louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02015182: Bupivacaine Pharmacokinetics Following TAP Block
Official title: Bupivacaine Pharmacokinetics in Children Following Transversus Abdominis Plane Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transversus Abdominis Plane Block
Keywords: Bupivacaine
Sensorcaine
Population pharmacokinetics
Children
Pediatrics
Transversus abdominis plane (TAP) block
Regional Anesthesia
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing TAP block for postoperative pain control

Brief summary: The aims of this study are to determine population PK parameters of bupivacaine in children following TAP block using a population-based PK approach, and to evaluate the influence of patient covariates on drug disposition.

Detailed description: The number of published pediatric studies on the use of transversus abdominis plane (TAP) block has increased in recent years. The transversus abdominis plane (TAP) block has been used for postoperative analgesia for surgery to the abdominal wall and involves the injection of local anesthetic solution into a plane between internal oblique (IO) and transversus abdominis (TA) muscles. The TAP block has the advantage of providing unilateral analgesia in instances of non-midline abdominal incision and is particularly useful in cases where epidural blockade is either contraindicated or technically or logistically not feasible. Bupivacaine and ropivacaine have been used as local anesthetics for TAP blocks in published studies to date. However, no data exist regarding the pharmacokinetics of bupivacaine after TAP block in children. The aims of this study are to determine population pharmacokinetic (PK) parameters of bupivacaine in children following a TAP block, using a population-based PK approach.

Eligibility criteria: Inclusion Criteria:

* Patients receiving a TAP block as part of routine anesthetic management
* Patients older than 3 months and less than 18 years of age
* Patients weighing ≥ 6 kg
* Patients with American Society of Anesthesiologists (ASA) score 1-3

Exclusion Criteria:

* Patients with known severe preexisting liver disease
* Patients with known severe (i.e. requiring dialysis) preexisting renal disease
* Patients who will be discharged the day of surgery
* Refusal to consent

Primary outcomes:
measure: Population pharmacokinetics of bupivacaine and the influence of patient covariates on drug disposition
timeFrame: 0 - 360 minutes after the TAP block is performed
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jason Hayes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06432582: hepatomiR cACLD Study
Official title: Assessment of a hepatomiR Cut-off for Predicting Specific Hepatic Decompensation Events in Advanced Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Liver Disease and Cirrhosis
Chronic Liver Disease
Portal Hypertension
Keywords: hepatomiR
micro-RNA
hepatic decompensation
ACLD
Lead sponsor: Karl Landsteiner University of Health Sciences
Sponsor class: OTHER
Collaborators: name: University Hospital St. Polten
First posted: 2024-05-29
Enrollment: 156
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: The study population is made up of patients with compensated advanced chronic liver disease (cACLD) regardless of etiology; cACLD will be defined as per the Baveno VII consensus (LSM values: ≥ 10 kPa ACLD, less than 10 kPa non-ACLD).

Brief summary: This study looks to gather data on hepatomiR, a CE-certified test already intended for gauging liver-related outcomes, in order to define a cut-off regarding specific decompensation events (ascites, variceal hemorrhage, hepatic encephalopathy) in chronic liver disease (CLD). Based on these data, it is aimed to advance the current understanding of factors driving decompensation, with potential repercussions for future risk management and therapy.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Chronic liver disease (more than 6 months)
* LSM ≥ 10 kPa
* Outpatient at the Clinical Department of Internal Medicine II, University Hospital St. Pölten
* Signed patient consent form

Exclusion Criteria:

* Age older than 18 years
* Pregnancy
* Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread

Primary outcomes:
measure: Occurrence of any hepatic decompensation event (per patient)
timeFrame: 12 months
Secondary outcomes:
measure: Number and type of individual decompensation events (per patient)
timeFrame: 12 months
measure: Number of hospital admissions (per patient)
timeFrame: 12 months
measure: Number of acute on chronic liver failure events (per patient)
timeFrame: 12 months
measure: Number of ICU (intensive care unit) admissions (per patient)
timeFrame: 12 months
measure: Development of hepatocellular cancer or cholangiocarcinoma (per patient)
timeFrame: 12 months
measure: Number of deaths
timeFrame: 12 months
Other outcomes:
Locations:
city: St. Pölten
country: Austria
facility: University Hospital St. Pölten
state: Lower Austria
Study officials:
affiliation: Karl Landsteiner University of Health Sciences
name: Andreas Maieron, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02189382: Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2014-07-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age;
* provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* complete a confidentiality disclosure agreement;
* be in good general health as determined by the Investigator/designee;
* agree not to participate in any other oral/dental product studies during the course of this study;
* agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
* agree to refrain from the use of any non-study oral hygiene products;
* agree to return for all scheduled visits and follow study procedures; and.
* have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge

Exclusion Criteria:

* self-reported pregnancy or nursing;
* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* active treatment of periodontitis;
* fixed facial orthodontic appliances;
* a history of kidney stones;
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
* any diseases or conditions that might interfere with the safe completion of the study; or
* an inability to undergo any study procedures.

Primary outcomes:
measure: Change From Baseline Air Challenge
timeFrame: 30 days
Secondary outcomes:
measure: Change From Baseline in Tactile Threshold
timeFrame: 30 days
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Silverstone Research Group
state: Nevada
Study officials:
References:
Clinical trial NCT02749682: Relationship Between Constipation and Inguinal Hernia
Official title: Impact of Chronic Constipation on the Development Inguinal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Constipation
Keywords: Nyhus classification
constipation severity scale
groin hernia
Lead sponsor: Siverek Devlet Hastanesi
Sponsor class: OTHER
Collaborators: name: Harran University
First posted: 2016-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study group: 100 patients with groin hernia above age of 18 kontrol group: 100 healthy volunteers

Brief summary: The purpose of this study is to asses the effect of chronic constipation on formation of inguinal hernia using Constipation Severity Scale.

Detailed description: Causes of inguinal hernia are known to be multifactorial, although not fully understood. Besides family history, and connective tissue diseases, the sudden increase in abdominal pressure as heavy lifting, chronic constipation , coughing, straining , situations such as difficulty urinating facilitate the formation and emergence of hernia.

Constipation severity scale(CSS) was developed by Varma et al in 2008. CSS is a scale to determine the individuals defecation frequency, the intensity and difficulty during defecation.CSS has three subscales including Pain, Congestion stool and Large Intestine laziness(0-73 points).High scores indicate that serious symptoms.

Investigators found no studies that show how constipation impact on groin hernias. Investigators are planning to understand the effect of constipation on direct and indirect hernia formation.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers(n:100)
* patients above age of 18(n:100)
* patients with groin hernia(n:100)

Exclusion Criteria:

* previous inguinal hernia surgery
* patients who did not accept the procedure
* patients under age of 18

Primary outcomes:
measure: Impact of chronic constipation on the development inguinal hernia
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harran University
name: Ali Uzunköy
role: STUDY_DIRECTOR
affiliation: Şişli Etfal Hospital
name: Bülent Çitgez
role: STUDY_DIRECTOR
References:
Clinical trial NCT01820182: Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule
Official title: Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Gastrointestinal Bleedings
Méléna
Angiodysplasia
Polyps
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
Collaborators: name: Capso Vision, Inc.
First posted: 2013-03-28
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.

Detailed description: Objectives

Main objective

To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k\>0,6

Secondary objectives

To compare the sensitivity and specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* obscure digestive bleeding justifying capsule endoscopy
* complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation
* absence of concomittent ongoing study
* absence of occlusive symptoms of suspected Crohn's disease nor of previous small bowel radiotherapy
* filled inform consent
* no implanted pace maker
* patient being affiliated to the CPAM

Exclusion Criteria:

* under 18 years old
* oral iron within 8 days before capsule endoscopy
* gastroparesis
* pacemaker
* swallowing troubles
* presence of oclusive symptoms suspected Crohn's disease nor of previous small bowel radiotherapy
* pregnancy or risk of pregnancy without efficient oral contraception
* absence of written informed consent

Primary outcomes:
measure: number of discordant films between the two capsules with two different readers
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Saurin JS Jean Christophe, Msd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02185482: Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus
Official title: Physician Led Counseling for Depression in Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Type 2 Diabetes Mellitus
Keywords: Psychological counselling
Randomized single blind study
Depression
Diabetes
Lead sponsor: Adwin Life Care
Sponsor class: INDUSTRY
Collaborators: name: NMP Medical Research Institute
First posted: 2014-07-09
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality physician's care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.


Eligibility criteria: Inclusion Criteria:

* Eligible patients are ambulatory,
* Had adequate hearing to complete a telephone interview,
* Diabetic patients screened for depression

Exclusion Criteria:

* Currently in care with a psychiatrist;
* Diagnosis of bipolar disorder or schizophrenia;
* Use of antipsychotic or mood stabilizer medication
* Mental confusion on interview, suggesting significant dementia.

Primary outcomes:
measure: change in depression using SCL-90 depression scale
timeFrame: Change from baseline to six month
Secondary outcomes:
measure: Glycemic control measured using glycosylated hemoglobin levels
timeFrame: Change from baseline to six month
Other outcomes:
measure: Global assessment of improvement using Patient Global Impression
timeFrame: Change from baseline to six months
Locations:
city: Kaithal
country: India
facility: NMP Medical Research Institute
state: Haryana
city: Jaipur
country: India
facility: GyanSanjeevani
state: Rajasthan
Study officials:
affiliation: NMP Medical Research Institute
name: Ram Sharma, MD
role: STUDY_DIRECTOR
affiliation: Kaithal Civil Hospital
name: Naresh C Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06966882: Research on the Real-World Community Application of Large Language Models
Official title: Research on the Real-World Community Application of Large Language Models
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ophthalmic Diseases (Specific Types Not Restricted)
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 314
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample or primary care clinic

Brief summary: There is an imbalance between the supply and demand of eye care services, especially in local communities and remote areas. To address this, it's important to use new intelligent technologies to expand the reach of eye disease screening and treatment. Large language models (LLMs) are a type of deep learning technology that can learn from large amounts of text and generate human-like language to help with medical tasks such as diagnosing diseases and answering health-related questions. The investigator's team has previously developed a localized LLM capable of answering ophthalmology-related medical questions. Building on this, this study plans to use a screening-based trial design to explore how accurately the LLM can make referral decisions for eye diseases, diagnose conditions, recommend appropriate tests, and receive user feedback in real-world community settings. The goal is to improve the ability to screen for eye diseases in grassroots and regional areas.


Eligibility criteria: Inclusion Criteria:

* Participants of any age and gender
* Belonging to one of the following ophthalmic categories: Patients requiring specialist referral；Patients manageable at community level；Individuals without ocular pathology
* Voluntary participation with written informed consent

Exclusion Criteria:

* Investigator-determined clinical contraindications

Primary outcomes:
measure: Metrics for Evaluating Referral Accuracy of Large Language Models: Sensitivity, Specificity, Accuracy, Positive Predictive Value, Negative Predictive Value.
timeFrame: through study completion, up to 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02884882: Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia
Official title: Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia: Neuropsychological and Neurophysiological Study of Changes in Emotional Experiences
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke Basal Ganglia
Keywords: Stroke Basal Ganglia
Emotional change
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.


Eligibility criteria: Inclusion Criteria:

* For cases :

  * right-handed patient
  * ischemic or hemorrhagic stroke older than 3 months with single lesion preferably less than 20 mm in diameter affecting the basal ganglia and sparing cortex
  * Rankin score estimated prior stroke must be equal to 0 and after stroke \<3 (at inclusion).
* For participants control : right-handed patient

Exclusion Criteria:

* For cases : severe aphasia - Prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - History of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter Fazekas a score of\> 2 (periventricular or subcortical) - Contraindications to MRI
* For participants control : No history neurosurgical - No history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - No psychotropic treatment

Primary outcomes:
measure: The emotional experience
timeFrame: Baseline
Secondary outcomes:
measure: The recognition of facial expressions
timeFrame: Baseline
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire de Brest
Study officials:
affiliation: Centre Hospitalier Régional de Brest
name: Serge TIMSIT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02272582: A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS)
Official title: A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Montreal Heart Institute
name: Somahlution LLC
First posted: 2014-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A prospective randomized, double-blinded, comparative within-person study to evaluate the use of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.

Detailed description: Saphenous vein (SV) harvesting will be performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions. Imaging, using 64-slice or better MDCT, will be completed 4-6 weeks and 3 months post surgery (CABG) procedure.

Eligibility criteria: Inclusion Criteria:

* Patient is to undergo primary, multi-vessel CABG with at least two saphenous vein grafts (SVGs)

Exclusion Criteria:

* Patient has in-situ Internal Mammary Artery graft(s) (IMA) only, (no SVG or free arterial grafts)
* Patients has had prior CABG or planned concomitant valve surgery or aortic aneurysm repair.

Primary outcomes:
measure: Mean wall thickness of paired grafts within 100 participants measured at 4-6 weeks and 3 months post-CABG surgery using 64-slice multidetector computed tomography (MDCT) angiography.
timeFrame: 4-6 weeks to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Louis P Perrault, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ben Ali W, Voisine P, Olsen PS, Jeanmart H, Noiseux N, Goeken T, Satishchandran V, Cademartiri F, Cutter G, Veerasingam D, Brown C, Emmert MY, Perrault LP. DuraGraft vascular conduit preservation solution in patients undergoing coronary artery bypass grafting: rationale and design of a within-patient randomised multicentre trial. Open Heart. 2018 Apr 13;5(1):e000780. doi: 10.1136/openhrt-2018-000780. eCollection 2018.