louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01412320: Cocoa Flavanols in Renal Disease
Official title: The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: End Stage Renal Disease
Endothelial Dysfunction
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).

Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.


Eligibility criteria: Inclusion Criteria:

* end stage renal disease
* \>18 years
* chronic intermittent hemodialysis

Exclusion Criteria:

* acute Infection
* acute renal failure
* heart failure (NYHA IV)
* pregnancy
* anuria

Primary outcomes:
measure: The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Heinrich-Heine-University
state: NRW
Study officials:
References:
citation: Balzer J, Rassaf T, Heiss C, Kleinbongard P, Lauer T, Merx M, Heussen N, Gross HB, Keen CL, Schroeter H, Kelm M. Sustained benefits in vascular function through flavanol-containing cocoa in medicated diabetic patients a double-masked, randomized, controlled trial. J Am Coll Cardiol. 2008 Jun 3;51(22):2141-9. doi: 10.1016/j.jacc.2008.01.059.
citation: Luedike P, Rammos C, Pohl J, Heisler M, Totzeck M, Kleophas W, Hetzel GR, Kelm M, Hendgen-Cotta U, Rassaf T. Filtration of Macrophage Migration Inhibitory Factor (MIF) in Patients with End Stage Renal Disease Undergoing Hemodialysis. PLoS One. 2015 Oct 20;10(10):e0140215. doi: 10.1371/journal.pone.0140215. eCollection 2015.
Clinical trial NCT06581120: GLP_1 RA Ultrasound Study
Official title: Assessment of Gastric Contents in Patients Taking Glucagon-Like Peptide-1 Receptor Agonists: a Prospective Observational Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Glucagon Like Peptide-1 (GLP-1
Delayed Gastric Emptying
Risk of Aspiration
Diabetes
Morbid Obesity
Keywords: GLP-1
Glucagon like Peptide 1
Aspiration
Gastric empty
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the endocrine clinic and from the preoperative surgical schedule.

Brief summary: The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index over 35
* Type 2 Diabetes
* Currently taking GLP01 RA agonist (for GLP 1 group)
* Not taking GLP-1 RA agonist (for control group)

Exclusion Criteria:

* Diagnosis of gastroparesis
* patient refusal to participate
* Previous gastric bypass or any other gastric surgery
* Currently on peritoneal dialysis
* Abdominal pathology
* Gastro-intestinal obstruction
* Pregnancy

Primary outcomes:
measure: Aspiration Risk determined by POGUS
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04993573: Acceptability, Representations and Experiences of the COVID-19 Pandemic
Official title: Acceptability, Representations and Experiences of the COVID-19 Pandemic : the ARECOVID Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: COVID-19
caregivers
older
ageism
public health
hospital
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Jean Monnet University
name: Saint Etienne School of Mine
name: Gerontopole Auvergne Rhone-Alpes (AURA)
First posted: 2021-08-06
Enrollment: 520
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older 65 people Caregivers who works in gerontology

Brief summary: The "ARECOVID" project is a comprehensive sociological study of what is being played out in organizational terms in the face of the COVID-19 pandemic. Through quantitative methods (questionnaires) and qualitative methods (semi-directive interviews), we would understand the essential views of the populations concerned by COVID-19, but also that of actors taking care of vulnerable elderly non-COVID. Special attention will be paid to the care pathway of elderly people with and without the virus, in a health system in full reorganization. We will try to understand the needs and experiences of all health actors (hospital/city) involved in COVID-19 and the experience of confinement and the Covid-19 of the elderly living at home, in order to reflect on a possible improvement in the health response of elderly people in the event of an epidemic health crisis.

Detailed description: understand the needs and experiences of all health actors (hospital/city) involved in COVID-19 and the experience of confinement and the Covid-19 of the elderly living at home

Eligibility criteria: Inclusion Criteria:

* For older people : minimum age : 65 years
* For caregivers : works in gerontology

Exclusion Criteria:

* Person with a neurological disease
* Person under guardianship or curatorship

Primary outcomes:
measure: Analysis representations of COVID-19 and confinement of older people
timeFrame: Day 20
Secondary outcomes:
measure: Analysis impacts of COVID-19 in works of caregivers
timeFrame: Day 20
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Gérontopole AURA
Study officials:
affiliation: Gerontopole Auvergne Rhone-Alpes (AURA)
name: Pauline Gouttefarde
role: STUDY_CHAIR
References:
Clinical trial NCT00962273: The Pandemic Stress Vaccine: A Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak
Official title: The Pandemic Stress Vaccine: Randomized Controlled Trial of an Educational Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychological Stress
Keywords: health personnel
communicable diseases
stress, psychological
resilience, psychological
disaster planning
education
online
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine the effects of an interactive, computerized learning resource designed to increase resilience in hospital-based health care workers preparing for an influenza pandemic. The effects of the learning resource will be compared to a non-interactive learning resource condition and a control condition. It is hypothesized that (a) online pandemic-related education reduces absenteeism and interpersonal problems for healthcare workers (HCWs), and improves their pandemic self-efficacy in the short and long-term, and (b) an interactive format for online education is necessary for its benefits.


Eligibility criteria: Inclusion Criteria:

* employee or professional staff of a hospital

Exclusion Criteria:

* unable to read and write English

Primary outcomes:
measure: Absenteeism
timeFrame: 32 weeks
Secondary outcomes:
measure: Pandemic self-efficacy
timeFrame: 32 weeks
measure: Interpersonal problems
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: William J. Lancee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Robert G. Maunder, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maunder RG, Lancee WJ, Balderson KE, Bennett JP, Borgundvaag B, Evans S, Fernandes CM, Goldbloom DS, Gupta M, Hunter JJ, McGillis Hall L, Nagle LM, Pain C, Peczeniuk SS, Raymond G, Read N, Rourke SB, Steinberg RJ, Stewart TE, VanDeVelde-Coke S, Veldhorst GG, Wasylenki DA. Long-term psychological and occupational effects of providing hospital healthcare during SARS outbreak. Emerg Infect Dis. 2006 Dec;12(12):1924-32. doi: 10.3201/eid1212.060584.
Clinical trial NCT05527873: Respiratory Complications of Operated Esophageal Atresia in Children
Official title: Respiratory Complications of Operated Esophageal Atresia in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Atresia
Keywords: esophageal atresia
esophageal malformation
gastroesophageal reflux
asthma
bronchial hyperreactivity
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 67
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child aged 1 to 12 years old operated on for esophageal atresia and followed up at the University Hospitals of Strasbourg

Brief summary: The respiratory complications of esophageal atresia have already been identified.

They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux.

In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion.

The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus.


Eligibility criteria: Inclusion criteria:

* Child aged 1 to 12 years old
* Child operated on for esophageal atresia between 01/01/2010 and 31/12/2020 and followed up at the University Hospitals of Strasbourg
* Child who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research
* Parental authority having not expressed, after being informed, their opposition to the reuse of their child's data for the purposes of this research.

Exclusion criteria:

Subject and/or parental authority having expressed their opposition to participating in the study

Primary outcomes:
measure: Retrospective study of respiratory complications of esophageal atresia in children
timeFrame: Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France
Study officials:
affiliation: Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France
name: Laurence WEISS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01444573: Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation
Official title: Rate Ventricular Control Therapy by Implantable Continuous Monitor in Patients With Permanent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Rate control
ILR
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2011-09-30
Enrollment: 90
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: The investigators hypothesized that very lenient rate control is not inferior to strict or lenient rate control assessed by implantable continuous ECG monitor for preventing cardiovascular hospitalization and mortality in patients with long-standing persistent or permanent atrial fibrillation


Eligibility criteria: Inclusion Criteria:

* Long-standing persistent or permanent atrial fibrillation
* Mean resting heart rate \> 80 beats per minute with or without rate control medication
* Age \< 70 years old
* Constant use of anticoagulation therapy

Exclusion Criteria:

* Paroxysmal or persistent atrial fibrillation
* Non-stable heart failure or \> III NYHA FC
* Indications for IPG/CRT/ICD
* Thyroid dysfunction
* Inability to walk or bike.

Primary outcomes:
measure: Hospitalization for all cardio-vascular events
timeFrame: 12 months
Secondary outcomes:
measure: All-cause death
timeFrame: 12 months
measure: stroke
timeFrame: 12 months
measure: life-threatening arrhythmic and drugs adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny A Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05312073: Study of in Vivo and in Vitro Transcriptomic and Proteomic Signatures in Unhereditary Ichtyosis
Official title: Study of In Vivo and in Vitro Transcriptomic and Proteomic Signatures in Unhereditary Ichtyosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autosomal Recessive Congenital Ichthyosis
Epidermolytic Ichthyosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 18
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to identify important biological pathways involved in a variety of ichtyosis, using transcriptomic and proteomic techniques, with the aim of guiding the development of new therapeutis.


Eligibility criteria: Inclusion Criteria:

* Aged 15-80 years old
* Having an ARCI or EI, confirmed by a molecular diagnosis of a mutation in at least one of the following genes: TGM1, ALOX12B, NIPAL4, ABCA12, keratin 1 and keratin 10)
* Having stopped all topical treatments in at least 1% of the total body surface (equivalent to one palm of the hand of the patient), at least 8 days before the skin biopsy (which will be performed on this untreated area).
* Patients having a molecular diagnostic of genetic ichtyosis
* No contraindication to skin biopsy
* Health insurance coverage
* Signature of written consent

Exclusion Criteria:

* Aged less than 15 of over 80 years old
* Ichtyosis without a molecular confirmed diagnosis or with a different diagnosis
* History, in the 8 previous days, of any topical treatment on the area intended for the skin biopsy.
* No health insurance coverage
* Pregnant or breastfeeding woman
* Patient under guardianship or curatorship
* Patient under State Medical Assistance (AME)

Primary outcomes:
measure: Transcript and protein levels of all genes measured by NGS mRNA sequencing and by mass spectrometry in lesioned skin biopsies
timeFrame: Up to 6 months post inclusion
Secondary outcomes:
measure: Transcript and protein levels of all genes assessed by NGS mRNA sequencing and by mass spectrometry (keratinocytes)
timeFrame: Up to 6 months post inclusion
measure: Phenotype of circulating PBMCS assessed by flow cytometry analysis using monoclonal Antibodies (mAbs)
timeFrame: Up to 6 months post inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Louis Hospital
Study officials:
References:
Clinical trial NCT00456573: Cytokine Profiles in Children With Obstructive Sleep Apnea
Official title: Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Pediatric Obstructive sleep apnea syndrome
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.

Detailed description: We will recruit subjects with OSA about to undergo adenotonsillectomy and collect a blood sample and portion of their tonsils after the induction of general anesthesia. The mononuclear cells will be isolated from both these tissues and stimulated with different markers and cytokines assayed and compared. We will also recruit patients with no symptoms of OSA undergoing unrelated elective surgery and ascertain the absence of OSA by having the parents fill out a sleep questionnaire. We will then collect blood samples from these patients after the induction of anesthesia and examine the cytokine secretion profile and compare it to that of the children with OSA.

Eligibility criteria: Inclusion Criteria:

* OSA documented by polysomnography and clinical symptoms.
* Patients with no symptoms of OSA and negative sleep questionnaire.

Exclusion Criteria:

* Significant systemic disease except mild asthma

Primary outcomes:
measure: levels of cytokines released from PBMCs of OAS subjects and controls
timeFrame: just prior to surgery
Secondary outcomes:
measure: cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Fuad M Baroody, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02458573: Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

* patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
* gastric cancer patient undergoing laparoscopic gastrectomy

Exclusion Criteria:

* ASA physical status Ⅳ
* bradycardia (\< 60 bpm), arrhythmia
* uncompensated heart failure
* hepatic failure (Child-Pugh score B)
* renal failure (eGFR MDRD \< 60 ml/min/1.73m2)

Primary outcomes:
measure: the time to first gas passing after surgery
timeFrame: within 5days after surgery
measure: the time to resume water intake after surgery
timeFrame: within 5days after surgery
measure: soft diet intake after surgery
timeFrame: within 5days after surgery
Secondary outcomes:
measure: postoperative pain
timeFrame: immediately after surgery to 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04688073: Effect of Muscle Damage After Downhill Running on Postprandial Lipids
Official title: Effect of Muscle Damage After Downhill Running on Postprandial Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional and Metabolic Diseases
Lipemia
Keywords: triglyceride
non-esterified fatty acids
eccentric exercise
cardiovascular disease
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 9
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: All participants underwent three experimental trials, namely downhill running (DR), level running (LR), and the control (CON) in a cross-over design. Each trial lasted for 2 days. The participants were fed the same breakfast and lunch on day 1 in each trial. The participants arrived at the laboratory at 18:00 on day 1 and ran on the treadmill at 60% VO2max (downhill and level surface trials) or rested (CON trial) for 30 min. Subsequently, they were fed a standardized dinner (A meal box containing chicken, vegetables, and rice, 692 kcal, with 50% energy from carbohydrate, 32% from fat, and 18% from protein) within 20 min.

The participants returned to the laboratory at 07:30 on day 2 after an overnight fast. After baseline blood and gas samples were collected, the participants were fed a high-fat meal that included cereal, white bread, whipping cream, cheese, and butter. The high-fat meal provided fat 1.2 g/kg (65% energy), carbohydrate 1.1 g/kg (27% energy), protein 0.33 g/kg (8% energy), and 16.5 kcal/kg.

A 10-mL blood sample was collected from a forearm vein into nonheparinized tubes before and immediately after exercise or rest on day 1. On day 2, postprandial blood samples were collected from forearm veins into nonheparinized tubes by using an indwelling venous needle and a three-way stopcock. A 10-mL blood sample was collected before (0 h) and 0.5, 1, 2, 3, 4, 5, and 6 h after the high-fat meal.


Eligibility criteria: Inclusion Criteria:

* generally healthy, had not engaged in regular exercise or received any medication in the past 6 months

Exclusion Criteria:

* history of cardiovascular disease, hypertension, hyperlipidemia, diabetes, atherosclerosis, or osteoporosis, free of any musculoskeletal injury during the study

Primary outcomes:
measure: TG AUC
timeFrame: 6 hours
Secondary outcomes:
measure: NEFA AUC
timeFrame: 6 hours
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
References: