bioihbjkbjnl/mcl2 huggingface dataset:
Non-invasive Quantification of Muscle and Liver Glutathione GSH-MRS
Condition: Assay Muscle; Liver Glutathione in Healthy Human
Study type: Interventional

Summary: 
      Glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. It participates
      also in the detoxification of electrophiles molecules of which paracetamol. It is synthesized
      in the liver during the postprandial phase, which establishes a stock that is mobilized for
      the other tissues (muscle)during the postabsorptive period. It is of common knowledge that
      the decrease in glutathione concentrations associated with ageing could be involved in the
      development of the degenerative pathologies linked to the old age. These changes could be
      reversed by an increase in dietary cysteine, the amino acid limiting of the endogenous
      synthesis of GSH. The development of nutritional strategies aiming at an improvement of the
      status glutathione requires the determination of its concentration within tissues, where it
      is active. The quantification of tissue concentrations of glutathione by biochemical
      techniques requires tissue biopsies. Such a method can be performed for the muscle, but liver
      biopsy is not feasible outside of a surgery. It is necessary to set up a non-invasive method
      to quantify muscle and liver glutathione.
    

Detailed description: 
      The study will validate the detection and the quantification of glutathione in muscle and
      liver using 1H MRS. The accuracy of the method will be assessed from intra and
      inter-volunteer measurements. 1H MRS measurements will be performed with the Magnetic
      Resonance Imaging (MRI) 3 Tesla system of the Hospital, twice for each volunteer.

      Prior to the measurements, volunteers will have a protein rich breakfast at home and a
      protein rich lunch at the Clinical Investigation Center.
    

Intervention name(s): Proton magnetic resonance spectroscopy (1H MRS); a protein rich breakfast at home; a protein rich lunch at the Clinical Investigation Center
Intervention type(s): Device; Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Glutathione; Liver; Muscle; Proton magnetic resonance spectroscopy; Healthy human
Effect of Moringa Oleifera Leaf on Hemoglobin Levels in Anemia
Condition: Anemia of Pregnancy
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study was to compare the results of hemoglobin levels between
      pregnant women in the treatment group and the control group. Participants will be subjected
      to anthropometric measurements, recall of food intake for 1 x 24 hours, check hemoglobin
      before and after being given the intervention and participants in the treatment group are
      given moringa leaf capsules and iron tablets while participants in the control group are only
      given iron tablets. Researchers will compare the final results of hemoglobin levels between
      the treatment group and the control group
    


Intervention name(s): Moringa oleifera capsules; iron and folic acid supplements
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): In this arm, pregnant mothers receive capsules containing 500 mg of powdered Moringa oleifera leaves which contain 13.09 mg of iron per100 gram. Dose: 2 × 2 capsules per day for 30 days; In this arm, pregnant mothers receive IFA tablets 2 × 1 tablet a day for 30 days. Each IFA tablet contains 400 mcg folic acid and 180 mg Ferrous Fumarate.
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1 group receives capsules of powdered Moringa leaves (active comparator), and the other group receives IFA tablets as part of routine clinical care.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Effect of Diabetes on the Newborn
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The aim of this study is to test and compare biochemical, hematological, and inflammatory
      factors in diabetic and healthy pregnant mothers and in their newborns.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who plan to deliver at Western Galilee Hospital
A Study of Sofosbuvir and Ledipasvir From Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three way three sequence two treatment partial replicate
      crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from
      Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets
      (Gilead Sciences, Canada) in Healthy Human Volunteers Under Fed Condition.
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary
      Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for
      transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and
      AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of
      logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within
      80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Magicbuvir Plus; Harvoni (fist dose); Harvoni (second dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir; 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir; 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
Other intervention name(s): Harvoni; Harvoni; Harvoni
Intervention MeSH terms: Ledipasvir, sofosbuvir drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effects of Foot Medial Arch Electrical Stimulation on Foot Functions and Balance
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to investigate the immediate effects of sole session of foot medial
      arch' NMES on foot strength, arch stability, static plantar pressure distribution and dynamic
      postural balance.
    

Detailed description: 
      The study design is a randomised controlled trial in population with pronated feet. The aim
      of this study is to investigate the immediate effects of sole session of foot medial arch'
      NMES on foot strength, arch stability, static plantar pressure distribution and dynamic
      postural balance. This is the 2nd study to investigate the effect one session as previous
      study showed immediate effect on plantar pressure distribution on the midfoot and durable
      effect at 2 months follow-up. However, no studies investigated the effects on others
      parameters than plantar pressure.The general objective of our study is to question electrical
      stimulation as a modality for foot strengthening to enhance dynamic postural balance and foot
      functions.
    

Intervention name(s): NMES; TENS
Intervention type(s): Device; Device
Intervention description(s): Neuromuscular Electrical Stimulation (NMES) is a non pharmacological intervention that sends electrical impulses to nerves leading to muscle contraction. The electrical stimulation can increase strength and is often used to re-educate or re-train muscles.; Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be allocated to the intervention or control group using permuted block randomization with blocks of 4 or 6 patients on a 1:1 ratio.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Foot; Foot strength; Stability; Plantar pressure; Dynamic postural balance; Neuromuscular Electrical Stimulation; NMES; Transcutaneous Electrical Nerve Stimulation; TENS
Clinical Diagnosis of Teenagers Admitted to Pediatric Departments
Condition: Anorexia; Thalassemia; Sickle Cell Anemia; Chronic Renal Failure; Suicide Attempt
MeSH terms: Kidney Failure, Chronic; Thalassemia; Anemia, Sickle Cell; Anorexia; Suicide; Suicide, Attempted
Study type: Observational

Summary: 
      This study intends to analyze the clinical characteristics of teenagers admitted to pediatric
      wards due to organic illness and non organic diagnosis, including patients suffering from
      chronic diseases and comorbidity.
    

Detailed description: 
      The intention is to summarize the data from year 2000 to 2007 af all the teenagers aged 14 ys
      to 20 yes admitted to the pediatric wards at the Ha'Emek Medical Center. The demographic and
      clinical date will be summarized.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Data summary only
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        About 800 teenagers are admitted each year to the pediatric departments at the Ha'Emek
        Medical Center. Three principal conditions are the causes of admission: chronic diseases,
        acute "organic" diseases, and psychiatric diseases including suicide attempts, anorexia,
        and others.
Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to investigate and evaluate the effects of different
      interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections,
      3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in
      newly-diagnosed type 2 diabetic patients.
    

Detailed description: 
      ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects
      responsible for the development of hyperglycemia. With continuous presence of insulin
      resistance, progressive loss of ß-cell function is the crucial defect. Hyperglycemia has
      deleterious effect on β-cell function, which is partially reversible by adequate glycemic
      control. In newly diagnosed type 2 diabetic patients with severe hyperglycemia, 2 weeks
      continuous subcutaneous insulin infusion (CSII) can induce adequate glycemic control with
      improvement of β-cell function. Nearly half of the patients can maintain euglycemia longer
      than 12 months by transient CSII. The improvement of β-cell function, especially the
      restoration of the first-phase insulin response is related to sustained euglycemia in the
      newly diagnosed type 2 diabetic patients. But it is unclear whether any other interventions
      (such as oral hypoglycemic agents and multiple daily injections) inducing optimal glycemic
      control in a short period of time can have the same effect. As a multicenter, open-label,
      randomized, parallel-group study will be needed to further prove and clarify the findings.
    

Intervention name(s): Human Insulin (Novolin-R, Novo Nordisk); H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland; Pre-meal; Novolin-R; Human Insulin NPH (Novolin-N, Novo Nordisk); Gliclazide (Diamicron, Servier); Diamicron and Glucophage
Intervention type(s): Drug; Device; Other; Drug; Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Gliclazide; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus; therapy; sulfonylureas; metformin; insulin
Sphenopalatine Nerve Block for Headache Tx360
Condition: Headache; Migraine
MeSH terms: Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block
      utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the
      duration of the analgesia.
    


Intervention name(s): Bupivacaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion; Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
Other intervention name(s): Normal Saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Headache; Migraine
Hereditary Colorectal and Associated Tumor Registry Study
Condition: Lynch Syndrome; FAP; Hereditary Diffuse Gastric Cancer; Juvenile Polyposis Syndrome; Peutz-Jeghers Syndrome
MeSH terms: Colorectal Neoplasms, Hereditary Nonpolyposis; Peutz-Jeghers Syndrome; Syndrome
Study type: Observational

Summary: 
      After informed consent, participants will be asked to complete a medical/family history
      questionnaire and provide a blood sample. Participants will also be asked for their
      permission for study investigators to access medical records and/or recontact them for
      updates to their medical and family histories. Data and biospecimens will be stored for
      potential future research projects.
    


Intervention name(s): Research Registry
Intervention type(s): Other
Intervention description(s): Information regarding medical and family history is stored in the registry to be used for potential future studies
Observational model: Family-Based
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Potential research subjects are recruited from our Hereditary GI clinic.
      
Biospecimen description: 
      Serum, plasma, and extracted DNA are stored for potential future studies.
LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of
      the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell
      chronic lymphocytic leukemia who have received at least one prior fludarabine-containing
      regimen.
    


Intervention name(s): LFB-R603
Intervention type(s): Drug
Intervention description(s): intravenous administration, dose-escalation study
Other intervention name(s): ublituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes
Condition: Retinal Ischemia; Diabetes Complications; Ischemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Complications; Ischemia
Study type: Interventional

Summary: 
      Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue
      against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown
      whether this can be used in retinal ischemic diseases. The purpose of the present study is to
      examine if the autoregulation of retinal vessel diameters in diabetic patients change after
      remote ischemic conditioning and if the observations are different from what have been
      observed in normal persons.
    


Intervention name(s): Remote Ischemic Conditioning
Intervention type(s): Other
Intervention description(s): Brief reversible restriction of blood flow to upper limb in four cycles of 5 minutes of inflation at 200mm Hg followed by 5 minutes of deflation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Metabolic Response of Intestinal Microbiota to Guar Gum Consumption
Condition: Healthy
Study type: Interventional

Summary: 
      Some components of the diet are not absorbed in the small intestine and pass into the colon,
      where they may be fermented by the microbiota, releasing gas. A series of recent studies
      suggest that some non-absorbable, fermentable meal products (prebiotics) serve as substrate
      to colonic bacteria and change their composition, thereby producing beneficial effects to the
      host. These products are fermented by bacteria and at initial intake increase gas production;
      however, after 7-10 days administration some prebiotics induce an adaptation of intestinal
      microbiota towards more efficient metabolic pathways with less gas production. Hence,
      intestinal gas production may serve as an index of microbiota metabolic activity. Gas
      production may induce gas-related symptoms, such as flatulence, abdominal bloating and
      distention, and the symptoms improve when the microbiota adapts to the prebiotic and gas
      production declines. Guar gum is classified as a fiber, but it remains uncertain whether and
      to what extent it is fermented by colonic microbiota and whether it has prebiotic properties.
      Aim: to determine the metabolic reaction of intestinal microbiota in response to guar gum
      consumption, specifically, the extent of initial fermentation and subsequent
      adaptation.Design: Single-centre, single arm, open label, proof-of-concept study testing the
      effect of guar gum on microbiota metabolism and adaptation in healthy subjects Intervention:
      guar gum (8 g/d) will be administered for 18 days. Outcomes: during 4 days immediately
      before, at the beginning and at the end of the administration phase participants will be put
      on a standard diet and the following outcomes will be measured: a) number of gas evacuations
      during daytime for 2 days by means of an event marker; b) perception of digestive sensations
      by daily scales; c) microbiota composition by fecal analysis; d) metabolites in urine.
    


Intervention name(s): Prebiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Guar gum (8 g/d) will be administered for 18 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intestinal gas; healthy subjects; microbiota; prebiotic
Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin
      glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level

      Secondary objective:

      To compare the incidence of hypoglycemia in each treatment group
    


Intervention name(s): Glimepiride; Metformin; Insulin Glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once a day before breakfast; After breakfast and supper; Injection in the morning
Intervention MeSH terms: Metformin; Insulin Glargine; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether beclomethasone dipropionate / formoterol
      (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to
      fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients
      switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared
      with patients not switched.
    


Intervention name(s): Fixed dose combination salmeterol / fluticasone; Fixed-dose combination beclometasone dipropionate / formoterol
Intervention type(s): Drug; Drug
Intervention description(s): Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy; Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Other intervention name(s): FP/SAL; Seretide® 125; BDP/FOR; Fostair® 100/6
Intervention MeSH terms: Fluticasone; Beclomethasone; Formoterol Fumarate; Salmeterol Xinafoate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients receiving ICS/LABA therapy as FP/SAL (Seretide® 125) who, at an index prescription
        date (IPD) receive a routine asthma review* and either:

        (i) Switched to BDP/FOR (Fostair®)at same or lower BDP-equivalent ICS dose;

        OR,

        (ii) Continues on FP/SAL (Seretide® 125) for the duration of the outcome period at the same
        or lower BDP-equivalent ICS dose prescribed at baseline.
      
Keywords: Asthma; Combination therapy; Primary care management; Switch; ICS/LABA; Fostair; Seretide