louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02861547: Development and Validation of a Prognostic Score for Early Death in Head Injury Patients.
Official title: Development and Validation of a Prognostic Score for Early Death in Head Injury Patients in the Traumatic Brain Injury Intensive Care Unit of Dijon CHU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 355
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalisés pour traumatic brain injury

Brief summary: Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis.

The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury.

This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death.

We will subsequently test this score in a prospective validation cohort.


Eligibility criteria: Inclusion Criteria:

Traumatic brain injury (PMSI code (Programme Médicalisation des Systèmes d'Information) S 06.70 and S 06.71) Age\>14 years Surviving more than 6h after the trauma Hospitalized in the traumatic brain injury intensive care unit and managed in accordance with international guidelines Who underwent a cerebral CT-scan

Exclusion Criteria:

Ongoing treatment with anticoagulants or antiplatelets Pregnant women Persons without national health insurance cover Children less than 15 years old Under guardianship.

Primary outcomes:
measure: Early death
timeFrame: Through the study completion up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05455047: Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy
Official title: Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who came to the nuclear medicine department between 2009 and 2021 for an 18F-FDG PET/CT scan as part of a pre-operative assessment for epilepsy surgery

Brief summary: 18F-Fluoro-deoxy-glucose (18F-FDG) positron emission tomography (PET) has a high sensitivity for temporal lobe epilepsy (TLE), the most common form of focal epilepsy, with a detection range of 86-90% . Therefore, 18F-FDG PET is a useful tool to identify the epileptogenic zone (ETZ) in the inter-ictal phase of drug-resistant temporal epilepsy during pre-surgical evaluation . Based on stereotactic electroencephalography (SEEG) findings, a correspondence between electrical data and metabolic changes on PET was found at the group level by identifying four different patterns of TLE . As expected, hypometabolism was not limited to the EZ defined by SEEG, but underlay broader epileptic networks . Because of the different electroclinical presentations of TLE, 18F-FDG PET appears to be a very useful tool in these temporal epilepsies. Indeed, it has been recently demonstrated that a gradient of PET hypometabolism from the uninvolved area to the spreading area, then to the epileptogenic area and to the lesion area is observed with consequently a good performance of 18F-FDG PET in defining the EZ .

Therefore, it is interesting to study PET metabolism as a network and not as a combination of regional metabolic measures in epilepsy.


Eligibility criteria: Inclusion Criteria:

* Patients with drug-resistant temporal epilepsy with an accurate diagnosis on SEEG
* Patients with epilepsy who have had a PET/CT scan with 18F-FDG as part of a pre-operative assessment
* Person having received complete information on the organization of the research and not having objected to the use of these data;
* Patients affiliated to a social security system

Exclusion Criteria:

* Person who has not received full information on the organization of the research and who has opposed the use of this data
* A person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice).
* A person of full age who is unable to give consent and who is not subject to a legal protection measure

Primary outcomes:
measure: Metabolic connectivity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Nancy's Hospital
Study officials:
References:
Clinical trial NCT06544447: Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction
Official title: Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction, A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Dry Eye
Keywords: Dry eye,
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 135
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: Dry Eye Disease With Meibomian Gland Dysfunction
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction.

Methods: We enrolled 270 patients at Beijing Tongren Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.

OSDI score, TBUT, OPAS, NPSI-eye, and Schirmer I expressibility and secretion score to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

1. Age \>=18 and Age \<=65.
2. Clinical diagnosis of dry eye disease with meibomian gland dysfunction.

Exclusion Criteria:

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.

Primary outcomes:
measure: OSDI
timeFrame: Baseline, month 1, 3, and 6
Secondary outcomes:
measure: OPAS
timeFrame: Baseline, month 1, 3, and 6
measure: NPSI-eye
timeFrame: Baseline, month 1, 3, and 6
measure: TBUT
timeFrame: Baseline, month 1, 3, and 6
measure: SchirmerI
timeFrame: Baseline, month 1, 3, and 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Beijing TongRen Hospital, Capital Medical University Beijing, China
state: Beijing
Study officials:
References:
Clinical trial NCT04639947: Reliability and Reproducibility of the Eye Check Tonometer
Official title: Reliability and Reproducibility of the Eye Check Tonometer Pressure Measurements as Measured by Patients Reliability and Reproducibility of the Eye Check Tonometer Pressure Measurements as Measured by Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Glaucoma, Suspect
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will first take their pressure using the EyeCheck with contact lens in and then remove their lens have pressures taken with Goldmann and Tonopen (two standard of care techniques of taking pressures of the eyes).
Primary purpose: DIAGNOSTIC

Brief summary: To investigate whether the new applanation tonometer (EyeCheck monitor) can provide intraocular pressure (IOP) measurements comparable to those of traditional tonometers such as the Goldmann applanation tonometer and the Tonopen.


Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older,
* Any glaucoma patient or glaucoma suspect patient
* Presents for an appointment wearing their own soft contact lens.

Exclusion Criteria:

* Arthritis affecting the upper extremity in the patient or caregiver
* Patient unwilling or assessed to be unable to comply with the study protocol
* Any corneal abnormalities such as opacities, scars, Fuchs dystrophy, map dot fingerprint dystrophy, history of recurrent corneal abrasion, corneal surgery such as Lasik, PRK, DSAEK, transplant or implant
* History of any ongoing ocular symptoms such as eye pain or redness or discharge
* History of recent ocular surgery (done in the past 3 months)
* History of a any filtering or tube surgery for glaucoma (to reduce risk of infection associated complications)
* Recent eye infection (within the past 3 months)
* History of diabetes for \> 5 years duration
* Monocular patient
* Best corrected visual acuity\< 20/70
* Head or hand tremors

Primary outcomes:
measure: Intraocular Pressure (IOP) Measurements
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke Eye Center
name: Sanjay Asrani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01049347: Amitriptyline and Paroxetine Treatment of Major Depression
Official title: Hypothalamus-pituitary-adrenal System: Role of the Mineralocorticoid Receptor and Longitudinal Study in Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unipolar Depression
Keywords: depression
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 127
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: Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week study period in order to study endocrine and metabolic parameters.


Eligibility criteria: Inclusion Criteria:

* age: above 18
* depression according DSM-IV

Exclusion Criteria:

* bipolar disorder
* substance dependency

Primary outcomes:
measure: Hamilton Depression Rating Scale (21-item version)
timeFrame: baseline, weekly assessments for 5 weeks
Secondary outcomes:
measure: cortisol in saliva (8.00, 16.00, 22.00) during wash-out (6 days) and 35 days of treatment
timeFrame: daily during wash-out (days -6 to -1) and active treatment (days 1 to 35)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
Study officials:
affiliation: Central Institute of Mental Health, Mannheim
name: Michael Deuschle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schilling C, Gilles M, Blum WF, Daseking E, Colla M, Weber-Hamann B, Lederbogen F, Krumm B, Heuser I, Wudy SA, Kopf D, Deuschle M. Leptin plasma concentrations increase during antidepressant treatment with amitriptyline and mirtazapine, but not paroxetine and venlafaxine: leptin resistance mediated by antihistaminergic activity? J Clin Psychopharmacol. 2013 Feb;33(1):99-103. doi: 10.1097/JCP.0b013e31827cb179.
citation: Paslakis G, Kopf D, Westphal S, Gilles M, Lederbogen F, Hamann B, Heuser I, Deuschle M. Treatment with paroxetine, but not amitriptyline, lowers levels of lipoprotein(a) in patients with major depression. J Psychopharmacol. 2011 Oct;25(10):1344-6. doi: 10.1177/0269881110382469. Epub 2010 Oct 15.
Clinical trial NCT06020547: Cystic Fibrosis and Frailtyh What's in Common?
Official title: Cystic Fibrosis in Adults and Frailty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty Syndrome
Cystic Fibrosis
Keywords: functional status
frailty
Cystic Fibrosis
geriatric syndrome
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 139
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: The study population consists of 139 CF patients referred to the Cystic Fibrosis for the Adults Centre of the University Federico II of Naples.

Brief summary: The goal of this observational study is to assess the main clinical and anamnestic characteristics, and frailty syndrome in an adult Cystic Fibrosis population. The main question it aims to answer is the possible association of the frailty status with the main clinical, therapeutical characteristics, including the genotyping classification of Cystic Fibrosis patients.

Detailed description: Participants will be assessed for the pulmonary status by spirometry (for Forced Expiratory Volume in 1 second \[FEV1 - L\]; Forced Expiratory Volume in 1 second percent predicted \[ppFEV1%\]; Forced Vital Capacity \[FVC - L\]; Forced Vital Capacity percent predicted \[FVC %\]; Maximal Mid-Expiratory Flow \[MMEF\]); for the functional status by evaluating the activities of daily living \[ADLs\], and the instrumental ADLs \[IADLs\]; and for frailty by the Study of Osteoporotic Fractures \[SOF\] Index. The height and weight will be also recorded, and Body Mass Index \[BMI\] calculated as body weight divided by height squared \[Kg/m2\]. Body weight will be measured in a fasting state in the morning with a mechanical balance.

Eligibility criteria: Inclusion Criteria:

* who met the diagnostic criteria for CF,
* over 18 years old,
* pathological sweat chloride levels (chloride \>60 mEq/L) and two CFTR mutations

Exclusion Criteria:

* who did not meet the diagnostic criteria for CF
* under 18 years old
* over 18 years old with normal sweat chloride levels (chloride \>60 mEq/L)

Primary outcomes:
measure: Pre-Frail/Frail Status
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Cystic Fibrosis for the Adults Centre
Study officials:
affiliation: Federico II University
name: Graziamaria Corbi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06063577: Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
Official title: A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: C.Surgical Procedure; Disruption of Wound, Suture
Lead sponsor: West Michigan Cancer Center
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2023-10-02
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: Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

Detailed description: Determine whether the use of Stratafix Symmetric™ sutures reduces the development of Ventral Incisional Hernia (VIH) in patients undergoing complex GI surgery compared to standard laparotomy closure. Determine the safety of Stratafix Symmetric™ sutures compared to standard laparotomy closure sutures and the impact on quality of life and level of pain.

Eligibility criteria: Inclusion Criteria:

1. Participant is a male or female 18 years of age or older.
2. Participant is a current patient at West Michigan Cancer Center.
3. Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery.
4. Participant is willing and able to provide written informed consent before surgery.

Exclusion Criteria:

1. Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified).
2. Participant has history of previous VIH.
3. Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.

Primary outcomes:
measure: Number of participants who develop ventral incisional hernia
timeFrame: From enrollment to end of study participation at 12 months
Secondary outcomes:
measure: Safety of stratafix sutures compared to standard of care wound closure
timeFrame: From enrollment to end of study participation at 12 months
measure: Change in quality of life
timeFrame: "Month 1," "Month 3," "Month 6," "Month 12"
measure: Change in quality of life
timeFrame: "Day 1," "Month 1," "Month 3," "Month 6," "Month 12"
measure: Post operative pain
timeFrame: From enrollment to end of study participation at 12 months
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
Study officials:
affiliation: West Michigan Cancer Center
name: Gitonga Munene
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02731677: Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease
Official title: Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 22
Sex: ALL
Minimum age (years): 38
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep disorders correspond to a non-motor symptom present in DP, being represented by daytime sleepiness and maintenance insomnia. This study aims to evaluate the effects of acupuncture on sleep disorders in patients with PD assisted by Pró-Parkinson Program at University Hospital of Pernambuco, Brazil. Its a randomized clinical trial approved by the Ethics Committee for Research with Human. It was included patients with diagnosed with Idiopathic Parkinson's disease, Mini Mental State Examination (MMEE) according to education, stages 1, 2 and 3 in the Hoehn-Yahr scale. It was used the sleep Scale for Parkinson's disease (PDSS), a self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Twenty-two subjects were allocated in two groups: experimental and control. Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE once a week, eight sessions in the experimental group. The control group no suffered intervention. The paired analyzes were performed using the Wilcoxon test and the independent analyzes using the Mann-Whitney test.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Idiopathic Parkinson's disease
* Mini Mental State Examination (MMSE) According to education
* Stages 1, 2 and 3 in the Hoehn-Yahr scale.

Exclusion Criteria:

* Patients who have another neurological disorder associated with Parkinson's disease
* Cardiac with pacemaker (contraindicated the use of electrotherapy).

Primary outcomes:
measure: Scale for Parkinson's disease (PDSS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de Pernambuco
name: NADJA ASANO, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06229977: A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
Official title: A Randomized Controlled Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bipolar Depression
Keywords: cytokine levels
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Baszucki Brain Research Fund
First posted: 2024-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to o evaluate the antidepressant efficacy of the PEA in Bipolar Depression and the association between antidepressant response with endogenous cannabinoids and cytokine levels


Eligibility criteria: Inclusion Criteria:

* diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D
* currently in use of at least one FDA approved mood stabilizer with or without antidepressant
* medically and neurologically healthy on the basis of medical history, physical examination

Exclusion Criteria:

* Cannabis misuse according to clinical judgement
* unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects
* active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder)
* acute high suicidal risk
* in a manic episode
* current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination
* pregnant or nursing women
* unstable medical conditions
* clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available

Primary outcomes:
measure: Change in depression as assessed by the Hamilton Depression rating Scale (HAM-D)
timeFrame: Baseline, 6 weeks follow up
Secondary outcomes:
measure: Percentage of participants that show a remission of depressive symptoms as assessed by the HAM-D scale.
timeFrame: from baseline to end of study (6 week follow up)
measure: Percentage of participants that show a response as assessed by the HAM-D scale
timeFrame: from baseline to end of study (6 week follow up)
measure: Number of participants that show early improvement as defined by >20% improvement in HAM-D depression score
timeFrame: From baseline to week 2 visit
measure: Change in depression as assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)
timeFrame: Baseline, 6 weeks follow up
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: Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc
role: PRINCIPAL_INVESTIGATOR
References: