bioihbjkbjnl/mcl2 huggingface dataset:
Ketones in Heart Failure - Effects on Cardiac Efficiency
Condition: Heart Failure, Systolic; Ketonemia
MeSH terms: Heart Failure; Heart Failure, Systolic; Ketosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Ketones may have beneficial effects on myocardial metabolism and hemodynamics. In the present
      study, healthy test subjects and patients with heart failure with reduced ejections fraction
      will be investigated in a randomized cross-over design with ketone infusions and placebo.
      Myocardial efficiency and hemodynamics will be evaluated.
    

Detailed description: 
      The prevalence of patients with heart failure and reduced ejection fraction (HFrEF) is 1-2%,
      and the lifetime risk of heart failure at age 55 years is approximately 30%. Despite advances
      in treatment, hospitalization rate and mortality remains high. It is well known that
      myocardial metabolism changes during development of HFrEF, and may contribute to contractile
      dysfunction. However, the myocardium can be considered an omnivore regarding substrate
      utilization, conferring an important adaptive property. Hence, it metabolizes either glucose,
      lipids, lactate, amino acids or ketones (3-hydroxybutyrate) depending on substrate
      availability, hormonal status and cardiac demands. These substrates differ with regard to
      myocardial energy efficiency (MEE) (cardiac work related to oxygen consumption). Since high
      MEE is associated with a better prognosis in HFrEF, manipulating substrate uptake could be a
      new treatment modality in heart failure patients.

      Recently, it was shown that the human myocardium increases 3-hydroxybutyrate (3-OHB)
      metabolism during development of HFrEF. These changes may be beneficial as 3-OHB could
      increase myocardial efficiency and lower oxidative stress by scavenging free radicals.
      However, until now this has not been investigated in clinical trials, and the effect of 3-OHB
      on cardiac function, oxygen consumption and perfusion remains undetermined in HFrEF patients.

      In the present study the investigators will evaluate whether elevated circulating 3-OHB
      affect myocardial oxygen consumption, MEE and perfusion in healthy subjects and patients with
      HFrEF, and whether 3-OHB affect hemodynamics and contractile function.

      10 healthy test subjects and 20 HFrEF patients will be subjected to placebo and 3-OHB
      infusion in a randomized cross-over design. Acetate-PET, echocardiography and right sided
      heart catheterization will be applied.
    

Intervention name(s): Infusion of 3-OHB; Infusion of placebo
Intervention type(s): Biological; Biological
Intervention description(s): Increase in 3-OHB levels; NaCl
Other intervention name(s): Na-3-OHB; NaCl
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized dobbel-blinded crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myocardial metabolism; Positron emission tomography; Echocardiography; Right sided heart catheterization
Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers
Condition: Muscle Strength; Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus
      the femoral nerve block versus placebo on muscle strength in healthy volunteers. The
      investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of
      the quadriceps muscle strength compared to the femoral nerve block.
    


Intervention name(s): Adductor-Canal-Blockade; The femoral nerve block; Placebo
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): US-guided Adductor-Canal-blockade with Ropivacaine; US-guided femoral nerve block with ropivacaine; US-guided Adductor-Canal-Blockade/femoral nerve block with saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor-Canal-blockade,; human volunteers,; US-guided nerve block; femoral nerve block
Drug-Drug Interaction Study With Aricept® (Donepezil)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out if the plasma concentration of donepezil is changed
      when BMS-708163 is administered at the same time
    


Intervention name(s): Donepezil; BMS-708163
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 5 mg, Once Daily, Days 1-28; Capsule, Oral, 125 mg, Once Daily, Days 15-28
Other intervention name(s): Aricept®
Intervention MeSH terms: Donepezil; BMS 708163
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will provide preliminary safety and comparative immunogenicity data for the E.coli
      derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses
      will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with
      phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.
    

Detailed description: 
      This is a safety study with an open-label part (2 groups), followed by a dose-ranging part
      evaluating safety and immunogenicity using a double-blind, sequential-group design with
      randomization and placebo-control within each of the 6 groups. Volunteers in each dose group
      will receive two IM injections at Day 0 and Month 1
    

Intervention name(s): Anthrax; Alhdryogel or PBS
Intervention type(s): Biological; Biological
Intervention description(s): Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel; Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Anthrax
Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125
Condition: Hyperglucagonemia
Study type: Interventional

Summary: 
      The aim of the study was to investigate the role of the Trasylol in glucagon prevention in
      degradation using radioimmunoactive method with I125. Additionally different incubation time
      was introduced in human plasma samples after oral glucose stimulation, also in fasted and
      hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the
      techniques for the glucagon measurement are well described nowadays.
    


Intervention name(s): Fasting glycemia; Hypoglycemia
Intervention type(s): Other; Other
Intervention description(s): no intervention; Insulin induced hypoglycemia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once
      daily either in the morning or the evening and GW685698X 250mcg administered once daily in
      the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
    


Intervention name(s): GW685698X (fluticasone furoate) 100mcg Morning; GW685698X (fluticasone furoate) 100mcg Evening; GW685698X (fluticasone furoate) 250mcg Evening; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days; GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days; GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days; Placebo inhaled twice daily (morning and evening) for 28 days
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Omega-3 Supplementation to ADHD Medication in Children
Condition: Attention Deficit Hyperactivity Disorder; Deficient Emotional Self-Regulation
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids
      for deficient emotional self-regulation (DESR) as a supplement to Attention
      Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention
      Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently
      be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR
      traits.
    


Intervention name(s): Omega-3 Fatty Acid; ADHD Medication
Intervention type(s): Dietary Supplement; Drug
Other intervention name(s): Fish Oil; Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid; Nordic Omega-3 Fishies; Stimulant; Concerta; Ritalin; Focalin; Vyvanse; Adderall; Dexedrine; Amphetamine; Methylphenidate; Stratterra; Tenex
Intervention MeSH terms: Methylphenidate; Amphetamine; Adderall; Dextroamphetamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; DESR; Deficient Emotional Self-Regulation; Emotional Dysregulation; Omega-3 Fatty Acids; Fish Oil
Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether intranasal fentanyl is better than placebo
      at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG
      study.
    

Detailed description: 
      Studies have shown that the voiding cystourethrogram (VCUG) can be distressful and painful
      for children as the child is catheterized during the procedure. Currently no sedation or
      analgesia is recommended for the procedure. The practice of pediatrics is constantly seeking
      measures to decrease pain and distress for children. The opioid fentanyl was originally
      synthesized in the 1950's and 60's as an alternative to morphine and meperidine. The safety
      and efficacy of intranasal (IN) fentanyl has been previously demonstrated in the setting of a
      pediatric emergency department.

      We are proposing the use of IN fentanyl for analgesia prior to the catheterization for a
      voiding cystourethrogram (VCUG). If we prove that IN fentanyl is effective in reducing the
      pain while ensuring patient safety, it could become the analgesic of choice for this
      procedure.
    

Intervention name(s): Fentanyl; Sterile water
Intervention type(s): Drug; Drug
Intervention description(s): The dose of fentanyl that each child will receive will be 2 mcg/kg based on the child's weight. The medication will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.; The dose of sterile water that each child will receive will be 2 mcg/kg based on the child's weight. It will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatrics; Pain; Voiding Cystourethrogram; Catheterization; Fentanyl
Pilot Testing a Novel Non-invasive Lactate Sensor
Condition: Hyperlactatemia
MeSH terms: Hyperlactatemia
Study type: Interventional

Summary: 
      To test the efficacy and accuracy of a novel non-invasive lactate sensor in humans undergoing
      strenuous leg exercise.
    

Detailed description: 
      The study investigators have designed a novel non-invasive lactate sensor (Lactisense)
      Lactisense is a planar, flexible, passive, chip-less resonator that can be taped to the skin
      in order to measure lactate levels in the body. It sends a signal to a nearby reader, which
      can be translated into a concentration value. It has so far been tested in the lab with good
      accuracy, but has not been tested on humans. The sensors are designed to use very low energy
      microwaves that can detect alterations in interstitial and muscle metabolites.

      In this study the investigators will test the sensor by having participants perform strenuous
      exercise (lifting weights) with Lactisense sensors attached to their skin on the top of the
      thigh and upper arm to evaluate lactate levels at the site of production and systemic levels
      respectively. The exercise will be performed using a well-established protocol to elevate
      lactate levels using a leg-press weights machine. The investigators will use a commercial
      capillary blood lactate meter (via finger prick) to verify whether lactate levels are
      actually changing in the body, and use Lactisense to try to measure these changes and compare
      to the values obtained using the commercial capillary blood lactate meter.
    

Intervention name(s): Lactate sensor (Lactisense)
Intervention type(s): Device
Intervention description(s): Non-invasive monitoring of interstitial lactate levels during and after exercise.
Intervention model: Single Group Assignment
Intervention model description: The investigators will test the device on 8 male and 8 female participants to determine if there are any sex differences in the performance of the sensor. As there is likely going to be inter-individual variability in the participants, the investigators have chosen to test 8 males and 8 females rather than 5 and 5 as suggested by the reviewer.
Masking: None (Open Label)
Primary purpose: Device Feasibility
The Effect of Renastart Formula Supplementation in Children With Acute Kidney Injury in Maintaining Normal Serum Electrolytes Levels
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      This clinical trial will evaluate Renastart formula effectiveness in children with acute
      kidney injury (AKI) and acute on top of chronic kidney disease (CKD), in maintaining normal
      serum electrolytes levels without using electrolyte binders,24 patients will be recruited
      from Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University, they will be
      assigned randomly in to two arms, arm 1 including patients who will be treated by
      electrolytes binders, arm 2 including patients who will be treated by Renastart formula,
      after initial assessment serum electrolyte evaluation will be followed up monthly for 3
      months.
    


Intervention name(s): Renastart formula; calcium carbonate (phosphorus binder) with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Renastart formula is an artificial formula is made by Vitaflo USA, Nestle Health Science Company.
Renastart formula preparation: Adding one level scoop of Renastart to 30 ml water.
Renastart formula will be used with breast milk, standard infant formula, standard pediatric infant feed and/ or mixed with diet.
Renastart formula dosage will be adjusted to be 1/4 Renastart and 3/4 breast milk, standard infant formula or standard pediatric infant daily caloric feed ratio.
Readjusting dosage ratio according to serum electrolytes levels especially potassium.; calcium carbonate (phosphorus binder) in dosage of 45-65 mg/kg/day orally with / or sodium polystyrene sulfonate (potassium binder) in dosage of 0.5-1mg/kg/day orally.
Intervention MeSH terms: Calcium Carbonate; Calcium; Polystyrene sulfonic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine Incidence of Hypoventilation in Patients Who Have Undergone Gastric Bypass
Condition: Morbid Obesity; Bariatric Surgery
MeSH terms: Hypoventilation; Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      The purpose of this study is to determine if gastric bypass patients experience
      hypoventilation in the immediate postoperative period, and to what degree.
    

Detailed description: 
      We propose to determine if patients with clinically significant obesity (body mass index,
      BMI, between 40 kg/m2 and 85 kg/m2), who have undergone gastric bypass procedures under
      general anesthesia hypoventilate during the initial twenty-four hour postoperative period,
      and if so, to what degree. Adequacy of ventilation will be assessed by serial arterial blood
      analyses. Patients will be monitored for SpO2 in the preoperative holding area, in the
      operating room, and the post-anesthesia care unit (PACU) by conventional and study pulse
      oximeters. SpO2 data will be collected continuously and recorded on the study pulse oximeter
      for the entire study period. Arterial blood samples will be drawn for analysis every four
      hours by in-dwelling arterial catheter, using standard sterile technique. Hypoventilation is
      defined as an increase in PaCO2 five or more mm Hg above patient's baseline.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include male and female adult patients (age 18-65) with
        clinically significant obesity (body mass index (BMI) between 40-85 kg/m2), who are
        approved for gastric bypass surgery for weight loss. Patients must have documented
        obstructive sleep apnea and use continuous positive airway pressure (CPAP) or bilevel
        positive airway pressure (BiPAP), and have an American Society of Anesthesiologists (ASA)
        Physical Status Classification I-III.
Effects of a Probiotic on Body Weight
Condition: Obesity
Study type: Interventional

Summary: 
      Probiotics administration is associated with health benefits on gut barrier integrity and
      immunological functions of the gastrointestinal tract. Recently, probiotics consumption was
      proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al.
      2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the
      effects of probiotics in weight control are not well understood.

      The primary objective of the clinical trial is to investigate whether a consumption of a
      probiotic formula when compared to an intake of a placebo, is associated with a greater
      reduction of body weight.
    


Intervention name(s): Probiotic; Placebo
Intervention type(s): Other; Other
Intervention description(s): daily probiotic consumption; daily placebo consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Probiotics, Weight control, Body composition
Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
Condition: Scar Prevention
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare how well EXC 001 works versus placebo in reducing the appearance of
      scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety
      of EXC 001 in healthy adult subjects.
    


Intervention name(s): EXC 001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intradermal injections of EXC 001 and placebo given on various schedules.; Intradermal injections of EXC 001 and placebo given on various schedules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Scarring
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Condition: Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug
      product in the treatment of vulvar and vaginal atrophy.
    


Intervention name(s): estrace cream (Perrigo); estrace cream (Reference); Placebo cream
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Perrigo product; Reference Listed Drug product
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional
Phase: Phase 1

Summary: 
      The histaminergic system is phylogenetically one of the oldest parts of the nervous system
      but it is a relatively recent discovery. It is involved with several vegetative functions
      like sleep, attention and learning, feeding and satiety, working memory, cognition,
      depression, and most of all arousal and energy
    

Detailed description: 
      1. Establish in an open label clinical trial the tolerability and safety of various doses
           of l-histidine and lodosyn that may increase levels of l-histidine and histamine in the
           serum and cerebrospinal fluid (CSF).

        2. Perform pharmacokinetic studies in serum and CSF of study subjects the levels of
           l-histidine and histamine after treatment with various combination of l-histidine and
           lodosyn.

        3. Preliminary information will also be collected on the effects of this intervention on
           alleviation of fatigue.

      The findings from this study go beyond the effects of histamine on fatigue. If central
      histamine can be increased by the strategy outlined above, a number of other vegetative
      hypothalamic functions intricately associated with fatigue including sleep, cognition and
      satiety need to be examined in MS patients in future studies.
    

Intervention name(s): Carbidopa; L-Histidine
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): All subjects will receive a fixed dose of 50mg of Lodosyn twice daily.; Sequential Dose Escalation of 250mg to 500mg to 1000mg twice daily.
Other intervention name(s): Lodosyn
Intervention MeSH terms: Carbidopa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fatigue; Histamine