bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This long-term extension study is an open-label, multiple-dose study to evaluate the
      long-term safety, tolerability, efficacy and PD of vamorolone administered once daily by
      liquid oral suspension over a Treatment Period of 24 months to young boys with DMD who
      participated in the VBP15-002 Phase IIa and VBP15-003 Phase IIa extension core studies.
    

Detailed description: 
      This study will evaluate if it is safe to use a new medication called vamorolone for more
      than two weeks in children with DMD, if boys with DMD who take the study medication have
      improved muscle function compared to boys with DMD in other studies who did not take any type
      of steroid, and to see if boys with DMD who take the study medication gain less weight
      compared to boys with DMD in a prior study who took another type of steroid called
      prednisone. Enrolled participants will take the study medication for 24 months.
    

Intervention name(s): Vamorolone 0.25 mg/day/day; Vamorolone 0.75 mg/day/day; Vamorolone 2.0 mg/day/day; Vamorolone 6.0 mg/day/day
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of 0.25 mg/kg/day daily for 24 months.; Oral administration of 0.75 mg/kg/day daily for 24 months.; Oral administration of 2.0 mg/kg/day daily for 24 months.; Oral administration of 6.0 mg/kg/day daily for 24 months.
Other intervention name(s): VBP15; VBP15; VBP15; VBP15
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duchenne muscular dystrophy; vamorolone
Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine two questions: 1. Whether insulin treatment of high blood sugar in
      patients with diabetes while they are in the emergency room will improve how quickly they
      recover from illness if they need to be hospitalized. 2. Whether immediately beginning long
      lasting insulin detemir in patients with diabetes when they are admitted to hospital from the
      emergency room will improve how quickly they recover from the illness which necessitated
      hospitalization.
    


Intervention name(s): insulin aspart; insulin detemir
Intervention type(s): Drug; Drug
Intervention description(s): insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.
If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.; insulin detemir: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.
If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study of HEC68498 in Patients With Advanced Refractory Solid Tumors
Condition: Advanced Refractory Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical study of HEC68498 in patients with advanced refractory solid tumors. The primary
      objective is to determine the maximum tolerated dose and dose limiting toxicity of HEC68498
      in patients with advanced refractory solid tumors
    

Detailed description: 
      An open label multicentric Phase 1 study of HEC68498 in patients with advanced refractory
      solid tumors.The study will follow a 3+3 design until significant toxicity as described in
      the protocol and considering pharmacokinetics of the study drug determined from cohorts.
    

Intervention name(s): HEC68498
Intervention type(s): Drug
Intervention description(s): HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Plasma Lipids on β Cell Function and Insulin Sensitivity
Condition: Hypertriglyceridemia; Glucose Intolerance
MeSH terms: Insulin Resistance; Hypertriglyceridemia; Glucose Intolerance
Study type: Interventional

Summary: 
      The investigators aim to evaluate whether and to what extent glucose tolerance, beta cell
      function, insulin clearance, and glucose metabolic fluxes change in response to an acute
      increase in plasma triglycerides during lipid infusion, independently of free fatty acid
      (FFA) levels, in nondiabetic subjects.
    

Detailed description: 
      Mild hypertriglyceridemia is associated with reduced glucose tolerance and increased risk of
      type 2 diabetes, independent of obesity, in both cross-sectional and prospective studies. It
      is unclear whether this association is direct or mediated by circulating lipid substrates of
      triglycerides (free fatty acids, or FFA) and which are the mechanisms involved.

      To comprehensively examine the effects of mild acute hypertriglyceridemia on major glucose
      homeostatic mechanisms involved in diabetes progression, two dual-labeled oral glucose
      tolerance tests (OGTT) during 5-hour intravenous infusions of either 20% Intralipid or normal
      saline will be performed in healthy lean volunteers. Lipid-induced changes in glucose
      tolerance and insulin metabolism will be evaluated.
    

Intervention name(s): 20% Intralipid; Normal Saline
Intervention type(s): Other; Other
Intervention description(s): Participants will receive a 5 h primed (375 mL/m2)-continuous (25 mL h-1 m-2) i.v. infusion of 20% fat emulsion (Intralipid 20%), together with a 5 h primed (28 µmol/kg)-continuous (0.28 µmol min-1 kg-1) infusion of 6,6-[2H2]glucose. After 2 h, participants will consume within 5 min an oral glucose drink consisting of 147 mL of 50% dextrose solution (wt/vol) enriched with 1.5 g of [U-13C] glucose.; Participants will receive a 5 h primed (375 mL/m2)-continuous (25 mL h-1 m-2) i.v. infusion of normal saline (Sodium Chloride 0.9%), together with a 5 h primed (28 µmol/kg)-continuous (0.28 µmol min-1 kg-1) infusion of 6,6-[2H2]glucose. After 2 h, participants will consume within 5 min an oral glucose drink consisting of 147 mL of 50% dextrose solution (wt/vol) enriched with 1.5 g of [U-13C] glucose.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Observational

Summary: 
      We propose to pilot a telehealth approach to evaluate components of risk communication by:

        1. Providing personalized tailored patient feedback to help initiate and maintain specific
           diabetic kidney disease (DKD)-related behaviors (e.g., medication adherence, weight,
           exercise, diet, smoking cessation) to reduce their risks.

        2. Evaluating how this feedback can be incorporated into clinical care by examining 6 month
           patient outcomes.

      Specific Aims are:

        1. To evaluate the feasibility and acceptability of providing both patients and their
           provider feedback on individuals' DKD risk via the telehealth intervention and
           incorporating it into regular clinical practice.

        2. If improvements in outcomes are found, to estimate the cost of the program in terms of
           the patient, provider, and overall costs of implementing the program.
    

Detailed description: 
      We propose an innovative telehealth approach that has reduced antecedents of kidney disease,
      including poor blood pressure and glucose control, but has never been used to treat DKD. To
      mitigate the growing burden of DKD, these studies are designed to determine whether a
      potentially scalable, telehealth intervention effectively slows progression of DKD in a
      diverse US population and whether it is also cost-effective. The intervention simultaneously
      addresses medication management and behavioral therapies and education that seek to optimize
      adherence and self-efficacy. This proposed pilot trial will begin to evaluate if a
      multifactorial telehealth intervention may be effective in reducing progression of DKD.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetics with progressive kidney disease
      
Keywords: DKD
The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease
Condition: Hypertension; Coronary Artery Disease
MeSH terms: Hypertension; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to see if the blood pressure lowering effect of an approved drug
      nebivolol is comparable to that of another approved drug carvedilol for the treatment of
      hypertension in patients who have coronary artery disease.
    


Intervention name(s): Nebivolol; Carvedilol
Intervention type(s): Drug; Drug
Intervention description(s): Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily; Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily
Other intervention name(s): Bystolic; Coreg
Intervention MeSH terms: Carvedilol; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: carvedilol; Coreg (TM); hypertension; blood pressure; coronary artery disease; Nebivolol; BYSTOLIC (TM)
Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to study the long-term efficacy, safety and tolerability of
      Human-cl rhFVIII in previously treated patients with severe hemophilia A.
    


Intervention name(s): Human-cl rhFVIII
Intervention type(s): Biological
Intervention description(s): Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Effect of Bone Marrow Derived Cd133+ Cells in Patient With Osteonecrosis of Femoral Head
Condition: Osteonecrosis
MeSH terms: Osteonecrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Avascular necrosis is a disease where there is cellular death (necrosis) of bone components
      due to interruption of the blood supply. Without blood, the bone tissue dies and the bone
      collapses. If avascular necrosis involves the bones of a joint, it often leads to destruction
      of the joint articular surfaces. Avascular necrosis is especially common in the hip joint. A
      variety of methods are now used to treat avascular necrosis the most common being the total
      hip replacement, or THR.A new, more promising treatment is hip resurfacing or metal on metal
      (MOM) resurfacing.Another treatment is utilization of bone marrow derived stem cells.these
      stem cells can provide angiogenic factors and osteogenic cytokine to improve angiogenesis and
      bone formation.
    

Detailed description: 
      A vascular necrosis of femoral head is a debilitating disease resulting from interruption of
      blood supply to the bone. This pathologic process results in the death of marrow and
      osteocytes and, in its final stage, femoral head collapse. The most widespread treatment in
      the early stage of this disease is core decompression. This surgical procedure involves
      drilling into the femoral neck through the necrotic area, which reduces pressure within the
      bone and allows more blood vessels to form. This study is designed to evaluate the clinical
      safety and efficacy of CD133+ enriched bone marrow infusion adjacent with core decompression
      in patients with a vascular necrosis of femoral head . Patients will undergo core
      decompression followed by CD133+cell infusion into the cored area. Clinical assessment
      includes a MRI, Harries Hip Score,SF36, Visual Analogue Scale(VAS), and the WOMAC
      osteoarthritis Index.
    

Intervention name(s): CD133+ cells
Intervention type(s): Biological
Intervention description(s): bone marrow derived CD133+ cells injection with core compression
Other intervention name(s): cell injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Avascular osteonecrosis,CD133+,core decompression
Bioavailability of Omega-3 Food Supplements in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted
      conditions in healthy adult subjects. Each subject will participate in 5 treatment periods.
      The order of treatments will be in accordance with the randomisation schedule.There will be a
      minimum of 4 treatment-free days between each treatment period. On each dosing occasion,
      subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing.
      Twenty-four subjects will be enrolled to complete dosing of 20 subjects.
    


Intervention name(s): PronovaPure 150:500 triglycerides; Pronovum PRF-048; Pronovum PRF-037; PronovaPure 500:200 TG; Pronovum PRF-047
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE; Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE; Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE; Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE; Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: omega-3 based dietary supplements; Bioavailability
Experimental Study of Strength Training to Activate the Quadriceps Muscle After Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Background:

      Progressive strength training is a training modality used in rehabilitation after total knee
      arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be
      present in the operated leg after TKA, which relates to reduced central nervous system (CNS)
      activation of the muscle. As increased CNS activation occurs during strength training when
      muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this
      also is the case after TKA. The clinical implication is that repetitions performed to
      contraction failure during strength training, may help reduce CNS activation deficits of the
      quadriceps muscle after TKA.

      Purpose:

      The aim of this study is to investigate CNS activation of the quadriceps muscle during
      strength training performed with repetitions to contraction failure after TKA.

      Method:

      Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL),
      semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions
      performed in a knee extension machine until contraction failure. The relative loading will be
      10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a
      minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will
      be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure,
      etc.) of the set to failure.

      Hypothesis:

      Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA,
      the EMG amplitude will increase while the median power frequency will decrease during a
      strength training set performed to contraction failure after TKA.
    


Intervention name(s): 1 strength training set performed until contraction failure
Intervention type(s): Other
Intervention description(s): Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine in a single set performed until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. Range of motion and time under tension for each repetition will be controlled for.
Other intervention name(s): Resistance training.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: strength training; resistance training; fatigue; knee extension; total knee arthroplasty; total knee replacement; electromyography; physical therapy modalities
Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators propose that the sustained administration of a vaginal ring would have a
      better response with respect to pain and a better safety profile than the oral administration
      of a non-steroidal anti-inflammatory drug.

      To assess the relief of the symptoms associated with dysmenorrhea, a specific survey was
      elaborated that also includes a Visual Analog Scale (VAS) to objectify and measure
      dysmenorrhea as is the case with McGill's Pain Questionnaire (MPQ).
    


Intervention name(s): Meloxicam; Diclofenac Potassium; Placebo Oral; Placebo Vaginal
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 Meloxicam Vaginal Ring (MVR) for 4-6 days; 1 tablet 50 mg diclofenac every 12 hours for 4-6 days; 1 placebo tablet every 12 hours for 4-6 days; 1 placebo vaginal ring for 4-6 days
Intervention MeSH terms: Diclofenac; Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health
Condition: Cardiovascular Diseases; Kidney Diseases
MeSH terms: Kidney Diseases; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The disruption of colonic microbiota has been linked to a number of diseases, mainly
      cardiovascular and kidney diseases. One possible means to improve the microbiota is to
      increase dietary fiber intake as the intake of dietary fiber shifts the fermentation from
      proteolytic saccharolytic fermentation.

      Beta-glucans are soluble dietary fibers mainly found in oats and barley. Results from
      previous studies suggest that the consumption of barley reduces the risk of cardiovascular
      and kidney diseases. Therefore, this study will explore the effect of barley beta-glucans on
      markers of Cardiovascular and Renal health.
    


Intervention name(s): Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health
Intervention type(s): Other
Intervention description(s): Intervention will involve intake of 50% barley substituted wheat bread.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: TBARs; TAC; pCS; Barley; Beta-glucan; E-selectin; NO