louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04796363: US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
Official title: Ultrasound Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Breast Cancer
Keywords: Erector spinae plane block
Ultrasound guided
Breast cancer surgery
Natural killer cells
Analgesia
spread
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective interventional study

Detailed description: The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery.

The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB.

The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery.

Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.

Eligibility criteria: Inclusion Criteria:ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia

-

Exclusion Criteria:

1. Patient refusal.
2. Allergy or contraindication to any of the studied medications or anaesthetic agents.
3. Chronic opioid analgesic use.
4. Pregnancy.
5. Morbid obesity (BMI ≥ 40 kg/m2).
6. Scoliosis or any vertebral anomalies or previous spinal surgeries.
7. Infection at the site of injection or any other contraindication for regional anaesthesia.
8. Duration of surgery more than 90 minutes.
9. Renal impairment.

Primary outcomes:
measure: Analgesic efficacy of ESPB
timeFrame: Up to 24 postoperative hours
Secondary outcomes:
measure: Spread of the injected dye in Erector Spinae plane
timeFrame: Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.
measure: Dermatomal sensory coverage of ESPB
timeFrame: Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.
Other outcomes:
measure: Immunomodulation of ESPB
timeFrame: Before ESPB and 24 hours after the block.
Locations:
city: Alexandria
country: Egypt
facility: Medical Research Institute, Alexandria University
Study officials:
affiliation: University of Alexandria
name: Emad Eldin Abd El Monem Arida, Professor
role: STUDY_CHAIR
References:
citation: Abdella AMMR, Arida EEAEM, Megahed NA, El-Amrawy WZ, Mohamed WMA. Analgesia and spread of erector spinae plane block in breast cancer surgeries: a randomized controlled trial. BMC Anesthesiol. 2022 Oct 17;22(1):321. doi: 10.1186/s12871-022-01860-w.
Clinical trial NCT03470363: Effect of Spinal or Sevoflurane Anesthesia on Neutrophil Activation During Knee Surgery With Pneumatic Tourniquet
Official title: Effect of Spinal or Sevoflurane Anesthesia on Neutrophil Activation After Tourniquet Induced Ischemia-reperfusion in Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Surgery With Tourniquet
Keywords: total knee arthroplasty
tourniquet
sevoflurane
spinal anesthesia
myeloperoxidase
elastase
neutrophil
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Aim of study : Assessement of neutrophil activation during ischemia reperfusion associated with tourniquet use for total knee arthroplasty. This activation was compared in a group of patient scheduled for spinal anesthesia and for sevoflurane anesthesia

Detailed description: Aim of study : Assessement of neutrophil activation during ischemia reperfusion associated with tourniquet use for total knee arthroplasty. This activation was compared in a group of patient scheduled for spinal anesthesia and for sevoflurane anesthesia This activation was assessed by plasma myeloperoxidase and elastase measurements in four consecutive blood samples during and after surgery (before surgical incision and 1, 3, 24 hours following tourniquet release.

Eligibility criteria: Inclusion Criteria:

* Total knee arthroplasty under spinal or sevoflurane anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists class 3 and 4
* vascular disease of the lower limbs
* cardiac or respiratory disease
* immune disorder

Primary outcomes:
measure: Changes in plasmatic concentration of myeloperoxidase and elastase
timeFrame: Before surgical incision and one hour after tourniquet release
measure: Changes in plasmatic concentration of myeloperoxidase and elastase
timeFrame: Before surgical incision then 3 and 24 hours after tourniquet release
Secondary outcomes:
measure: Changes in plasmatic concentration of endothelial biomarkers
timeFrame: Before surgical incision and one hour after tourniquet release
measure: Changes in plasmatic concentration of endothelial biomarkers
timeFrame: Before surgical incision then 3 and 24 hours after tourniquet release
Other outcomes:
Locations:
Study officials:
affiliation: University of Liege
name: Jean-François Brichant, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00824486: Home Safety Intervention Using a Safe Home Model
Official title: A Randomized Trial of a Home Safety Intervention Using a Safe Home Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: child
injury prevention
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2009-01-16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This project seeks to determine the efficacy of safety education using a safe home model. The 4 X 8 ft. model is designed to look like a house; each of 4 "rooms" has a focused safety message. Families will be enrolled in the clinic and randomized to one of two groups, the safe home model group and the printed safety education materials (TIPP materials) group. The investigators will compare the retention of safety information among caregivers instructed using these two methods. The hypothesis is that families in the safe home model group will have improved retention of safety information.


Eligibility criteria: Inclusion Criteria:

* Caregivers of children younger than 6 years old

Exclusion Criteria:

* Language other than English or Spanish

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT04314986: Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Arthrosi Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A study to assess multiple ascending doses of AR882 in healthy adult males.


Eligibility criteria: Inclusion Criteria:

* Screening serum uric acid level ≥ 4.5 mg/dL (268 µmol/L) and \< 9 mg/dL (535 µmol/L)
* Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
* Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History and/or presence of drug addiction or excessive use of alcohol

Primary outcomes:
measure: To evaluate the safety profile of AR882 based on incidence of adverse events
timeFrame: 22 Days
measure: To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
timeFrame: 22 Days
measure: To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings
timeFrame: 22 Days
measure: To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings
timeFrame: 22 Days
measure: Area under the curve (AUC) for plasma AR882
timeFrame: 15 Days
measure: Time to maximum plasma concentration (Tmax) for AR882
timeFrame: 15 Days
measure: Maximum plasma concentration (Cmax) for AR882
timeFrame: 15 Days
measure: Apparent terminal half-life (t1/2) for AR882
timeFrame: 15 Days
measure: Amount excreted (Ae) into urine for AR882
timeFrame: 15 Days
measure: Fractional Excretion (FEUA) for AR882
timeFrame: 15 Days
Secondary outcomes:
measure: PD profile following multiple doses of AR882
timeFrame: 15 Days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty, Ltd.
state: Victoria
Study officials:
References:
Clinical trial NCT00177086: Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
Official title: Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Calculi
Ureteral Calculi
Colic
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Manoj, Monga, M.D.
First posted: 2005-09-15
Enrollment: 76
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: This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.


Eligibility criteria: Inclusion Criteria:

* Age =\>18
* \<8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram

Exclusion Criteria:

* Subject with know hypersensitivity to Alfuzosin hydrochloride or any component of Alfuzosin hydrochloride tablets
* Pregnant/Nursing females
* Solitary kidney
* Renal insufficiency (Creatinine\>1.8)
* Urinary infection (fever \>101, positive urine culture, many bacteria on urinalysis)
* Moderate or severe hepatic insufficiency (Childs-Pugh categories B and C)
* Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since Alfuzosin blood levels are increased
* Other alpha-blockers
* Phosphodiesterase type 5 inhibitors for erectile dysfunction
* Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study

Primary outcomes:
measure: Spontaneous stone passage for distal ureteral calculi
timeFrame: increased
Secondary outcomes:
measure: Decrease the pain and narcotic use associated with stone passage
timeFrame: decrease
measure: Decrease the time to spontaneous passage
timeFrame: decrease
measure: Shift the size distribution of stones passed towards larger sizes
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota and VAMC Minneapolis
name: Manoj Monga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173186: Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
Official title: Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Septal Defects, Ventricular
Aortic Valve Insufficiency
Keywords: ventricular septal defect
aortic regurgitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 411
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: The major risk factors of aortic valve replacement in three outlet types VSD after surgical repair were the severity of preoperative AR and older operation age. For those patients with less than moderate degree AR preoperatively, AR progressed rarely and all in those with aortic valvar and subvalvar anomalies.

Detailed description: Progression of aortic regurgitation (AR) in repaired outlet (juxta-arterial, muscular outlet and perimembranous outlet) ventricular septal defect (VSD) remains unclear.

From 1987 to 2002, 411 patients with complete follow-up after repair of outlet VSD constituted the study population. Study end point was aortic valve replacement or mortality.

Aortic valve replacement was performed in seventeen patients (4.1%), in whom logistic regression showed only the severity of preoperative AR and age at VSD repair as the predictors. After excluding the eleven patients with endocarditis from analysis, there were 377 patients with none to mild AR (Group I) and 23 with moderate to severe AR (Group II) preoperatively. Total follow-up was 2,230 person-years. After VSD repair, the 5- and 10-year freedom from aortic valve replacement in Group I was 100%, and in Group II 50.2%. In Group II, ten patients received aortic valve replacement and 8 underwent valvuloplasty with VSD repair. One patient needed valve replacement four years later. Age at VSD repair was the predictor for aortic valve replacement. In Group I, AR progressed in four patients (1.2%, two juxta-arterial and two perimembranous outlet) 3.5 to 7.9 years later and was associated with aortic valvar or subvalvar anomalies. The event-free curves in three outlet types VSD showed no differences.

Although AR progressed rarely (probably not in muscular outlet type) in repaired outlet types VSD with none to mild preoperative AR, in the presence of aortic valvar or subvalvar anomalies, early surgical repair of the VSD is still warranted.

Eligibility criteria: Inclusion Criteria:

* ventricular septal defect patients receiving total repair from Jan, 1987 to Dec, 2002.
* follow up more than 1 year after operation

Exclusion Criteria:

* complex cardiac lesions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Pediatrics, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Mei-Hwan Wu, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06826586: Identification of Microplastics in Liver, Stomach, Blood, and Feces of Obese Patients and Their Association Analysis with Macrogenomics and Metabolomics.
Official title: Identification of Microplastics in Liver, Stomach, Blood, and Feces of Obese Patients and Their Association Analysis with Macrogenomics and Metabolomics.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity and Overweight
Keywords: microplastics
obesity
macro-genomic
metabolomics
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with obesity

Brief summary: The aim of this study was to identify and quantify microplastics in the stomach, liver, feces, and blood of obese patients to be treated with bariatric surgery by using a variety of advanced analytical techniques to explore the association between obesity and visceral microplastics, and to investigate the effects of microplastics on the visceral microbiota and metabolic profiles of obese patients by combining the macro-genomic and metabolomics approaches.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* BMI ≧30;
* proposed to undergo bariatric surgery and need to remove part of the liver tissue for fatty liver test;
* complete clinical data and basic information;
* willing to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Receive chemotherapy, radiotherapy, immunotherapy;
* have other history of digestive diseases;
* combined with malignant tumors;
* have serious cardiorespiratory insufficiency and other systemic diseases that affect the choice of treatment plan;
* not willing to participate in this study.

Primary outcomes:
measure: Differences in microbial communities
timeFrame: From the diagnosis of obesity, through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT01271686: 24-hour IOP-lowering Effect of 0.01% Bimatoprost
Official title: 24-hour IOP-lowering Effect of 0.01% Bimatoprost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraocular Pressure
Glaucoma
Ocular Hypertension
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension

Detailed description: Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP).

Design Prospective, open-label experimental study.

Setting Single tertiary ophthalmic clinic.

Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years).

Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions.

Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared with baseline.

Eligibility criteria: Inclusion Criteria:

* primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Women of childbearing potential previous glaucoma surgery presence of other eye disease

Primary outcomes:
measure: Nocturnal Intraocular Pressure (IOP) Change
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Shiley Eye Center
state: California
Study officials:
affiliation: University of California, San Diego
name: John Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.
Clinical trial NCT01555086: Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
Official title: Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Lymphadenectomy
Prostate cancer
Lead sponsor: Association of Urologic Oncology (AUO)
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 500
Sex: MALE
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: This study examines Limited versus extended pelvic lymphadenectomy.

Detailed description: This study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. Patients with indication to prostatectomy due to prostate cancer will be included.

Both extensions of lymphadenectomy are used in hospitals as a free choice. This study shell show if one method is more effective than the other.

Eligibility criteria: Inclusion Criteria:

* stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as Gleason-Score 7-10 or PSA \> 10 ng/ml)
* locally-operable tumor according to DRU/TRUS
* negative bone scan
* negative CT abdomen / pelvis
* general condition according to Karnofsky \>/= 80%
* written consent of the patient
* adequate hematological, renal and coagulation physiological functions
* Patient compliance and geographic proximity to allow adequate follow-up

Exclusion Criteria:

* Manifest secondary malignancy
* Secured metastasis by histologically or by imaging
* Myocardial infarction or stroke within the last 6 months
* Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 \<60 mmHg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
* Severe active or chronic infections (eg pos. HIV-Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
* severe psychiatric disease
* prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
* previous pelvic radiotherapy
* Patients in a closed institution according to an authority or court decision
* People who are in a dependent relationship or working relationship with the sponsor or investigator
* simultaneous participation in another clinical trial

Primary outcomes:
measure: PSA-progress
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of overall survival
timeFrame: 5 years
measure: Comparison of morbidity
timeFrame: 5 years
Other outcomes:
Locations:
city: Krefeld
country: Germany
facility: Krankenhaus Maria Hilf
state: Dießemer Bruch 80
city: Hamburg
country: Germany
facility: Martiniklinik am UKE
state: Martinistraße 52
city: Gronau
country: Germany
facility: St. Antonius-Krankenhaus
state: Möllenweg 22
city: Fulda
country: Germany
facility: Städtisches Klinikum Fulda
state: Pacelliallee 3-5
city: Aachen
country: Germany
facility: RWTH Aachen
state: Pauwelsstraße 30
Study officials:
References: