bioihbjkbjnl/mcl2 huggingface dataset:
Overcoming Analgesic Tolerance to TENS
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine if changing the frequency or intensity of
      transcutaneous electrical nerve stimulation (TENS) can reduce the development of tolerance to
      TENS treatment.
    

Detailed description: 
      Healthy adults will come daily for 5 consecutive days to the testing room. Pressure pain
      thresholds (PPT) will be the outcome measure and will be used to measure the subject's pain
      threshold to deep mechanical pressure. Subjects will push a button to stop the PPT test when
      they first begin to feel a sensation of pain. The PPT test will be done before TENS
      application. The TENS unit will be applied based on random assignment to 1 of 5 treatment
      types and subjects will not be told which group they are assigned to. Those groups are: 1)
      placebo TENS, 2) high frequency TENS, 3) alternating frequency TENS, 4) modulated frequency
      TENS, or 5) high frequency TENS with increased intensity daily. The TENS unit will be applied
      for 30 minutes. After 20 minutes the PPT test will be completed a second time. This procedure
      will occur on all 5 consecutive days of testing. Data will be measured and recorded by an
      assessor blind to subject group. Blinding will be assessed at the end of testing on day 5.
    

Intervention name(s): Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Device
Intervention description(s): Transcutaneous electrical nerve stimulation (TENS) is utilized clinically by a variety of health care professionals for the reduction of pain. The mechanisms by which TENS produces analgesia or reduces pain are only recently being elucidated. TENS is a non-invasive modality that is inexpensive, safe and easy to use with relatively few contraindications. Frequency of stimulation is broadly classified as high frequency (>50Hz), low frequency (<10Hz) TENS. Intensity is determined by the response of the patient as either sensory level (low-intensity) TENS strong but comfortable. With sensory level TENS, the voltage (i.e. amplitude) is increased only until the patient feels a comfortable tingling (perceived with high frequency) or tapping (perceived with low frequency) sensation without motor contraction. With strong but comfortable TENS the intensity is increased to a strong but comfortable level which may include muscle contraction.
Other intervention name(s): TENS; Electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial -double blind
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Journaling and Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study to evaluate the effect of keeping a 'gratitude journal' on the outcome
      of a weight loss program. All the subjects will be enrolled in the Lifesteps weight
      management program. The experimental group will maintain a gratitude journal and the control
      group will maintain a 'neutral' journal.
    

Detailed description: 
      Subjects who are referred to the Preventive Cardiology Program for weight management will be
      enrolled in the study after obtaining informed consent.

      Subjects are enrolled into the program in groups of 10 to 12 every 6 weeks. Alternate groups
      will be will assigned to the two types of journaling. Each group will be given specific
      instructions related to the form of journaling assigned. These instructions will be in
      addition to the usual care prescribed in the Lifesteps® program. In the intervention group,
      patients will be introduced to gratitude journaling at the beginning of the 12 week class
      series and asked to journal each day. They will turn in their gratitude journal weekly. At
      the beginning of each weekly class, five minutes will be spent discussing the journaling.

      The control groups will not receive the information on gratitude journaling, but instead will
      be asked to complete a neutral journal in which they will journal in a general manner
      regarding their experiences participating in the Lifesteps® weight management program. These
      will also be collected weekly. At the beginning of class, five minutes will be spent
      discussing the journaling.

      There will be one consent form for the two groups. The instruction (either gratitude
      journaling or neutral journaling) that will be given to the subjects will reflect the group
      to which they have been randomized. Both types of journals will be reviewed initially, at
      mid-point and final by the psychologist (Robert Emmons) to verify the quality of reporting.

      Routine tests- Weekly weights

      Study Tests:

      Pre/post depression: Beck Depression Inventory II; Pre/post Locus of Control:
      Multidimensional Health Locus of Control Scale; Pre/post SF 36 Quality of Life Questionnaire;
      Pre/post Gratitude Questionnaire
    

Intervention name(s): Gratitude Journaling; Neutral Journaling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be asked to write down 5 things every day for which they are grateful.; Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity
Neural and Visual Responses to Light in Bipolar Disorder: A Novel Putative Biomarker
Condition: Bipolar Depression
MeSH terms: Depression; Bipolar Disorder
Study type: Observational

Summary: 
      Objective. Bipolar Disorders (BD) are a major public health problem. The investigators still
      lack knowledge of the mechanisms which contribute to BD. Hence treatments are few and
      limited, and clinical decision making is less refined. Currently, the investigators are
      investigating the effects of midday bright light therapy for the treatment of bipolar
      depression (University of Pittsburgh IRB approved protocol titled Light Therapy for Bipolar
      Disorder, IRB#: PRO09020546). In this study, the investigators propose to investigate a
      possible biological mechanism which might explain response to light treatment in depressed
      bipolar patients.
    

Detailed description: 
      The study goal is to understand how the response to light therapy relates to changes in
      vision, brain function and improvement in bipolar symptoms. The aims are to investigate mood
      levels plus the eye and brain responses to visual contrast stimuli in healthy comparators
      (HC) and bipolar depressed patients.

      Study Design and Methods. Overview. The investigators plan to enroll 18-50 year old adults
      with BD Type I or II and a current episode of major depression on stable-dosed antimanic
      drugs, and age and sex-matched HC - without mental disorders. Depressed patients with BD will
      be assigned randomly to receive active light therapy vs inactive comparator for 6 weeks. The
      investigators will examine responses to contrast stimuli from measures of visual evoked
      potentials and electro-retinography in HC and depressed bipolar patients before and after
      6-weeks of daily midday light therapy. The investigators will assess repeated measures of
      mood symptom levels, attention and circadian rhythms.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        community patient sample
      
Keywords: Bipolar Disorder; Depression; Light Therapy; Contrast Sensitivity; Visual Evoked Potential; Visual or Neural Responses; Biomarker
A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals
Condition: HIV Infections
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To determine whether combination vaccination, i.e., priming with a vaccinia
      recombinant-containing HIV envelope (HIVAC-1e) followed by boosting with a recombinant
      subunit envelope protein (gp160 or gp120), provides enhanced immunogenicity compared to
      subunit vaccination with the individual recombinant envelope proteins only. To compare the
      relative immunogenicity of a panel of HIV envelope subunit vaccines when administered as
      boosters following recombinant HIV-vaccinia priming. To evaluate the relative immunogenicity
      of one versus two doses of recombinant HIV-vaccinia prior to the subunit protein boost.

      Secondary: To examine the safety of administering the individual subunit vaccines in
      combination with the HIV envelope vaccinia recombinant, and to extend the population to whom
      these proteins have been administered.

      Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting
      with subunit envelope proteins offers the most promising strategy to date for a safe and
      immunogenic vaccine in humans. This study will further examine the combination vaccine
      approach and define an optimal prime-boost strategy.
    

Detailed description: 
      Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting
      with subunit envelope proteins offers the most promising strategy to date for a safe and
      immunogenic vaccine in humans. This study will further examine the combination vaccine
      approach and define an optimal prime-boost strategy.

      Healthy volunteers are randomized to one of eight groups. All patients receive initial
      immunization with HIVAC-1e, followed by two boosts at months 8 and 12 of rgp120/HIV-1SF2
      (BIOCINE), rgp120/HIV-1IIIB (Genentech), rgp120/HIV-1MN (Genentech), or gp160 MN (Immuno-AG).
      Additionally, half of the patients in each subunit vaccine group receive a repriming with
      HIVAC-1e at month 4. Subjects are followed for 18 months.
    

Intervention name(s): gp160 Vaccine (Immuno-AG); rgp120/HIV-1IIIB; rgp120/HIV-1MN; rgp120/HIV-1 SF-2; HIVAC-1e
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV Envelope Protein gp160; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Does the Insula Control Smoking-Induced Dopamine Release? A TMS/[11C]-PHNO Study in Humans.
Condition: Healthy
Study type: Interventional

Summary: 
      Findings from this study may demonstrate how the insula contributes to reward pathways
      involved in addiction. There are three main hypotheses for this trial. The first is that
      inhibiting the insula using transcranial magnetic stimulation (TMS) will not cause noticeable
      changes of dopamine release in the striatum. The second is that stimulating the insula with
      TMS will increase dopamine release in the striatum, and will be visualized on PET imaging as
      decreased radiotracer binding. The third hypothesis is that the participants will not
      experience major side effects from TMS on the insula.
    

Detailed description: 
      This project will take advantage of the recently developed Deep rTMS coil to target the
      insular cortex. Few studies have examined the possibility of using repetitive Transcranial
      Magnetic Stimulation (rTMS) for nicotine addiction and none so far have explored the use of a
      coil that specifically targets the insular region. The objective of this study is to test
      whether low and high-frequency rTMS of the insula modulates striatal dopamine (DA) release in
      healthy humans. Positron Emission Tomography (PET) with [11C]-(+)-PHNO, a radiotracer which
      is very sensitive to fluctuations in DA transmission in the human brain, will be used to
      assess the impact of rTMS on dopamine levels. This project will yield the first data in
      humans linking the insula to the DA system in vivo. These findings could lead to the
      identification of optimal parameters for Deep rTMS to use secondarily in a proof of principle
      clinical study in smokers.
    

Intervention name(s): repetitive Transcranial Magnetic Stimulation; repetitive Transcranial Magnetic Stimulation Sham
Intervention type(s): Device; Other
Intervention description(s): Each participant will participate in all three arms to receive sham, 1hz and 10hz rTMS as well as PET imaging.; The sham coil is built in the same helmet of the active coil. The sham coil is has a circular shape and placed perpendicular to the scalp within the same helmet. This coil produces a similar sound and scalp sensation as the real coil.
Other intervention name(s): Deep Repetitive Transcranial Magnetic Stimulation; DTMS HLRIADD-COIL, Model 102B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Deep rTMS; Insular cortex; PET; [11C]-PHNO
Compare the Efficacy and Safety of Genoss® DCB and IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease
Condition: Peripheral Artery Disease; De Novo Stenosis
MeSH terms: Peripheral Arterial Disease
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to demonstrate the non-inferiority of GENOSS DCB versus
      IN.PACT Admiral DCB on late lumen loss 6 months after the procedure in patients with de novo
      or non-stented restenotic lesions of the superficial femoral artery and popliteal artery and
      to evaluate the safety.

      This clinical trial will be conducted on a total of 118 patients at 11 domestic institutions
      (taking into account the dropout rate of 30%).
    

Detailed description: 
      In this clinical trial, IN.PACT Admiral, which is the most similar to GENOSS DCB, a test
      device, and the product type and purpose of use, and whose efficacy has already been proven
      through numerous clinical studies, was selected as a control product.

      Due to the nature of this clinical trial, the investigator cannot be blinded to the treatment
      method to which the subject is assigned, so it is designed as a double-blind design in which
      only the subject and the independent evaluator are blinded.

      For efficacy and safety evaluation, follow-up is performed up to 12 months after procedure of
      the clinical trial medical device.

      The primary endpoint of the efficay evaluation was performed by an independent evaluator and
      CT angiography at 6 months of in-segment late lumen loss.

      It is evaluated the revascularization rate, Rutherford classification, the amount of change
      in ABI or TBI at 1, 6, and 12 months, the procedural success rate during the clinical trial
      period, and the device success rate immediately after the procedure.

      Safety evaluation is confirmed through all adverse events, MAE (Major adverse event), vital
      signs, physical examination and laboratory test results that occur to the subject during the
      clinical trial period after procedure of the clinical trial medical device.
    

Intervention name(s): Genoss® DCB; IN.PACT Admiral® DCB
Intervention type(s): Device; Device
Intervention description(s): Peripheral Drug Coated Balloon; Peripheral Drug Coated Balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Hospital record of the patients of liver disease admitted from April-May 2021 and April-May
      2019 will be reviewed. Patients will be analyzed and compared for the demographic
      characteristics, severity of liver disease at time of admission and outcome in form of
      survival or mortality, liver transplantation rates in the two time periods and the subsequent
      30 d and 90 day readmission rate.

      Monitoring and assessment: Hospital records of all patients of liver disease needing
      admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be
      reviewed. Patients will be analyzed and compared for the demographic characteristics,
      severity of liver disease at time of admission and outcome in form of survival or mortality,
      liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.
    


Intervention name(s): This is an observational study
Intervention type(s): Other
Intervention description(s): This is an observational study
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients of liver disease without COVID-19 infection admitted in the time period April- May
        2021 and April-May 2019.
A Nurse Led Intervention to Promote Physical Activity
Condition: Sedentary Behavior; Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Regular physical activity should be the essence of treatment in patients with cardiovascular
      risk factors. Unfortunately, these interventions are usually insufficiently promoted and
      therefore have only limited efficacy. The aim of the study was to determine the benefits of
      nurse led intervention to promote physical activity in sedentary older adults with
      cardio-vascular risk factors in the outpatient setting. Eligible patients are randomized in a
      1:1 fashion to receive nurse led tutorial on life-style modification including pedometer
      hand-out with a daily goal of at least 7000 steps and supporting phone calls (study group) or
      without a goal or calls (control group). The primary end-point of the study is change in body
      weight. Secondary end-points include changes in resting heart rate, systolic and diastolic
      blood pressure, total cholesterol and fasting glucose and clinical outcomes at 3 months
      follow-up.
    


Intervention name(s): Nurse led tutorial on lifestyle management and pedometer hand-out; Steps goal setting and supporting phone calls
Intervention type(s): Other; Other
Intervention description(s): Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out; A goal of minimum 7000 steps per day, phone calls to assess the goal meeting and to support goal achievement every 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: sedentary; older adults; risk factor; intervention; pedometer; clinical trial
Magnesium Administration in Liver Transplantation and Reperfusion Injury
Condition: Living Donor Liver Transplantation; Reperfusion Injury
MeSH terms: Reperfusion Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of intravenous magnesium infusion before
      reperfusion with employing some clinical parameters including blood lactate levels, because
      the intraoperative changes in the blood lactate levels after hepatic allograft reperfusion
      served as an accurate predictor of the initial graft function in living donor liver
      transplantation.
    

Detailed description: 
      Clinically significant hemodynamic deterioration occurs immediately after reperfusion of the
      grafted liver by unclamping of the portal vein. Profound hypotension, bradycardia, systemic
      vasodilation, and a decrease in cardiac output have been reported, and this is described as
      postreperfusion syndrome (PRS). This hemodynamic instability usually requires adequate and
      aggressive cardiovascular pharmacologic management and fluid support, and recovers slowly
      over a period of 30 to 60 minutes.Because the severity of PRS correlates with patient and
      allograft outcome, prevention of its occurrence or attenuation of the hemodynamic changes may
      improve outcome. However, not much is known about how to protect against this reperfusion
      injury.

      Reperfusion injury also occurs in myocardial infarction, ischemic spinal cord injury and
      stroke. Recent experiments have shown protective effects of magnesium to reduce the
      reperfusion injury of these conditions. Magnesium administration may provide cellular
      protection during ischemia and reperfusion with stabilizing the cellular transmembrane
      potential, suppressing excessive cellular calcium influx and energy demand.
    

Intervention name(s): magnesium; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Thirty minutes after the beginning of the anhepatic phase, the patients were received a magnesium solution (MgSO4 25 mg•kg-1 mixed in 100 ml of normal saline) over 20 minutes. A resident anesthesiologist, who was blinded to the group assignment, performed intravenous administration of the study solution and assessed study outcomes.; Thirty minutes after the beginning of the anhepatic phase, the patients were received 100 ml of normal saline over 20 minutes. A resident anesthesiologist, who was blinded to the group assignment, performed intravenous administration of the study solution and assessed study outcomes.
Other intervention name(s): magnesium sulfate; N/S
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: magnesium and reperfusion injury
Effectiveness of Individual Physical Activity Programs to Prevent Sarcopenia and Frailty Among Older Adults
Condition: Sarcopenia; Frailty
MeSH terms: Sarcopenia; Frailty
Study type: Interventional

Summary: 
      Sarcopenia and frailty could be prevented and rehabilitated through individual physical
      activities in the form of combined exercise that could be practiced at home in daily life.
    

Detailed description: 
      The volunteers were randomly assigned to either the intervention or control group using
      sealed envelopes containing documents marked with either IG (intervention group) or CG
      (control group). The intervention group received training, after which they demonstrated and
      practiced the physical activities. They were provided with an exercise leaflet for
      self-practice at home and were followed up by phone, LINE application, and leaders of social
      club for older adults at least once a week to ensure regular practice. The older adults'
      relatives and caregivers were also trained and encouraged to practice with them in a 1:1
      match. Support techniques and warning signs for stopping or taking a break during exercise
      were added to each posture, along with suggestions for suitable environmental management,
      such as flat plains, sufficient light, and no barriers within 2 meters, to reduce the risks
      of accidents. However, the control group did not receive any intervention apart from general
      suggestions and continued with their usual daily activities.
    

Intervention name(s): Physical activity
Intervention type(s): Behavioral
Intervention description(s): resistance, aerobic, and flexibility exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention