louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05162651: Effect of Extended Cannabis Abstinence on PTSD Symptoms
Official title: Effect of Extended Cannabis Abstinence on PTSD Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Cannabis Use
Cognitive Symptom
Comorbidities and Coexisting Conditions
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This will be a 12-week randomized trial. Outpatients and patients from the Mood and Anxiety program at the Centre for Addiction and Mental Health (CAMH) with a current diagnosis of post-traumatic stressed disorder (PTSD) and cannabis-use disorder (CUD) will be randomized to receive individual motivational interviewing therapy and contingency management (n = 12) or individual motivational interviewing therapy alone (control group, n = 12) after enrolment.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged between 18 and 55 years (from both sexes \[or genders\]);
2. Diagnosed with CUD (moderate or severe) according to the Structured Clinical Interview for DSM-IV (SCID) (mode of cannabis consumption can be inhalation or ingestion);
3. Diagnosis of current (past 30 days) PTSD, using the CAPS-5 on screening;
4. On antidepressant medication(s) for at least 1 month (to ensure safety and homogeneity as PTSD treatment of our population);
5. Be able to provide written informed consent; and
6. Be able to communicate in English.

Exclusion Criteria:

1. diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per the study physician;
2. diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder or current acute psychosis or mania based on DSM-5 criteria;
3. current suicidality risk as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after the study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes" 34; and
4. have pain interfering with normal function as reported by the 12-Item Short Form Survey (SF-12) (moderate or higher interference).

Primary outcomes:
measure: Severity of PTSD symptoms, as measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 4
timeFrame: Week 0-4
Secondary outcomes:
measure: Changes in cognitive function, as measured with various Cambridge Automated Neuropsychological Test Automated Battery (CANTAB) cognitive tests
timeFrame: Week 0-4
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References:
Clinical trial NCT01461551: Anesthesia and Lymphocytes Apoptosis
Official title: Different Effects of Sevoflurane, Propofol and Combine of Sevoflurane and Propofol Maintained Anesthesia on Peripheral Blood Lymphocytes During Off-pump Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: troponin I
creatine kinase mb
hospital days
lymphocyte apoptosis
intensive care unit days
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 105
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.


Eligibility criteria: Inclusion Criteria:

* male adults
* aged 18-80 yr
* undergoing elective OPCAB surgery containing left anterior descending artery bypass

Exclusion Criteria:

* a previous unusual response to any of the experimental anesthetics
* severe cardiac dysrhythmias or ejection fraction below 30%
* hemodynamic instability
* previous surgical coronary artery repair
* anemia, abnormal leukocytes or coagulopathy
* severe hypertension
* severe hepatic (albumin\<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions
* concomitant surgical procedures and psychiatric disorders
* Insulin-dependent diabetics

Primary outcomes:
measure: Lymphocyte Count
timeFrame: 1 day after surgery
Secondary outcomes:
measure: Intensive Care Unit Staying Days
timeFrame: participants will stay in intensive care unit after surgery, an expected average of 2 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao tong University School of Medicine
name: Bu-Wei Yu, Ph.D., M.D.
role: STUDY_DIRECTOR
References:
citation: Jia L, Dong R, Zhang F, Wang W, Lu H, Luo Y, Xue Q, Yu B. Propofol Provides More Effective Protection for Circulating Lymphocytes Than Sevoflurane in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1172-9. doi: 10.1053/j.jvca.2015.01.008. Epub 2015 Feb 19.
Clinical trial NCT00413751: Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Large pupils rendering night vision difficulties such as haloes, glare, and monocular diplopia
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
First posted: 2006-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.


Eligibility criteria: Inclusion Criteria:

* Adult active duty personnel between 18 and 50 years of age with best corrected visual acuity of 20/20 or better.

Exclusion Criteria:

* Patients not meeting above stated age criteria
* Females that are pregnant or lactating (non pregnant females of childbearing potential will have pregnancy test prior to participating in study)
* History of serious ocular, neurological, cardiovascular disease
* History of severe systemic disease
* History of arrhythmias or high blood pressure
* Patients currently taking any type of ocular or systemic medications except multivitamins.
* Patients with abnormal pupil shape, Addie's pupil, anisocoria, or abnormal pupil defect.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: KRAIG S. BOWER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00987051: Sentinel Node and Endometrial Cancer
Official title: Validation of the Sentinel Node in Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Neoplasms
Keywords: sentinel node procedure
radiocolloid
patent blue
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 133
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

Detailed description: To investigate the relevance of sentinel node in endometrial cancer. Sentinel node is though to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. The objective of our trial is to validate the concept of sentinel node in endometrial cancer.

Eligibility criteria: Inclusion Criteria:

* patient over 18 years old with a surgery planned for endometrial cancer
* endometrial cancer proved by biopsy
* early stage of endometrial cancer (FIGO stage 1-2)
* without contraindication to surgery
* inform consent signed
* affiliated to general health system

Exclusion Criteria:

* endometrial cancer FIGO stages 3-4
* previous history of surgery modifying lymphatic drainage (conization myomectomy)
* pregnant women or breast feeding

Primary outcomes:
measure: Detection and false negative rates of sentinel node
timeFrame: During the surgery (hysterectomy)
Secondary outcomes:
measure: Morbidity and recurrence rates
timeFrame: During 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Tenon Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Emile DARAÏ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Darai E, Dubernard G, Bats AS, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Ballester M. Sentinel node biopsy for the management of early stage endometrial cancer: long-term results of the SENTI-ENDO study. Gynecol Oncol. 2015 Jan;136(1):54-9. doi: 10.1016/j.ygyno.2014.09.011. Epub 2014 Oct 22.
citation: Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.
Clinical trial NCT00000251: Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3
Official title: Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
isoflurane
subjective effects
psychomotor
healthy volunteer
drug interaction
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Logical reasoning test
timeFrame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation
measure: Free recall memory test
timeFrame: 15 & 30 min inhalation and 5, 30, & 60 min post inhalation
measure: Auditory reaction time
timeFrame: 15 & 30 min inhalation and 5,30 & 60 min post inhalation
measure: Digit symbol substitution test
timeFrame: 2,15 & 30 min inhalation and 5,30 & 60 min post inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zacny JP, Yajnik S, Lichtor JL, Klafta JM, Young CJ, Thapar P, Rupani G, Coalson DW, Apfelbaum JL. The acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations on cognitive and psychomotor performance in healthy volunteers. Anesth Analg. 1996 Jan;82(1):153-7. doi: 10.1097/00000539-199601000-00028.
citation: Whelan J, Hackshaw A, McTiernan A, Grimer R, Spooner D, Bate J, Ranft A, Paulussen M, Juergens H, Craft A, Lewis I. Survival is influenced by approaches to local treatment of Ewing sarcoma within an international randomised controlled trial: analysis of EICESS-92. Clin Sarcoma Res. 2018 Mar 30;8:6. doi: 10.1186/s13569-018-0093-y. eCollection 2018.
Clinical trial NCT03204851: Microlyte Dressing in the Management of Wounds
Official title: An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Heal
Lead sponsor: Mission Health System, Asheville, NC
Sponsor class: OTHER
Collaborators: name: Imbed Biosciences
First posted: 2017-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Primary clinical end point of study is percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. Patient population comprises patients referred to Mission's Wound Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer \[DFU\] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients).


Eligibility criteria: Inclusion Criteria:

* Men and women ≥18 years of age, inclusive
* Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to be referred to Clinical Investigators at Mission's Wound Care and Bariatric Center
* Patient must be competent to consent for self

Exclusion Criteria:

* Patients younger than 18 years of age
* Women who are pregnant or nursing
* Prisoners

Primary outcomes:
measure: percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mission Health System
state: North Carolina
Study officials:
affiliation: Mission Health System
name: William Shillinglaw, DO
role: STUDY_CHAIR
References:
Clinical trial NCT04238351: Transnasal Humidified Rapid Insufflation System for Intubation
Official title: Effect of Transnasal Humidified Rapid Insufflation Ventilator Exchange During Anesthesia Induction With Double Lumen Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxemia
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Applying Transnasal humidified rapid insufflation ventilator exchange
Primary purpose: PREVENTION

Brief summary: Transnasal humidified rapid insufflation ventilator exchange (THRIVE) or not during the anesthesia induction

Detailed description: Control group-usual mask ventilation during apnea for anesthetic intubation and check tube positioning THRIVE group-applying THRIVE during apnea for anesthetic intubation and check tube positioning

Eligibility criteria: Inclusion Criteria:

* Patients who scheduled for elective lung surery with one lung ventilation

Exclusion Criteria:

* suspicious difficult intubation (BMI \>35kg/m2, mouth opening \< 3 finger, Mallampati G \>3), Room air SpO2 \< 90%, active pulmonary infection, emergency operation, pregnancy

Primary outcomes:
measure: Desaturation
timeFrame: during the anesthesia induciton
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02287051: Bowel Prep Acceptance in Clinical Practice
Official title: Acceptance and Compliance of Split-dose Bowel Preparation for Colonoscopy in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy: Bowel Preparation
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population undergoing colonoscopy

Brief summary: Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure depends on an adequate visualization of the mucosa of the colon.There is strong evidence that the quality of bowel preparation is inversely correlated with the interval between the end of the assumption of the purgative and the start of colonoscopy (shorter intervals are associated with higher levels of preparation).Recent studies have shown that split dose prep significantly improves the quality of bowel cleansing. In light of these data, both the American College of Gastroenterology (ACG) and the European Society of Gastrointestinal Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel cleansing. Despite these recommendations, the uptake of schemes in divided doses appears clearly underused in actual clinical practice. In particular, in Italy only a few centers routinely adopt the regime split as their first choice for the preparation for colonoscopy.The reasons why the "split dose" is under-utilized in clinical practice are not entirely clear, but probably in part reflecting gastroenterologists' concerns about potential elements that theoretically could make it less acceptable to the patient (get up early in the morning, potential problems during the journey from home to the hospital) The hypothesis of the study is that many patients would still be willing to accept these potential drawbacks if they were adequately informed about the positive impact of the scheme in divided doses on the effectiveness of bowel preparation, which results in higher reliability of the examination, shorter duration of the procedure, and less risk of rescheduling the exam in the near future


Eligibility criteria: Inclusion Criteria:

* adult patientes undergoing colonscopy

Exclusion Criteria:

* afternoon colonoscopy
* partial colonoscopy
* ASA III-IV
* pregnancy
* incapacity to give informed consent

Primary outcomes:
measure: acceptance
timeFrame: 3 month
measure: compliance
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Radaelli F, Paggi S, Repici A, Gullotti G, Cesaro P, Rotondano G, Cugia L, Trovato C, Spada C, Fuccio L, Occhipinti P, Pace F, Fabbri C, Buda A, Manes G, Feliciangeli G, Manno M, Barresi L, Anderloni A, Dulbecco P, Rogai F, Amato A, Senore C, Hassan C. Barriers against split-dose bowel preparation for colonoscopy. Gut. 2017 Aug;66(8):1428-1433. doi: 10.1136/gutjnl-2015-311049. Epub 2016 Apr 19.
Clinical trial NCT02553551: Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy
Official title: Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy; a A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Cholecystitis
Cholelithiasis
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 320
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: The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.

Detailed description: The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.

The primary purpose of this study is to confirm the reduce of postoperative pain through the oral supplement of Vitamine C before and after the surgery. For this purpose, we compared the dosage or counts of opioids usage with the oral supplement of Vitamine C or not.

The secondary purpose is to assess the pain score, postoperative morbidities, postoperative length of stay or postoperative time between two groups.

Eligibility criteria: Inclusion Criteria:

* chronic cholecystitis
* gallbladder polyp

Exclusion Criteria:

* grade I Tokyo guideline for acute cholecystitis
* grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation
* gallbladder cancer
* the patient who underwent reduced port surgery
* the patient who underwent common bile duct exploration during the operation
* the patient who underwent concurrent operation
* the patient who had past history of upper abdominal surgery
* the patient who had a immunodeficiency state
* the case which had a suspicion of delayed bile leakage
* the case which had a incomplete cystic duct ligation
* the patient who underwent open conversion surgery during the operation
* the patient who had a high risk of bleeding

Primary outcomes:
measure: The postoperative pain
timeFrame: The change of pain score between 6hours after operation and 24hours after operation
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of HBP Surgery, Seoul St. Mary's hospital
state: Seocho-gu, Banopo-dong
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Taeho Hong
role: PRINCIPAL_INVESTIGATOR
References: