louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04087902: Long-Term Longitudinal QoL in Patients Undergoing EEA
Official title: A Prospective Longitudinal Quality of Life Study in Patients Undergoing Endoscopic Endonasal Skull Base Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pituitary Tumor
Meningioma
Rathke Cleft Cysts
Chordoma
Chondrosarcoma
Craniopharyngioma
Encephalocele
Esthesioneuroblastoma
Keywords: Endoscopic Endonasal Approach Surgery
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are 18 years of age or older and undergoing surgery via Endoscopic Endonasal Approach.

Brief summary: This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.

Detailed description: This is a prospective single-institution longitudinal study to access quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base. Patients will be followed before surgery and up to twenty-four months post-surgery. The primary goal of the study is to assess the alterations to patient quality of life following endoscopic endonasal surgery using modern sinonasal reconstruction techniques. Secondary goals are to better understand the time course of normal healing and patient/procedural risk factors associated with poorer quality of life outcomes.

Eligibility criteria: Inclusion Criteria:

* Patient is scheduled to undergo endoscopic endonasal surgery. Multiple, staged surgeries are not exclusionary
* 18 years of age or older
* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent

Exclusion Criteria:

* Patient is a prisoner
* Patient is not English speaking
* Patient is not expected to survive until the 2-year follow-up

Primary outcomes:
measure: PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.
timeFrame: 24-months post-operatively
Secondary outcomes:
measure: ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery
timeFrame: 24 months post-operatively
measure: Number of patients with long-term quality of life risk factors using PROMIS-29
timeFrame: 24 months post-operatively
measure: Number of patients with long-term procedural comorbidities using ASK-Nasal 12.
timeFrame: 24 months post-operatively
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kyle Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871802: Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia
Official title: A Prospective, Randomized, Comparative Study in Two Groups to Assess the Effect of the Use of a Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID Pneumonia and on the Biological Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective of the study is to evaluate the effect of Taxifolin Aqua therapy on the indicators of respiratory function, the state of the arterial wall, the contractile function of the myocardium, as well as to assess the effect of Taxifolin Aqua therapy on markers of biological age, quality of patients life.

Detailed description: The study will include 100 patients who had covid pneumonia 3 months ago. If the inclusion / exclusion criteria are met, the patient is asked to sign an informed consent to participate in the study. Consenting patients are randomized to an intervention group or a control group. The control group (n = 50) will receive standard therapy, patients from the intervention group (n = 50) will be prescribed Taxifolin Aqua 30 mg per day in addition to standard therapy. Patients will be randomized to the control and main group using random number spreadsheets, assuming that the control and main groups will be homogeneous in the main demographic and clinical parameters. Patient monitoring will be carried out within 2 months from the date of inclusion. A follow-up visit is scheduled in 2 months. During the study, the patient will be regularly monitored for tolerance and safety of therapy with Taxifolin Aqua.

Eligibility criteria: Inclusion Criteria:

Patients of both sexes who had covid pneumonia 3 months ago and signed an informed consent and aged 18+.

Exclusion Criteria:

Standard contraindications to Taxifolin Aqua use.

Primary outcomes:
measure: Dynamics of spirometry indices
timeFrame: In 2 months after recruitment
measure: Dynamics of ECHO CG
timeFrame: In 2 months after recruitment
measure: Dynamics of pulse wave velocity
timeFrame: In 2 months after recruitment
measure: Dynamics of augmentation index
timeFrame: In 2 months after recruitment
Secondary outcomes:
measure: Dynamics of biological age
timeFrame: In 2 months after recruitment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Clinical Research Center for Gerontology
Study officials:
affiliation: Clinical Reserach Center for Gerontology
name: Irina Strazhesko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01217502: Self-management for Dual Sensory Impaired
Official title: Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Low Vision
Keywords: Aged
Homes for the aged
Self management
Personal autonomy
Disease management
Self efficacy
Participation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 89
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine the effectiveness of a self-management program for elderly with an acquired and concurrent hearing and visual impairment due to age-related disease processes.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of hearing loss and low vision
* at least one sensory loss acquired after the age of 55
* living in a home for the elderly

Exclusion Criteria:

* congenital deaf persons
* a dual sensory loss before the age of 55

Primary outcomes:
measure: Participation in social, leisure and communicative activities.
timeFrame: 6 months
Secondary outcomes:
measure: work satisfaction professional caregivers
timeFrame: 6 months
measure: Depressive feelings
timeFrame: 6 months
measure: Autonomy.
timeFrame: 6 months
Other outcomes:
Locations:
city: Geertruidenberg
country: Netherlands
facility: Foundation Riethorst Stromenland
state: Gelderland
city: Herkenbosch
country: Netherlands
facility: Foundation Zorggroep Noord-Limburg
state: Limburg
city: Kaatsheuvel
country: Netherlands
facility: Maasduinen Foundation
state: Noord-Brabant
city: Haarlem
country: Netherlands
facility: Zorgbalans Foundation
state: Noord-Holland
Study officials:
affiliation: Radboud University Nijmegen Medical Centre, The Netherlands
name: M. Vernooij-Dassen, Prof. dr.
role: STUDY_CHAIR
References:
citation: Roets-Merken LM, Zuidema SU, Vernooij-Dassen MJFJ, Teerenstra S, Hermsen PGJM, Kempen GIJM, Graff MJL. Effectiveness of a nurse-supported self-management programme for dual sensory impaired older adults in long-term care: a cluster randomised controlled trial. BMJ Open. 2018 Jan 24;8(1):e016674. doi: 10.1136/bmjopen-2017-016674.
citation: Roets-Merken LM, Vernooij-Dassen MJ, Zuidema SU, Dees MK, Hermsen PG, Kempen GI, Graff MJ. Evaluation of nurses' changing perceptions when trained to implement a self-management programme for dual sensory impaired older adults in long-term care: a qualitative study. BMJ Open. 2016 Nov 17;6(11):e013122. doi: 10.1136/bmjopen-2016-013122.
citation: Roets-Merken LM, Graff MJ, Zuidema SU, Hermsen PG, Teerenstra S, Kempen GI, Vernooij-Dassen MJ. Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial. Trials. 2013 Oct 7;14:321. doi: 10.1186/1745-6215-14-321.
Clinical trial NCT00627302: Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Keywords: Quality of Vision
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
First posted: 2008-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.


Eligibility criteria: Inclusion Criteria:

* Males or females \> 21 years old
* Scheduled to undergo bilateral LASIK
* Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

* Prior or current use of topical cyclosporine within the last 1 year
* Known contraindications to any study medication or ingredients
* Ocular disorders
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies
* Complications at the time of surgery

Primary outcomes:
measure: Quality of vision
timeFrame: 5 months
Secondary outcomes:
measure: Efficacy
timeFrame: 5 months
Other outcomes:
Locations:
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of long Island
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: Eric Donnenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06723002: Effect of Olive Leaf Extracts on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
Official title: Effect of Olive Leaf Extracts on Endothelial Dysfunction and Short-term Outcome in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Coronary Syndrome (ACS)
Reactive Hyperemia
Endothelial Dysfunction
Keywords: acute conary syndrome
endothelial dysfunction
olive leaf extract
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three groups:

Intervention Group 1:Patients in this group will receive the study drug (olive leaf extract) at a dose of 500 mg (two capsules) twice daily, for a total of 1000 mg per day, for one month.

Intervention Group 2:Patients in this group will receive the study drug (olive leaf extract) at a dose of 250 mg (one capsule) twice daily, for a total of 500 mg per day, for one month.

Control Group:Patients in this group will receive a placebo, with one capsule prescribed twice daily, for one month.
Primary purpose: TREATMENT

Brief summary: the study aims to examine the short-term (30 days) effects of olive leaf extract on endothelial function in patients with acute coronary syndrome (ACS).

This investigation will be conducted on patients admitted to the emergency department for ACS. All participants will be screened and included within 24 hours post-ACS event and prior to discharge from the emergency department.


Eligibility criteria: Inclusion Criteria:

Age over 18 years. Patients presenting with ST-segment alterations at rest, including ST elevation, with or without troponin elevation.

Patients who have not undergone surgery or have no additional primary percutaneous coronary intervention (P-PCI) planned within 8 weeks from the initial P-PCI.

Patients who provide informed consent. Patients available for and willing to adhere to follow-up procedures. Patients without significant cognitive impairment. Patients with a life expectancy of at least 2 years.

Exclusion Criteria:

* Severe LV hypertrophy (\>15 mm);
* Patients with any evidence of inflammatory or malignant disease.
* Patient having valvular heart disease, pacemaker; cardiogenic shock
* Patient having any serious non-cardiac disease associated with a life expectancy \<1 year
* Patients undergoing surgery within 30 days
* Patient having gastrointestinal disorder such as Crohn's disease

Primary outcomes:
measure: Reactive Hyperemia Index (RHI)
timeFrame: 30-day
Secondary outcomes:
measure: MACE rate
timeFrame: 30-day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02897102: Effects of a Training Program Based on Abacus and Other Activities in Healthy Older Adults
Official title: Effects of a Training Program Based on Abacus and Other Activities in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to investigate the effects of a structured program, which was based on abacus training associated with other activities, administered as weekly group classes over a 7 month period in older adults.

Detailed description: Cognitive stimulating activities are often recommended for older adults; however, little is known regarding the effects of these activities on cognition, motivation and quality of life in this population. The aim of this study was to investigate the effects of a structured program, which was based on abacus training associated with other activities, administered as weekly group classes over a 7 month period in older adults. Eighty-eight older adults were enrolled in an open-label controlled clinical trial to evaluate the effects of this training program on cognition, motivation and quality of life. Training had a significant effect over time; the training group maintained their level of performance on verbal learning and memory tasks, whereas the control group exhibited a significant decrease in performance from baseline to post-intervention. The subjects in the training group were more motivated to learn at study entry; however, the training had no significant effect on motivation or quality of life. Abacus training associated with other activities may benefit verbal learning and memory in older adults. Additional studies with longer follow-ups are necessary to determine whether the results of this training will have a positive effect on the lives of older adults.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* Score ≥ 26 on the Mini-Mental State Examination
* Portuguese as a native language.

Exclusion Criteria:

* A neurological or serious medical condition that would prevent participation in the study.

Primary outcomes:
measure: Reasoning score change
timeFrame: After 7 month
measure: Attention score change
timeFrame: After 7 month
measure: Speed of processing score change
timeFrame: After 7 month
measure: Working memory score change
timeFrame: After 7 month
measure: Verbal learning and memory score change
timeFrame: After 7 month
measure: Visual learning and memory score change
timeFrame: After 7 month
measure: Executive function score change
timeFrame: After 7 month
Secondary outcomes:
measure: Motivation
timeFrame: After 7 months
measure: Quality of life
timeFrame: After 7 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01833702: Use of a Mobile-based App for SCD Patients
Official title: Use of a Mobile-based Pain Assessment Application for SCD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Chronic Pain
Keywords: Sickle cell
Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing pain or patients with sickle cell disease

Brief summary: The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily.

The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily.

The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement.

This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system.

Detailed description: The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily. The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement. This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system. The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily. Patients enrolled in this study will be ask to use a mobile device such as a smartphone or a tablet with Android or iOS operating system to record daily pain level and related information once daily or more frequently for a period of forty-two days. A 1:1 randomization assignment will be made to have patients receive automated "canned" provider feedback or not.

Eligibility criteria: Inclusion Criteria:

* SCD, thalassemia, or history of experiencing pain

Exclusion Criteria:

* none

Primary outcomes:
measure: Usability
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jude Jonassaint, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Laura De Castro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Nirmish Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06736002: Effects of Mega-dose Vitamin D Pulse and Maintenance Therapy on Seizure Frequency, Fatigue, and Quality of Life: a Prospective Study
Official title: Effects of Mega-dose Vitamin D Pulse and Maintenance Therapy on Seizure Frequency, Fatigue, and Quality of Life: a Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Mega-Vitamin D
Epilepsy
Fatigue
Quality of life
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT study with Mega-Vitamin D compare placebo Experimental group: Mega-Vitamin D 100.8 million IU for three months Control group: placebo for three months
Primary purpose: TREATMENT

Brief summary: We inform consent overall process of this trial study through face-to-face use of the IRB, clarify patient questions, and allow subjects to fully understand the trial study.


Eligibility criteria: Inclusion Criteria:

* Aged 20 or above (inclusive)
* Diagnosed patients (refractory epilepsy refers to those who have used more than two drugs, and each drug has reached the When epileptic seizures cannot be well controlled at standard reasonable treatment doses, it is called refractory epilepsy)
* There is no imaging evidence of persistence or expansion of brain damage in the past three years
* Subjects or family members (caregivers) can comply with the trial plan and take vitamin D patients

Exclusion Criteria:

-

Primary outcomes:
measure: seizure frequency
timeFrame: three time points: before starting the medication, one month after starting the medication, and three months after starting the medication.
Secondary outcomes:
measure: Quality of life
timeFrame: before starting the medication and again three months after treatment
measure: fatigue
timeFrame: before starting the medication and three months after starting it.
measure: Serum tests
timeFrame: three time points: before starting the medication, one month after starting it, and three months after starting it.
Other outcomes:
Locations:
Study officials:
References: