bioihbjkbjnl/mcl2 huggingface dataset:
Role of the Protein Matrix in the Anabolic Response to a Ground Beef Patty as Opposed to the Impossible (Vegi-) Burger
Condition: Protein Metabolism
Study type: Interventional

Summary: 
      Several of the investigator's recent studies have shown that all dietary proteins are not
      equal when it comes to making proteins in human bodies. Generally, foods made from animal
      muscle tissue are much more efficient at making new proteins in the body that those from
      plant sources. This study will measure the amount of protein growth in participants after
      consuming either one beef patty, one vegi-burger, or two vegi-burgers. By using stable
      isotope infusions and collecting blood and leg muscle samples, the investigator's lab can
      determine the rate of muscle metabolism that happens after a participant eats a
      protein-containing food. The investigator wants to determine if the vegi-burger is as
      efficient as the beef patty at creating proteins in a participants. The investigator will
      measure this metabolism over a 10-hour period, with the food being eaten at the 4 hour mark.
      The investigator plans to perform this procedure on up to 8 participants per food option (24
      total).
    

Detailed description: 
      According to the USDA Economic Research Service Food Availability Data, beef consumption has
      been on a general decline for the past 40 years, with current per capita consumption
      approximately 35% lower in 2020 than in 1980. Some of this decline over the past few years
      can be attributed to politically motivated claims that carbon emissions from cattle represent
      a major threat to the global environment. However, the major reason for declining beef
      consumption is the widely promulgated claim that beef is unhealthy. The hamburger in
      particular has become a poster child for the notion that beef consumption is responsible for
      the increasing occurrence of obesity in the United States. The trend of decreasing beef
      consumption due to perceived health concerns, particularly obesity and associated health
      problems, has led major fast-food chains such as Burger King and McDonalds, to offer
      vegetarian burgers as healthy alternatives to the traditional beef burger. However,
      examination of the components of the macronutrient matrix of a typical vegetarian burger
      gives reason to question the health benefits as compared to a traditional beef
      patty-hamburger.
    

Intervention name(s): food: cooked 85% lean ground beef; food: Impossible Burger (R)
Intervention type(s): Other; Other
Intervention description(s): see arm description; see arm description
Other intervention name(s): hamburger; Impossible Burger (R)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Study of Nevirapine and Prednisone to Determine the Safety and Effectiveness in Preventing Nevirapine Associated Rash in Human Immunodeficiency Virus (HIV) Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to determine the incidence of rash between the group receiving nevirapine without
      prednisone and the group receiving nevirapine with prednisone
    


Intervention name(s): Nevirapine; Prednisone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nevirapine; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients
Condition: Vaccine Responsiveness in Allergy; Vaccine Responsiveness During Allergy De-sensitization Treatment
MeSH terms: Encephalitis, Tick-Borne; Encephalitis; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Allergic patients especially those undergoing de-sensitization treatment have an altered
      immune responsiveness. The investigators aim to find out whether this influences immune
      responses to primary and booster vaccinations.
    

Detailed description: 
      Allergic patients generally have an altered immunologic profile (Th2 bias), and allergic
      individuals undergoing de-sensitization treatment display an increased production of immune
      suppressive cytokines. The investigators measure humoral and cellular immune responses to
      routine vaccination (Tick-borne Encephalitis [TBE] booster) in allergic patients with and
      without de-sensitization treatment to determine whether allergy negatively influences vaccine
      induced immune responses and protection.
    

Intervention name(s): TBE booster vaccination
Intervention type(s): Biological
Other intervention name(s): Vaccine: FSME-Immun® (Fruehsommer-Meningoencephalitis); One dose (0.5 ml) contains:; 2.4 micrograms Tick-Borne Encephalitis Virus ( strain Neudoerfl),; adsorbed on aluminium oxide, hydrated (0.35 milligrams Al3+); Manufacturer: Baxter Innovations GmbH
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Singing in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the effects of the practice of singing for a long
      period of time on pulmonary function data, quality of life, and dyspnea sensation of patients
      with COPD in stable clinical conditions. As singing is a type of respiratory training, the
      study hypothesis is that singing would improve maximal respiratory pressures, dyspnea
      sensation, and overall quality of life of these patients.
    

Detailed description: 
      Thirty COPD patients in stable clinical conditions are going to be randomized in two groups:
      the first one is going to have singing classes for six months; the other one is going to have
      classes of general manual arts for a similar period of time. The patients of both groups are
      going to perform spirometry, measurements of maximal respiratory pressures and answer the
      health related quality of life questionnaires SF-36 and Saint George's before the beginning
      of practice and after 6 months.Both singing and manual arts practices are going to be
      administered one hour a week by specialized teachers.
    

Intervention name(s): Singing practice; Singing classes; Hand craft classes
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Pulmonary function; Respiratory muscle; Dyspnea; Quality of life
CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome
Condition: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Relapsed Adult Acute Myeloid; Myelodysplastic Syndromes, Previously Treated
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage
      therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or
      refractory AML or myelodysplastic syndrome.
    


Intervention name(s): CPX-351; Fludarabine; Melphalan; Rabbit Anti-Human T-Lymphocyte Globulin; Haplo-Cord Stem Cell Transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Biological
Intervention description(s): Salvage Chemotherapy: CPX-351 at 120 u/m2 on Days -21, -19, and -17; Fludarabine 150 mg/m2 (30 mg/m2/day x 5 days, Day -7 to Day -3); Melphalan 140 mg/m2 (Day -2); Rabbit ATG (rATG)-thymoglobulin 4.5 mg/kg (1.5 mg/kg/day x 3 days); Allogeneic stem cell transplantation using a haploidentical donor and umbilical cord blood unit.
Other intervention name(s): Cytarabine:Daunorubicin Liposome Injection; Fludara; Alkeran; Thymoglobulin
Intervention MeSH terms: Cytarabine; Fludarabine; Melphalan; Daunorubicin; Thymoglobulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly
Condition: Elderly
Study type: Interventional

Summary: 
      The investigators hypothesize that spirulina-silicon supplementation will lead to an
      improvement in vasomotor endothelial function, followed by decreased arterial wave velocity
      on the aorta and central arterial pressure compared to placebo subjects.
    


Intervention name(s): 3.5g of spirulina per day in 1% silicone; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 tablets of 700mg per day; 5 tablets per day of potato-based placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Dialysability of Dotarem® in Dialysed Patients
Condition: End-stage Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients
      with chronic renal failure who require hemodialysis treatment.
    

Detailed description: 
      Ten adult patients suffering from end stage renal failure and requiring hemodialysis
      treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1
      mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® .
      After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:

      The first hemodialysis session started between 1 to 2 h after the injection; The second
      hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third
      hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.

      The decrease in serum Dotarem® concentration was assessed after each hemodialysis session.
      Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and
      laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and
      one 3 months (± 4 days) after the Dotarem® injection.
    

Intervention name(s): Dotarem® IV injection at 0.1 mmol/kg
Intervention type(s): Drug
Intervention description(s): Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).
Other intervention name(s): gadoterate meglumine; gadoteric acid
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Dotarem; Dialyses; Dialysed; Safety; Safety and dialysability of Dotarem in dialysed patients
Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of a combined dermatological
      treatment in children up to 5 years old with mild or moderated atopic dermatitis.
    

Detailed description: 
      The intensive cream and body lotion of the PediATOPIC® products are two emollients expressly
      formulated to serve as adjuvants in the management of Atopic Dermatitis. Both products
      contain Dermosense complex®, a complex that includes 3 products: Bodyfensine peptide®
      (inductor of dephensine synthesis against microbial aggressions), Unimoist® (the mimetizing
      complex of the skin's natural hydration factor), and Ramnosoft® (polysaccharide that inhibits
      the adhesion of pro-inflammatory drugs and bacteria, while limiting the spread of
      inflammatory reactions in skin cells). They also contain Bisabolol, (plant extract with
      anti-inflammatory, anti-irritant and antimicrobial properties) and Panthenol (Pro vitamin B5
      that accelerates the skin's natural regeneration process).
    

Intervention name(s): Pediatopic Treatment Cream; Pediatopic Body lotion
Intervention type(s): Other; Other
Intervention description(s): Applied twice a day minimum.; Applied at libitum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Juvenile primary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the
      fingers and sometimes can affect the toes, nose, or ears. When children with primary
      Raynaud's Phenomenon are exposed to chilly or cold conditions from weather, cold
      temperatures, or even holding cold items from the refrigerator, their fingers may become
      cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud's Phenomenon
      have no underlying systemic disease. The cause for their symptoms is unknown. The
      investigational drug, Pletal(cilostazol), which has been approved for other conditions,
      inhibits the ability of one type of blood cell, platelets, to form blood clots, and also
      widens narrowed blood vessels. It has been used in a variety of other conditions in which
      blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol)
      to lessen the severity of the symptoms and decrease the number of primary Raynaud's episodes
      in juvenile patients.
    


Intervention name(s): Pletal
Intervention type(s): Drug
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: circulatory; vascular; idiopathic
Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety,
      Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.
    


Intervention name(s): Velusetrag; Velusetrag; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules; Capsules; Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's disease; Elderly
Polarization Sensitive Retinal Tomography for Glaucoma Diagnosis
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      The proposed human clinical studies have three main objectives:

        1. To determine reproducibility of peripapillary birefringence maps and identify features
           that measure the health of the RNFL.

        2. To determine the normal variation in the birefringence maps with age.

        3. To develop and test a classifier for glaucoma based on the birefringence maps using a
           case-control clinical trial.

      This study is a case-control study intended to optimize feature selection for a future
      multi-center blinded study. The proposed clinical study does not measure conversion from
      normal to glaucoma.
    

Detailed description: 
      This study evaluates RNFL Birefringence in normal and glaucoma human subjects: The primate
      experimental glaucoma study will characterize the spatial and temporal dynamics of RNFL
      birefringence during glaucoma progression and establish an initial feature set and classifier
      for a case-control clinical study. The case-control clinical study will refine the initial
      feature set and classifier and use ROC analysis to test sensitivity and specificity of the
      feature set and classifier for discriminating between normal and glaucomatous human eyes. The
      feature set and classifier formulated in the case-control clinical study is a prerequisite
      for planning a large-scale longitudinal study. A large-scale longitudinal study to compare
      different approaches for detecting early glaucoma is outside the scope of the proposed
      research. Moreover, considering the large number of subjects required for statistical
      significance when the conversion rate from ocular hypertensive to glaucoma is low
      (<10%/year), a longitudinal study is best performed in a multi-institution clinical trial
      over several years.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        45 normal volunteers and 40 glaucoma patients (known visual field defects)with equal sex
        distribution between the ages of 40 and 80 will be recruited for this study by H. Grady
        Rylander, M.D. at The Eye Institute of Austin and grouped by age into the following
        categories: 40-49, 50-59, 60-69, 70-79. Every effort will be made to equalize the number of
        patients in each age category and to recruit volunteers representing the race distribution
        in our community. Maps of RNFLT, phase retardation, and RNFL birefringence will be acquired
        from individuals within each age category.
      
Keywords: Glaucoma; Neurotubules; Birefringence; Retinal Nerve Fiber Layer (RNFL)
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional
Phase: Phase 4

Summary: 
      It is hypothesized that the use of a partial supplement diet, which includes the use of meal
      replacements, will result in significantly greater weight loss after three and six months
      compared to an isocaloric diet that does not include supplements. It is also hypothesized
      that the partial supplement diet will result in larger improvements in body composition,
      disease biomarkers, and health parameters (blood pressure, lipids) compared to the
      non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be
      significantly higher, and ratings of hunger lower, in the group consuming a partial
      supplement diet.
    

Detailed description: 
      In recent decades, the prevalence of overweight and obesity has increased dramatically in
      developed countries. Obesity is associated with diseases such as diabetes, cardiovascular
      disease, hypertension, and certain cancers. Modest amounts of weight loss (e.g., 5% to 10% of
      initial body weight) significantly improve health and improve disease status. Recent evidence
      suggests that the use of supplements or meal replacements promotes greater weight loss than
      isocaloric food-based diets. In addition, diets that are high in protein are associated with
      greater ratings of satiety and reduced food intake, as well as greater weight loss, compared
      to lower protein diets.

      The purpose of the proposed study is to test the effect of a partial supplement diet on body
      weight, body composition, and biomarkers for disease compared to an isocaloric diet that
      consists of a traditional food-based meal plan. Overweight and obese (BMI 25 to 35)
      participants will participate in this six-month study. The primary outcome variable is body
      weight loss and the secondary outcome variables include body composition, blood pressure,
      lipids, and subjective ratings of satiety.
    

Intervention name(s): MicroDiet; Healthy Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MicroDiet; Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Metformin's Effect on Glucagon-induced Glucose Production and Protein Metabolism.
Condition: Insulin Resistance; Prediabetic State
MeSH terms: Insulin Resistance; Prediabetic State
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to understand metformin's mechanisms of action regarding glucose
      production, protein metabolism, and mitochondrial function.
    

Detailed description: 
      It is believed that Metformin antagonizes the action of glucagon through different pathways.
      In mice, Metformin leads to inhibition of adenylate cyclase, reduction of levels of cyclic
      AMP and protein kinase A (PKA) activity, therefore blocking glucagon-dependent glucose output
      form hepatocytes. Glucagon plays an important role in the increased catabolic state seen in
      insulin deficiency. Hyperglucagonaemia states have been shown to accelerate proteolysis and
      leucine oxidation in insulin-deficient humans. Patients with insulin resistance and increased
      levels of glucagon have an increased in energy expenditure which may contribute to the
      catabolic state associated with this condition. We hypothesized that treatment with Metformin
      for 2 weeks will significantly inhibit glucagon-induced endogenous glucose production in
      insulin resistant individuals. We also hypothesized that glucagon-induced alterations in
      whole body protein metabolism and the increases in O2 consumption associated with
      hyperglucagonaemia states will be significantly inhibited by Metformin in these individuals.
      This would open the door for the development of other antidiabetic drugs with antagonism of
      glucagon as their principal mechanism of action.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 1000mg daily for one week, then 2000 mg daily for the second week. 4 week washout period, then crossover to placebo.; Placebo tablets for 2 weeks, then 4 weeks of washout period, then crossover to metformin.
Other intervention name(s): Glucophage; Lactulose
Intervention MeSH terms: Metformin; Lactulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Insulin Resistance; Prediabetic State; Metformin