bioihbjkbjnl/mcl2 huggingface dataset:
MDRS for Prevention of Nocturnal Hypoglycemia
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators have developed a unique Remote & Safety diabetes management system (MDRS)
      that offers real-time remote monitoring and control of glucose levels. The system allows the
      supervising personal to alarm the patient and intervene in cases such as pending
      hypoglycemia, long standing hyperglycemia or technical faults.The aim of this feasibility
      study is to evaluate the efficacy of the MDRS system in preventing nocturnal hypoglycemia in
      children and young adults with type 1 diabetes.
    


Intervention name(s): MDRS System (Remote & Safety diabetes management system); Continuous Glucose Monitoring
Intervention type(s): Device; Procedure
Intervention description(s): Participants will be using the MDRS system combined with their regular Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults; Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 1 diabetes; Continuous Glucose Monitoring; Nocturnal Hypoglycemia
Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray
Condition: Tubal Sterilization
Study type: Observational

Summary: 
      Tubal sterilization is the most prevalent form of contraception in the United States and the
      world. Currently, approximately half of these are performed with a laparoscope and half
      through a mini-laparotomy after delivery. Micro-insert hysteroscopic sterilization system
      received FDA approval for elective sterilization in 2003. Compared to other forms of female
      sterilization, this procedure is minimally invasive and does not require entering the
      abdominal cavity. In addition, it is at least as effective in preventing pregnancy as other
      forms of tubal occlusion. Given the distinct advantages of this method, it could become the
      preferred method of tubal sterilization for physicians and their patients. Currently, there
      is no published data concerning the appearance of the micro-inserts system using other
      imaging modalities that are commonly used in gynecologic practice. As the use of this device
      becomes more widespread it will be more commonly encountered in radiographic imaging
      performed as part of routine patient care. The main objective of this study is to provide
      important descriptive data concerning the ultrasonographic and x-ray appearance of the
      micro-insert hysteroscopic sterilization device. An additional objective of this study is to
      identify characteristics on plain film and ultrasound (US) that correlate with tubal
      occlusion or patency.
    


Intervention name(s): Micro-insert hysteroscopic sterilization; Plain abdominal Xray; Pelvic Ultrasound; Hysterosalpingogram
Intervention type(s): Procedure; Radiation; Procedure; Radiation
Intervention description(s): Placement of micro-inserts transcervically with the aid of a hysteroscope; Performed immediately after micro-inserts placement and at 3 months; Performed immediately after micro-inserts placement and at 3 months.; Performed 3 months after micro-inserts placement
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty-five subjects for this study will be recruited from patients who have requested a
        form of permanent sterilization, and who, after considering all the options, choose the
        trans-cervical hysteroscopic sterilization for this end. Any subject who is deemed suitable
        for the micro-insert hysteroscopic sterilization system (Essure micro-insert system,
        Conceptus Incorporated, Mountain View, California) placement will be offered the
        opportunity to participate in the study. Consent will be documented on a Mayo Clinic
        patient consent form at the time the decision is made to schedule the procedure.
      
Keywords: female sterilization, micro-insert, hysteroscopy
A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
Condition: Airway Management; Laryngeal Mask Airway; Fibreoptic Intubation
Study type: Interventional

Summary: 
      The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as
      well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version
      of the mask has been introduced. The Fastrach single use laryngeal mask is beng compared to
      the new, low-priced single use intubating laryngeal mask Ambu Aura-i™.
    

Detailed description: 
      Eighty patients undergoing general anaesthesia with planned tracheal intubation for elective
      surgical procedures are enrolled in the study after checking for inclusion and exclusion
      criteria. Patients are randomised to either LMA group for blind tracheal intubation with
      either a standard PVC tracheal tube, or a specifically for the LMA Fastrach developed tube,
      yielding 4 subgroups.

      After a standardised anaesthesia induction, blind intubation is performed in each study
      group. Different time intervals are documented, such as time to first adequate lung
      ventilation, or f.e. time for laryngeal mask placement. A crossover-design is performed after
      unsuccessful intubation, using the alternate LMA or the other tracheal tube. LMA placement is
      visualised by fibreoptic control.

      An estimated success rate for blind intubation of 60% in the Aura-i group versus 90% in the
      Fastrach group yields a sample size of n= 38. To compensate for dropouts, n=40 subjects are
      enrolled in each group.
    

Intervention name(s): Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™; Crossover Ambu Aura-i™ / LMA ETT™; Crossover FASTRACH™ / Rüsch Super Safety Silk™; Crossover FASTRACH™ / LMA ETT™
Intervention type(s): Device; Device; Device; Device
Intervention description(s): After unsuccessful blind intubation in the Ambu Aura-i™ / Rüsch Super Safety Silk™ group: crossover design using the Ambu Aura-i™ mask in combination with the LMA ETT™ tracheal tube; After unsuccessful blind intubation in the Ambu Aura-i™ / LMA ETT group: crossover design using the Ambu Aura-i™ mask in combination with the Rüsch Super Safety Silk™ tracheal tube; After unsuccessful blind intubation in the FASTRACH™ / Rüsch Super Safety Silk™ group: crossover design using the FASTRACH™ mask in combination with the LMA ETT™ tube; After unsuccessful blind intubation in the FASTRACH™ / LMA ETT™ group: crossover design using the FASTRACH™ mask in combination with the Rüsch Super Safety Silk™ tube
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease
Condition: Blood Pressure
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood
      pressure fluctuations in individuals with Parkinson's disease.
    

Detailed description: 
      We will be monitoring 24 hour ambulatory BP and HR in subjects with PD on 3 separate visits.
      The first visit will be without an intervention to establish a baseline of 24 hour BP
      fluctuations. One week later the subject will be given either L-tyrosine (2,000 mg) with B6
      (10 mg) or a sugar pill. We will monitor 24 hour BP and HR after supplementation. One week
      later the subject will repeat the same procedures with either supplement or placebo.

      This is a total of 3 visits with 24 hour ambulatory BP and HR monitoring.
    

Intervention name(s): L-tyrosine; Sugar Pill
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.; Each subject will receive a sugar pill BID for 24 hours.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice
      daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on
      short-term lower leg growth in prepubertal children with mild persistent asthma. The study
      duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each
      treatment), and a wash-out period (2 weeks). The study will provide further data on safety
      and tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Child; Fluticasone propionate; HPA-axis; Pediatric; Linear growth rate
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Diabetes is a disorder of energy energy metabolism. Glucose is the main energy substrate for
      generation of ATP to maintain cellular metabolism, structure and function. Glucokinase (GK)
      serves as a glucose sensor for the initiation of the energy generation.for energy metabolism.
      Dorzagliatin is a novel, first-in-class, dual-acting allosteric GK activator (GKA). It
      increases the affinity of GK for glucose by directly binding a pocket distal to its active
      site, thus lowering the set point for glucose-stimulated insulin secretion in the beta-cell.

      Dorzagliatin is a new drug which acts as GK sensor activator (GKA). It can restore the
      sensitivity of the pancreas cells to glucose and improve glucose control. The drug has been
      trialled in healthy volunteers and in individuals with type 2 diabetes.

      The aim of this study is to understand the way in which dorzagliatin works to improve blood
      sugar control in people with diabetes. The study will look at how dorzagliatin affects
      insulin secretion and the sensitivity of the pancreas to changes in blood sugar levels. We
      will examine whether dorzagliatin can restore the function of this GK sensor in patients with
      known mutations. In a cross-over study, we will evaluate the effects of dorzagliatin, a
      specific GKA versus placebo in terms of insulin secretion and beta-cell glucose sensitivity
      in patients with newly-diagnosed T2D and patients who are known heterozygous carriers of GK
      mutations.
    


Intervention name(s): Dorzagliatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet; placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Intraoperative Protective Ventilation and Postoperative Pulmonary Complications
Condition: Complication of Ventilation Therapy; Postoperative Respiratory Complications
Study type: Interventional

Summary: 
      The purpose of this pilot study is to identify the optimal way to ventilate patients during
      abdominal surgery in order to reduce the amount of post-operative pulmonary complications in
      patients at moderate and high-risk for them.
    

Detailed description: 
      The investigators plan to prospectively compare two methods to individualize Positive End
      Expiratory Pressure (PEEP) settings in the operating room during abdominal surgery: (1)
      Maximization of respiratory compliance during a decremental PEEP titration, and (2)
      Prevention of negative end-expiratory transpulmonary pressures.

      The investigators will exploit the usual intraoperative requirement for a naso/orogastric
      tube to assess transpulmonary pressures,and respiratory mechanics measurements from
      anesthesia machines to titrate PEEP.

      The investigators will measure biomarkers of lung injury and lung function to compare those
      methods between themselves and to the control group. In the process, the investigators will
      assess the ease and reliability of anesthesia teams in implementing the methods. These data
      will allow us to determine the PEEP strategy best suited for the full-scale trial, and to
      estimate the degree of separation the experimental lung protective approach will have from
      the protocolized usual care control settings.
    

Intervention name(s): Maximal Compliance; Transpulmonary Pressure
Intervention type(s): Other; Other
Intervention description(s): PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.; We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Phase 1 Comparative Study of E2022 Current and New Patch Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and pharmacokinetics of new patch
      formulation (tape) of E2022 by conducting patch test.
    


Intervention name(s): E2022- Current Formula Tape; E2022- New Formula Tape; E2022 Matching Placebo- Current Formula Tape; E2022 Matching Placebo- New Formula Tape
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days.; Cohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days.
Other intervention name(s): Cohort I: E2022 Matching Placebo current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.; Cohort I: E2022 Matching Placebo new formula tape administered on a skin application site and evaluated for
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: volunteer
The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)
Condition: Malnutrition, Child
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      This research compares the effects of one-year continuous whole egg supplement vs. egg yolk
      substitutes and control on anthropometry, biochemical blood parameters, metabolic enzymes and
      microbiome data in primary school children.
    

Detailed description: 
      This research study determine the long-term effects of egg supplementation on growth, blood
      lipoproteins, blood proteins, nutritional status, metabolic enzymes and microbiomes in
      children, enrolling in the school lunch program.
    

Intervention name(s): whole eggs; yolk-free egg substitutes
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): whole eggs; yolk-free egg substitutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled cluster trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: malnutrition; whole egg consumption; primary school student; growth
A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's
      Disease.
    


Intervention name(s): KHK6640; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending dose administration; Single ascending dose administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: KHK6640; Phase 1; Japanese; single dose; Alzheimer's disease
Evaluation of the Performance of the Motus Cleansing System
Condition: Colonoscopy Procedure
Study type: Interventional

Summary: 
      The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
    

Detailed description: 
      Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20
      mg Bisacodyl (4*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.

      following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the
      procedure.
    

Intervention name(s): Motus Cleansing System
Intervention type(s): Device
Other intervention name(s): Motus CleanC
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.
Masking: None (Open Label)
Primary purpose: Screening
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
Condition: Dyslipidemia
MeSH terms: Dyslipidemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of
      ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
    


Intervention name(s): ETC-1002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ETC-1002 daily for 12 weeks; Placebo daily for 12 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to evaluate how the body processes and removes mirikizumab. The study
      also evaluated safety and disease response in pediatric participants with UC taking
      mirikizumab. The study lasted about 52 weeks and included up to 18 visits.
    


Intervention name(s): Mirikizumab
Intervention type(s): Drug
Intervention description(s): Administered IV and SC
Other intervention name(s): LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interleukin-23 (IL-23) antibody; IL-23p19; Pediatric
A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America. The aim of this trial is to
      investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the
      body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide
      in obese children aged 7 to 11 years
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): For subcutaneous (s.c., under the skin) injection once daily.; For subcutaneous (s.c., under the skin) injection once daily.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      To investigate the effectiveness of two doses of the probiotic strain Bif-038 on markers of
      low-grade inflammation in a elderly population
    

Detailed description: 
      The study is a randomized, double-blind, 3-arm, placebo-controlled pilot study in an elderly
      population (60-85 years) with low-grade inflammation (hs-CRP 2-10 mg/L) comparing two doses
      daily intake of Bif-038 at 1 and 10 billion CFU to placebo for 12 weeks. The subjects will
      receive either one of the two test products or the placebo product daily for a period of 12
      weeks.

      During the entire study period, five visits are scheduled. The subjects will participate in
      two screening visits; a baseline visit, a visit after 6 weeks of intervention and an
      end-of-study visit after 12 weeks of intervention. Visit 1 and 2 are screening- and
      recruitment visits with at least two weeks apart. Only participants with a hs-CRP within
      2.0-10.0 mg/L will be invited for the second screening visit. Participants with repeated
      hs-CRP levels within 2.0-10.0 mg/L will be invited for baseline visit 3, to be included and
      randomized in the study.

      At the screening visits the eligibility will be checked after the participants have given
      their written informed consent.

      Blood samples and stool samples will be collected during the study and subjects will be asked
      to complete questionnaires and a dietary diary.

      No sample size calculations were performed due to the exploratory nature of a pilot study
      design. Planned number to include is 20 subjects per study arm, thus 60 subjects in total.
    

Intervention name(s): Experimental: Bif-038 arm, high dose; Experimental: Bif-038 arm, low dose; Placebo Comparator: Placebo arm
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Active trial product with minimum 10 billion CFU daily dose; Active trial product with minimum 1 billion CFU daily dose; Similar product to trial product but without Bif-038
Other intervention name(s): Probiotic; Probiotic; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention