louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05987904: Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment with the LynxPatch Device
Official title: MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Keywords: Cardiac Diagnosis
Lead sponsor: Lynx Health Science GmbH
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2023-08-14
Enrollment: 1097
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, all patients will be consecutively recruited that are either scheduled for an echocardiographic examination or that will be subjected to a non-cardiac surgical procedure according to their respective standard procedure.

Brief summary: In this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the LynxPatch.

Detailed description: The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The study population includes 1100 patients that scheduled for an echocardiographic assessment or for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Provision of informed consent, i.e., the subject must be able to understand and sign the Patient Information and Consent Form.
* Group 1: Patients that have an indication for an echocardiographic assessment.
* Group 2: Patients that are scheduled for a non-cardiac surgery

Exclusion Criteria:

* Subjects has implanted cardioverter defibrillator
* Subject is pregnant
* Subject is breastfeeding
* Subject has compromised skin in the location where the LynxPatch is intended to be positioned

Primary outcomes:
measure: Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
timeFrame: 30 minutes per individual
Secondary outcomes:
measure: Accuracy of the LynxPatch device predictions of an adverse perioperative outcome
timeFrame: 30 days per individual
measure: Usability of the LynxPatch device
timeFrame: 30 minutes per individual
measure: Rate of LynxPatch-related safety incidents
timeFrame: 30 minutes per individual
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Med. Klinik II - Kardiologie und Angiologie
Study officials:
affiliation: BG Universitätsklinikum Bergmannsheil
name: Aydan Ewers, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01694004: Nutrient Sensing in the Duodenum
Official title: Duodenal Lipid Sensing and Nutrient Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: The Effect of LCFA on Nutrient Absorption
Keywords: Nutrient absorption
Duodenal feeding tube
Gut-brain-gut axis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-09-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Preliminary studies in humans suggest that the presence of lipids in the gut can modify glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid sensing in the duodenum has a significant role in modifying nutrient (glucose and amino acid) absorption from the GI tract through a gut-brain-gut axis.

Detailed description: The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid tracers and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow the investigators to determine if LCFA can alter nutrient absorption and glucose and amino acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK, GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs) will be measured during all infusion periods.

Eligibility criteria: Inclusion Criteria:

* BMI = 19-27 kg/m2
* 30-55 years of age

Exclusion Criteria:

* Contraindication for nasal tube placement (e.g. deviated septum, prior upper gastrointestinal bleed, or history of easy bleeding)
* Prior gastric or intestinal surgery or pancreas resection
* Females with a positive pregnancy test
* Known history of intestinal diseases including (but not limited to) inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), celiac sprue, Barrett's esophagus
* Type 1 or type 2 diabetes
* Gastroenteritis (diarrhea and/or vomiting) or constipation within the past week

Primary outcomes:
measure: Nutrient Absorption
timeFrame: 6 hours
Secondary outcomes:
measure: Substrate Oxidation
timeFrame: 6 hours
measure: Gut Hormone Levels
timeFrame: 6 hours
Other outcomes:
measure: Bioactive Lipids
timeFrame: 6 hours
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Robyn Tamboli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Naji Abumrad, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00204204: Importance of Forces and Safety Features in Car Crash Multitrauma
Official title: The Multitraumatized Patient. What is the Importance of Forces Involved and the Use of Safety Equipment for the Amount of Trauma to the Patient Inside the Vehicle.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Trauma
Keywords: multiple trauma
traffic accident
outcome
safety
injury severity
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Royal Department of Transportation
name: Ullevaal University Hospital
name: Health Region East, Norway
name: Norwegian Air Ambulance Foundation
First posted: 2005-09-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The pupose of the study is a prospective evaluation of external and internal factors/causes of importance for the trauma and final outcome experienced by persons inside motor vehicles in serious car accidents. We hypothesise that there is an association between the use and function of safety features and the results for the patient and an association between material damage and the severity of injury.

Detailed description: We plan to study approximately 200 road accidents with multitraumatised patients and accidents with modern cars and severe material damage with little or moderate damage to persons inside the vehicle. A researcher will be alerted by the call centre (Norwegian 911-equivalent), move to the place of accident and take a pure observers role (unless ethically unacceptable due to lack of other health personnel). He will document the accident including use and condition of safety features, conditions inside the coupe, weather conditions, etc. Other available information on the vehicles, crashtests etc will be gathered from the manufacturer. All medical information will be gathered from the ambulance service, hospitals, pathology and forensic departments. Information from police and fire department will also be gathered.

Patient, next-of-kin, others invloved will be interviewed as appropriate in follow-up.

Four accident groups: Front-to-front or -object \> 60 km/hour, same \< 60 km/hour, car rolled over on road, car rolled over out-of-road. Factors: Age of vehicle, damage to coupe, cause of accident, on-scene time, initial evaluation by health personnel, injury severity scoring in hospital.

Eligibility criteria: Inclusion Criteria:

* patients with multiple trauma from severe motor vehicle accidents in Eastern Norway patients from motor vehicle accidents in Eastern Norway with severe material damage

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Lars Wik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06221904: The Effect of Simple Gymnastics Training for Parkinson's Patients in the Community
Official title: A The Effect of Simple Gymnastics Training for Parkinson's Patients in the Community: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Detailed description: In the early stages of Parkinson's disease, many patients do not seek medical attention. The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility criteria: Inclusion Criteria:

* Age \>60 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.

Exclusion Criteria:

* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: day 1 and day 21
Secondary outcomes:
measure: The Berg Balance Scale
timeFrame: day 1 and day 21
measure: Patient Health Questionnaire-9
timeFrame: day 1 and day 21
measure: Generalized Anxiety Disorder-7
timeFrame: day 1 and day 21
Other outcomes:
Locations:
city: Kai Feng
country: China
facility: Tielu Community
state: Henan
Study officials:
affiliation: Zhengzhou Tielu Hospital
name: Sumei Wang, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT05410704: Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture
Official title: Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise Via Telerehabilitation on Body Posture and Quality of Life Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Telerehabilitation
Body Posture
Pelvic Floor Muscle Training
Diaphragmatic Breathing
Quality of Life
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study; It will be done in order to show evidence of the effects of pelvic floor muscle training and diaphragmatic breathing exercise via telerehabilitation on body posture and quality of life in healthy individuals. International Physical Activity Quastionnaire Short Form (IPAQ), Pelvic Floor Impact Quastionnaire Short Form (PFIQ-7), 36-Item Short Form Survey(SF-36) and New York Posture Rating Chart will be applied.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index between 18-25
* Being a woman over the age of 18

Exclusion Criteria:

* obstructive or restrictive lung disease
* diagnosed with urinary incontinence or pelvic organ prolapse
* pelvic pain
* history of pelvic surgery
* Any history of spinal, thoracic or abdominal surgery
* To smoke
* cardiac, neurological and rheumatological disease
* Congenital deformity or previous history of surgery in the spine and thorax
* endocrine and metabolic disease
* psychiatric disorders
* cardiological disorders
* malignancy
* Doing regular physical activity or sports for the last 3 months

Primary outcomes:
measure: Assessment of Quality of Life
timeFrame: baseline
measure: Assessment of Body Posture
timeFrame: baseline
Secondary outcomes:
measure: Assessment of Physical Activity Level
timeFrame: baseline
measure: Assessment of Pelvic Floor Muscle Function
timeFrame: baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Tülay Ülkü SEVİM
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Meltem VURAL
role: STUDY_DIRECTOR
References:
Clinical trial NCT02834104: Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers
Official title: Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Fibrosis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Myocardial fibrosis is recognized as the pathologic entity of extracellular matrix remodeling. Diffuse, reactive fibrosis is increasingly recognized in a variety of conditions despite the absence of ischemia. Regardless of the etiology, fibrosis leads to increased myocardial stiffness thereby promoting cardiac dysfunction. This dysfunction may present clinically with symptoms of cardiac failure although this is often a subclinical disease. Various imaging modalities and collagen biomarkers have been used as surrogate markers to assess the presence, extent, and turnover of myocardial fibrosis. Techniques using echocardiography, cardiac magnetic resonance, and nuclear imaging have been developed to detect early features of systolic and diastolic left ventricular dysfunction and impaired contractile reserve. Further identification of diffuse reactive fibrosis may be possible with evolving cardiac magnetic resonance and molecular techniques. The goal of this protocol is to validate cardiac magnetic resonance imaging as a new tool for fibrosis quantification against histology as standard of reference.


Eligibility criteria: Inclusion Criteria:

* All patients who require surgical aortic valve replacement , which will benefit from an MRI to measure fibrosis in the months preceding the surgery.
* Patient submitted to the social security scheme
* Patient agreeing to participate in the study and who signed the informed consent.

Exclusion Criteria:

* A history of myocardial
* Unstable Patients requiring treatment with catecholamines.
* hepatocellular insufficiency of alcoholic origin
* Severe renal impairment
* Appearance before examining coronary syndrome at high risk, defined according to international recommendations.
* History of known allergy to gadolinium at diagnosis
* Pregnant or lactating
* Patient \< 18 years

Primary outcomes:
measure: quantification of myocardial fibrosis by RMI
timeFrame: 5years
Secondary outcomes:
measure: measuring biomarkers of fibrosis
timeFrame: 5 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT02682004: Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study
Official title: Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Depression
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: According to Edinburg depression scale womenn who taken 13 point and above.

Brief summary: After vaginal delivery, all of the participants will evaluate by using Edinburg depression scale and venous blood sample will obtain. Postpartum depression will consider the result of scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin level will compare between depressed and nondepressed women.


Eligibility criteria: Inclusion Criteria:

* All women who gave birth

Exclusion Criteria:

* women with previously diagnosed depression and any psychiatric disorders
* women with previously take antidepressan and antipshycothic
* women giving birth to children with anomalies
* women with undertake surgery for peripartum hemorrhage

Primary outcomes:
measure: Blood level (ng/ml) ELİSA
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study officials:
References:
citation: Hu Y, Dong X, Chen J. Adiponectin and depression: A meta-analysis. Biomed Rep. 2015 Jan;3(1):38-42. doi: 10.3892/br.2014.372. Epub 2014 Oct 16.
citation: Skalkidou A, Sylven SM, Papadopoulos FC, Olovsson M, Larsson A, Sundstrom-Poromaa I. Risk of postpartum depression in association with serum leptin and interleukin-6 levels at delivery: a nested case-control study within the UPPSAT cohort. Psychoneuroendocrinology. 2009 Oct;34(9):1329-37. doi: 10.1016/j.psyneuen.2009.04.003. Epub 2009 May 7.
citation: Mansur RB, Rizzo LB, Santos CM, Asevedo E, Cunha GR, Noto MN, Pedrini M, Zeni M, Cordeiro Q, McIntyre RS, Brietzke E. Adipokines, metabolic dysfunction and illness course in bipolar disorder. J Psychiatr Res. 2016 Mar;74:63-9. doi: 10.1016/j.jpsychires.2015.12.003. Epub 2015 Dec 12.
Clinical trial NCT04356001: The "One-piece" Autologous Tuberosity Graft
Official title: The "One-piece" Autologous Tuberosity Graft : a Novel Concept in Ridge Preservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: extraction
socket preservation
autologous
maxillary tuberosity
hard and soft tissue graft
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction.

Detailed description: Patients scheduled for a single mono-rooted tooth extraction are included in the study. After atraumatic extraction, sockets are filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. CBCTs are performed before the extraction and 4 months after ridge preservation, to analyze the vertical and horizontal alterations of the ridge, using 'ITK-Snap' software.

Clinical measurements of both soft and hard tissues are also assessed during the extraction and implant placement.

Eligibility criteria: Inclusion Criteria:

* Healthy patient
* Patient with at least one single-rooted tooth to be extracted and be replaced with an implant
* No signs of acute infection : edema, suppuration, abscess, spontaneous bleeding
* Non-smoker or Light Smoker \< 10 cigarettes/day

Exclusion Criteria:

* Pregnant or lactating females
* Non-controlled periodontal disease
* Medical conditions that contraindicate implant surgery
* Metabolic bone disorders such as osteoporosis,..
* Severe psychiatric conditions
* Heavy smoker \> 10 cigarettes/day

Primary outcomes:
measure: Change of volume of the ridge from baseline to 4 months post-op
timeFrame: 4 months
measure: Change of Vertical dimension of the ridge from baseline to 4 months post-op
timeFrame: 4 months
measure: Change of Horizontal dimension of the ridge from baseline to 4 months post-op
timeFrame: 4 months
measure: Change in Soft tissue from baseline to 4 months post-op
timeFrame: 4 months
Secondary outcomes:
measure: Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)
timeFrame: 4 months
measure: Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)
timeFrame: 4 months
measure: Change in Hard tissue from baseline to 4 months post-op (clinical measurements)
timeFrame: 4 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint-Joseph university
Study officials:
References: