louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03139773: Nutrition Intervention to Measure Metabolic Response in Children
Official title: Nutrition Intervention to Improve Energy Metabolism, Energy Intake, and Metabolic Response in Overweight and Obese School-aged Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 27
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The long-term objective of this study is to determine if habitual consumption of high-quality protein at breakfast will lead to improved energy metabolism and decreased daily energy intake in normal weight and overweight children. The investigators hypothesize that increasing protein intake at breakfast will improve energy metabolism and reduce energy intake throughout the day in overweight/obese school-aged children. The significance of the study is that improving nutrient intake at breakfast can potentially lead to a future reduction in childhood obesity rates.


Eligibility criteria: Inclusion Criteria:

* Habitual breakfast consumer
* No known medical issues

Exclusion Criteria:

* Food allergies
* Medication
* Claustrophobic
* Dietary restrictions
* Picky eater (determined by parent/guardian)

Primary outcomes:
measure: The effect of breakfast type on energy expenditure four hours postprandial
timeFrame: Change from baseline to four hours postprandial.
measure: The effect of breakfast type on postprandial appetite
timeFrame: Change from baseline to four hours postprandial.
measure: The effect of breakfast type on appetite hormone secretion
timeFrame: Change from baseline to four hours postprandial.
measure: The effect of breakfast type on energy expenditure over 14 days of dietary adaptation.
timeFrame: Fourteen days
Secondary outcomes:
measure: Metabolic health measures
timeFrame: Baseline and day 14 of each intervention
measure: Gut microbiota
timeFrame: Baseline and day 14 of each intervention
measure: Proteomic analysis using TMT labeling
timeFrame: Fasting levels at baseline
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: Assistant Professor
name: Jamie I Baum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725373: Angioplasty of Left Main - lAriboisiere Registry
Official title: Prospective Registry in Patients With Unprotected Left Main Disease Treated by Percutaneous Coronary Intervention: The ALMA (Angioplasty of Left Main - lAriboisiere) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: left main, stent,angioplasty
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with stenosis of unprotected left main and schedulded angioplasty in the Department of Cardiology, Lariboisiere Hospital.

Brief summary: In patients with unprotected left main disease (ULMD), angioplasty is emerging as an alternative technique. The investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ULMD in a "real world" registry.

Detailed description: Current guidelines recommend coronary artery bypass graft surgery as the "gold standard" treatment in patients with unprotected left main disease. However, patients with ULMD and high surgical risk score or favourable anatomy are still referred for angioplasty. Recently, several studies and registries comparing surgery and percutaneous intervention with drug eluting stents report similar results regarding cardiovascular death and myocardial infarction in patients with multivessel coronary artery disease including unprotected left main disease.

The aim of the study is to evaluate major cardiovascular events in a "real world" registry.

Eligibility criteria: Inclusion Criteria:

* stable or unstable angina and/or documented ischemia
* 50% de novo ULMD referred for angioplasty

Exclusion Criteria:

* acute coronary syndrome with ST elevation,
* cardiogenic shock or out of hospital cardiac arrest

Primary outcomes:
measure: Major cardiovascular events (MACCE)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement of Cardiology, Laribosiere Hospital, APHP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Patrick Henry, MD-PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06686173: Effect of Donor Chose on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG/PTCy for Haplo-HSCT
Official title: The Effect of the Parous Female and Young Male Donor on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG and PTCy for Haplo-HSCT: a Prospective, Multi-center, Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: High-Risk Acute Myeloid Leukemia
Relapse And/or Refractory AML
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The high-risk, relapse and refractory AML patients were enrolled in this study

Brief summary: This is a prospective, multicenter, cohort study. The high-risk, relapse and refractory AML patients were enrolled in this study. And the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (GVHD) prophylaxis underwent the combination of ATG and PTCy for haploidentical peripheral blood stem cell transplantation


Eligibility criteria: Inclusion Criteria:

1. Acute myeloid leukemia was diagnosed according to the 2016ELN criteria with any of the following:

1. ELN prognostic stratification high-risk group (see Appendix for criteria)
2. Non-remission (NR) AML: including primary refractory AML and NR patients after relapse.

2. Patients must have a suitable hematopoietic stem-cell donor.

1. Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy;
2. Related donors had to be related donors matched 5/10-7/10 for HLA-A, -B, -C, -DQB1 and -DRB1 3. All the enrolled patients received a unified GVHD prevention regimen based on ATG and PTCy

Exclusion Criteria:

1. Intermediate-low risk AML patients (ELN criteria);
2. Patients with extramedullary active lesions at the time of transplantation;
3. Haploidentical collateral donors;
4. Patients who refused allogeneic hematopoietic stem cell transplantation;

Primary outcomes:
measure: RFS
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01380873: A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This trial is conducted to

1. assess whether SLM0807 alters pharmacodynamics of HKB0701
2. estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and multiple co-administration of HKB0701/SLM0807 in healthy subject


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
* Subjects with no history of any significant chronic disease
* Subjects with FPG\<100mg/dL and 2hr glucose after 75g OGTT\<140mg/dL
* Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
* Available for the entire study period
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
* Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
* Subjects with a history of clinically significant allergies including drug allergies
* Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT \>1.25 times to normal range or total bilirubin \> 1.5times to normal range)
* Subjects with a history of drug, caffeine abuse(caffeine drink \>5cups/day)
* Subjects with a history of alcohol abuse(alcohol\>30g/day) or who have ever drank alcohol within 7 days prior to drug administration
* Heavy smoker ( \>10cigarettes/day)
* Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
* Subjects who have donated plasma within 60days prior to drug administration
* Subjects who have participated in a clinical study within 90days prior to drug administration
* Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator within 10days prior to drug administration (cimetidine within 7days prior to drug administration)
* Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control

Primary outcomes:
measure: AUC0-2h of plasma glucose
timeFrame: up to 2hrs
measure: △Cmax of plasma glucose
timeFrame: up to 2hrs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inje University
name: Jae Gook Shin, MD, ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01698073: Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents
Official title: Teen Pregnancy Prevention Among Native Youth of the Northern Plains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy Prevention
Keywords: Teen pregnancy prevention
American Indian
Group-randomized trial
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 167
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior compared to youth who do not receive the program.

Detailed description: Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior and fewer pregnancies compared to youth who do not receive the program.

Eligibility criteria: Inclusion Criteria:

* 10-12 years old at baseline
* A member of participating Native Boys and Girls Club
* Signed Parental Consent Form
* Signed Parental Permission Form
* Signed Child Assent Form

Exclusion Criteria:

* None Noted

Primary outcomes:
measure: Ever had sexual intercourse
timeFrame: Baseline, 3 months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado Anschutz Medical Campus, Centers for American Indian and Alaska Native Health
name: Carol E Kaufman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaufman CE, Litchfield A, Schupman E, Mitchell CM. Circle of Life HIV/AIDS-prevention intervention for American Indian and Alaska Native youth. Am Indian Alsk Native Ment Health Res. 2012;19(1):140-53. doi: 10.5820/aian.1901.2012.140.
citation: Kaufman CE, Whitesell NR, Keane EM, Desserich JA, Giago C, Sam A, Mitchell CM. Effectiveness of Circle of Life, an HIV-preventive intervention for American Indian middle school youths: a group randomized trial in a Northern Plains tribe. Am J Public Health. 2014 Jun;104(6):e106-12. doi: 10.2105/AJPH.2013.301822. Epub 2014 Apr 22.
citation: Black KJ, Morse B, Tuitt N, Big Crow C, Shangreau C, Kaufman CE. Beyond Content: Cultural Perspectives on Using the Internet to Deliver a Sexual Health Intervention to American Indian Youth. J Prim Prev. 2018 Feb;39(1):59-70. doi: 10.1007/s10935-017-0497-0.
Clinical trial NCT04359173: Propensity Score Matched Comparison of HMP vs. SCS in Kidney Transplantation
Official title: A Retrospective Propensity Score Matched Analysis Reveals Superiority of Hypothermic Machine Perfusion Over Static Cold Storage in Deceased Donor Kidney Transplantation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Graft Function
Keywords: kidney transplantation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All deceased donor kidney transplants performed between 08/2015 and 12/2019

Brief summary: Hypothermic machine perfusion (HMP) is considered superior to static cold storage (SCS) in kidney transplantation, but the true benefit in the real-world experience remains incompletely understood.

The aim of our study is to investigate the real-world impact of HMP on kidney graft function after deceased donor kidney transplant in an HMP cohort propensity score matched with SCS.

Propensity score matching will be based on CIT, ECD, gender mismatch, CMV mismatch, re-TX and ET-senior program with a caliper of 0.05


Eligibility criteria: Inclusion Criteria:

* single kidney transplantation from a deceased donor at Medical University of Innsbruck between 08/2015 and 12/2019

Exclusion Criteria:

* combined kidney transplantation with an other organ
* living donor kidney transplantation

Primary outcomes:
measure: Delayed graft function (DGF)
timeFrame: 7 days post transplant
Secondary outcomes:
measure: graft survival
timeFrame: 24 months post transplant
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University of Innsbruck
name: Stefan Schneeberger, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02050373: Low-level Laser Therapy on Inflammatory Mediators During Chemotherapy-induced Oral Mucositis
Official title: Effect of Low-level Laser Therapy on Inflammatory Mediators Release During Chemotherapy-induced Oral Mucositis: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Keywords: Mucositis
inflammation
Chemotherapy
Hematopoietic stem cell transplant
Low level laser therapy
oxidative stress
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
name: Araujo Jorge Hospital
First posted: 2014-01-30
Enrollment: 51
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of low-level laser therapy (LLLT) on the severity of oral mucositis (OM) and inflammatory mediators (pro- and anti-inflammatory cytokines, metalloproteinases and growth factors) levels in saliva and blood; furthermore, analyze the effect of LLLT in product modulation of oxidative stress and cell damage from the oral mucosa transplant patients.

Detailed description: This is a randomized clinical trial in which the proposed analysis will be performed from saliva samples of patients transplanted bone marrow, divided into two different groups (control and laser) and collected at different times during the hospitalization of the patient. the group laser receive prophylactic laser therapy, in order to evaluate the effects of LLLT in inflammatory mediators (cytokines pro- and anti-inflammatory) as well as their effect on modulation of oxidative stress products and cell damage (nitric oxide, myeloperoxidase, interleukin-8).

Eligibility criteria: Inclusion Criteria:

* Schedule to receive myeloablative conditioning regimens using chemotherapy; oral mucosa lining intact on the first day of the conditioning regimen;

Exclusion Criteria:

* Patients who presented with oral oral ulceration or erosion, active oral, viral, bacterial, or fungal infections on admission, or active oral bleeding which was uncontrollable during laser therapy or had required oral tracheal intubation during hospitalization in the HSCT Unit.

Primary outcomes:
measure: Severity of Oral Mucositis
timeFrame: On day of the transplant (D0), on seventh day after the transplant (D7) and discharge of the patient (HD) or until day 20 (D+20).
Secondary outcomes:
measure: Level of Inflammatory Mediators
timeFrame: The samples were collected at three different moments of treatment: at the time of admission (AD), on the seventh day after transplantation (D+7), and on the day of discharge (with neutrophil >0.5 × 109/l for two consecutive days) (HD).
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de Goias
name: Geisa BL Silva, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias
name: Aline C Batista, Doctor
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Goias
name: Daniella RN Salvador
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01789073: Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay
Official title: Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Postoperative
Complications
Elective
Surgery
GI surgery
Immunonutrition
Immune-enhancing
Immune-modulating
Nutrition
Pancreatic cancer
Postoperative complications and length of hospital stay after major gastrointestinal (GI) elective surgery.
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2013-02-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.


Eligibility criteria: Inclusion Criteria:

* Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer
* Age \> 18 years.

Exclusion Criteria:

* Age \< 18 years
* Pregnant and lactating women
* Persons who cannot understand and/or speak Danish
* Renal dysfunction
* Milk allergy
* Participants are excluded if elective surgery is not indicated after all

Primary outcomes:
measure: Overall postoperative complications after major gastrointestinal (GI) elective surgery.
timeFrame: Within the first 30 days after surgery
Secondary outcomes:
measure: Length of hospital stay after major gastrointestinal (GI) elective surgery
timeFrame: Within the first 30 days after surgery
Other outcomes:
measure: Weight stability, functional capability and patients´ satisfaction with the overall study course.
timeFrame: from recruitment and within 30 days after surgery
Locations:
city: Copenhagen
country: Denmark
facility: Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen, Chief Phys., Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gade J, Levring T, Hillingso J, Hansen CP, Andersen JR. The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial. Nutr Cancer. 2016;68(2):225-33. doi: 10.1080/01635581.2016.1142586. Epub 2016 Mar 4.
Clinical trial NCT05435573: Cardiac Output in Preeclamptic
Official title: Coload Effect on Cardiac Output Measurement Using Transthoracic Echocardiography in Preeclamptic Patients Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Echocardiography
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated via sealed opaque envelops into 2 groups of 17 patients each; crystalloid group and group crystalloid-colloid group
Primary purpose: TREATMENT

Brief summary: There is high incidence of hypertensive disorders during pregnancy.The maternal cardiovascular system had significant changes during pregnancy. The colloid oncotic pressure is decreased during preeclampsia.

Detailed description: Transthoracic echocardiography considered an accurate non-invasive device and has validity for measuring cardiac functions in pregnancy.

Eligibility criteria: Inclusion Criteria:

* Pre-eclampsia
* Age 18-45 years.
* Singleton pregnancy scheduled for elective CS delivery under spinal anesthesia.
* American Society of Anesthesiologists (ASA Ⅱ, Ⅲ).

Exclusion Criteria:

* Body mass index \< 18 or ≥40 kg/m²
* Women presenting in labor
* Current administration of vasoactive drugs including salbutamol and thyroxin.
* Diabetes mellitus.
* Hemoglobin \<10 g/dl.
* Cardiovascular, cerebrovascular, or renal disease
* Increased serum creatinine level ≥1.1 mg/dL.
* Contraindications to spinal anesthesia:(increased intracranial pressure, coagulopathy, or local skin infection)

Primary outcomes:
measure: Cardiac output measurement
timeFrame: 1 hour from the spinal anesthesia
Secondary outcomes:
measure: Cardiac output measurement
timeFrame: 5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia
measure: Left ventricular end diastolic volume (LVEDV) measurement
timeFrame: 1 hour from the spinal anesthesia
measure: Urine output volume
timeFrame: 1hour and 2 hours post spinal anesthesia
measure: Heart rate (HR)
timeFrame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
measure: Mean Blood pressure
timeFrame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University-Emergency hospital-ICU
Study officials:
References: