louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02359240: HO-1 and Muscle Mitochondrial Dysfunction in Sepsis
Official title: Skeletal Muscle Wasting in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Atrophy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: septic patients; non septic patients with a femoral fracture,who need an fixation surgery

Brief summary: The current project was designed to examine dynamic changes in muscle wasting during sepsis. Researchers will focus the mitochondrial dysfunction of muscle cells and investigate the role of HO-1 in it. Researchers interested in identifying factors involved in the pathology of muscle wasting during sepsis.

Detailed description: Rapid muscle atrophy or muscle wasting occured to septic patients.Sepsis induced muscle wasting has become a severe, frequent, and persistent complication among critically ill patients. Multiple factors including ubiquitin-proteasome system, proinflammatory cytokines and oxidative stress contribute muscle proteolysis.

It is known that heme oxygenase-1 (HO-1) possesses a variety of functions like anti-inflammatory, antioxidative and anti-apoptosis effects. In order to investigate the mechanisms under the condition, researchers are going to examine the role of HO-1 in muscle atrophy during sepsis.

Eligibility criteria: Inclusion Criteria:

* sepsis, severe sepsis, septic shock
* clinical reason for fixation surgery of femoral fractures

Exclusion Criteria:

* no informed consent
* medical history of myopathy
* unintended weight loss before surgery or ICU admission
* chronic use of corticosteroids

Primary outcomes:
measure: HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis
timeFrame: 3 days after diagnosis
Secondary outcomes:
measure: length of ICU stay
timeFrame: 60 days
measure: length of mechanical ventilation
timeFrame: 60 days
measure: muscle myosin content
timeFrame: 3 days after diagnosis
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Anesthesiology and Intensive Care, Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Xiaoming Deng, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03478540: Gut Microbiota and Immune Recovery
Official title: Impact of Gut Microbiota on the Immune Recovery in HIV-infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1-infection
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2018-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected patients initiating antiretroviral therapy with CD4 T cell counts\< 350cells/mm3

Brief summary: To explore whether gut microbiota would impact CD4 T cells recovery in HIV-infected patients on antiretroviral therapy (ART). We prospectively enroll patients initiate ART and collect their fecal at followup for one year.


Eligibility criteria: Inclusion Criteria:

* Confirmed HIV infection
* Antiretroviral therapy naive
* CD4 T cell counts\<350cells/mm3
* Agree to participate

Exclusion Criteria:

* Don't want to start antiretroviral therapy
* Cocurrent cancer or opportunistic infection
* Liver diseases
* received antibiotics within four weeks of enrollment

Primary outcomes:
measure: Immune recovery
timeFrame: 48 weeks
Secondary outcomes:
measure: HIV viral load
timeFrame: 48 weeks
measure: Microbiota composition
timeFrame: week 0 and 48
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02094040: Municipality-based Post-discharge Follow-up Visits
Official title: Effect of Municipality-based Post-discharge Follow-up Visit Including the Primary Physician on Early Re-hospitalization in High Risk People of 65+ Years. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Readmission
Transition
Primary Care
Keywords: frailty
readmission
transition
discharge
primary care
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Region Sjælland
name: Danish Institute for Public Health
First posted: 2014-03-21
Enrollment: 531
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether discharge follow-up visit by primary physician and community-based nurse affects the risk of early re-hospitalisation among high risk older people discharged from a medical ward.


Eligibility criteria: Inclusion Criteria:

* Patient geography (The participant live in; Holbæk Kommune, Odsherred Kommune or Kalundborg Kommune.)
* Discharged from medical ward Holbæk Sygehus.
* Frailty (Rated by following criterion: dementia or a minimum of two of the following conditions; two or more hospitalisations within 12 month prior to follow up, los of physical function, treatment of two or more concurrent medical and/or surgical conditions, psychiatric disease, multi-pharmacy of more than 6 prescription medication, suspicious of congenital disturbances, substance abuse problem, disadvantaged social network, need for increasing home care following index hospitalization.)

Exclusion Criteria:

* Not discharged to home (If the patient are not discharged to home.)
* No written consent (If the patient does not wish to participate / written consent are not signed.)

Primary outcomes:
measure: Re-admission
timeFrame: Within 30 days from discharge
Secondary outcomes:
measure: Long-term hospitalization rate
timeFrame: Within 180 days from discharge
Other outcomes:
measure: Long-term death rate
timeFrame: Within 180 days from discharge
measure: Long-term use of primary health care services
timeFrame: Within 180 days from discharge
measure: Long-term use of secondary health care services
timeFrame: Within 180 days from discharge
Locations:
city: Holbæk
country: Denmark
facility: Medicinsk Afdeling, Holbæk Sygehus
Study officials:
affiliation: Medicinsk Afdeling, Holbæk Sygehus
name: Thomas Gjørup
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thygesen LC, Fokdal S, Gjorup T, Taylor RS, Zwisler AD; Prevention of Early Readmission Research Group. Can municipality-based post-discharge follow-up visits including a general practitioner reduce early readmission among the fragile elderly (65+ years old)? A randomized controlled trial. Scand J Prim Health Care. 2015 Jun;33(2):65-73. doi: 10.3109/02813432.2015.1041831. Epub 2015 Jun 10.
Clinical trial NCT05788640: Circadian and Seasonal Variation in Acute Myocardial Infarction
Official title: Circadian and Seasonal Variation in Acute Myocardial Infarction in Relation to Blood Viscosity and Outcome Among Adults Attending the Main Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample size was calculated using Epi- Info7. Expected frequency of cardiac onset is 15%. Based on this frequency and with a confidence limits of 6% and a confidence level of 90%, the sample needed for the study was estimated to be about from 138 patients and 196 at 95% CI .The sample will be calculated in the seasons of extreme seasonal changes at 2023, 2024

Brief summary: Circadian and seasonal variation in acute myocardial infarction .

Detailed description: Circadian and seasonal variation in acute myocardial infarction and relation between circadian rhythm and seasonal variations with biological and physiological markes of normal human being.

Eligibility criteria: Inclusion Criteria:

* 1.All patients above (16) years old 2.Complaint occur during acute climate changes

Exclusion Criteria:

* 1.Patients below 16 years old 2.Complaint during normal climate

Primary outcomes:
measure: Circadian and seasonal variation in acute myocardial infarction
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Nagarajan V, Fonarow GC, Ju C, Pencina M, Laskey WK, Maddox TM, Hernandez A, Bhatt DL. Seasonal and circadian variations of acute myocardial infarction: Findings from the Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) program. Am Heart J. 2017 Jul;189:85-93. doi: 10.1016/j.ahj.2017.04.002. Epub 2017 Apr 12.
citation: Thosar SS, Butler MP, Shea SA. Role of the circadian system in cardiovascular disease. J Clin Invest. 2018 Jun 1;128(6):2157-2167. doi: 10.1172/JCI80590. Epub 2018 Jun 1.
Clinical trial NCT02671240: Prognosis of Behavioral Addiction in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Addiction
Keywords: Parkinson disease
behavioral addiction
akinéto-rigid syndrome
dopamine agonist
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 164
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease who developed or not a behavioral addiction

Brief summary: Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously including apathy.

Our goal is to describe the natural history of Behavioral Addiction under the effect of the evolution of the disease and adapt treatment according to the prior art, through a study of a larger population of patients than in the few published studies.


Eligibility criteria: Inclusion criteria:

* Age greater than or equal to 30 years
* Parkinson's disease according to the criteria of UKPDSBB
* Time evolution of the top disease or equal to 5 years

Exclusion criteria:

* Lack of Parkinson's disease and atypical parkinsonism
* Patient not previously included in PD-BADGE

Primary outcomes:
measure: Survival time before disappearance of behavioral addiction defined by a score of less than 2 on the scale of behavioral assessment of Parkinson's disease
timeFrame: 12 months after selection
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Neurologie
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Mathieu ANHEIM, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00817440: Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat
Official title: Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: growth hormone insulin signaltransduction signalpathways
growth hormone and insulin signalpathways
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hypothesis: under fasting there will primarily be an activation of growth hormone(GH) signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under physical activity.

Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max.

In addition to this we will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.


Eligibility criteria: Inclusion Criteria:

* healthy men
* Body mass index (BMI) 20-26
* age 18-45 years

Exclusion Criteria:

* any kind of disease
* any use of medicine

Primary outcomes:
measure: Growth hormone and insulin signal pathways
timeFrame: 30 min
Secondary outcomes:
measure: aminoacid and glucose turnover
timeFrame: 4 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus sygehus
state: Jylland
Study officials:
References:
Clinical trial NCT01620840: Lacosamid-i.v.-Register
Official title: Lacosamid-i.v.-Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy With Partial Onset Seizures With or Without Secondary Generalization
Keywords: oral administration of Lacosamide is not possible or adequate
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 130
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: Patients who are treated with Lacosamide i.v.-solution in routine clinical practice.

Brief summary: Lacosamide is a new antiepileptic drug (AED) marketed as Vimpat with three different formulations, tablets, oral syrup and a solution for intravenous infusion. Lacosamide is approved as adjunctive therapy in epilepsy patients with partial onset seizures with or without secondary generalization. The i.v. solution is used in patients in which oral administration is not possible or adequate. Bioequivalence with oral tablets and safety could be demonstrated in healthy volunteers and in patients switched from tablets to Lacosamide i.v. solution. A recently published study demonstrates the feasibility of single loading doses up to 300 mg. The aim of this Lacosamide i.v. registry is to collect systematically data on the safety, tolerability and administration procedures when Lacosmide i.v. is used in routine daily clinical practice, mainly in hospitals. These data will help treating physicians to optimize the use of Lacosamide i.v. in clinical routine.


Eligibility criteria: Inclusion Criteria:

* before any data are collected for any patient in this registry an ehtical committee must be notified of the registry and written data consent must be properly executed and documented

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Neurologie
state: Schleswig-Holstein
Study officials:
affiliation: University hospital Schleswig-Holstein, Germany
name: Ulrich Stephani, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04903340: Assessment of the Impact of Acquisition Time, Respiratory Gating and New Qclear Reconstruction Modalities on the Quantification of Dosimetry in Selective Internal Radiotherapy
Official title: Assessment of the Impact of Acquisition Time, Respiratory Gating and New Qclear Reconstruction Modalities on the Quantification of Dosimetry in Selective Internal Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2021-05-26
Enrollment: 30
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: Patient with hepatocellular carcinoma

Brief summary: Post-processing of Positron Emission Tomography (PET) acquired images, performed following radioembolization treatment with microspheres at 90Y in hepatocellular carcinoma patients, is subject to changes commercialized by General Electric : respiratory motion correction, specific reconstruction algorithms. We propose to test the possible combinations of these reconstruction parameters to determine which ones to apply for an optimal quality exam with the shortest scan time possible


Eligibility criteria: Inclusion Criteria:

* patient with hepatocellular carcinoma
* with radioembolization treatment decided
* over the age of 18

Exclusion Criteria:

* radiembolization not possible
* acquisition of PET/CT imaging at 90Y not possible

Primary outcomes:
measure: Average dose value (Gy) of tumor liver and healthy liver obtained according to reconstruction configuration.
timeFrame: Day 0 (PET/CT Exam)
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References:
Clinical trial NCT05246540: Evaluation of PET/CT of Cephalic Arteries for the Diagnosis of Giant Cell Arteritis
Official title: Evaluation of PET/CT of Cephalic Arteries for the Diagnosis of Giant Cell Arteritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient

Brief summary: Giant cell arteritis (GCA) is the most common vasculitis in adults. The diagnosis of GCA is evoked by the association of clinical signs and biological anomalies (inflammatory syndrome) in patients over 50 years of age. On the other hand, starting a treatment implies being certain of the diagnosis which requires performing a temporal artery biopsy under local anesthesia. This examination is therefore an invasive procedure for patients whose sensitivity is not optimal. This is why imaging techniques (echo-Doppler or MRI of the temporal arteries) have been developed to look for signs of vasculitis without the need to perform a biopsy. However, these examinations lack sensitivity (=falsely concluding the absence of GCA) and specificity (=falsely concluding the presence of GCA). Recently, advances in imaging, and in particular positron emission tomography (PET), have made it possible to visualize the cephalic arteries, including the temporal artery.

The aim of this study is therefore to evaluate the sensitivity and specificity of PET of the cephalic arteries for the diagnosis of GCA and to compare them with those of echo-Doppler and MRI of the temporal arteries.


Eligibility criteria: Inclusion Criteria:

* Any patient for which the diagnosis of GCA is suspected and who underwent a cervical PET/CT

Exclusion Criteria:

* previously diagnosed GCA, glycemia \> 7 mmol/L, PET CT performed more than 72 h after introduction of glucocorticoids, age \< 50 years

Primary outcomes:
measure: Sensitivity / specificity of cervical PET/CT for the diagnosis of GCA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
citation: Thibault T, Durand-Bailloud B, Soudry-Faure A, Greigert H, Drouet C, Devilliers H, Ramon A, Bejot Y, Martin L, Creuzot-Garcher C, Falvo N, Audia S, Cochet A, Bonnotte B, Alberini JL, Samson M. PET/CT of cranial arteries for a sensitive diagnosis of giant cell arteritis. Rheumatology (Oxford). 2023 Apr 3;62(4):1568-1575. doi: 10.1093/rheumatology/keac430.
Clinical trial NCT03479840: Age-Dependent Impact of the SYNTAX-score on Mortality
Official title: Age-Dependent Impact of the SYNTAX-score on Mortality After Percutaneous Coronary Intervention in an All-Comer Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
PCI
Keywords: SYNTAX score, PCI, elderly
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 1331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comer population undergoing PCI

Brief summary: The SYNTAX-score has been proposed as a tool for risk stratification and guiding revascularization therapy in patients with complex coronary artery disease.

There are limited data on the prognostic value of the SYNTAX-score among elderly patients.

Aim of this study was to investigate whether age modifies the impact of the SYNTAX-score on all-cause mortality at 2 years after percutaneous coronary intervention (PCI).

Detailed description: SYNTAX score has been used as a tool to quantify severity of coronary artery disease. Interventional or operative treatment of patients is associated with improvement in SYTAX score after PCI so called residual SYNTAX score. The higher the SYNTAX score value the higher is the mortality. Whereas this is true for both young and old patients is debatable. Therefore we aim to investigate in this registry age-dependent impact of baseline and residual SYNTAX score on 1- and 2-year mortality after PCI

Eligibility criteria: Inclusion Criteria:

* patients undergoing PCI at our center

Exclusion Criteria:

* prior coronary artery bypass grafting
* no PCI

Primary outcomes:
measure: Medium- to long-term Mortality
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilians University
Study officials:
affiliation: LMU Klinikum
name: Julinda Mehilli, MD
role: PRINCIPAL_INVESTIGATOR
References: