bioihbjkbjnl/mcl2 huggingface dataset:
CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia
Condition: Polycythemia
MeSH terms: Polycythemia
Study type: Interventional

Summary: 
      The optimized CO-Rebreathing is an efficient method to evaluate the red cell mass and has
      been used in the vast majority of studies in sport medicine. However, this method has never
      been evaluated on a large scale in the diagnosis of primitive or secondary polycythemia. The
      standard procedure to evaluate the red cell mass is based on isotopic measurement using
      Cr51-labelled red cells, but its lack of availability in many centers highlights the need for
      a non-invasive and rapid alternative method. The purpose of this study is to evaluate and
      validate the CO-Rebreathing method in this set of indications.
    

Detailed description: 
      The definition of a true polycythemia is stricto sensu an increased red cell mass (RCM) above
      125% of the expected value depending on the size and the weight of the patient. However, this
      measurement requires an isotopic labeling of red cells and is not available in most of the
      hospitals. Therefore, the diagnosis of polycythemia, and particularly Polycythemia Vera (PV)
      is based on routine red blood cells parameters, i.e. hemoglobin level and hematocrit. If
      these parameters are efficient in marked polycythemia, discrepancies have been observed in
      milder cases. Two situations where a RCM evaluation is particularly required can be
      described:

        -  In patients with a hematocrit level between 52 and 60% (men) or between 48 and 56%
           (women) in order to limit invasive investigations to patients with a confirmed
           polycythemia diagnosis

        -  In JAK2V617F positive myeloproliferative neoplasms (MPN) with hematocrit and hemoglobin
           levels under the PV cut-off in order to discriminate between masked PV and essential
           thrombocythemia CO-Rebreathing is a fast, non invasive alternative method for RCM
           evaluation. It is based on the high affinity of carbon monoxide (CO) for hemoglobin. The
           decrease in the HbCO percentage after CO inhalation is dependent on the total hemoglobin
           mass from which RCM can be obtained. The investigators propose a tri-centric study
           evaluating CO-Rebreathing as an alternative tool to measure RCM in the diagnosis of
           polycythemia in the two categories of patients described above.
    

Intervention name(s): CO-Rebreathing technique at diagnosis of polycythemia
Intervention type(s): Other
Intervention description(s): The intervention consists in one red cell mass determination using the CO-Rebreathing technique at diagnosis of polycythemia, in addition to the regular tests performed in this indication, including RCM isotopic measurement.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Polycythemia; CO-Rebreathing; red cell mass determination; myeloproliferative neoplasms
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state
      pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose
      combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in
      Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of
      dosing of LDV/SOF FDC in HCV-infected pediatric participants.

      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate
      LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover
      into the Treatment Phase with no interruption of study drug administration. The primary
      objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and
      tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants
      with HCV.

      During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to
      swallow tablets.
    


Intervention name(s): LDV/SOF; RBV
Intervention type(s): Drug; Drug
Intervention description(s): LDV/SOF FDC administered orally once daily; Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
Other intervention name(s): Harvoni®; GS-5885/GS-7977; REBETOL®
Intervention MeSH terms: Ribavirin; Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mitochondrial Energy Metabolism in Obese Women
Condition: Metabolism Disorder; Mitochondrial Alteration; Physical Activity; Obesity
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Considering that the failure of the treatment of obesity is justified by the multifactorial
      pathophysiology of this morbidity, the present project has the following hypotheses:

        1. The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;

        2. The unbalance is therapeutically modified through physical training ;

        3. Obesity courses with the break-down in energy metabolism mitochondrial disease
           associated with systemic inflammatory characteristics that can be corrected through a
           combined long-term physical training program.

      This study have as objective : to analyse changes in mitochondrial function, inflammatory
      profile, oxidative stress and energy metabolism caused by concurrent physical training in
      obese women.
    

Detailed description: 
      Specific objectives:

      Body composition by deuterium oxide; Metabolic rate of resting and oxidation of substrates by
      indirect calorimetry; Proinflammatory cytokines Anti-inflammatory cytokines Oxidative Stress:
      Malondialdehyde, Superoxide Dismutase, Glutathione-Peroxidase; Fatty acids: ceramide and
      palmitate; Mitochondrial respiration and citrate synthase enzyme; Quantify and qualify:
      mitochondrial number, endoplasmic reticulum structure, adipose cell size; Gene expression,
      quantify by microscopy and analyze the protein by western blot.

      The study began with 20 women, however, there was withdrawal of 6, ending with 14 women.
    

Intervention name(s): Physical Training
Intervention type(s): Other
Intervention description(s): Intervention with concurrent physical training: strength and aerobic exercises in the same session.
Duration: 2 weeks of adaptation to physical exercise, 8 weeks of training. Frequency: 3 times a week. Time: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined Nutrient Intake and Muscle Protein Synthesis
Condition: Aging
Study type: Interventional

Summary: 
      Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is
      to test whether combined nutrient intake plays an important role in stimulation of the muscle
      protein growth in elderly people; and whether it represent effective strategies to overcome
      the impaired muscle protein synthesis in elderly when compared with young subjects.
    


Intervention name(s): protein; protein and carbohydrate; protein and leucine
Intervention type(s): Other; Other; Other
Intervention description(s): 20g protein; 20g protein and 20g carbohydrate; 20g protein, 2.5g leucine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: muscle; FSR; protein; carbohydrate; leucine
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3
Condition: Type 1 Diabetes
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias; Hypoglycemia
Study type: Interventional

Summary: 
      It has been found that in some cases, when a person with Diabetes Mellitus has an episode of
      low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another
      bout of hypoglycemia during that exercise. The purpose of this study is to determine what
      factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia
      while exercising later.
    

Detailed description: 
      The SPECIFIC AIM of the study outlined in this proposal is to determine if hypoglycemia
      blunts counterregulatory responses during subsequent exercise in Type 1 Diabetes Mellitus due
      to physiologic increases in plasma cortisol.
    

Intervention name(s): glucose clamp; glucose clamp; glucose clamp; glucose clamp
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Day 1 hyperinsulinemic euglycemic glucose clamp procedure x 2 and Day 2 hyperinsulinemic hypoglycemic glucose clamp procedure; Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study; Hyperinsulinemic euglycemic glucose clamp procedure x 2 with cortisol infusion at 2 ug/kg on Day 1 and hyperinsulinemic hypoglycemic glucose clamp procedure on Day 2.; Hyperinsulinemic euglycemic glucose clamp procedure x 2 with cortisol infusion at 1 ug/kg on Day 1 and hyperinsulinemic hypoglycemic glucose clamp procedure on Day 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: cortisol; catecholamines; Type 1 DM
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
Condition: Healthy Volunteers; Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study two different tablets for oral use of a known investigational medicinal
      product, called semaglutide, will be tested. One is the current formulation and the other one
      is a new formulation of semaglutide. Both will be administered as a tablet and are for the
      treatment of diabetes. Currently, semaglutide is only prescribed as injections for the
      treatment of diabetes in some countries. The aim of this study is to find out if the dosage
      strength of the current formulation of semaglutide can be reduced in the new tablet
      formulation. For this purpose, it will be measured how much semaglutide is taken up in the
      body from the two (2) different tablet formulations each with three (3) different dosage
      strengths. The tablet version of the study medicine is a new medicine that cannot yet be
      prescribed. Participants will either get semaglutide in the current tablet formulation
      previously tested in many large studies, or get the tablet that contains semaglutide in a new
      formulation - which treatment is decided by chance. Participants will get one tablet per day
      over 4 weeks in each of the 3 treatment periods (i.e. treatment in a total of 12 weeks). The
      tablets should be taken in the morning together with half a glass of water (120 mL), after an
      overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed
      from 2 hours before dosing. After dosing participants must wait 30 minutes before they may
      eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.
    


Intervention name(s): Oral semaglutide
Intervention type(s): Drug
Intervention description(s): Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in
      healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.
    

Detailed description: 
      This is a single-center, open-label (all people know the identity of the intervention),
      single-dose study in healthy adult Taiwanese participants. A minimum of 6 participants
      identified as having the UGT2B7 *2/*2 variant genotype and 12 participants identified as
      having the UGT2B7 *1/*1 wild type genotype will be included in the study. The study will
      explore the impact of genetic polymorphism in the UGT2B7 gene (occurrence of variants of this
      gene) on the pharmacokinetics (how the drug is absorbed in the body, distributed within the
      body, and how it is removed from the body over time) of OROS hydromorphone. This study
      consists of a screening phase followed by a 5-day open-label treatment phase. During the
      screening phase, a blood sample will be collected for a genetic test to confirm the presence
      of the UGT2B7 gene. During the study period, upon completion of a 12-hour overnight fast,
      participants will receive a single oral 16-mg dose of OROS hydromorphone in the morning of
      Day 1. Blood samples will be collected through 72 hours after dosing for the determination of
      plasma hydromorphone and hydromorphone 3-glucuronide concentrations. The safety and
      tolerability of 16-mg OROS hydromorphone will also be assessed. The total study duration for
      each participant is approximately 33 days.
    

Intervention name(s): Hydromorphone 16 mg
Intervention type(s): Drug
Intervention description(s): type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg.
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Pharmacokinetics; OROS Hydromorphone; Hydromorphone; Taiwan; UGT2B7 Gene
Porous and Non-porous Bone Grafts in Intra-bony Periodontal Defects
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Till date, no study has been reported in the literature where porous bioactive glass was used
      for the management of periodontal osseous defects. In this context, the present study is
      designed to assess the efficacy of the porous variant of bioactive glass and compare with
      that of nonporous variant using cone beam computed tomography.
    

Detailed description: 
      OBJECTIVES:

        1. To evaluate clinically the periodontal healing with Porous variant of Bioactive Glass
           placed in the intra bony defects at an interval of 6 months.

        2. To evaluate clinically the periodontal healing with Non Porous variant of Bioactive
           Glass placed in the intra bony defects at an interval of 6 months.

        3. To evaluate the radiographic changes in the intra bony defect grafted with Porous
           variant of Bioactive Glass at baseline and an interval of 6 months.

        4. To evaluate the radiographic changes in the intra bony defect grafted with Non Porous
           variant of Bioactive Glass at baseline and an interval of 6 months.

        5. To compare clinically soft tissue healing for sites grafted with Porous variant of
           Bioactive Glass and sites grafted with Non Porous variant of Bioactive Glass in the
           treatment of periodontal intra bony defects at an interval of 6 months.

        6. To compare the radiographic changes for sites grafted with Porous variant and sites
           grafted with Non Porous of Bioactive Glass in the treatment of periodontal intra bony
           defects at an interval of 6 months.
    

Intervention name(s): Porous variant of Bioactive Glass.; Non porous variant of Bioactive Glass.
Intervention type(s): Drug; Drug
Intervention description(s): Flap surgery with Porous variant of Bioactive Glass.; Flap surgery with non-Porous variant of Bioactive Glass.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Melatonin in Relapsing-Remitting Multiple Sclerosis Patients
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether melatonin is effective in the treatment of
      relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying
      drugs.
    

Detailed description: 
      Multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous
      system, and the major cause of disability in the youngsters all over the world, still with no
      definitely known etiology and treatment. Melatonin is a hormone secreted by pineal gland
      famous for its role in circadian rhythm regulation, and with known antioxidant effects. It
      was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in
      comparison to other diseases and is correlated with the Multiple Sclerosis Functional
      Composite score of the patients. Melatonin is also suggested to have an immunomodulatory
      role. Therefore, we hypothesize that melatonin can be effective in the treatment of
      relapsing-remitting multiple sclerosis patients.
    

Intervention name(s): Melatonin
Intervention type(s): Drug
Intervention description(s): 3mg oral, daily, one hour before sleep
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma
Condition: Untreated CD20-positive Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3
      of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell
      lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international
      prognostic index (Aa-IPI).
    

Detailed description: 
      This is a phase II, multicentric, open-label, non-randomized study, evaluating the efficacy
      of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP
      regimen during 4 cycles in patients aged 18 to 60 years with previously untreated CD20+
      diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the
      age-adjusted international prognostic index (Aa-IPI), and eligible for transplant.

      It is anticipated that 60 subjects will be enrolled over 2 years (from 2004 to 2006), in a
      group sequential manner one planned interim analysis.

      The duration of the treatment period is approximately 26 weeks and patients are followed
      until Death.

      The total Duration of the study is expected to be 2.5 years.
    

Intervention name(s): Rituximab + ACVBP regimen plus Pegfilgrastim; Autologous stem cell transplant
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffuse large B cell lymphoma; Pegfilgrastim; Autotransplant
Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This will be a randomized, cross-over design. Subjects will be randomized to one of three
      interventions on three separate study days, 1 week apart.
    

Detailed description: 
      Following consent, subjects will be randomized to one of three arms. After an overnight fast
      an intravenous line will be placed for blood withdrawal. The subject will then consume the
      randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at
      specified intervals after the product has been consumed.
    

Intervention name(s): Boost Glucose Control (A); Boost Glucose Control (B); Boost Original
Intervention type(s): Other; Other; Other
Intervention description(s): Oral nutrition supplement; Oral nutrition supplement; Oral nutrition supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block
      for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients
    


Intervention name(s): erector spinea block; Caudal epidural block
Intervention type(s): Procedure; Procedure
Intervention description(s): the patients will receive a single injection erector spinea block after induction of general anesthesia; the patients will receive caudal epidural block after induction of general anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The present study is designed to test the hypothesis that resveratrol supplementation will
      improve the function of the endothelium in patients with type 2 diabetes mellitus.

      The function of the endothelium will be tested with a non-invasive technique that uses
      ultrasound to measure the amount of dilation that occurs in the brachial artery following
      5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also
      collect blood, urine, and cell samples and test the effects of treatment on protein
      expression, nitric oxide production, and function of mitochondria.
    


Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.; Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: endothelium; mitochondria; reactive oxygen species; vascular biology; arterial stiffness; nitric oxide