bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This clinical trial will identify exercise-related and emotional stress related effects on
      glycemic control in patients with type 1 diabetes using sensor-augmented pump (SAP) therapy.
    

Detailed description: 
      Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the
      outpatient setting performing their normal activities, to include their normal diet and
      exercise, while assessing the amount of type of exercise performed, and emotional stress
      levels, using stress sensor, questionnaires and salivary cortisol levels.
    

Intervention name(s): Observation During Exercise and Stress
Intervention type(s): Other
Intervention description(s): Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the outpatient setting performing their normal activities, to include their normal diet and exercise, while assessing the amount of type of exercise performed, and emotional stress levels, using stress sensor, questionnaires and salivary cortisol levels.
Subjects at the William Sansum Diabetes Center will perform graded exercise on a treadmill for up to 45 minutes with all activity and stress monitors running, achieving 30 and 60% calculated heart rate reserve, once during the study. Subjects at Mayo Clinic will perform a graded exercise test on a treadmill to determine V02max and ensure stable cardiac status, once during the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: type 1 diabetes; hypoglycemia; exercise; stress; artificial pancreas; cortisol
Study of the Safety, Tolerability, and PK of MRX-8 Administered Intravenously to HVs in SAD and MAD Cohorts
Condition: Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is designed to assess the safety and tolerability of single and multiple
      intravenous (IV) doses of MRX-8, to assess the pharmacokinetics of MRX-8 and its primary
      metabolite following single and multiple IV doses, and to measure the elimination of MRX-8
      and its metabolite in urine.
    

Detailed description: 
      This is a first-in-human, randomized, double-blind, placebo-controlled study consisting of 3
      parts. Part 1 will evaluate single ascending doses (SAD) of study drug. Part 2 will evaluate
      multiple ascending doses (MAD) of study drug administered for 7 days. Part 3 will evaluate
      MAD of study drug administered for 14 days.
    

Intervention name(s): MRX-8; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): novel semi-synthetic polymyxin B analog.; 5% dextrose in water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      This study aims to evaluate the psychometric properties of the Compliance of Parents of
      Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a
      caregiver-report for adherence and frequency of home program implementation of parents of
      children with Cerebral Palsy.
    


Intervention name(s): Questionnaire Development
Intervention type(s): Other
Intervention description(s): To evaluate psychometric the properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants in the current study were parents of chlidren with 2 to 18 years and recruited
        at Hecettepe Univercity Physical Therapy and Rehabilitation Faculty Cerebral Palsy and
        Pediatric Rehabilitation Unit.
      
Keywords: home program; cerebral palsy; questionnaire development; parent
Bioequivalence Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      To compare the single-dose oral bioavailability of clarithromycin 250-mg/5 mL powder for oral
      suspension of Ranbaxy Laboratories with that of Abbott Laboratories (Biaxin®) following
      administration of a 250 mg/5 mL dose in healthy, adult, human, male subjects under fasting
      conditions.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioavailability study on clarithromycin formulations
      comparing clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with
      Biaxin® granules 250 mg/5 mL oral suspension (containing clarithromycin 250 mg/5mL) of Abbott
      Laboratories in healthy, adult, human, male subjects under fasting conditions.

      A single oral dose of clarithromycin 250-mg/5 mL was administered during each period of the
      study under supervision of a trained Medical Officer.

      During the course of the study safety parameters assessed were vital signs, twelve-lead ECG,
      clinical examination, medical history, clinical laboratory safety tests (hematology,
      biochemical parameters and urine analysis) at base line and hematology and biochemical
      parameters at 24 hours post dose of the last period of the study. Twelve-lead ECG was
      recorded at 4 and 8 hours post-dose in each period.

      A Validated analytical method was used for the analysis of Clarithromycin in human plasma.
      Pharmacokinetic and statistical analysis was performed to conclude the bioequivalence.
    

Intervention name(s): clarithromycin 250 mg/5 mL powder for oral suspension
Intervention type(s): Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequiavelnce clarithromycin
Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
Condition: Impetigo
MeSH terms: Impetigo
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 study evaluating the safety, tolerability, systemic exposure, and activity
      of topical ATx201 GEL (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary
      nonbullous or bullous impetigo.
    


Intervention name(s): ATx201; ATx201 GEL Vehicle
Intervention type(s): Drug; Other
Intervention description(s): ATx201 GEL; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis
Condition: Neuropathic Pain; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Neuralgia; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether nabilone (Cesamet) when used as an
      adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief over
      gabapentin alone for the management of neuropathic pain in MS.
    

Detailed description: 
      Neuropathic pain syndromes, which occur due to damage to central and/or peripheral nerve
      axons, are often more difficult to manage and are commonly refractory to the conventional
      analgesia approach described by the World Health Organization, including NSAIDs and narcotic
      agents. These pain syndromes are often described by symptoms of burning, stabbing, crawling,
      shock-like, numbness and/or tingling, and can be quite concerning to the patient, especially
      when there is an inadequate response to treatment. It has been estimated that the prevalence
      of chronic pain in MS ranges anywhere from 30-90%, placing it as the second worst
      disease-induced symptom experienced by this patient population.

      The pathophysiologic causes of this pain syndrome are complex and multifaceted, with no one
      specific link attributed to the pain response. Due to the complexity of neuropathic pain -
      which is only partially understood at best - it may be necessary in many cases to treat the
      source of the pain with more than one agent in order to address the many different
      contributors to this pain process. More thorough review of how the currently available agents
      for NPP work together would provide clinicians with safety and efficacy data which would aid
      in providing optimal pain management.
    

Intervention name(s): nabilone; placebo
Intervention type(s): Drug; Other
Intervention description(s): Cesamet (nabilone) capsules given at titrating dosages as per protocol.; placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.
Other intervention name(s): Cesamet
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuropathic pain; Multiple Sclerosis; Nabilone; Gabapentin
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, randomized, placebo-controlled, double blind safety and feasibility
      clinical trial.
    

Detailed description: 
      To assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered
      via an intramyocardial route in the treatment of chronic ischemic heart disease in patients
      who are not eligible for percutaneous or surgical revascularization.
    

Intervention name(s): ADRCs processed by the Celution System; Placebo Comparator: Lactated Ringer's and Subject's Blood
Intervention type(s): Device; Device
Intervention description(s): Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.; Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.
Other intervention name(s): ADRCs; Intramyocardial injections; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic heart disease; Coronary artery disease; Chronic heart failure; Cardiovascular disease; Adult stem cells; Adipose derived regenerative cells
Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated
      contacts in a day care setting; and if so, to estimate the rate of transmission.
    


Intervention name(s): CAIV-T
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
The Effect of Polycystic Ovary Syndrome on Pelvic Floor Structure and Function
Condition: Reproductive System Disorder; Urinary Incontinence; Urogenital Disease; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Urinary Incontinence; Enuresis; Urogenital Diseases; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Polycystic Ovarian Syndrome (PCOS) is the most common endocrinological disorder in women of
      reproductive age, and its prevalence is reported to be 6-21% in women aged 15-49 (1).
      Although its etiopathogenesis is still not clear, it is known that it is due to the
      disregulation of ovarian steroidogenesis under the influence of some environmental and
      genetic factors. Diagnosis of ESHRE / ASRM has set Rotterdam criteria in 2003; one of these
      criteria is the presence of hyperandrogenism (2). Hyperandrogenism leads to an increase in
      general muscle mass in the body (1, 3, 4).

      Pelvic floor muscles are associated with urethra in the anterior compartment, rectum and anus
      in the posterior compartment, and uterine support in the apex; major urinary and fecal
      continence ensuring its functions in order to stop in the appropriate position of the pelvic
      organs (5). The well-being of the pelvic floor muscle strength has a protective effect from
      urinary and fecal incontinence.

      It has been emphasized that the "anogenital distance" determined by the measurement of the
      anal region anterior to the clitoris anterior may also be a criteria in the diagnosis of
      Polycystic Ovary Syndrome (7,8,9).

      In this study, patients in the reproductive age between 18-40 years, who applied to our
      gynecology outpatient clinic and were diagnosed as PCOS according to Rotterdam criteria wil
      be study gorup and the women without PCOS will be control group. We aimed to evaluate the
      pelvic muscle strength with perineometry, to measure anogenital distance and to determine
      possible relationships with each other. In addition to demographic information, ICIQ-SF
      (Urinary incontinence inquiry short form) will also be taken to evaluate pelvic floor
      function (10).
    


Intervention name(s): Anogenital distance measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Measurements of AGD and perineal muscle strength
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Reproductive aged females, age between 18-40 yrs.
      
Keywords: polycystic ovary syndrome; urinary incontinence; anogenital distance
The Effect Of Aspirin On Survival in in Patients Undergoing Chronic Hemodialysis
Condition: Hemodialysis
Study type: Interventional

Summary: 
      The aim of present study is to examine the effect of low-dose aspirin on the incidence of
      cardiovascular events and mortality in patients undergoing chronic hemodialysis.
    

Detailed description: 
      This study prospectively evaluate the impacts of low dose aspirin on survival and
      cardio-cerebral vascular events in a large cohort of Chinese patients undergoing chronic
      hemodialysis. Between January 2008, consecutive patients with hemodialysis with aspirin were
      enrolled.We examine the association of aspirin with all-cause mortality in patients matched
      by propensity scores using the Kaplan-Meier method and Cox models in "intention-to-treat"
      analyses.The secondary endpoint was rate of cardio-cerebral events.
    

Intervention name(s): acetylsalicylic acid
Intervention type(s): Drug
Intervention description(s): 75-100mg,per day
Other intervention name(s): Aspirin
Intervention MeSH terms: Aspirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: aspirin
Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients
Condition: Cataract; Spherical Aberrations; Intraocular Lenses; Depth of Focus
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate differences in the depth of focus after implantation
      of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation
      of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to
      emmetropic patients due to a larger amount of spherical aberrations.
    


Intervention name(s): AMO Tecnis ZA9003; AMO Sensar AR40e
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
VR System for Cross-modal Rehabilitation of Hemianopia
Condition: Hemianopia, Homonymous; Hemianopsia, Homonymous
MeSH terms: Hemianopsia
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate the effectiveness of a new
      rehabilitation for visual hemianopia. The study team believes a cross-modal rehabilitation
      technique delivered by a virtual reality system can help restore the visual field for
      subjects with homonymous hemianopia.
    

Detailed description: 
      The study tests a novel rehabilitation system, translated from promising cross-modal
      rehabilitation animal research, that is the first treatment capable of restoring the visual
      field for hemianopia patients. This noninvasive technique uses a virtual reality device to
      deliver visual and auditory stimulus. The goals of this study are to obtain proof of concept
      and procure rehabilitation data to support the development of this novel rehabilitation
      treatment.
    

Intervention name(s): Cross-model Visual Auditory Rehabilitation
Intervention type(s): Device
Intervention description(s): Subjects will put on a virtual reality rehabilitation system which will present sights and sounds.
Intervention model: Single Group Assignment
Intervention model description: All study participants will be given the same treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemianopia; Virtual Reality; Rehabilitation; Hemianopsia
Dietary Fat and High-Density Lipoprotein (HDL) Metabolism-Effect of Carbohydrate and Fat Intake
Condition: Overweight; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Overweight
Study type: Interventional

Summary: 
      Generally, people with low levels of high-density lipoprotein (HDL) in blood are more likely
      to get heart disease than those who have normal or high levels. Dietary fat, whether the
      harmful type (saturated) or beneficial type (unsaturated) raises HDL levels. Dietary
      carbohydrate lowers HDL. The investigators are doing this research study to find out why the
      amount of HDL in a person's blood is affected by dietary unsaturated fat and carbohydrate.
      The investigators will trace the ability of the HDL in a person's blood to take up
      cholesterol, get bigger, and then leave the blood by passing into the liver. The
      investigators want to know if dietary unsaturated fat improves the ability of HDL to do this
      compared to dietary carbohydrate.
    

Detailed description: 
      The investigators will study the kinetics of multiple types of high-density lipoprotein (HDL)
      in humans under two strictly controlled dietary conditions, high unsaturated fat and high
      carbohydrate, in 20 individuals with low HDL cholesterol and overweight or obesity. The
      participants will be given the controlled diets for 4 weeks in a randomized crossover design.
      They will be admitted to the Brigham & Women's Hospital Center for Clinical Investigation
      (CCI) the morning of Day 28 when they will be infused intravenously with a stable isotope
      tracer, trideuterated (D3), leucine for 10 minutes as a bolus. Blood will be sampled in the
      hospital through 24 hours, and thereafter at the ambulatory clinical center throughout 94
      hours. HDL subtypes will be prepared in Dr. Sacks's laboratory at Harvard School of Public
      Health (HSPH) and analyzed for content of lipids and proteins, and for incorporation of the
      tracer into apolipoprotein A-I, the principal protein of HDL. These data will be studied by
      interactive modeling to a multi-compartment model of human HDL physiology that best fits the
      observed data. The model will yield HDL metabolic rates during unsaturated fat and
      carbohydrate-rich diets which will be tested for statistical significance.
    

Intervention name(s): Low Fat and High Carbohydrate Diet; High Fat and Low Carbohydrate Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Low Fat and High Carbohydrate Diet; High Fat and Low Carbohydrate Diet
Other intervention name(s): Diet and HDL Metabolism; Diet and HDL Metabolism
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Relations Between Atherogenic Index of Plasma-Glucose Metabolism
Condition: Diabetes Mellitus Risk
Study type: Observational

Summary: 
      In this study, the investigators aimed to find out whether there is any association between
      the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the
      well-known diabetic risk factors, the investigators purposed to reveal new ones.
    

Detailed description: 
      Atherogenic index of plasma (AIP) is a relatively new index and a predictor of cardiovascular
      risk. AIP has been shown to be associated with impaired glucose metabolism. This study aimed
      to evaluate the relationship between AIP and parameters of glucose metabolism.

      Methods: This observational study involved 448 healthy individuals who were at risk for
      diabetes. They were sent to hospital for diabetes check. According to the 75 g oral glucose
      tolerance test participants were categorized into the three groups; non-diabetic,
      prediabetic, and diabetic based on the criteria of the American Diabetes Association (ADA).
      The association between the diabetes group, AIP and parameters of glucose metabolism was
      analyzed.

      The accuracy of registry data compatible with medical records. Statistical analyses were
      carried out using the Statistical Package for Social Sciences, Windows version 15.0 (SPSS,
      Chicago, Illinois, USA). Descriptive statistics for each variable were determined. Normality
      of the data distribution was assessed with the Kolmogorov-Smirnov test. For continuous
      variables, non-parametric statistics (Mann-Whitney or Kruskal-Wallis), and parametric
      statistics (t-test, ANOVA analysis) were used as appropriate. Statistically significant
      differences between the groups were determined by the chi-square test for categorical
      variables. Associations between the variables were explored using the Pearson correlation and
      Spearman's rho (for data that was not normally distributed). Linear regression analysis with
      backward elimination was also performed to define variables associated with AIP.
    

Sampling method: Non-Probability Sample
Study population: 
        448 healthy individuals who were at risk for diabetes. According to the 75 g oral glucose
        tolerance test participants were categorized into the three groups; non-diabetic,
        prediabetic, and diabetic based on the criteria of the American Diabetes Association.