louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04632602: Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure
Official title: Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient will be his own control. The order of the experimental periods will be:

1. arm A: prone position followed by dorsal decubitus
2. arm B: dorsal decubitus followed by ventral decubitus A 30-minute wash-out period is set between the end of sequence 1 and the start of sequence 2.
Primary purpose: OTHER

Brief summary: Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.

Detailed description: Awake prone position has been proposed as an additional treatment to alleviate hypoxemia during COVID-19 acute respiratory failure and potentially to avoid in some case tracheal intubation and invasive ventilation. Potential mechanism is improvement of ventilation: perfusion mismatch through redistribution of ventilation to the dorsal part of the lungs where perfusion is prominent. Electrical impedance tomography (EIT) is a non-invasive functional lung imaging of distribution of ventilation. Therefore, we aim to assess EIT on lung ventilation inhomogeneity during supine and prone position in COVID-19 patients.

Eligibility criteria: Inclusion Criteria:

* more than 18 Years (Adult, Older Adult)
* Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab)
* Acute respiratory failure with 100 \< PaO2:FiO2\< 300 mmhg
* Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen
* Written informed consent of the patient

Exclusion Criteria:

* Contra-indication to prone position including pregnancy
* Presence of pacemaker
* Severe hypoxemia with PaO2/FiO2 \< 100 mmHg
* Evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours

Primary outcomes:
measure: Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.
timeFrame: 2hours
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Höpitaux de Marseille
Study officials:
affiliation: ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
name: Jean-Olivier ARNAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04693702: Observational Study of Vision Improvement in Patients With Retinal Disorders
Official title: Observational Study of Vision Improvement in Patients With Retinal Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration
Diabetic Macular Edema
Keywords: Age-related macular degeneration
Diabetic macular edema
Lead sponsor: Optimal Acuity Corporation
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with vision impairment due to retinal disorders involving central vision loss

Brief summary: The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.

Detailed description: The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Eligibility criteria: Inclusion Criteria:

1. - Female or male
2. - Any race
3. - Patient is at least 50 years old
4. - Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
5. - Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
6. - Patient had moderate to severe baseline vision impairment with CDVA of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s)
7. - Patient CDVA records are available at baseline and at 1m or longer post-Tx times

Exclusion Criteria:

1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study

-

Primary outcomes:
measure: CDVA
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Bochner Eye Institute
state: Ontario
Study officials:
affiliation: Optimal Acuity Corporation
name: Michael J Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05322902: Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance
Official title: Comparison of Intraoperative Remifentanil Requirements During Remimazolam Versus Propofol Total Intravenous Anesthesia With Analgesia Nociception Index-guided Remifentanil Administration: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Total Knee Arthroplasty
Remimazolam
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. The purpose of this study is to compare the intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when the intraoperative remifentanil dose adjustment was performed under the ANI guidance while maintaining a similar depth of anesthesia with remimazolam or propofol.


Eligibility criteria: Inclusion Criteria:

1. Patients 19\~80 years of age who are expected to elective total knee arthroplasty under general anesthesia
2. ASA PS 1-3

Exclusion Criteria:

1. Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both
2. Previous hepatectomy or liver transplant
3. Estimated glomerular filtration rate \< 30 mL/min/1.73m2
4. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
5. Uncontrolled hypertension (systolic blood pressure \> 160mmHg)
6. Acute narrow angle glaucoma
7. Myasthesia gravis
8. Known allergy to the drugs included in the study
9. Cardiac arrhthmia (non-sinus rhythm)
10. Taking drugs that affect the autonomic nervous system of diabetes
11. Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction)
12. History of drug or alcohol abuse

Primary outcomes:
measure: Intraoperative remifentanil consumption (mcg/kg/min)
timeFrame: Day 0, intraoperative
Secondary outcomes:
measure: Numeric rating scale pain score at rest
timeFrame: up to 24 hours after the surgery
measure: Postoperative opioid consumption
timeFrame: up to 24 hours after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT01276002: Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.
Official title: Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Acute Pancreatitis
Keywords: disrupted duct
pancreatic pseudocysts
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 0
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: The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical recovery and avoidance of recurrence of pancreatic pseudocysts.


Eligibility criteria: Inclusion Criteria:

* pancreatic pseudocyst, at least 6 cm in diameter
* symptomatic pancreatic pseudocyst
* increasing size of pancreatic pseudocyst within 6 weeks

Exclusion Criteria:

* Pregnancy
* Age less than 18 years
* Postoperative status preventing access to papilla
* Allergy to contrast preventing from ERP
* Missing informed consent to study
* PTT above 1.5 times of normal, unless substituted
* Platelet count less than 50.000/µl, unless substituted
* Pancreatic ascites or fistula
* Life expectancy less than 2 years
* Percutaneously drained cysts are not part of the study

Primary outcomes:
measure: Recurrence of pancreatic pseudocyst
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
Study officials:
affiliation: Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
name: Mark Ellrichmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
name: Annette Fritscher-Ravens, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02205502: Lidocaine as Local Anesthetics in Children Under Ketamine Sedation
Official title: Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Conscious Sedation Failure During Procedure
Analgesia
Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ketamine seems an obvious choice in the setting of an emergency department in laceration repair.

Lidocaine is the local anesthetics widespread used.

Ketamine leads to dissociative amnesia.

Theoretically , lidocaine is not useful in laceration repair using ketamine.

However, lidocaine is used with ketamine in many emergency department.

The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure


Eligibility criteria: Inclusion Criteria:

* patients who need suturing for laceration under procedural anesthesia using ketamine

Exclusion Criteria:

* contraindication to ketamine and lidocaine
* patients involved to other studies
* more or equal to American Society of Anesthesiologist (ASA) class III
* not alert

Primary outcomes:
measure: Children's Hospital of Eastern Ontario Pain Scale (CHEOPS
timeFrame: up to 1 hour
Secondary outcomes:
measure: Sedation scale
timeFrame: up to 1 hour
measure: Complication
timeFrame: up to 1 hour
measure: Satisfaction of parents and clinicians
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin Hee Lee, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Jin Hee Lee,, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05891002: Accuracy of Robotically Assisted Cranial Biopsies
Official title: Diagnostic Accuracy of Robotically Assisted Cranial Biopsies Using Cirq Active Cranial and Automatic Image Registration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Neoplasm
Lead sponsor: Brainlab AG
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 consecutive patients who are planned to undergo a brain biopsy will be included. Since this is a confirmatory study, a sample size calculation was not able to be performed.

Brief summary: This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial. The goal is to determine whether the robotic procedure to be examined can achieve a clinically acceptable value of at least 90% in terms of diagnostic yield.

Detailed description: The goals of the project are to determine the accuracy of Cirq® Robotic Alignment Module Cranial navigated biopsy procedures, Automatic Image Registration accuracy within the workflow, and compatibility of Cirq® Robotic Alignment Module Cranial in the clinical workflow. Patients will undergo cranial biopsies according to standard of care using released products within their intended use with the exception that the accuracy of the biopsy needle will be measured using a specific intraoperative workflow.

Eligibility criteria: Inclusion Criteria:

* Intracranial lesion and the indication for a diagnostic stereotactic biopsy validated by the neurosurgical staff
* Ability to consent to the procedure

Exclusion Criteria:

* Pregnancy
* Contraindications on narcosis, operation, CT scan, MRI scan and/or Gadolinium contrast agent

Primary outcomes:
measure: Diagnostic yield
timeFrame: 24 months
Secondary outcomes:
measure: Target point and entry point error
timeFrame: 24 months
measure: Time for procedure
timeFrame: 24 months
Other outcomes:
Locations:
city: Angers
country: France
facility: The Centre Hospitalier Universitaire (CHU) d'Angers health establishment
Study officials:
affiliation: University Hospital, Angers
name: Jean-Michel Lemée, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05481502: An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Official title: A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor, Adult
Solid Tumor, Childhood
Hematologic Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a study to explore the phenotypic and transcriptional changes of different cellular components in the tumor following the injection of somatic cell therapy drugs.

The second objective is to explore phenotypic and transcriptional changes of different cellular components in blood and bone marrow following injection of somatic cell therapy drugs.Then correlate the phenotypic and transcriptional profile of different tumor, blood and bone marrow immune populations with clinical response and/or toxicity. And to finish this study is designed in order to identify a phenotypic, transcriptional and epigenetic profile of intra-tumoral adoptive cells and correlate this profile with clinical response and/or toxicity.


Eligibility criteria: Inclusion Criteria:

* Patient affiliated to a social security regimen
* Tumor lesion accessible to core biopsies
* Patient who is fully informed, able to comply with the protocol and who signed the informed consent
* Pediatric patients \> than 2 years old can be included
* No restriction about the Eastern Cooperative Oncology Group (ECOG) status

Exclusion Criteria:

* Coagulation abnormality prohibiting a biopsy (but patients can still give their consent for blood and bone marrow samples).
* Tumor lesion not accessible to core biopsies.
* Pregnant or nursing women cannot participate in this study.

Primary outcomes:
measure: Comparison of frequency, phenotype and transcriptional profile of the different immune subsets in the tumor following adoptive cell therapy infusion using spectral flow cytometry and RNA sequencing
timeFrame: 3 months following ACT
Secondary outcomes:
measure: Objective Response
timeFrame: 3 months following ACT
measure: Progression-free survival
timeFrame: 5 years after first ACT infusion
measure: Overall survival
timeFrame: 5 years after first ACT infusion
measure: Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0
timeFrame: From enrollment to 30 days after the last sample
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
state: Val De Marne
Study officials:
References:
Clinical trial NCT03352102: Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients
Official title: Effects of Neuromuscular Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness Myopathy
Respiration, Artificial
Keywords: Electric Stimulation
Intensive Care Units
Mechanical Ventilation
Ventilator Weaning
Lead sponsor: Universidade Estadual do Oeste do Paraná
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

Detailed description: Objective: Evaluate the effectiveness of the Neuro Muscular Electrical Stimulation therapy in quadriceps versus diaphragm subjects on mechanical ventilation (MV). Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or more
* 24 hours of MV or more

Exclusion Criteria:

Hemodynamic instability, pregnancy, body mass index(BMI) \>35 kg/m2, history of neuromuscular disease at admission, brain death, diseases with systemic vascular involvement, bone fractures, use of an internal or external fixator, skin lesions, end-stage cancer, use of pacemakers, spinal injuries, or inability to receive an Medical Research Council score because of the cognitive state.

Primary outcomes:
measure: ICU and Hospital length of stay
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cascavel
country: Brazil
facility: Hospital Universitário do Oeste do Paraná
state: Paraná
Study officials:
affiliation: Hospital Universitário do Oeste do Parana, Universidade Estadual do Oeste do Parana.
name: Pericles Duarte
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07016802: A Clinical Study of GenSci134 in Healthy Male Adults
Official title: A Randomized, Double-Blind, Placebo and Positive Drug-Controlled, Single-Dose, Dose-Escalation Phase I Clinical Study of GenSci134 Injection in Healthy Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers

Detailed description: GenSci134 was tested in 7 predetermined dose groups with placebo and positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 64 healthy adult male subjects

Eligibility criteria: Inclusion Criteria:

* Healthy adult male subjects aged 18-45 years (inclusive of boundary values);
* Body Mass Index (BMI): 19.0-24.0 kg/m² (inclusive of boundary values);
* Good health status;
* Able to understand and willing to sign the Informed Consent Form (ICF), and comply with study requirements and restrictions.

Exclusion Criteria:

* Subjects with significant medical history or clinical manifestations determined by the investigator;
* History of hypersensitivity, intolerance, or allergy to any drug, compound, food, or other substances, or known allergy to any excipients of the study drug;
* History of neurological or psychiatric disorders, or subjects with impaired consciousness or cognitive dysfunction;
* Subjects with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and clinically significant;
* Subjects with immunodeficiency or immunosuppressive diseases at screening;
* Subjects who have undergone major surgery within 12 months prior to screening;
* Subjects with a history of neoplastic diseases;
* Subjects who have participated in any other clinical trial of drugs or medical devices and have used the investigational medicinal product within 28 days or 5 half-lives (whichever is longer) before dosing.

Primary outcomes:
measure: Incidence and severity of adverse events and serious adverse events
timeFrame: 36 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Dongyang LIU, PHD
role: PRINCIPAL_INVESTIGATOR
References: