bioihbjkbjnl/mcl2 huggingface dataset:
Dark Chocolate and Glucose Levels in Diabetes
Condition: Type 2 Diabetes; Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Diabetes is a growing concern in the world with an estimated 9.3% of adults, ages 20-79, with
      it in 2019, type 2 diabetes accounting for 90% of this total. A common recommendation for
      individuals with diabetes is to limit sugars and sweets as it may cause a high blood glucose
      response. As a result, chocolate is often avoided due to the sugar content; though,
      high-polyphenol chocolate may have a beneficial effect on hyperglycaemia and vascular
      function. The sugar-free chocolate from Ross Chocolates is formulated with a blend of inulin,
      erythritol, and stevia. These alternatives to sugar are not expected to cause a significant
      change in blood glucose levels following consumption. The main objective of this study is to
      verify glucose levels before and after consumption of Ross Chocolates' blend of sweeteners
      dark chocolate and conventional chocolate in people with diabetes.
    

Detailed description: 
      Individuals with type 1 or type 2 diabetes (10 participants each) will consume a Ross
      Chocolate or conventional sugar-sweetened dark chocolate bar on two occasions in a randomized
      crossover trial. Blood glucose levels will be measured by finger prick for 120 minutes after
      consumption to determine postprandial glucose excursions after consumption of each type of
      chocolate bar.

      Due to the COVID-19 pandemic, the trial was converted to be completed remotely/virtually with
      participants completing the testing at their home under the supervision of a research team
      member who will describe the study procedures and monitor testing via video conferencing.
    

Intervention name(s): Dark chocolate
Intervention type(s): Dietary Supplement
Intervention description(s): Dark chocolate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease
Condition: Pediatric End Stage Renal Disease; Hemodialysis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body.
      Many children with permanent kidney failure undergo dialysis, a life saving procedure that
      takes the place of a kidney. Currently, many children with permanent kidney failure only
      receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on
      dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than
      their healthy counterparts. Survival for these children has not improved over the last 20
      years. These data indicate that the current dialysis treatment strategy is unacceptable.

      This research project will study if more frequent dialysis, performed 5 days per week, will
      improve the health of children with permanent kidney failure compared to the current
      treatment strategy. Children will be treated with both traditional and more frequent dialysis
      schedules to measure improvements in their health and well being.
    


Intervention name(s): Hemodialysis
Intervention type(s): Procedure
Intervention description(s): 5 days per week hemodialysis
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Pediatric; Outcomes; Comparative Effectiveness; End Stage Renal Disease
Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities
Condition: Preventive Measures
Study type: Interventional

Summary: 
      The purpose of this project is to improve cancer screening rates within practices serving
      low-income minority patients
    

Detailed description: 
      This project is designed to implement and rigorously evaluate a cancer screening quality
      improvement project within a practice serving underserved patients. The project involves use
      of a patient registry coupled with patient reminders,recall and outreach.All unscreened
      patients will receive the benefit of this intervention, though some sooner than others for
      the purpose of evaluation.
    

Intervention name(s): Early Intervention; Delayed intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.; One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: cancer screening; screening disparities; underserved populations
A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the study drug,
      taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED).
      The study will last about up to 25 months for each participant.
    


Intervention name(s): Tadalafil
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY450190
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Measurement of Retinal Venous Pressure Under Short-term Low-oxygen Environment
Condition: Healthy
Study type: Observational

Summary: 
      The hypothesis is that the pressure in the retinal veins increases under a short-term lack of
      oxygen and leads to a decreased blood circulation. On the basis of measurements in the
      hypobaric chamber this hypothesis should be verified.
    

Detailed description: 
      Conduct a pilot study to describe and quantify the retinal venous pressure (RVP) in healthy
      volunteers under conditions of controlled, reduced ambient and oxygen partial pressure in the
      pressure chamber of the Aeromedical Institute FAI in Dübendorf, Switzerland. Obtaining
      evidence of the adaptation behavior of the retinal vascular system in controlled, short-term
      hypoxic changes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Keywords: retinal venous pressure; reduced ambient pressure; oxygen partial pressure; short-term hypoxic changes
Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer
Condition: Overall Survival
Study type: Interventional
Phase: Phase 2

Summary: 
      To identify the efficiency of Irinotecan, Oxaliplatin, and S1 in patients with previously
      untreated local regional or metastatic pancreatic cancer.
    

Detailed description: 
      This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an
      investigational drug f Irinotecan,Oxaliplatin, and S1, with the goal of determining the OS of
      advanced pancreatic adenocarcinoma..

      Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer
      and meet all inclusion/exclusion criteria.

      Treatment consists of treatment with Irinotecan 165mg/m2, Oxaliplatin 85mg/m2 on day 1, and
      S1 40mg orally on day 1-14, every 21 days each cycle. Treatment will be administered until
      untolerable toxicities or progression or subject death, or either the subject or sponsor
      discontinues the study.
    

Intervention name(s): Irinotecan,Oxaliplatin, and S1
Intervention type(s): Drug
Intervention description(s): Drug: Irinotecan is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Drug: Oxalipatin Oxaliplatin is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells
Drug: S1 is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells
Other intervention name(s): CPT-11/L-OHP/TS-1
Intervention MeSH terms: Oxaliplatin; Irinotecan
Intervention model: Single Group Assignment
Intervention model description: Experimental: Irinotecan,Oxaliplatin, and S1
S1 will be administered orally days 1 and 14 of a 21 day cycle
Irrinotecan 165 mg/m2 and Oxaliplatin 85mg/m2 will be administered IV days 1 of a 21 day cycle.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overall survival; Irinotecan; Oxaliplatin; S1; Chemotherapy
Clinical Performance of Zirconia Reinforced GI Versus Conventional Viscous GI in Geriatric Patients
Condition: Geriatric; Performance
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is conducted to evaluate the clinical performance of Zirconomer Improved GI
      restoration compared to Conventional viscous GI restoration in geriatric patients with
      Posterior carious lesions in class I or II cavities
    

Detailed description: 
      This study will be conducted to determine the clinical performance of the Zirconia reinforced
      glass ionomer restorations ( Zirconomer improved) under stress bearing posterior area (class
      I or claa II cavities) in geriatric population in comparison to Conventional viscous glass
      ionomer restorations (Ketac molar quick Aplicap) using the modified United States Public
      Health Service (USPHS) criteria

      P: Geriatric Patients with posterior Caries lesions I: Zirconia reinforced GI (Zirconomer
      Improved) C: Conventional viscous GI, (Ketac Molar quick Aplicap) O: The Clinical performance
      of the Glass Ionomer restorations Using USPHS Criteria
    

Intervention name(s): Zirconomer Improved; Ketac Molar quick Aplicap
Intervention type(s): Drug; Drug
Intervention description(s): glass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics; highly viscous glass ionomer with improved mechanical properties than the conventional GI
Other intervention name(s): zirconia reinforced GI; KMQ aplicap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glass ionomer; Restorations
Running Effect on Cardiovascular and Muscular Parameters
Condition: Males; Untrained; 30-50 Years Old; Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the effect of 16 weeks of running exercise on
      various parameters related to heart, vascular systems, blood, and muscle in untrained males
      30-50 years old.

      Further, the investigators assess which of the above mentioned parameters may explain the
      increase of running performance most accurate.
    


Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): 16 week of periodized progressive running exercise 2-4 times/week
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: running exercise; cardiac hypertrophy; blood; maximum oxygen uptake; intervention; untrained; males
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the bioequivalence between single doses of GXR manufactured in Merck
      Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug)
      under fed and fasted state in healthy participants.
    


Intervention name(s): Test GXR; Reference GXR
Intervention type(s): Drug; Drug
Intervention description(s): Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) under fasting or fed conditions on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).; Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/France) under fasting or fed conditions on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
Other intervention name(s): Metformin hydrochloride; Metformin hydrochloride
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes Mellitus; Glucophage Extended Release (GXR); Bioequivalence Study
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of administration of canagliflozin 100 mg
      and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type
      1 Diabetes Mellitus (T1DM).
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), double-blind (neither
      physician nor participant knows the identity of the assigned treatment), placebo-controlled
      (an inactive substance that is compared with a medication to test whether the medication has
      a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin
      therapy for participants with type 1 diabetes mellitus and inadequate glycemic control.

      Approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either
      canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. About 90 participants (30 per
      treatment group) will be selected for a substudy with a purpose of a continuous glucose
      monitoring (CGM) assessment for 7 days at baseline and 7 days at the end of treatment.

      The total duration of the participation will be about 22 weeks, during which participants
      will need to return to investigational sites for approximately 9 visits. During the study
      participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis
      (DKA), as well as on compliance with diet and exercise.
    

Intervention name(s): Canagliflozin 100 mg; Canagliflozin 300 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.; Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.; Matching placebo capsule will be taken orally, before the first meal of the day.
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Canagliflozin; Continuous Glucose Monitoring
Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, placebo control, cross-over study tested the hypothesis that
      periradicular injections of Meloxicam would reduce recent onset low back pain and improve
      physical activity compared to saline injection at 3 months follow-up evaluation
    

Detailed description: 
      In the present study we use a well-known non steroidal anti-inflammatory drug, meloxicam, in
      a novel way, an IM administration near a nerve root.
    

Intervention name(s): saline; Meloxicam
Intervention type(s): Other; Drug
Intervention description(s): The patients received an IM injection of saline near the nerve root (periradicular); The patients received an IM injection of meloxicam near the nerve root (periradicular)
Other intervention name(s): mobic
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Potential of a Low Glutamate Diet as a Treatment for Pediatric Epilepsy
Condition: Epilepsy in Children; Epilepsy in Youth; Randomized Controlled Trial; Refractory Epilepsy; Diet Intervention
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional

Summary: 
      The study is investigating if following the low glutamate diet for 1 month, as compared to
      care as usual, can improve seizure frequency, severity, and duration; cognitive functioning;
      and/or quality of life in children with epilepsy.
    

Detailed description: 
      Epilepsy is estimated to effect 470,000 children within the U.S. About a third of epilepsy
      patients are refractory. For these patients, dietary therapy is an alternative option.
      However, current dietary therapies present issues with compliance, palatability, adverse
      events, and providing necessary nutrients for brain growth and development during childhood.
      A dietary option that can improve tolerability, increase compliance, and reduce or eliminate
      adverse effects, while also optimizing nutrient intake, is critical for the advancement of
      dietary therapy options in epilepsy.

      Glutamate is found in the diet as a flavor enhancer; and is also an important
      neurotransmitter in the body which mediates seizure activity. Dietary sources of free
      glutamate are common and include numerous food additives (including many hidden sources) and
      some items which naturally contain higher amounts of glutamate. The low glutamate diet
      reduces the consumption of free glutamate, while optimizing dietary micronutrient and
      antioxidant intake, which can protect against the negative effects caused by high glutamate
      concentrations in the brain. Additionally, the low glutamate diet is balanced, nutritious and
      palatable, with no side effects.

      The study is investigating if following the low glutamate diet for 1 month can improve
      seizure frequency, severity, and duration; cognitive functioning; and/or quality of life, in
      children with epilepsy. Participation in the study will be done virtually and over a 2- or 3-
      month study period, depending on group randomization. All participants will have the
      opportunity to undergo dietary training and follow the diet.
    

Intervention name(s): Low Glutamate diet
Intervention type(s): Other
Intervention description(s): Participants will be given extensive online dietary training and assigned to follow the low glutamate diet for one month. The low glutamate diet reduces the consumption of free glutamate, while optimizing dietary micronutrient and antioxidant intake.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
GLPG0492 Pharmacodynamics
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      GLPG0492 is a selective androgen receptor modulator: the compound should help protect against
      (or help restore) muscle loss in case of immobilization (e.g. after orthopedic surgery) or
      due to aging (androgenic effect), but without anabolic effects (e.g. effect on testosterone).
      In the first part of the current study it will be tested whether GLPG0492 given orally to
      healthy male volunteers increases the protein synthesis in muscle, as measured by the uptake
      into the muscle of intravenously infused phenylalanine.

      In the second part of the study, the effect of the compound on the "hormone household" in
      healthy, postmenopausal women will be assessed.
    


Intervention name(s): GLPG0492; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; Placebo oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; Pharmacodynamics
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a global multicenter study designed to evaluate the safety and clinical effects of 4
      oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or
      mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks),
      run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24
      weeks).
    


Intervention name(s): TCH346
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ALS; Lou Gehrig's disease
Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Adolescents
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      A single center, stratified, randomized and double-blind phase II clinical trial was
      conducted in adolescents to evaluate the safety and immunogenicity of a split-virion pandemic
      influenza A vaccine (H5N1).
    


Intervention name(s): split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: immunogenictiy; safety; pandemic influenza A vaccine
Laparoscopic Enucleation of Frantz's Tumor of the Pancreas
Condition: Solid Pseudopapillary Neoplasm of the Pancreas
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      The present study describes a 32-year-old female patient, in whom a preoperative imaging
      diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the
      anamnesis, on the preoperative diagnosis, and on the general status of the patient, the
      decision was made to performed laparoscopic enucleation of the pancreatic tumor. The
      operation and postoperative recovery passed without complications. A minimally invasive
      surgical approach should be applied whenever the dimensions and the localization of the tumor
      permits it, bearing in mind all the benefits and advantages that this surgical technique has
      to offer.
    


Intervention name(s): Enucleation of a tumor of the pancreas
Intervention type(s): Procedure
Intervention description(s): Enucleation of a tumor in the pancreas is feasible and safe, as it offers a minimally invasive approach, and morbidities are fewer than open or conventional approach
Intervention MeSH terms: Pancrelipase
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a diagnosed pancreatic tumor by image study.