louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05836792: The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis
Official title: The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Sensation Disorders
Keywords: Knee Osteoarthritis
Deep Sensation
Cycle Ergometer
Biofeedback
Lead sponsor: Yeditepe University
Sponsor class: OTHER
Collaborators: name: Sante Medical Center
First posted: 2023-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the randomized controlled study is to investigate the effects of the cycle ergometer with biofeedback on deep sensation in elderly people who has knee osteoarthritis

Detailed description: Participants will be randomly divided and registered into 2 groups: Thera-train tigo group (TG) or control group(CP)

For 20 participants 20 minute tens, 5 minute ultrasound, 10 times with 2 sets quadriceps isometric exercise will be applied. The other 20 participants will use Thera-train tigo for 20 minute in addition to tens, us, quadriceps isometric exercise.

Conditions of the participants will be measured before(1st day) and after(15th day) a span of 3 week treatment. We will use Demographic Information Questionnaire, Western Ontario and McMaster Universities (WOMAC) osteoarthritis index, Physical Activity Scale for the Eldery (PASE) and 6 minute walking test for all patients. Then we will measure knee vibration sense with diapason. Knee joint position sense will be measured with a digital goniometer.

Eligibility criteria: Inclusion Criteria:

Knee osteoarthritis (Kellgren-Lawrance score between 1-3)

Exclusion Criteria:

* Previous knee surgery
* Diabetus Mellitus
* Thyroid disease
* Visual deficit
* Gait disorder
* Mental Disability
* Presence of neuropathy

Primary outcomes:
measure: Diapason survey
timeFrame: 3 weeks
measure: Digital Goniometer
timeFrame: 3 weeks
measure: 6 Minute Walking Test (6MWT)
timeFrame: 3 weeks
Secondary outcomes:
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 3 weeks
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sante Medical Center
state: Kadıköy
Study officials:
References:
Clinical trial NCT06748092: Clinical Validation of iCare IC1000 Tonometer
Official title: Clinical Validation of iCare IC1000 Tonometer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: Icare Finland Oy
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Subjects with only one functional eye
* Subjects having poor or eccentric fixation in the study eye
* High corneal astigmatism \>3D in the study eye
* Central corneal scarring
* History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
* Microphthalmos
* Buphthalmos
* Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
* Dry eyes (clinically significant)
* Lid squeezers - blepharospasm
* Nystagmus
* Keratoconus
* Any other corneal or conjunctival pathology or infection relevant to this study
* Central corneal thickness greater than 600 µm or less than 500 µm in the study eye
* Cataract Extraction within last 2 months in the study eye

Primary outcomes:
measure: Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Retrospective analysis of "Quick Measure" mode
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health/Dalhousie University
state: Nova Scotia
Study officials:
References:
Clinical trial NCT04483492: Direct Effect of Caffeine on Diaphragmatic Muscles
Official title: Direct Effect of Caffeine on Diaphragmatic Muscles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Caffeine
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newborns under 32 weeks with respiratory support on their first week

Brief summary: The mechanism of methylxanthines is thought to increase chemoreceptor responsiveness to CO2 in central nervous system. Besides, effect of methylxanthines on diaphragmatic contractility has also been found in experimental studies. A study of premature newborns has showed caffeine increase diaphragmatic activity and tidal volume. But, there is limited data about caffeine direct effect on diaphragma.

Objective: The investigators aimed to show the direct effect of caffeine on diphragmatic contractility.

Method: The babies under 32 weeks with respiratory support, are being enrolled in this study if caffeine treatment is decided to receive. Evaluation of muscle contraction is being made by ultrasound before and 30 minutes after caffeine loading dose. Right and left sides of diaphragm thickness are being measured by two clinicians on B mode ultrasound by anterior subcostal view. The velocity before and after caffeine administration will be calculated, dividing excursion frequency (parameter) for inspiratory time. Movement of the diaphragm at inspiratory and expiratory phases are also observed on M mode and the difference between the two phases are measured.


Eligibility criteria: Inclusion Criteria:

* newborns under 32 weeks with respiratory support
* caffeine is decided to give

Exclusion Criteria:

* babies with congenital malformations

Primary outcomes:
measure: diphragmatic contractility
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
citation: Kraaijenga JV, Hutten GJ, de Jongh FH, van Kaam AH. The Effect of Caffeine on Diaphragmatic Activity and Tidal Volume in Preterm Infants. J Pediatr. 2015 Jul;167(1):70-5. doi: 10.1016/j.jpeds.2015.04.040. Epub 2015 May 15.
Clinical trial NCT05180292: Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.
Official title: Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute on Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. These patients will be assessed for the liver transplant free survival at 28 days and complications \[PHT related bleed, AKI, infections, HE\] within 90 days; transplant-free survival rate at 90 days; evolution of the AARC score for 2 wk.


Eligibility criteria: Inclusion Criteria:

1. Patients of ACLF (APASL criteria) - jaundice (serum bilirubin ≥ 5 mg/dL and coagulopathy (INR ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis,
2. Age 18-70 yrs
3. Baseline HVPG ≥ 12 mmHg.

Exclusion Criteria:

1. Contraindications to NSBB (heart rate \< 65 /min, BP \< 110/65 mm Hg, asthma, heart failure),
2. Portal Vein Thrombosis,
3. Hepatocellular carcinoma,
4. HVOTO,
5. HE grades 2-4,
6. NSBB therapy within 5 days,
7. Pregnancy,
8. Lactation,
9. Planned for LT in the next 12 weeks
10. No consent.

Primary outcomes:
measure: Liver transplant free survival
timeFrame: Day 28
Secondary outcomes:
measure: Complications [PHT related bleed, AKI, infections, HE] within 90 days
timeFrame: 90 days
measure: Liver transplant-free survival rate
timeFrame: 90 days
measure: Correlation with evolution of AARC score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT05253092: The Effects of Mindfulness Meditation on Sleep Quality and Perceived Stress
Official title: The Effect of Mindfulness Meditation on Sleep Quality and Perceived Stress of Students in Higher Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep, perceived stress, higher education, mindfulness meditation
Lead sponsor: University of the Sciences in Philadelphia
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Higher education students 18 years or older will participate in 8- virtual mindfulness meditation sessions over 3 to 4 weeks (minimum of 3 sessions per week). Each session will be 30 minutes long, 15 minutes for guided mindfulness meditation run by researchers, followed by a short discussion period to understand mindfulness meditation better. Before starting the mindfulness meditation session, baseline data will be collected.

Detailed description: Sleep consider a restorative occupation that affects other daily activities, such as academic performance. Mindfulness meditation may improve sleep quality and decrease perceived stress in higher education students. There is limited research on virtual mindfulness meditation involving sleep quality and perceived stress in higher education students. The researchers will measure changes in sleep quality and perceived stress after participants completed 8- virtual mindfulness meditation sessions using PSQI, PSS, and the Fitbit Inspire 2™.

Eligibility criteria: Inclusion Criteria:

* Must be a student at the University of the Sciences
* 18 years or older and fluent in English
* Students must have access to a device with internet connection and Zoom capabilities
* Students must have a smartphone to download the Fitbit®: Health \& Wellness application.

Exclusion Criteria:

* Students who do not attend the University of the Sciences
* Students do not have access to an internet connection and an electronic device
* Students do not comprehend and speak English
* Students under the age of 18 years old

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 10 minutes
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: 10 minutes
Other outcomes:
measure: Fitbit Inspire 2
timeFrame: up to 5 weeks or until study completion
Locations:
city: Philadelphia
country: United States
facility: University of the Sciences
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03754192: Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma
Official title: Prediction Value of Perfusion and Dual Energy Computer Tomography for Microvascular Invasion in Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Perfusion computer tomography
dual-energy computer tomography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dual-energy computed tomography and perfusion computed tomography
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of Hepatocellular carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the pathological data of the surgical specimens.

Detailed description: Dual-energy computer tomography and perfusion computer tomography (General Electric revolution Hight definition Gemstone™ Spectral Imaging) will be performed in all patients. Iodine concentration and quantitative perfusion parameters of the Hepatocellular carcinoma and surrounding liver parenchyma data will be compared with the pathological results.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Hepatocellular carcinoma made according to the guidelines of the American Association for the study of the Liver
* Affiliation to a national health insurance
* An indication for hepatic resection during the decision-making stage
* A request for a pre-operative Computer Tomography in our radiology unit
* An affiliation to a social security
* Informed consent given by the patient

Exclusion Criteria:

* Previous treatments of Hepatocellular carcinoma (medicated or surgical)
* Patient under tutorship or curatorship
* Pregnant or lactating woman

Primary outcomes:
measure: Pefusion parameters
timeFrame: 5 minutes
Secondary outcomes:
measure: Pathological examination
timeFrame: 1 month
Other outcomes:
Locations:
city: Villejuif
country: France
facility: CHU Paul Brousse
Study officials:
affiliation: APHP
name: LEWIN MAITE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewin M, Laurent-Bellue A, Desterke C, Radu A, Feghali JA, Farah J, Agostini H, Nault JC, Vibert E, Guettier C. Evaluation of perfusion CT and dual-energy CT for predicting microvascular invasion of hepatocellular carcinoma. Abdom Radiol (NY). 2022 Jun;47(6):2115-2127. doi: 10.1007/s00261-022-03511-7. Epub 2022 Apr 13.
Clinical trial NCT06524492: Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
Official title: Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Lead sponsor: Rhaeos, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 52
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: Pediatric and adult patients with an existing ventricular shunt will be enrolled in this study.

Brief summary: This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.


Eligibility criteria: Inclusion criteria

1. A ventricular CSF shunt with a region of overlying intact skin appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
4. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion criteria

1. Presence of an interfering open wound or edema in the study device measurement area
2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
4. Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
5. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Primary outcomes:
measure: Study Device Sensitivity
timeFrame: Approximately 1 hour
measure: Study Device Specificity
timeFrame: Approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa Marriott Water Street
state: Florida
city: Chicago
country: United States
facility: Rhaeos, Inc.
state: Illinois
city: Rolling Meadows
country: United States
facility: Northwest Special Recreation Association
state: Illinois
Study officials:
References:
Clinical trial NCT05089292: Increasing Breast Cancer Screening in Chinese Immigrants
Official title: Increasing Breast Cancer Screening in Chinese Immigrants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screening Mammogram
Keywords: Breast cancer screening
Health education
Chinese immigrant
Health disparities
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-22
Enrollment: 99
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre/Post-test design
Primary purpose: SCREENING

Brief summary: The long-term goal of this research is to increase breast cancer screening rates in NYC Chinese immigrants. The researchers plan to accomplish this objective by developing and testing a culturally- and linguistically-adapted Witness Project program for Chinese immigrants. To inform the intervention development, the study team will identify barriers and facilitators to breast cancer screening in Chinese immigrants through individual qualitative interviews.

A total of 156 participants will be recruited during the entire study.

In Aim 1 which started in July 2021, 60 women were recruited for in-depth interviews to assess their breast cancer knowledge, perceived barriers and benefits/risks to completing mammography, perceived susceptibility to breast cancer, fatalism, screening intention, acculturation, language preference, and health literacy.

In Aim 2, 96 women will be recruited to participate in the pilot testing of the intervention. Recruitment will take place at community sites that serve Chinese immigrants in New York City. Enrollment for Aim 2 is anticipated to start in March of 2022.


Eligibility criteria: Inclusion Criteria:

* ≥ 40 years of age
* female
* born in China
* read and speak Cantonese, Mandarin, or English

Exclusion Criteria:

- none

Primary outcomes:
measure: Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire
timeFrame: immediately post presentation (presentation approximately 1 hour)
measure: Number of Participants Who Were Engaged in Program
timeFrame: Baseline
measure: Percentage of Community Organizations Willing to Host Program
timeFrame: 7 months
Secondary outcomes:
measure: Change in Breast Cancer Knowledge
timeFrame: baseline and 6 months post intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Lina Jandorf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00043992: Outdoor Allergen Exposure, Sensitivity, and Acute Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Allergens
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-08-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To examine the role of outdoor pollen grains and fungal spores in the exacerbation of asthma and to produce forecasting models to predict days of high concentration.

Detailed description: Asthma is a growing problem, and outdoor allergens play a role in exacerbation of many cases. A clearer understanding of this role and its magnitude, and a means of controlling the effects of outdoor allergen exposures is needed. We propose Poisson time-series and conditional panel studies to test these hypotheses: 1) The incidence of acute asthma attacks, as measured by urgent care inhalation treatments and hospitalizations for asthma, has a dose-dependent relationship with exposure to specific outdoor allergens; 2) Specific sensitization to outdoor allergens is a risk factor for having an acute attack; and 3) Exposure conditions that lead to acute asthma attacks can be forecast, creating an opportunity to reduce asthma morbidity and mortality ny targeting pretreatment and/or exposure controls.

Eligibility criteria: Must be a member of the Fallon HMO and be treated for acute asthma exacerbation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Fallon Clinic and Fallon Community Health Plan
state: Massachusetts
Study officials:
References:
Clinical trial NCT01921192: Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated with extracellular matrix changes. Many studies demonstrated that high levels of this aminoacid in diabetic patients increases significantly the risk of the development of this pathology. This study has been undertaken to investigate the role of homocysteine and its cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic retinopathy.


Eligibility criteria: Inclusion Criteria:

* diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

* Patients with chronic liver disease Patients with kidney disease.

Primary outcomes:
measure: homocysteine
timeFrame: 12 months
Secondary outcomes:
measure: folic acid
timeFrame: 12 months
Other outcomes:
measure: vitamin B6
timeFrame: 12 months
measure: vitamin B12
timeFrame: 12 months
Locations:
city: Catania
country: Italy
facility: University of Catania, Cannizzaro Hospital
Study officials:
References: