bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions
Condition: Coronary Artery Disease; Diabetes Mellitus; Percutaneous Coronary Intervention
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation
      tool, as well as to improve the long-term prognosis of planned percutaneous coronary
      interventions in patients with type 2 diabetes
    

Detailed description: 
      Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One
      group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary
      interventions and for 12 months thereafter in addition to previously taken hypoglycemic
      therapy. Patients of the second group will continue to take previously prescribed
      hypoglycemic therapy.

      Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients
      with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as
      well as the impact on the immediate and long-term outcomes of percutaneous coronary
      interventions in comparison with patients on standard hypoglycemic therapy
    

Intervention name(s): Empagliflozin 10Mg Tab; hypoglycemic therapy
Intervention type(s): Drug; Drug
Intervention description(s): Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication; hypoglycemic therapy.
Other intervention name(s): metformin; metformin
Intervention MeSH terms: Metformin; Empagliflozin; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stable coronary artery disease; empagliflozin
Comparison Between Enlite and Flash Glucose Monitoring
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with
           a standardized breakfast test. Patients receive a standardized breakfast. The usual
           insulin bolus will be administered at breakfast. After breakfast, a venous blood sample
           is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time,
           the glucose value shown by the sensors will be noted. A comparison of the blood glucose
           value with the data recorded by the sensor can evaluate the accuracy of the sensor and
           also estimate the lag-time between the sensor glucose and the venous glucose.

        2. Patient satisfaction will be evaluated using a questionnaire that will be completed
           after the Enlite sensor has been worn for 1 month.

        3. The development of skin reactions will be checked by a short questionnaire, supplemented
           with a picture of possible skin phenomena.

        4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within
           target,% under target, amount of hypoglycemia) in the month prior to sensor switching
           will be compared to the same data recorded by the Enlite sensor during the first month
           of use.
    


Intervention name(s): Enlite sensor communicating with Minimed 640G pump
Intervention type(s): Device
Intervention description(s): Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and
        wearing a FreeStyle Flash Libre glucosesensor
      
Biospecimen description: 
      blood samples
    
Keywords: Enlite glucose monitoring; accuracy; usability; skin reactions; type 1 diabetes mellitus
Decision Making Support for Parents and Caregivers
Condition: Neonatal Critical Illness; Pediatric Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The purpose of this study is to test the feasibility and acceptability of a tool to support
      decision making for parents of critically ill infants.
    

Detailed description: 
      The intervention includes a paper-based decision guide. This decision guide includes content
      related to decisional awareness, values clarification, and a series of question prompts that
      are directed toward guiding parents through health care decision making.
    

Intervention name(s): Decision Making Guide
Intervention type(s): Other
Intervention description(s): The tool will be used by parent(s) to help guide them in discussion with their infant's clinicians.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid
      vaccine when given along with the routine infant immunizations in Philippines.
    


Intervention name(s): Rotarix™; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): oral doses; oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Placebo; Double blind; Gastroenteritis; Randomized; Oral live attenuated human rotavirus liquid vaccine
Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a
      daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a
      12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in
      non-diabetic patients with the metabolic syndrome (see Table 1).
    

Detailed description: 
      This is a two-arm, parallel, double-blind randomized prospective clinical trial. The subjects
      will be asked to provide informed consent, and then undergo screening for enrollment criteria
      at the first visit (-5 weeks). The subjects who are eligible, and provide informed consent
      will return for Visit 2 baseline data (-4 weeks), and then begin the unblinded niacin-ER
      titration. Specifically, subjects will receive a starting dose of niacin-ER of 500 mg per
      day, which will be increased in 500 mg increments every week up to a dose of 2000 mg per day.
      Subjects will need to tolerate at least 1500 mg per day of niacin-ER in order to remain in
      the study and be randomized. Thus subjects who are unable to tolerate the 2000 mg daily dose
      of niacin-ER will be taken back to 1500 mg per day for one week and then randomized. Subjects
      who develop prohibitive side effects at doses less than 1500 mg per day will be discontinued
      from the study. All subjects who are able to take the target dose of niacin-ER will continue
      that dose of niacin-ER and come to the General Clinical Research Center (GCRC) to be
      randomized in a 1:1 fashion to either niacin-ER plus pioglitazone or niacin-ER plus matching
      placebo for 12 weeks. Pioglitazone will be started at 30 mg and then increased to 45 mg at
      week 6. This entry design is designed to minimize the differences in mean dose of niacin-ER
      and dropout rate between study groups.
    

Intervention name(s): Pioglitazone; Placebo; Niacin ER; Aspirin
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Pioglitazone, initially 30 mg, then titrated to 45 mg/day; Pioglitazone placebo; Niacin ER 2.0 g/day; asprin 325 mg/day
Other intervention name(s): Actos
Intervention MeSH terms: Aspirin; Niacin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HDL cholesterol; Metabolic syndrome
Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection
Condition: Treatment of Helicobacter Pylori
Study type: Interventional

Summary: 
      Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold
      standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and
      either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an
      increasing evidence of H. pylori resistance to classical triple therapy. Another reason for
      this failure being low patient compliance with treatment. A regimen useful in one
      geographical area may not be effective or practical in another area. The aim of this study
      was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and
      safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed
      with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14
      days.
    


Intervention name(s): Augmentin (Amoxicillin-clavulanic); Furoxone (furazolidone); Cebes (colloidal bismuth subcitrate); Esso (esomeprazole)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Amoxicillin-clavulanic acid 1 gram b.i.d; furazolidone 200 mg b.i.d; colloidal bismuth subcitrate 240 mg b.i.d; esomeprazole 40 mg b.i.d for 14 days
Intervention MeSH terms: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Furazolidone; Bismuth tripotassium dicitrate; Esomeprazole; Bismuth
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: H.pylori; Triple therapy failure; Quadruple therapy
Radiographic Evaluation of All-on-4 Implant Prosthesis With Different Materials and Bar Construction Techniques
Condition: Bone Loss
Study type: Interventional

Summary: 
      Eighteen patients will be selected from the outpatient clinic of the Prosthodontic
      Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation.

      patients will be randomly divided into three groups according to the framework materials:
      PEEK, Soft metal, and selective laser melting construction.
    

Detailed description: 
      All patients will receive conventional maxillary and mandibular complete dentures.

      2. The mandibular denture will be modified by shortening the flanges and cutting the
      posterior part till the 1st molar then 3D scanned for recording the correct dimension of each
      tooth to be concerned during the construction of the superstructure and the final prosthesis.

      3. Abutment level impression will be made, and the resultant cast will be 3D scanned for
      CAD/CAM construction of superstructure with abutments.

      4. patients will be randomly divided into three groups according to the framework materials:
      PEEK, Soft metal, and selective laser melting construction.

      5. The fit of the framework will be verified intraorally, and the final prosthesis will be
      digitally constructed; according to the dimensions of the scanned denture; to fit over the
      framework.

      Evaluation Radiographic evaluation of circumferential bone level around implants and bone
      changes in the posterior mandible will be done using CBCT at one, two, three, and five years
      after insertion of the final prosthesis.
    

Intervention name(s): screw retained prosthesis
Intervention type(s): Device
Intervention description(s): all-on-4 screw-retained prosthesis.
Other intervention name(s): hybrid prosthsis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: All-on-Four implant; PEEK framework; Soft metal; Selective laser melting
Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this single-dose, open-label, randomized, two-period crossover study was to
      compare the rate of absorption and oral bioavailability of a test formulation of morphine
      sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division
      Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x
      100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered as
      a sprinkle on applesauce after a 10-hour overnight fast.
    


Intervention name(s): morphine sulfate sustained-release capsules; KADIAN (morphine sulfate sustained-release) capsules
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 200 mg, single-dose capsule; 2 x 100 mg, single-dose capsule
Other intervention name(s): Treatment A; Test product; Treatment B; Reference product
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence; morphine sulfate sustained release capsules; KADIAN capsules; 200 mg; applesauce
Blood-Brain-Barrier Opening Using Focused Ultrasound With IV Contrast Agents in Patients With Early Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This is a prospective, non-randomized, single-arm, feasibility study to evaluate the safety
      and initial effectiveness of opening of the Blood-Brain Barrier with intravenous contrast
      agents using the ExAblate Neuro System in patients with early stage Alzheimer's Disease.
    

Detailed description: 
      This study is a prospective, single-arm, non-randomized, feasibility, phase I trial to
      evaluate the safety of focal BBB opening using the ExAblate® Transcranial (220 kHz) system
      and Definity® ultrasound contrast in 6 patients with mild Alzheimer's Disease. This phase I
      trial will be divided into two stages. In the first stage, patients will undergo small volume
      BBB opening, establishing the minimum required sonication parameters to open the BBB, as
      evidenced by gadolinium enhancement on T1-weighted MRI. Stage I is defined as a discrete
      region of approximately 9 mm x 9 mm area in the right frontal lobe. Multiple sonications will
      be performed starting at low energy and ramping up until the BBB is observed to open. The
      subjects will then be removed from the ExAblate® Neuro device and followed for safety for 30
      days. If the subject experienced BBB opening without any serious adverse effects (such as
      brain edema), then the subject may proceed to Stage two where a larger volume (2.5-3.0 cm)
      will be targeted. Subjects will be followed for an additional 60 days for safety and
      preliminary effectiveness.
    

Intervention name(s): BBB opening
Intervention type(s): Device
Intervention description(s): Open BBB using ExAblate focused ultrasound and (Definity®) contrast agent
Intervention model: Single Group Assignment
Intervention model description: Transcranial ExAblate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood-Brain Barrier
Isokinetic Testing Protocol in Elderly and Young Men
Condition: Healthy
Study type: Interventional

Summary: 
      An age-related decrease in muscular strength may have a detrimental effect on muscle fatigue
      and recovery. To date, only one study has determined the effect of varied rest intervals (RI)
      between exercise sets in active younger and older women. They reported that active younger
      and older women require similar RI between sets to recovery full isokinetic knee extension
      peak torque (PT). However, we are unaware of any published studies comparing RI PT recovery
      between younger and older men. Thus, the purpose of this study was to compare the effect of
      two different RI's between sets of isokinetic knee extension exercise on PT, and Total Work
      (TW) between untrained younger and older men.
    

Detailed description: 
      18 young men (24.22 ± 2.58 yrs) and 20 older men (66.85 ± 4.02 yrs) performed 3 sets of 10
      unilateral isokinetic knee extension repetitions at 60°/s. The rest intervals between sets
      were 1 and 2 minutes and were counterbalanced across 2 testing days, separated by a minimum
      of 48 hours. The work-to-rest ratio was 1:3 and 1:6. All subjects were not involved in
      exercise programs that included resistance exercises within the last 6 months. Statistical
      evaluation of the data was performed using a 2x 2 x 3 mixed factor repeated measures ANOVA
      [age (younger and older) x rest interval (1 and 2 min) x set (1st, 2nd, and 3rd)].
      Statistical significance was set at p < 0.05 for all comparisons.
    

Intervention name(s): Isokinetic Dynamometer (Biodex system III)
Intervention type(s): Device
Intervention description(s): Biodex system III Isokinetic Dynamometer (Biodex Medical, Inc., Shirley, NY).
Other intervention name(s): Biodex Isokinetic Dynamometer; Cybex Isokinetic Dynamometer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Isokinetic; Fatigue; Strength; Older
A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy
Condition: Rhinoconjunctivitis Due to Grass Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated
      allergies. The disadvantages of SIT, however, are the requirement of numerous allergen
      administrations over three to five years, and that the treatment itself causes frequent
      allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting
      the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety
      and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract
      injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54
      injections over 3 years.

        -  Trial with immunodulatory product / biological
    


Intervention name(s): Allergen specific immunotherapy
Intervention type(s): Biological
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional

Summary: 
      The aim of this study is to generate epidemiological data to further explore determinants of
      Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral
      pathogens to Acute Exacerbation of COPD (AECOPD) episodes.
    


Intervention name(s): Blood sample; Sputum sample; Nasopharyngeal swab; Urine sample; End tidal breath sample; Data collection; Tests
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Other; Other
Intervention description(s): Blood samples will be collected from all patients at enrolment, at follow-up visits, at exacerbation visits, and during the final visit.; Sputum will be collected from all patients at enrolment, at monthly follow-up visits, at exacerbation visits, and during the final visit. Sputum will be obtained by spontaneous expectoration or induced by stimulation according to standard methods.; Nasopharyngeal swabs will be collected from all patients at enrolment and from a subcohort of 30 patients at monthly follow-up visits and at exacerbation visits during the first year.; Urine samples will be taken at enrolment and exacerbation visits from all subjects and from the same subcohort of 30 patients providing nasopharyngeal swabs, at monthly follow-up visits during the first year.; Breath samples will be collected from all patients at enrolment, at follow-up visits (monthly), at exacerbation visits, and during the final visit.; Patient interview, diary cards review and questionnaires completion; Urine pregnancy test, chest CT-scan, lung function testing and 6-min walk test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pathogen; Chronic Obstructive Pulmonary Disease; Acute Exacerbations of Chronic Obstructive Pulmonary Disease; COPD; respiratory; AECOPD; exacerbation
ERAS for Patients Received Neoadjuvant Chemotherapy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the
      enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.
    

Detailed description: 
      Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs
      accelerate the postoperative rehabilitation of gastric cancer patients without increasing
      postoperative complications. However, in most trials, patients who received neoadjuvant
      chemotherapy were excluded. The investigators designed this trial for patients received
      neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with
      locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the
      investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled
      into the ERAS programs for locally advanced gastric cancer.
    

Intervention name(s): ERAS group; SC group
Intervention type(s): Procedure; Procedure
Intervention description(s): ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.; Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a parallel, open-label randomized controlled trial.
Masking: None (Open Label)
Primary purpose: Treatment