bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin B12 Supplementation in Diabetic Neuropathy
Condition: Diabetes Mellitus; Diabetic Neuropathies; Diabetic Complication; Diabetic Foot
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetic Foot; Diabetes Mellitus; Diabetes Complications
Study type: Interventional

Summary: 
      This prospective double-blind placebo-controlled trial aims to investigate the safety and
      efficacy of oral dispersible tablet of vitamin B12 for 1 year, in 90 patients with diabetes
      mellitus type 2 and neuropathy.
    

Detailed description: 
      In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes
      on metformin treatment for at least four years, and both peripheral and autonomic diabetic
      neuropathy were randomized to an active treatment group (n=44) receiving B12, and a control
      group (n=46) receiving placebo. All patients had B12 levels less than 400 pmol/L. Subjects
      underwent measurement of sural nerve conduction velocity and amplitude, vibration perception
      threshold, and performed cardiovascular autonomic reflex tests (CARTs: Mean Circular
      Resultant, Valsalva test, postural index and orthostatic hypotension]). Sudomotor function
      was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and
      feet. The Michigan Neuropathy Screening Instrument Questionnaire and Examination and
      questionnaires to evaluate quality of life and level of pain were also used.
    

Intervention name(s): B12 fix 1000mcg; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): oral dispersible tablet with vitamin B12 1000mcg; Placebo tablet
Other intervention name(s): vitamin B12
Intervention MeSH terms: Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind Placebo Controlled Randomized Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetic neuropathy; vitamin B12; SUDOSCAN; metformin; diabetic foot; Diabetes Mellitus; autonomic neuropathy; peripheral neuropathy; painful neuropathy
Malaria Survey in Mbarara District, Uganda 2010
Condition: Malaria
MeSH terms: Malaria
Study type: Observational

Summary: 
      Malaria is one of the major public health problems in Sub-Saharan Africa. In response to this
      threat, Roll Back Malaria (RBM) has rolled back a strategy using ACT as first line therapy
      for malaria episode, a wide distribution of Insecticide Treated Bednet (ITN), intermittent
      presumptive treatment of pregnant women and indoor residual spraying. Recent epidemiological
      observations suggested a decline in malaria prevalence in some countries but further
      evidences are still needed to confirm this evolution. The RBM strategy requires the use of
      reliable rapid diagnostic test (RDT) for which an operational assessment is necessary.
      Lastly, home-based management of malaria is also an important compound of this strategy.
      However, a better understanding of the actual use of antimalarial drugs, of the use of bednet
      and of the barrier to the use of health care is important to implement good quality
      strategies for malaria control.

      This study is a cross-sectional community based survey made of two rounds (one in January
      2010 and the second in June 2010). The general objective is to measure the prevalence of
      infection with Plasmodium falciparum at two periods of the year (at the moment of lowest and
      highest transmission based on the seasonal rainfalls) and to compare it with the prevalence
      estimated in 2004 after the rainy season for the same area. Specific objective are the
      estimation of the prevalence by age stratum, the analysis of the geographical distribution of
      the infection, the description of the parasitological characteristics, the assessment of
      three RDT, the description and the analysis of the prevention and care seek behaviours
      related to malaria.

      The study area is the great Mbarara district located in south-west of Uganda. A three-stage
      cluster sampling method will be used. Spatial information will be collected with global
      positioning system and imported to Geographical Information System. Behaviour information
      will be collected through face to face interview.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children living in Great Mbarara district
      
Biospecimen description: 
      Blood sample for:

      Malaria rapid diagnostic test, Malaria Blood smear, Malaria PCR, Anopheles mosquitoes
      anti-saliva antibodies
    
Keywords: prevalence; transmission; knowledge; attitude; practice
Screening for Barrett's Esophagus in Otolaryngology Patients
Condition: Extraesophageal Symptoms; Cough; Throat Clearing; Hoarseness; Difficulty Swallowing
MeSH terms: Barrett Esophagus; Deglutition Disorders; Hoarseness
Study type: Interventional

Summary: 
      The purpose of this project is to develop an accurate method to identify patients that suffer
      from acid reflux, but may not present with classic reflux symptoms (such as heart burn).
      Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber
      Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients
      with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR.
      Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed
      up through the esophagus and may affect the vocal cords and upper respiratory tract.

      It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus
      similar to that found in a population with typical reflux symptoms. We propose to
      systematically test this hypothesis using the USE.

      This project is designed to improve the methods of identifying patients with a form of acid
      reflux that is often undetected, and thus untreated. If this project is successful then more
      patients with Barrett's esophagus will be identified; furthermore, screening and treatment
      for this pre-cancerous condition will be improved.
    


Intervention name(s): Screening for Barrett's Esophagus
Intervention type(s): Diagnostic Test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: laryngopharyngeal reflux; extraesophageal reflux symptoms
A Study to Assess the Systemic Disposition of ASP1585 After Administration of 14C-labeled Drug
Condition: Healthy; Pharmacokinetics of ASP1585
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the systemic disposition of ASP1585 after oral
      administration of 14C-labeled drug in healthy male subjects.
    

Detailed description: 
      Subjects will receive study drug for 18 days with a radioactive dose of study drug given on
      Day 15. Blood, urine and feces will be collected to confirm recovery of radioactivity.
    

Intervention name(s): ASP1585; 14C-Labeled ASP1585
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ASP1585; Healthy Volunteers
Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis
Condition: Arthropathy of Knee Joint
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of the current study is to analyze and compare the lower-limb joint motions and
      muscle activation patterns during activities of daily living as well as self reported health
      related functional outcomes for patients with osteoarthritis of the knee undergoing one of
      two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the
      Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).
    

Detailed description: 
      Inclusion:

      40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement
      for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control
      participants will be recruited from the general population for the present study matching to
      experimental groups for age, gender and BMI.

      Patients who do not meet any exclusion criteria.

      Exclusion:

      Potential participants for the control group will be asked if they have had degenerative
      osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be
      excluded.

      Exclusion for patient group

        1. Patients suffering from any other lower-limb joint disorders other than the one for
           which total knee arthroplasty.

        2. Patients with any other joint replacement in the ipsilateral and contralateral limb.

        3. Patients with evidence of active infection.

        4. Patients with neurologic or musculoskeletal disease that may adversely affect gait,
           weight-bearing or quadriceps function.

        5. Patients with neuropathic joints.

        6. Patients requiring structural bone grafts.

        7. Patients with a documented allergy to cobalt chromium molybdenum.

        8. Patient with a BMI larger than 30 kg/m2.
    

Intervention name(s): Total Knee Arthroplasty; Motion analysis
Intervention type(s): Procedure; Procedure
Intervention description(s): Total Knee Arthroplasty; Motion analysis (Gait/EMG during walking and functional tasks)
Other intervention name(s): non applicable; non applicable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: knee replacement motion analysis
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine whether insulin glulisine decreases the breakfast post prandial glycemic
      excursion in comparison to insulin aspart.
    

Detailed description: 
      This is a treatment, open label, crossover study comparing two and four hour breakfast post
      prandial blood glucose levels after receiving a dose of insulin glulisine or insulin aspart
      administered subcutaneously and consuming the breakfast meal from a prescribed menu
      containing 45, 60 or 75 grams of carbohydrate. Each subject will receive insulin glulisine
      for ten days and insulin aspart for ten days.
    

Intervention name(s): insulin glulisine; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days; Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.
Other intervention name(s): (Apidra®); (NovoLog®)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin glulisine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes mellitus in children; insulin glulisine; insulin aspart; post prandial
A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This 8-week randomized, open-label evaluation will examine the acute safety and tolerability
      of 4 different dosing regimens of Acthar to inform dose selection for future studies of
      Acthar in patients with Amyotrophic Lateral Sclerosis (ALS). The study will also investigate
      the mean rate of change in the ALSFRS-R total score as an exploratory endpoint to help design
      future studies.

      This study will enroll up to 40 patients and include an optional 28-week open-label extension
      period plus a 3-week treatment taper and 1-week follow up period. After completion of Week 8,
      patients enrolled in a treatment group that is considered safe and tolerable at that time
      have the option to continue into the open-label extension period. A 3-week treatment taper
      and a follow-up visit are planned for all patients enrolled in the study, beginning either at
      Week 8 or at Week 36 if a patient continues into the optional open-label extension period.
    


Intervention name(s): Repository corticotropin injection
Intervention type(s): Drug
Intervention description(s): Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks
Other intervention name(s): H.P. Acthar Gel; Acthar; ACTH Gel; ACTH
Intervention MeSH terms: Adrenocorticotropic Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: H.P. Acthar Gel; Acthar; amyotrophic lateral sclerosis; ALS
Feasibility Study on the Use of Redormin®500 on Day-time Cognition
Condition: Sleep Disorders, Circadian Rhythm; Cognitive Dysfunction
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, double-blind, parallel groups, placebo-controlled, baseline/run-in period of 21
      days followed by trial period of 21 days, digital phenotyping (sleep, cognitive/psychological
      parameters and HRV).

      The aim of this study is to determine the feasibility of investigating the effects of
      Redormin® 500 on day-time cognition and to assess psychological parameters (subjective
      cognitive performance, tiredness, mood, stress level, quality of life, motivation), in people
      with occasional sleep problems.

      Sleep tracking data will be collected using consumer devices of the Charge series by Fitbit.
    

Detailed description: 
      The overall objective of this study is to evaluate the feasibility of the planned study
      design and to evaluate the effect of Redormin® 500 on cognitive performance (reaction time,
      working memory) and psychological parameters with daily measures.

      The primary objective of this study is to evaluate the feasibility of the study design to be
      able to design a confirmatory study.

      The secondary objectives are to assess the influence of Redormin® 500 on cognitive
      performance (reaction time, working memory) and psychological parameters (subjective
      cognitive performance, stress levels, tiredness, mood, quality of life, and motivation; all
      of these measures with reference to the current day) with daily measures in the evening, and
      on sleep parameters and heart rate variability (HRV) as an objective measure for the stress
      level during day as assessed by the Fitbit tracker.

      Safety objectives: Safety will be evaluated by obtaining and analysing adverse events during
      run-in period and treatment period.
    

Intervention name(s): Valerian-Hop Extract; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): herbal drug; Placebo
Other intervention name(s): Redormin® 500
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double blind, placebo-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Other
Mechanisms and Innovations in Cardiac Resynchronisation Therapy
Condition: Heart Failure; Left Ventricular Systolic Dysfunction; Left Bundle-Branch Block; Right Bundle-Branch Block; Non-Specific Intraventricular Conduction Defect
MeSH terms: Bundle-Branch Block; Heart Block; Ventricular Dysfunction, Left; Cardiac Conduction System Disease
Study type: Interventional

Summary: 
      The aim of this study is to compare the effectiveness of multiple modalities of cardiac
      resynchronisation therapy using high precision acute electrical and haemodynamic
      measurements.These modalities include biventricular pacing and conduction system pacing
      utilising His bundle and left bundle pacing. Conduction system pacing is a more physiological
      form of pacing. The study hypothesises that this will produce more effective cardiac
      resynchronisation.
    

Detailed description: 
      This is a single centre acute electrical/haemodynamic and observational study of a subgroup
      of patients with heart failure. A total of 60 will be recruited. The acute study involves
      within patient comparison of biventricular and conduction system pacing using detailed
      electrical mapping and high precision haemodynamic measurement protocol.

      Participants will have permanent conduction system pacing if;

        -  Baseline left bundle branch block and QRS > 140ms or QRS >150ms and any QRS morphology
           AND

        -  Conduction system pacing is successful at reducing QRS duration by 20ms or more with
           satisfactory pacing parameters.

      Participants who receive permanent conduction system pacing will have follow up at 6 weeks, 3
      months, 6 months and 12 months. Non-invasive markers including mechanical activation pattern
      (echocardiography and cardiac MRI) and electrical activation pattern (ultra-high frequency
      electrocardiography) will be used to identify the characteristics of patients who benefit
      from conduction system pacing.
    

Intervention name(s): His-bundle pacing.
Intervention type(s): Device
Intervention description(s): Cardiac resynchronisation therapy can be achieved using biventricular pacing involving placement of three leads into the right atrium, right ventricle and coronary sinus (epicardial left ventricle). Alternatively the third lead may be placed at the bundle of His or left ventricular septum to pace the left bundle directly.
Other intervention name(s): Left bundle pacing; Biventricular pacing; Combined His-bundle and left ventricular epicardial pacing (HOT-CRT)
Intervention model: Single Group Assignment
Intervention model description: 60 patients with heart failure, severe left ventricular systolic dysfunction and cardiac conduction abnormality (QRS > 120ms) will be recruited and undergo an attempt at His bundle, left bundle pacing and biventricular pacing. Patients will have acute haemodynamic and electrical measurements.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac resynchronization therapy; His bundle pacing; Haemodynamics; ECGI
Comparison of IONM Between Remimazolam and Propofol
Condition: Ossification Posterior Longitudinal Ligament; Cervical Spondylotic Myelopathy
MeSH terms: Spinal Cord Diseases
Study type: Interventional

Summary: 
      Inhalation anesthetics significantly can delay latency and reduce amplitude of cortical MEPs
      and SSEPs signals compared to intravenous anesthetics by acting on not only GABA
      (γ-aminobutyric acid) receptors but also NMDA (N-methyl-D-aspartate) receptors, so total
      intravenous anesthesia (TIVA) have been more preferred for neurophysiological monitoring
      follow-up during surgery. However, just less than inhalation anesthetics, the decrease of
      amplitude and the delay of latency also occur according to the dose dependant of propofol.
      Moreover, it can cause various adverse effects such as delayed recovery after anesthesia or
      propofol infusion syndrome, consequently, combined methods with other agents or conversion to
      other relative anesthetics are being made. Remimazolam is a ultra-short-acting
      benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in
      plasma and not accumulates in the body for long periods of infusion or even with high dose
      administration. Recently, there have been repored that continuous infusion of 0.5-1.5 mg/kg
      of remimazolam has little effect on the motor evoked potential (MEPs) of cervical spine
      surgery patients, but this is a case report without the control group; further prospective
      studies are definitely needed. Therefore, in the case of using propofol or remimazolam for
      total intravenous anesthesia, we aim to investigate which intravenous anesthetic is more
      appropriate for intraoperative neurophysiological monitoring by comparing the results of the
      somatosensory evoked potential (SSEPs) and MEPs according to these anesthetics.
    


Intervention name(s): Arm I (Propofol); Arm II (Remimazolam)
Intervention type(s): Drug; Drug
Intervention description(s): Propofol group will be inducted and maintained total intravenous anesthesia with propofol 2% and remifentanil under Shinider and Minto target controlled infusion (TCI) model, respevtively.; Remimazolam group started total intravenous anesthesia with remiamazolam at 6 mg/kg/h at the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Emergency Department (ED) Drug Interaction in Emergency Department Patients
Condition: Drug Interactions
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of
      oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.
    

Detailed description: 
      Patients with pain and/or nausea are enrolled in the Emergency Department (ED). They are
      given either oxycodone, hydrocodone, or ondansetron at the discretion of the Emergency
      Department (ED) provider or the triage nurse by triage protocol. Detailed prescription, over
      the counter, herbal, supplement, and illicit drug ingestion histories are taken from the
      patient or their health care proxy. Serial visual analogue scales are captured prior to study
      drug administration then between 30 and 90 minutes following drug administration.
    

Intervention name(s): Oxycodone; Hydrocodone; Ondansetron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.; Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.; Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.
Other intervention name(s): Oxycodone, oxycontin; Vicodin; Zofran
Intervention MeSH terms: Oxycodone; Hydrocodone; Ondansetron
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Interactions; CYP2D6; opioid efficacy; pain; nausea
Study To Evaluate Upper Arm Autologous Fat Transfer
Condition: Cosmetic and Circumferential Change After Fat Transfer
Study type: Observational

Summary: 
      The objective of this pilot study is to observe the utility of autologous transfer of fat
      collected using ultrasonic assisted liposuction into the upper arms with ultrasonic
      visualization.
    


Intervention name(s): Autologous fat transfer
Intervention type(s): Procedure
Intervention description(s): Autologous fat transfer from abdomen to upper arms
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients undergoing abdominal liposuction who wish autologous fat transfer to the
        upper arms
      
Keywords: fat, transfer, autologous fat transfer, bicep