louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06162416: Non-opioid Anesthesia in Bariatric Surgery
Official title: Non-opioid Anesthesia in Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Obesity
Keywords: Bariatric surgery
Opioid-free anesthesia
Non-opioid anesthesia
Severe obesity
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥ 18 years old) who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019

Brief summary: Opioid-free anesthesia is a new approach to anesthesia, described and used for many years. If it represents many advantages by reducing the side effects of morphine, its precise place in current practice and in terms of postoperative rehabilitation remains to be determined. Studies are not yet numerous enough to affirm a real benefit.

Obese patients are potentially able to benefit from the reduction in the use of morphine during surgery, in terms of quality of postoperative analgesia, side effects (respiratory depression, ileus, somnolence) and early rehabilitation.


Eligibility criteria: Inclusion criteria:

* Major subject (≥ 18 years old),
* who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019
* Subject who has not expressed his or her opposition, after information, to the reuse of his or her data for the purpose of this research

Exclusion Criteria:

* Subject who has expressed his/her opposition to participate in the study
* Subjects under guardianship, curatorship or legal protection, pregnant women

Primary outcomes:
measure: Dose of morphine used intraoperatively
timeFrame: Intraoperative (during the operation)
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Réanimation Chirurgicale - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01656616: Hydroxycobalamin and Rural Emergency Medical Services Cyanide Exposure Patients: A Cost Analysis
Official title: Hydroxycobalamin and Rural Emergency Medical Services Cyanide Exposure Patients: A Cost Analysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cyanide Poisoning
Keywords: Pharmacoeconomics
Cost effectiveness
Cyanide
Fire
Emergency Medical Services
Smoke Inhalation
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EMS patients possibly exposed to cyanide via poisoning or smoke exposure.

Brief summary: The costs to a rural emergency medical services (EMS) system of a change from a traditional cyanide antidote kit to a kit containing hydroxocobalamin alone are currently unknown. The purpose of this study is to use current EMS data to calculate the costs to a rural EMS system associated with the adoption of a hydroxocobalamin protocol for the treatment of suspected cyanide exposure.


Eligibility criteria: Inclusion Criteria:

* Included in Maine EMS database
* House Fire Victim
* Poisoning

Exclusion Criteria:

* No potential cyanide exposure
* Incomplete data available

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center Department of Emergency Medicine
state: Maine
Study officials:
affiliation: MaineHealth
name: Tania D Strout, PhD, RN, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00719316: Aliskiren and Muscle Sympathetic Nerve Activity
Official title: Effect of Aliskiren on Muscle Sympathetic Nerve Activity (MSNA) in Hypertensive Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Hypertension
Muscle Sympathetic Nerve Activity
Keywords: Renin inhibitor
Patients
ACE inhibitor or ARB
Chronic Kidney Disease
Hypertension
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The central hypothesis of this project is that Aliskiren causes a substantial decrease in MSNA in hypertensive patients with CKD.

Detailed description: Cardiovascular (CV) morbidity and mortality are frequently occurring problems in chronic kidney disease (CKD) patients. Apart from the so called traditional risk factors, also risk factors more or less specific to CKD contribute in the pathogenesis of these problems. There is strong evidence that the sympathetic hyperactivity, which often characterizes CKD, is one such factor. Previously, we have shown that angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) reduce but not normalize this sympathetic hyperactivity. We re-analysed the cohort of patients who were investigated in the past and subsequently treated according to present guidelines. The results show that, despite of treatment, the unfavourable relation between sympathetic hyperactivity and clinical outcome still exits. This might mean that treatment is insufficient. In present study, we want to study the effect of Aliskiren 300mg on sympathetic nerve activity.

Eligibility criteria: Inclusion Criteria:

* Patients with stable chronic kidney disease and hypertension: i.e. using antihypertensive drugs and/or blood pressure \> 145/90 mmHg when off medication.
* Patients on ACE inhibitor or ARB

Exclusion Criteria:

* Patients with diabetes mellitus
* Patients on renal replacement therapy
* Pregnant patients Using of antihypertensive which cannot be stopped
* Patients on immunosuppressive therapy and active nephrotic syndrome

Primary outcomes:
measure: Normalisation of muscle sympathetic nerve activity
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure and Blood tests
timeFrame: 1 year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center utrecht
Study officials:
affiliation: UMC Utrecht
name: P. J. Blankestijn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siddiqi L, Oey PL, Blankestijn PJ. Aliskiren reduces sympathetic nerve activity and blood pressure in chronic kidney disease patients. Nephrol Dial Transplant. 2011 Sep;26(9):2930-4. doi: 10.1093/ndt/gfq857. Epub 2011 Apr 5.
Clinical trial NCT05119816: Music Therapy Intervention During Kidney Biopsy.
Official title: Effect of Music Therapy Intervention on Heart Rate, Anxiety and Pain During Kidney Biopsy: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Kidney Dysfunction
Kidney Disease, Chronic
Keywords: music therapy
anxiety
pain
heart rate variability
satisfation
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Kidney biopsy (KB) is an invasive procedure that is very useful in diagnosing kidney disease in both the native kidney and the transplanted kidney. Patients undergo KB can feel anxiety and pain. Pain is considered one of the worst experiences for patients and anxiety affects the sympathetic nervous system, the endocrine system and the immune system. The aim of this preliminary study was to evaluate the influence of MTI as a complementary/nonpharmacological intervention on heart rate variability, anxiety and pain and promote more compliant behaviours during KB.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* not severe neurological or psychiatric conditions
* not hearing impairment

Exclusion Criteria:

* age under 18 years
* severe neurological or psychiatric conditions
* hearing impairment

Primary outcomes:
measure: State Trait Anxiety Inventory Y-1
timeFrame: 30 minutes before biopsy
measure: State Trait Anxiety Inventory Y-1
timeFrame: 1 hour after biopsy
measure: visual analogic scale (VAS)
timeFrame: through study completion - 5 minutes after biopsy
Secondary outcomes:
measure: heart rate variability
timeFrame: during biopsy procedure
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUConsorziale Policlinico Di Bari
Study officials:
References:
Clinical trial NCT03592316: Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
Official title: Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Amputation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 11
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: The LEAP protocol is a prospective cohort study of dysvascular patients designed to determine whether implementation of a multi-disciplinary lower extremity amputation protocol in the peri-operative period can shorten post-operative length of stay in patients undergoing trans-tibial or trans-femoral amputations. A consecutive sample of patients diagnosed with peripheral vascular disease and/or diabetes requiring major lower extremity amputation will be enrolled in the study and compared to retrospective controls.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age diagnosed with peripheral vascular disease and/or diabetes mellitus
* Patients undergoing trans-tibial or trans-femoral amputations

Exclusion Criteria:

* Patients undergoing amputation for trauma, malignancy, or necrotizing fasciitis with no dysvascular diagnosis
* Patients who have previously undergone an amputation
* Patients who were unable to function independently prior to admission
* Patients admitted to the ICU prior to surgery
* Attending surgeon does not approve of the patient being enrolled
* Prisoners
* Pregnant women

Primary outcomes:
measure: Hospital length of stay
timeFrame: Through hospital discharge, approximately 3 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: Up to 6 months after surgery
measure: Major adverse limb event
timeFrame: Up to 6 months after surgery
measure: In-hospital morbidity
timeFrame: Through hospital discharge, approximately 3 days after surgery
measure: Return to functional independence
timeFrame: Up to 6 months after surgery
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Leigh Ann O'Banion, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04400916: Topical Tranexamic Acid After Intravitreal Injections
Official title: Topical Use of Tranexamic Acid for Prevention of Subconjunctival Hemorrhage After Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subconjunctival Hemorrhage
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We aim to investigate whether topical administration of Tranexamic acid can reduce the occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal conditions.


Eligibility criteria: Inclusion Criteria:

Subjects receiving intravitreal injections as part of their routine ophthalmological care

Exclusion Criteria:

Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure, active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased risk for thromboembolic events, known sensitivity to the study drug

Primary outcomes:
measure: Subconjunctival hemorrahge
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02146716: Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms.
Official title: Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Withdrawal Syndrome
Keywords: RESC, alcohol withdrawal syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to measure the benzodiazepine amount prescribed during the withdrawal time.


Eligibility criteria: Inclusion Criteria:

* Men and women between 18 and 80 years,
* Patient with alcohol addiction,
* Patient needing alcohol withdrawal in a hospital.
* Patient with social Security,
* Patient with inform consent signed.

Exclusion Criteria:

* Pregnant women
* Minor.
* Major with guardianship.
* People without sufficient information because of troubles of cognitive functions, or without sufficient knowledge of French language.

Primary outcomes:
measure: Cushman Score measure after Energetic Resonance by Cutaneous Stimulation
timeFrame: daily during one week
Secondary outcomes:
measure: Anxiety depression scale
timeFrame: pre-screening, day 3 and day 7
measure: prescribed benzodiazepine amount
timeFrame: day 0 to day 7
measure: Analogic Visual Scale
timeFrame: before and after each Energetic Resonance by Cutaneous Stimulationsession at day 2, day 4 and day 6.
measure: Quality of life scale
timeFrame: day 0
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital croix rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Claude Augustin-Normand, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02565316: Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial
Official title: Efficacy of Nepeta Menthoides Boiss & Bohse Freeze Dried Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Anxiety
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 assess the efficacy of Nepeta menthoides as an anti anxiety herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial. A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz medical university, who having depression according to Persian-language version of the Beck Depression Inventory-Second edition and get score above 11 according to Persian version of Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and 1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation, allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism and patients who used substances or alcohol and patients who had indication for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd week, 4th week and then two weeks after the end of the intervention (in 6th week)


Eligibility criteria: Inclusion Criteria:

1. having depression according to Persian-language version of the Beck Depression Inventory-Second edition
2. get score above 7 according to Persian version of Beck Anxiety Inventory (BAI)

Exclusion Criteria:

1. pregnancy and lactation
2. allergy to N. menthoides and Lamiaceae family
3. patients with suicidal thoughts or previous suicidal attempt
4. patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism
5. patients who used substances or alcohol
6. patients who had indication for electroconvulsive therapy -

Primary outcomes:
measure: Persian version of Beck Anxiety Inventory (BAI)
timeFrame: 6 weeks
Secondary outcomes:
measure: side effects of intervention drugs
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00935116: Etoricoxib for Postoperative Pain After Thyroid Surgery
Official title: Effect of the Administration of Etoricoxib on Postoperative Pain and Quality of Recovery in Patients Undergoing Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: Hospital Padre Hurtado
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is evaluate the analgesic efficacy and safety profile of the Cox-2 specific analgesic Etoricoxib (arcoxia®) when administrated pre and postoperatively for controlling pain in adult patients undergoing thyroid surgery. Patients will be followed up in the immediate postoperative period, during the first postoperative (POD) day and in POD 2, 3 and 7. It is expected that with the addition of Etoricoxib, patients will experience less pain during the overall postoperative period and also a better quality of recovery when compared with the traditional analgesic regimen.


Eligibility criteria: Inclusion Criteria:

* age \>18 and \<70 years
* body weight within normal ranges
* ability to understand the use of pain assessment scales and the PCA device

Exclusion Criteria:

* known allergy to any of the drugs utilized
* contraindication to opioid and non-opioid analgesic drugs
* a history of bleeding disorders, peptic ulceration or anticoagulant use within the last month
* pregnant or breast-feeding patients
* history of known or suspected drug abuse or patients who had taken NSAIDs within 24 h prior to surgery

Primary outcomes:
measure: Maximum pain scores during postoperative period
timeFrame: every 6 hours, 24hours,48hours,72hours.
Secondary outcomes:
measure: Total amount of rescue analgesics
timeFrame: 24hours, 48hours, 72hours.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04823416: Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Official title: Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: seeking to identify risk factors leading to mortality in obstructed left cancer colon


Eligibility criteria: Inclusion Criteria:

* Patient aged above 18 years admitted at Mansoura University Hospitals complaining from intestinal obstruction due to obstructed left sided carcinoma.

Exclusion Criteria:

* Treatment with non-surgical intervention or spontaneous relief of obstruction

Primary outcomes:
measure: Risk Factors for Mortality in cases of obstructed left colonic Carcinoma
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: Eldakahlia
Study officials:
References:
Clinical trial NCT02829216: Graft-versus-host Disease Associated Myelosuppression
Official title: Functional Profiling of the Hematopoietic Stem Cell Niche in Graft Versus Host Disease Mediated Bone Marrow Insufficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abnormal Hematopoiesis
Allogenic Disease
Graft vs Host Disease
Keywords: myelosuppression
mesenchymal stromal cells
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AML/MDS receiving an allogeneic hematopoietic stem cell transplantation

Brief summary: The objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.


Eligibility criteria: Inclusion Criteria:

* age \>18
* acute myeloid leukemia
* myelodysplastic syndrome
* hematopoietic stem cell transplantation

Exclusion Criteria:

* not willing to take part

Primary outcomes:
measure: Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation
timeFrame: up to 1 year after allogeneic hematopoietic stem cell transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden
Study officials:
affiliation: Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden
name: Malte von Bonin, MD
role: PRINCIPAL_INVESTIGATOR
References: