louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03930966: Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome
Official title: Study of the Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome After Severe Trauma Requiring General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Trauma
General Anaesthesia
Keywords: Severe trauma
General anaesthesia
Peri-traumatic dissociation state
Post-traumatic stress disorder
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Study
Primary purpose: PREVENTION

Brief summary: Patients will be selected after studying clinical records.Patients who had general anesthesia due to an injury related to severe trauma within 6 to 12 months prior to inclusion will be included.

Three self-survey will be completed by the patient: PDEQ, PCL-5 and a demographic questionnaire. According to the PDEQ and PCL-5 scores, an association between a peri-traumatic dissociation state and a post-traumatic stress disorder can be established.


Eligibility criteria: Inclusion Criteria:

* Patients with general anesthesia for a surgical wound with violent trauma in the road, a fall of more than 6 meters, burn, accident at work, explosion, aggression) in the 6 to 12 months before the inclusion
* Time between trauma and general anesthesia should not exceed 48 hours
* Patient agreeing to participate in the study.

Exclusion Criteria:

* Minor patients
* Patients under curatorship, and tutorship
* Patient deprived of liberty
* Patients who do not speak French
* Patients who are not in satisfactory neurological state to answer the questionnaire (pyschotic, demented states)
* Patients who have been sedated (apart from general anesthesia) when receiving or having a Glasgow score \<14

Primary outcomes:
measure: Studying association between the presence of peri-traumatic dissociation state and the achievement of post-traumatic stress disorder between 6 and 12 months in traumatized patients
timeFrame: study baseline (6 to 12 months after initial hospitalisation)
Secondary outcomes:
measure: Measurement of the frequency of PTSD after severe trauma requiring general anesthesia.
timeFrame: study baseline (6 to 12 months after initial hospitalisation)
measure: Research of Risk Factors Associated with the Occurrence of PTSD
timeFrame: study baseline (6 to 12 months after initial hospitalisation)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
affiliation: philippe.aries@chu-brest.fr
name: Philippe ARIES, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00934466: Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)
Official title: A Randomized Clinical Trial to Assess the Effects of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will assess transcranial magnetic stimulation (TMS) as a biomarker and characterize TMS readouts of the activity of MK2637 and dextromethorphan. Resting quantitative electroencephalography(qEEG) readouts are also characterized with MK2637 and dextromethorphan.


Eligibility criteria: Inclusion Criteria:

* Subject is right-handed
* Subject is in good health
* Subject is a nonsmoker

Exclusion Criteria:

* Subject works a night shift
* Subject has a history of any illness that might make participation in the study unsafe or confound the study results
* Subject has a history of head injury

Primary outcomes:
measure: Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
timeFrame: 5 Hours after initial dosing
measure: Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo
timeFrame: 4 Hours after initial dosing
Secondary outcomes:
measure: Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo
timeFrame: 6.5 hours after initial dosing
measure: Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo
timeFrame: 5 hours after initial dosing
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06088966: Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation
Official title: Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Output, Low
Lead sponsor: Karlsburg Hospital
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients after surgery without exclusion criteria

Brief summary: Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.


Eligibility criteria: Inclusion Criteria:

* patients with pulmonary artery catheter after cardiac surgery

Exclusion Criteria:

* minimally invasive surgery
* unstable conditions
* bleeding
* unability to fit cuirass

Primary outcomes:
measure: Stroke Volume Index in ml/m2
timeFrame: 1 hour
Secondary outcomes:
measure: Heart rate in beats/min
timeFrame: 1 hour
measure: blood pressure in mm/Hg
timeFrame: 1 hour
measure: arterial oxygen saturation in %
timeFrame: 1 hour
measure: mixed venous oxygen saturation in %
timeFrame: 1 hour
measure: right ventricular ejection fraction in %
timeFrame: 1 hour
measure: end diastolic volume index in ml/m2
timeFrame: 1 hour
measure: Cardiac index in l/min/m2
timeFrame: 1 hour
measure: tricuspid annular plane systolic excursion in mm
timeFrame: 1 hour
measure: right ventricular fractional area change in %
timeFrame: 1 hour
measure: Vena contract of tricuspid valve in mm
timeFrame: 1 hour
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Klinikum Karlsburg, Klinik für Anästhesiologie
state: Mecklenburg Vorpommern
Study officials:
References:
Clinical trial NCT04553666: Reducing Frailty for Older Cancer Survivors Using Supplements
Official title: Reducing Frailty for Older Cancer Survivors Using Supplements (ReFOCUS): A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Frailty
Inflammation
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the intervention Arm will receive 800 mg Epigallocatechin gallate (EGCG) + 250mg Ascorbic Acid
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer


Eligibility criteria: Inclusion Criteria:

1. Be age 65 or over.
2. Be diagnosed with stage I-III Cancer.
3. Have completed curative intent treatment ≤10 years prior to screening. (Patients on endocrine therapies are allowed to enroll.)
4. Have a Fried's Frailty Score (FFS) of ≥ 2.
5. Able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and University of Rochester Cancer Control guidelines.

Exclusion Criteria: Study subjects must not:

1. Have chemotherapy planned for the during of the study.
2. Have abnormal liver function tests (ALT, AST and bilirubin ≥3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening).
3. Have uncontrolled or unmanaged liver disease.
4. Consume more than 6 cups of green tea per day.
5. Have known allergies to caffeine.
6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
7. Be diagnosed with dementia.
8. Cannot provide informed consent due to lack of decision making capacity (as determined by the patient's oncologist) and has no patient-designated health care proxy per institutional policies and University of Rochester Cancer Control URCC guidelines.

Primary outcomes:
measure: Recruitment Feasibility: Rates of Consent
timeFrame: Baseline
measure: Recruitment Feasibility: Rates of Randomization
timeFrame: Baseline
measure: The Proportion of Participants That Completed the Study
timeFrame: 12 week
measure: The Proportion of Participants That Were Adherent to the Intervention
timeFrame: 12 week
measure: Safety of the EGCG Intervention
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT03009266: Ischemic Memory Imaging With Myocardial Contrast Echocardiography
Official title: Ischemic Memory Imaging With MCE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Myocardial Ischemia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The overall aim of this study is to determine whether non-invasive imaging with myocardial contrast echocardiography using can provide information on the presence and spatial extent of recent myocardial ischemia by non-invasive echocardiographic imaging.


Eligibility criteria: NORMAL CONTROL GROUP

Inclusion Criteria:

* Normal control individuals

Exclusion Criteria:

* History of cardiovascular disease (coronary artery disease, MI, peripheral artery disease)
* allergy to eggs or ultrasound contrast agents
* known or detected right to left shunt
* presence of a wall motion abnormality
* pregnancy

ACS GROUP

Inclusion Criteria:

* Patients with diagnosis of acute coronary syndrome with either unstable angina or non-ST-elevation MI
* Referred for primary percutaneous intervention
* At least 1 high risk features (ST changes, positive troponin, wall motion abnormality)

Exclusion Criteria:

* allergy to eggs or ultrasound contrast agents
* hemodynamic instability or shock
* known or detected right to left shunt
* pregnancy
* multivessel CAD requiring multivessel PCI

Primary outcomes:
measure: Dose optimization
timeFrame: 3 months
measure: Detection of Ischemia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References:
citation: Davidson BP, Hodovan J, Layoun ME, Golwala H, Zahr F, Lindner JR. Echocardiographic Ischemic Memory Molecular Imaging for Point-of-Care Detection of Myocardial Ischemia. J Am Coll Cardiol. 2021 Nov 16;78(20):1990-2000. doi: 10.1016/j.jacc.2021.08.068.
Clinical trial NCT06293066: Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study.
Official title: Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Postmenopausal Bleeding
Endometrial Cancer
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 330
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with postmenopausal bleeding referred to the gynaecology rapid access clinic

Brief summary: Primary Objective:

To assess whether there is a higher incidence of uninformative ultrasound in black vs white women

Detailed description: Retrospective cohort study

Study Subjects:

Women 45 years or over seen in the 'two-week wait' rapid access Gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022. Only people with documented ethnicity will be included.

Study Procedures:

Cases will be identified by searching our two-week referral and ultrasound records . Clinical data collected includes age, BMI, previous abdominal uterine surgery (Caesarean section or open myomectomy) and parity. Symptoms will be categorised into postmenopausal bleeding with no hormone use, unscheduled bleeding on hormone replacement therapy (HRT) or abnormal perimenopausal bleeding (in women over 45 years of age).

Ultrasound data recorded will be the presence or absence of fibroids, whether transabdominal ultrasound was needed in addition to transvaginal or transrectal ultrasound, whether the endometrium could be seen clearly (i.e whether the ultrasound examination was informative) and the endometrial thickness in those where it was. Clinical outcomes recorded will be the need for endometrial sampling, mode of sampling and histology results. The local cancer registry will be checked for the year following the study to check for any subsequent cancers in women discharged without endometrial sampling.

Eligibility criteria: Inclusion Criteria:

* Women seen in the 'two-week wait' rapid access Gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022

  * 45 years of age or older
  * Ethnicity documented in their clinical notes

Exclusion Criteria:

* Ethnicity data not available

Primary outcomes:
measure: To assess whether there is a higher incidence of uninformative ultrasound in black vs white women
timeFrame: Review of patients who attended clinic in 2022
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Suite 8, King's College Hospital
Study officials:
References:
Clinical trial NCT05345366: The Correlation Between CITED2 and Collateral Circulation in Acute Ischemic Stroke
Official title: The Impact of CITED2 on Collateral Circulation and Early Neurological Functional Outcome for Ischemic Stroke by Critically Regulating HIF-1α-VEGF Pathway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were diagnosed with acute ischemic stroke in the neurology department of our hospital from November 2020 to November 2023.

Brief summary: Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the imaging examination. At present, there is no effective and sensitive biomarker for collateral circulation. Thus, the research objective was to evaluate the predicting role of the CBP/P300-interacting transactivator with Glu/Asp-rich C-terminal domain 2 Ratio (CITED2) from peripheral blood mononuclear cells in the collateral circulation of AIS. We classified the AIS patients into two groups (the good collateral group and the poor collateral group) by DWI-ASPECTS score. The western blot was applied to test the protein expression of vascular endothelial growth factor (VEGF) and CITED2. Then, we collected other clinical data. Binary logistic regression analysis between collateral circulation and clinical data was performed. Finally, Receiver operating characteristic (ROC) curve analysis was used to explore the predictive value of the CITED2.


Eligibility criteria: Inclusion Criteria:

* the first-time onset or previous stroke with mRS score ≤1, and the onset time less than 3 days without intravenous thrombolysis or endovascular therapy ;

  * age range of 18 to 80 years old;

    * patients with a clinical diagnosis of acute ischemic stroke; ④ NIHSS score ≥4; ⑤ patients volunteer to participate in this study and signed a written informed consent

Exclusion Criteria:

* ①the patients with AIS combined with other diseases that may affect the CITED2 and VEGF expression, such as acute myocardial infarction, peripheral artery occlusion disease and congenital heart defect;

  * the patients exhibited serious heart, live or kidney diseases; ③disturbance of consciousness or mental illness; ④ patients with tumor; ⑤ pregnant and lactating patients.

Primary outcomes:
measure: CITED2
timeFrame: within 24 hours after hospitalization
measure: VEGF
timeFrame: within 24 hours after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
References:
citation: Lu M, Liu Y, Xian Z, Yu X, Chen J, Tan S, Zhang P, Guo Y. VEGF to CITED2 ratio predicts the collateral circulation of acute ischemic stroke. Front Neurol. 2022 Sep 30;13:1000992. doi: 10.3389/fneur.2022.1000992. eCollection 2022.
Clinical trial NCT05254366: A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
Official title: A Domestic, Prospective, Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroscopic and Colonoscopic Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving remazolam toluenesulfonate for painless gastroscopy and colonoscopy

Brief summary: This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained


Eligibility criteria: Inclusion Criteria:

1. Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
2. Patients need to sign informed consent

Exclusion Criteria:

1. Patients who are participating in or planning to participate in any interventional clinical trial
2. The investigator considers that there are any other reasons for the patient's ineligibility for the study

Primary outcomes:
measure: Adverse events
timeFrame: Within 3 days of receiving gastroscopy and colonoscopy
Secondary outcomes:
measure: Serious adverse events
timeFrame: Within 3 days of receiving gastroscopy and colonoscopy
measure: Adverse drug reactions
timeFrame: Within 3 days of receiving gastroscopy and colonoscopy
measure: Injection pain questionnaire
timeFrame: Within 3 days of receiving gastroscopy and colonoscopy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06416566: Low-Dose Enoxaparin in Psoriasis
Official title: The Efficacy of Low-Dose Enoxaparin in Psoriasis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psoriasis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-05-16
Enrollment: 30
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: Rationale:

* Psoriasis is a chronic immune-mediated inflammatory skin disorder where T cells play a fundamental role in its pathogenesis.
* Low molecular weight heparin has been reported to exert immunomodulatory effect at small doses through inhibition of T cells heparinase enzyme.
* Low molecular weight heparin may have promising results for treatment of psoriasis.

Research question:

* Can low molecular weight heparin be used safely for treatment of psoriasis with good outcome?
* Is enoxaparin inhibitory effect on T cell heparinase enzyme responsible for its beneficial effect?

Hypothesis:

* Low molecular weight heparin can achieve good results when used at small doses for treatment of psoriasis.
* Heparin can exert immunomodulatory effect in psoriasis through inhibition of T cell heparinase enzyme.

AIM OF WORK

-The aim of this work is to assess the possible clinical efficacy and safety of low-dose enoxaparin in the treatment of psoriasis and to detect if inhibition of heparinase enzyme might account for its beneficial therapeutic effect.

Objectives:

* To evaluate safety and efficacy of low molecular weight heparin at small dose for treatment of psoriasis.
* Contribute to the ongoing efforts to optimize psoriasis management and improve the lives of individuals affected by this chronic condition.


Eligibility criteria: Inclusion Criteria:

* Patients with plaque psoriasis, who met the following criteria will be enrolled.

  1. Age 18 and above.
  2. No systemic (oral, parenteral, photobiological) treatment for psoriasis within the last 2 months.
  3. No topical treatment for psoriasis within the last 2 weeks.

Exclusion Criteria:

* 1. Pregnancy or lactation. 2. Hypersensitivity to heparin and heparin derivatives and a history of heparin-induced thrombocytopenia.

  3. History of bleeding diathesis, uncontrolled hypertension, cerebrovascular accident, peptic ulcer, liver disease and/or abnormal liver function tests or abnormal kidney function tests.

  4. History of major surgery within the last 3 months. 5. A family history of bleeding diathesis, or cerebrovascular accident. 6. Concomitant use of oral anticoagulants, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs.

Primary outcomes:
measure: Psoriatic Area and Severity Index score
timeFrame: weekly for 6 weeks and at follow up period of 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: