louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06294106: eTMS for Veterans and First Responders With PTSD
Official title: Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Wave Neuroscience
First posted: 2024-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 participants will receive eTMS treatment 10 participants will receive sham eTMS treatment
Primary purpose: BASIC_SCIENCE

Brief summary: A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.

Detailed description: Veterans and first responders diagnosed with PTSD will be studied to evaluate safety and efficacy of an EEG personalized TMS paradigm. All participants will undergo 2 days of extensive testing prior to eTMS application and 2 days of testing after. Testing will include MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study.

Eligibility criteria: Inclusion Criteria:

* Veteran or first responder
* diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above

Exclusion Criteria:

* Claustrophobia
* Contraindications to MRI
* Pregnant
* Uncontrolled medical, psychological, or neurological conditions
* Unable to calculate EEG alpha frequency
* History of ECT or rTMS
* History of intracranial lesion or increased intracranial pressure
* History of stroke
* History of other neurologic conditions
* Family history of epilepsy
* Personal history of epilepsy
* certain medications

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 7 weeks
measure: Report of Symptoms
timeFrame: Up to 7 weeks
Secondary outcomes:
measure: PCL-5
timeFrame: Up to 7 weeks
measure: fMRI
timeFrame: 1 session 1 week pre treatment and 1 session 1 week post treatment
measure: OPM
timeFrame: 1 session 1 week pre treatment and 1 session 1 week post treatment
measure: EEG
timeFrame: Up to 7 sessions collected over 7 weeks.
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Wynn Legon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901706: Multidimensional Assessment and Intervention for Elder Self-Neglect
Official title: Multidimensional Assessment and Intervention for Elder Self-Neglect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Self-Neglect
Cognitive Ability, General
Geriatric Disorder
Keywords: Self-Neglect
Comprehensive Geriatric Assessment (CGA)
Geriatric Syndromes
Quality of Life
Basic Activities of Daily Living
Instrumental Activities of Daily Living
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
First posted: 2009-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to assess the best method for caring for elders reported to Adult Protective Services (APS) for self-neglect. Specifically, this study will compare APS usual care coupled with interdisciplinary comprehensive geriatric care to APS usual care alone in improving the health and quality of live among elders with substantiated self-neglect.


Eligibility criteria: Inclusion Criteria:

* 65 years of age or older
* English Speaking
* Resident of Harris County, Houston Texas
* Community-dwelling
* Substantiated Self-Neglect

Exclusion Criteria:

* No other substantiated allegations
* Non-community dweller
* No available for projected follow-up period
* Impaired decision-making with no available proxy
* Already receiving care from TEAM or within the past year
* Terminal Illness

Primary outcomes:
measure: Self-Neglect Severity Scale (SSS)
timeFrame: Baseline and 6-months
Secondary outcomes:
measure: Functional Status
timeFrame: Baseline and 6-months
measure: Kohlman Evaluation of Living Skills (KELS)
timeFrame: Baseline and 6-months
measure: Mini-mental State Exam (MMSE)
timeFrame: Baseline and 6-months
measure: 15-item Geriatric Depression Scale
timeFrame: Baseline and 6-months
measure: Physical Performance Test (PPT)
timeFrame: Baseline and 6-months
measure: SF-36 Health Survey
timeFrame: Baseline and 6-months
measure: The Duke Social Support Index (DSSI)
timeFrame: Baseline and 6-months
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Baseline and 6-months
measure: Costs of Social Services and Health Care Utilization and Costs
timeFrame: Months 1,2,3,4,5,6
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Carmel B. Dyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06650306: The Impact of Soft Contact Lenses on the Corneal Neuromediators and Optical Quality in High Myopia Prior to SMILE
Official title: The Impact of Soft Contact Lenses on the Corneal Neuromediators and Optical Quality in High Myopia Prior to SMILE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Contact Lens Complication
Keywords: Corneal Neuromediator
Soft contact lenses
Corneal optical density
Corneal aberration
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with high myopia who underwent SMILE surgery at Shanghai Tenth People's Hospital in Shanghai, China, between October 2020 and October 2023.

Brief summary: To investigate the influence of Neuromediators expression in corneal stromal lenticules and corneal injury repair after small incision extraction

Detailed description: This study included 160 eyes from high myopia patients who underwent Small Incision Lenticule Extraction. Patients were devided into three groups based on duration of wearing SCLs: \> 10 years group, ≤ 10 years group, and NW group (not SCLs). Corneal higher-order aberrations and densitometry were evaluated using a Pentacam system. Neuromediator levels in corneal stromal lenticules were analyzed using ELISA and immunofluorescence

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years with stable refraction for at least two years;
* spherical equivalent (SE) \< -6.00 D;
* corrected distance visual acuity of 20/20 or better;
* no history of using rigid gas permeable lenses or orthokeratology (OK) lenses prior to examination

Exclusion Criteria:

- a history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery.

Primary outcomes:
measure: Corneal stromal lenticule Neuromediators
timeFrame: baseline
Secondary outcomes:
measure: Corneal Aberration
timeFrame: baseline
measure: Corneal Densitometry
timeFrame: baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02352506: Serum MIF in Acute Kidney Injury
Official title: Macrophage Migration Inhibitory Factor in the Serum of Critically Ill Patients as an Early Marker for Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical care patients

Brief summary: Acute kidney injury (AKI) is a common complication in critical care patients. Currently no parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate the time course of MIF concentrations in patients with AKI.


Eligibility criteria: Exclusion Criteria:

* Age \< 18 years and \> 80 years
* Patients with chronic dialysis
* Patients with continuous hemodialysis, hemofiltration or hemodiafiltration within 4 weeks prior to the study
* Patients with an expected length of ICU stay shorter than 3 days
* Patients with a low probability of surviving the first 2 days after ICU admission
* Pregnancy and nursing

Primary outcomes:
measure: Macrophage migration inhibitory factor
timeFrame: Up to 14 days
Secondary outcomes:
measure: Serum creatinine
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01559506: Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery
Official title: ABS to Reduce Contamination in Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: CFU
surgery site
Lead sponsor: Nimbic Systems, LLC
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures

Detailed description: The ABS is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion Criteria:

* Active infection
* Prior prosthesis infection

Primary outcomes:
measure: CFU Density
timeFrame: Surgical case CFU density will be determined at up to 1 month from completion of surgical cases
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Rabih O Darouiche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nimbic Systems
name: Sean Self
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402206: Management of Depression in Primary Care
Official title: Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Intervention
Primary health care
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2011-07-26
Enrollment: 258
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Most people in Sweden with mild to moderate depression are treated in primary care, but follow-up is unstructured, and we know little about whether structured, follow-up would affect the prognosis for depression and working life. The purpose of this study is to determine the effectiveness of regular, structured, patient-centered visits on mild to moderate depression.


Eligibility criteria: Inclusion criteria

* Age 18 years and up
* Attends a participating primary health care center in the region
* Diagnosis of mild/moderate depressive disorder (new episode)
* No change in possible antidepressant maintenance therapy during the preceding 1 month
* Provided written informed consent

Exclusion criteria

* Antidepressant medication initiated or changed during the preceding 1 month
* Patient diagnosed with major depressive disorder (BDI-II \>28)
* Patients diagnosed of severe mental psychiatric disorder (i.e. bipolar disorder, antisocial personality disorder, psychosis, substance use disorder or other serious mental disorder)
* Suicidal ideation or intentions
* Inability to speak and understand Swedish language well enough to take part in the activities required in the study.
* Cognitive impairment that makes it impossible to take part in the activities required in the study
* Does not provide written informed consent to participation in the study

Primary outcomes:
measure: Change in Depressive symptoms
timeFrame: 3, 6 and 12 months.
Secondary outcomes:
measure: Change in Quality of life
timeFrame: 3, 6 and 12 months
measure: Prescriptions for antidepressants
timeFrame: 12-month follow-up period
measure: Change in Activity/work ability
timeFrame: 12-month follow-up period
measure: sick-listing data
timeFrame: 12 month follow up
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: University of Gothenburg
Study officials:
affiliation: Göteborg University
name: Cecila Björkelund, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wikberg C, Westman J, Petersson EL, Larsson ME, Andre M, Eggertsen R, Thorn J, Agren H, Bjorkelund C. Use of a self-rating scale to monitor depression severity in recurrent GP consultations in primary care - does it really make a difference? A randomised controlled study. BMC Fam Pract. 2017 Jan 19;18(1):6. doi: 10.1186/s12875-016-0578-9.
Clinical trial NCT03478306: Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
Official title: Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Retinopathy
Melatonin
Circadian Dysrhythmia
Circadian Rhythm Sleep Disorder, Unspecified Type
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Copenhagen
First posted: 2018-03-27
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Double-blind, randomized, placebo-controlled trial
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the patients will cross over to the other treatment arm.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients
* Age range 40-75 years
* Participant should be legally competent

Exclusion Criteria:

* Other known eye disease.
* Eye disease manifestation during ocular examination.
* Competing neurologic and systemic conditions affecting retina.
* Use of any drugs influencing pupillary light reflex and sleep pattern.
* Refractive error with need of \> 6 diopter lenses.
* Pregnancy
* Alcohol consumption during the trial
* Lack of cooperation
* Allergy to melatonin and/or preservatives in melatonin and placebo
* Reduced hepatic function
* Fluvoxamin intake due to drug interaction
* Consumption of Alpha-1 and beta-1 adnergic antagoists.
* Alcohol consumption during treatment

Primary outcomes:
measure: Progression of diabetic retinopathy, oscillary potential
timeFrame: 3 weeks
Secondary outcomes:
measure: Post-illumination pupillary light response
timeFrame: 3 weeks
measure: Circadian photoentrainment
timeFrame: 3 weeks
measure: Retinal structure
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Rigshospitalet-Glostrup
state: RegionH
Study officials:
affiliation: Department of Ophthalmology, Rigshospitalet-Glostrup
name: Shakoor Ba-Ali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02872506: Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection
Official title: Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Quality of Life
Keywords: Quality of life
Crohn's disease
Ileocecal resection
Anti TNF
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Compare the quality of life at 6 months between 2 populations of patients followed for terminal ileitis of Crohn's disease treated with anti-TNF or ileocecal resection.

Detailed description: Two groups of patients suffering from Crohn's terminal ileitis will be matched by sex, age (A2, A3), the time evolution of the disease, the length of the diseased ileal segment (less than 10 cm; 10 to 30; 30 to 50 cm) and the Montreal classification (B1, B2). The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time. The surgical group are the patients operated on for the first time by means of ileocecal resection by laparoscopy or laparotomy without any severity criteria or perianal lesions and do not require prophylactic treatment of recurrence.

Eligibility criteria: Inclusion Criteria:

* isolated Crohn's ileitis without history of bowel resection and never previously been treated with anti-TNF
* Men and woman over 18 years
* Patient with social security cover
* reapproved indication during multidisciplinary meeting
* Patient able to receive clear information in written and oral
* Informed consent signed by the patient

Exclusion Criteria:

* Prophylactic treatment of recurrence before endoscopic control at the 6th postoperative month.
* Contraindication to Anti-TNF after the initial lap works.
* The side effects of surgery or anti-TNF are not exclusion criteria.

Primary outcomes:
measure: quality of life (QoL) by Inflammatory Bowel Disease Questionnaire
timeFrame: at 6 months from the beginning of medical treatment or surgical resection
Secondary outcomes:
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: at baseline (beginning of medical treatment or surgical resection), at 6 months
measure: Crohn's disease activity index (CDAI)
timeFrame: at baseline, at 6 months
measure: Length of small intestine segment resection
timeFrame: at baseline
measure: Duration of hospital stay
timeFrame: at baseline
measure: Clavien-Dindo classification of surgical complications
timeFrame: at baseline, at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Philippe Zerbib, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00717106: Observational Study of the Sleuth Implantable ECG Monitoring System
Official title: Observational Study of the Sleuth Implantable ECG Monitoring System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope
Presyncope
Fainting
Cardiac Arrhythmia
Keywords: ILR
ECG monitoring
cardiac arrhythmia
syncope
presyncope
fainting
Lead sponsor: Transoma Medical
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 250
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: cardiology or primary care clinics

Brief summary: The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
* Patients who experience transient symptoms that may suggest a cardiac arrhythmia

Exclusion Criteria:

* Patients that have had a myocardial infarction (MI) \< 30 days prior to implant

Primary outcomes:
measure: Time to diagnosis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Cumberland
country: United States
facility: Western Maryland Health Systems
state: Maryland
city: Lapeer
country: United States
facility: Cardiology Consultants of East Michigan
state: Michigan
city: New York
country: United States
facility: St. Luke's - Roosevelt
state: New York
city: Akron
country: United States
facility: SUMMA-NEOCS Health Systems
state: Ohio
city: Wynnewood
country: United States
facility: Main Line Health - Lankenau Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Center for Cardiac Arrhythmias
state: Texas
city: Morgantown
country: United States
facility: Morgantown Internal Medicine Group
state: West Virginia
Study officials:
affiliation: Transoma Medical
name: Wim Stegink
role: STUDY_DIRECTOR
References: