louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06348030: Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC
Official title: Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels \<7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 120 years at time of consent
* Ability to speak and understand English
* Clinical stage I, II or IIIa NSCLC
* Candidate for RTS, as determined by the operating surgeon

Exclusion Criteria:

* Anticoagulation with inability to cease anticoagulant therapy prior to surgery
* Incurable coagulopathy
* Systemic vascular disease or vasculitis
* Not a candidate for RTS

Primary outcomes:
measure: Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection
timeFrame: Up to 3 weeks following hospital discharge
Secondary outcomes:
measure: Operating Room Time
timeFrame: 3 weeks post-surgery
measure: Length of Stay in Hospital
timeFrame: 3 weeks post-surgery
measure: Duration of Chest Tube
timeFrame: 3 weeks post-surgery
measure: Intraoperative Complications and Adverse events (AEs)
timeFrame: 3 weeks post-surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Waël C Hanna, MDCM, MBA, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03134430: Effects of Regional Nerve Block on Cancer Recurrence
Official title: Effects of Regional Nerve Block on Cancer Recurrence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Patient
Keywords: Regional nerve block
cancer recurrence
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the patients in treatment group will received reginoal nerve block with 0.35% Ropivacane and 0.5% lidocaine in normal saline under ultrasound guide, while those in control group received equal volume of normal saline.
Primary purpose: TREATMENT

Brief summary: It has been reported local anesthetics could inhibit tumor cell proliferation, metastasis and invasion ability，but it is still lack of clinical evidence. Our study aims to explore the effects of regional nerve block on cancer recurrence and the mechanism.

Detailed description: 1. To study the effects of TAP block under ultrasound guide on the recurrence of gastric carcinoma, colon cancer, rectal carcinoma and liver cancer and the underlying mechanisms.
2. To clarify the effects of Lateral thoracic nerve block under ultrasound guide on the recurrence of lung cancer and the underlying mechanisms.

Eligibility criteria: Inclusion Criteria:

* Patients with primary cancer undergoing elective surgery under general anesthesia

Exclusion Criteria:

* Disagree to participate，drop out,lose track, infectious abdominal wall，abnormal puncture point，coagulation dysfunction，allergy of local anesthetic ，immune disease,cancer metastasis,mental disease, acute and chronic infectious disease or other severe disease.

Primary outcomes:
measure: the effect of nerve block on the cancer recurrence rate and survival rate postoperation
timeFrame: up to 5 years after surgery
Secondary outcomes:
measure: dosage of intraoperative anesthetic
timeFrame: intraoperative period
measure: the effect of nerve block on the percentage and classification of immunocyte and content of cytokines
timeFrame: at 0h, 24h, 48h after nerve block
measure: VAS after operation
timeFrame: at 24h, 48h after nerve block
measure: activity after operation
timeFrame: up to 2 weeks
measure: Hospital stay
timeFrame: up to 4 weeks after surgery
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The first affiliated hospital of nanchang university
state: Jiangxi
Study officials:
affiliation: The First Affiliated Hospital of Nanchang University
name: Foquan Luo, professor
role: STUDY_CHAIR
References:
Clinical trial NCT05348330: Mid-point to Pleura Transverse Process Block Versus Thoracic Intervertebral Foramen Block
Official title: Mid-point to Pleura Transverse Process Continuous Block Versus Thoracic Intervertebral Foramen Continuous Block, for Analgesia in Polytraumatic Patients with Multiple Rib Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Rib Fractures
Polytrauma
Keywords: Analgesia
Local anesthetics
Myofascial block
Ultrasound guidance
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 100
Sex: ALL
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: The analgesic effect of continuous mid-point to pleura transverse process block compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures.

Detailed description: The analgesic effect of continuous mid-point to pleura transverse process block will be compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures, by using the numeric rating scale (NRS) for pain.

Eligibility criteria: Inclusion Criteria:

* ribs fracture after polytrauma

Exclusion Criteria:

* pregnancy
* allergy to anesthetics
* head trauma
* history of neurological impairment (primary or secondary)
* history of cancer
* history of chronic obstructive pulmonary disease
* infections of skin close to the block site
* systemic infections

Primary outcomes:
measure: Pain intensity
timeFrame: First 72 hours from the block
Secondary outcomes:
measure: Diaphragmatic motion
timeFrame: First 72 hours from the block
measure: Arterial blood gas analysis
timeFrame: First 72 hours from the block
measure: Airflow rate
timeFrame: First 72 hours from the block
measure: Blood pressure
timeFrame: First 72 hours from the block
measure: Sensory block
timeFrame: First 72 hours from the block
measure: Request of analgesic drugs
timeFrame: First 72 hours from the block
measure: Anesthetic spread
timeFrame: First 72 hours from the block
measure: Complication
timeFrame: First 72 hours from the block
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Emiliano
Study officials:
affiliation: San Salvatore Acadec Hospital of L'Aquila (Italy)
name: Emiliano Petrucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02381730: Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypoidal Choroidal Vasculopathy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-03-06
Enrollment: 37
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.

This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).


Eligibility criteria: Inclusion Criteria:

* Active polypoidal choroidal vasculopathy,
* Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32)
* Age above 45
* No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability
* Intravitreal injection of aflibercept is indicated by current clinical recommendations

Exclusion Criteria:

* Simultaneous treatment with another anti-VEGM agent
* Diabetic retinopathy
* Personal history of vitrectomy or uveitis
* Personal history laser photocoagulation and/or verteporphin phototherapy
* Tear in the pigmentary epithelium
* Chorioretinitis scar
* Macular atrophy in the pigmentary epithelium
* Treatment with corticosteroids
* Eye surgery less than 3 months before inclusion

Primary outcomes:
measure: Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: CHU Lyon Croix Rousse
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
city: Strasbourg
country: France
facility: Centre Médical de la Rétine Maison Rouge
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Martine Mauget-Faysse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355130: Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study
Official title: Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Donors
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To collect data on BM harvest in healthy donors who don't have PAD collected. We expect that no allogeneic transfusions are required and that Hb levels after collection are similar to those recorded in our historical cohort receiving 1 or 2 PAD.

Brief summary: Despite perioperative autologous donation (PAD) is widely used in healthy bone marrow (BM) donors to restrain the hemoglobin decrease after BM harvest, this practice is not supported by strong clinical evidences and has been abandoned by some transplant teams. The critical revision of data relative to 102 BM collection procedures performed at our center between 2014 and 2018 failed to demonstrate an advantage of 1 over 2 PAD. Conversely, clearly emerged that PAD reduce the hemoglobin levels at BM harvest. Basically, PAD practice consists in the transfer of RBCs from the subject into a plastic bag and back to the subject at BM harvesting. Indeed, the evidence of clinical benefits of PAD in BM donors are still elusive. For this reason, current procedures on unrelated donors recommend iron and vitamin supplementation before the BM harvest, but let the decision to perform or not PAD at collection centers. Detailed data on the safety and feasibility of BM harvest procedures in absence of PAD have been rarely reported. The investigators collect data on BM harvest in healthy donors who don't have PAD collected. The investigators expect that no allogeneic transfusions are required and that Hb levels after collection are similar to those recorded in the historical cohort gathered at the same center receiving 1 or 2 PAD.


Eligibility criteria: Inclusion Criteria:

* Familial donors qualified to donate BM hematopoietic stem cells and accepting to participate to this study

Exclusion Criteria:

* Any planned deviation connected with abnormalities in the health status and/or laboratory tests of the donor, even though it does not prevent him from donation.

Primary outcomes:
measure: Hb values
timeFrame: during procedure
Secondary outcomes:
measure: Hb values
timeFrame: day 1 post BM harvest
measure: Hb values
timeFrame: day 7 post BM harvest
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Luciana Teofili
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03230630: Plasma Melatonin AND Mortality After Acute Myocardial Infarction
Official title: Early-morning Plasma Melatonin Levels Predict Cardiovascular Mortality After Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melatonin
Myocardial Infarction
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A single center study on PCI-treated myocardial infarction patients

Brief summary: Pre-clinical and clinical studies have demonstrated that melatonin has cardio-protection effects. Melatonin has anti-inflammatory, antioxidant, antihypertensive, antithrombotic and antilipaemic properties, which plays important roles in a variety of cardiovascular pathophysiologic processes. Nocturnal melatonin levels decreased after AMI, and lower serum melatonin concentrations after AMI are associated with more heart failure and cardiac death and left ventricular remodeling. Moreover in women with increased BMI, lower melatonin secretion is associated with higher risks of MI. Early-morning blood collection is easier in clinical practice. Therefore, the investigators carried out a cohort study to evaluate the prognostic value of plasma soluble melatonin in hospitalized patients with acute myocardial infarction (AMI).


Eligibility criteria: Inclusion Criteria:

* consecutive patients of acute AMI come to department of cardiology, 301 hospital (Beijing, China),absent of cardiogenic shock, and survival for at least 24 h after percutaneous coronary intervention treatment.

Exclusion Criteria:

* patients with autoimmune diseases, collagen tissue diseases, drug addiction, radiotherapy, patients receiving immunosuppressive treatment, taking sedatives, antiepileptic drugs, tricyclic antidepressants or any medication known to influence melatonin metabolism, psychiatric sleeping disorders, shift workers, and subjects with jet-lag syndrome

Primary outcomes:
measure: cardiovascular mortality
timeFrame: The median follow-up was 31.6 months
Secondary outcomes:
measure: non-cardiovascular mortality
timeFrame: The median follow-up was 31.6 months
measure: Myocardial infarction
timeFrame: The median follow-up was 31.6 months
measure: heart failure readmission
timeFrame: The median follow-up was 31.6 months
measure: Stroke
timeFrame: The median follow-up was 31.6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06807320: COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS
Official title: CLINICAL and RADIOGRAPHIC COMPARISON of MINERAL TRIOXIDE AGGREGATE and CALCIUM HYDROXIDE AS INDIRECT PULP CAPPING AGENTS in PRIMARY MOLARS: a RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Indirect Pulp Cap
Keywords: Indirect Pulp cap
primary molar
MTA
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed as randomized clinical trial performed at the Department of Pediatric Dentistry , Pakistan Institute of Medical Sciences (PIMS) , Islamabad on primary molars requiring indirect pulp treatment in patients aged 5 to 9 years. Two groups , I and II of 40 teeth each will be selected according to inclusion criteria . In Group I , indirect pulp capping will be done with Calcium hydroxide while in Group II , it will be done with MTA . Both the groups will be evaluated clinically and radiographically at 0, 3 and 6 months . Results were compiled and analyzed using standard statistical techniques.


Eligibility criteria: Inclusion Criteria:

* Clinical Criteria :

  * Primary molars with deep carious lesions
  * No H/O spontaneous pain
  * No associated swelling
  * No tenderness to percussion
  * Absence of pathological mobility
  * No sinus tract
  * Restorable

Radiographic Criteria :

* No periapical radiolucency
* No loss of lamina dura
* No physiological root resorption
* Teeth with radiographic evidence of more than 0.25mm remaining dentin thickness
* No furcal radiolucency

Exclusion Criteria:

* Non restorable teeth

  * Teeth with pathological mobility
  * Teeth with extensive external/internal root resorption.
  * Teeth with pulp canal calcifications
  * Subjects inability to tolerate any of the dental products being used
  * Systemic disease or severe medical complications ; Lack of compliance

Primary outcomes:
measure: Dentine bridge thickness (DBT)
timeFrame: 3 and 6 months follow up appointment in all successful cases.
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan Institute of Medical Sciences
state: Capital
Study officials:
References:
Clinical trial NCT04274920: Dentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide
Official title: Clinical Response of Human Pulps Capped With Bioactive Glass Incorporated in Resin Composite and Adhesive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Disease, Dental
Dental Caries
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of application of bioactive glass in different protocols on the formation of dentin bridge after indirect pulp capping using resin composite with its adhesive both are containing bioactive glass.


Eligibility criteria: Inclusion Criteria:

* Active carious lesion in deep dentin of molars.
* Absence of cavitated lesions at the buccal or lingual surfaces as determined by clinical and radiographic examination.
* Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and abnormal tooth mobility;
* Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure;
* The extension of the carious lesion should be such that complete caries removal would risk pulp exposure, as determined by clinical and radiographic assessment;
* Absence of radiolucencies at the interradicular or periapical regions, or thickening of the periodontal spaces, that would indicate the presence of irreversible pulp pathologies or necrosis;
* Absence of internal or external root resorption.
* Co-operative patients approving the trial.

Exclusion Criteria:

* Patients with systemic medical conditions
* pregnant females
* Teeth with spontaneous pain or sensitivity to percussion.
* Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
* Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.

Primary outcomes:
measure: Change of dentine thickness
timeFrame: baseline, one month, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar University, Faculty of Dentistry for Girls
Study officials:
References:
Clinical trial NCT03359720: Knowledge Attitudes Behaviours and Practices Regarding HIV of Men Who Have Sex With Men in the French Antilles and French Guiana
Official title: Knowledge Attitudes Behaviours and Practices Regarding HIV of Men Who Have Sex With Men in the French Antilles and French Guiana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 766
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men who have sex with men

Brief summary: determine the Knowledge attitudes behaviours and practices regarding HIV of men who have sex with men in the French Antilles and French Guiana


Eligibility criteria: Inclusion Criteria:

* men who have sex with men aged over 18

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Knowledge attitudes behaviours and practices regarding HIV of men who have sex with men in the French Antilles and French Guiana - Questionnaire Survey
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: