® device on the
      aerosol deposition pattern of concomitant inhalation medication using FRI.

      Secondary:

      The secondary objective of this study is to evaluate the effect of the Aerobika® device on
      the airway volume (iVaw), lung and lobe volume (iVlobes), airway resistance (iRaw),
      hyperinflation, airway wall thickness (iVaww), blood vessel density (iVbv), and air trapping
      using FRI.
    


Intervention name(s): Aerobika® Device; HRCT scans
Intervention type(s): Device; Radiation
Intervention description(s): For a period of 15 +/- 3 days subjects will use the Aerobika® device before administration of their stable standard of care treatment regimen (i.e. study patients should use the device before each inhalation medication administration, with a minimum use of the device of twice daily).; A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, and visit 3. An upper airway (UA) scan will be taken on visit 1.
Other intervention name(s): Aerobika® Oscillating Positive Expiratory Pressure Therapy System; High Resolution Computed Tomography scans
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HRCT; High Resolution Computed Tomography scans; Functional Respiratory Imaging; CT scan; Computed Tomography; COPD; sputum producing COPD patients; Aerobika® device
Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
Condition: Stroke
MeSH terms: Stroke; Paralysis
Study type: Interventional

Summary: 
      The investigators evaluate the effectiveness of the application of continuous passive motion
      device for hand rehabilitation in two classes of patients: with a residual active motion and
      without a residual active motion.
    

Detailed description: 
      We will conduct a double blind clinical trial. A sample size calculation were performed to
      determine the necessary number of subjects needed for this study and was based upon the
      results of a previous pilot study. All patients had functional impairments of their upper
      extremities after the stroke.

      We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve
      edema by paralysis of the upper limb even in patient without sensory pathway recovery.
    

Intervention name(s): A-ROM Continuous Passive Rehabilitation; P-ROM Continuous Passive Rehabilitation
Intervention type(s): Device; Device
Intervention description(s): Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).; Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
Other intervention name(s): Continuous Passive Motion device for hand: Gloreha; Continuous Passive Motion device for hand: Gloreha
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hand Edema; Exercise Therapy
Biomarkers in Tumor Tissue Samples From Patients With Peripheral T-cell Lymphoma or Natural Killer Cell Neoplasms
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer. It may also help doctors find better ways to treat the cancer.

      PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with
      peripheral T-cell lymphoma or natural killer cell neoplasms.
    

Detailed description: 
      OBJECTIVES:

        -  To identify mutations in oncogenes and tumor suppressors of peripheral T-cell lymphoma
           or natural killer (NK) cell neoplasm.

        -  To delineate the mechanisms that mediate oncogenic effects and their clinical prognostic
           significance in these diseases.

        -  To perform a comprehensive mutation analysis via whole exome resequencing in a panel of
           peripheral T-cell or NK lymphomas.

      OUTLINE: Fixed paraffin-embedded tumor tissue samples are analyzed for mutations by the
      Illumina HiSeq platform. Sequencing reads are performed by GAPipeline version 1.5.1 and
      mapping on the human genome performed using the MAQ software version 0.7.1. Genes harboring
      validated somatic mutations are then amplified by PCR and analyzed by Sanger resequencing.
    

Intervention name(s): DNA analysis; cytogenetic analysis; gene mapping; mutation analysis; polymerase chain reaction; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patient enrolled on E2404 from whom samples were submitted for research
      
Keywords: peripheral T-cell lymphoma; stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; anaplastic large cell lymphoma
Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance
Condition: Muscle Weakness Condition
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      Resistance training has been widely recognized as an effective stimulus for increasing
      skeletal muscle size and strength. This study intends to compare the effects of high
      resistance training without blood flow restriction and the low resistance training with blood
      flow restriction training on bicep muscle performance.
    

Detailed description: 
      The study is Randomized Control Trail, which is being conducted in RIPHAH COLLEGE OF
      REHABILITATION SCIENCES. Sample size of 40 individual was calculated using Epitool with 95%
      confidence interval (CI) and power 80%. Individual will be screened out according to
      inclusion criteria. Individuals will be allocated randomly into two groups, 20 in high
      resistance training group and 20 in low resistance training with blood flow restriction group
      by sealed envelope method.

      High resistance training will be use in control group.Low resistance with blood flow
      restriction training will be used in experimental group.

      Assessment will be done on baseline 2-4 days prior to the intervention and after 8 weeks of
      training.

      Data will be analyzed on SPSS version 21.
    

Intervention name(s): Low Resistance training with venous blood flow restriction; High Resistance training
Intervention type(s): Other; Other
Intervention description(s): Total 20 males will participate in this group after warmup , Blood flow restriction will be provided through sphygmomanometer optimum pressure will be measured through following formula occlusion pressure (mmHg) = 0.514 (SBP) + 0.339 (DBP) + 1.461 (Arm circumference) + 17.236 then 30% of 1RM will be used for training . The standard protocol will be used which is four sets (1st set-30 repetitions, 2nd set-15 repetitions, 3rd set-15 repetitions, and 4th set-15 repetitions) with 30-60 s of interval between sets. ( the cuff must be deflated between sets of exercise) for 8 weeks (24) sessions on non-consecutive days. participants will be re-assessed for all baseline variables after 8 weeks of training biceps curls will be used for training.
Heart Rate and oxygen saturation will be measured during the session through Pulse oximeter; Total 20 males will participate in this group after warm up. 80% of 1RM will be used for training, 3 sets of 8 repetitions will be used with 30-60 s of interval between sets. for 8 weeks (24) sessions on non-consecutive days.No blood flow restriction will be applied to this group Participants will be re-assessed for all baseline variables after 8 weeks of training. Bicep curls will be used for training.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both experimental and control groups will be treated at the same time following their respective protocols
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Exercise Training