louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04159714: Bandage Contact Lens Application for the Management of Corneal Abrasion
Official title: Bandage Contact Lens Application for the Management of Corneal Abrasion in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Corneal Abrasion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 1
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: The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Superficial Corneal Abrasion

Exclusion Criteria:

* Incarceration
* Pregnancy
* Inability to Provide Informed Consent
* Infectious keratitis
* Retained foreign bodies in the eye
* Active infection involving the orbit or periorbital region
* Patients who are not able to or who are deemed unlikely to follow-up with ophthalmology
* A history or recent contact lens wear
* A lack of trauma or an unclear history of trauma as the inciting cause of the abrasion
* Allergy to the antimicrobial solution (POLYTRIM)
* Women who are currently breastfeeding
* Chronic eye drop use
* A history of eye surgery other than cataract surgery (greater than 6 months prior to abrasion)
* Diabetes (Patients with even mild diabetic neuropathy can have decreased pain sensation and also delayed corneal epithelial healing)
* Any eye condition that may be deemed to interfere with the conduct of the protocol or outcome measurement.

Primary outcomes:
measure: Change in Pain Score
timeFrame: Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert Hyde
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05407714: SpaceOAR System RWS in China
Official title: A Real Word Study to Evaluate the Safety and Performance of SpaceOAR System When Used to Create Space Between the Rectum and Prostate in Men Undergoing Radiotherapy for Localized T1-T2 Prostate Cancer in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Localized T1-T2 Prostate Cancer
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting the real word data of SpaceOAR System used, to generate local clinical evidence on Chinese patients.

Detailed description: This study is a retrospective and prospective, single arm, real world study. For those patients who have already received the SpaceOAR treatment before study kick-off, the data at baseline and the day of procedure will be retrospectively collected. For those patients who will receive SpaceOAR treatment after study kick-off, the clinical data at baseline, the day of procedure and 30 days post procedure will be prospectively collected.

Up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.

Eligibility criteria: Inclusion Criteria:

* Subjects has provided the written informed consent, willing to participate in clinical data collection and willing to receive visit at 30 days post procedure. (for subjects enrolled prospectively)
* Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated or will be treated with Space OAR Hydrogel in hospital in Hainan Boao Lecheng medical pilot zone.

Exclusion Criteria- no specific exclusion criteria unless the patients refuse to sign the informed consent.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: Within 10 days post spaceOAR hydrogel administration.
measure: Primary Safety Endpoint
timeFrame: Within 30 days following procedure
Secondary outcomes:
measure: Functional Success
timeFrame: Within 10 days post spaceOAR hydrogel administration.
Other outcomes:
Locations:
city: Qionghai
country: China
facility: Boao First Life Care Center-Hospital
state: Hainan
Study officials:
affiliation: Boao Yiling Life Care Center
name: Sujun Han
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976014: Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study
Official title: Effects of Long-term Therapy With LDL-lowering Plus HDL Raising on Carotid Intima-media Thickness (CIMT) - Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 76
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects known to have Atheroscloerosis.

Brief summary: This observational study looks at Carotid Stenosis in two groups of subjects using a non-invasive procedure, B-mode ultrasound.

One group of subjects has had long-term intensive lipid altering therapy (lowering LDL-C plus raising HDL-C). The second group of patients has been on conventional "standard of care" treatment for carotid stenosis.

The study will look at the Carotid Intima-media Thickness (CMIT) in both groups.

Hypothesis: CIMT will differ between the two groups, such that the CIMT will be less in the subjects on intensive lipid altering therapy.


Eligibility criteria: Inclusion Criteria:

* Intensive Lipid-lowering Therapy Group: Subjects currently enrolled in the Familial Atherosclerosis Treatment Observational Study.
* Usual Care Group: Subjects who were in the FATS OS Study in the past, but have since quit the study and opted for conventional "standard of treatment".

Exclusion Criteria:

* No past or present participation in the FATS OS Study.

Primary outcomes:
measure: Carotid Intima-media Thickness
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Xue-Qiao Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phan BA, Moore AB, Davis J, Pollan LJ, Neradilek B, Brown BG, Zhao XQ. Prolonged combination lipid therapy is associated with reduced carotid intima-media thickness: a case-control study of the 20-year Familial Atherosclerosis Treatment - Observational Study (FATS-OS). J Clin Lipidol. 2014 Sep-Oct;8(5):489-93. doi: 10.1016/j.jacl.2014.07.004. Epub 2014 Jul 12.
Clinical trial NCT06806514: The Relationship Between Upper Extremity Exercise Capacity, Respiratory and Peripheral Muscle Strength in Chronic Low Back Pain
Official title: The Relationship Between Upper Extremity Exercise Capacity, Respiratory and Peripheral Muscle Strength and Level of Disability in Individuals With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low Back Pain
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with chronic low back pain who are being followed up at the Department of Physical Medicine and Rehabilitation at Kirsehir Ahi Evran University will be included in the study.

Brief summary: The aim of the study was to evaluate the upper extremity exercise capacity of individuals with chronic low back pain and to investigate its relationship with respiratory muscle strength, peripheral muscle strength, chest expansion, pain, disability level, fear of movement and quality of life.


Eligibility criteria: Inclusion Criteria:

* Voluntary participation in the study
* Being aged 18-65
* Chronic low back pain for at least the last 3 months
* Pain intensity according to Visual Analogue Scale (VAS) ≥3

Exclusion Criteria:

* History of cancer
* Presence of spinal infection
* Presence of rheumatological disorders
* Presence of spinal fracture
* Red flag signs
* Having a psychological disorder
* Presence of spinal surgery
* Having radiculopathy
* Presence of anatomical and congenital abnormalities

Primary outcomes:
measure: Upper extremity exercise capacity
timeFrame: 1st day
measure: Respiratory muscle strength
timeFrame: 1st day
measure: Peripheral muscle strength
timeFrame: 1st day
measure: Chest expansion
timeFrame: 1st day
measure: Disability level
timeFrame: 1st day
Secondary outcomes:
measure: Kinesiophobia
timeFrame: 1st day
measure: Quality of life
timeFrame: 1st day
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
References:
Clinical trial NCT03192514: Electronic Deprescribing Tool for the Prevention of PIP
Official title: Electronic Deprescribing Tool for the Prevention of Potentially Inappropriate Prescribing for Older Patients: A Protocol for a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prevention
Benzodiazepine Dependence
Keywords: Polypharmacy
Benzodiazepine use
Lead sponsor: University of Beira Interior
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a cluster randomized control trial aimed to measure the effectiveness of an educational knowledge transfer intervention to prescribers on the discontinuation of two targeted classes: Benzodiazepines andNon-benzodiazepine hypnotics.

Detailed description: The investigators intend to develop an electronic decision support tool based on the best evidence available. This electronic deprescribing tool provides the rationale on the indications of prescribing or deprescribing Benzodiazepines or/and Non-benzodiazepine hypnotics and also provides interactive tapering suggestion integrated on a calendar. It is designed to help family doctors with the goal of improving health outcomes for the elderly.

Eligibility criteria: Inclusion Criteria:

* patients ≥65 years who have been taking Benzodiazepines or/and Non-benzodiazepine hypnotics for at least 3 months and who do not meet any exclusion criterion

Exclusion Criteria:

* incapacity or unwillingness to provide written informed consent. Patient with dementia, psychotic disorder, a severe personality disorder; institutionalization; terminal illness, seizure disorders, rapid eye movement sleep disorders, benzodiazepine withdrawal, ethanol withdrawal, severe generalized anxiety disorder, epilepsy and periprocedural anesthesia

Primary outcomes:
measure: Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 3 months
timeFrame: 3 months
measure: Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 6 months
timeFrame: 6 months
measure: Change from baseline of benzodiazepine and Non-benzodiazepine hypnotics consumption at 12 months
timeFrame: 12 Months
Secondary outcomes:
measure: Health-related quality of life of patients
timeFrame: At baseline, 3 months, 6 months, 12 months
measure: number of falls of patients
timeFrame: At baseline, 3 months, 6 months, 12 months
measure: motor vehicle crashes of patients
timeFrame: At baseline, 3 months, 6 months, 12 months
measure: Adverse drug withdrawal effects
timeFrame: At baseline, 3 months, 6 months, 12 months
measure: GPs level satisfaction regarding deprescribing
timeFrame: At baseline, 12 months
measure: Patients Beliefs about Medicines
timeFrame: At baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: Luís Monteiro
Study officials:
References:
Clinical trial NCT00920114: Estimate of the Activity and the Forecast of the Lupus Disease of the Adult by a Transcriptomic Score (STUDY LU-PUCE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Lupus erythematosus systemic is an auto-immune disease the evaluation of the activity of which remains very difficult because of an heterogeneousness of the clinical and biological symptoms. The aim of this study is to develop objective, specific and not invasive methods of evaluation of the activity and the forecast of the disease by using an analysis of the transcriptome on circulating blood. A transcriptomic analysis will be realized in parallel by the usual clinico-biological follow-up at the patients affected by systemic lupus, while the diagnosis before treatment, then during every revaluation of the disease during the period of the study. The already treated patients can also be included in this study.


Eligibility criteria: Inclusion Criteria:

* Lupus disease diagnosed for lupus disease arm
* Signed assent

Exclusion Criteria:

* non-compliance
* pregnancy
* persons without social coverage

Primary outcomes:
measure: Identify the genes expressed during the disease to allow the calculation of a transcriptomic score and study the correlation of this transcriptionnal score with the SLEDAI score
timeFrame: 2 years
Secondary outcomes:
measure: Identify genes correlated in various histological classes of lupus renal disease and types of pushes of the disease; to allow the calculation of a transcriptomic score and its correlation with the BILAG score
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique-Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique-Hôpitaux de Marseille
name: Laurent CHICHE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jourde-Chiche N, Whalen E, Gondouin B, Speake C, Gersuk V, Dussol B, Burtey S, Pascual V, Chaussabel D, Chiche L. Modular transcriptional repertoire analyses identify a blood neutrophil signature as a candidate biomarker for lupus nephritis. Rheumatology (Oxford). 2017 Mar 1;56(3):477-487. doi: 10.1093/rheumatology/kew439.
citation: Chiche L, Jourde-Chiche N, Whalen E, Presnell S, Gersuk V, Dang K, Anguiano E, Quinn C, Burtey S, Berland Y, Kaplanski G, Harle JR, Pascual V, Chaussabel D. Modular transcriptional repertoire analyses of adults with systemic lupus erythematosus reveal distinct type I and type II interferon signatures. Arthritis Rheumatol. 2014 Jun;66(6):1583-95. doi: 10.1002/art.38628.
Clinical trial NCT03936114: Stress Management and Resiliency Training (SMART) for Family Medicine Residents at Eglin AFB
Official title: Stress Management and Resiliency Training (SMART) for Family Medicine Residents at Eglin AFB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Quality of Life
Lead sponsor: Eglin AFB Regional Hospital
Sponsor class: FED
First posted: 2019-05-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research seeks to identify if the practice of the SMART program mindfulness decreases stress and increase resilience in family medicine residents.

Detailed description: This research seeks to identify if the practice of the SMART program mindfulness decreases stress and increase resilience in family medicine residents.

Eligibility criteria: \*\*Patients must be able to get care at Eglin Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Male and female active duty military family medicine residents
* Age 18 or older
* Amenable to participation in training and filling out questionnaires

Exclusion Criteria:

* Unwilling to participate

Primary outcomes:
measure: Change in "Mindful Attention Awareness Scale"
timeFrame: baseline, 12 weeks, 12 months
measure: Change in "Perceived Stress Scale"
timeFrame: baseline, 12 weeks, 12 months
measure: Change in "Connor-Davidson Resilience Scale 10" (CD-RISC-10)
timeFrame: baseline, 12 weeks, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eglin Air Force Base
country: United States
facility: 96th Medical Group
state: Florida
Study officials:
References:
citation: Ludwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.
citation: Holzel BK, Carmody J, Vangel M, Congleton C, Yerramsetti SM, Gard T, Lazar SW. Mindfulness practice leads to increases in regional brain gray matter density. Psychiatry Res. 2011 Jan 30;191(1):36-43. doi: 10.1016/j.pscychresns.2010.08.006. Epub 2010 Nov 10.
citation: Kerr CE, Sacchet MD, Lazar SW, Moore CI, Jones SR. Mindfulness starts with the body: somatosensory attention and top-down modulation of cortical alpha rhythms in mindfulness meditation. Front Hum Neurosci. 2013 Feb 13;7:12. doi: 10.3389/fnhum.2013.00012. eCollection 2013.
citation: Sibinga EM, Wu AW. Clinician mindfulness and patient safety. JAMA. 2010 Dec 8;304(22):2532-3. doi: 10.1001/jama.2010.1817. No abstract available.
citation: Sood, Amit. Train Your Brain....Engage Your Heart....Transform Your Life: A Course in Attention & Interpretation Therapy (AIT). Morning Dew Publications, LLC; 2009, 2010
Clinical trial NCT01319214: Reducing Drug Craving Memories
Official title: Reconsolidation as a Treatment Target for Cocaine Addiction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cocaine Addiction
Keywords: cocaine addiction treatment craving
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The primary objective is to investigate the potential ability of Inderal (propranolol hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in cocaine dependent participants. If effective in this laboratory model, Inderal may have clinical efficacy.


Eligibility criteria: Inclusion Criteria:

* 60 psychotropic medication-free men or women (15 subjects x 4 groups) who have met DSM-IV-TR diagnostic criteria for cocaine dependence for the past 6 months (age 18 - 50 years old);
* Minimum of three days cocaine abstinent on study days;
* Primary use of cocaine is intra-nasal or smoked crack

Exclusion Criteria:

* Medical conditions that might be aggravated by participation in the study:

  * cardiovascular disorders that might be aggravated by participation in the study: hypotension (SBP: \< 100 mmHg), bradycardia (heart rate \< 60 /min), severe atrioventricular block (Type II or III), severe hypertension (SBP: \> 160 mmHg; DBP: \> 100 mmHg), myocardial infarction, history of chest pain and admission to ED for chest pain;
  * respiratory disorders: bronchial asthma and chronic obstructive pulmonary disease;
  * diabetic patients treated with insulin or oral hypoglycemic agents. Propranolol may mask the first signs of a developing hypoglycemia.
* Seropositive pregnancy test
* Comorbidity with current axis I psychiatric disorders other than anxiety, affective and substance use disorders
* Severe liver disfunction
* Current or recent (\< 5 half lives) use of medications that may interact with Inderal (see above)
* Positive urine tox screen for barbiturates. Positive breath alcohol screen. {Note: all urine tox screen results will be destroyed immediately after collection. The information will not be stored}

Primary outcomes:
measure: Self-report drug craving
timeFrame: One day and one month post-treatment
Secondary outcomes:
measure: Drug use
timeFrame: One month after the intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04969614: Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients
Official title: Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
SARS-CoV-2 Acute Respiratory Disease
Vaccine
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving kidney transplantation in West China Hospital between 01/01/2015 and 01/03/2021

Brief summary: The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has a major impact on transplant recipients, with mortality rates up to 20%. However, immunocompromised individuals have been excluded from studies of SARS-CoV-2 vaccines. In such patients, the immune response to vaccination may be blunted. To better understand the immunogenicity of SARS-CoV-2 vaccines in transplant recipients, we quantified the humoral response to SARS-CoV-2 vaccine in kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

Receiving kidney transplantation in West China Hospital, Sichuan University

Exclusion Criteria:

1) History of rejection or infection over the previous 3 months; 2) receiving kidney transplantation \>3 months; 3) Combined with HBV/HVC/HIV infection in the donor or recipient; 4) Malignancy history in the donor and recipient; 5) organ transplant history in the recipient.

Primary outcomes:
measure: seropositive anti-COVID-19 antibody
timeFrame: 2 to 6 weeks after the second injection of inactivated vaccine
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: