bioihbjkbjnl/mcl2 huggingface dataset:
Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
Condition: HIV-1 Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      DNA vaccines consist of small pieces of DNA also known as plasmids, and have several
      potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well
      tolerated in humans. We have developed DNA vaccine, PENNVAX-B, which includes plasmids
      targeting the gag, pol, and env proteins of HIV-1. The vaccine will be delivered via
      electroporation (EP) which uses the CELLECTRA constant current device to deliver a small
      electric charge following injection, since animal studies have shown that this delivery
      method increases the immune response to vaccine. The vaccine will be given to HIV-1 infected
      subjects whose viral load is undetectable on a HAART regimen, with CD4 lymphocyte count above
      400 cells/µL of blood. It is hypothesized that PENNVAX-B + EP will be safe and well
      tolerated.
    

Detailed description: 
      A single group of approximately 12 HIV-infected subjects will receive a 4 dose series of
      PENNVAX-B containing 3 mg of DNA/dose at study entry (Day 0), Week 4, 8, 16 and will be
      followed for a total of 48 weeks.
    

Intervention name(s): PENNVAX-B
Intervention type(s): Biological
Intervention description(s): DNA plasmids delivered via IM injection + electroporation using CELLECTRA device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Infection; DNA vaccine; Electroporation; HIV therapeutic vaccine
Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment
      for patients with non-alcoholic fatty liver disease.
    

Detailed description: 
      In this study phlebotomy will be evaluated as a therapy for non-alcoholic fatty liver disease
      (NAFLD), a common and important cause of liver disease. Phlebotomy has been used for many
      years in the treatment of disorders of iron overload such as hemochromatosis, where it is
      well tolerated and improves symptoms and survival. There is some evidence that it is also
      effective in treating NAFLD. However, previous studies have not evaluated whether phlebotomy
      improves liver biopsy findings. We will measure the severity disease in NAFLD patients prior
      to phlebotomy therapy and again at the end of treatment. This will allow us to accurately
      determine the benefit of this therapy in these patients.
    

Intervention name(s): Phlebotomy
Intervention type(s): Procedure
Intervention description(s): Phlebotomy involves the removal of blood (approximately 500mL) each week until body iron levels reach the low-normal level
Other intervention name(s): Venesection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-alcoholic fatty liver disease; liver fibrosis; metabolic syndrome; iron overload; phlebotomy
Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain
Condition: Neuropathic Pain; Spinal Stenosis
MeSH terms: Spinal Stenosis; Neuralgia
Study type: Interventional
Phase: Phase 4

Summary: 
      Gabapentin is a first line medication and fentanyl is second line medication in neuropathic
      pain. But, there is no head to head study on the efficacy of those medication in neuropathic
      pain.

      The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not
      inferior to the gabapentin in neuropathic pain.
    


Intervention name(s): transdermal fentanyl matrix, gabapentin
Intervention type(s): Drug
Intervention description(s): transdermal fentanyl matrix: during 1st to 6th days, 12ug/h of fentanyl matrix will be applied. During 7th to 28th days, the dosage of fentanyl matrix will be increased until the pain score decrease not more than 2 every 6 days. The maximal dosage is 100ug/h. During 29th to 56th days, the dosage will be maintained.
Gabapentin: the 1st day, 300mg hs, the 2nd day, 300mg bid, the 3th to 4th days, 300mg tid, the 5th to 6th days, 300mg-300mg-600mg the 7th to 28 days, the dosage will be increased until the pain score decreased not more than 2 and the maximal dose is 2400mg per day. During 29th to 56th days, the dosage will be maintained.
Intervention MeSH terms: Fentanyl; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuropathic pain; gabapentin; transdermal fentanyl matrix; multicenter; non-inferiority trial
Prediction of Hemodynamic Reactivity During General Anesthesia Using Analgesia/Nociception Index (ANI)
Condition: Anesthesia
Study type: Observational

Summary: 
      The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the
      prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower
      limb orthopedic surgery on desflurane/remifentanil general anesthesia.
    

Detailed description: 
      Measurement of analgesia/nociception index at different time points during procedure and
      assessment of analgesia/nociception index to predict hemodynamic reactivity by building
      receiver observer's characteristic curve.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients underoing ear-nose-throat or orthopedic lower limb surgery performed on
        desflurane/remifentanil general anesthesia
      
Keywords: Analgesia/nociception index; Desflurane; Remifentanil; Orthopedic surgery; Ear-nose-throat surgery; Hemodynamic reactivity
Non-invasive Lipolysis on Human Thighs and Saddlebags
Condition: Adipose Tissue Reduction
Study type: Interventional

Summary: 
      The study is a prospective two-arm, open-label, interventional study with four treatment
      procedures and two follow-up visits.
    

Detailed description: 
      This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for
      non-invasive lipolysis and fat reduction in the thigh and saddlebag area. This is a
      prospective, open-label, two-arm study; therefore the participants will be assigned to two
      study groups. Each participant will complete 4 treatment visits and 2 follow-up visits.
    

Intervention name(s): BTL-899
Intervention type(s): Device
Intervention description(s): Treatment with study device.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the impact of curcumin, administrated orally, on
      iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin
      expression that the investigators observed in vitro and serum hepcidin levels.
    


Intervention name(s): curcuma longa
Intervention type(s): Drug
Intervention description(s): oral administration of 6 grams of curcumin
Intervention MeSH terms: Turmeric extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
Condition: Oral Ulcer
MeSH terms: Oral Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      Children with acute diseases with oral ulcers (not included PRESENTATIONS OF SLE, IBD or
      IMMUNOCOMPRMIZED STATES)will receive several doses (drinking or mouth rinsing) of either
      pasteurized goat milk or cow milk. Children will than be followed for length of the disease -
      signs and symptoms.
    

Detailed description: 
      A prospective randomized controlled study that will include 110 previously health 6months - 5
      years children (55 in each group) with acute oral ulcer disease (< 48 hours). Children will
      receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow
      milk. Children will than be followed for length of the disease - sings and symptoms by
      questioner to parents, and physical examination by there physicians. .
    

Intervention name(s): Drinking or rinsing the mouth 2-3 times for 1 day; Pasturlized cow milk
Intervention type(s): Biological; Biological
Intervention description(s): Drinking or rinsing the mouth 2-3 times for one day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: children
Bupivacaine Pharmacokinetics Following TAP Block
Condition: Transversus Abdominis Plane Block
Study type: Observational

Summary: 
      The aims of this study are to determine population PK parameters of bupivacaine in children
      following TAP block using a population-based PK approach, and to evaluate the influence of
      patient covariates on drug disposition.
    

Detailed description: 
      The number of published pediatric studies on the use of transversus abdominis plane (TAP)
      block has increased in recent years. The transversus abdominis plane (TAP) block has been
      used for postoperative analgesia for surgery to the abdominal wall and involves the injection
      of local anesthetic solution into a plane between internal oblique (IO) and transversus
      abdominis (TA) muscles. The TAP block has the advantage of providing unilateral analgesia in
      instances of non-midline abdominal incision and is particularly useful in cases where
      epidural blockade is either contraindicated or technically or logistically not feasible.
      Bupivacaine and ropivacaine have been used as local anesthetics for TAP blocks in published
      studies to date. However, no data exist regarding the pharmacokinetics of bupivacaine after
      TAP block in children. The aims of this study are to determine population pharmacokinetic
      (PK) parameters of bupivacaine in children following a TAP block, using a population-based PK
      approach.
    

Intervention name(s): Blood sample for bupivicaine pharmacokinetics
Intervention type(s): Other
Intervention description(s): Bupivacaine levels will be measured with an assay developed on the 4000 QTrap Tandem Mass Spectrometer (Applied Biosystems/ MDS Sciex).
Data will be collected and analyzed using the Agilent ChemStation software (Rev A.10.02). The analytical column is an Agilent Zorbax Eclipse XDB-C8 (4.6 x 150mm, 5µm).Quantification of bupivacaine is based on analyzing a six point calibration curve (0 to 4.0 mg/L). An internal standard (Prilocaine 221.2/86.1) is included with each calibrator, quality control or patient sample. Instrumentation and Chromatographic conditions: The HPLC system consists of a Specta-System P1000 Isocratic Pump and an AS3000 Autosampler (Thermo Electron Corporation, Waltham MA).
Intervention MeSH terms: Bupivacaine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing TAP block for postoperative pain control
      
Biospecimen description: 
      Blood (serum)
    
Keywords: Bupivacaine; Sensorcaine; Population pharmacokinetics; Children; Pediatrics; Transversus abdominis plane (TAP) block; Regional Anesthesia
Evaluating the Effectiveness of a Family Heart Health Educational Program (The FIT-Heart Study)
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      The primary objective of the FIT Heart Study was to test the effectiveness of a
      hospital-based standardized screening and educational intervention targeted to family members
      of patients hospitalized with CVD, to increase adherence to CVD prevention guidelines.
    

Detailed description: 
      FIT Heart was a randomized controlled trial that tested a novel systems approach to increase
      adherence to national prevention guidelines among family members of patients hospitalized
      with CVD. Participants were blood relatives or cohabitants of patients hospitalized with
      atherosclerotic cardiovascular disease, aged 20-79 years, did not have established
      cardiovascular disease or diabetes, and spoke English or Spanish. Participants randomized to
      a special intervention group received behavioral counseling and education on diet and
      physical activity; personalized risk factor screening and immediate feedback; and
      reinforcement and follow-up throughout the year. The control group received a brief CVD
      prevention message in the form of a handout. All participants received standardized
      assessments of diet, lifestyle, and CVD risk factors at baseline and 1 year (94% follow-up).
      The main findings have been published showing the mean percent change in LDL-cholesterol
      level from baseline to 1-year improved in both groups and was not significantly different in
      the special intervention vs. control group (-1% vs. -2%; p=.64).
    

Intervention name(s): Family Passport to Heart Health Program; General Educational Materials
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this group received personalized heart disease risk factor screening at the baseline study visit. They were taught lifestyle approaches to risk reduction based upon national heart disease prevention guidelines, including the Adult Treatment Panel (ATP) III recommendations for improving blood cholesterol levels with a TLC diet. Participants had regular contact with study staff and will receive individualized feedback throughout the study.; Participants in the control group received an educational brochure about heart health at the baseline study visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention
MIDNOR-TIA - a Study of 600 Patients With Transient Ischemic Attack
Condition: Ischemic Attack, Transient; Stroke
MeSH terms: Ischemic Attack, Transient; Ischemia
Study type: Observational

Summary: 
      Patients with a transient ischemic attack (TIA) are at high risk of stroke. Rapid assessment
      and treatment can reduce the risk. Several international guidelines recommend a test, the
      ABCD2 score, to identify TIA patients with low and high risk for stroke. The main purpose of
      this study is to investigate stroke risk after TIA in both short (1 week) and long term (3
      months/1 year), and to assess whether the ABCD2 score ('Age, blood pressure, clinical
      features, duration of TIA, diabetes score) is an adequate tool for predicting stroke risk.
      Secondary aims are to explore whether adopting imaging modalities (ultrasound, MRI) and
      biological markers of blood into a risk score could improve the predictive value of the ABCD2
      score and still be feasible in a daily clinical practice. Further on overall risk factors in
      TIA patients, and the incidence of other vascular events will be studied. A substudy designed
      as a randomised controlled trial evaluates pharmaceutical counseling in a subset of
      participants. Cost-benefit analysis, and a long-term follow-up (5 years) is planned.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to a hospital in Central Norway with a recent probable or possible
        transient ischemic attack
      
Biospecimen description: 
      Blood samples
    
Keywords: Risks; Risk Factors; ABCD2 score; Predictive Value of Tests; Risk Assessment; Severity of Illness Index; Decision Support Techniques
Effects of TEAS on Stress Response During Extubation of General Anesthesia in Elderly Patients
Condition: Stress
Study type: Interventional

Summary: 
      Elderly patients have an increased risk of stress responses during extubation after general
      anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses
      during extubation after general anaesthesia remains challenging for the anaesthesiologist. In
      this study, we aimed to investigate whether transcutaneous electrical acupoint stimulation
      (TEAS) might decrease the stress responses and improve the quality of recovery in the elderly
      patients who underwent elective supratentorial craniotomy under general anaesthesia.
    

Detailed description: 
      A total of 100 elderly patients scheduled for elective supratentorial craniotomy under
      propofol-remifentanil total intravenous anaesthesia were randomly divided to either TEAS
      group (received stimulation at LI4, PC6, LU7, LU5, LI18 and ST9 acupoints, 2/10Hz, 6-15 mA)
      or Sham group (received no stimulation). The primary outcomes were the haemodynamic
      parameters and plasma concentrations of epinephrine (E), norepinephrine (NE) and cortisol
      (Cor). The secondary outcomes were the consumption of remifentanil and propofol, the time
      from discontinuation of anesthetics to extubation and reorientation, extubation quality
      score, the quality of postoperative recovery and postoperative complications.
    

Intervention name(s): Hwato Electronic Acupuncture Treatment Instrument; Placebo
Intervention type(s): Device; Device
Intervention description(s): Thirty minutes prior to the induction of anaesthesia, the patients in the TEAS group started to receive TEAS by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model No.: SDZ-II, Suzhou Medical Appliances Co., Ltd., Suzhou, China) to the right hand, forearm and neck by an experienced acupuncturist at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints. TEAS was peformed with an alternate dense-disperse frequency of 2 and10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, The stimulus continued until 5 min before the end of surgery.; The patients in the Sham group were also connected to the apparatus, but electronic stimulation was not applied.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcutaneous electrical acupoint stimulation; stress response
Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses
Condition: HIV
Study type: Interventional

Summary: 
      This study is a pilot study to evaluate impact of Tripterygium Wilfordii Hook F (TwHF) on T
      cell immune activation and immune activation in HIV-infected immunological non-responders.
      The investigators aim to evaluate the safety and efficacy profiles of TwHF in HIV
      immunological non-responders.
    

Detailed description: 
      The investigators recruited 23 patients from Peking Union Medical College Hospital Outpatient
      clinic. They were all immunological non-responders. Nineteen patients will receive Triptolide
      wilfordii Hook F extract (10mg tid po) plus current cART, while 4 patients will continue
      their current cART. This study will last for 12 months. Patients will be followed up at month
      0, 3, 6, 9, and 12. During each follow-up time point, adverse effects, T cell subsets, T cell
      activation markers and other routine tests will be ordered. The investigators hypothesis that
      TwHF might boost CD4 cell recovery by reducing immune activation.
    

Intervention name(s): Tripterygium Wilfordii Hook F extract (TwHF extract); cART
Intervention type(s): Drug; Drug
Intervention description(s): The extract Tripterygium wilfordii Hook F (TwHF), a traditional Chinese medication, has been used as anti-inflammatory therapy to treat autoimmune diseases including rheumatoid arthritis and Crohn's disease.; Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.
Other intervention name(s): Triptolide Wilfordii; Combination antiretroviral therapy
Intervention MeSH terms: Triptolide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-infected immunological non-responders; Tripterygium Wilfordii Hook F; Immune activation
Cerebello-thalamo-cortical Coupling in Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      Essential tremor (ET) is a frequent and disabling disorder with progressive worsening of
      postural tremor of the upper limbs that impairs most of the manual activities of every day
      life (feeding, drinking, etc.). Although the pathophysiology of essential tremor (ET) is not
      fully elucidated, tremor is associated with abnormal activity within different brain regions,
      in particular the thalamus and the cerebellum. Deep brain stimulation (DBS) of the ventral
      intermediate nucleus of the thalamus (VIM-Thal) reverses the symptoms of tremor but is an
      invasive procedure. Transcranial stimulation of the cerebellum may represent a non-invasive
      therapeutic option for ET patients. Here, the investigators propose to test the efficacy of
      cerebellar stimulation in 15 ET patients previously operated for DBS of the thalamus. To
      further understand how this treatment provokes tremor reduction, the investigators will
      analyse the brain neuronal activity in 13 others ET patients candidate to thalamic DBS by
      using combined electrophysiological recordings of the thalamus (with the electrodes
      implanted), the cerebellum and the cortex with magnetoencephalography.
    


Intervention name(s): tACS of the cerebellum
Intervention type(s): Device
Intervention description(s): tACS of the cerebellum
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Stage-Specific Recovery Changes in the International Classification of Functioning Components Following Conservative Rehabilitation of Trigger Finger
Condition: Trigger Finger
MeSH terms: Trigger Finger Disorder
Study type: Observational

Summary: 
      The aim of this study was to determine the effectiveness of conservative rehabilitation on
      the multi-dimensional health components based on WHO ICF model in Stage 1, Stage 2 and Stage
      3 trigger finger and to determine the functional recovery patterns of each dimension during a
      three-month rehabilitation period. Thirty-four patients were participated in the study.
    


Intervention name(s): conservative treatment
Intervention type(s): Other
Intervention description(s): All patients had rehabilitation for a total of three months, including activity modification, splinting and exercises.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson
        Classification
      
Keywords: trigger finger; ICF; rehabilitation; splinting