louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02120209: Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital
Official title: Nurse Screening Tool for Fall Risk : Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: to Elaborate a New Simple Clinical Tool for the Risk of Falls Among Older Inpatients.
Keywords: assessment; falls; older adults; prediction scale; standardized declaration
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-04-22
Enrollment: 1300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized in acute care units participating in study in Angers University Hospital with respect to the eligibility criteria

Brief summary: The primary objective of this study is to elaborate a new simple clinical tool for the risk of falls among older inpatients.

Detailed description: Falling is a common event within hospitals, with a rate calculated between 2.9-13 per 1,000 bed-days . Falls lead to prolonged length of hospital stays (LHS). The first step of an efficient and cost-effectiveness strategy of fall prevention is the screening of individuals at higher risk of falls. Recently, a brief geriatric assessment (BGA) composed of a few number of items has demonstrated to successfully predict the risk of prolonged LHS (5). We hypothesized that the use of the BGA items would make it possible to predict the occurrence of falls among older inpatients.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* participants who did not issue opposition to participation in the study
* Patients hospitalized at the University Hospital of Angers in acute care units participating in study
* Being affiliated to a social security regime

Exclusion Criteria:

* Opposition to the use of information collected for research purposes.
* Age \< 65 years

Primary outcomes:
measure: Clinical characteristics (i.e., Brief geriatric assessment items)
timeFrame: recorded at baseline when older adult were admited to acute care units.
Secondary outcomes:
measure: Occurrence of falls
timeFrame: assessed between 2 and 21 hospitalization days
measure: Number of falls
timeFrame: assessed between 2 and 21 hospitalization days
measure: Severity of falls
timeFrame: assessed between 2 and 21 hospitalization days
Other outcomes:
Locations:
city: Angers
country: France
facility: University Memory Center, Angers University Hospital
state: Pays de la Loire
Study officials:
References:
Clinical trial NCT00035009: Treatment of Patients With Major Depressive Disorder With MK0869 (0869-059)
Official title: A Double-Blind, Multicenter, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder With Melancholic Features
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression

Detailed description: The duration of treatment is 8 weeks.

Eligibility criteria: Major Depressive Disorder

Primary outcomes:
measure: Change from baseline in HAMD-17 total score at week 8. Mk-0869 will be generally well tolerated
Secondary outcomes:
measure: Actual CGI-I score at week 8, improving social disability by change from baseline in Sheehan Disability Score at Week 8, change from baseline in the HAMA score at week 8, change from baseline in depressed mood of the HAMD-17 at week 8
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Liu KS, Snavely DB, Ball WA, Lines CR, Reines SA, Potter WZ. Is bigger better for depression trials? J Psychiatr Res. 2008 Jul;42(8):622-30. doi: 10.1016/j.jpsychires.2007.07.003. Epub 2007 Sep 7.
citation: Keller M, Montgomery S, Ball W, Morrison M, Snavely D, Liu G, Hargreaves R, Hietala J, Lines C, Beebe K, Reines S. Lack of efficacy of the substance p (neurokinin1 receptor) antagonist aprepitant in the treatment of major depressive disorder. Biol Psychiatry. 2006 Feb 1;59(3):216-23. doi: 10.1016/j.biopsych.2005.07.013. Epub 2005 Oct 24.
Clinical trial NCT02020109: Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia
Official title: Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia (CLL)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Leukemia, Chronic Lymphatic
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic lymphatic leukaemia (CLL).

Brief summary: Retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (CLL).

Detailed description: The study will include patients with CLL treated with splenic irradiation in Maastro Clinic, Maastricht, The Netherlands, Maxima Medisch Centrum Veldhoven/Catharina hospital, Eindhoven, The Netherlands and Modena hospital, Modena, Italy. Data will be collected from patient records in an uniform database. Data will include demographic data, CLL stadium (RAI and Binet) at diagnosis and at the time of irradiation treatment, clinical data at diagnosis (haematology), splenic irradiation data, follow-up data such as date of progression or death

Eligibility criteria: Inclusion Criteria:

* patients with chronic lymphatic leukaemia.

Exclusion Criteria:

* none

Primary outcomes:
measure: Clinical and haematological response
timeFrame: 13 years
Secondary outcomes:
measure: Progression of chronic Lymphatic leukaemia
timeFrame: 13 years
measure: Death
timeFrame: 13 years
measure: Toxicity of splenic irradiation
timeFrame: 13 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastro Clinic
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Jacques Borger, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01253109: Continuous Intraocular Pressure (IOP) Monitoring in Pigmentary Dispersion Syndrome and Pigmentary Glaucoma Patients
Official title: Detection of Induced IOP Fluctuations by SENSIMED Triggerfish® in Pigmentary Syndrome and Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pigmentary Dispersion Syndrome
Pigmentary Glaucoma Patients
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
Collaborators: name: Private practicioner, Dr Sunaric Mégevand
name: Orasis, AugenZentrum Pajic
First posted: 2010-12-03
Enrollment: 15
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: Patients with confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes

Brief summary: This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish® output signal peak after induced fluctuation by physical exercise or pupil dilation.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
* IOP of ≥ 15 mmHg
* 18-60 years.
* Patients able to jog continuously for at least 25 minutes
* Phakic eyes
* Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion Criteria:

* Pigmentary glaucoma already treated with peripheral laser iridotomy (PLI), argon laser peripheral iridoplasty (ALPI), argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT) in any eye
* Patients treated with pilocarpine or other mydriatic agent within the last 4 weeks in any eye
* Anti-hypertensive treatment in the 4 weeks preceding the study and throughout the study. Following signature of informed consent, anti-hypertensive treatment will be washed out for 4 weeks prior to study procedures in enrolled patients
* Patients with pseudoexfoliative (PEX) syndrome or PEX glaucoma in any eye
* Patients not able to understand the nature of the research
* Patients under tutorship
* Corneal abnormality
* Subjects with contraindications for wearing contact lenses
* Full frame metal glasses during SENSIMED Triggerfish® monitoring
* History of other ocular surgery except uncomplicated strabismus surgery no later than 3 months prior to study procedures
* Ocular inflammation or infection
* History of cardiac or pulmonary disorder
* Pregnancy and lactation
* Simultaneous participation in other clinical research

Primary outcomes:
measure: SENSIMED Triggerfish output values
timeFrame: during 4 to 6 hours
measure: Goldmann Applanation Tonometry values
timeFrame: During 4 to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Private practice - Dr Sunaric Mégevand
Study officials:
affiliation: Private Practice
name: Gordana Sunaric Megevand, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01571609: Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
Official title: Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Diabetes Mellitus
Metabolic Syndrome
Arterial Hypertension
Obesity
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
name: Aarhus University Hospital
name: Vejle Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Steno Diabetes Center Copenhagen
name: University of Copenhagen
First posted: 2012-04-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant X in order to determine the effect of the genetic variant on various metabolic parameters.


Eligibility criteria: Inclusion Criteria:

* Male
* 18-70 years of age
* Member of Biobank Vejle
* BMI\<30

Exclusion Criteria:

* Diabetes mellitus
* Severe illness

Primary outcomes:
measure: insulin secretion
timeFrame: 10 minutes
Secondary outcomes:
measure: Insulin resistance
timeFrame: 240 minutes
measure: body composition
timeFrame: 60 minutes
measure: atherosclerosis
timeFrame: 30 minutes
measure: biochemical blood profiling
timeFrame: at baseline
measure: Insulin resistance
timeFrame: 60 minutes
measure: Blood pressure
timeFrame: 24 hours
measure: Indirect calorimetry
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medicinsk forskningslaboratorium, Aarhus Universitet
Study officials:
affiliation: University of Aarhus
name: Niels Møller, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Copenhagen
name: Oluf B Pedersen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Copenhagen
name: Torben Hansen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Jørgen Rungby, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoy J, Kampmann U, Mengel A, Magnusson NE, Jessen N, Grarup N, Rungby J, Stodkilde-Jorgensen H, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N. Reduced CD300LG mRNA tissue expression, increased intramyocellular lipid content and impaired glucose metabolism in healthy male carriers of Arg82Cys in CD300LG: a novel genometabolic cross-link between CD300LG and common metabolic phenotypes. BMJ Open Diabetes Res Care. 2015 Aug 26;3(1):e000095. doi: 10.1136/bmjdrc-2015-000095. eCollection 2015.
citation: Stoy J, Grarup N, Horlyck A, Ibsen L, Rungby J, Poulsen PL, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N, Kampmann U. Blood pressure levels in male carriers of Arg82Cys in CD300LG. PLoS One. 2014 Oct 14;9(10):e109646. doi: 10.1371/journal.pone.0109646. eCollection 2014.
Clinical trial NCT00254709: Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
Official title: Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure
Graft Rejection
Aged
Keywords: kidney transplant
elderly
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-16
Enrollment: 66
Sex: ALL
Minimum age (years): 60
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 test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

* End stage renal disease
* Kidney transplantation
* Both donor and recipient older than 60 years

Exclusion Criteria:

* Prior or concurrent transplant of any organ other than the kidney
* Current clinically significant infections

Primary outcomes:
measure: Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
Secondary outcomes:
measure: Incidence of acute rejections at 3 and 12 months
measure: Patient and graft survival at 3 and 12 months
measure: Incidence and duration of episodes of acute tubular necrosis
measure: Time to recover renal function (creatinine< 2 mg/dl)
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05653609: Sensitivity and Specificity of the Clinical Classifications Generated by the Cureety Digital Telemonitoring Tool
Official title: A Study Evaluating the Sensitivity and Specificity of the Clinical Classifications Generated by the Cureety Digital Telemonitoring Platform: a Database Study to Validate the Cureety TechCare Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Lead sponsor: Cureety
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be randomly selected from all 1530 patients that used the Cureety telemonitoring platform between the 1st of October 2019 and the 30th of September 2022.

Brief summary: Cureety is a digital telemonitoring platform specifically designed to monitor cancer patients through self-reporting of adverse events, accompany patients and their medical teams and complement existing healthcare practices. The platform aims to detect signs and symptoms of health deterioration and disease progression, allowing the medical team to intervene earlier than usual compared to conventional care.

The patients are asked to respond to an electronic patient-reported outcome (ePRO) questionnaire. The digital tool is configured for each patient that generates specific questions that allow grading of adverse events relevant to their specific treatment and disease profile.

At the core of the platform is the medical device "Cureety TechCare", an algorithm that outputs a "clinical classification" based on the adverse events reported by the patients. There are four levels that correspond to the patients' health states, either "critical" ("red"), "to be monitored" ("orange"), "compromised" ("yellow"), or "correct" ("green"). In the case of a red or orange classification, the patients are asked to contact their medical team. In addition, the medical team can monitor the patient classifications from a distance including receiving notifications when patients are classified red and orange.

The present study was designed to retrospectively evaluate the performance of the "Cureety TechCare" medical device in real-life using data collected in the Cureety database.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years or older.
* Patients that have completed at least one questionnaire in Cureety
* Patients that have not exercised their right to oppose to the use of their data for clinical research.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Sensitivity
timeFrame: Between the 1st of October 2019 and the 30th of September 2022
Secondary outcomes:
measure: Specificity
timeFrame: Between the 1st of October 2019 and the 30th of September 2022
Other outcomes:
Locations:
city: Dinan
country: France
facility: Cureety
state: Bretagne
Study officials:
References:
Clinical trial NCT01205009: Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: in-vitro fertilization
poor responders
human chorionic gonadotropin
Fertility Agents, Female
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-09-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.


Eligibility criteria: Inclusion Criteria:

* women \>39 years on IVF treatment

Exclusion Criteria:

* polycystic ovary syndrome
* Any allergy to injection of human chorionic gonadotropin before

Primary outcomes:
measure: number of oocytes retrieved
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Mushira Aboo Dia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06835309: Isokinetic Strengthening of Hip Muscles Effect on Pelvic Floor Muscles Function in Females With SUI
Official title: Implications of Isokinetic Strengthening of Hip Muscles on Pelvic Floor Muscles Function in Women Experiencing Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Isokinetic Strengthening
Pelvic Floor Muscles
Stress Urinary Incontinence (SUI)
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the impact of isokinetic strengthening of hip muscles on pelvic floor muscles function in women experiencing stress urinary incontinence Does isokinetic strengthening of hip muscles impact pelvic floor muscles function in women experiencing stress urinary incontinence?


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with stress urinary incontinence
* age between 30 and 50 years

Exclusion Criteria:

* low back pain
* lower limb muscle pathology and/or joint degeneration
* cardiovascular, metabolic or pulmonary disease
* body mass index (BMI) \> 30 kg/m2.

Primary outcomes:
measure: Pelvic floor muscle strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Stress urinary incontinence.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: British University in Egypt
Study officials:
References:
Clinical trial NCT03161509: Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy
Official title: Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy
Primary purpose: BASIC_SCIENCE

Brief summary: Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.

Detailed description: Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol (in consenting subjects that are undergoing sleeve gastrectomy) and antiepileptic drugs (in consenting subjects that are chronically treated by a stable dose) before and 6 months after sleeve gastrectomy in 10 subjects.

Blood tests will be taken for drug levels before and 4-8 times after the subject takes the drug. A pharmacokinetic curve will be calculated and compared for each subject between prior to surgery and after surgery.

Eligibility criteria: Inclusion Criteria:

1. BMI over 30 and eligible for sleeve gastrectomy
2. Mentally capable for consent
3. (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug

Exclusion Criteria:

1. Gastrointestinal illness impairing absorption
2. renal failure (glomerular filtration rate\<45)
3. liver cirrhosis
4. heart failure (New York Heart Association class III or IV)

Primary outcomes:
measure: Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
Study officials:
affiliation: Rambam Healthcare Campus
name: Irit Hochberg, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: