bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Diet Modification; Child, Only
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low
      carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes.
      Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39%
      of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total
      daily calories). The investigators will evaluate metabolic effects of these diets by
      measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3
      months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain,
      lipid profiles, and body composition.
    

Detailed description: 
      The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low
      carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes.
      Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39%
      of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total
      daily calories). The investigators will evaluate metabolic effects of these diets by
      measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3
      months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain,
      lipid profiles, and body composition.

      Participants will be admitted to the Clinical Research Center at baseline and 3 months.
      Gradual reduction in serum glucose to under 80 mg/dL will be achieved by an increase in their
      insulin infusion rate through their insulin pump. Plasma glucose, catecholamines
      (epinephrine, norepinephrine), glucagon, and serum ketones are measured at baseline and after
      glucose is below 80 mg/dL. All subjects will have lipid evaluation and body composition (DXA
      scan) at baseline and 6 months. Subjects' growth will be evaluated by comparing their height
      and weight z-score before and after the 6 months of diet intervention. Change in growth
      velocity will also be assessed. During the study, participants not already using continuous
      glucose monitoring will be placed on Dexcom G5 to monitor blood sugars regularly. Subjects
      will also be monitoring serum ketones at home regularly.
    

Intervention name(s): Low carbohydrate diet; Very low carbohydrate diet
Intervention type(s): Other; Other
Intervention description(s): Low carbohydrate diet; Very low carbohydrate diet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized to either low or very low carbohydrate diet
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; low carbohydrate diets; insulin pump therapy; continuous glucose monitoring
A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics
      (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal
      impairment.
    

Detailed description: 
      This is a phase I, open-label, multicenter, single dose study to evaluate the PK and safety
      of pasireotide s.c. injection in subjects with varying degrees of renal impairment compared
      to healthy subjects with normal renal function. Subjects will be classified by their
      respective degree of renal functions (normal, mild, moderate, severe, and ESRD (End Stage
      Renal Disease) according to eGFR as determined at the screening visit.
    

Intervention name(s): SOM230
Intervention type(s): Drug
Intervention MeSH terms: Pasireotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal, impairment, endstage renal disease; renal; impairment; endstage renal disease
Effectiveness of a Pain Education Program on Chronic Neck Pain Patients
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This project aims to study the effectiveness of a pain education program in the improvement
      of chronic pain and disability/impairment. Assuming the definition established in the United
      States in 1975 on the fourth working group of the National Conference on Preventive Medicine:
      "Health education must be a process that informs, motivates and helps people to adopt and
      maintain practices and healthy lifestyles, environmental advocates changes necessary to
      facilitate these objectives and professional training and directs research towards the same
      objectives. " Once the need of educating patients is stablished on subjects with diseases, it
      is necessary to encourage them to actively participate on the control of them and to achieve
      significant improvement of adherence
    

Detailed description: 
      BACKGROUND AND PURPOSE:

      Patient education over the knowledge of pain causes and perpetuating psicosocial factos, so
      as a gradual physical therapy intervention may success in modifying habits, and consequently
      emotional state and behaviour in order to maintain or recover subject's social participation
      being this program effective in pain diminution over chronic neck pain.

      Main goal: To evaluate the effectiveness of a pain education program for patients with
      chronic neck pain, to decrease the intensity of pain in front of one physiotherapy program
      (TENS and exercise)

      Experimental group: Will receive five group sessions of 60-120 minutes twice a week with a
      maximum of 10 participants.

      Control group: Five individual sessions twice a week, will be performed of transcutaneous
      electrical nerve stimulation (TENS) on neck area an exercises.

      OUTCOMES

      Primary outcome

        -  Intensity of pain, measured by the visual analog scale: VAS. The mean of the values wil
           be calculated described in the assessment, the mean of the last week was also compiled.

        -  The degree of neck disability/impairment measured using the Northwick Park Pain
           Questionnaire (NPPQ)
    

Intervention name(s): Session of Pain Education programe; Control Group
Intervention type(s): Other; Other
Intervention description(s): Five group sessions of patient education pain of 60-120 minutes one for week with a maximum of 10 participants.; Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation
Condition: Anesthesia, Caudal; Pediatrics; Elevated Intracranial Pressure
MeSH terms: Intracranial Hypertension
Study type: Interventional

Summary: 
      Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a
      certain volume of fluid into the epidural space for cauda anesthesia may push some
      cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the
      head. Such mild changes are compensated well by healthy individuals and no clinical sequel is
      seen, however at-risk populations may be affected. We aim to see how different amounts of
      fluid injected into the epidural space may change two clinical parameters affected by
      intracranial pressure to determine if a lower volume is safer than a higher one.
    

Detailed description: 
      Caudal epidural injection of local anesthetic solution is a common neuraxial anesthesia
      technique that provides excellent peri-operative analgesia in children. Unfused sacral hiatus
      allows for easy and safe access into the epidural space. Anatomically, injection of a certain
      volume of fluid over the dural sac inside the closed spinal canal can push the cerebrospinal
      fluid cranially. This push may lead to increased intracranial pressure. We will measure two
      findings affected by intracranial pressure (optic nerve sheath diameter and cerebral
      oxygenation) and compare the effects of two different volumes of caudal injections on these
      measures.

      Children with closed fontanelles and scheduled to undergo elective surgery, for which caudal
      anesthesia is an effective method for peri-operative analgesia, will be recruited for this
      study. Injection volume will be determined depending on the level of analgesia required for
      the surgical procedure. Ultrasonographic measurements of optic nerve sheath diameter and
      near-infrared spectrometry measurement of cerebral oxygenation will be taken before and after
      caudal anesthesia.
    

Intervention name(s): Caudal anesthesia
Intervention type(s): Procedure
Intervention description(s): Caudal epidural injection will be performed after induction of general anesthesia.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will receive either a low or high volume of caudal injection.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: optic nerve sheath diameter; cerebral oximetry; caudal epidural anesthesia
Taste-masking Study for Tricaprilin in Sensory Panelists
Condition: Taste Profile Assessments
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label multiple-dose study of the taste profile of tricaprilin formulated as a
      powder for reconstitution.
    


Intervention name(s): Tricaprilin
Intervention type(s): Drug
Intervention description(s): Tricaprilin with flavoring agents added
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Methodologies to Measure Blood Flow and Oxygenation in Adults With Sickle Cell Disease
Condition: Healthy; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      The purpose of the study is to determine whether imaging techniques, such as magnetic
      resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging
      (LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in
      different organ systems of participants with sickle cell disease (SCD). Differences in blood
      flow and oxygen levels detected by these techniques will be evaluated to determine their
      utility as biomarkers of clinical disease pathophysiology.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with mild to severe VOC
      
Biospecimen description: 
      Blood samples will be collected for hematology, blood chemistry, and venous blood gas
      analysis. Blood samples will also be used for exploratory biomarker development specific to
      SCD.
Development and Evaluation of a Hormone Replacement Therapy Decision-Aid
Condition: Menopause; Hormone Replacement Therapy
Study type: Interventional

Summary: 
      The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT)
      is complex because patients must balance the short and long-term risks and benefits.
      Information from new and important clinical trials must also be considered. The purpose of
      this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in
      improving the decision making process for women considering the use of estrogen HT.
    

Detailed description: 
      Background:

      The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT)
      is complex because patients must balance the short and long-term risks and benefits.
      Information from new and important clinical trials must also be considered. The purpose of
      this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in
      improving the decision making process for women considering the use of estrogen HT.

      Objectives:

      The objectives of the study are to: 1) develop a model of the decision-making process for
      postmenopausal women considering hormone (HT), based on Multi-Attribute Utility Theory
      (MAUT); 2) produce an interactive CD-ROM decision-aid for HT; 3) evaluate the effect of the
      interactive CD-ROM decision-aid on patient satisfaction with decision (SWD) and knowledge
      about menopause and HT; and 4) test the effect of the interactive CD-ROM decision-aid on
      women�s decisions regarding use of HT.

      Methods:

      Phase I (completed) used structured interviews and surveys in the development of a decision
      model for HT. In phase II, an interactive CD-ROM decision-aid was developed and a randomized
      controlled trial (RCT) of its effect on decision processes was conducted. Postmenopausal
      women, aged 45-74 were recruited from the primary care clinics of the four participating
      Veterans Affairs hospitals: Milwaukee, Madison, Chicago-Hines, and Chicago-Westside. The
      primary hypothesis was that women who use the CD-ROM decision-aid would demonstrate increased
      satisfaction with their decision regarding hormone replacement therapy use compared to women
      receiving the control intervention.

      Status:

      Enrollment and follow-up assessments have been completed. The study is in the analysis phase.
      The study was presented to the VA HSR&D Combined Monitoring Board on February 5, 2003 and the
      committee voted unanimously to recommend continuation of the trial. The study has had one
      publication and several scientific abstract presentations.
    

Intervention name(s): Hormone Replacement Therapy Decision-Aid
Intervention type(s): Behavioral
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
Condition: Major Depressive Disorder; Psychotic Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called
      cortisol. Under normal conditions, cortisol and other hormones are created by the body in
      response to physical and emotional stress, triggering a healthy stress response. People who
      suffer from psychotic major depression may have unusually high levels of cortisol circulating
      within them or abnormal patterns of cortisol levels, overloading the stress response
      mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If
      Corlux can keep the body's cortisol receptors from being overloaded, the stress response
      system may return to normal function, which may result in improvement of symptoms. The
      purpose of this study is to allow patients who have already participated in an earlier 8 week
      study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment
      with Corlux periodically if a psychotic episode should reappear during a period of one year.
    


Intervention name(s): Mifepristone
Intervention type(s): Drug
Intervention MeSH terms: Mifepristone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PMD; Depression; Psychosis; Psychotic Major Depression; Major Depression
The Effects on Growth of a Non-Routine Infant Formula
Condition: Growth
Study type: Interventional

Summary: 
      A study to evaluate the growth and development of term infants fed either an extensively
      hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an
      extensively hydrolyzed formula without probiotics
    


Intervention name(s): infant formula
Intervention type(s): Other
Intervention description(s): hydrolyzed infant formula without probiotics
hydrolyzed infant formula with probiotics
hydrolyzed infant formula with probiotics
Other intervention name(s): no other names for any of the intervention arms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: infant formula
HIIT Improves Survival of Heart Failure Patients
Condition: Heart Failure; Cardiac Rehabilitation; Cardiac Remodeling, Ventricular
MeSH terms: Heart Failure; Ventricular Remodeling
Study type: Observational [Patient Registry]

Summary: 
      BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies.
      High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF
      patients, which was hypothesized to improve the survival of HF patients.

      OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of
      HF patients.

      METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease
      management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity
      (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV
      end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic
      peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF
      patients with LVEF> 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were
      classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the
      interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up.
      Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF
      during at end of the study.
    


Intervention name(s): High-intensity interval training
Intervention type(s): Behavioral
Intervention description(s): Patients warmed up for 3 min at 30% of peak oxygen consumption (VO2peak). Five 3-minute intervals at 80% of VO2peak and each interval was separated by 3-minute exercise at 40% of VO2peak. The exercise session was terminated by 3-minute cool-down at 30% of VO2peak. All subjects used a EKG and BP monitors as indicators of the assigned exercise intensity. Borg 6-to-20 scale was used to assess the rate of perceived exertion during and after each exercise session. Patients suffering unstable hemodynamic, ischemic cardiac symptoms/signs, and uncontrolled arrhythmia were instructed to immediately terminate exercise training.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Baseline information of all eligible candidates, including age, gender, body mass index
        (BMI), and disease duration were recorded. Serum low-density lipoprotein (LDL), creatinine
        (Cre), high sensitivity C-reactive protein (hs-CRP), glycohemoglobin (Hba1c), and b-type
        natriuretic peptide (BNP) were evaluated during the follow-up. Each blood sampling for BNP
        analysis and short form-36 health survey (SF-36) of physical component score (PCS) and
        mental component score (MCS) for qualities of life were performed just before each
        cardiopulmonary exercise test and echocardiographic examination.
A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits,
      hands, and feet) affects approximately 4.8% of the US population and is believed to be caused
      by an overactive cholinergic response of the sweat glands. Current therapies have limited
      effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide
      (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis.
      This Phase 3 study will assess the long-term safety, tolerability, and efficacy of
      sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.
    

Detailed description: 
      This is a randomized, open-label, phase 3 long-term study designed to evaluate the safety,
      local tolerability and efficacy of sofpironium bromide gel when applied topically to the
      axillae.

      Subjects will apply the gel once daily at bedtime, to both axillae.

      A maximum of 300 subjects, will be randomized to receive one of two sofpironium bromide gel
      concentrations.

      Adverse events, vital signs, and local tolerability assessments will be collected at each
      visit. Urine pregnancy tests will be taken throughout the course of the study for women of
      child bearing potential. Blood and urine samples will be collected and analyzed for routine
      hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported
      outcome assessments will be recorded during the study at predefined time points.

      The study will be comprised of a total of 17 scheduled visits to take place over a 52 week
      period.
    

Intervention name(s): Sofpironium Bromide Gel, 5%; Sofpironium Bromide Gel, 15%
Intervention type(s): Drug; Drug
Intervention description(s): Sofpironium Bromide Gel, 5%; Sofpironium Bromide Gel, 15%
Other intervention name(s): BBI-4000; BBI-4000
Intervention MeSH terms: Bromides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment