louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02335216: A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)
Official title: A Post Market ObServational StudY on the Effect of DRG StiMulation in PATients witH Chronic Pain Following Surgical Lumbar DiscectomY (Failed Back Surgery Syndrome): SYMPATHY
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Failed Back Surgery Syndrome
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-09
Enrollment: 22
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 suffering from chronic pain post discectomy surgery

Brief summary: 18-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic pain following surgical lumbar discectomy for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the subjects primary area of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.
12. Subject has an anatomical spinal abnormality which is anticipated to require further surgery

Primary outcomes:
measure: Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
timeFrame: Baseline, 3, 6 and 12 Months
measure: Percentage of Subjects With at Least 50% Pain Reduction
timeFrame: 3, 6 and 12-Month Visits
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
Study officials:
References:
Clinical trial NCT06965816: Using Neuroimaging to Early Diagnose Alzheimer's Disease Through Hippocampal Atrophy Assessment
Official title: Using Neuroimaging to Early Diagnose Alzheimer's Disease Through Hippocampal Atrophy Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer&#39;s Disease
Hippocampus
Brain Atrophy
Magnetic Resonance Imaging
Leukoaraiosis
Neurodegenerative Diseases
Cortical and Subcortical Atrophy
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from a retrospective cohort of patients who underwent brain MRI scans (3D T1 Bravo and Cube FLAIR sequences) between January 2018 and June 2022. The study population includes two groups: patients diagnosed with Alzheimer's disease based on clinical and biological assessments, and cognitively healthy individuals with no history of neurological or psychiatric disorders, serving as controls.

Brief summary: This study aims to better understand Alzheimer's disease by looking at brain scans, specifically MRI images, to detect early signs of brain changes linked to the disease. Researchers are focusing on the hippocampus, a part of the brain that shrinks in people with Alzheimer's. The study will also explore other brain changes that often happen alongside hippocampal shrinkage. By analyzing these brain images, the study hopes to find ways to diagnose Alzheimer's earlier and more accurately using advanced imaging techniques.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent a brain MRI (3D T1 Bravo and Cube FLAIR sequences) between January 2018 and June 2022.
* Diagnosis of Alzheimer's disease (for the Alzheimer group).
* No neurological disease for control group participants.
* Complete clinical and biological assessments available.
* Quality imaging without motion artifacts.

Exclusion Criteria:

* Incomplete clinical or radiological data.
* Poor image quality (e.g., motion artifacts).
* Presence of other neurodegenerative or psychiatric disorders.

Primary outcomes:
measure: Hippocampal Volume Measured by 3D MRI
timeFrame: Retrospective analysis between January 2018 and June 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: France
Study officials:
References:
Clinical trial NCT04555616: Environmental Design for Behavioral Regulation in People With Dementia
Official title: Environmental Design for Behavioral Regulation in People With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: environment
Occupational therapy
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Individuals with dementia present with changes in behaviors throughout the continuum of cognitive decline. Environmental features may be influential in behavioral regulation. The purpose of this study is to assess the feasibility of environmental design protocols in older adults with dementia and their caregivers. Thirty subjects with moderate to severe Alzheimer's disease as primary dementia type, and their caregivers, will be randomly assigned to one of three arms: standard care; standard environmental design protocol; or personalized environmental design protocol.


Eligibility criteria: Inclusion Criteria:

* Men or women aged 21-90, inclusive.
* Living at home in the community with one primary caregiver.
* Diagnosis of Alzheimer's disease as primary dementia type of moderate to severe stages
* Stable medical condition for one month prior to screening visit
* Stable medications for 4 weeks prior to screening visit
* Caregiver report of challenges related to behaviors within 4 weeks of study enrollment
* Caregiver willing to participant throughout duration of study

Exclusion Criteria:

* Unstable medical conditions for 3 months prior to screening
* Wheelchair or bed bound.
* Residence in skilled nursing facility or facility-based care.
* Skin lesions or skin abnormalities throughout upper extremities.

Primary outcomes:
measure: Success Rate of Adherence
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Occupational Performance
timeFrame: 10 weeks (at baseline, 6 weeks and the 4 week follow up)
measure: Change in Behavior
timeFrame: 10 weeks (at baseline, 6 weeks and the 4 week follow up)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentcuky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gregory Jicha, MD-PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06795516: Observational Study on the Clinical Use of Ex Vivo Lung Perfusion (XPS™) for Lung Transplantation
Official title: Observational Study on the Clinical Use of Ex Vivo Lung Perfusion (XPS™) for Lung Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplantation
Keywords: Ex-vivo Perfusion
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Listed patients for lung transplantation

Brief summary: Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis.


Eligibility criteria: Inclusion Criteria:

* Min Age 18 years
* Acceptance of the organ using the XPS™ ex vivo lung perfusion system is made by the center based on clinical assessment and visual inspection

Exclusion Criteria:

* The usual criteria for the assessment of donors apply
* The transplanting surgeon is not satisfied with the lung assessment on the XPS™ according to clinical criteria

Primary outcomes:
measure: Survival of patients 1 year after transplantation
timeFrame: 1 year after transplantation
Secondary outcomes:
measure: Occurrence of primary graft dysfunction (PGD) after transplantation
timeFrame: 0, 24, 48, 72 hours postTx
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
Study officials:
affiliation: Hannover Medical School
name: Fabio Ius, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205816: Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
Official title: An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Keywords: Bacterial Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.
* Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.
* Patient must give informed consent.

Exclusion Criteria:

* Patients with an expected survival of less than 2 weeks.
* Patients who have been designated as "Do Not Resuscitate".
* Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents.
* Pregnant women or nursing mothers.

Primary outcomes:
measure: response
Secondary outcomes:
measure: micro response at subject level
measure: micro response at pathogen level
measure: clinical response at pathogen level
measure: development of decreased susceptibility
Other outcomes:
Locations:
city: Heidelberg
country: Germany
city: Gdansk
country: Poland
city: Poznan
country: Poland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.
Clinical trial NCT00803816: Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Official title: Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveitis
Keywords: endogoneous
posterior
intermediate
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2008-12-08
Enrollment: 12
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: Study efficacy of everolimus on course of uveitis:

* obtain quiescence of inflammation after start of treatment
* duration to obtain quiescence of inflammation
* number of patients with quiescence of inflammation

Detailed description: occurence of new complications from uveitis

* course of visual acuity (LogMAR): percentage of patients with visual loss of 10 or more numbers on ETDRS as compared to baseline
* change of recurrence rate as compared to time before everolimus treatment
* occurence of recurrence after obtaining remission with everolimus treatment
* duration to occurence of recurrence o number of patients with recurrence
* corticosparing effect from everolimus
* number of patients without topical corticosteroids; number of patients with reduced topical corticosteroids (\<3x/daily)
* number of patients without systemic corticosteroids; number of patients with reduced systemic corticosteroids (\<10mg/daily)
* efficacy of uveitis within 12 months
* maintenance of remission after withdrawel of everolimus treatment at 12 months o course of cystoid macula edema (FLA, OCT)

Eligibility criteria: Inclusion Criteria:

* endogenous intermediate or posterior uveitis
* no quiesence in previous 3 months under systemic and topical steroids or systemic cyclosporine A
* indication for steroid sparing therapy
* uveitis related vision threating complications
* negative pregnancy test
* effective contraception

Exclusion Criteria:

Ophthalmic parameters:

* silicone oil in anterior chamber of both eyes para- or intraocular corticosteroid injections within previous 8 weeks
* opacities of optic media that obscure visualization of anterior or posterior eye segments

General parameters:

* requirement for combined immunosuppression for systemic immune-mediated disease contraindication against everolimus or cyclosporine A
* positive tuberculine test (GT 10
* currently immunosuppressive therapy with immunosuppressive drug other than cyclosporine
* poor compliance
* known intolerance to medication

Primary outcomes:
measure: Inactivity of uveitis
timeFrame: 1 year
Secondary outcomes:
measure: Reoccurence of uveitis
timeFrame: 2 years
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Ophthalmology at St. Franziskus Hospital
Study officials:
affiliation: Department of Ophthalmology at St. Franziskus Hospital
name: Arnd Heiligenhaus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595816: Injury Prevention Among Conscripts
Official title: Prevention of Musculoskeletal Injuries in Finnish Conscripts. A Cluster Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Problems and Other Musculoskeletal Injuries
Keywords: low back pain
physical fitness
injury
prevention
conscripts
Lead sponsor: UKK Institute
Sponsor class: OTHER
Collaborators: name: Finland's Slot Machine Association (RAY)
name: Ministry of Education
name: Scientific Advisory Board for Defence (MATINE)
First posted: 2008-01-16
Enrollment: 800
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to study the effect of neuromuscular training program and regular safety counselling on the risk of musculoskeletal injuries in adolescent conscripts.

800 voluntary participants are recruited from the four army companies in western Finland during the years 2007 and 2008.


Eligibility criteria: Inclusion Criteria:

* healthy conscripts who gave informed consent for participation

Exclusion Criteria:

* disease or injury preventing physical training

Primary outcomes:
measure: Musculoskeletal injuries
timeFrame: 12 months
Secondary outcomes:
measure: Intensity of low back pain, Physical fitness
timeFrame: 1,2,6 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Jari Parkkari
state: P.O Box 30
city: Tampere
country: Finland
facility: Jari Parkkari
Study officials:
affiliation: The UKK Institute
name: Jari P Parkkari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suni J, Rinne M, Natri A, Statistisian MP, Parkkari J, Alaranta H. Control of the lumbar neutral zone decreases low back pain and improves self-evaluated work ability: a 12-month randomized controlled study. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E611-20. doi: 10.1097/01.brs.0000231701.76452.05.
citation: Suni JH, Taanila H, Mattila VM, Ohrankammen O, Vuorinen P, Pihlajamaki H, Parkkari J. Neuromuscular exercise and counseling decrease absenteeism due to low back pain in young conscripts: a randomized, population-based primary prevention study. Spine (Phila Pa 1976). 2013 Mar 1;38(5):375-84. doi: 10.1097/BRS.0b013e318270a12d.
citation: Parkkari J, Taanila H, Suni J, Mattila VM, Ohrankammen O, Vuorinen P, Kannus P, Pihlajamaki H. Neuromuscular training with injury prevention counselling to decrease the risk of acute musculoskeletal injury in young men during military service: a population-based, randomised study. BMC Med. 2011 Apr 11;9:35. doi: 10.1186/1741-7015-9-35.
Clinical trial NCT05429216: Endoscopic Resection for Small Rectal Neuroendocrine Tumors
Official title: Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection for Small Rectal Neuroendocrine Tumors Less Than 1 cm: a Muticenter Randomized Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Neuroendocrine Tumor
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it has shorter operation times and lower hospitalization costs. However, a multicenter randomized controlled trial is needed to prove the universality and generality of these findings.

Detailed description: Investigators aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with ESD for the treatment of small rectal neuroendocrine tumors (NETs) in six tertiary hospitals in China.

Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 75 years;
2. With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;
3. With tumor size ≤10 mm assessed by colonoscopy;
4. Plan to receive mEMR-C or ESD treatment and provide written informed consent;

Exclusion Criteria:

1. Unable to tolerate ESD or MEMR-C as assessed by the research team of each center;
2. Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;
3. Rectal NET with lymph node metastasis or distant metastasis;
4. Received resection of rectal neuroendocrine tumor by other surgical procedures;
5. Multiple rectal neuroendocrine tumors;
6. Vulnerable groups such as pregnant women or patients with mental disorders;
7. Poor compliance, unable to cooperate with treatment.

Primary outcomes:
measure: histological complete resection
timeFrame: within 14 days after procedure
Secondary outcomes:
measure: success rate of operation
timeFrame: intraoperative
measure: en bloc resection
timeFrame: intraoperative
measure: operation time
timeFrame: intraoperative
measure: complications
timeFrame: within 14 days after procedure
measure: length of stay
timeFrame: within 14 days after procedure
measure: hospitalization cost
timeFrame: within 14 days after procedure
measure: operation cost
timeFrame: within 14 days after procedure
measure: histopathologic grade
timeFrame: within 14 days after procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06913816: Effects Of Optimized Blinking Training on Visual Function and Tear Film Parameters in Individuals With CVS
Official title: Effects Of Optimized Blinking Training on Visual Function and Tear Film Parameters in Individuals With Computer Vision Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Computer Vision Syndrome
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: "Computer vision syndrome (CVS), refers to a range of eye and vision issues caused by extended use of computers, tablets, e-readers, and smartphones. Computer users experience visual symptoms, such as eyestrain, headaches, eye discomfort, dry eyes, double vision, and blurred vision, especially after long periods of looking at screens, whether up close or at a distance.

Detailed description: Individuals will be randomly assigned to either an experimental group (group A) receiving OBT with routine rehabilitation CVS management 20-20-20 rule, blue light-blocking glasses, and polyvinyl alcohol eye drops or a control group (group B) receiving only routine rehabilitation, including the 20-20-20 rule, blue light-blocking glasses, and polyvinyl alcohol eye drops. OBT consisted of structured blinking exercises performed thrice daily for three months. Objective outcomes, including tear film parameters and visual function using subjective Computer Vision Syndrome Questionnaire (CVS-Q) shall be evaluated. The collected data will be analysed by using SPSS."

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18-40 years who work on computers or digital devices for at least 3 to 6 hours daily.
* Both Male and Female.
* Individuals who could undergo a complete ocular examination.
* Presence of symptoms consistent with digital eye strain.
* Presented with eye complaints such as eye fatigue, burning, irritation, redness, and blurred vision due to long-term computer or digital screen use.
* Symptoms worsened during exposure to digital screen light.

Exclusion Criteria:

* Use of medications that might influence tear production or ocular surface status (e.g., antihistamines, antidepressants).
* Diagnosed neurological or systemic conditions that impact vision or blink patterns (e.g., Parkinson's disease, multiple sclerosis).
* Individual's with a history of ocular surface diseases such as conjunctivitis or keratitis.
* History of any psychiatric diagnosis."

Primary outcomes:
measure: Computer Vision Syndrome (CVS-Q)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kasur
country: Pakistan
facility: Ramzan Eye Care and Optix Khudian Khas
state: Punjab
Study officials:
References: