louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00781729: Yoga for Kyphosis Trial
Official title: Phase 2 Study of Yoga for Excess Thoracic Curvature.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kyphosis
Keywords: Kyphosis
Yoga
Aging
Physical performance
Quality of Life
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-10-29
Enrollment: 118
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to determine whether a specially designed Hatha Yoga program can reduce hyperkyphosis in men and women who are at least 60 years of age and who have excessive thoracic kyphosis.


Eligibility criteria: Inclusion Criteria:

* age 60 years or greater
* willingness to accept randomization
* adult-onset hyperkyphosis (noticed after age 50)
* measured Debrunner kyphometer angle \>40 degrees

Exclusion Criteria:

active angina; uncontrolled hypertension (SBP greater than 160 or DBP greater than 90); high resting pulse or respiratory rate (HR \>90 or RR\>24 after 5 minutes seated); current unstable asthma or exacerbated chronic obstructive pulmonary disease; cervical spine instability; unstable knee or shoulder joints; hemiparesis or paraparesis; use of assistive walking device or wheelchair; unable to hear or see adequately for participation in Yoga classes; unable to comprehend and follow directions (in English); unable to attend in-person classes; likely to move within the year after screening; has not had check-up by health care provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken) and is not willing to do so prior to enrollment; cannot pass physical safety tests. Physical safety was assessed as the ability to stably execute each of the following movements without human assistance: transition from standing to recumbent on the floor and get up from the floor to standing; lift both arms to shoulder level without losing balance; stand with feet side-by-side for 30 seconds; and stand with feet hip-width apart for 60 seconds.

Primary outcomes:
measure: The primary outcomes were change in the following: Debrunner kyphometer-assessed kyphosis angle, standing height, timed chair stands, functional reach and walking speed.
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Secondary outcomes were change in: kyphosis index, flexicurve kyphosis angle, Rancho Bernardo Blocks, pulmonary function and several domains of health-related quality of life (HRQOL).
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Division of Geriatrics
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Gail A Greendale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04624529: Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke
Official title: Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Cognitive Dysfunction
Keywords: Occupational therapy
Evaluation tool
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with stroke admitted to the acute stroke unit are consecutive recruited.

Brief summary: Cognitive disorders are common early after stroke but can be overseen in patients with mild stroke who seem to be functionally recovered but are at risk to experience difficulties in advanced daily activities affecting social, vocational and family responsibilities. Acute stroke units admit a large number of patients and adequate referral to rehabilitation services is essential in terms of quality of care. A self-evaluation tool to evaluate cognitive function was developed by the occupational therapy department.

Patients with mild strokes and pre-stroke independent for instrumental daily activities fill out this self-evaluation tool, which is a paperwork task. Semi-structured interpretation is performed by physician and may result in referral to the occupational therapist for comprehensive evaluation.

In this study the validity and reliability of the self-evaluation tool will be examined.


Eligibility criteria: Inclusion Criteria:

* diagnose of stroke
* written consent
* age 18 years or older
* less than 1 week after stroke onset

Exclusion Criteria:

* not able to write/read
* not able to understand Dutch
* unilateral motor deficit in upper limb (NIHSS score for upper limb +2)
* referred to stroke unit with Transcient Ischemic Attack

Primary outcomes:
measure: Self-evaluation tool
timeFrame: within one week after stroke onset
measure: Oxford Cognitive Screen
timeFrame: within one week after stroke onset
measure: Montreal Cognitive Assessement
timeFrame: within one week after stroke onset
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ/KU Leuven
name: Robin Lemmens, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390129: Remote Ischemic Preconditioning in Aortic Valve Surgery
Official title: Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-07-08
Enrollment: 100
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: RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of troponin-I.

Detailed description: The hypothesis tested in this research proposal is that remote ischemic preconditioning initiated immediately before aortic valve surgery reduces myocardial damage related to surgery.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Aortic valve surgery for aortic stenosis
* Written informed consent

Exclusion Criteria:

* Aortic valve surgery combined with CABG or an other valve surgery
* Previous Q-wave myocardial infarction or previous coronary artery bypass graft
* Coronary artery stenosis \>70%
* Ejection fraction \<35%
* Surgery performed in emergency
* Nicorandil ou metformin treatment within 8 days before surgery
* Patient refusal / patient not having provided written informed consent.

Primary outcomes:
measure: Infarct size
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital, Angers
Study officials:
affiliation: University Hospital, Angers
name: Fabrice Prunier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chao de la Barca JM, Bakhta O, Kalakech H, Simard G, Tamareille S, Catros V, Callebert J, Gadras C, Tessier L, Reynier P, Prunier F, Mirebeau-Prunier D. Metabolic Signature of Remote Ischemic Preconditioning Involving a Cocktail of Amino Acids and Biogenic Amines. J Am Heart Assoc. 2016 Sep 24;5(9):e003891. doi: 10.1161/JAHA.116.003891.
Clinical trial NCT04012229: IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)
Official title: IMpact of BrcA Status on Survival in Adjuvant Breast Cancer (IMBASSA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Keywords: Breast cancer
BRCA1
BRCA2
Chemotherapy
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 2295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in region Franche-Comté, France, for an early breast cancer, by neoadjuvant and/or adjuvant chemoterapy.

Eight center were included : University hospital of Besançon, Polyclinique de Franche-Comté (Besançon), Clinique Saint-Vincent (Besançon), Hospitals of Vesoul, Lons-le-Saunier, Pontarlier, Dole and Montbéliard.

Brief summary: Relationship between the presence of the BRCA mutation (BReast Cancer) and outcomes is unclear in high-risk early breast cancers (BC).

This study is a multi-center retrospective cohort of patients treated in region Franche-Comté for an early BC by neoadjuvant and/or adjuvant chemotherapy.

The primary aim was to describe clinical and pathological characteristics considering BRCA mutated (BRCAm) patients versus BRCA wild type (BRCAwt) patients or untested patients. The second objective was to assess the prognostic impact of germinal BRCAm in this high-risk population.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old,
* Histologically confirmed invasive early breast cancer
* Neo-adjuvant and/or adjuvant chemotherapy with the first cure of chemotherapy received between January 1st, 2003 and December 31th, 2013

Exclusion Criteria:

* Clinical, radiological or histological confirmed metastatic disease
* Non-invasive breast cancer,
* Patients who received incomplete treatment
* Patients who did not speak French

Primary outcomes:
measure: Age of diagnosis
timeFrame: one day
measure: Pathological tumor size
timeFrame: one day
measure: Pathological nodal involvement
timeFrame: one day
measure: Clinical tumor size
timeFrame: one day
measure: Clinical nodal involvement
timeFrame: one day
measure: Estrogen receptor expression status
timeFrame: one day
measure: Progesterone receptor expression status
timeFrame: one day
measure: HER2 status
timeFrame: one day
measure: Sexe
timeFrame: one day
measure: Scarff Bloom and Richardson grade (SBR)
timeFrame: one day
measure: In situ component
timeFrame: one day
measure: Pathological histotype
timeFrame: one day
measure: Metastatic sites (if available)
timeFrame: one day
measure: Medical treatment
timeFrame: one day
Secondary outcomes:
measure: Overall Survival
timeFrame: one day
measure: Invasive Disease Free Survival
timeFrame: one day
measure: Distant Disease Free Survival
timeFrame: one day
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital Jean Minjoz
state: Franche-Comté
Study officials:
References:
Clinical trial NCT00789529: Objective Testing of Tear Film Stability
Official title: Objective Testing of Tear Film Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Solutions
Keywords: Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film
Lead sponsor: Manhattan Vision Associates
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2008-11-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.


Eligibility criteria: Inclusion Criteria:

1. The subject must be at least 18 years of age and no more than 80 years of age.
2. The subject must have a best corrected visual acuity of 20/30 or better for each eye.
3. The subject must habitually wear contact lenses.
4. The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.
5. The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
6. The subject must read understand and sign the Statement of Informed Consent.
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or disease that might interfere with contact lens wear.
2. Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
3. Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Pregnancy or lactation.
7. Diabetes
8. Infectious diseases (e.g. hepatitis, tuberculosis)
9. Contagious immunosuppressive diseases (e.g. HIV)

Primary outcomes:
measure: Objective, In-vivo Soft Contact Lens Wettability Index
timeFrame: 2 weeks
Secondary outcomes:
measure: Subject Questionnaire Response
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New York City
country: United States
facility: MVA/IVR
state: New York
Study officials:
affiliation: MVA/IVR
name: George Zikos, OS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05957029: Evaluation of Thermal Outcome and Safety of Nuera Tight RF System
Official title: Evaluation of Thermal Outcome and Safety of Nuera Tight RF System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects of either gender, 18 years of age or older
* Subject is able to read, understand and sign an informed consent form
* Subject is willing to comply with all study procedures

Exclusion Criteria:

* Subjects taking medicines that increase skin sensitivity to heat
* Subjects taking medicines that change skin metabolism
* Cancer or any pigmentary or vascular lesions in the planned treatment area
* Subjects with Herpes simplex in the area to be treated
* Pregnant women
* Subjects wearing pacemakers and/or any other type of implanted electronics
* Subjects with any inflammatory skin conditions
* Subjects with active cold sores, open lacerations, abrasions
* Chronic or acute skin infections
* Subjects with active local or systemic infections
* Subjects with any disease in which an increase of skin temperature is contraindicated
* Subjects wearing piercing in the area to be treated
* Subjects have nerve insensitivity to heat in the area to be treated
* Subjects have metal implants in the area to be treated, excluding dental implants
* Subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile
* Any condition where the study investigator determined that the subject is not adequate for this study
* Subjects participating in other studies

Primary outcomes:
measure: tissue heating
timeFrame: 12 minutes
measure: temperature stability
timeFrame: 12 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Cosmedic Dermatology
state: Michigan
city: New York
country: United States
facility: Lewis Dermatology & Associates
state: New York
Study officials:
affiliation: Lewis Dermatology & Associates
name: Amy Lewis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cosmedic Dermatology
name: Shauna Diggs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06373029: Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury
Official title: Deep Learning-enabled Ultrasound Classification of Anterior Talofibular Ligament Injury in China: A Prospective, Multicentre, Diagnostic Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ultrasound
Anterior Talofibular Ligament
Deep Learning
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As mentioned above

Brief summary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. The investigators have already developed a deep convolutional network (DCNN) model that automates detailed classification of ATFL injuries. The investigators hope to use the DCNN in real-world clinical setting to test its diagnostic accuracy.


Eligibility criteria: Inclusion Criteria:

* age\> 18 years old
* patients who underwent an acute ankle sprain
* patients with a surgery results of the sprained ankle

Exclusion Criteria:

* age\< 18 years old
* patients with a previous history of ankle surgery
* patients with ankle tumors
* patients with a previous history of rheumatoid arthritis

Primary outcomes:
measure: classification of ATFL injury
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jiaan Zhu, Dr
role: STUDY_CHAIR
References:
citation: Gribble PA, Bleakley CM, Caulfield BM, Docherty CL, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Verhagen EA, Vicenzino BT, Wikstrom EA, Delahunt E. Evidence review for the 2016 International Ankle Consortium consensus statement on the prevalence, impact and long-term consequences of lateral ankle sprains. Br J Sports Med. 2016 Dec;50(24):1496-1505. doi: 10.1136/bjsports-2016-096189. Epub 2016 Jun 3.
citation: Kramer Z, Woo Lee Y, Sherrick R. Acute Ankle Sprains. Clin Podiatr Med Surg. 2023 Jan;40(1):117-138. doi: 10.1016/j.cpm.2022.07.008.
Clinical trial NCT03403829: Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage
Official title: A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to now, IMRT has largely improved the local control of locally advanced nasopharyngeal carcinoma (NPC), leaves the distant metastasis as the main treatment failure modality of patients with bulky lymph nodes (especially N3 stage). Although concurrent chemoradiotherapy (CCRT) continues to stand as the standard treatment of these patients, the role of adjuvant chemotherapy remains controversial due to its relatively severe toxicities and inferior compliance. However, our retrospective study of 2D-RT and IMRT era had proved adjuvant chemotherapy played key role in N3 NPC patients in terms of reducing distant metastasis and improving overall survival. Maintenance chemotherapy of gemicitabine single drug is promising with adequate efficacy and moderate toxicities. So we aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

Detailed description: We aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

Eligibility criteria: Inclusion Criteria:

* AJCC/UICC 8th edition N3 nasopharyngeal carcinoma
* Pathology: WHO II/II
* No prior anti-tumor treatment
* Age 18-60
* KPS≥70
* Adequate blood supply
* Informed consent obtained

Exclusion Criteria:

* Pathology: WHO I
* Pregnant
* Combined with other malignant tumor

Primary outcomes:
measure: Distant metastatic free survival
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan Universtiy Shanghai Cancer Centre
state: Shanghai
Study officials:
affiliation: Fudan University Shanghai cancer centre
name: Chaosu Hu, M.D
role: PRINCIPAL_INVESTIGATOR
References: