bioihbjkbjnl/mcl2 huggingface dataset:
TeLIPro Health Program - Active With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In a randomized-controlled trial the hypothesis should be tested that the Telemedical
      Lifestyle Intervention Program TeLIPro could significantly improve HbA1c (primary outcome),
      body weight and composition, cardiovascular risk factors, quality of life, eating behavior,
      and medication demand (secondary outcomes) in type 2 diabetes mellitus (T2DM) patients.
    

Detailed description: 
      T2DM patients, assured at the health insurance AOK Rhineland / Hamburg will be randomized
      into two parallel groups. In addition to routine care both groups will be provided a scale as
      well as a step counter and access to a secured online portal. The TeLIPro group will
      additionally got a glucose meter with test stripes fpr self-monitoring of blood glucose and
      telemedical coaching.

      Participants of both groups will enter their anthropometric and metabolic data into a
      database on quarterly basis. In addition, the costs for diabetes-specific treatment,
      inpatient and outpatient treatment costs and drug costs will be analyzed on the basis of the
      routine data of the AOK Rhineland / Hamburg.

      Patient preference for type 2 diabetes intervention will be recorded using Discrete Choice
      Experiment (DCE) questionnaires at the beginning of the program and at the end of the
      intervention. As part of the development and validation of the DCE, focus groups are used to
      determine the DCE attributes. In addition, focus groups should also be used during the data
      collection in order to obtain additional information on patient preferences by means of
      qualitative analysis.
    

Intervention name(s): Scale; Step counter; Blood glucose meter with test stripes; Access to the online portal; Telemedical coaching
Intervention type(s): Device; Device; Device; Other; Other
Intervention description(s): self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal; self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal; self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal; self-monitoring of health parameters; regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diabetes Mellitus, Type 2
Respiratory Physiology Under High Flow Therapy
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to gain knowledge about effects of high flow transnasal insufflation
      on various breathing parameters like intratracheal pressure conditions, CO2 elimination,
      breathing frequency and tidal volume.
    

Detailed description: 
      Ten patients, who are supplied with a tracheostomy stent (placeholder) for reinsertions after
      long term ventilation will be treated for a short time during the day with the nasal high
      flow system AIRVO at different flow rates (15, 30, 45L/min) to estimate possible long term
      implications of high flow treatment.

      Respiration is measured by impedance plethysmography with a calibrated belt system
      (Respitrace, VIASYS). Pressure and end tidal CO2 concentration is measured inside of the
      placeholder.

      The order of the high flow rates (15, 30, 45L/min) is randomized; each flow rate is measured
      for 15 minutes. A wash out time of ten minutes is planned after each phase. In this time the
      patient breathes his individual oxygen flow rate with attention to the oxygen saturation,
      which should not exceed 96%. Transcutaneous PCO2 and SpO2 is monitored with TOSCA during the
      study.
    

Intervention name(s): High flow therapy
Intervention type(s): Procedure
Intervention description(s): Each patient is treated with nasal high flow at different flow rates (15, 30, 45L/min). The order of flow rates is randomized. Each flow rate will be used for 15 minutes. A wash out time of ten minutes is planned after each phase, during which the patient uses his his individual oxygen flow.
Other intervention name(s): AIRVO (Fisher and Paykel)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD; Nasal High Flow Therapy; tracheotomy stent; tracheotomy
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
Condition: Post Concussion Symptoms
MeSH terms: Post-Concussion Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine the number of children who have symptoms
      of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's
      Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed
      concussion. This study is the first phase of a two-part study looking at the effects of
      anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently,
      the decision to continue with surgery in patients with a diagnosed concussion is based on
      clinical judgment by the patients.
    

Detailed description: 
      Phase I's specific aim is to estimate the incidence of symptomatic concussion in the
      pediatric orthopedic surgical population.

      The first phase of this study requires a member of the research team to administer a paper
      questionnaire to all eligible, consented orthopedic surgery patients in either the
      Pre-operative Clinic or in the Day Surgery Unit over a period of four months. The research
      member will only approach adolescents that are scheduled for repair of orthopedic traumatic
      injury as defined in the inclusion criteria. The questionnaire is specifically designed to
      elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a,
      which asks "At the time of the injury do you recall a blow to the head, neck, face or body
      that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion,
      nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting
      symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire
      will be used to determine the incidence of symptomatic concussions, either known or
      unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical
      repair. If the participant scores higher than a 0 on the SCAT3 the results will be conveyed
      to the surgeon prior to the start of the scheduled surgical procedure. A copy of the
      completed SCAT3 will also be placed in the medical record. The decision to continue with
      surgery and need to possibly refer the patient to the Boston Children's Hospital Sports
      Concussion Clinic after the SCAT3 will remain at the surgeon's discretion.

      Information will be gathered from the questionnaire and the SCAT3, then entered into the
      REDcap database under a de-identified subject number.
    

Intervention name(s): Concussion Questionnaire
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Pilot-Scale Clinical Trials of Kibow Biotics® in Chronic Kidney Failure
Condition: Chronic Kidney Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Observational

Summary: 
      The bowel can serve as a complement to the kidneys' excretory function

      A specifically formulated probiotic product comprised of defined and tested microbial strains
      may afford renoprotection in what has been called "enteric dialysis"® Confirm the alleviation
      of uremic syndrome hypothesis Determine the outcome of probiotics treatment Confirm U.S.
      FDA's Generally Recognized As Safe (GRAS) status - if needed
    

Detailed description: 
      Probiotics are increasingly utilized clinically. As their safety and health benefits are
      established, it is reasonable to anticipate that probiotic bacteria will be incorporated into
      a growing number of clinical regimens.

      Following exploratory testing of orally administered probiotic bacteria in rats and minipigs
      with surgically induced chronic kidney disease (CKD), a trial is now in progress to determine
      whether daily treatment with gastrointestinal (GI) probiotic bacteria will delay the onset of
      and/or improve established signs and symptoms of human CKD.

      To assess the potential benefit in devising a gut-based probiotic formulation (Kibow
      Biotics®) as a dieatary supplement - Over The Counter (OTC)product in CKD applications.

      Extensive in vitro R&D investigations in Kibow's laboratories

      Simulated Human Intestinal Microbial Ecosystem (SHIME, Ghent University, Belgium) utilized in
      a computer-controlled in vitro system validated the concept that the chosen microbial
      formulation would metabolize and reduce concentration of nitrogenous components including
      urea, creatinine, and uric acid. Bacterial strains studied were Streptococcus thermophilus
      (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).

      Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat
      model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University,
      Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr)
      levels.

      Two independent veterinarians investigated the effect of Kibow Biotics® on clinically
      manifested renal failure in uremic cats and dogs of both genders and varying body weights.
      Based on positive results, this formulation, marketed and distributed as AzodylTM, is
      currently licensed for veterinary applications to Vetoquinol USA
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Out patient Hospital setting
      
Keywords: Chronic Kidney failure stage three and four; Probiotics; Kibow Biotics; Enteric Dialysis; Gut based removal uremic toxin removal
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
Condition: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset
      counts during the first year of treatment in subjects with relapsing-remitting multiple
      sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute
      lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.
    


Intervention name(s): dimethyl fumarate
Intervention type(s): Drug
Intervention description(s): Initial oral dose for 7 days with maintenance dose thereafter
Other intervention name(s): BG00012; Tecfidera; DMF
Intervention MeSH terms: Dimethyl Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tecfidera; DMF; dimethyl fumarate
Hip Scope Fascia-iliaca (FI) Block Study
Condition: Hip Dysplasia; Femoroacetabular Impingement; Acetabular Labrum Tear
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Femoracetabular Impingement
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients undergoing a hip scope procedure will be recruited for this study. They will be
      randomized to either receive a nerve block or no nerve block (pain medicine only). Pain
      levels and clinical outcomes will be assessed through 3 months post-operatively.
    


Intervention name(s): ropivicaine; clonidine; Epinephrine; Noropin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Clonidine; Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip Arthroscopy
Evaluating the Effect of Food on Absorption of Megace ES
Condition: Pharmacokinetics; Bioavailability; Absorption
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625
      mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in
      healthy individuals.
    


Intervention name(s): Megestrol acetate oral suspension 625 mg/5 mL; Megestrol acetate oral suspension 625 mg/5 mL
Intervention type(s): Drug; Drug
Intervention description(s): Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal; Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast
Other intervention name(s): Megace ES; Megace ES
Intervention MeSH terms: Megestrol; Megestrol Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Food Effect; Bioavailability; Megace ES
Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children
      who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary
      vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed
      hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in
      this study will be either an investigational Merck product (Modified Process Hepatitis B
      Vaccine) or licensed ENGERIX-B vaccine.
    


Intervention name(s): Comparator: Modified Process Hepatitis B Vaccine; Comparator: Comparator: ENGERIX-B
Intervention type(s): Biological; Biological
Intervention description(s): Single dose 5 µg/0.5ml modified process hepatitis B vaccine; Single dose 10 µg/0.5ml ENGERIX-B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the study is to help answer the following research questions, and not
      to provide treatment for Rheumatoid Arthritis (RA):

        -  The safety of LY2439821 and any side effects that might be associated with it.

        -  Whether LY2439821 can help participants with active RA.

        -  How much LY2439821 should be given to participants.
    

Detailed description: 
      Study I1F-MC-RHAK is a multicenter study in participants with active RA on concomitant
      conventional DMARD therapy. The study is a Phase 2 study with 2 parts. Part A is a
      randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design and Part B
      is an optional, open-label extension design. Two participant populations will be evaluated in
      this study: bDMARD-naive participants and TNFα-IR participants. Participants in Part A
      receive multiple subcutaneous injections of LY2439821 [bDMARD-naive participants: 0
      (placebo), 3, 10, 30, 80, or 180 mg; TNFα-IR participants: 0 (placebo), 80 or 180 mg] at
      Weeks 0, 1, 2, 4, 6, 8, and 10. Participants in Part B receive subcutaneous injections of
      LY2439821 160 mg at Weeks 16, 18, and 20, and every 4 weeks thereafter through Week 60.
      Participants who complete both Part A and B have a total study participation of up to
      approximately 72 to 84 weeks.
    

Intervention name(s): LY2439821; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Subcutaneous; Subcutaneous
Other intervention name(s): ixekizumab
Intervention MeSH terms: Ixekizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; RA
Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood
Condition: Chronic Kidney Diseases; Hypertension; Blood Pressure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Hypertension is an increasingly common problem in children, especially among those who are
      obese or with diabetes and chronic kidney disease. This study is a pilot randomized
      controlled trial designed to test whether improved blood pressure control can be achieved
      with the use of remote home blood pressure monitoring in children with uncontrolled blood
      pressure.
    

Detailed description: 
      Hypertension is an increasingly common problem in children, especially among those who are
      obese or with diabetes and chronic kidney disease. This study is a pilot randomized
      controlled trial designed to test whether improved blood pressure control can be achieved
      with the use of remote home blood pressure monitoring in children with uncontrolled blood
      pressure. Study investigators will randomize 60 children who have elevated BP (defined as
      receipt of ≥1 anti-hypertensive agent or office SBP ≥90th percentile) to either home BP
      monitoring with a home SBP target of < 90th percentile or less than 120 mm Hg, which ever is
      lower (intervention group) versus usual care group in 2:1 ratio. This study aims to (1)
      compare the safety of BP lowering in intervention versus usual care patients, (2) determine
      the efficacy of the intervention and provide estimates for the refinement of sample size
      determination for an eventual full-scale trial, and (3) assess the feasibility and
      acceptability of the intervention, recruitment rates, and barriers to trial completion.
    

Intervention name(s): strict blood pressure control
Intervention type(s): Other
Intervention description(s): Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases
Condition: Short Message Service; Adherence; Stent Exchange; ERCP; Biliary Stricture
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      Endoscopic implantation of plastic or covered metal stents is widely used in a variety of
      benign pancreaticobiliary diseases, including duct stricture, large or difficult stones, bile
      or pancreatic juice leak, etc. There are some late-stage adverse events after stent
      insertion, such as stent occlusion, proximal or distal migration, secondary duct injury and
      failure of stent removal, etc. The longer the stents were inserted, more likely the adverse
      events would happen.

      Although the optimal time of stent placement has not been well established, it has been
      recommended that plastic stent should be removed/exchanged within 3-4 months and covered
      metal stent be removed within 6 months. However, it was not uncommon that patients with stent
      implantation did not follow the recommendation of further stent management by endoscopists.

      Many methods have been used to improve the adherence of patients in medical service. With the
      advance of mobile technology and popular use of mobile phones, it was believed that the
      patient-centered outcome could be improved by mobile telecommunication with the timely
      support of a patient by a health professional. Thus we hypothesize that mobile technology,
      reminding the patients the necessity of stent management in time by short message service
      (SMS), might increase the patient adherence in patients with benign pancreaticobiliary
      diseases after ERCP.
    


Intervention name(s): SMS reminder; Conventional reminder
Intervention type(s): Other; Other
Intervention description(s): Each month after stent implantation, one investigator sent a text massage by SMS to inform patients the necessity of regular stent removal/exchange and the disadvantage of delayed management, and to remind them the appropriate date back to the hospital for stent management. Patients were requested to response by SMS and were encouraged to contact with the investigator if they had any questions about stent management.; After stent implantation, all patients received oral instruction about further management. If single or multiple plastic stents were inserted, patients were informed back to our hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed back to the hospital at 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention