louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06727903: Predictive Model for Mortality in Older People With Critical Illness
Official title: Development of a Predictive Model for Mortality in Patients Aged 75 or Older With Critical Illness
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Critical Illness
Keywords: Critical Illness
Mortality
Aged
Intensive Care Units
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 450
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to a Intensive Care Unit

Brief summary: The present study aims to develop a predictive model to identify elderly patients with the highest likelihood of mortality upon admission to an intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 75 or older.
* Admission to an ICU from the Emergency Department.
* Availability of or possibility to contact a participant's informant.
* Informed consent for participation in the study, either by the participant or a valid legal representative.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will not be included in the study:

* Patients transferred to the Emergency Department from a hospital ward.
* Patients who die within the first 24 hours of ICU admission.
* Patients admitted to Step-Down Units.
* Patients requiring ICU admission for any of the following reasons:

Orotracheal intubation or advanced cardiopulmonary resuscitation performed prior to arrival at the Emergency Department.

AV block awaiting pacemaker implantation. Activation of the STEMI or Stroke care pathway. Post-cardiac catheterization for acute coronary syndrome.

* Participation in another clinical study involving an intervention, procedure, or visit schedule that is incompatible with the present study.

Primary outcomes:
measure: mortality
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Pere de Ribes
country: Spain
facility: Consorci Sanitari Alt Penedès-Garraf
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital de Mataró
city: Barcelona
country: Spain
facility: Hospital de Terrassa
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Dexeus Barcelona
city: Barcelona
country: Spain
facility: Hospital General de Catalunya
city: Barcelona
country: Spain
facility: Hospital General de Granollers
city: Barcelona
country: Spain
facility: Hospital Sagrat Cor
city: Girona
country: Spain
facility: Clinica Girona
city: Girona
country: Spain
facility: Hospital Santa Caterina
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta
Study officials:
References:
Clinical trial NCT00572403: Risk Factors Contributing to the Development of Microalbuminuria
Official title: Risk Factors Contributing to the Development of Microalbuminuria Over a 5 Year Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microalbuminuria
Keywords: microalbuminuria
risk factors
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Merck Frosst Canada Ltd.
First posted: 2007-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants returning for a 4-5 year follow-up visit as part of an ongoing research project will be screened for microalbuminuria and invited to participate if they meet the appropriate criteria.

Brief summary: This research project will look at the relationship between baseline variables, and the new onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker, losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back for a 4-5 year follow up visit as part of a continuing project. We hypothesize that the new onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1 year as well as being associated with elevated left ventricular mass index. The rate of new onset microalbuminuria in non-diabetics is not established and this prospective study will provide data.

Detailed description: The primary objective of this research project is to determine risk factors related to the development of microalbuminuria. The secondary objective is to determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. Of participants returning for a 4-5 year follow up visit as part of a continuing project, we will examine the proportion that have developed microalbuminuria. Subjects found to have microalbuminuria will be offered therapy with the ARB losartan and will be followed at three months to determine if there has been a reduction in levels.

Eligibility criteria: Inclusion Criteria:

* participation in the Double Exposure study
* elevated microalbuminuria

Primary outcomes:
measure: To determine risk factors related to the development of microalbuminuria.
timeFrame: 3 months
Secondary outcomes:
measure: To determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria.
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Sheldon Tobe, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01985503: Longitudinal Follow-up of Brown Adipose Tissue Function and Structure
Official title: Brown Adipose Tissue: Longitudinal Follow-up of Brown Adipose Tissue Structure and Associations With Obesity and Cardiovascular Risk Factors in Healthy Participants of Baseline PET Studies (BAT-Follow-Up)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: positron emission tomography
magnetic resonance imaging
brown adipose tissue
obesity
cardiovascular disease
subclinical atherosclerosis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2013-11-15
Enrollment: 95
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study subjects are healthy 22-55-year-old Caucasians. Population contains both lean and obese subjects.

Brief summary: In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up study to examine associations between obesity, cardiovascular risk factors, serum metabolic profile and BAT structure at baseline and during follow-up several years later. 43 BATPET participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52 FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years. The aim of this study is to examine longitudinal associations between BAT function and structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.


Eligibility criteria: Inclusion Criteria:

* All study subjects have been screened prior to acceptance in BATPET, FATBAT and Dixon-BAT studies and no screening for inclusion is required in the current study.

Exclusion Criteria:

* 1) Smoking 2) Blood pressure \> 160/100 mmHg 3) Pregnancy or lactation 4) Medication (expected effect on study variables)

Primary outcomes:
measure: Correlation between baseline brown adipose tissue activity according to PET imaging and serum lipoprotein concentrations at follow-up 5 years later
timeFrame: 5 years
Secondary outcomes:
measure: Association between brown adipose tissue structure at baseline and at follow-up
timeFrame: 5 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: PET Centre, Turku University
Study officials:
affiliation: PET Centre, Turku Univesity
name: Juho RH Raiko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05756803: Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)
Official title: Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients presenting with erectile dysfunction are often found to have increased corporal firmness on elastography. We hypothesize that this corporal firmness reflects reversable changes that can be altered by Low-Intensity Shockwave Therapy (LiST). In this pilot study patients found to have increased corporal firmness will be treated with LiST.

Detailed description: This study will enroll men between the ages of 18 and 65 with corporal cavernosal firmness on elastography. The participants study duration is 3 months long and includes eight visits at the study center. Study visits consist of physical exam, vital signs, questionnaires, blood draws, and administration of low-intensity shockware therapy (LiST).

Low intensity extracorporeal (i.e., outside the body) shockwave therapy (LiST) is a treatment that has been in use since 2010 and has become commonly used Internationally and in the United States since 2015. The device applies a low-intensity shockwave to the surface of the penis using an ultrasound gel as the coupling agent.

The study will evaluate changes in corporal cavernosal firmness and changes in penile vascular blood flow.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Men aged 18-64
4. Sexually active men and evidence of increased firmness on elastography during their standard evaluation for erectile dysfunction.

Exclusion Criteria:

1. Within two weeks of Visit 1 using erectogenic medications including PDE5 inhibitors and/or penile injection therapy
2. Presence of a penile implant.
3. Presence of cardiac pacemaker or defibrillator
4. Patients who are using devices which are sensitive to electromagnetic radiation.
5. Screening ultrasound positive for testicular cancer
6. Presence of untreated prostate cancer
7. Patients with severe coagulation disorders
8. Patient that in the opinion of the Principal Investigator would be non-compliant with the study

Primary outcomes:
measure: Evaluate changes in corporal cavernosal firmness with Low-Intensity Acoustic Shockwave Therapy (LiST)
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Private Office
state: New York
city: Lake Success
country: United States
facility: The Smith Institute for Urology
state: New York
Study officials:
References:
Clinical trial NCT06376903: Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women
Official title: Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Stress Incontinence
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: • This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women

Detailed description: Pilates exercises help in the controlled movement of the core, that act as a corset and it activates both core muscle and synergistically the PFM. (Trantafylidis, 2009).

There is limited evidence regarding the use of Pilates exercises for the management of stress urinary incontinence (SUI) in older women (Keri, 2013; Pyria et al, 2021). So this study will be conducted to determine the effect of Pilates exercises on SUI in postmenopausal women which provide an insight about the benefits of such exercise on postmenopausal SUI.

Eligibility criteria: Inclusion Criteria:Postmenopausal women (at least 12months after menstrual cessation), diagnosed with SUI by the gynecologist.

* Their ages will range from 50-60 years old .
* Their BMI will be less than 30kg/m2 .
* All of them suffer from mild to moderate degree of SUI .
* All of them delivered vaginally.
* All are multipara with 2 or more children.
* All are of sedentary life style.

Exclusion Criteria:Women will be excluded from the study if they have:

* Previous bladder surgery.
* Post pelvic radiotherapy.
* Vaginal/abdominal hysterectomy.
* Vaginal infection.
* Severe urinary tract infection.
* Uterine Prolapse

Primary outcomes:
measure: • Revised urinary incontinence scale
timeFrame: 6 weeks
Secondary outcomes:
measure: • Quality of Life Questionnaire (QOL) for stress urinary incontinence
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00581503: Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer
Official title: Optical Coherence Tomography for Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Pleural Cancer
Prostate Cancer
Keywords: early detection of lung and pleural cancer
early detection of prostate cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-12-27
Enrollment: 0
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: Study Population will be identified at UCIMC, who is scheduled for prostatectomy, endobronchial, transbronchial, and pleural biopsy will be recurited to participate in the study.

Brief summary: This study has been designed to utilize already obtained biopsy specimens for investigation of the utility of a new, non-invasive optical diagnostic technique. The study will allow a careful correlation between the Optical coherence tomography findings and conventional histology.

Detailed description: Optical coherence tomography is a non-invasive diagnostic technique that can provide information about tissue abnormalities, change in structure of an organ. This technique uses a near-infrared diode to emit light that can produce images of the specimen under investigation without causing damage or alterations.

Eligibility criteria: Inclusion Criteria:

* Adult 18 years and older
* Having procedure of endobronchial, transbronchial, and / or pleural biopsy

Exclusion Criteria:

* Currently participating in any other investigational drug or device evaluation.
* Currently taking drugs that are sensitive to light.

Primary outcomes:
measure: Pathology results.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Pulmonary and Critical Care Medicine, UCI Medical Center
state: California
city: Orange
country: United States
facility: Urology department, UCI Medical Center
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Matthew Brenner, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579903: Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)
Official title: An Open-Label, Randomized, Two-period Crossover Study To Compare Relative Bioavailability of Two Formulations of Moroctocog Alfa (Af-cc) In Subjects With Moderately Severe Or Severe Hemophilia A (FVIII:C </=2%)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemophilia A
Keywords: Hemophilia A
moroctocog alfa (AF-CC)
ReFacto AF
dual-chamber syringe
bioavailability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-04-18
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.

Detailed description: This study is being conducted in order to satisfy a post-approval EMA commitment to compare the pharmacokinetics of the 2 dose presentations used in this study.

Eligibility criteria: Inclusion Criteria:

* Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).
* Negative test for facto VIII inhibitor.
* If applicable, HIV or hepatitis treatment is stable at the time of enrollment.
* Ability to abstain from use of FVIII products for 72 hours at a time.

Exclusion Criteria:

* History of any positive test result for factor VIII inhibitor.
* Presence of any bleeding disorder in addition to Hemophilia A.
* Body weight less than 50 kg.
* History of alcoholism.
* Treatment with investigational drug or device within 30 days prior to the Screening visit.

Primary outcomes:
measure: Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf)
timeFrame: Periods 1 and 2, Day 1 through 4
Secondary outcomes:
measure: Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (secondary PK parameters include: tmax, λz, t1/2, CL, Vss, and FVIII Recovery)
timeFrame: Periods 1 and 2, Day 1 through Day 4
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Shafer F, Charnigo RJ, Plotka A, Baumann J, Liang Y, Korth-Bradley J. Assessment of relative bioavailability of two presentations of moroctocog alfa (AF-CC) in subjects with moderately severe or severe hemophilia A. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):237-41. doi: 10.1002/cpdd.168. Epub 2014 Oct 27.
Clinical trial NCT01501903: Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)
Official title: Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Tumors
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion.

Detailed description: Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass.

Standard technique: FNA performed in unidirectional fashion.

Eligibility criteria: Inclusion Criteria:

* Age \> 19 years
* Solid Pancreatic Mass Lesions

Exclusion Criteria:

* Age \< 19 years
* Coagulopathy
* Unable to consent

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 2 months
Secondary outcomes:
measure: Number of passes for diagnosis
timeFrame: 2 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bang JY, Magee SH, Ramesh J, Trevino JM, Varadarajulu S. Randomized trial comparing fanning with standard technique for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic mass lesions. Endoscopy. 2013 Jun;45(6):445-50. doi: 10.1055/s-0032-1326268. Epub 2013 Mar 15.