louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02698982: Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly
Official title: Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly ; Moderate Risk Surgery
Keywords: elderly
postoperative cognitive dysfunction
postoperative delirium
depth of anesthesia
intraoperative blood pressure monitoring
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 41
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital length of stay.

Detailed description: Postoperative cognitive impairment (delirium and cognitive dysfunction) are frequent and feared complications in the elderly; they increase the postoperative morbidity and mortality, worsen the cognitive and functional outcome with loss of independence and increase the hospitalization length and costs . However, the etiology of these postoperative cognitive impairment, although probably multifactorial, remains unclear and strongly debated.

The investigators hypothesize that excessive anesthesia depths associated with intraoperative hypotension may play a critical role in the pathogenesis of cognitive impairment following surgery.

Eligibility criteria: Inclusion Criteria:

* elderly patients (over the age of 70) undergoing elective moderate risk surgery requiring a general anesthesia
* Patients who provide written informed consent
* patient fluent in french

Exclusion Criteria:

* Patients under 70 years of age
* Surgery under locoregional anesthesia or emergent surgery or minor risk surgery
* Patients requiring invasive blood pressure monitoring (for medical reason or high risk surgery)
* Patients with arrhythmia and/or atrial fibrillation
* Patients with preoperative delirium or cognitive dysfunction (moca test \< 26)
* Patients not fluent in French
* Patients without the capacity to give written informed consent or refusal of consent
* Patients undergoing surgery or included in another protocol within 3 months

Primary outcomes:
measure: postoperative delirium detected by the Confusion Assessment Method (CAM)
timeFrame: 3 day postoperative
Secondary outcomes:
measure: postoperative change in cognitive function detected by a battery of neuropsychological test.
timeFrame: baseline and 1 week and 3 month postoperative
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme hospital
name: Luc Van Obbergh, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05904782: Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients With Advanced Cancer
Official title: Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients With Advanced Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2023-06-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To learn more about the experience and wellbeing of people who provide care for cancer patients.

Detailed description: OBJECTIVES

Primary Objectives:

The primary objective of this proposal is to identify relevant themes and content essential to adapt PAT to a caregiving in advanced cancer context (PAT-C) and develop a Brief (5-session) version of PAT-C. Findings from this study are essential to inform future RCTs to test the feasibility, efficacy, dose and explore potential mediators of treatment outcomes of this intervention.

Secondary Objectives:

The secondary objective is to characterize psychosocial distress and psychosocial health of caregivers in the supportive care clinic. This data will be essential to inform appropriateness of the supportive care clinic as a potential site for future RCTs (i.e., determine if there are enough caregivers in this clinic who might benefit from this specific supportive care strategy).

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Males and female adults ≥18 years
* Able to read and speak English
* Caregiver of a patient diagnosed with stage IV solid malignancy, with whom they have been residing for \>6 months
* Access to necessary resources for participating in a technology-based intervention (i.e., telephone, internet access)

Exclusion Criteria:

* Current participation in consistent (self-defined) psychotherapy
* Caregivers who are considered part of a vulnerable population (i.e. cognitively impaired (self-reported or patient-reported), pregnant, military personnel) will not be eligible.

Primary outcomes:
measure: Quality of Life questionnaire (Qol)
timeFrame: through completion of study; approximately 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Juliet Kroll
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03517982: Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan
Official title: MyOra® (Mycophenolate Mofetil) Post-Authorization Safety Study for Prophylaxis in de Novo Renal Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant
Keywords: MyOra
Mycophenolate Mofetil
End stage renal disease
De novo Renal transplant
Post authorization safety study
Immunosuppressant
Cohort study
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were enrolled from a single public hospital in Jordan

Brief summary: The purpose of this observational study was to assess the safety and efficacy of generic mycophenolate mofetil in de novo renal transplant patients in Jordan where no visits or intervention(s) additional to the daily practice were performed.

Detailed description: A single center, observational, open-label, longitudinal, prospective study combined with retrospective data collection for 12 de novo renal transplant patients. Ten patients were prospectively followed for 12 months after receiving MyOra® (mycophenolate mofetil) and two patients were previously on MyOra® (mycophenolate mofetil), thus their data was retrospectively collected from their hospital records and all relevant workup tests results. Outcomes include occurrence of AEs and proportion of patients with normal graft function.

Eligibility criteria: Inclusion Criteria:

* Patient received de novo renal transplant
* Patient treated with MyOra® according to the attending physician's judgment (either post-transplant or induction)
* Patient provided written informed consent

Exclusion Criteria:

* Hypersensitivity to mycophenolate mofetil, mycophenolic acid (MPA) or any of the constituents of MyOra®

Primary outcomes:
measure: Incidence, severity and relationship of adverse events (AEs) to the Study medication
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with normal graft function
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Prince Hamza Hospital
Study officials:
References:
Clinical trial NCT02158182: Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
Official title: Comparison of Three Different Schemes:Lactulose, L-ornithine L-aspartate, or Rifaximin, Versus Placebo, as Primary Prophylaxis of the Development of Hepatic Encephalopathy After Acute Variceal Bleeding in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Keywords: Hepatic Encephalopathy
Acute Variceal Bleeding
Cirrhosis
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2014-06-06
Enrollment: 88
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: PREVENTION

Brief summary: The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding


Eligibility criteria: Inclusion Criteria:

-Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria

Exclusion Criteria:

* Age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder or dementia, presence of active bacterial or fungal infections, receiving antibiotics for any cause, previous diagnosis of hepatic encephalopathy and receiving therapy with lactulose, rifaximin, L-ornithine L-aspartate, source of bleeding different from variceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renal failure. Therapy in the previous six months with any of the drugs that will be used in this clinical trial.

Primary outcomes:
measure: Development of clinical hepatic encephalopathy
timeFrame: 7 days
Secondary outcomes:
measure: Development of minimal hepatic encephalopathy
timeFrame: 7 days
Other outcomes:
measure: Development of adverse effects
timeFrame: 7 days
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de Mexico
Study officials:
References:
citation: Higuera-de-la-Tijera F, Servin-Caamano AI, Salas-Gordillo F, Perez-Hernandez JL, Abdo-Francis JM, Camacho-Aguilera J, Alla SN, Jimenez-Ponce F. Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. Can J Gastroenterol Hepatol. 2018 Jul 10;2018:3015891. doi: 10.1155/2018/3015891. eCollection 2018.
Clinical trial NCT01319682: The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion
Official title: Intravenous Lidocaine for Effective Pain Relief After Posterior Lumbar Spinal Fusion: a Prospective, Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Pain
Preemptive
Lidocaine
Intravenous
Lumbar fusion
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion.

A total of 54 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.

Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.


Eligibility criteria: Inclusion Criteria:

* 1-level posterior lumbar fusion

Exclusion Criteria:

* mental change
* allergy to local anesthetics
* chronic analgesics user

Primary outcomes:
measure: Postopeartive pain measured using Visual analogue scale at postoperative 4hour
timeFrame: post op 4hour
Secondary outcomes:
measure: visual analogue scale 12 hour
timeFrame: Post op 12 hour
measure: visual analogue scale 24hour
timeFrame: Post op 24 hour
measure: Visual analogue scale 48hour
timeFrame: Post Op 48hour
measure: Opioid consumption 4hour
timeFrame: Post Op 4hour
measure: Opioid consumption 24hour
timeFrame: Post op 24 hour
measure: Opioid consumption 12 hour
timeFrame: Post Op 12 hour
measure: Opioid consumption 48hour
timeFrame: Post Op 48 hour
measure: FPB 4 hour
timeFrame: Post Op 4 hour
measure: FPB 12 hour
timeFrame: post op 12 hour
measure: FPB 24 hour
timeFrame: Post Op 24 hour
measure: FPB 48 hour
timeFrame: Post Op 48 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ChungAng University
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyun Kang, Ph.D.,
role: STUDY_CHAIR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Young-Baeg Kim, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8.
Clinical trial NCT01209182: In Vitro Detection of Tissue Abnormality
Official title: In Vitro Detection of Tissue Abnormality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: LS BioPath
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 121
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 2 phase study: Phase 1 - Validation of safety and accuracy when used ex-vivo to image excised breast surgery specimens Phase 2 - To guide surgeon's decision to re-excise additional margins during primary operation
Primary purpose: TREATMENT

Brief summary: Intraoperative ex-vivo use of the ClearEdge Imaging Device in Breast Conserving Surgery to image the excised tissue surgical margins. The study is designed to demonstrate reduction in the need for repeat surgeries after breast conserving surgeries by using the ClearEdge as an adjunct imaging device to the standard of care.

Detailed description: Intraoperative real-time margin assessment of breast conserving surgeries can reduce the need for repeat operations due to cancer involved margins. Repeat operations result in excessive removal of benign tissue, increased risk for infection, slower healing and inferior cosmetic results. In the current standard of care, the status of the margins is determined by pathology only several days after surgery. An intraoperative assessment of the margins enables complete tumor excision in a single surgery.

The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.

ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients aged 25-80 who are scheduled for surgical excision of tissue.

Exclusion Criteria:

* No prior history of surgery at location of current surgery.

Primary outcomes:
measure: •Accuracy of LS BioPath TOUCH device compared to pathology
timeFrame: 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: St. Mary's
state: California
Study officials:
affiliation: St. Mary's Medical Center
name: Michael Lagios, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023982: Pectoralis and Serratus Nerves Block in Thoracic Surgery
Official title: Ultrasound Guided PECs II (Pectoralis and Serratus Nerves) Block in Patients Undergoing a Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anesthesia
Surgery
Block
Thoracic Injury
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves block) has been described for pain control after thoracic surgery, one of the indications to perform this method is analgesia for surgeries or procedures involving lateral chest wall

Detailed description: The PECs I block was found to be very effective after breast cancer surgery and sub-pectoral prosthesis for pain control management.

This block is provided by injection into another myofascial plane, this time between pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.PECs II block is simple in performance with a high success rate and minimal incidence of complications, especially, if used ultrasound approach that gives a good understanding of anatomy of the lateral thoracic wall.

In present clinical trial we are going to compare PECs block for pain control with traditional pain management techniques based on IV opioids and NSAIDs treatment in patient undergoing thoracic surgery in early postoperative period.

Eligibility criteria: Inclusion Criteria:

1. All patients undergoing thoracic surgery, older ≥18 years
2. Patients who meet criteria of ASA I-II-III class.

Exclusion Criteria:

1. Patients who will be unconscious or mentally incompetent
2. Patients refusal to participate in the study
3. ASA -IV -V
4. Patient with coagulopathy
5. Hemodynamically unstable (systolic BP \< 90, HR \> 100)
6. Allergy to local anesthetic drugs or opioids
7. Pregnant patient
8. History of opioid abuse

Primary outcomes:
measure: Comparison Visual Analog Score between groups
timeFrame: First 24 hours from the surgery
Secondary outcomes:
measure: Total NSAIDs dosage (mg) in the PACU and department
timeFrame: First 24 hours from the surgery
measure: Length of hospital stay
timeFrame: up to 21 days
measure: Total morphine dosage (mg) in the PACU and department
timeFrame: First 24 hours from the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04586582: ST-Segment Resolution as a Marker for Myocardial Scar in ST-Segment Elevation Myocardial Infarction
Official title: The First Affiliated Hospital of Chongqing Medical University.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 42 patients.

Brief summary: Clinical studies found that poor ST-segment resolution (STR) in electrocardiogram (ECG) occurred in major adverse cardiovascular events (MACE), arrhythmia and heart failure was significantly higher . In clinical work, in patients have poor ST-segment decline, the investigators found by CMR-LGE the corresponding myocardium become thinner and other signs of myocardial scar.

The investigators aimed to establish whether poor ST-segment resolution in ECG, as well as CMR-LGE, could detect the presence of myocardial scar in early STEMI patients. In order to provide convenient, cheap and widely used test method for patients who cannot tolerate CMR-LGE.

42 STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured on the baseline and 24 hours after PCI. The study population was divided into two groups by late gadolinium enhanced cardiac magnetic resonance (LGE- CMR), with transmural myocardial scar (\>75%) or non-transmural myocardial scar (\<75%).


Eligibility criteria: Inclusion Criteria:

1. Single-branch coronary artery stenosis or occlusion
2. Restoration of coronary perfusion to TIMI flow grade 3 after PCI

Exclusion Criteria:

1. A prior history of the acute coronary syndrome
2. Coronary revascularization
3. Severe chronic kidney disease
4. Intracardiac pacing leads or other implants precluding CMR-LGE
5. Hemodynamic instability
6. Known claustrophobia

Primary outcomes:
measure: ST-segment resolution<40.15%
timeFrame: 1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.
measure: ST-segment resolution>40.15%
timeFrame: 1) Emergency admission: ST-segment elevations were measured. 2) 24 hours after PCI: ST-segment elevations were measured. 3) 7 days after PCI: CMR-LGE was performed.
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The first affiliated hospital of Chongqing medical university
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dongying Zhang, phD.
role: STUDY_DIRECTOR
References: