bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn about an investigational drug known as oral lipoic acid
      (LA) that may help treat multiple sclerosis. This study will measure how a person's body
      absorbs and breaks down the drug (pharmacokinetics) and will compare four different forms of
      the drug from four different manufacturers as well as LA in conjunction with fish oil.
    

Detailed description: 
      Multiple sclerosis (MS) is a common, often disabling inflammatory disease of the central
      nervous system (CNS). Present treatments for MS are only partially effective, available only
      in injectable forms, have significant side effects and are very costly. Developing more
      effective and better-tolerated treatments of MS thus remains an important goal for the
      improvement of the care of MS. Lipoic acid (LA) is an antioxidant that is widely available as
      a dietary supplement.

      The primary outcome of this study is to determine the pharmacokinetics of oral LA 1200 mg to
      see if we can identify factors affecting the bioavailability of LA. We will also study the
      salivary concentrations of oral LA and its correlation with the serum LA concentrations. We
      will also study the effects of LA on the immunological markers after four hours of
      administration.
    

Intervention name(s): oral lipoic acid (LA); lipoic acid (LA) with fish oil and LA without fish oil; R lipoic acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single 1200 mg dose of oral LA will be administered.; Subjects will be randomized to receive either 1 dose of 1200 mg LA with fish oil and then will be crossed-over to receive 1 dose of 1200 LA without fish oil. There will be a 1-week wash out period between the cross over.; A single oral dose of 1200mg R enantiomer LA will be administered.
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; lipoic acid; LA; pharmacokinetics; immunological effects
INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      The investigation is a multi-year observational study following the completion of the
      open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC
      cells into 12 subjects with thoracic spinal cord injury.

      Subjects will be monitored at routine intervals for safety and preliminary efficacy for 5
      years post-transplantation of the Phase I/II investigation CL-N02-SC.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Spinal cord injured patients T2-T11
Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Esophagus is commonly affected in Systemic Sclerosis (SSc) and esophageal function is
      compromised in about 75% of patients. Previous studies have shown that buspirone, an orally
      available 5-HT1A (serotonin 1a receptor agonist), enhances esophageal motility in healthy
      volunteers. Recently, the investigators observed that a single dose of buspirone (10mg)
      improves lower esophageal sphincter (LES) function in patients with SSc and esophageal
      involvement .

      Objectives: To evaluate the effect of continuous administration of buspirone on esophageal
      dysfunction and related symptoms in SSc using high resolution manometry (HRM).
    

Detailed description: 
      Systemic sclerosis (SSc) is a chronic autoimmune disease affecting the skin and other organs
      especially the gastrointestinal tract. Esophageal involvement occurs in up to 90% of SSc
      patients. Symptoms of esophageal disease are due to gastroesophageal reflux disease (GERD)
      and esophageal motor dysfunction. Thus, heartburn, regurgitation and dysphagia have been
      reported by 80% of SSc patients.

      The gold standard method for the assessment and detection of esophageal dysmotility in SSc
      patients is manometry. High-resolution manometry (HRM) is the most accurate tool to assess
      esophageal motility using multiple closely spaced (<2cm) pressure sensors, assessment of
      esophageal motility is more sensitive ,and allows a better assessment of LES and of the whole
      esophagus.

      Buspirone, an orally available 5-HT1A receptor agonist, exerts a beneficial acute effect on
      esophageal motor dysfunction and LES pressure and may enhances an important role in
      improvement of esophageal symptoms in SSc patients. Thus, the investigators will conduct a
      study to evaluate the putative beneficial long-term effect of buspirone i) on esophageal
      motor dysfunction and ii) on esophageal symptoms in symptomatic SSc patients.
    

Intervention name(s): buspirone
Intervention type(s): Drug
Intervention description(s): buspirone 10 mg X2 for 4 weeks
Other intervention name(s): bespar
Intervention MeSH terms: Buspirone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)
Condition: Pregnancy Related; Antepartum DVT
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized control trial to compare gestational age-based dosing with
      standard dosing of unfractionated heparin for thromboprophylaxis of hospitalized antepartum
      patients. The investigators aim to determine the effect of dosing on receipt of neuraxial
      anesthesia and pregnancy outcomes and evaluate the pharmacokinetics and pharmacodynamics of
      unfractionated heparin in pregnancy.
    

Detailed description: 
      Venous thromboembolism is one of the leading causes of maternal morbidity and mortality, and
      antepartum hospitalizations place pregnant patients at an even higher risk of developing
      thromboembolism. As a result, there is an increased emphasis on administering pharmacologic
      thromboprophylaxis for antepartum patients with prolonged hospitalizations. Previously,
      standard dosing of unfractionated heparin was widely adopted for thromboprophylaxis in the
      pregnant population. However, due to a suspected altered metabolism of unfractionated heparin
      in pregnancy resulting in a decrease response, the American College of Obstetricians and
      Gynecologists (ACOG) currently recommends considering gestational age-based dosing for
      unfractionated heparin for thromboprophylaxis in pregnancy with standard dosing as an
      alternative option. The data supporting altered dosing is very limited. In addition,
      increased dosing of heparin may result in challenges in anesthetic management, potentially
      limiting the receipt of neuraxial anesthesia resulting in increased need for general
      anesthesia associated with both increased maternal and fetal risks. The potential effects of
      higher prophylactic unfractionated heparin dosing in pregnant patients need to be further
      explored before being widely adopted for inpatient antepartum thromboprophylaxis. The
      investigators propose this study to provide a direct comparison of gestational age-based
      unfractionated heparin dosing to standard dosing of unfractionated heparin for pharmacologic
      thromboprophylaxis of hospitalized antepartum patients.
    

Intervention name(s): Standard Dose of Unfractionated Heparin; Gestational Age-Based Dose of Unfractionated Heparin
Intervention type(s): Drug; Drug
Intervention description(s): 5,000 units subcutaneous unfractionated heparin every 12 hours; First trimester (< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours
Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours
Third trimester (> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Thromboprophylaxis; Antepartum admission; Heparin
Evaluation of Shear Wave Elastography Reproducibility in Achilles Tendons and Plantar Fascia
Condition: Achilles Tendon; Plantar Fascia
Study type: Observational

Summary: 
      Achilles tendon plays a significant role in walking and sporting activities, particularly
      through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line
      examination of choice for patients suspected of having Achilles tendon injury, which is more
      and more frequent. Nowadays, ultrasound elastography can be used to evaluate the
      viscoelasticity properties of Achilles tendon, however little is known about the
      reproducibility of the technique. This study aims to evaluate the reproducibility of
      supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in
      Achilles tendon and plantar fascia.
    


Intervention name(s): Supersonic ShearWave Elastography
Intervention type(s): Other
Intervention description(s): ShearWave Elastography (SWE) is part of routine ultrasound examination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers without any Achilles tendon disease
      
Keywords: Elastography; Musculoskeletal System
Effect of NeuroAD on Alzheimer Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer
      for the treatment of Alzheimer patients.
    

Detailed description: 
      Synchronized TMS and cognitive training for the treatment of mild to moderate Alzheimer's
      patients. Treatment is delivered 5 days a week, for 6 weeks, visit is about an hour long.

      Evaluation is by neuropsychological evaluation at 6 weeks.
    

Intervention name(s): NeuroAD; Sham device
Intervention type(s): Device; Device
Intervention description(s): synchronized TMS+COGNITIVE TRAINING; Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.
Other intervention name(s): NICE; Control device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; TMS; NeuroAd; cognitive training; ADAS-Cog
Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
Condition: Dehiscence, Surgical Wound
MeSH terms: Surgical Wound Dehiscence; Surgical Wound
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB
      system for soft tissue bonding.
    

Detailed description: 
      Dermatologic wounds can be closed by a variety of methods. The choice of a particular closure
      technique should be based on the patient, wound, tissue characteristics, and anatomic
      location. The purpose of these closure methods is an approximation of wound lips until the
      regenerate tissue reach a phase, where it is closed and can sustain the daily tensile forces.

      Several methods are used for wounds closure such as sutures, staples, tapes, tissue adhesives
      and laser energy. There have been two fundamental approaches to laser assisted bonding of
      tissues:

        1. Laser welding-heating the approximated edges of cuts in tissues by a laser beam;

        2. Laser soldering- applying a biological solder onto the approximated edges and heating
           the solder (and the underlying tissue).

      Seraffix has developed the Seraffix LTB (Laser Tissue Bonding) System - a laser system for
      soft tissue bonding. This innovative system includes features that make laser soldering
      suitable for clinical use. The Seraffix system is composed of CO2 laser device, propriety
      grip device (Clamps) and soldering agent (Human Albumin).
    

Intervention name(s): Seraffix LTB
Intervention type(s): Device
Intervention description(s): laser soldering for soft tissue wounds
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laser bonding soft tissue albumin
Safety and Dose-finding Study of DC-TAB in Healthy Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective
      immune tolerance induction in humans.
    

Detailed description: 
      This study is a double-blind, randomized, placebo-controlled, dose-escalation study of DC-TAB
      in healthy human volunteers. DC-TAB is a solution of the small heat-shock protein alpha
      B-crystallin for intravenous injection, designed to induce selective immunological tolerance
      as a treatment for multiple sclerosis. In this first-in-man study, DC-TAB is administered to
      healthy subjects in varying doses and for a varying number of times, after which safety and
      tolerability is evaluated, as well as the impact of the treatment on antigen-specific
      responses by peripheral blood T cells and serum antibodies. Blood samples are additionally
      collected to measure serum concentrations of DC-TAB, and to determine the rate of clearance
      from the circulation. The study is double blind and placebo-controlled to strengthen the
      significance especially of immunological evaluations.

      The study consists of two parts. In Part 1, subjects receive a single dose of DC-TAB or
      placebo whereas in Part 2, (different) subjects receive DC-TAB or placebo on 3 consecutive
      days. In Part 1, four groups of subjects (n=10) are studied in a single dose, dose-escalation
      design. Each group of subjects are randomized to receive either DC-TAB (n=8) or placebo (n=2)
      once. In Part 2, three groups of subjects (n=12) are studied in a multiple dose,
      dose-escalation design. Each group of subjects are randomized to receive either DC-TAB (n=9)
      or placebo (n=3) once daily on 3 consecutive days. The next higher dose group in each part of
      the study only starts once safety data up to 4 days for Part 1, up to 8 days for Part 2 of
      the previous dose group have been reviewed and have raised no safety concerns. Part 2 is
      started once all safety data of Part 1 have been reviewed. Immunological effects of the
      treatments are evaluated over a period of 28 days.
    

Intervention name(s): recombinant human alpha B-crystallin; placebo comparator
Intervention type(s): Biological; Other
Intervention description(s): intravenous injection; intravenous injection
Other intervention name(s): HspB5; CRYAB; DC-TAB; phosphate-buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alpha B-crystallin; immune tolerance
PERFECT Project - Part 2 - Study 3
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional

Summary: 
      The objectives are to test the acute effects of different bagels containing pulse ingredients
      on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood
      glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours
      following the exercise session. We hypothesize that consumption of bagels containing pulse
      ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen
      consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction
      in lactate production during compared to the same exercise session following the ingestion of
      a non-pulse food. We also hypothesize that consumption of bagels containing pulse ingredients
      will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie
      compensation, following a 60-minute aerobic exercise session compared to the same exercise
      session following the ingestion of a non-pulse food.
    


Intervention name(s): Control; Pea flour; Pea fibre; Pea flour and pea fibre; Pea flour and pea protein; Pea flour + pea fibre + pea protein
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Non pulse ingredient bagel; Pulse ingredient bagel; Pulse ingredient bagel; Pulse ingredient bagel; Pulse ingredient bagel; Pulse ingredient bagel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
The Influence of Conversation Map on the Health Behaviors of Diabetes Patients
Condition: Diabetes Mellitus; Health Knowledge, Attitudes, Practice; Health Behavior; Glycated Hemoglobin (HbA1c)
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The American Diabetes Association indicates that diabetes self-management is a skill that
      diabetic patients must learn in the Diabetes Self-Management Education; thus, this
      contributes to shared care for diabetes, in which teams of physicians, professional nurses,
      and dietitians offer shared care to patients. However, according to the statistical analysis
      of the conditions of glycemic control in diabetic patients in 28 countries across 4
      continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c) of
      the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among
      diabetic patients in a shared-care program found that the percentage of patients with HbA1c
      lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed
      both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1%
      during that period. These results suggest that despite the increase in the proportion of
      patients who successfully managed their diabetes, some patients still encountered difficulty
      in glycemic control.Therefore, numerous health education tools on diabetes continue to be
      developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial
      influence on the dietary habits of diabetic patients, and that individual health education
      had the largest effect on diabetes control. In addition, using the conversation map for
      diabetes control also had a substantial influence on improving health behaviors. Among
      existing studies that have adopted the conversation map, no large-scale research has been
      conducted, the research samples and relevant studies in Taiwan have been scant, and no
      theoretical foundation has been applied in evaluating the effects of the conversation map.
      Accordingly, the investigators aimed to enhance the mutual experience exchange and learning
      among diabetic patients through adopting the conversation map to observe its influence on
      their health behaviors by incorporating it into existing health education modalities.
      Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed
      for assessing the effectiveness of glycemic control in diabetic patients.
    


Intervention name(s): Map group; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): diabetes shared care plus conversation map intervention; diabetes shared care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      This study is to see if a high response to the TTG screening test for celiac disease is as
      accurate as the current method of diagnosing celiac disease which entails a general
      anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening
      blood test is highly accurate, then some patients that are being evaluated for celiac disease
      may not require an upper GI endoscopy and can be treated more quickly. If they respond to the
      therapy then they will be deemed to have celiac disease.
    

Detailed description: 
      All patients scheduled for upper GI endoscopy will be approached for recruitment into the
      study. A minimum of 4 small intestinal biopsies will be taken from all subjects and controls.
      All TTG specimens will be run through the hospital laboratory. Intermediate level TTG values
      20-100 will be assessed separately and as part of the larger group. An optional part B of the
      study will assess the frequency of lactose intolerance in subjects prior to the start of a
      gluten free diet.
    

Intervention name(s): Diagnosis of Celiac Disease
Intervention type(s): Procedure
Intervention description(s): During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Aged 2 months to 18 years with a planned upper GI endoscopy.
      
Keywords: TTG; pediatric; comparison study