louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01991769: Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training
Official title: Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: exercise
endothelium
postprandial period
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function.

Both healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an unhealthy meal high in saturated fat and fast carbohydrates. The two different exercise training modes used are high intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise training in advance of an unhealthy meal will improve endothelial- and cardiac function in healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects on the endothelium more than MIT.


Eligibility criteria: Inclusion Criteria:

* healthy or type 2 diabetes

Exclusion Criteria:

* type 2 diabetes more than 10 years
* unstable angina
* myocardial infarction
* overt cardiovascular disease.
* severe valvular disease.
* overt lung disease.
* orthopedical- /neurological restrictions
* severe disease related to diabetes type 2 (neuropathy, micro-or macroalbuminuria, retinopathy)
* body mass index \>35
* severe eating disorders.
* personality disturbances.
* planned surgery during the project period.
* patients who achieve greater than the current exercise guidelines for type 2 diabetes (210 min/week) before the start of the study.
* uncontrolled hypertension
* kidney failure
* cardiomyopathy
* smoking
* patients who probably not will be able to complete the study
* alcohol or drug abuse

Primary outcomes:
measure: endothelial function
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Forskningsposten, St Olavs Hospital
city: Trondheim
country: Norway
facility: ISB
Study officials:
affiliation: Norwegian University of Science and Technology
name: Charlotte B Ingul, PhD
role: STUDY_DIRECTOR
References:
citation: Hollekim-Strand SM, Malmo V, Follestad T, Wisloff U, Ingul CB. Fast food increases postprandial cardiac workload in type 2 diabetes independent of pre-exercise: A pilot study. Nutr J. 2015 Aug 14;14:79. doi: 10.1186/s12937-015-0069-1.
Clinical trial NCT06324669: The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes
Official title: Investigating the Blood Glucose Lowering Effect of Exogenous Ketone Ingestion in People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Medical Research Council
First posted: 2024-03-22
Enrollment: 15
Sex: ALL
Minimum age (years): 41
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised cross over trial counterbalanced for trial order
Primary purpose: BASIC_SCIENCE

Brief summary: Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D.


Eligibility criteria: Inclusion Criteria:

1. Aged 41-70 years old
2. Body mass index 27-40 mg/m²
3. Type 2 diagnosis for more than 1 year
4. HbA1c \>6%

Exclusion Criteria:

1. Currently following ketogenic diet
2. Use of insulin
3. HbA1c \>10%
4. Recent weight loss (\>5kg in 6 months)
5. Recent eGFR \<30mL/min
6. Heart failure
7. Substance abuse
8. Cancer
9. Myocardial infarction within 6 months
10. Pregnancy or consideration of
11. Use of antipsychotic drugs

Primary outcomes:
measure: Rate of endogenous glucose production
timeFrame: 4 hours
Secondary outcomes:
measure: Total rate of glucose appearance
timeFrame: 4 and 8 hours
measure: Exogenous glucose rate of appearance
timeFrame: 4 and 8 hours
measure: Total rate of glucose disappearance
timeFrame: 4 and 8 hours
measure: Rate of gluconeogenesis
timeFrame: 4 and 8 hours
measure: Rate of glycogenolysis
timeFrame: 4 and 8 hours
measure: Beta-cell function
timeFrame: 4 and 8 hours
measure: Insulin concentration
timeFrame: 4 and 8 hours
measure: Glucagon concentration
timeFrame: 4 and 8 hours
measure: GLP-1 concentration
timeFrame: 4 and 8 hours
measure: GIP concentration
timeFrame: 4 and 8 hours
measure: Glycerol concentration
timeFrame: 4 and 8 hours
measure: Free fatty acid concentration
timeFrame: 4 and 8 hours
measure: Ketone concentration
timeFrame: 4 and 8 hours
measure: Energy expenditure
timeFrame: 4 and 8 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Francis B Stephens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02558569: The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block
Official title: The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Tumor
Keywords: fentanyl, scalp block
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor patients. The control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive scalp nerve block with 0.5% levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. The scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general anesthesia.

Detailed description: Fentanyl has widely been used for intraoperative analgesia for craniotomy. In craniotomy, the long and complex operation, the continuous infusion or repeated use of fentanyl can significantly delay emergence from general anesthesia. The scalp block with local anesthesia is widely used for awake craniotomy with great success but it is not routinely used in general craniotomy. In this study, the control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive the addition of scalp nerve block with 0.5% levobupivacaine (local anesthetic). The scalp nerve block might reduce the total dose of fentanyl and promote faster emergence from general anesthesia.

Eligibility criteria: Inclusion Criteria:

* supratentorial brain tumor

Exclusion Criteria:

* tumor size\>4 cm
* Glasgow Coma Score (GCS) \<15
* already intubated
* uncontrolled hypertension
* can not communicate

Primary outcomes:
measure: The total dose of fentanyl being used during craniotomy
timeFrame: One day
Secondary outcomes:
measure: Awakening time from general anesthesia
timeFrame: One day
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Manee Raksakietisak
city: Bangkok
country: Thailand
facility: Siriraj Hospital Mahidol University
Study officials:
affiliation: Mahidol University
name: Manee Raksakietisak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01417169: Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
Official title: Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neutropenia
Fungal Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 112
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

Detailed description: The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after Autologous hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation
2. Under 21 years old, pediatric, adolescent patients.

Exclusion Criteria:

1. Aspartate transaminase or alanine transaminase level \> 5 times UNL
2. Bilirubin \> 2.5 times UNL
3. History of allergy, sensitivity, or any serious reaction to an echinocandin
4. Invasive fungal disease at the time of enrolment
5. Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
6. Positive pregnancy test

Primary outcomes:
measure: Absence rate of IFDs assessed by physical examination and serum galactomannan test
timeFrame: 4 weeks
Secondary outcomes:
measure: Survival rate
timeFrame: 100 days
measure: Safety assessed by lab-test and adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Chongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Hyoung Jin Kang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04914169: The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study
Official title: The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Rehabilitation
Keywords: cardiac rehabilitation
cardiorespiratory fitness
aerobic exercise
endurance training
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: The Intelligent Cardiopulmonary Rehabilitation System (ICRS) was developed to automatically control the resistance of pedaling in combination with the conventional stationary bike by monitoring the user's heart rate for clinical use. To test its feasibility, 8 healthy participants were recruited to complete 12 sessions (3 times per week for 4 weeks) of indoor cycling on the stationary bicycle with ICRS. Subjects were received cardiopulmonary exercise testing (CPET) before and after the biking sessions.The 60-80% of heart rate reserve (HRR) of each participant was determined according to their first CPET results. The algorithm of ICRS was designed to enable the bicycle to adjust its training intensity in accordance with the subject's 60-80% HRR which was detected by wearing a wristband heart rate monitor during cycling. With ICRS, the participants' heart rates during training were expected to fall in the 60-80% HRR, increasing their cardiopulmonary fitness after 12 sessions of indoor cycling.


Eligibility criteria: Inclusion Criteria:

* age of 20-50
* no regular exercise habits
* no documented cardiopulmonary disease

Exclusion Criteria:

* abnormal lung function
* medications affecting exercise capacity
* hypertension
* diabetes mellitus
* recent illness including upper respiratory tract infection
* the presence of any factor that may limit ability to participate in the CPET

Primary outcomes:
measure: Peak oxygen consumption (VO2-peak)
timeFrame: 4 weeks
Secondary outcomes:
measure: Peak workload
timeFrame: 4 weeks
measure: Compliance of training during the training sessions
timeFrame: 4 weeks
measure: Averaged workload during the training sessions
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan Fan Hospital
Study officials:
References:
Clinical trial NCT06975969: Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
Official title: Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blood Clots
Vascular Disease
Embolism Thrombosis
Cardiovascular Diseases
Lung Diseases
Keywords: thrombolysis
pulmonary catheter
hemodynamic monitoring
catheter directed therapy
Lead sponsor: Liquet Medical Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age 18 - 80 years old who present with symptoms requiring intervention with delivery of physician-specified thrombolytics to the pulmonary vasculature, including patients who present with submassive pulmonary embolism (PE), who receive treatment using the Versus™ Catheter.

Brief summary: Assess the functionality of the Versus Catheter for catheter-directed thrombolysis of pulmonary blood clots, including advanced imaging assessment. An evaluation of patient outcomes from the cases included in this study will also be conducted.

Detailed description: The objective of this study is to assess the functionality of the Versus™ Catheter for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients, including advanced Computerized Tomography Angiogram (CTA) imaging assessment. This study will include an evaluation of patient outcomes and physician user experience with the Versus™ Catheter among up to 10 patients meeting the criteria for enrollment.

Eligibility criteria: Inclusion Criteria:

* Patients 18 - 80 years, inclusive
* Patients who present with submassive pulmonary embolism (PE)
* Patients requiring thrombolytic intervention to the pulmonary vasculature
* Physician decision to use the Versus™ Catheter during the treatment of the patient

Exclusion Criteria:

* Concurrent treatment with thrombectomy
* Concurrent treatment with a catheter-directed thrombolysis device that is NOT the Versus™ Catheter
* Massive pulmonary embolism (PE)
* Active bleeding disorder1
* Recent cerebrovascular accident or transient ischemic attack1
* Recent neurosurgery1
* Recent intracranial trauma1
* Absolute contraindication to anticoagulation1
* BMI \> 45kg/m2
* In the opinion of the investigator, the participant is not a suitable candidate for the study

Primary outcomes:
measure: Blood Clot resolution
timeFrame: Within one week of hospital admission
measure: Physician user experience
timeFrame: Periprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: University of Virgina (UVA)
name: Luke Wilkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03991169: Oral Iron in Children With Chronic Kidney Disease
Official title: Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Kidney Insufficiency
Chronic Kidney Diseases
Keywords: Anemia
Iron
Children
Chronic kidney disease (CKD)
Appetite
Physical activity
Muscle strength
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2019-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.


Eligibility criteria: Key inclusion criteria:

* Age 1-21 years old (muscle strength will be assessed only in children \>3 year old)
* Estimated glomerular filtration rate (GFR) \< 90 ml/min/1.73m2 by bedside Schwartz formula \[height (cm) \*0.413 / serum creatinine (mg/dL)\]
* Hemoglobin (Hb) more or equal than 9.0 at the previous clinic visit
* Hb less than 11.5 g/dL in children younger than 5 years Hb less than 12.0 g/dL in children 5-12 years Hb \<12.5 g/dL in children 12-15 yrs and females \>15 yrs. Hb \<13.5 g/dL in males \>15 years (all at the previous clinic visit)

Children with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng/mL will be randomized into one of the arms

Key exclusion criteria:

* Transferrin saturation \<5%
* Serum ferritin \< 10 ng/mL
* Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization
* Blood transfusion within 4 months prior to enrollment
* Children on hemodialysis
* Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months
* Pregnancy and breast-feeding

Primary outcomes:
measure: Change in muscle strength
timeFrame: 0 and 3 months
measure: Change in the percentage of transferrin saturation in the participants' blood
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Change in sedentary time
timeFrame: 0 and 3 months
measure: Change in the percent of skeletal muscle mass
timeFrame: 0 and 3 months
measure: Change in eating behavior
timeFrame: 0 and 3 months
measure: Change in quality of life: PROMIS
timeFrame: 0 and 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine / New York Presbyterian Hospital
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Weill Cornell College of Medicine
name: Oleh Akchurin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04726046: Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate
Official title: Prospective Randomized Control Study of Clinical Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cholecystitis
Keywords: GB stone
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 529
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria.

They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

Detailed description: 529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria. They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

Eligibility criteria: Inclusion Criteria:

patients who have diagnosed -cholecystitis with / without GB stone, GB polyp

Exclusion Criteria:

1. Suspected cholangitis and GB cancer
2. CBD stone history
3. Preoperative administration of antibiotics within 7days.
4. Suspected pregnancy
5. Open conversion.
6. Patients refuse this study

Primary outcomes:
measure: surgical complication
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chonkbuk national university
name: Jae Do Yang
role: STUDY_DIRECTOR
References: