louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01953302: Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair
Official title: Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Ventral Hernia
Recurrent Ventral Hernia
Keywords: ventral hernia
infection
hematoma
seroma
recurrence
mesh technique
Lead sponsor: Varazdin General Hospital
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique.

Detailed description: We analyzed early postoperative complications (EPCs; wound infection, hematoma, and seroma) and late postoperative complications (recurrence) in 124 patients operated for IHs and recurrent IHs (RIHs) using our new technique. Our technique involved repairing hernias by preserving the hernia sac, which was later used to conceal the mesh that replaced the abdominal wall defect, thus dividing the mesh from subcutaneous tissue.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 years or older
* American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria:

* refusal of the patients to give informed consent

Primary outcomes:
measure: Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
timeFrame: four weeks after the surgery
Secondary outcomes:
measure: Number of Patients With Postoperative Hernia Recurrence
timeFrame: up to 36 months after the surgery
Other outcomes:
Locations:
city: Varazdin
country: Croatia
facility: Varazdin General Hospital
Study officials:
affiliation: Varazdin General Hospital
name: Ranko Stare, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pajtak A, Stare R, Biskup I, Lukic A, Skorjanec S, Hrzenjak K. A modified open intraperitoneal mesh (Garestin) technique for incisional ventral hernia repair. Asian J Surg. 2017 Jul;40(4):278-284. doi: 10.1016/j.asjsur.2016.02.001. Epub 2016 May 18.
Clinical trial NCT02128802: Obesity Surgery and Kidney Transplant for Patients With Obesity and Renal Failure
Official title: Weight Reduction Surgery Followed by Kidney Transplantation for Patients With Class III Obesity and Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Obesity
Renal Failure
Keywords: Obesity
Renal failure
Gastric bypass
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.


Eligibility criteria: Inclusion Criteria:

* Body mass index 40-55 kg/m2
* Age less than 60 years
* Available support person
* Adequate insurance
* All other criteria required for renal transplantation

Exclusion Criteria:

* Schizophrenia
* Bipolar disorder
* Crohn's disease
* Human Immunodeficiency Virus
* Cirrhosis
* Prior weight loss surgery
* Prior mesh hernia repair
* Prior anti-reflux surgery
* Inability to walk 200 feet
* Significant coronary disease
* Significant lung disease - Fixed expiratory volume 1 less than 75% or on oxygen
* Addiction to alcohol or drugs
* Inability to quit smoking
* Jehovah's witness
* Non-compliance with dialysis regimen
* Previous renal transplant
* Non-English speaking

Primary outcomes:
measure: Ability to reach medical suitability for renal transplant within 18 months after initiating treatment and the change and trajectory of health-related quality of life (HRQOL)
timeFrame: 18 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 5 years
measure: Weight loss
timeFrame: 5 years
measure: Surgical outcomes
timeFrame: 5 years
measure: Development or regression of diabetes
timeFrame: 5 years
measure: Development or regression of other comorbidities
timeFrame: 5 years
measure: Health care utilization
timeFrame: 5 years
measure: Nutritional status
timeFrame: 5 years
measure: Hormonal and metabolic status
timeFrame: 5 years
Other outcomes:
measure: Prograf dosing
timeFrame: 5 years
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Seth Karp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023202: UWCCC Molecular Tumor Board Registry
Official title: UWCCC Precision Medicine Molecular Tumor Board Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Neoplasms
Solid Neoplasm
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include all patients age ≥18 with clinically suspected or histologically confirmed solid or hematological malignancy who will undergo genetic testing of their tumor. It will require each patient to have the ability to understand and willingness to sign a written informed consent document.

Brief summary: This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor Board, and to track patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Clinically suspected or histologically confirmed solid or hematological malignancy
* Undergoing genetic testing of tumor
* Ability to understand written informed consent document
* Willingness to sign written informed consent document

Exclusion Criteria:

* Pediatric patients (age\<18 years) will be excluded due to a lack of expertise on the molecular tumor committee

Primary outcomes:
measure: Frequency of acceptance of molecular tumor board recommendations
timeFrame: Up to 5 years
measure: Benefit from PMMTB recommended treatment
timeFrame: Up to 5 years
Secondary outcomes:
measure: Correlation of mutations with protein overexpression
timeFrame: Up to 5 years
measure: Correlations of mutations with circulating tumor DNA
timeFrame: Up to 5 years
measure: Correlations of mutations with spheroid culture investigations
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mark Burkard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584402: Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Official title: Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Neoplasms
Keywords: liver cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas \& metastases) within the liver.

Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography

Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography

Detailed description: An estimated 75 patients (age 18 years of age or older) will be enrolled from the population of patients who present for ultrasound-guided radiofrequency ablation (RFA) of CT or MRI-confirmed multiple primary hepatocellular carcinoma (HCC) or metastatic carcinoma, with at least one of the tumors being ≤ 1.5 cm in diameter.

Eligibility criteria: Inclusion Criteria:

* Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment
* Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter
* Patient is stable and is to be managed conservatively (i.e. non-surgically)
* 18 years of age or older
* Ability and willingness to provide written informed consent

Exclusion Criteria:

* Known or suspected cardiac shunt(s)
* Known sensitivity to octafluoropropane
* Pregnant or breastfeeding

Primary outcomes:
measure: Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
timeFrame: 15 min
Secondary outcomes:
measure: Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth
timeFrame: 15 min
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis School of Medicine Dept. of Radiology
name: John P. McGahan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05953402: A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Official title: ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ulcerative Colitis
Keywords: ZEPOSIA®
Ozanimod
Pregnancy
Sphingosine-1-phosphate (S1P) therapies
Inflammatory Bowel Disease
IBD
Ulcerative Colitis
UC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 1182
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include women of any age who i) are currently or recently have been pregnant; ii) have a diagnosis of UC; iii) reside in a country where ozanimod is prescribed for the treatment of UC; iv) provide consent to participate as well as medical releases for their Healthcare Providers (HCPs) to provide data to the registry; and v) meet the criteria for inclusion.

Brief summary: The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.


Eligibility criteria: Inclusion Criteria:

* Currently or recently pregnant
* Diagnosis of UC
* Resident of country where ozanimod is prescribed for the treatment of UC

Exclusion Criteria:

* Exposure to other S1P therapies at any time during pregnancy

Other protocol-defined eligibility criteria apply.

Primary outcomes:
measure: Event rate of Major Congenital Malformations (MCM)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Event rate of minor congenital malformations
timeFrame: Up to 12 months
measure: Event rate of pre-eclampsia
timeFrame: Up to 9 months
measure: Event rate of eclampsia
timeFrame: Up to 9 months
measure: Event rate of Spontaneous Abortion (SAB)
timeFrame: Up to 9 months
measure: Event rate of stillbirth
timeFrame: Up to 9 months
measure: Event rate of elective termination
timeFrame: Up to 9 months
measure: Event rate of preterm birth
timeFrame: Up to 9 months
measure: Event rate of Small for Gestational Age (SGA)
timeFrame: Up to 12 months
measure: Event rate of postnatal growth deficiency
timeFrame: Up to 12 months
measure: Event rate of infant developmental deficiency
timeFrame: Up to 12 months
measure: Event rate of perinatal death
timeFrame: Up to 10 months
measure: Event rate of neonatal death
timeFrame: Up to 1 month
measure: Event rate of infant death
timeFrame: Up to 12 months
measure: Event rate of serious or opportunistic infant infections
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06763302: NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL
Official title: NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: B Cell Precursor Acute Lymphoblastic Leukemia
Pediatric
Minimal Residual Disease
Next Generation Sequencing (NGS)
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 1220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment.

The main questions it aims to answer are:

1. Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy?
2. Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?


Eligibility criteria: Inclusion Criteria:

* Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).
* Age ≥1 year and \<18 years.
* Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.

Exclusion Criteria:

* Age \<1 year or ≥18 years.
* Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.
* Secondary leukemia or second tumor, CML blast phase ALL.
* Other tumors or immunodeficiency diseases present.

Primary outcomes:
measure: event free survival
timeFrame: From enrollment to the 3-year after the end of treatment
measure: Relapse free survival
timeFrame: From enrollment to the 3-year after the end of treatment
Secondary outcomes:
measure: Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: From enrollment to the 3-year after the end of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Chen H, Gu M, Liang J, Song H, Zhang J, Xu W, Zhao F, Shen D, Shen H, Liao C, Tang Y, Xu X. Minimal residual disease detection by next-generation sequencing of different immunoglobulin gene rearrangements in pediatric B-ALL. Nat Commun. 2023 Nov 17;14(1):7468. doi: 10.1038/s41467-023-43171-9.
Clinical trial NCT05569902: tACS Improves Memory in Elders With Subjective Memory Complaints
Official title: Remember NIBS? tACS Improves Memory Performance in Elders With Subjective Memory Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Deficits
tACS
Keywords: Episodic memory
medial Prefrontal Cortex
tACS
SMC
Lead sponsor: University of Tehran
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjective memory complaints (SMC), the main cognitive component of which is event memory, is a predictor of Alzheimer's disease in elderly people. The purpose of this study was to investigate the effect of transcranial alternating current stimulation (tACS) with theta frequency (6 Hz) on the medial prefrontal cortex in the improvement of episodic memory in individuals with SMC in a double blind, randomized, and sham-controlled parallel study. Sixteen participants with SMC received either active or sham theta tACS on the medial prefrontal cortex (mPFC). EEG was recorded and Rey Auditory Verbal Learning Test (RAVLT) was administered. The aim of the current study was to see if theta tACS over the mPFC can improve event memory in individuals with SMC and thus can be considered a potential therapeutic intervention for this population or not.


Eligibility criteria: Inclusion Criteria:

* Being 50 or older,
* Mini Mental State Examination (MMSE) grade from 27 to 30
* Total score of 58 or more on the Everyday Memory Questionnaire (EMQ)
* no indications of depression and anxiety measured by Geriatric Depression Scale (GDS) and State-Trait Anxiety Inventory (STAI)
* No sign of dementia based on Diagnostic and statistical manual of mental disorder, 5th edition (DSM-V) criteria

Exclusion Criteria:

* History of a major psychological or neurological condition
* History of head trauma leading to unconsciousness,
* Presence of metal in the head
* History of seizures
* Serious cardiovascular disease
* Use of medications with an impact on cognitive functions
* Recent use of alcohol or substance abuse

Primary outcomes:
measure: Change in performance
timeFrame: 25 minutes i.e., before versus after the stimulation
Secondary outcomes:
measure: Change in EEG power in theta frequency band
timeFrame: 30 minutes, i.e., before versus after stimulation
measure: Change in phase synchronization connectivity in theta frequency band
timeFrame: 30 minutes, i.e., before versus after stimulation
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Brain Mapping Lab
Study officials:
affiliation: University of Tehran
name: Reza Rostami, M.D.
role: STUDY_DIRECTOR
affiliation: University of Tehran
name: Sahereh Varastegan, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04817202: Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)
Official title: hzVSF-v13 - A Phase I, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics After Intravenous and Subcutaneous Administration in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: ImmuneMed, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Assessment of the safety, tolerability and pharmacokinetics (PK) characterization of hzVSF-v13 with single and multiple doses (intravenous and subcutaneous) compared to placebo in healthy subjects.

Detailed description: A phase I, double-blind, placebo-controlled, single and multiple dose

Eligibility criteria: Inclusion Criteria:

* Males or females (of either childbearing or non-childbearing potential), of any race, between 18 and 60 years of age, inclusive on day of screening.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive on day of screening.

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).

Primary outcomes:
measure: Changes from baseline QTc interval at each time point
timeFrame: Group A1~A7: Day 1 (pre-dose), Day 8, Day 15, Day 22, Day 29, Day 36, Day 50, Day 64, Day 78, Day 92 Group B1~B2: Day 1 (pre-dose), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 98, Day 162
Secondary outcomes:
measure: Pharmacokinetic - Cmax
timeFrame: Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98
measure: Pharmacokinetic - AUC0-∞
timeFrame: Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX, Clinical Research Pty Ltd.
state: South Australia
Study officials:
affiliation: CMAX Clinical Research Pty Ltd
name: +61-8-70887900 Wabnitz, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04019821: Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal
Official title: Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index Meal in Children With Type 1 Diabetes Mellitus- Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Keywords: super bolus
diabetes type 1
insulin bolus
high glycemic index meal
prandial insulin requirement
postprandial glycemia
insulin pump therapy
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 72
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).


Eligibility criteria: Inclusion Criteria:

* duration of type 1 diabetes longer than 12months,
* insulin pump therapy longer than 3 months,
* written informed consent to participate in the study signed by parents (and patient older than 16 years).

Exclusion Criteria:

* celiac disease,
* diabetes related complications (e.g. nephropathy),
* BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex,
* withdrawal of consent to participate in the study,
* comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.

Primary outcomes:
measure: Postprandial Glycemia
timeFrame: 90 minutes after the prandial bolus
Secondary outcomes:
measure: Hypoglycemia Episodes
timeFrame: 3-hours after the prandial bolus
measure: Glucose Area Under the Curve (AUC)
timeFrame: 3-hours after the prandial bolus
measure: Mean amplitude of glycaemic excursion (MAGE)
timeFrame: 3-hours after the prandial bolus
measure: Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus
timeFrame: 3-hours after the prandial bolus
measure: Glycemic rise (GR)
timeFrame: 3-hours after the prandial bolus
measure: Peak glucose level (PG)
timeFrame: 3-hours after the prandial bolus
measure: Time to glucose peak
timeFrame: 3-hours after the prandial bolus
measure: Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L)
timeFrame: 3-hours after the prandial bolus
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital
Study officials:
affiliation: Department of Pediatrics, Medical University of Warsaw
name: Agnieszka Szypowska, Prof.
role: STUDY_CHAIR
References:
citation: Kowalczyk E, Dzygalo K, Szypowska A. Super Bolus: a remedy for a high glycemic index meal in children with type 1 diabetes on insulin pump therapy?-study protocol for a randomized controlled trial. Trials. 2022 Mar 29;23(1):240. doi: 10.1186/s13063-022-06173-4.