bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Coffee Consumption on the Glycemic Index of Khalas Dates Tested in Healthy and Diabetic Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to evaluate the composition of Khalas, a very common type of dates
      used in the UAE and to determine the effects of drinking Arabic coffee on the results of GI
      tests in both healthy and diabetic subjects.
    

Detailed description: 
      Background:The consumption of dates along with coffee is a deeply rooted habit in many
      societies. This study was designed to determine the effect of coffee consumption on the
      glycemic index of a common variety of dates (Khalas) tested in healthy subjects and
      individuals with type 2 diabetes mellitus.

      Methods:Composition analysis was carried out for Khalas dates (Tamer stage) and the weight of
      the dates flesh equivalent to 50 g of available carbohydrate was calculated. The study
      subjects were thirteen healthy volunteers with a mean (± SD) age of 40.2 ± 6.7 years and ten
      participants with type 2 diabetes mellitus (controlled on lifestyle measures and/or
      metformin) with a mean HbA1c (± SD) of 6.6 ± (0.7 %) and a mean age (± SD) of 40.8 ± 5.7
      years. Each subject was tested on five separate days with 50 g of glucose (on 3 occasions)
      and 50 g equivalent of available carbohydrates from the dates without coffee (on one
      occasion) and with coffee (on another occasion). Capillary glucose was measured in the
      healthy subjects at 0, 15, 30, 45, 60, 90 and 120 min and for the diabetics at 0, 30, 60, 90,
      120, 150 and 180 min. The glycemic indices were determined as ratios of the incremental areas
      under the response curves for the dates alone/with coffee compared to glucose. Statistical
      analyses were performed using Student's t-tests.
    

Intervention name(s): Khalas dates
Intervention type(s): Other
Intervention description(s): every subject recieved 50 grams reducing carbohydrates equivalent of khalas dates
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Glycemic index; Dates; Diabetes; Coffee
Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      YH004 is a humanized monoclonal antibody that specifically binds to 4-1BB, and acts as an
      agonist against 4-1BB.

      This first in human study of YH004 is designed to establish the maximum tolerated dose (MTD)
      and/or the recommended Phase II dose (RP2D) of YH004, both as a single agent (monotherapy)
      and in combination with a fixed dose of anti-PD-1 antibody (Toripalimab) in the treatment of
      advanced solid tumors and relapsed or refractory non-Hodgkin Lymphoma.
    

Detailed description: 
      This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated
      dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD
      and/or RP2D of YH004 as a single agent (monotherapy) and in combination with Toripalimab. The
      first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of
      the study is the dose expansion phase (i.e., Phase 1b). During the study, dose
      interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are
      permitted following protocol guidelines. Intra-patient dose escalations will be allowed for
      the early dose cohorts (single-patient dose groups) in Phase 1a. Patients will be considered
      evaluable for safety and tolerability if they receive at least one dose of YH004 or
      Toripalimab at the specified cohort dose. Patients in all parts of the trial will remain on
      therapy until confirmed disease progression or for 1 year, whichever occurs first. However,
      patients who are clinically unstable will discontinue following the initial assessment of
      disease progression.
    

Intervention name(s): YH004
Intervention type(s): Drug
Intervention description(s): IV infusion once every 3 weeks (Q3W).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eucure; YH004; anti-4-1BB; Toripalimab; anti-PD-1
Predictive Role of Urodynamics on Mid-urethral Sling Failure
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Observational

Summary: 
      Purpose The aim of this study is to investigate the contribution of preoperative urodynamics
      to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and
      easily accessible tools Methods Women with stress urinary incontinence and who desired
      surgical correction of their incontinence were included in the study. The selection of the
      procedure was according to an algorithm used in an institution developed by a chief of
      urogynecology department who had 25 years of urogynecology experience. Urodynamic and
      baseline factors that may be associated with surgery failure were analyzed in MUS failure.
    


Intervention name(s): Midurethral sling mesh
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with stress urinary incontinence and who desired surgical correction of their
        incontinence
      
Keywords: Urodynamics; Midurethral sling; Transobturator tape (TOT); Tension free vaginal tape (TVT)
Fluid Management for Cesarean Section III
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia
      (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that
      epidural and spinal anesthesia during cesarean section possesses different responsiveness to
      fluid (including crystalloid and colloid) management given prior or posterior to anesthesia.
      Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia
      for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of
      duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown.
      The investigators hypothesized that fluid management during CSEA would produce different
      effect on hemodynamics in cesarean section compared with epidural and spinal anesthesia.
    


Intervention name(s): Ringer's Lactate; Six percent hydroxyethyl starch
Intervention type(s): Drug; Drug
Intervention description(s): Ringer's Lactate 8 ml/kg was given intravenously before or after CSEA in cesarean section; Hydroxyethyl starch (6%) was given before or after CSEA in cesarean section
Other intervention name(s): Lactated Ringer's solution; HES/HAES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Combined epidural spinal anesthesia; Fluid therapy
The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Observational

Summary: 
      The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes
      in mitochondrial function in claudication. Final purpose is to determine the optimal exercise
      frequency in treatment of claudication.
    


Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): one bout of exercise training
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatient clinic, vascular surgery, Trondheim, Norway
      
Biospecimen description: 
      muscle tissue
    
Keywords: Mitochondria, Muscle; Exercise
Upper Facial Remodeling With Perlane-L and Dysport
Condition: Mild to Moderate Temporal Atrophy; Moderate to Severe Glabellar Rhytids; Moderate to Severe Periorbital Rhytids
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to provide data to support combination treatment of the upper
      face with Perlane-L® and Dysport™. This study will assess the outcome of upper face
      rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also
      be assessed as a secondary endpoint.
    


Intervention name(s): Dysport; Perlane L
Intervention type(s): Drug; Device
Intervention description(s): Patients entering will be based on gender and assessment of procerus and corrugator muscle mass. Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large) by assessment of the procerus/corrugator muscles. Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ Female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region
Subjects will be treated with Dysport™ 20 or 30 units bilaterally to crow's feet.
Subjects will be treated at baseline and if maximum amount of product has not been used at 1 month follow up subject will receive a touch up. No further treatment will be done for the remaining study visits.; The subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area.
Intervention MeSH terms: abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrophy; rhytids; glabellar; periorbital
Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2.
      Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with
      3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an
      8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the
      consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The
      endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical
      markers), inflammatory markers and nutritional status were evaluated before and after each
      phase. Previously a pilot study was completed with no placebo (n=30) to determinate the
      effective dose of Functional Supplement.
    


Intervention name(s): punicalagin and hydroxytyrosol mixture; Control supplement (maltodextrin)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Antioxidant Supplement (punicalagin and hydroxytyrosol mixture) During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity.; During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity.
Other intervention name(s): Punicalagin and hydroxytyrosol; Maltodextrin
Intervention MeSH terms: 3,4-dihydroxyphenylethanol; Phenylethyl Alcohol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cross-over studies; Antioxidants; Hydroxytyrosol; Punicalagin; Treatment outcome; Inflammatory markers; Endothelial function; Humans; Adults; volunteers
Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed Condition
Condition: Healthy Volunteers
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate bioequivalence between Test Product (A):
      Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding
      Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma,
      Inc., USA in 36 normal, healthy, adult, male subjects under fed condition.
    

Detailed description: 
      Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be
      administered either the Test or the Reference Product with 240 mL of water in each period as
      per the randomization schedule. Subjects will fast for at least 10 hours prior to High Fat
      Breakfast half an hour before administration of the study drug and for four (4) additional
      hours each, post dose during each study period. Standardized meals will be provided in each
      study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post
      dose in each period. A total of 26 blood samples will be withdrawn for pharmacokinetic
      profiling. The whole blood concentrations of Tacrolimus will be measured by a validated
      LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log
      transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on
      log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence
      interval will be constructed for the ratio of geometric least square mean of the Test and
      Reference products, obtained from the log-transformed data. Bioequivalence will be concluded
      if the ratio estimate as well as its 90% confidence interval, both falls within the
      acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
    

Intervention name(s): Tacrolimus 1 mg Capsule
Intervention type(s): Drug
Intervention description(s): Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
Other intervention name(s): Tacrolimus Capsule
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study in healthy volunteers
Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to assess the possibility of the potential integration of malaria
      vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and
      immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI
      vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Detailed description: 
      Two vaccination schedules will be studied, which constitutes the two alternative three dose
      regimens for the malaria candidate vaccine 257049 integration into EPI. The co-administered
      EPI vaccines include GSK Biologicals' Tritanrix™-HepB/Hiberix™, a measles vaccine (depending
      on the supply availability), Aventis Pasteur's Yellow Fever vaccine Stamaril™ and GSK
      Biologicals' Oral Polio vaccine Polio Sabin™. Tuberculosis vaccine (Bacillus of Calmette and
      Guerin, BCG) will be administered according to national medical practice and will not be
      administered as part of this protocol, but will be documented.
    

Intervention name(s): GSK 257049; Tritanrix™ HepB/Hib; Rouvax™; Stamaril™; Polio Sabin™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine; GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™); Aventis Pasteur's attenuated measles vaccine.; Aventis Pasteur's attenuated yellow fever vaccine.; GSK Biologicals' oral polio virus vaccine
Other intervention name(s): DTPwHepB/Hib vaccine; Yellow Fever Vaccine; Oral Polio vaccine (OPV).
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Africa; Plasmodium falciparum; Malaria
Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of NAFLD
Condition: Non-alcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      To assess the effect of a methionine metabolism-based dietary strategy in patients with
      non-alcoholic fatty liver disease in order to reduce complications while improving the
      quality of life for patients.
    

Detailed description: 
      A randomized controlled clinical trial with parallel design was performed, a ratio of at
      least one patient in the control group for each subject in the experimental group.
    

Intervention name(s): Experimental group (with diet)
Intervention type(s): Dietary Supplement
Intervention description(s): Two nutritionists performed both diet instruction and 24-hour reminder monitoring monthly. At the end of the three-month follow-up, the 24-hour reminder data such as food consumed, daily rations, and the monthly average of milligrams of consumed methionine contained in the food, were recorded in a database for subsequent analysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental group: It consisted of a nutritional therapy administration of foods with a high content of methionine according to the National Nutrient Database For Standard Reference (USDA) and adapted to the consumption and usual cost in the Mexican diet. The supervision of the nutritional therapy was carried out through 24-hour reminders, where each patient wrote down the amount and food consumed described in the diet during a 3-month follow-up period. Because the daily requirement for methionine for adults is 260 to 700 mg 98, patients were instructed to combine the foods until they reached a daily intake of at least 700 mg of methionine. Two nutritionists performed both diet instruction and 24-hour reminder monitoring monthly. At the end of the three-month follow-up, the 24-hour reminder data such as food consumed, daily rations, and the monthly average of milligrams of consumed methionine contained in the food, were recorded in a database for subsequent analysis.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-alcoholic Fatty Liver Disease; Nutrition Therapy; Randomized Controlled Trials
CRF - Nociceptin Receptor Interactions
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To determine if [C-11]NOP-1A receptor binding (VT) can be altered by an intravenous
      hydrocortisone (cortisol) challenge through CRF-NOP interactions
    

Detailed description: 
      Examines changes in [C-11]NOP-1A pharmacokinetics caused by an intravenous hydrocortisone
      challenge (1 mg/kg)
    

Intervention name(s): Hydrocortisone; [C-11]NOP-1A
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Hydrocortisone
Intervention model: Single Group Assignment
Intervention model description: Baseline [C-11]NOP-1A scan Post-hydrocortisone [C-11]NOP-1A scan
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the relative bioavailability of the mitapivat
      coated granule formulation compared to the tablet formulation following a single oral dose of
      mitapivat under fasted conditions in healthy adult participants.
    


Intervention name(s): Mitapivat tablets; Mitapivat coated granules
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral coated granules
Other intervention name(s): AG-348; AG-348 sulfate hydrate; Mitapivat sulfate; AG-348; AG-348 sulfate hydrate; Mitapivat sulfate
Intervention MeSH terms: Mitapivat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has been designed to conduct as Randomized comparative clinical study.
    

Detailed description: 
      Two groups, group B received Qurse Mafasil tablet orally two tablets two times daily for 8
      weeks while group A received Leech therapy once weekly for 8 weeks along with Qurse mafasil.
    

Intervention name(s): Hirudinaria granulosa, qurse mafasil
Intervention type(s): Biological
Intervention description(s): compare the efficacy of both groups
Other intervention name(s): leech and drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Qurse mafasil; leech therapy; Hirudinaria granulosa
BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas
      recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60
      mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with
      stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the
      recommended dose for the Phase II trial.
    


Intervention name(s): BIBF 1120 M + docetaxel M; BIBF 1120 M + docetaxel H; BIBF 1120 H + docetaxel H; BIBF 1120 L + docetaxel M; BIBF 1120 H + docetaxel M
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): BIBF 1120 Medium dose bid + docetaxel 60 mg/m2; BIBF 1120 Medium dose bid + docetaxel 75mg/m2; BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2; BIBF 1120 Low dose bid + docetaxel 60 mg/m2; BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2
Intervention MeSH terms: Docetaxel; Nintedanib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
eCoin for OAB Feasibility Follow-on Study
Condition: Overactive Bladder; Urge Incontinence; Incontinence, Urinary; Urinary Urge Incontinence
MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety
      and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary
      incontinence (UUI) as defined by the American Urological Association (30). The follow-on
      study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and
      patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks
      from study device reimplantation).
    


Intervention name(s): eCoin Tibial Nerve Stimulation
Intervention type(s): Device
Intervention description(s): Subcutaneous stimulation of the tibial nerve using the eCoin device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment