louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01874210: Study on Colonic Fermentation in Chronic Kidney Disease Patients
Official title: Study on Colonic Fermentation in Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months

Brief summary: Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect findings suggest that chronic kidney disease influences the colonic microbial metabolism with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore, this study aims to elucidate the influence of renal dysfunction on microbial metabolism and to test the hypothesis that chronic kidney disease patients carry a different fecal metabolite profile.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 95 years
* Treatment with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months
* Written informed consent

Exclusion Criteria:

* History of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy)
* History of colonic surgery
* Recipient of a renal or other solid organ transplant
* Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks

Primary outcomes:
measure: difference in fecal metabolite profile (Chronic kidney disease vs. control)
timeFrame: baseline
Secondary outcomes:
measure: difference in fecal metabolite profile depending on dialysis modality
timeFrame: baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ruben Poesen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Björn Meijers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Kristin Verbeke, Pharm PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Pieter Evenepoel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652210: Use of Multiphoton Microscopy in the Diagnosis of Cancer
Official title: Use of Multiphoton Microscopy in the Diagnosis of Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bladder Cancer
Prostate Cancer
Keywords: Bladder cancer
prostate cancer
multiphoton microscopy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-04-03
Enrollment: 344
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level. Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder urothelium from atypical and malignant urothelium in the ex vivo setting. After development of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a non-invasive means to image the interior of the bladder at the cellular level, which would provide direct evidence of the presence of tumor without a biopsy. After exhibiting usefulness of MPM imaging for bladder cancer, we will look at other organs beginning with the colon.

Detailed description: Same as above

Eligibility criteria: Inclusion Criteria:

* Anyone who presents with bladder and/or prostate cancer

Primary outcomes:
measure: After several delays, the multiphoton microscope has been delivered to Weill Cornell Medical College. We have been using this time to set-up and fine tune the multiphoton microscope. As of current, no negative events have occurred.
timeFrame: 10/14/2007 to 2/15/2008
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Douglas S Scherr, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01256710: Trifecta™ Durability Study
Official title: Trifecta™ Durability Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 1151
Sex: ALL
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: Patients that are candidates for implantation or have been implanted over the past 9 months with a Trifecta™ aortic valve.

Brief summary: The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.


Eligibility criteria: Inclusion Criteria:

* Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines
* Patient requires aortic valve replacement.
* Patient is legal age in host country.
* Patients must be able and willing to provide written informed consent to participate in this investigation
* Patients must be willing and able to comply with all follow-up requirements

Exclusion Criteria:

* Patients with contraindication for cardiac surgery
* Patients who are pregnant.
* Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
* Patient has active endocarditis
* Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery.
* Patient is undergoing renal dialysis.
* Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
* Patient has a documented thrombus in left atrium or left ventricle.
* Patient had in the past mitral or tricuspid valve replacement.
* Patient needs mitral and/or tricuspid valve replacement.
* Patient has an Ejection Fraction \< 25%
* Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted
* Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
* Patient has a life expectancy less than two years.

Primary outcomes:
measure: Actuarial Freedom From Reintervention Due to Structural Valve Deterioration
timeFrame: 10 years
Secondary outcomes:
measure: Actuarial Freedom From All-cause Mortality
timeFrame: 10 years
measure: Freedom From Valve Related Mortality
timeFrame: 10 years
measure: Freedom From Structural Valve Deterioration
timeFrame: 10 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitat Herzzentrum Leipzig
Study officials:
affiliation: Universitat Herzzentrum Leipzig
name: Sven Lehmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04644510: Feasability of Lung Ultrasonography in General Practice
Official title: Feasability of Lung Ultrasonography in General Practice: A Multicentic, Observational and Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Education
General Practice
Keywords: Ultrasonography
General Practice
Feasability
Lung ultrasonography
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 111
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting their family physician

Brief summary: A major barrier to ultrasonography in general practice (GP) is the time restriction of their medical consultation. We aimed to evaluate the feasibility of lung ultrasonography (LUS) realized by general practitioners (GP's) into their medical consultation.

A prospective, observational, multi-centric and open study conducted in 3 different centers by 15 GP in France. Patient receiving LUS were recruited from December 2019 to January 2020. GP's were all novices and received a training course by LUS expert before the study. Eight-points LUS exam was recorded, timed, and interpreted by GP's.

Among the 111 LUS performed, 110 LUS were interpreted. Time duration was 4 (3-5) min with 13% of LUS superior to 5 minutes. There was no significant difference in time duration after stratification by age. Patients were mainly satisfied after receiving LUS, and 80% of patients had a better understanding about their disease due to US realization.

In this first prospective, and multicenter study, involving patients consulting in General Practice, we found that LUS seems to be feasible by GP's in a medical consultation. We showed that LUS can be performed fast enough for a GP consultation, and easy to learn. These findings will need to be valided in a randomized and controlled study.


Eligibility criteria: Inclusion Criteria:

* Age \> 3 months; lung ultrasonography performed by GP

Exclusion Criteria:

* Age \< 3 months or rejection to participate to the study

Primary outcomes:
measure: Duration of Lung Ultrasonography
timeFrame: 2 months
Secondary outcomes:
measure: Time limit exceeded lung ultrasonography
timeFrame: 2 months
measure: Interpretation of lung ultrasonography images
timeFrame: 2 months
measure: Stratification by age
timeFrame: 2 months
measure: Survey results
timeFrame: 2 months
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital, Caen
state: Calvados
Study officials:
References:
Clinical trial NCT04934410: Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation
Official title: Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure, Low
Keywords: Blood Pressure
Catecholamines
Heart failure
High risk patients
Left ventricular assist device
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 50
Sex: ALL
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: Patients with terminal heart failure which are scheduled for implantation of a left ventricular assist device (LVAD)

Brief summary: The induction of anesthesia is one of the most critical situations for high-risk-patients undergoing major surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase.

This observational study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of antihypotensive drugs during the induction and the surgical procedure in heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD).


Eligibility criteria: Inclusion Criteria:

- Heart failure patients scheduled for implantation of left ventricular assist device (LVAD)

Exclusion Criteria:

* Pregnancy
* Presence of another cardiac assist device in the patient (for example ECLS)
* No consent of the patient

Primary outcomes:
measure: Post-Induction hypotension
timeFrame: First 30 minutes after induction of anesthesia
Secondary outcomes:
measure: Antihypotensive drugs after induction
timeFrame: First 30 minutes after induction of anesthesia
measure: Antihypotensive drugs during the procedure
timeFrame: Begin of the procedure until end of the procedure
measure: Length of stay on the intensive care unit (ICU)
timeFrame: After the procedure and transport to intensive care unit, total time in hours until submission from I. Expected time frame is 48 to 96 hours.CU
measure: Delirium
timeFrame: First 24 hours after the end of the procedure
measure: Kidney
timeFrame: First 28 days after procedure
measure: Mortality
timeFrame: First 28 days after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
name: Adrian E Stephan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05785910: Adaptation of the Uniform Data Set for Telematic Administration
Official title: Harmonization and Updating of Cognitive and Behavioral Assessment Procedures in Neurology: Adaptation of the Uniform Data Set for Telematic Administration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia, Mild
Dementia of Alzheimer Type
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The present project is an evolution of the previous RIN 2019 study aimed at validating and standardizing the Uniform Data Set (UDS) for dementia, a battery of tests exploring various cognitive domains (memory, language, praxis, executive functions) and involving partial tablet-based computerization for data collection.

In the present study, a UDS-based instrument that can be used in remote examiner-assisted telematic administration will be validated. This will be followed by standardization of the same on a sample of healthy subjects.


Eligibility criteria: Inclusion Criteria:

* female and male subject between 50 and 90 years
* no negative score on the Anamnestic Questionnaire
* internist pathology in pharmacological compensation
* signing of informed consent

Exclusion Criteria:

* neurological pathologies
* decompensated metabolic pathology
* use of Benzodiazepine and psychoactive drugs

Primary outcomes:
measure: concordance index
timeFrame: from baseline through study completion, an average of 1 year and a half
Secondary outcomes:
measure: regression lines
timeFrame: from baseline through study completion, an average of 1 year and a half
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria
state: Lazio
Study officials:
affiliation: Memory clinic, Fondazione Policlinico Gemelli, IRCCS, Università Cattolica del Sacro Cuore
name: Camillo Marra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06394310: Dry Needling in Multiple Sclerosis
Official title: The Effectiveness of Dry Needling on Reducing Spasticity and Promoting Mobility and Balance in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Spasticity
Keywords: multiple sclerosis
Dry needling
Spasticity
Mobility
Balance
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. It differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. Dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. The investigators hope to see if dry needling also helps enhance balance and walking abilities. This might provide potential improvements inoverall mobility and balance.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 64 years
* Clinical diagnosis of Multiple Sclerosis based on the McDonald Criteria
* Spasticity in their lower legs
* Patient Determined Disease Steps (PDDS) score of 5 or below

Exclusion Criteria:

* Inability to communicate effectively with study personnel
* Needle phobia
* Severe varicose veins
* Presence of an active implanted device
* Pregnancy
* Any active cancer or history within 1 year
* known or suspected infection at the site of needling or in the surrounding area
* Presence of a fixed plantarflexion contracture at the ankle
* Acute fracture of dislocation in the region (bilateral lower extremity)
* Deep vein thrombosis or peripheral vascular disease
* Thrombophlebitis, or active osteomyelitis in the region (bilateral lower extremity)
* Any medication changes, including antispastic medicines, for the past three months.

Primary outcomes:
measure: Spasticity
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas city
country: United States
facility: Mobility and Falls Lab
state: Kansas
Study officials:
References:
Clinical trial NCT02957110: Laughter Frequency and Fibromyalgia Symptoms
Official title: The Relationships Between Laughter Frequency, Pain Perception, and Affect in Fibromyalgia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Lead sponsor: Walden University
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have been diagnosed with fibromyalgia syndrome.

Brief summary: The purpose of this study is to investigate whether daily laughter frequency is associated with pain intensity and emotional state ratings in individuals who have fibromyalgia syndrome.

Detailed description: Participants will be asked to provide (or authorize the researcher to obtain) fibromyalgia diagnosis confirmation from a health care provider.

Initially, participants will complete a demographics form and two screening assessments. Then for 14 days, they will be asked to rate their momentary mood and overall pain levels three times per day (shortly after waking up, around 3:00 p.m., and at about an hour before bedtime). At the same time, they will be asked to log each instance of laughter as it occurs, daily, for 14 days. They will carry the log with them throughout each day in order to document each instance of laughter.

Eligibility criteria: Inclusion Criteria:

* Individuals who have fibromyalgia syndrome

Exclusion Criteria:

* None.

Primary outcomes:
measure: Laughter Frequency
timeFrame: 14 days
measure: Pain Ratings
timeFrame: Three times per day for 14 days
measure: Emotional State
timeFrame: Three times per day for 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Walden University
state: Minnesota
Study officials:
affiliation: Walden University
name: Ellen Levine, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02131610: Epigenetics Modifications in Obstructive Sleep Apnea
Official title: Epigenetics Modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Snoring
Keywords: Sleep apnea
Obstructive sleep apnea
Subclinical atherosclerosis
Epigenetics
T cells
Lead sponsor: Aragon Institute of Health Sciences
Sponsor class: OTHER
Collaborators: name: Instituto Aragones de Ciencias de la Salud
name: Hospital Miguel Servet
First posted: 2014-05-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that will be study because suspected OSA

Brief summary: Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic dysfunction in OSA are linked with accelerated cardiovascular morbidity.

Detailed description: Design. EPIOSA is a 5-yr non-interventional longitudinal prospective study being conducted at the Sleep Clinic of the Hospital Miguel Servet, a large teaching hospital in Zaragoza (Spain). Following a baseline visit, subjects are to be followed-up at 3 months, and then every year.

Subject participation. The investigators will enroll a total 300 consecutive OSA male patients aged 20-60 yrs, with baseline apnea-hypopnea index ≥ 5 events per hour of sleep (AHI). In addition, 50 control subjects (AHI \< 5) aged 20-60 yrs and matched by body mass index (BMI) are also to be recruited. Exclusion criteria will include any comorbid condition including alcohol and tobacco use.

Measurements: Routine clinical assessment, full sleep study, bilateral carotid ultrasonography, biochemistry, circulating inflammatory cytokines, T cell subsets and epigenetics studies at baseline and every year until at least 5 years of follow-up.

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 60

Exclusion Criteria:

* Any comorbid condition

Primary outcomes:
measure: Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes
timeFrame: 5 years
Secondary outcomes:
measure: biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression.
timeFrame: 5 years
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Miguel Servet
name: Jose M Marin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marin JM, Artal J, Martin T, Carrizo SJ, Andres M, Martin-Burriel I, Bolea R, Sanz A, Varona L, Godino J, Gallego B, Garcia-Erce JA, Villar I, Gil V, Forner M, Cubero JP, Ros L. Epigenetics modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA study. BMC Pulm Med. 2014 Jul 12;14:114. doi: 10.1186/1471-2466-14-114.