louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02859181: Protein Requirements for Active Adolescent Males (IAAO-AM)
Official title: Evaluation of Protein Requirements in Active Adolescent Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Increased Metabolic Requirement
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2016-08-08
Enrollment: 7
Sex: MALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adolescents have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data.

The purpose of this study is to measure the protein requirement in adolescent, males using the IAAO technique in the presence of a variable intensity exercise stimulus.


Eligibility criteria: Inclusion Criteria (Adolescents):

* Healthy, active adolescent who regularly participates in moderate to vigorous physical activity 5 times a week for a minimum of 1 hour.
* Being -0.5 to +1.0 years from peak height velocity, determined by the ratio of standing to sitting height, with the maximal age for adolescents being 16 years.
* Obtaining a minimum level of 8.3 on the Beep Test

Exclusion Criteria (All Subjects):

* Inability to meet health and physical activity guidelines according to the Physical activity readiness questionnaire (PAR-Q+) and Physical Activity Questionnaire,
* an inability to adhere to any of the protocol guidelines (i.e. caffeine consumption)
* a biological age falling outside of the aforementioned ranges

Primary outcomes:
measure: 13CO2 ([13]Carbon Dioxide) Excretion (µmol/kg/h)
timeFrame: 4 hours per study day
Secondary outcomes:
measure: [13C]Phenylalanine Oxidation (µmol/kg/h)
timeFrame: 4 hours per study day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport
state: Ontario
Study officials:
affiliation: University of Toronto
name: Daniel Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01386281: Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
Official title: Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Keywords: Julina
Postmenopausal osteoporosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-07-01
Enrollment: 506
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patients who have received a prescription of Julina on the basis of the decision of the treating gynecologist. The study is expected to collect data of 100 patients in about 20 gynecological practices in Japan.

Brief summary: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.


Eligibility criteria: Inclusion Criteria:

* Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in subject who received Julina
timeFrame: After Julina administration, upto 1 year
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina
timeFrame: At baseline and after Julina administration, upto 1 year
measure: Change from baseline in grad of hot flush and sweating at the end of Julina treatment
timeFrame: At baseline and at end of Julina treatment, upto 1 year
measure: Change from baseline in with/without vaginal atrophy at the end of Julina treatment
timeFrame: At baseline and at end of Julina treatment, upto 1 year
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06198881: Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study
Official title: Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Birth Weight
Macrosomia, Fetal
Keywords: macrosomia
labor induction
perineal tears
hemorrhage
full-term deliveries
singleton
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 4500
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The selected patients are thoses who gave birth at term (\>37 weeks) of a macrosome fetus (\>4000g) in one of the maternity wards of the civil hospices of Lyon (Hospital de la Croix Rousse, Hopital Femme Mere Enfant or Hopital Lyon Sud). Patients are subsequently categorized based on whether their labor was induced or not. The characteristics of the pregnancy, the route of delivery and the fetal outcome are then collected in the computerized medical records and analyzed.

Brief summary: The rising prevalence fof fetal macrosomia represents a significant challenge in obstetrics, affecting both maternal and neonatal outcomes. Such challenges include complications like perineal tears and postpartum hemorrhage. Concurrently, the frequency of labor induction practices on the rise, yet the implications for neonatal weight are inadequately understood. To address this gap, our study aims to evaluate the association between labor induction and neontal birth weight through a population-based cohort study. The findings have the potential to inform more accurate clinical guidelines, thereby enhancing the quality of maternity care.


Eligibility criteria: Inclusion Criteria:

* Full-term deliveries (≥ 37 weeks of gestation)
* Singleton
* Birth weight \> 4000g
* Complete medical records available for analysis

Exclusion Criteria:

* Delivery \< 37 weeks
* Uterus \> bi-scarred
* Presentation of the headquarters
* Maternal or fetal pathology modifying the route/time of delivery (pre-eclampsia, fetal heart rate abnormalities, cholestasis, chorioamnionitis, metrorrhagia, covering placenta, etc.)

Primary outcomes:
measure: Number of vaginal deliveries among the population studied
timeFrame: during Delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
References:
Clinical trial NCT04706481: Archival of Human Biological Samples in CU-Med Biobank
Official title: Archival of Human Biological Samples in CU-Med Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Cancer
Heart Diseases
Neurological Diseases or Conditions
Kidney Diseases
Diabetes
Other Disease
Keywords: Biobanking
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The diverse group of biorepositories with focus on normal cohorts and cancer-related or other disease cohorts.

Brief summary: CU-Med Biobank collaborates with different researchers for collecting and distributing human biospecimens and clinical data for assisting scientific research.

Detailed description: CU-Med Biobank will collect and store high-quality specimens from cancer-related or other diseases. All samples are linked to annotated clinical data from approved consented protocols. This system provides researchers with high- quality biological samples and comprehensive clinical, pathological including molecular/genetic information for their research. This standardized CU-Med Biobank is a pivotal bridge to improve the translation of basic research into clinical applications. These findings will contribute to improve prevention, enhance diagnosis, develop new treatment and eventual cure of diseases.

Eligibility criteria: Inclusion Criteria:

* Enrolled subjects that have provided signed consent for the specimens and de-identified data to be collected, stored and distributed.

Exclusion Criteria:

* Subjects without signed informed consent for the specimens and de-identified data to be collected, stored and distributed.

Primary outcomes:
measure: To distribute human biospecimens for clinical research
timeFrame: 99 years
measure: To discover the pathological mechanism of different acute and chronic diseases such as cancer, stroke, heart disease, dementia & diabetes
timeFrame: 99 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: CU-Med Biobank
Study officials:
affiliation: Chinese University of Hong Kong
name: Ching Wan MA, MB BChir
role: STUDY_CHAIR
References:
Clinical trial NCT02128581: A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake
Official title: A Dose-response Study of the Effects of Exendin-9,39 on Gastrointestinal Symptoms and Food Intake.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Diabetes
Roux-en-Y Gastric Bypass
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Research Resources (NCRR)
First posted: 2014-05-01
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.


Eligibility criteria: Inclusion Criteria:

* Subjects who have undergone Roux en-Y Gastric Bypass at least 6 months prior to enrollment in the study.
* Subjects without active systemic illness.

Exclusion Criteria:

* Subjects \<20 years of age will not be studied to minimize the possibility of type 1 diabetes.
* Subjects \>70 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.

Primary outcomes:
measure: Calories consumed during buffet meal test
timeFrame: approximately 300 minutes after initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06999681: Postoperative Arrhythmia and Preoperative Cardiac Function
Official title: A Prospective Study on the Association of Perioperative Echocardiographic Parameters and Other Risk Factors With Postoperative Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: The Cardiac Function
Keywords: cardiac echo
cardiac surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 200
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: patients undergoing cardiac surgery

Brief summary: This study aims to investigate the association between echocardiographic parameters-including preoperative cardiac echo, as well as postoperative follow-up echocardiography and other associated parameters-and the risk factors related to postoperative arrhythmia

Detailed description: Postoperative atrial fibrillation (POAF), defined as newly onset atrial fibrillation occurring during hospitalization, is a common complication following cardiac surgery, affecting approximately 20-30% of patients. Studies have shown that patients who develop POAF experience longer hospital stays, incur higher medical costs, and have increased rates of stroke- and heart failure-related complications, as well as higher risks of readmission and mortality.

POAF is generally believed to result from acute perioperative triggers acting on preexisting structural abnormalities of the atria or ventricles. However, the echocardiographic predictors of POAF remain poorly understood. While previous studies have examined the association between preoperative transthoracic echocardiography (TTE)-assessed left atrial and left ventricular function and the development of POAF, the detailed relationship between intraoperative transesophageal echocardiography (TEE)-assessed atrial and ventricular function, its intraoperative changes, and POAF remains insufficiently explored.

This study aims to investigate the association between echocardiographic parameters-including preoperative TTE and TEE, as well as postoperative follow-up parameters-and the risk factors related to POAF.

Eligibility criteria: Inclusion Criteria:

* patients receiving cardiac surgery

Exclusion Criteria:

* preoperative arrhythmia

Primary outcomes:
measure: The occurrence of postoperative arrhythmia
timeFrame: postoperative 1 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01764581: Randomized Controlled Trial of ImmuKnow in Liver Transplantation
Official title: Randomized Controlled Interventional Trial of Immunosuppression Modification Based on the Cylex™ ImmuKnow® Assay in Adult Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Disease
Keywords: immune monitoring
immune cell function ImmuKnow
randomized controlled trial
immunosuppression management
infection
rejection
liver transplantation
Cylex
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression. The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte activation. This study uses the ImmuKnow assay to proactively adjust immunosuppressive therapy in adult liver transplant recipients to reduce the risk of adverse events

Detailed description: We performed a randomized prospective interventional trial where the Interventional group had immunosuppression modified according to ImmuKnow values. Immunosuppression was decreased by 25% if ImmuKnow values were less than 130 ng/mL ATP. Similarly, immunosuppression was increased by 25% if ImmuKnow values were greater than 450 ng/mL ATP. Immunosuppression of the Control group was managed by the Standard of Care at our institution. ImmuKnow was performed before liver transplant, after surgery and at each clinic visit with the approximate schedule: day 1; weekly, weeks 1-4; week 6; week 8; monthly, months 3-6; and months 9 and 12. ImmuKnow testing was repeated within 7 days of a suspected/confirmed rejection or infection and again within 1 week of resolution.

Eligibility criteria: Inclusion Criteria:

* consecutive adult liver transplant recipients at our center;
* patients not entered into other studies;
* provided consent.

Exclusion Criteria:

* available follow-up;
* consent removed.

Primary outcomes:
measure: Comparison of adverse events
timeFrame: 12 months posttransplant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of General Surgery and Transplantation; S.Orsola-Malpighi Hospital, University of Bologna
name: Antonio Daniele Pinna, MD
role: STUDY_DIRECTOR
References:
citation: Ravaioli M, Neri F, Lazzarotto T, Bertuzzo VR, Di Gioia P, Stacchini G, Morelli MC, Ercolani G, Cescon M, Chiereghin A, Del Gaudio M, Cucchetti A, Pinna AD. Immunosuppression Modifications Based on an Immune Response Assay: Results of a Randomized, Controlled Trial. Transplantation. 2015 Aug;99(8):1625-32. doi: 10.1097/TP.0000000000000650.
Clinical trial NCT01277081: Effect of Paracetamol on the Common Cold
Official title: To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects With the Common Cold.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Cold
Keywords: Paracetamol
Common cold
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet


Eligibility criteria: Inclusion Criteria:

* Symptoms of the common cold of no more than 120 hours duration
* Self-rating congestion of at least moderate severity
* Suffering from at least four symptoms of common cold or flu

Primary outcomes:
measure: Breathing Scores Post 15 Minutes
timeFrame: Baseline to 15 minutes
Secondary outcomes:
measure: Breathing Score Post 60 Minutes
timeFrame: Baseline to 60 minutes
measure: Cold Symptoms Score Post 15 Minutes
timeFrame: Baseline to 15 minutes
measure: Cold Symptoms Score Post 60 Minutes
timeFrame: Baseline to 60 minutes
measure: Soothing Attribute Scores
timeFrame: Baseline to 15 and 60 minutes
measure: Overall Cold Symptoms Score
timeFrame: Baseline to 15 and 60 minutes
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Common Cold Centre
state: Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03971981: Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect
Official title: Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect (In-vivo and In-vitro Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Periodontal Diseases
Keywords: Xylitol
Saliva
Bacteria
Dental Plaque
Antimicrobial effect
Chewing gum
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2019-06-03
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a double-blind cross-over in vivo study was performed to measure the salivary concentration of Xylitol released from the two chewing gums containing different amount of the polyol. The study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out period, the two sub-groups inverted the chewing gums. Subjects were instructed to consume the products as they normally would be consumed.
Primary purpose: PREVENTION

Brief summary: a double-blind cross-over in vivo study was performed to measure the salivary concentration of Xylitol released from the two chewing gums containing different amount of the polyol. The study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out period, the two sub-groups inverted the chewing gums. Subjects were instructed to consume the products as they normally would be consumed.

Detailed description: x

Eligibility criteria: Inclusion Criteria:

* good general health,
* the absence of diseases that can alter the saliva secretion rate
* a stimulated saliva flow at least of 1 ml/min.

Exclusion Criteria:

-

Primary outcomes:
measure: Change of Salivary concentration of Xylitol
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Department of Surgery, Microsurgery and Medicine Sciences University of Sassari
state: Sardinia
Study officials:
affiliation: Università degli Studi di Sassari
name: Guglielmo Campus
role: PRINCIPAL_INVESTIGATOR
References: