louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00288314: fMRI in Posttraumatic Stress Disorder (PTSD) During Working Memory Updating
Official title: Working Memory Updating in Posttraumatic Stress Disorder (PTSD): Study of Neural Correlates Using fMRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Traumatic Stress Disorders
Anxiety
Amnesia, Dissociative
Keywords: PTSD
MRI, Functional
Anxiety
Working Memory
Processing speed
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2006-02-07
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: PTSD related to sexual abuse vs controls, in right-handed females.

Brief summary: Neuropsychological studies investigating trauma-exposed and posttraumatic stress disorder (PTSD) subjects have generally underlined the significantly poorer performance of tasks that require attention, concentration, and verbal memory, and difficulty in regulating memories surrounding the traumatic event. A previous study (El Hage et al. Cognitive Neuropsychiatry, 2006) revealed that the trauma-exposed subjects scored higher on anxiety/depression scales, and lower on processing speed tests. Moreover, the study showed significant impairment in working memory partially mediated by speed processing, but not by anxiety or depression. These results suggest that processing speed makes a major contribution to trauma-related working memory decline, and needs to be investigated in further studies.The aim of the present study is to explore correlation between hippocampus volume, frontal dysfunction and cognitive slowing in trauma-exposed subjects, while examining brain activation during performance of working memory tasks using functional magnetic resonance.

Detailed description: Working memory performance will be assessed using the "3-back test", and processing speed evaluated with "words comparison test". The study will be conducted on 2 years. The study should include 18 right-handed females victims of sexual abuse and suffering from PTSD, and 18 controls right-handed females without any history of abuse ad not suffering from PTSD. Brain activation will be measured during performance of working memory tasks (3-back test) and processing speed test using functional magnetic resonance.

Eligibility criteria: Inclusion Criteria:

* Right-handed women
* Victim of sexual abuse
* Suffering from PTSD

Exclusion Criteria:

* Epilepsy
* Claustrophobia
* MRI contre-indication
* Addictive disorders
* Sightless
* Detection of a brain injury at the MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
state: Centre
Study officials:
affiliation: UNIVERSITY HOSPITAL OF TOURS
name: Wissam EL HAGE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Hage W, Gaillard P, Isingrini M, Belzung C. Trauma-related deficits in working memory. Cogn Neuropsychiatry. 2006 Jan;11(1):33-46. doi: 10.1080/13546800444000164.
Clinical trial NCT01769014: Adherence and Quality of Life in People With Schizophrenia and Schizoaffective Disorder
Official title: In the Cantons Graubunden and Glarus as Well as in the Principality of Liechtenstein: Influence of Intensive Outpatient Treatment of People With Schizophrenia and Schizoaffective Disorder on Quality of Life and Adherence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Schizoaffective Disorder
Quality of Life
Keywords: adherence
Lead sponsor: Psychiatrische Dienste Graubuenden
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who suffer from schizophrenia or schizoaffective disorder, following DSM IV criteria and who live in the cantons Glarus, Graubuenden or the Principality of Liechtenstein.

Brief summary: It is the goal of this study adherence and quality of life in a population of people suffering from schizophrenia or schizoaffective disorder and to analyze if these factors are influenced by treatment, support, social services, and residential treatment. The study population is drawn from the the cantons Glarus and Graubunden as well as Liechtenstein.


Eligibility criteria: Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* 18 - 65 years old
* treated in the PDGR within the past 19 years

Exclusion Criteria:

* organic brain disorder
* alcohol or drug dependence
* low intelligence
* unable to give consent
* no legal competency
* lacking knowledge of German language
* current psychiatric inpatient treatment

Primary outcomes:
measure: Quality of life
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Moritz
country: Switzerland
facility: Psychiatrische Dienste Graubuenden
state: Graubuenden
Study officials:
References:
Clinical trial NCT02309814: Eyelid Movement Sensor Device- Blinking Characterizing
Official title: Eyelid Movement Sensor Device- Blinking Characterizing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eyelid Movement Disorders
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators have developed a simple to use device that facilitates the monitoring of the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and graphic presentation of the results. the device system consists 3 components : glasses for the patient including magneto sensitive probes, hardware and dedicated software.

Our purpose is to characterize eyelid motion in normal population. The methods include measuring each patient 10 minutes during watching a short movie.

Detailed description: Essentially, for Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid.

Eligibility criteria: Inclusion Criteria:

* healthy 18-67 year olds with no eye medical history

Exclusion Criteria:

* pregnancy
* head trauma history
* using contact lens

Primary outcomes:
measure: Demonstrate and describe measurable blinking character in normal population.(Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: haemek medical center
name: daniel briscoe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05685914: Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.
Official title: Outcomes of Endoscopic Operation in COVID-19 Infection: Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Surgery-Complications
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing endoscopic surgery done in an operating theatre by a surgeon.

Brief summary: The goal of this observational study is to determine 30-day mortality and post endoscopic surgery complications in patients with COVID-19 infection who undergo endoscopic surgery.This results will inform future risk stratification, decision making and improve patient's clinical care.This study is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing any type of endoscopic surgery in an operating theatre and these patients had COVID-19 infection either at the time of surgery or within 30 days of surgery.

Exclusion Criteria:

* If COVID-19 infection is diagnosed \>30 days after discharge, the patient should not be included.

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
Study officials:
References:
Clinical trial NCT03871114: Evaluation of Salivary Level of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid
Official title: Evaluation of Salivary Levels of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atrophic/erosive oral lichen planus

Brief summary: Thirty patients will be recruited from the outpatient clinic of the faculty of dentistry.fifteen systemically healthy individuals with normal mucosa and fifteen atrophic/erosive oral lichen planus patients. Oral lichen planus patients will be treated with a topical steroid and miR-155 and IL-10 will be assessed in saliva before and after 4 weeks of topical steroids use


Eligibility criteria: Inclusion Criteria:

* Patients clinically and histopathologically diagnosed as having atrophic/erosive OLP.
* Patients free from any other oral lesions
* cooperative patients who agrees to take the supplied medications.
* Patients who are systemically healthy

Exclusion Criteria:

* Patients suffering from any systemic disease.
* Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
* Treatment with any oral topical medications for at least four weeks prior to the study.
* Pregnant and lactating women.

Primary outcomes:
measure: Measurement of salivary levels of miR-155 in OLP before treatment
timeFrame: baseline
measure: Measurement of salivary levels of IL-10 in OLP before treatment
timeFrame: baseline
Secondary outcomes:
measure: Measurement of salivary levels of miR-155 in OLP after treatment
timeFrame: 4 weeks
measure: Measurement of salivary levels of IL-10 in OLP after treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT05594914: AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma
Official title: The Preliminary Efficacy and Safety of AK104 Plus Concurrent Chemoradiation Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: 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 assess the safety and efficacy of AK104 plus concurrent chemoradiation therapy in unresectable locally advanced esophageal squamous cell carcinoma

Detailed description: AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles. Assess disease efficiency( objective response rate; disease control rate; duration of overall response; time to resolve) and safety( adverse event).

Eligibility criteria: Inclusion Criteria:

* unresectable locally advanced esophageal squamous cell carcinoma; ECOG PS 0-1; At least one measurable lesion according to RESIST standard 1.1； not received anti-tumor treatment in the past

Exclusion Criteria:

* received immunotherapy in the past； Active hepatitis B, hepatitis C and other infectious diseases； Severe liver and kidney function, cardiovascular and cerebrovascular abnormalities

Primary outcomes:
measure: ORR
timeFrame: 24 months
measure: DCR
timeFrame: 24 months
measure: DoR
timeFrame: 24 months
measure: TTR
timeFrame: 24 months
measure: AE
timeFrame: 24 months
Secondary outcomes:
measure: PFS
timeFrame: 24 months
measure: OS
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00134914: Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence
Official title: Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-08-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.

Detailed description: Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to characterize the effects of buprenorphine/naloxone in opioid-dependent individuals.

This study will last 10 weeks. Participants will stay in a residential research unit, and will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions, participants will be randomly assigned to receive either sublingual tablets, intramuscular injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.

Eligibility criteria: Inclusion Criteria:

* Currently opioid dependent
* In good health, as determined by a pre-participation medical examination
* Seeking and eligible for methadone maintenance or detoxification treatment

Exclusion Criteria:

* Significant medical or psychiatric illness, other than drug dependence

Primary outcomes:
measure: Opioid agonist rating
timeFrame: up to one day
measure: opiate withdrawal
timeFrame: up to one day
measure: physiologic measures
timeFrame: up to one day
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C. Strain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoller KB, Bigelow GE, Walsh SL, Strain EC. Effects of buprenorphine/naloxone in opioid-dependent humans. Psychopharmacology (Berl). 2001 Mar;154(3):230-42. doi: 10.1007/s002130000637.
Clinical trial NCT00483314: Homocystinuria: Treatment With N-Acetylcysteine
Official title: Homocystinuria: Treatment With N-Acetylcysteine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Homocystinuria
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: March of Dimes
First posted: 2007-06-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: 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 determine if oral N-acetylcysteine is effective in lowering homocysteine in individuals with homocystinuria.

Detailed description: Homocystinuria (MIM 236200) due to CBS deficiency is the most common inborn error of sulfur amino acid metabolism with severe clinical manifestations. We propose:

1. An open-label pilot study of N-acetylcysteine (NAC) to lower plasma homocysteine levels in those that have not responded to conventional treatment which includes betaine (Cystadane®, Orphan Medical Inc.), which while lowering Hcy levels does not normalize it, and is very expensive. There are no known contraindications to NAC used for nutritional supplementation and it is relatively inexpensive.

   Oral NAC has reduced total plasma homocysteine in healthy subjects in a dose-dependent fashion.
2. Measurement of flow-mediated vasodilation of the brachial artery (endothelial function) in response to NAC treatment. Endothelial dysfunction is a precursor of atherogenesis.
3. Sequencing the CBS gene in these individuals in order to identify novel mutations causing homocystinuria and identify polymorphisms in other genes that may affect response to treatment.

Eligibility criteria: Inclusion Criteria:

* Homocystinuria (lens dislocation and hyperhomocysteinemia)
* Age ≥ 18 (the age of majority in Canada)

Exclusion Criteria:

* Nursing mothers or pregnant women
* Chronic liver disease
* Taking nitrates
* Cystine stone formers
* History of active peptic ulcer disease
* Subjects receiving carbamazepine and metoclopramide
* Use of other products containing cysteine or N-acetylcysteine (e.g. nebulized NAC, cysteine supplements, methionine restriction)
* Hypersensitivity to any ingredient in the study product
* Clinically significant, abnormal laboratory test on screening (Visit 2)

Other Criteria:

* Women of child-bearing capacity must be using an acceptable method of birth control and have a negative pregnancy test before being enrolled

Primary outcomes:
measure: Lowering plasma total homocysteine
timeFrame: 3 months
Secondary outcomes:
measure: Change in flow-mediated dilatation of brachial artery
timeFrame: 3 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC-Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Brian M GILFIX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06805214: Increased Body Temperature Post Tracheostomy: a Retrospective Study
Official title: Increased Body Temperature Post Tracheostomy: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheostomy Complication
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU from 1.2020 to 1.2025 who underwent tracheostomy during ICU admission

Brief summary: Tracheostomy is one of the most common procedures in intensive care units. Post-tracheostomy increased body temperature within 24 hours is common. However, frequently sepsis workup is performed along with initiation of broad spectrum antibiotic therapy. We will investigate the incidence of post tracheostomy fever and whether retrospectively the increased temperature indicated development of sepsis or not. The study is retrospective and will be based on data collection.


Eligibility criteria: Inclusion Criteria: Patients admitted to the ICU from 1.2020 to 1.2025 who underwent tracheostomy during ICU admission -

Exclusion Criteria: Patients who did not fullfil the above criteria

-

Primary outcomes:
measure: Post tracheostomy fever
timeFrame: 24 hours post tracheostomy
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT05416814: Safety and Feasibility of Kefir Administration in Critically Ill Adults
Official title: Safety and Feasibility of Kefir Administration in Critically Ill Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Critically Ill
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.


Eligibility criteria: Inclusion Criteria:

* Critically ill adult patients receiving antibiotics.
* Functional GI tract (able to tolerate oral diet or tube feeding).

Exclusion Criteria:

* Received antibiotics for \>72 hours prior to enrollment.
* Known immunosuppression (due to medications including chronic steroids, TNF-alpha inhibitors, monoclonal antibodies, immunosuppressive antimetabolites, etc.).
* Compromised gut integrity (bowel resection, GI malignancy, GI bleed, inflammatory bowel disease).
* History of CDI within 60 days.
* Liver failure or pancreatitis.
* Dairy intolerance or milk allergy.
* Patients consuming probiotics at baseline.
* Artificial heart valve.
* Extremely poor prognosis and not expected to survive the treatment period.

Primary outcomes:
measure: Adverse Events
timeFrame: 30 days
measure: Feasibility of Kefir administration
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lioudmila Karnatovskaia, MD
role: PRINCIPAL_INVESTIGATOR
References: