louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02584582: The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate
Official title: The Effect of GLP-1 on Postprandial Glucagon Secretion During Prolonged and Intermittent Stimulation of the GLP-1 Receptor Independent of The Gastric Emptying Rate. A Randomized, Open-label Study in People With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes
Keywords: Glucagon
Glukagon-like peptide-1 (GLP-1)
GLP-1 receptor agonist (GLP-1RA)
Incretins
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.

Detailed description: Aim: To investigate the glucagonostatic effects of glucagon-like peptide-1 (GLP-1) during prolonged and intermittent stimulation of the GLP-1 receptor independent of the gastric emptying rate. Glucagon concentrations will be measured following a liquid meal administered in duodenum at baseline and after exenatide, and liraglutide treatment.

Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes
* \>18 years
* No residual beta-cell function (stimulated C-peptide \< 60 pmol)

Exclusion Criteria:

* Pancreatitis
* gastroparesis
* history of alcohol and/or drug abuse
* pregnancy and lactation
* other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment
* contraindications to gastroscopy
* cancer (unless in complete remission \> five years)

Primary outcomes:
measure: Glucagon concentration (postprandial)
timeFrame: 4 hours
Secondary outcomes:
measure: Postprandial glucose concentrations
timeFrame: 4 hours
measure: glucagon-like peptide-1 (GLP-1)
timeFrame: 4 hours
measure: glucagon-like peptide-2 (GLP-2)
timeFrame: 4 hours
measure: glucose-dependent insulinotropic polypeptide (GIP)
timeFrame: 4 hours
measure: Cholecystokinin (CCK)
timeFrame: 4 hours
measure: Peptide YY (PYY)
timeFrame: 4 hours
measure: Ghrelin
timeFrame: 4 hours
measure: Gastrin
timeFrame: 4 hours
measure: Oxyntomodulin
timeFrame: 4 hours
measure: Free fatty acids (FFA)
timeFrame: 4 hours
measure: triacylglycerol (TAG)
timeFrame: 4 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05477082: Blood Biomarkers in Pediatric Kidney Transplant Recipients
Official title: Use of Blood Gene Expression Profile and Donor-derived Cell-free DNA to Monitor Response to Treatment After Biopsy-proven Acute Rejection in Pediatric Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rejection of Kidney Allograft
Keywords: acute rejection
kidney transplant
pediatric
biomarker
cell free DNA
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 30
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric kidney transplant recipients, ages \< 21 years, scheduled to undergo a for-cause kidney biopsy to rule out graft rejection

Brief summary: The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients
* Participants undergoing a for-cause kidney biopsy to rule out graft rejection
* Ages 21 years and less

Exclusion Criteria:

* Participants who have opted out of research
* Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read.
* Participants, 18 years and older, who are illiterate and cannot read.
* Participants, less than 18 years of age, whose parents or legal guardians do not speak English.
* Participants, 18 years and older, who do not speak English
* Participants who are pregnant as confirmed by medical records

Primary outcomes:
measure: Biopsy-proven acute rejection
timeFrame: 7 days from baseline
measure: Clinical resolution of rejection
timeFrame: 8 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sarah Kizilbash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04979182: Clinical Characterization of Frequent Monogenic Forms of Neurodevelopmental Disorders
Official title: Somatic and Neurobehavioral Clinical Characterization of Frequent Monogenic Forms of Neurodevelopmental Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurodevelopmental Disorders
Keywords: Neurodevelopmental disorders
Rare disease
Genetic Diseases
Monogenic syndromes
Intellectual Disability
Autism spectrum disorder
Neurobehavioral Manifestations
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated for TND linked to a mutation in one of the genes frequently mutated in this pathology, such as the DYRK1A, KMT2A or other genes

Brief summary: The main objective is to constitute a precise and exhaustive collection of clinical data (somatic and neurobehavioral data) of individuals affected by various frequent monogenic forms of neurodevelopmental disorders to better characterize the clinical phenotype of these disorders.

A better knowledge of these manifestations is necessary to improve the management of individuals with these disorders.

The secondary objectives of this research are to inform practitioners, patients and their families about the clinical characteristics of these disorders to better understand their diversity and, finally, to improve their screening and diagnosis. Thus, our study aims at establishing clinical scores, linking genotypes and phenotypes and producing documents for professionals (such as the PNDS (National Diagnostic and Care Protocols))


Eligibility criteria: Inclusion criteria:

* Minor patient whose age is ≥ 4 years and ≤18 years
* Major patient with intellectual disability
* Patient treated in a participating center for TND linked to a mutation in one of the genes frequently mutated in this pathology, such as the DYRK1A, KMT2A or other genes;
* Patient having previously been seen in genetic consultation
* Parent (or legal guardian) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

- Parent (or legal guardian) who expressed his opposition to participating in the study.

Primary outcomes:
measure: Study of clinical profiles associated to different monogenic form of NDD
timeFrame: Files analysed retrospectively from January 01, 2015 to March 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Génétique Moléculaire Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Génétique Moléculaire Hôpitaux Universitaires de Strasbourg
name: Amélie PITON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04889482: Functional Testing and Performance in Tennis
Official title: Functional Testing and Performance in Tennis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tennis
Keywords: tennis serve, performance, functional testing
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 34
Sex: MALE
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Forty healthy tennis players (aged 14-30) and ITN 2-4 will be recruted in the clubs of the Province of Liege.

Brief summary: The aim of this study was to correlate functional tests, clinical tests and rotator cuff strength with the speed of serve.

For that purpose, tennis players (ITN 2-4) will be recruted among tennis players in the Province of Liege. They will be assessed 2 times.

During the first assessment, lateral medicine ball throw, 2 ball throws, upper extremity y balance test and shoulder rotation range of motion will be assessed.

During the second assessment, lateral medicine ball throw, the 2 ball throws and rotator cuff strength will be assessed.

Detailed description: Forty healthy tennis players (ITN 2-4) will be recruted among players in the club of the Province of Liege.

First session :

* Clinical testing

  1. Upper extremity Y Balance Test
  2. Range of motion (internal/external rotation)
* Functional tests

  a. Lateral Medecine Ball throw (5 repetitions) b. Single arm ball throw (1,5kg) d. Core endurance test
* Assessment of serve speed (radar) during 15 serves

Second session :

* Clinical testing

  a. Assessment of rotator cuff muscles strength
* Functional tests

  1. Lateral Medecine Ball throw (5 repetitions)
  2. Single arm ball throw (1,5kg)

Eligibility criteria: Inclusion Criteria:

* playing tennis at a level of ITN2-4
* being healthy

Primary outcomes:
measure: Shoulder range of motion
timeFrame: through study completion, an average of 3 months
measure: Shoulder strength
timeFrame: through study completion, an average of 3 months
measure: Serve speed
timeFrame: through study completion, an average of 3 months
measure: Upper extremity Y balance test
timeFrame: through study completion, an average of 3 months
measure: Lateral Medicine Ball Throw
timeFrame: through study completion, an average of 3 months
measure: Single Arm ball throw
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Tennis Club in the Province of Liege
state: Liege
Study officials:
References:
Clinical trial NCT01863082: Resistant Hypertension and Physical Activity Performed in a Heated Pool
Official title: Effects of Training in a Heated Pool in Patients With Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension, Resistant to Conventional Therapy
Keywords: Resistant Hypertension
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-05-27
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: patients with resistant hypertension will be submitted to an exercise protocol in a heated pool for three months

Detailed description: pacient´s blood pressure behavior will be compared before and after intervention

Eligibility criteria: Inclusion Criteria:

* patients with uncontrolled blood pressure despite concurrent use of 3 antihypertensive agents, including a diuretic, or the need for more than 3 medications to control blood pressure

Exclusion Criteria:

* poor adherence to the treatment
* obesity
* diabetes
* smokers
* secondary causes of hypertension
* motor disabilities to perform the training

Primary outcomes:
measure: blood pressure value
timeFrame: Change from Baseline in Blood Pressure at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute of São Paulo University Medical School
Study officials:
affiliation: Heart Institute (InCor) HC FMUSP
name: Lais GB Cruz
role: STUDY_CHAIR
affiliation: Heart Institute (InCor) HC FMUSP
name: Guilherme V Guimarães, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06974682: Effect of Target Temperature Management on Intestinal Flora and Its Metabolites in Patients With Cardiac Arrest
Official title: Effect of Target Temperature Management on Intestinal Flora and Its Metabolites in Patients With Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Arrest (CA)
Keywords: Cardiac Arrest
intestinal flora
Intestinal metabolites
Macrogenome
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.

Brief summary: Based on the self-control design, this study explored the dynamic regulation of target temperature management therapy (TTM) on intestinal flora structure and metabolites of patients after cardiopulmonary resuscitation (CPR). This study is a single-center prospective observational study. Patients with spontaneous circulation recovery (ROSC) after CPR and TTM were included before and after self-hypothermia treatment, and the time series changes of intestinal flora and metabolites at some representative time points before and after treatment were compared. Thirty-five adult patients (age ≥18 years) who met the admission criteria were included. Before TTM treatment (0h after ROSC, baseline), 48 h after TTM warming (T1) and 48 h after rewarming (T2), fecal samples (macro-gene sequencing) and blood samples (metabonomics) were collected to analyze the changes of intestinal flora and metabolites in patients with cardiac arrest, and to screen the differential flora and metabolites regulated by TTM and their dynamic correlation.


Eligibility criteria: Inclusion Criteria:

* (1).18 years old and above; (2) Successful resuscitation after cardiopulmonary resuscitation (including chest compressions, electric shock defibrillation, etc.) and target temperature management;

Exclusion Criteria:

* (1) Pregnant or lactating women; (2) Patients with intestinal dysfunction: including severe acute intestinal injury, intestinal obstruction or other diseases that affect the normal function of the intestine; (3) Immunosuppression status: such as patients who use immunosuppressants, or patients with obvious immune dysfunction (such as HIV infection, organ transplant patients, etc.); (4) Those who have recently undergone intestinal surgery or endoscopy; (5) The patient or his family failed to sign the informed consent or refused to participate in the study;

Primary outcomes:
measure: Intestinal flora structure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing chaoyang hospital, Beijing, Beijing 100020
Study officials:
References:
Clinical trial NCT01995682: Feasibility Clinical Study of NLA Tool-US
Official title: Evaluate the Feasibility of the NLA Tool, a Combined Assessment of Nutritional and Physical Functional Status, to Provide Personalized Advice for the Independence and Mobility of Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Independent living
walk with or without walking aids
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 154
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Independently living men and women at 65-90 years old who are able to walk with or without walking aid

Brief summary: The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.

Detailed description: * Determining the proportion of elderly subjects who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status;
* Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength and endurance performance (33% +/- 10% of target group)

Eligibility criteria: Inclusion Criteria:

1. aged between 65 and 90 years,
2. able to walk with or without walking aid,
3. having obtained the subject's written informed consent
4. free of cognitive impairment (3MSE),

Exclusion Criteria:

1. self reported restriction to exercise(by a physician or other).
2. unable to carry out performance tests and questionnaires correctly,
3. self reported lower or upper extremity surgery or fracture in the last 3 months
4. self-reported symptomatic coronary artery disease, myocardial infarction in last 6 months
5. self reported history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment
6. uncontrolled hypertension (\>150/90 mm Hg)
7. self reported congestive heart failure
8. unable to communicate in English. Non-English speaking individuals will be excluded due to safety concerns in being able to understand testing instructions.

Primary outcomes:
measure: NLA feasibility
timeFrame: One day
Secondary outcomes:
measure: Evaluate the average time required for completing the NLA
timeFrame: One day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
state: Massachusetts
Study officials:
affiliation: Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
name: Roger A Fielding, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04921020: Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method
Official title: Department of Ophthalmology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eyelid Diseases
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 normal volunteers without eyelid diseases 100 patients with blepharoptosis 100 patients with blepharospasm 100 patients with dry eye disease 100 patients with Graves' disease

Brief summary: This study plans to assess eyelid topology (such as margin reflex distance, eyelid contour, and corneal exposure area) and blinking (such as frequency, velocity, and duration), using deep learning method to automatically extract eyelid topological features, and to predict subtypes of levator function, using deep learning method to extract blinking features, in order to provide new ideas and means to assess eyelid topology and kinetics.


Eligibility criteria: Inclusion Criteria:

1. normal volunteers without eyelid diseases
2. patients with blepharoptosis
3. patients with blepharospasm
4. patients with dry eye disease
5. patients with Graves' disease

Exclusion Criteria:

variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil

Primary outcomes:
measure: one-dimensional parameters of eyelid topology
timeFrame: through study completion, 5 years
measure: two-dimensional parameters of eyelid topology
timeFrame: through study completion, 5 years
measure: subtypes of levator function
timeFrame: through study completion, 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Juan Ye
state: Zhejiang
Study officials:
References:
Clinical trial NCT02072720: Angiogenic Factor Expression During Fractionated Irradiation
Official title: Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Primary Esophageal Carcinoma
Keywords: Radiotherapy
VEGF
esophagus carcinoma
bevacizumab
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Noordwest Ziekenhuisgroep
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2014-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main question of this study is if and when VEGF (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor.

* Therefore the first aim of this study is to identify the time point of induction of VEGF in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks of chemoradiation).
* If we identify increased expression of VEGF at a certain time point, our second aim is to determine if we can inhibit the subsequent tumor vessel growth by administration of bevacizumab.


Eligibility criteria: Inclusion Criteria:

* patients that will receive chemoradiation following CROSS-schedule before surgery for esophageal carcinoma
* ability to give informed consent
* age 18 years or older

Exclusion Criteria:

* pregnancy
* evidence of bleeding diathesis, coagulopathy
* inflammation of the GI-tract
* brain metastases
* diastolic/ systolic hypertension, not responding to treatment
* arterial thromboembolism in medical history
* surgery within the month prior to start of bevacizumab treatment

Primary outcomes:
measure: Change of VEGF mRNA expression in tumor biopsies
timeFrame: 5 weeks
measure: Change of VEGFR2 phosphorylation with IHC
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of mRNA expression of other pro-angiogenic factors
timeFrame: 5 weeks
measure: Changes in protein expression of pro-angiogenic factors
timeFrame: 5 weeks
measure: Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU university medical center
state: Noord-Holland
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
References: