louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03264469: Improvement of the Diagnosis and Medico-legal Management of Psychological Trauma in Patients Involved in the Terrorist Attack in Nice on the 14th July 2016
Official title: DIAGNOSIS and FORENSIC MANAGEMENT OF PSYCHOLOGICAL TRAUMA IN PATIENTS INVOLVED IN THE TERRORIST ATTACK IN NICE ON THE 14TH JULY 2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Registration of a Complaint Following the Terrorist Attack of 14 July 2016
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registration of a complaint following the terrorist attack of 14 July 2016

Brief summary: Psychological trauma is a major public health concern that affects numerous patients who have experienced traumatic events.

The objective of our research was to improve the diagnosis and management of persons experiencing such events.

We will seek to determine factors brought into play in the construction of psychological trauma and the best way to identify them so as to implement the optimal management of patients and ensure recognition of this condition.

In addition, in the context of our activity as expert witnesses, we will study the methods used to assess and quantify psychological trauma.

In this respect, a medical appointment will be made by a nurse of the Forensic Medicine Department of Dijon CHU. During this consultation, a self-report questionnaire will be completed by the patient alone to evaluate the level of acute stress followed by a psychiatric consultation and completion of the IES-R questionnaire with the doctor to identify symptoms of psychological trauma.


Eligibility criteria: Inclusion Criteria:

- Patients who have registered a complaint leading to the involvement of the Forensic Medicine Department of DIJON CHU to evaluate requests for temporary sick leave for psychological reasons following the event in NICE on the 14 July 2016.

Exclusion Criteria:

* Refusal of the patient to attend the consultation proposed by the Forensic Medicine Department of DIJON CHU,
* Refusal of the patient to take part in a clinical study.
* Verbal information about the clinical study when the appointment was made by the Forensic Medicine nurse,
* Reiteration of the verbal information during the consultation,
* A letter and an official information document given to each patient by the DIJON CHU research Unit stating the objectives and methods of the clinical study,
* Contact details of the Forensic Medicine Department given to patients if they have any questions about the study.

Primary outcomes:
measure: PID scale
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03200769: Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
Official title: Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Epilepsies, Partial
Keywords: CPAP
Sleep Apnea Syndrome
Pharmacoresistant Epilepsy
Apnea Hypopnea-Index
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 103
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: Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.


Eligibility criteria: Inclusion Criteria:

* Male or female age ≥ 18.
* Patient suffering of pharmacoresistant epilepsy.
* Frequency of epilepsy crisis : minimum 4 per month.
* Antiepileptic drug on a stable dose for at least 2 months.
* SA-SDQ score ≥ 25.
* Written informed consent obtained.
* Patient affiliated with a social security regimen.

Exclusion Criteria:

* Pregnant females (female subjects who are lactating are not excluded).
* Anterior CPAP treatment.
* Central apnea \>20% during the initial polysomnography.
* Mental retardation or severe cognitive impairment.
* Presence of pseudo-crisis.

Primary outcomes:
measure: Number of patients from group IIa and IIb with decreased seizure frequency
timeFrame: At 3 months
Secondary outcomes:
measure: Number of patients from group IIa and IIb with decreased seizure frequency
timeFrame: At 6 months ; At 12 months
measure: Number of patients from group III with decreased seizure frequency
timeFrame: At 3 months ; At 6 months ; At 12 months
measure: Impact of AHI on the number of night seizures
timeFrame: At 12 months
measure: Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk
timeFrame: At 12 months
measure: Number of seizures based on the seizures diary
timeFrame: At 12 months
measure: Number of patients who became drug-susceptible based on the seizures diary
timeFrame: At 3 months ; At 6 months ; At 12 months
measure: Quality of life questionnaire (QOLIE 31)
timeFrame: At 3 months ; At 6 months ; At 12 months
measure: Anxiety and depression questionnaire (BECK)
timeFrame: At 3 months ; At 6 months ; At 12 months
measure: Somnolence questionnaire (Epworth)
timeFrame: At 3 months ; At 6 months ; At 12 months
measure: Cognitive capacity questionnaire (MOCA)
timeFrame: At 3 months ; At 6 months ; At 12 months
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique
Study officials:
affiliation: University Hospital, Lille
name: Philippe DERAMBURE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02259569: Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Urologic Surgeries
Keywords: Gastric insufflation
I-gel
Peak airway pressure
Pressure-controlled ventilation
Volume-Controlled Ventilation
pediatric patient
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient


Eligibility criteria: Inclusion Criteria:

① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.

Exclusion Criteria:

* parent refusal

  * clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration

Primary outcomes:
measure: Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.
timeFrame: 1 min after I-gel insertion
Secondary outcomes:
measure: oropharyngeal leak pressure
timeFrame: 1 min after caudal block
measure: FOB grade
timeFrame: 1 min after I-gel insertion
measure: peak airway pressure
timeFrame: 1 min after I-gel insertion
Other outcomes:
measure: dynamic compliance
timeFrame: 1 min after end of surgery
measure: typical gurgle or whoosh sound
timeFrame: 1 min after caudal block
Locations:
Study officials:
References:
Clinical trial NCT00756769: Systemic Lupus Erythematosus in Gullah Health
Official title: Systemic Lupus Erythematosus in Gullah Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: African Americans
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2008-09-22
Enrollment: 750
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sea Island Community

Brief summary: Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies, multiple organ involvement, and diverse clinical symptoms and immunologic manifestations. African Americans are at a disproportionately higher risk of developing SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with European Americans. Our central study hypothesis is that there are specific genetic factors that interact with environmental exposures leading to the development of SLE. The African American Gullah population from the Sea Islands of South Carolina and Georgia are unique in their genetic homogeneity with minimal non-African genetic admixture, making them an ideal cohort to address questions of environmental and genetic influence on the development and progression of SLE.


Eligibility criteria: Inclusion Criteria:

* Age 2 years and above;
* Self-identified as African-American "Gullah" from the Sea Island region of South Carolina;
* Have had at least 4 of the 11 diagnostic criteria for SLE as designated by the American College of Rheumatology (ACR), be a relative of a known SLE patient, or be an unrelated healthy Gullah control;
* Ability to speak and understand English;
* Ability and willingness to give informed consent

Exclusion Criteria:

* Race defined by participant as other than Black or African-American;
* Being a prisoner, mentally ill patient, or institutionalized individual;
* Unwilling or unable to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Diane L. Kamen, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamen DL, Barron M, Parker TM, Shaftman SR, Bruner GR, Aberle T, James JA, Scofield RH, Harley JB, Gilkeson GS. Autoantibody prevalence and lupus characteristics in a unique African American population. Arthritis Rheum. 2008 May;58(5):1237-47. doi: 10.1002/art.23416.
Clinical trial NCT02678468: Early Vision Screening in High-risk Children
Official title: Early Vision Screening With Automated Photorefraction in Pre-term, Low-birth- Weight and Development-delay Children in Far-Eastern Memorial Hospital, Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amblyopia
Child
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born and regular followed at pediatric clinic in Far Eastern Memorial Hospital

Brief summary: To evaluate the effect of early vision screening with automated photorefraction device in high risk children

Detailed description: Pre-term, low-birth-weight, and development delay are well-known risk factors related to higher incidence of high refractive error and strabismus, which can potentially lead to amblyopia and is regarded as amblyopia risk factors. This project is a cross-sectional controlled study. Our study includes high-risk group and normal group. High-risk group includes children with birth history of pre-term, low-birth-weight and the diagnosis of development delay in FEMH. Normal group enrolled age-matched children without those risk factors. Vision screening by FDA-approved photorefraction device as well as comprehensive ophthalmic exams for definite diagnosis will be performed on the high-risk group and the normal group.

Eligibility criteria: Inclusion Criteria:

* High risk group: children with gestational age less than 36weeks, birth weight less than 2500g and children diagnosed as develop delay
* Normal group: children with normal birth history and normal development

Exclusion Criteria:

* Children with known ophthalmic diseases
* Children with congenital systemic diseases

Primary outcomes:
measure: positive predictive value of vision screening
timeFrame: one year
Secondary outcomes:
measure: Odds ratio of having amblyopia risk factors
timeFrame: one year
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Other
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yao-Lin Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bloomberg JD, Suh DW. The accuracy of the plusoptiX A08 photoscreener in detecting risk factors for amblyopia in central Iowa. J AAPOS. 2013 Jun;17(3):301-4. doi: 10.1016/j.jaapos.2013.03.014.
Clinical trial NCT02913768: Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section
Official title: Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is associated with hypotension and bradycardia, which may be deleterious to both parturient and baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following subarachnoid block in parturients undergoing elective caesarean section.


Eligibility criteria: Inclusion Criteria:

* Undergoing an elective lower segment caesarean section.

Exclusion Criteria:

* Patients with contraindications to subarachnoid block (patient refusal, unstable haemodynamics, coagulation abnormality),
* History of hypersensitivity to ondansetron or local anaesthetic agents,
* Hypertensive disorders of pregnancy,
* Cardiovascular insufficiency,
* Receiving selective serotonin reuptake inhibitors or migraine medications.

Primary outcomes:
measure: Hypotension
timeFrame: intraoperative
Secondary outcomes:
measure: Bradycardia
timeFrame: intraoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References:
Clinical trial NCT00552968: Pain Prevalence in the Trauma Population
Official title: Pain Prevalence in the Trauma Population at Sunnybrook Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: trauma
pain
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have been admitted to hospital due to a traumatic injury.

Brief summary: The incidence of pain in the post traumatic population is an area that has little to no investigation. This study seeks to determine the incidence and experience of pain in this vulnerable population at different time points - while in hospital, 4 weeks post injury, 3 months post injury.

Detailed description: This pilot study will be a convenience sample from trauma inpatients at the Sunnybrook Campus. The purpose of the study is twofold: to investigate the prevalence of chronic pain that develops in the trauma population at Sunnybrook, and to see if neuropathic pain exists in this population, acute and/or chronically.

Eligibility criteria: Inclusion Criteria:

* Over 16 years of age
* ability to read / write in English
* ability to complete an informed consent

Exclusion Criteria:

* history of chronic pain
* unable to give informed consent
* unable to read / write English

Primary outcomes:
measure: Prevalence of pain at 3 months post traumatic injury.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Lynn Haslam, RN MN ACNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01136668: Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
Official title: Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia
Ostomy
Keywords: pediatrics
Transversus Abdominis Plane Block
Ostomy Surgery
Anesthesia
Regional Anesthetic
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 13
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.

Detailed description: Revision or closure of ostomy is a common elective surgical procedure at The Hospital for Sick Children. A retrospective audit conducted at SickKids demonstrated significant intraoperative opioid use and significant requirements for rescue opioids in recovery.

Concerns exist regarding the relative merits of opioid use in abdominal surgery. Opioids may decrease bowel motility leading to the increased incidence and duration of postoperative ileus. They may be associated with increased rates of post-operative nausea and vomiting and pruritus. Lastly children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique may benefit children undergoing revision of ostomy.

Eligibility criteria: Inclusion Criteria:

* children undergoing revision or closure of ostomy
* American Society of Anesthesiologists Classification 1-3.
* age ≥ 3 months

Exclusion Criteria:

* children undergoing an additional surgical procedure (e.g. circumcision) at an anatomical location not covered by a one-sided/ unilateral TAP block, during the same anesthetic
* children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection
* postoperative admission to the intensive care unit
* children with a known allergy to bupivacaine
* children with a history of chronic abdominal pain
* use of opioid analgesics prior to surgery
* pregnancy
* impaired renal function
* impaired hepatic function
* known impaired cardiac function
* hypersensitivity to sodium metabisulfite

Primary outcomes:
measure: Morphine Requirement
timeFrame: within the first 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Jason Hayes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06049368: 68Ga-P16-093 PET/CT Imaging in the Salivary Gland
Official title: 68Ga-P16-093 PET/CT Imaging in the Salivary Gland
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Primary Sjögren Syndrome
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in primary sjogren's syndrome patients.

Detailed description: Primary sjogren's syndrome (pSS) is a systemic autoimmune disease mainly presented hyperglobulinemia and exocrine gland involvement,and lack of diagnostic gold standard.Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by various solid organs , such as salivary gland,which is often observed damage in primary Sjogren's syndrome patients.Therefore, PSMA may be an ideal target for evaluating salivary gland injury.

Eligibility criteria: Inclusion Criteria:

* pathological diagnosis confirmed by operation or biopsy.
* Obtain written informed consent and accepted follow-up.

Exclusion Criteria:

* Pregnant, lactating women or having parenting plans during the study
* Head and neck radiotherapy history ;
* Active hepatitis C infection (PCR positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4 related diseases.
* Other situaition researchers considered it was not appropriate to participate in trials.

Primary outcomes:
measure: Diagnostic performance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: standardized uptake value (SUV) of lesion
timeFrame: through study completion, an average of 1 year]
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: