louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01404793: SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation
Official title: The Use Of Solid Phase Micro Extraction For Metabolomic Profiling And Concomitant Measurements Of Rocuronium Bromide Levels In Recipients Of Orthotopic Liver Transplantations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Failure
Keywords: Liver Transplantation
Solid Phase Micro Extraction
Rocuronium
Metabolomics
Pharmacokinetics
Clinical Marker
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of Waterloo
First posted: 2011-07-28
Enrollment: 28
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 receiving liver transplants at University Health Network, Toronto General Hospital.

Brief summary: Standard anesthetic management of liver transplantation patients includes a general anesthetic using multiple drugs, including the neuromuscular relaxant rocuronium. Pharmacokinetic modelling of this agent has been poorly described during liver transplantation, which impacts on appropriate dosing of this agent within this population where plasma concentrations can vary with fluid shifts and hepatic drug metabolism during the various phases of liver transplantation. Plasma drug and drug metabolite concentrations will be measured using the technique of solid phase micro-extraction (SPME). Measuring and correlating the levels of rocuronium and other liver metabolites with the degree of post transplantation hepatic dysfunction may serve as a simple and cost-effective marker to aid diagnosis, identify those at risk of hepatic dysfunction and potentially grade the severity


Eligibility criteria: Inclusion Criteria:

* First time liver transplant recipients above 18 years of age
* Elective cadaveric or living donor liver transplant patients will be recruited

Exclusion Criteria:

* All patients under 18 years of age
* Unable to give consent

Primary outcomes:
measure: Plasma drug and drug metabolite concentrations
timeFrame: 5, 30, 60, 90, 120, 180, 240, 300, 450 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Marcin Wasowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04042493: Connect for Health Pediatric Weight Management Program
Official title: Dissemination and Implementation of Effective Childhood Obesity Treatment Innovations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Severe Obesity
Keywords: Overweight
Obesity
Pediatric
Implementation
Dissemination
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Denver Health and Hospital Authority
name: Prisma Health-Upstate
First posted: 2019-08-02
Enrollment: 19304
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.


Eligibility criteria: Inclusion Criteria:

* All children receiving primary care at the participating health centers across the three health systems

Primary outcomes:
measure: Change in child Body Mass Index
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Greenville
country: United States
facility: Greenville Health System / Prisma Health
state: South Carolina
Study officials:
affiliation: Massachusetts General Hospital
name: Elsie Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simione M, Farrar-Muir H, Mini FN, Perkins ME, Luo M, Frost H, Orav EJ, Metlay J, Zai AH, Kistin CJ, Sease K, Hambidge SJ, Taveras EM; Connect for Health Collaborative. Implementation of the Connect for Health pediatric weight management program: study protocol and baseline characteristics. J Comp Eff Res. 2021 Aug;10(11):881-892. doi: 10.2217/cer-2021-0076. Epub 2021 May 24.
citation: Simione M, Frost HM, Cournoyer R, Mini FN, Cassidy J, Craddock C, Moreland J, Wallace J, Metlay J, Kistin CJ, Sease K, Hambidge SJ, Taveras EM. Engaging stakeholders in the adaptation of the Connect for Health pediatric weight management program for national implementation. Implement Sci Commun. 2020 Jun 17;1:55. doi: 10.1186/s43058-020-00047-z. eCollection 2020.
Clinical trial NCT03213093: Pressure and Diabetic Foot
Official title: Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes and Risk of Diabetic Foot Ulcer
Keywords: Diabetes
Diabetic Foot Ulcer
Plantar pressure
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Type 2 diabetic subject
* Absence of active diabetic foot ulcer
* Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:
* absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0"
* alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 1"
* alteration of perception of Monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the "grade 2"
* History of diabetic foot ulcer for the "grade 3"
* Signature of consent to participate in the study

Exclusion Criteria:

* Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day
* Pregnancy
* Congenital methemoglobinemia.
* Porphyria
* Skin injured on the tibia, whatever the lesion
* Recent major cardiovascular history (less than 3 months)
* Severe renal disease (serum creatinine\> 300 μmol.l-1)

Primary outcomes:
measure: the rate of incidence of diabetic foot ulcer
timeFrame: At any time during a 3 years follow-up
Secondary outcomes:
measure: Neurovascular response to pressure
timeFrame: At the end of the 3-year follow-up
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: service d'endocrinologie, Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT01308593: Brow Enhancement Study
Official title: Investigation Into Brow Aesthetics Using Botox in Conjunction With Juvederm Ultra XC as Evaluated by Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brow Ptosis
Lead sponsor: Skin Care and Laser Physicians of Beverly Hills
Sponsor class: OTHER
First posted: 2011-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated by patient satisfaction


Eligibility criteria: Inclusion Criteria:

* Men and women

Exclusion Criteria:

* Persons who have not had Botox for months.
* Women who are pregnant, breastfeeding, or trying to get pregnant.

Primary outcomes:
measure: Participant satisfaction with combined injection with Botox and Juvederm XC
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills
state: California
Study officials:
References:
Clinical trial NCT07020793: Green Subthreshold Laser Therapy for Chronic Central Serous Chorioretinopathy.
Official title: Efficacy of Green Subthreshold Laser Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Presence of Subretinal Fluid (SRF)
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes adult patients diagnosed with chronic Central Serous Chorioretinopathy (CSCR), defined by the presence of subretinal fluid (SRF) persisting for more than 4 months, as confirmed by optical coherence tomography (OCT)

Brief summary: Chronic Central Serous Chorioretinopathy (CSCR) is a vision-threatening retinal disorder characterized by persistent subretinal fluid due to choroidal vascular hyperpermeability and retinal pigment epithelium (RPE) dysfunction. This study evaluates the efficacy and safety of green subthreshold laser therapy using Norlase µSec Technology as a novel, tissue-sparing approach for treating chronic CSCR. By targeting RPE repair without inducing visible retinal damage, this technique aims to resolve subretinal fluid, restore retinal architecture, and improve visual function. This is the first study to report clinical outcomes with this specific laser platform in chronic CSCR management.


Eligibility criteria: Inclusion Criteria:

Subretinal fluid for more than three months, confirmed by multimodal imaging, diagnosis of chronic CSC in at least one eye.

Exclusion Criteria:

any evidence of choroidal neovascularization on multimodal imaging, as well as a history of previous photodynamic therapy (PDT) or focal laser treatment for CSC, prior diagnosis of ocular hypertension, glaucoma, and optic nerve disorders, presence of active retinal conditions such as vitreomacular traction, epiretinal membrane, diabetic retinopathy, or retinal vein occlusion, lens opacities that could interfere with retinal imaging or compromise visual acuity

Primary outcomes:
measure: change in central foveal thickness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: university of Naples Federico II
Study officials:
References:
Clinical trial NCT04000893: Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty
Official title: Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Aerobic Exercise
Resistance Exercise
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cardiac Rehabilitation, as art and acting science multiprofessional, is based on the training with exercises that provides the post-infarct patients to satisfactorily re-establish the patient's clinical condition and that improve the functional capacity of these individuals.

Evidence shows that aerobic exercise training provides improvements in the endothelial function of this population. However, we do not yet have strong evidence of other modalities of exercise in these parameters in post-infarction patients treated with angioplasty.


Eligibility criteria: Inclusion Criteria:

* Post-acute myocardial infarction patients
* Ergometric test 30 days after the infarction
* Ejection fraction\> 40% (Simpson's method)
* Regular use of optimized drugs

Exclusion Criteria:

* Unable to perform the randomized exercise

Primary outcomes:
measure: Endothelial function
timeFrame: Pre and post 5 minutes exercise session
Secondary outcomes:
measure: Arterial stiffness
timeFrame: Pre and post 5 minutes exercise session
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Alexandre Lehnen
state: Rio Grande Do Sul
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Alexandre Lehnen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kollet DP, Marenco AB, Belle NL, Barbosa E, Boll L, Eibel B, Waclawovsky G, Lehnen AM. Aerobic exercise, but not isometric handgrip exercise, improves endothelial function and arterial stiffness in patients with myocardial infarction undergoing coronary intervention: a randomized pilot study. BMC Cardiovasc Disord. 2021 Feb 17;21(1):101. doi: 10.1186/s12872-021-01849-2.
Clinical trial NCT03229993: OCT in Borderline Coronary Artery Lesions
Official title: The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optical Coherence Tomography (OCT)
Percutaneous Coronary Intervention (PCI)
Single-Photon Emission Computed Tomography (SPECT)
Coronary Angiography (CAG)
Borderline Coronary Artery Lesions
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis.

It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT.

Exclusion Criteria:

* Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions.

Primary outcomes:
measure: MACEs
timeFrame: 12 months
measure: TLR
timeFrame: 12 months
Secondary outcomes:
measure: Rehospitalization
timeFrame: 12 months
measure: Recurrent angina
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT06586593: Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)
Official title: ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma Metastatic
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with operable metastatic melanoma (stade III or IV of AJCC) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4)

Brief summary: This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.

The complete histological response will be assessed.


Eligibility criteria: Inclusion Criteria:

* Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer \[AJCC\] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient\&#39;s refusal to be operated.
* Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed

Exclusion Criteria:

* Uveal melanoma

Primary outcomes:
measure: Complete histological response
timeFrame: Day 1
Secondary outcomes:
measure: Objectival response rate
timeFrame: Day 1
measure: Event-free survival
timeFrame: Month 12
measure: Disease Free Survival after surgery
timeFrame: Month 12
measure: Overall survival
timeFrame: Month 18
measure: Metastases-free survival
timeFrame: Month 18
measure: Frequency of toxicities
timeFrame: Month 12
measure: Severity of toxicities
timeFrame: Month 12
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU de Besançon
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Boulogne-sur-Mer
country: France
facility: CH de Boulogne-sur-Mer
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lyon
country: France
facility: Centre de Lutte Contre le Cancer Léon Bérard
city: Saint-Herblain
country: France
facility: ICO René Gauducheau
city: Toulouse
country: France
facility: Institut Universitaire de Cancérologie de Toulouse
city: Valence
country: France
facility: CH de Valence
Study officials:
References:
Clinical trial NCT02156193: Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps
Official title: Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Large Pedunculated Colonic Polyps: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no randomized controlled study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So the investigators designed a randomized controlled trial to confirm the efficacy of application of prophylactic clip in the prevention of postpolypectomy bleeding in large polyps.

Detailed description: Patients who had pedunculated colorectal polyps with heads larger than 10 mm and stalks larger than 5 mm in diameter were included. In clip group, hemoclips were applied to the base of the stalk, followed by conventional snare polypectomy. In conventional group, conventional snare polypectomy was done without any preventive management. Immediate and delayed bleeding complications were assessed.

Eligibility criteria: Inclusion Criteria:

* Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.

Exclusion Criteria:

* bleeding tendency, poor preparation, sessile polyp

Primary outcomes:
measure: Postpolypectomy bleeding
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital, The Catholic University of Korea
Study officials:
affiliation: Incheon St. Mary's Hospital, The Catholic University of Korea
name: Jeong-Seon Ji, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gweon TG, Lee KM, Lee SW, Kim DB, Ji JS, Lee JM, Chung WC, Paik CN, Choi H. Effect of prophylactic clip application for the prevention of postpolypectomy bleeding of large pedunculated colonic polyps: a randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):148-154. doi: 10.1016/j.gie.2020.12.040. Epub 2021 Jan 5.
Clinical trial NCT03079193: Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?
Official title: Post Thyroidectomy Endoscopic Laryngeal Examination :Is it Mandatory?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid
Keywords: post thyroidectomy
laryngeoscopic examination
Lead sponsor: Khamis Mushayt General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Mansoura University
First posted: 2017-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients post thyroidectomy will be randomly divided into two groups group I for whom mandatory vedioscopic laryngeal examination is done while the other group II patients for whom no routine vedioscopic laryngeal examination done only if symptoms developed

Brief summary: Post thyroidectomy laryngeal nerve injuries are frequently encountered specially in total and near total thyroidectomy some unilateral injuries are not clinically evident and asymptomatic.

The aim of this study is to compare mandatory versus selective post-thyroidectomy endoscopic examination of larynx to detect laryngeal nerve injuries.

Detailed description: 100 patients were randomly divided into two groups, group I for whom mandatory post thyroidectomy endoscopic laryngoscopic examination and the other group of only symptomatic patients selected for direct laryngoscopic examination.

Eligibility criteria: Inclusion Criteria:

* all post thyroidectomy patients

Exclusion Criteria:

-

Primary outcomes:
measure: endoscopic laryngeal examination post thyroidectomy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: