louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06763510: Comparison of the Effects of Two Different Local Anesthetics Used in Spinal Anesthesia
Official title: Comparison of the Effects of Two Different Local Anesthetics Used in Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Local Anaesthesia
Keywords: Spinal anesthesia
Local anesthetics
Thermoregulation
Baricity
Lead sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Fatih University
First posted: 2025-01-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study was conducted on 40 full-term pregnant women aged 18-40, classified as ASA I-II, who were scheduled for elective cesarean sections under spinal anesthesia. All patients included in the study were informed and gave their written and verbal consent.

Brief summary: Objective: This study aimed to compare the effects of two different local anesthetics with different baricity used in spinal anesthesia on thermoregulation.

Materials and Methods: The study was conducted on forty full-term pregnant women scheduled for elective cesarean sections under spinal anesthesia. At an operating room temperature of twenty-four degrees Celsius, peripheral body temperature was measured using temperature probes attached to the lower medial parts of the same side's lower and upper extremities, and central body temperature was measured with a tympanic thermometer. Isobaric levobupivacaine and hyperbaric bupivacaine were used in spinal anesthesia applications. After spinal anesthesia, tympanic temperature, arm and leg temperatures, mean arterial pressure, heart rate, and oxygen saturation were measured and recorded at baseline, the first, third, and fifth minutes, and every five minutes thereafter until the end of surgery.


Eligibility criteria: Inclusion Criteria:

* Term pregnant with elective cesarean section planned under spinal anesthesia
* ASA I-II
* 18-40 years old

Exclusion Criteria:

* patients in whom spinal anesthesia is contraindicated,
* patients with neuromuscular disease,
* alcohol and substance abusers,
* patients with a body mass index (BMI) \<18.5 kg/m² or \>35 kg/m²,
* those taking medications that may affect thermoregulation such as vasodilators,
* patients with thyroid disease,
* patients with fever and infection,
* patients with known allergies to study drugs.

Primary outcomes:
measure: Temperature
timeFrame: During operation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Fatih University
Study officials:
References:
Clinical trial NCT05927610: Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma
Official title: Evaluating the Role of Cerebrospinal Fluid (CSF) Cell-free DNA (cfDNA) as a Prognostic Biomarker in Glioblastoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glioblastoma
Keywords: Glioblastoma
CSF cfDNA
cerebrospinal fluid cell free DNA
Memorial Sloan Kettering Cancer Center
23-058
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to determine the utility of cerebrospinal fluid (CSF) cell-free DNA (cfDNA) as a prognostic biomarker in glioblastoma (GBM).


Eligibility criteria: Inclusion Criteria:

Cohort A

* Participants must be able to understand and be willing to sign a written informed consent document
* Age ≥ 18 years
* MRI with contrast-enhancing lesion concerning for high-grade glioma in absence of known systemic malignancy
* Clinical consensus of presumed diagnosis of high grade glioma between (1) neuroradiology (2) neurosurgery; and (3) principal investigator
* No prior tumor directed therapy
* Planned radiation therapy for glioblastoma
* Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast
* Patients must be willing to consent to MSK IRB#12-245

Cohort B

* Participants must be able to understand and be willing to sign a written informed consent document
* Age ≥ 18 years
* Histologic confirmed glioblastoma (WHO grade IV), IDH wild type per IHC
* No prior tumor-directed therapies except surgical resection or biopsy
* Patients who have gliadel wafers placed during upfront surgery are excluded
* Planned radiation therapy for glioblastoma
* Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast
* Patients must be willing to consent to MSK IRB#12-245

Exclusion Criteria:

Cohorts A and B

* Any case for which there is a medical contraindication or safety concern regarding a lumbar puncture under standard medical guidelines at MSK
* Refusal to undergo serial lumbar punctures

Primary outcomes:
measure: Overall Survival
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alexandra Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00930410: Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Official title: Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Neoplasms
Bile Duct Diseases
Keywords: pancreas neoplasms
bile duct diseases
Cholangiopancreatography, Endoscopic Retrograde
ERCP
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 50
Sex: ALL
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 endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.

Detailed description: Primary objective:

Obtain a tissular characterization of a biliary or pancreatic stenosis with a confocal microscope which is in direct contact of the stenosis during the Endoscopic Retrograde Cholangio-Pancreatography (ERCP).

Secondary objectives:

* Compare the result of this "optical biopsy" to a conventional biopsy.
* Tolerance

Eligibility criteria: Inclusion Criteria:

* Patients aged from 18 to older
* Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal.
* Signed consent

Non inclusion Criteria:

* Patient who have no indication for an ERCP
* Allergy to fluorescein
* Allergic rhinitis, asthma, eczema
* Pregnancy, breast feeding
* Patients with dialysis
* Patient with severe heart failure
* Patient with cirrhosis
* Hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy

Primary outcomes:
measure: The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology.
timeFrame: 2 days
Secondary outcomes:
measure: Study of the concordance between optical and histological biopsy
timeFrame: 2 days
measure: Frequency and grade of adverse effects induced by the confocal endomicroscopy
timeFrame: 2 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut PAOLI-CALMETTES
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grasse
Study officials:
affiliation: Institut Paoli-Calmettes
name: Marc GIOVANNINI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03586310: Evaluation of the Ear-EEG System for Sleep Monitoring in Healthy Subjects
Official title: Evaluation of the Ear-EEG System for Sleep Monitoring in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Monitoring
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Uneeg medical
First posted: 2018-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Subjects sleep multiple nights in their own home, wearing actigraph, PSG (PolySomnoGraphy) and ear-EEG sensors. The object of the study is to determine the applicability of ear-EEG for sleep monitoring.


Eligibility criteria: Inclusion Criteria:

Informed consent obtained and letter of authority signed before any study related activities

Age 18-50 years

-

Exclusion Criteria:

1. BMI (body mass index) \> 30
2. Previous stroke or cerebral haemorrhage and any other structural cerebral disease
3. Known or suspected abuse of alcohol or any other neuro-active substance
4. Use of hearing aid or cochlear implants
5. Allergic contact dermatitis caused by metals or generally prone to skin irritation
6. Narrow or malformed ear canals
7. Obstructive sleep apnea
8. History of sleep disorders or neurological diseases
9. Chronic pain
10. People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
11. Use of medication known to influence the user's sleep (antidepressants, sedatives, antipsychotic-, and pain relieving medication)
12. Teeth grinding (bruxism)
13. Pregnancy

Primary outcomes:
measure: Cohens kappa
timeFrame: At study completion (average of 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Preben Kidmose, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03595410: Nomograms to Precisely Predict Conditional Risk of Recurrence for Patients With Laryngeal Cancer
Official title: Development and Validation of Nomograms to Precisely Predict Conditional Risk of Recurrence for Patients With Laryngeal Cancer: a Single-institutional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Laryngeal Cancer
Keywords: risk of recurrence
Nomograms
Laryngeal cancer
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with laryngeal cancer

Brief summary: Advanced laryngeal squamous cell carcinoma (SCC) remains a highly morbid and fatal disease despite aggressive interventions. Mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the United States, with over 3500 deaths annually.The results of the Veterans Affairs Cooperative Studies Program Laryngeal Cancer Trial and subsequent studies demonstrated similar overall survival (OS) rates for organ preservation protocols involving radiotherapy (RT) or chemoradiotherapy (CRT) when compared to surgery, with the benefit of preserving the larynx in a large majority of patients. As such, the use of RT or CRT has become the predominant initial intervention for patients with laryngeal SCC.6 However, the prognosis of recurrent and persistent laryngeal SCC is particularly dire.In this study, we sought to identify preoperative predictors of survival for patients with recurrent or persistent laryngeal SCC in order to set patient expectations and address modifiable risk factors. Identification of predictors of survival may also identify patients who could benefit from novel therapeutic agents in a neo/adjuvant fashion. Herein,we examine a cohort of patients with recurrent or persistent laryngeal SCC after definitive RT/CRT who has undergone total laryngectomy in order to identify potential preoperative predictors of clinical outcomes.

Detailed description: Demographic, clinical, and survival data were abstracted. Death was verified via medical records and the social security death index. Primary outcome measures were OS (time from salvage laryngectomy to death from any cause), disease-specific survival (DSS; time from salvage laryngectomy to death from recurrent/persistent laryngeal SCC), and DFS (time from salvage laryngectomy to laryngeal SCC recurrence)

Eligibility criteria: Inclusion Criteria:

patients with a diagnosis of laryngeal squamous cell carcinoma

Exclusion Criteria:

multiple primarry malignant neo-plasms

Primary outcomes:
measure: Overall survival
timeFrame: Follow up 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Genglong Liu
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Genglong Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00960310: Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions
Official title: Randomized, Open-Label, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex (Reference) Following a 50 mg Dose in Healthy Subjects Under Fed Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Hirsutism
Keywords: Treatment
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Anapharm
name: Richard Larouche, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00598910: Effect of Omacor on Triglycerides in HIV Infected Subjects
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Investigate the Effect of Omacor (n-3 PUFA) on Lipid Parameters in HIV Infected Subjects Treated With HAART
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hyper-Triglyceridemia
Keywords: HIV infection
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 51
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: Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment


Eligibility criteria: Inclusion Criteria:

* Triglycerides between 200 and 800
* diagnosed HIV infection
* following HAART therapy

Exclusion Criteria:

* other malignant disease
* not compliant
* allergy against fish oil
* soy or olive oil

Primary outcomes:
measure: Percent change in serum triglycerides from baseline to treatment endpoint versus placebo
timeFrame: 12 weeks treatment
Secondary outcomes:
measure: Absolute change in serum triglycerides
timeFrame: 12 weeks
measure: Absolute and percent change in cholesterol and cholesterol subfractions
timeFrame: 12 weeks
measure: Absolute and percent change in apolipoprotein A and B
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Site 2
city: Hannover
country: Germany
facility: Site 1
city: London
country: United Kingdom
facility: Site 3
city: London
country: United Kingdom
facility: Site 4
city: London
country: United Kingdom
facility: Site 5
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Peters BS, Wierzbicki AS, Moyle G, Nair D, Brockmeyer N. The effect of a 12-week course of omega-3 polyunsaturated fatty acids on lipid parameters in hypertriglyceridemic adult HIV-infected patients undergoing HAART: a randomized, placebo-controlled pilot trial. Clin Ther. 2012 Jan;34(1):67-76. doi: 10.1016/j.clinthera.2011.12.001. Epub 2011 Dec 31.
Clinical trial NCT04891510: A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
Official title: A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mastectomy
Mammaplasty
Breast Reconstruction
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.


Eligibility criteria: Inclusion Criteria:

* Female;
* Documented history of previous breast surgery (either complete or partial mastectomy);
* Available harvest sites for fat grafting as documented by plastic surgeon;
* BMI \> 20;
* Anticipated harvested fat volume \> 50cc;
* Competency and willingness to provide consent

Exclusion Criteria:

* Suspected or known to be pregnant

Primary outcomes:
measure: Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site
timeFrame: Baseline, 90 day follow-up
measure: Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire
timeFrame: Baseline, 90 day follow-up
Secondary outcomes:
measure: Number of palpable masses from the fat grafting technique, as measured by a physical exam.
timeFrame: 90 day follow-up
measure: Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam
timeFrame: 90 day follow-up
measure: Presence of infection from the fat grafting technique, as measured by a physical exam
timeFrame: 90 day follow-up
measure: Presence seroma from the fat grafting technique, as measured by a physical exam
timeFrame: 90 day follow-up
measure: Assessment of wound healing from the fat grafting technique, as measured by a physical exam
timeFrame: 90 day follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian - Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: David Otterburn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05601310: Metabolic Characteristics of Type 2 Diabetes Mellitus Combined With Acute Myocardial Infarction: A Untargeted Metabolomics Study
Official title: 12,13-DHOME and Noradrenaline Are Associated With Occurrence of Acute Myocardial Infarction in Patients With Type 2 Diabetes Mellitus: A Untargeted Metabolomics Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Keywords: STEMI
Metabolomics
Biomarkers
Type 2 Diabetes Mellitus
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ① Patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent emergency PCI in Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University. ②In the Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University, coronary angiography showed negative coronary angiography or coronary artery CT showed \<50% obstruction in patients with non-coronary heart disease.

Brief summary: This study is a retrospective case-control study. In this study, through untargeted metabolomics, investigators identified several specific changed serum metabolites in T2DM patients with or without AMI and their functions/category. Moreover, researchers selected several endogenous candidate biomarkers with larger fold change for validation in expanded population to find biomarkers which effectively predict the development of STEMI in patients with T2DM.


Eligibility criteria: Inclusion Criteria:

* STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)".
* STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University.
* All diabetic patients meet the diagnostic criteria for type 2 diabetes.
* They agreed to be enrolled in the trial and signed the informed consent.

Exclusion Criteria:

* Combined with severe valvular disease or congenital heart disease, hypertension, chronic kidney disease, stroke, hyperlipidemia, previous history of coronary artery disease.
* Involved in acute infection, severe hepatic dysfunction, tumor, rheumatic immune disease.
* Incomplete clinical information.

Primary outcomes:
measure: There are differences in the metabolic profile of diabetic patients with or without combined acute myocardial infarction
timeFrame: December 16th, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Weiping Li
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Weiping Li, MD
role: STUDY_DIRECTOR
References: