bioihbjkbjnl/mcl2 huggingface dataset:
Type 2 Diabetes and Exercise Function in Single Leg Exercises
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study plans to learn more about the effects of type 2 diabetes (T2DM) on exercise blood
      flow and muscle oxygen uptake. This study will evaluate & compare exercise function during
      single leg plantar flexion exercise in a total of 45 subjects from the Denver area (15 lean
      controls, 15 people with T2DM, and 15 overweight control subjects).

      Differences between the exercise responses in people with T2DM and healthy people will help
      further identify the disease process of T2DM and direct future research of treatments and
      interventions.
    

Detailed description: 
      It is well established that functional exercise capacity and peak oxygen uptake (VO2) are
      reduced in patients with type 2 diabetes mellitus (T2DM) compared with healthy counterparts.
      The mechanisms underlying the exercise deficit in T2DM remain largely unknown, but previous
      work has suggested that reduced exercise blood flow and impaired submaximal VO2 may be
      contributing factors. Both of these findings are consistent with a peripheral impairment of
      skeletal muscle oxygen delivery, oxygen utilization, or both. Indeed, dysfunction of skeletal
      muscle metabolism plays a key role in the pathophysiology of T2DM, and considerable work has
      described abnormalities of oxidative function in the skeletal muscle of people with T2DM.
      Given this, it is likely that the causes of exercise intolerance in T2DM may relate to
      specific defects at the level of the skeletal muscle, particularly given that skeletal muscle
      blood flow and oxidative capacity are impaired in diabetes. However, to our knowledge, no one
      has related these peripheral muscle abnormalities to the diminished exercise function in this
      patient group.

      The overarching hypothesis for the proposed research is that both a failure to adequately
      increase muscle oxygen delivery following the onset of exercise and reduced oxidative
      function of skeletal muscle contribute to the acute oxygen deficit and diminished exercise
      tolerance that has been observed in patients with T2DM.
    

Intervention name(s): Single Leg Exercise Training
Intervention type(s): Other
Intervention description(s): Following the completion of baseline testing, all 3 subject groups will undergo supervised single leg, exercise training of the index (dominant) calf muscle 5 days per week for two weeks - alternating weight-bearing single leg calf raises and single leg calf extensions by endurance resistance training (weight machine apparatus).
Other intervention name(s): Exercise Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Exercise Impairment; Blood Flow; Muscle Oxygen Uptake; Exercise Training
Targeting Social Determinants to Improve Chronic Kidney Disease Care
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The primary research goals of this application are to characterize social factors including
      health literacy and numeracy skills of CKD patients and examine associations with knowledge,
      self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an
      efficient interactive educational intervention to facilitate patient-provider communication.
      The investigators will accomplish these goals by executing a cluster-randomized controlled
      trial and performing detailed analysis of baseline measures. The specific aims of this study
      are:

      Specific Aim 1: Determine the association of social factors with patient kidney knowledge,
      self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to
      advanced CKD.

      Hypothesis: In patients with CKD, low health literacy and numeracy is common and associated
      with older age, non-white race, fewer years of education, lower socioeconomic (income)
      status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with
      medication and diet self-care recommendations. Low literacy/numeracy is also associated with
      higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance.

      Specific Aim 2: Evaluate the impact of a tailored literacy-sensitive educational tool used
      cooperatively by physicians and patients to improve self-care and outcomes in CKD.

      Hypothesis: Utilization of a concise literacy-sensitive physician-delivered educational tool
      will be feasible and associated with higher patient kidney knowledge, self-efficacy of
      self-care and greater adherence to medication and nutrition recommendations compared to usual
      care.
    


Intervention name(s): interactive educational intervention
Intervention type(s): Behavioral
Intervention description(s): Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: health literacy; health numeracy
A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of PRX-100 compared with aceclidine alone and vehicle in
      the treatment of early to moderate presbyopia.
    


Intervention name(s): Aceclidine+tropicamide combination; Aceclidine; Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ophthalmic Solution; Ophthalmic Solution; Ophthalmic Solution
Other intervention name(s): PRX-100
Intervention MeSH terms: Tropicamide; Aceclidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood
Condition: Empyema; Pneumonia
MeSH terms: Empyema
Study type: Interventional
Phase: Phase 3

Summary: 
      A great controversy exists about which is the best method to perform the evacuation of the
      collection. The purpose of this study is to evaluate which is the best initial treatment to
      drain complicated parapneumonic empyema (stages II and III) in children: the present study
      raises a hypothesis of equivalence between both arms of treatment (chest drainage plus
      intrapleural urokinase or videothoracoscopic debridement).
    


Intervention name(s): Urokinase; Video-Assisted Thoracoscopic
Intervention type(s): Drug; Procedure
Intervention description(s): Chest tube with intrapleural urokinase infusion for 3 days; Video-Assisted Thoracoscopic decortication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Empyema; Urokinase; Thoracoscopic; Childhood
Assessment of Thrombogenicity in Acute Coronary Syndrome
Condition: Type 2 Diabetes Mellitus; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Diabetes Mellitus; Diabetes Mellitus, Type 2; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to assess platelet dependent thrombogenicity in patients after
      acute coronary syndrome using an ex vivo arterial injury model.
    

Detailed description: 
      Abnormal platelet activity seen in patients with Type2 Diabetes Mellitus (T2DM) may be an
      important contributor to their enhanced cardiovascular risk and higher rates of
      cardiovascular events following acute coronary syndrome, despite dual antiplatelet therapy
      with aspirin and clopidogrel. We have earlier demonstrated high thrombogenicity in
      individuals with T2DM and CAD in the absence of acute ischaemic events, despite therapeutic
      doses of aspirin.We hypothesise that patients with T2DM will have increased thrombogenicity
      after acute coronary syndrome despite optimal secondary prevention medication.Measuring ex
      vivo thrombus area using an arterial injury model simulates plaque rupture and reflects the
      summative effect of all haemostatic abnormalities. The thrombus area of patients with ACS and
      T2DM will be compared to the controls without T2DM.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with non-ST elevation myocardial infarction - Acute Coronary syndrome (ACS) and on
        existing medication will undergo chamber study
      
Keywords: Type 2 Diabetes Mellitus; Acute Coronary Syndrome; Platelet dependent thrombogenicity
Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass
Condition: Gastroesophageal Reflux Disease; Morbid Obesity
MeSH terms: Gastroesophageal Reflux; Obesity, Morbid
Study type: Interventional

Summary: 
      The hypothesis of this study is that surgical techniques primarily designed for weight loss,
      ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.

      Therefore the present study intends to evaluate such impact on patients submitted to two of
      the most common techniques available, the Roux-en-Y Gastric Bypass and Vertical Sleeve
      Gastrectomy.
    

Detailed description: 
      In order to determine if weight loss surgeries do indeed ameliorate GERD in morbidly obese
      patients, esophageal syndromes will be evaluated following the Montreal Consensus, where
      troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for
      Portuguese language along with esophageal syndromes with injury assessed through upper
      endoscopy.

      Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid
      exposure will be characterized when total esophageal pH < 4 for at least 4% of its total
      monitoring time.
    

Intervention name(s): Roux-en-Y Gastric Bypass; Vertical Sleeve Gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): The Roux-en-Y gastric bypass procedure involves creating a stomach pouch out of a small portion of the stomach and attaching it directly to the small intestine, bypassing a large part of the stomach and duodenum. Not only is the stomach pouch too small to hold large amounts of food, but by skipping the duodenum, fat absorption is substantially reduced.; VSG surgery restricts food intake and decreases the amount of food used. Most of the stomach is removed during this surgery, which may decrease ghrelin, a hormone that prompts appetite. Lower amounts of ghrelin may reduce hunger more than other purely restrictive surgeries, such as AGB.
Other intervention name(s): GBP; Sleeve
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: GERD; Roux-en-Y Gastric Bypass; Vertical Sleeve Gastrectomy
A Comparison of Daily Disposable Contact Lenses.
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study seeks to evaluate the clinical performance of a new CE marked daily disposable
      contact lens that contains a wetting agent to a recently improved daily disposable contact
      lens.
    


Intervention name(s): nelfilcon A; narafilcon A
Intervention type(s): Device; Device
Intervention description(s): spherical soft contact lens; spherical soft contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: refractive error
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
Condition: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors; Healthy
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacokinetics of three different single doses activated recombinant human factor VII in
      Caucasian and Japanese healthy subjects.
    


Intervention name(s): activated recombinant human factor VII; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits; Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      1265162 in healthy male subjects following inhalative administration of multiple rising
      doses.

      Secondary objectives is the exploration of the pharmacokinetics (PK) including dose
      proportionality and time dependency of BI 1265162 after multiple dosing
    


Intervention name(s): BI 1265162; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple rising inhaled doses; Multiple rising inhaled doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Choosing the Technique for First Abdominal Entry in Laparoscopy
Condition: Decision-Making
Study type: Observational

Summary: 
      Several techniques for initial abdominal entry in laparoscopy have been introduced in
      literature. Various guidelines and recommendations are available on this subject, however,
      compliance to these are controversial. The purpose of this study is to evaluate the rationale
      and the process of decision making for first entry technique in laparoscopy.
    

Detailed description: 
      Several methods, i.e., the Veress needle, open approach using the Hasson trocar and direct
      trocar insertion without insufflation have been described for initial abdominal entry in
      laparoscopy. On the other hand, relatively new approaches, e.g., the optical or radially
      expanding trocars did not become common yet. Despite the advantages of laparoscopic surgery,
      serious complications can be encountered during the initial entry. Development of a
      complication, e.g., major vascular and intestinal injury, would affect the outcome of the
      operation and it may result in conversion to the open approach. Because of low incidence of
      these complications, it is impossible to show any superiority of one approach to another.

      In this study, we aimed to analyze the rationale and the process of decision making of a
      surgeon about initial abdominal entry technique for laparoscopy.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Close-ended survey will be performed to the participants. The survey consisted of 18 questions (Appendix). The first six questions (#1-6) were related with respondent's demographical and educational data and experiences of surgical and laparoscopic practices. There were five questions to determine preferred technique for first entry (#7-11), three questions for complications (#12-14), and remaining four questions for safety maneuvers (#15-18).
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Close-ended survey questions were formed and sent to general surgeons by e-mail containing
        the web address of the survey.
      
Keywords: Trocar entery; Surgery, Laparoscopic
Kinematical Evaluation of Lumbar Rotation in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Low back pain (LBP) is considered one of the most common musculoskeletal disorders in modern
      society, resulting in substantial costs to society. Factors associated with the development
      of low back pain include poor posture, strenuous work with the body, inadequate non ergonomic
      work and traumas.

      Rotation movement pattern of the lumbar spine in different positions is essential aspect in
      understanding the LBP Pathophysiology. Rotation coupled with forward bending (flexion) is a
      dominant factor which could increase the risk LBP and disc prolapse. There is also a decline
      in range of motion (ROM) of rotation in forward bending (flexion) compared to neutral
      position during sitting and standing.

      In addition,lumbar rotation movement patterns differ in population with LBP compared to
      asymptomatic individuals. Healthy individuals exhibit rotation accompanied by consistent
      coupled movement patterns of lateral bending in the opposite direction at thr upper levels,
      and by lateral bending in tge same direction at the lower levels . while Chronic LBP patients
      exhibit non consistent patterns altered from those of the normal population.
    

Detailed description: 
      According to the investigators, Kinematic measures of velocity and acceleration of lumbar
      rotation in neutral position and full flexion in sitting and standing did not studied yet.
      Evaluating these parameters, in addition to ROM and plains evaluation in the LBP population,
      compared to healthy population will contribute a lot in understanding this issue.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Individuals referred to physiotherapy for LBP
      
Keywords: Low Back Pain; Disability; Kinematic measures
A Study of Mucopolysaccharidosis Type IIIB (MPS IIIB)
Condition: Mucopolysaccharidosis Type IIIB; Mucopolysaccharidosis Type 3 B; MPS III B; MPS 3 B
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis III
Study type: Observational

Summary: 
      Mucopolysaccharidosis type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B) is a
      severe neurodegenerative disorder. The purpose of this study is to learn more about the
      health problems in patients with MPS IIIB and how to measure these problems over time. It
      will particularly look at how the disease develops in young children. This is an
      observational study, so no experimental drug will be given. The results from this study will
      help us design future studies to measure whether these health problems get better when we
      give experimental drug for MPS IIIB.
    

Detailed description: 
      This is a multicenter, multinational, longitudinal, observational study in subjects 1 through
      10 years of age who have been diagnosed with MPS IIIB. Data will be prospectively collected
      from 20 to 30 subjects to understand the clinical progression of MPS IIIB in terms of
      neurocognitive function, behavior, quality of life, imaging characteristics, genotype, and
      biochemical markers of disease burden. This information may help inform the design and
      interpretation of subsequent interventional studies.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study Population: Subjects diagnosed with MPS IIIB

        Males and females 1 through 10 years of age (ie, until they turn 11) with a documented
        diagnosis of MPS IIIB are eligible to participate in this observational study. Up to
        approximately 5 subjects 6 to 10 years old, inclusive, will be enrolled; the remaining
        subjects will be 1 to 5 years old, inclusive. Additional entry criteria follow.
      
Keywords: Sanfilippo Syndrome Type B
Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
Condition: Chronic Obstructive Pulmonary Disease; Emphysema
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is intended to be an initial "proof-of-concept" study to show feasibility, validate
      assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema
      patients who have clinically relevant (and quantifiable) autoimmune responses. The primary
      goal is to determine effects of belimumab on levels of autoantibodies against glucose
      regulated protein 78 (GRP78) among patients with pulmonary emphysema attributable to
      cigarette smoking. The investigators hypothesize that belimumab treatment will safely reduce
      circulating levels of autoantibodies that are associated with emphysema, and comorbidities of
      this lung disease, including atherosclerosis.
    

Detailed description: 
      Specific Aim 1: To conduct a double-blind, Phase IIa trial, in which 18 former smokers with
      pulmonary emphysema (per chest CT scans), and circulating anti-GRP78 autoantibody levels
      >mean normal values (by ELISA), will be randomized 2:1 to belimumab vs. placebo. Subjects
      will receive 8 infusions of either belimumab or placebo over a 6 month interval. Plasma
      anti-GRP78 will be measured pre-treatment, and at 1, 3, 5, and 7 months. The investigators
      hypothesize belimumab therapy will more effectively reduce anti-GRP78 IgG autoantibodies, the
      primary endpoint of this trial, compared to placebo.

      Specific Aim 2: To determine effects of the belimumab therapy on secondary endpoints (at the
      times detailed for Aim 1) that include levels of pneumococcal-binding antibodies (by ELISA),
      circulating B-cell numbers and phenotypes (by flow cytometry), and the rate and severity of
      adverse events (AE) at any time during treatment. The investigators hypothesize belimumab
      will have dose-related effects on B-cell numbers and their differentiation, while minimally
      reducing host defense antibodies, and will also have an acceptable AE profile.
    

Intervention name(s): Belimumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Belimumab is an anti-BLyS (B-lymphocyte stimulating factor) agent administered by infusion.; An identically appearing placebo infusion.
Other intervention name(s): Benlysta
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to receive active:placebo in a ratio of 2:1.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; belimumab; biologic agent; GRP78