bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Recombinant Vaccine to Prevent ETEC Diarrhea
Condition: Escherichia Coli Infection
MeSH terms: Escherichia coli Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine if immunization with a recombinant E. coli protein,
      dscCfaE, is safe and immunogenic when administered through the skin using a patch.
    

Detailed description: 
      The purpose of the study is to determine if immunization with dscCfaE with or without a
      modified E. coli heat labile enterotoxin, LTR192G, is safe and immunogenic when administered
      transcutaneously using a skin wet-patch. If the vaccine is found safe and adequately
      immunogenic in humans, a phase 2b vaccination/challenge study would be undertaken to further
      evaluate vaccine safety and allow a preliminary assessment of efficacy. With favorable
      evidence for safety, immunogenicity, efficacy, complemented by advances in standard
      methodology to combine multiple adhesins with an appropriate LT enterotoxoid form, a
      multivalent vaccine would be constructed and evaluated for further clinical development.
    

Intervention name(s): Recombinant fimbrial adhesin dscCfaE; Recombinant fimbrial adhesin dscCfaE; Recombinant fimbrial adhesin dscCfaE; Modified E. coli heat labile enterotoxin LTR192G
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 10 ug on study days 0, 21 and 42; 50 ug on study days 0, 21 and 42; 250 ug on study days 0, 21 and 42; 50 ug on study days 0, 21 and 42
Other intervention name(s): dscCfaE; dscCfaE; dscCfaE; LTR192G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ETEC; Diarrhea; Vaccine
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with constipation often have bloating and abdominal distension. It is unclear if
      this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce
      small bowel and colon bacteria colonization, a change in the balance of stool microorganisms,
      and improve the symptoms of dyspepsia and constipation.
    

Detailed description: 
      This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath
      test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a
      day for 4 weeks.
    

Intervention name(s): Lubiprostone
Intervention type(s): Drug
Intervention description(s): 24 mcg bid for 28 days
Other intervention name(s): Amitiza
Intervention MeSH terms: Lubiprostone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Constipation; small intestinal bacterial overgrowth; stool bacteria
The Effects of Cathodal tDCS on Muscle Strength in Healthy Adults
Condition: Healthy Participants
Study type: Interventional

Summary: 
      To investigate the effects of different intensity of cathodal tDCS on muscle strength in
      healthy adults.
    

Detailed description: 
      Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique
      that can modulate cortical excitability. In 2000, Nitsche and Paulus reported the
      polarity-dependent effect of tDCS in humans, i.e., anodal tDCS facilitates cortical
      excitability while cathodal tDCS decreases it. (Nitsche & Paulus, 2000). TDCS studies have
      been replicated by many researchers and reported similar effects of tDCS in humans when using
      anodal and cathodal tDCS with an intensity of 1 mA. The linear effect of tDCS also has been
      reported by various studies, i.e., when increase intensity, the polarity-dependent effect of
      tDCS also enhances. However, conflicting results of cathodal tDCS efficacy have been
      reported.

      Cortical excitability has been used to represent the efficacy of tDCS on neuroplasticity. The
      linear effect of cathodal tDCS on cortical excitability have been reported by researchers
      when using intensities at 1, 2, and 3 mA stimulated at the primary motor cortex in healthy
      participants (Batsikadze et al., 2013; Jamil et al., 2017; Kuo et al., 2013; Mosayebi Samani
      et al., 2019; Nitsche et al., 2003). Nevertheless, some studies showed the non-linear effects
      of cathodal tDCS (i.e., when increases intensity, cathodal tDCS enhances the cortical
      excitability) when using intensities at 1.5 and 2 mA in healthy participants (Batsikadze et
      al., 2013; Jamil et al., 2017; Mosayebi Samani et al., 2019). Hence, cathodal tDCS efficacy
      on cortical excitability is still controversy.

      Muscle performance is an outcome that represents clinical change induced by tDCS. Previous
      studies reported the tendency of cathodal tDCS efficacy in decreasing muscle performance of
      both upper and lower extremities in healthy participants (Cogiamanian et al., 2007; Tanaka et
      al., 2009). However, previous studies used a single intensity of tDCS in each study. Hence,
      there was no direct comparison between different intensities of cathodal tDCS on muscle
      performance in healthy participants.

      In our study, we aim to investigate the effect of different intensities of cathodal tDCS on
      muscle strength in healthy participants.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Cathodal tDCS will be applied for 20 mins.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy
Condition: Cerebral Palsy; Hemiplegic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      As many researches have been conducted to see the effects of vestibular system activation on
      gross motor activities of children with cerebral palsy but there are limited researches on
      improvement of motor abilities of hemiplegic cerebral palsy child using UEU or BOSU ball or
      treadmill in a single study. There is lack of research on vestibular stimulation in
      hemiplegic cerebral palsy along with neurodevelopmental treatment.

      This study will improve the gross motor activities of children with hemiplegic cerebral
      palsy. It will broaden up the ways for physical therapist to deal with this type of cerebral
      palsy (hemiplegic).
    

Detailed description: 
      There are various therapeutic approaches that are used to improve motor activities and
      postural control in CP child. Among these approaches vestibular stimulation is used to
      improve neuromotor development by different sensory stimulation techniques. It has shown
      positive effects on motor control of CP child. It also influences all sensory experiences and
      is an exercise based approach.
    

Intervention name(s): Neurodevelopmental technique
Intervention type(s): Other
Intervention description(s): st month: postural maintenance; exercises with weight on forearms and hands, in sitting, crawling, semi-kneeling and standing positions with support from therapist.
nd month: balance and corrective reactions; using CP ball and tilt board.
rd month: ambulation training; appropriate to motor development level (crawling, creeping, walking in a semi-kneeling position and walking between parallel bars).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor activity; spasticity; vestibular stimulation
Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 1

Summary: 
      This Open-Label Pilot Study Aims to Determine Whether a Two-Part Sequenced Out Patient
      Procedure Utilizing a Modified Ketogenic Diet Followed by a Series of Titrated Ketamine
      Infusions Results in Improvement or Remission of Chronic Anorexia Nervosa in Adults with
      Symptoms of Anorexia for at Least 3 Years Despite Treatment Involving at Least 2 Different
      Modalities. The Hypothesis is That the Diet Addresses Core Metabolic Deficits in the
      "Anorexic Brain" and Primes the Response to Ketamine.
    

Detailed description: 
      Participants Who Are Deemed Eligible Will Participate in an Open-Label Clinical Trial Using a
      Sequenced Treatment Previously Reported in One Case Study to Result in Complete and Sustained
      Remission of Anorexia Nervosa for Over One Year (and Continuing).

      Part 1 Involves a Group 2-Day Immersive In-Person Educational Program to Begin a Modified
      Ketogenic Diet, Under the Supervision of a Nutritionist Who Has Decades of Experience in
      Designing Ketogenic Diets for Seizure Patients. This Group Experience is Followed by a 4 Week
      Period of At-Home Adoption of the Diet, With Close Phone and E-Mail Follow-up.

      Part 2 Involves Administration of a Series of Titrated Intravenous Ketamine Infusions
      Scheduled Over 2 Weeks.

      During Part 1, and Part 2, There Will Be a Range of Objective and Psychological Measures To
      Assess Safety and Response. The Participants Will be Followed For 12 Months.
    

Intervention name(s): Ketamine Hcl 50Mg/Ml Inj
Intervention type(s): Drug
Intervention description(s): Racemic Ketamine Will Be Infused At A Starting Dose of 0.75 mg/kg Over A Period of 45 Minutes. The Dose Will be Titrated, Based on Clinical Signs With Changes of 0.3mg/kg Up to Maximum of 0.95 mg/kg, and Lowest Dose of 0.3 mg/kg
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Intervention model description: The 5 Participants Undergo A Sequenced Treatment of Adopting A Ketogenic Diet For at Least 4 Weeks, Followed by A Series of Intravenous Ketamine Infusions
Masking: None (Open Label)
Primary purpose: Treatment
Perioperative Aspirin Response in Patients Undergoing Vascular Surgery
Condition: Vascular Surgery Patient With PAD / Carotid Stenosis
MeSH terms: Carotid Stenosis
Study type: Interventional

Summary: 
      Reduced antiplatelet activity (low response (LR)/high on-treatment platelet reactivity (HPR))
      of aspirin (ALR) or clopidogrel (CLR) is associated with an increased risk of thromboembolic
      events. The prevalence figures for low-responders reported in the literature vary widely and
      there have been few investigations in vascular surgery patients to date. The aim of this
      prospective monocentric study was to increase the evidence base on vascular surgery patients
      and to detect any changes in the response following vascular surgery procedures.
    

Detailed description: 
      The activity of aspirin (acetylsalicylic acid, ASA) and clopidogrel is measured by whole
      blood impedance aggregometry using a multiple electrode aggregometer (Multiplate). The
      agonists used are arachidonic acid for aspirin and adenosine diphosphate (ADP) for
      clopidogrel. Vascular patients requiring treatment for peripheral artery disease (PAD) and/or
      carotid stenosis are included in the study. To identify possible risk factors demographic
      data, concomitant medication, laboratory parameters, co-morbidities, severity of the
      condition and the type of procedure performed are documented. In addition, a follow-up
      aggregometry is performed after completion of the vascular procedure.
    

Intervention name(s): Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).
Intervention type(s): Drug
Intervention description(s): To identify possible risk factors demographic data, concomitant medication, laboratory parameters, co-morbidities, severity of the condition and the type of procedure performed are documented.
Other Name: ASA (aspirin), Clopidogrel (Plavix)
Intervention MeSH terms: Clopidogrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients
Condition: Hyperparathyroidism Tertiary
MeSH terms: Vascular Calcification; Hyperparathyroidism
Study type: Observational

Summary: 
      The aim of this study is to assess the clinical, laboratory and vascular calcification
      outcome within 6 months duration in patients undergoing surgical parathyroidectomy (total,
      subtotal, and total with autotransplantation)
    

Detailed description: 
      All patients above the age of 18, with end stage renal disease maintained on regular
      hemodialysis and are indicated for surgical parathyroidectomy.

      The indications for parathyroidectomy included persistently elevated intact parathormone
      hormone levels of greater than 500 pg/mL, uncontrolled hypercalcaemia with hyperphosphataemia
      or clinical symptoms of secondary hyperparathyroidism refractory to medical treatment. These
      symptoms included bone pain, pruritus, fracture, fatigue and calciphylaxis

      These patients will be exposed to pre-operative evaluation of clinical, laboratory and
      vascular calcification in abdominal aorta and coronary calcium scoring using ECG- gated non
      contrast CT in hemodialysis patients undergoing parathyroidectomy

      Post-operative evaluation of clinical, laboratory and vascular calcification in abdominal
      aorta and coronary calcium scoring using non contrast CT will be done 6 months post-operative

      Assessment of the relation between preoperative and postoperative measures

      Patients with the following criteria will be excluded:

        1. chronic kidney disease patients not yet on regular Hemodialysis

        2. patients who had primary hyperparathyroidism

        3. patients who had received kidney transplantation

        4. patients who underwent repeated parathyroidectomy

        5. patients who were lost to follow-up or with missing data.
    

Intervention name(s): surgical parathyroidectomy
Intervention type(s): Procedure
Intervention description(s): total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients above the age of 18, with ESRD maintained on regular hemodialysis and are
        indicated for surgical parathyroidectomy
Repair Of Flexor Tendon In Zone II Using Minimal Incisions
Condition: Flexor Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      Repair of the zone II flexor tendon of the hand using minimal incisions is successful with
      good results which will improve the outcome of the repair.
    

Detailed description: 
      Flexor tendon laceration in the hand is a common injury with unique characteristics owing to
      the anatomy of flexor tendons contained within a flexor sheath, requiring good surgical
      technique as well as strict rehabilitation protocol for regaining function.

      The hand is divided into 5 zones (Verdan's). Zone II is described by Bunnel as "No Man's
      Land" historically back to the 14th century (an area outside London used for executions)
      because it was previously believed that primary repair should not be done in this zone. After
      understanding flexor tendon anatomy, biomechanics, and healing new techniques of surgery and
      anesthesia repair is possible with good results.

      Lacerated tendons in zone II can retract proximally to the PIP if the vinculum longus is
      intact or into the palm if it is disrupted. It will not retract to the level of the wrist
      because of the origin of the lumbrical insertion into the extensor mechanism.

      The laceration can be extended in a Brunner incision or a mid-lateral exposure but it is
      better skin incisions are minimal to minimize postoperative finger edema, potential
      adhesions, and injury of any delicate structures.

      There are a lot of techniques to retrieve the proximal tendon end as milking, using a
      hemostat or second incision proximal to the A1 pulley where the tendon is tied to a looped
      wire of silastic tube and pulled distally through the laceration in the tendon sheath. But
      little studies discuss the effect of minimal incision on functional outcomes post-operative.
    

Intervention name(s): repair of flexor tendon in Zone II
Intervention type(s): Procedure
Intervention description(s): Repair of Zone II flexor tendon of the hand using minimal incisions instead of whole tendon exposure
Intervention model: Single Group Assignment
Intervention model description: Minimal incisions in repair of Zone II flexor tendon of the hand instead of whole exposure of the tendon
Masking: None (Open Label)
Primary purpose: Treatment
Addictive Potential of LCCs in Dual Users
Condition: Tobacco Use Disorder; Dual Tobacco Use; Tobacco Dependence; Smoking; Smoking, Cigar; Smoking, Cigarette; Smoking, Tobacco
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study is about whether or not little cigars and cigarillos cause or maintain addiction,
      and if flavors, such as fruit, make them more addictive. The purpose of this study is to
      understand the addiction potential of little cigars and cigarillos compared to cigarettes in
      young adults who smoke both products. This study will also look at the differences between
      men and women. In the rest of this form, little cigars or cigarillos will be referred to as
      LCCs.
    


Intervention name(s): Flavored and unflavored little cigars/cigarillos (LCCs)
Intervention type(s): Other
Intervention description(s): Flavored and unflavored LCCs that are currently available for purchase
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross-over study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dual Use; Little Cigars and Cigarillos; Cigarettes; Flavored Tobacco Use; Addiction Potential
Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study
Condition: Traveler's Diarrhea
MeSH terms: Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent
      moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.
    


Intervention name(s): TD Vaccine System; TD Vaccine System
Intervention type(s): Biological; Biological
Intervention description(s): TD Vaccine System containing heat labile enterotoxin of E. coli (LT); TD Vaccine System Containing Placebo Product
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath
Condition: Dyspnea
MeSH terms: Dyspnea; Emergencies
Study type: Observational

Summary: 
      The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right
      ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial
      Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis.
      Primary outcomes measured are the magnitude of change in differential diagnoses.
    

Detailed description: 
      This prospective randomized control trial will be performed on a convenience sample of 200
      patients presenting with undifferentiated SOB to an academic emergency department (ED)
      (volume 56,000 patients/year). Subjects are excluded if they have a known history of asthma,
      are 20 or more weeks pregnant, or have had thoraco-abdominal trauma in the past 72 hours. The
      BRIPPED pilot investigation (IRB #10-02-FB-0026) enrolled 43 patients and physician subjects
      from 4/30/2010 to 1/20/2011. This study differs in methodology from the pilot study in the
      reduction of the total number of ultrasound images obtained to decrease the total time to
      perform the scan. Instead of a cohort study, this randomized control trial includes the
      addition of a control group for cost and time saved comparison. As in the pilot study,
      eligible patients will be evaluated by the treating ED physician who will rank potential
      diagnoses from most to least likely. A study investigator performs the B-RIPPED scan and
      provides the initial treating physician with the results. The treating physician will again
      be asked to complete a differential diagnosis ranking knowing the B-RIPPED results. Changes
      in the differential diagnosis ranking, physician orders, and interventions will be compiled.
      A randomized control cohort will be assigned for eligible patients. In the control group, the
      treating physician will complete the diagnosis rank list prior to the completion of the
      workup, and then once all lab values are back. Time to disposition, and comparison of labs
      and radiology tests ordered will be compared to the cohort receiving the BRIPPED scan.
      Patients will be assigned a number at time of enrollment, which randomly assigns them to the
      control or experimental (patients receiving the BRIPPED scan) group. Packets containing the
      appropriate data collection form (control or experimental) will be organized so even numbered
      patients will belong to one group, and odd numbered patients will be assigned to the other.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample of community subjects presenting to an Academic Hospital Emergency
        Department (volume approx 60,000 patients per year).
      
Keywords: Dyspnea; Ultrasonography; Emergencies; Critical Care
Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)
Condition: Advanced Hodgkin Disease
MeSH terms: Hodgkin Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD
      regimens.
    


Intervention name(s): COPPEBVCAD vs BEACOPP vs ABVD
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control
Condition: Healthy Participants
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive
      control
    


Intervention name(s): Road-tracking test; Car-following test; Harsh-braking test
Intervention type(s): Other; Other; Other
Intervention description(s): Driving with simulator program for SDLP measurement; Intervention Description: Driving with simulator program for DCV measurement; Driving with simulator program for BRT measurement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other