louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02900391: Urgent Care for the Elderly: Impairment and Home Care Services
Official title: Urgent Care for the Elderly: Impairment and Home Care Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impaired
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 3200
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 80 and over visiting the ED, taking in charge by SMUR (medical EMS) or calling SAMU (medical call center) during 24 hours

Brief summary: Elderly population is increasing quickly and their need for health care ressources through emergency care is also growing. While these patients are ageing physical impairment often happens along the way. Apart from senior homes, different types and levels of home care services have been developped in order to overcome or to adapt to these situations.

Our goals are:

* to assess mortality rate depending on home care services level for the elderly population consulting in the ED or being taken in charge by the Emergency Medical System in France.
* to describe this population in terms of autonomy, impairment and home care services


Eligibility criteria: Inclusion Criteria:

* patients aged 80 and over

Exclusion Criteria:

* aged\<80 years old

Primary outcomes:
measure: Mortality rate at hospital discharge
timeFrame: At hospital discharge or 30 days at most
Secondary outcomes:
measure: Admission rate
timeFrame: Admission is decided on the first 24 hours after EMS or ED care, the day of the inclusion
measure: Level of home care services
timeFrame: Questionnaires given the day of the inclusion
measure: Level of health care ressources
timeFrame: During the ED visit (less than 24 hours), the day of the inclusion
Other outcomes:
Locations:
Study officials:
References:
citation: Feral-Pierssens AL, Toury G, Sehimi F, Peschanski N, Laribi S, Carpentier A, Kraif M, Carbonnier C, Duchateau FX, Freund Y, Juvin P; EPIGER IRU-SFMU study group. Emergency department outcome of elderly patients assisted by professional home services, the EPIGER study. BMC Geriatr. 2020 Sep 21;20(1):355. doi: 10.1186/s12877-020-01742-1.
Clinical trial NCT01267591: Peripheral Artery Tonometry in Children With Type 1 Diabetes and Obese Children
Official title: Peripheral Artery Tonometry in Children With Type 1 Diabetes and Obese Children.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Tonometry
Diabetes
Children
Obesity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children seen at consultation in University Hospital

Brief summary: Background: The reactive hyperemia-peripheral artery tonometry (RH-PAT) is a newly developed method for noninvasive endothelial function assessment.

Objective: The goal of this study is to determine whether a significant difference in RH-PAT score is present between adolescents with type 1 diabetes (T1D) in comparison with controls. We will also compare RH-PAT scores in obese adolescents versus controls.


Eligibility criteria: Inclusion Criteria:

* 12-19 years of age

Exclusion Criteria:

* type 2 diabetes; obesity in group of type 1 diabetes

Primary outcomes:
measure: RHPAT
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
References:
citation: Pareyn A, Allegaert K, Verhamme P, Vinckx J, Casteels K. Impaired endothelial function in adolescents with overweight or obesity measured by peripheral artery tonometry. Pediatr Diabetes. 2015 Mar;16(2):98-103. doi: 10.1111/pedi.12139. Epub 2014 Apr 3.
Clinical trial NCT05699291: Cost of Using FLUOrescence to Green of Indocyanine for the Detection of Breast Cancer.
Official title: Analysis of the Cost of Using FLUOrescence in Green of Indocyanine for the Detection of the Sentinel Lymph Node in the Breast Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sentinel Lymph Node
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 163
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with histologically proven breast cancer, eligible for sentinel lymph node technique by Indocyanine Green or isotopes

Brief summary: The purpose of this study is to analyze the average direct costs of each of these techniques, represented by the costs directly linked to the management of breast cancer, to the surgical intervention and to the techniques evaluated (Indocyanine Green and isotopes) which are: consultations, hospitalizations, resources consumed during the surgical intervention, as well as the time of the patients, transport...

Detailed description: The main objective is to evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green compared to the technique using isotopes in patients with breast cancer, from the point of view of health insurance and the hospital.

The chosen time horizon is up to 1 month post-intervention. The choice of this time horizon corresponds to the usual duration of follow-up for patients who have benefited from one of the sentinel lymph node detection techniques, in order to collect the main post-surgical complications.

This is a multicenter, prospective, observational, non-randomized study, aimed at comparing the overall cost of two sentinel lymph node detection techniques (Indocyanine Green and isotope) from a dual perspective (health insurance and hospital).

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or over, having given her oral non-objection ;
* Patient with histologically proven breast cancer ;
* Patient eligible for the sentinel lymph node technique by Indocyanine Green or isotopes.

Exclusion Criteria:

* Patient who has expressed her opposition to the use of her medical data ;
* Patient under legal protection, guardianship or curatorship ;
* Pregnant patient ;
* Patient not affiliated to a social security scheme.

Primary outcomes:
measure: Average direct costs of the two techniques assessed (Indocyanine Green and isotopes)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital privé des Peupliers
Study officials:
References:
Clinical trial NCT05543291: Multi-omics Analysis of Chronic Kidney Disease
Official title: Multi-omics Analysis of Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKD
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

1. Confirmed CKD patients.
2. Age≥18 years.

Exclusion criteria：

1. Age\<18 years.
2. Patients with active gastrointestinal diseases, liver cirrhosis, cancer, active infection or cardiovascular event in the past 3 months, pregnancy or received renal replacement therapy.

Brief summary: Chronic kidney disease (CKD) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (ESRD), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year.


Eligibility criteria: Inclusion Criteria:

Age-matched and gender-matched HC with normal renal and liver function and not taking any medications were enrolled

Exclusion Criteria:

1. Age\<18 years.
2. Individuals with hypertension, diabetes, obesity, metabolic syndrome or pregnancy.
3. Individuals who received gastrointestinal operation, antibiotics or probiotic products within one month.

Primary outcomes:
measure: Functional and structural alteration of microbiotas and their crosstalk with CKD-associated metabolism
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrolgoy, Shanghai 10th People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01842191: Efficacy of Fish Oil in Multiple Sclerosis
Official title: Efficacy of Fish Oil on Serum TNFα, IL-1β, IL-6, Oxidative Stress Markers in Multiple Sclerosis Treated With Interferon Beta 1-b
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing- Remitting Multiple Sclerosis
Keywords: R-R MS
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2013-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present work was to evaluate the efficacy of fish oil supplementation on serum proinflammatory cytokines levels, oxidative stress markers and disease progression in MS.

Detailed description: Current research findings suggest that Omega-3 polyunsaturated fatty acids (PUFA) such as eicosahexanoic acid (EPA) and docosahexaenoic acid (DHA) contained in fish oil may have anti-inflammatory, antioxidant and neuroprotective effects. The aim of the present work was to evaluate the efficacy of fish oil supplementation on serum proinflammatory cytokines levels, oxidative stress markers and disease progression in MS. 50 patients with relapsing-remitting MS were enrolled. The experimental group received orally 4 g/day of fish oil for 12 months. The primary outcome was serum TNFα levels; Secondary outcomes were IL-1β, IL-6, nitric oxide catabolites, lipoperoxides, progression on the expanded disability status scale (EDSS) and annualized relapses rate (ARR).

Eligibility criteria: Inclusion Criteria:

* Patients had clinically definite and magnetic resonance image supported MS
* Had at least one relapse in the year before entry into the study
* EDSS score of 0-5
* Treated with subcutaneous 250 μg interferon beta-1b (Betaseron, Bayer)

Exclusion Criteria:

* they were taking another supplement
* had progressive forms of MS
* had history of severe depression
* had history of acute liver or renal dysfunction
* had history of tobacco, drug or alcohol abuse
* had intolerance, contraindication or allergy to fish oil

Primary outcomes:
measure: TNF alpha
timeFrame: 3 months
Secondary outcomes:
measure: IL-1 beta, IL-6, Lipoperoxides, nitric oxide
timeFrame: 3 months
Other outcomes:
measure: Expanded Disability Status Scale (EDSS) and Annualized rate of relapses (ARR)
timeFrame: 6 months
Locations:
city: Guadalajara
country: Mexico
facility: IMSS, Specialties Hospital, Neurology Departament
state: Jalisco
Study officials:
affiliation: Social Security Mexican Institute
name: Genaro G Ortiz, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ortiz GG, Macias-Islas MA, Pacheco-Moises FP, Cruz-Ramos JA, Sustersik S, Barba EA, Aguayo A. Oxidative stress is increased in serum from Mexican patients with relapsing-remitting multiple sclerosis. Dis Markers. 2009;26(1):35-9. doi: 10.3233/DMA-2009-0602.
Clinical trial NCT04110691: Impact of Stent Length and Diameter on Patients Undergoing Primary PCI
Official title: Impact of Stent Length and Diameter on Short Term Outcomes in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary PCI.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ST segment elevation myocardial infarction undergoing primary PCI

Brief summary: The goal of the study is to evaluate the Impact of coronary stent length and/or diameter in patients with ST segment myocardial infarction undergoing primary PCI, on Short term clinical outcomes.

Detailed description: * ST segment elevation myocardial infarction is serious condition to the blood supply to the heart muscle. Rapid reperfusion of the ischemic myocardium using percutaneous coronary intervention (PCI) is the standard treatment for acute myocardial infarction (MI) to rescue the ischemic myocardium and reduce infarction size.
* There are two types of stents:

  1. Drug-eluting stent which achieving local drug delivery to the injured blood vessel at the time of intervention, a drug is released from a polymer coating or loaded directly onto the stent (2). This is the best one.
  2. Bare metal stent is the old one and not effective as DES in reducing vascular restenosis by suppressing smooth muscle cell (SMC) proliferation.
* The management of long coronary lesions by percutaneous coronary intervention (PCI) has become increasingly important because of the rising incidence of long or complex lesions in aging populations (3) Stent length has been considered as an important predictor of adverse events after PCI. The exact impact of lesion length on the short- and long-term clinical outcomes of DES implantations is not clear yet.
* Myocardial necrosis complicates one-third of percutaneous coronary intervention (PCI) and may adversely affect the outcome(4)

Eligibility criteria: Inclusion Criteria:

* Patients with ST segment myocardial infarction who are eligible for PCI.
* All categories (all age groups and both sex groups)

Exclusion Criteria:

* Patients with previous PCI.
* Patients of ectatic lesions.
* Patients with with multi vessel disease and suitable for CABG.
* Patients with complex lesions including bifurcational lesions and LM stenting.

Primary outcomes:
measure: prognosis of patients with ST segment myocardial infarction undergoing primary PCI
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Nada Deyaa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00906191: Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects
Official title: An Open-Label, Single-Dose, Nonrandomized Study Of The Mass Balance And Metabolic Disposition Of Orally Administered 14C-Labeled SAM-531 In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-21
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to investigate how quickly and to what extent the 14-Carbon labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is radioactive, this enables the compound to be traced in blood, urine and feces.


Eligibility criteria: Inclusion Criteria:

* Men aged 18 to 50 years inclusive at screening
* Healthy as determined by the investigator on the basis of screening evaluations

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Primary outcomes:
measure: Radioactivity measurements in blood, urine and feces and pharmacokinetic parameters (Cmax, AUC, terminal elimination half life, total clearance and volume of distribution in the plasma ; urine clearance ; metabolite profiling in plasma, urine and feces.)
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01593891: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment
Official title: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Determine the Safety and Validity of Venous Angioplasty and
Valvuloplasty in the Treatment of CCSVI. In Addition, it Will
Allow Researchers to Sub-classify Valve Morphology in Relation
to Treatment Success. This Will be Evidenced by Venous Patency
Forty-eight Hours by Doppler Ultrasound as Well as Clinical
Symptom Improvement.
Keywords: IVUS, CCSVI
Lead sponsor: Synergy Health Concepts, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Many questions remain about how and when CCSVI might play a role in nervous system damage and whether venous angioplasty is helpful in treating the symptoms of CCSVI. Utilizing intravascular ultrasound (IVUS,) this pilot study will provide data that will allow researchers to evaluate venous morphology pre- and post- percutaneous angioplasty and sub-classify valve morphology as related to treatment success by distinguishing vessels which are more responsive to treatment. In addition, this study will validate the safety of valvuloplasty in various neurodegenerative disorders that involve venous obstruction.

Brief summary: Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment

Detailed description: To determine the safety and validity of venous angioplasty and valvuloplasty in the treatment of CCSVI. In addition, it will allow researchers to sub-classify valve morphology in relation to treatment success. This will be evidenced by venous patency forty-eight hours by Doppler ultrasound as well as clinical symptom improvement.

Eligibility criteria: Inclusion Criteria:

* Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
* Males or Females between the ages of 20 and 60 years of age.
* Voluntary agreement to participate in the study: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment.

Exclusion Criteria:

* Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study.
* History of uncontrolled hypertension
* Previous CCSVI treatment
* Presence of hypercoagulable state
* Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Synergy Health Concepts Inc.
state: California
Study officials:
affiliation: Study Principal Investigator
name: Michael Arata, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01660191: A Study Comparing CoQ10 Levels While Taking 3 Different Statins
Official title: A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: LDL, HDL
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Kowa Pharmaceuticals America, Inc.
name: Eli Lilly and Company
First posted: 2012-08-08
Enrollment: 134
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 purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.

Detailed description: Statins are known effectively treat high cholesterol and heart disease. However, statins may lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be responsible for side effects such as myalgia.

Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins do, while still lowering cholesterol.

In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking 3 different FDA-approved statins, in equipotent doses.

Eligibility criteria: Inclusion Criteria:

* LDL-C levels of 100-200mg/dl; triglycerides \</=200mg/dl at screening visit
* Willing to discontinue use of all lipid-altering doses fo medication or supplements for the duration of the study

Exclusion Criteria:

* LDL-C \<100mg/dl or \>200mg/dl, Triglycerides \>200mg/dl
* History of diabetes mellitus or documented fasting blood glucose \>125mg/dl or HbA1c \>6.4%
* History of coronary artery disease
* history of chronic renal or hepatic disease
* known sensitivity of intolerance to a statin
* persistent elevated liver enzymes or CPK (\>3 x upper normal limit)
* currently taking CoQ10 supplements and unable discontinue for duration of study

Primary outcomes:
measure: Changes in Plasma CoQ10 Levels
timeFrame: Change from Baseline to 12 Weeks
Secondary outcomes:
measure: Changes in Major Lipid Parameters - VLDL Size
timeFrame: Change from Baseline to 12 Weeks
measure: Changes to Glucose Metabolism - HbA1c and Insulin
timeFrame: Change from Baseline to 12 weeks
measure: Changes in HDL and LDL Size
timeFrame: Change from Baseline to 12 Weeks
measure: Changes to Glucose Metabolism - Fructosamine
timeFrame: Change from Baseline to 12 weeks
measure: Changes HDL Particle Number and LDL Particle Number
timeFrame: Change from Baseline to 12 Weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Patrick M Moriarty, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: