louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05164107: Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Official title: PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Globe Mapping and Ablation System
Atrial Fibrillation
Pulsed Field Ablation
Lead sponsor: Kardium Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).


Eligibility criteria: Inclusion Criteria:

1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF.

   1. Diagnosis must be confirmed within 12 months before enrollment.
   2. (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
2. Subjects between 18 and 75 years of age, inclusive

Exclusion Criteria:

1. Patients who have contraindications to open heart surgery
2. Patients from an Intensive Care Unit
3. Patients with active systemic infection (sepsis)
4. Patients who have had previous ablation in the left or right atrium
5. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
6. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
7. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
8. Patients with New York Heart Association Class III or IV heart failure
9. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
10. Bleeding disorder history
11. Patients with a known sensitivity to anesthesia or neuromuscular block agent
12. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
13. Myocardial infarction within the last three months
14. Atrioventricular (AV) block II° or III°
15. Left ventricular ejection fraction (LVEF) of less than 35%
16. Unstable angina

Primary outcomes:
measure: Rate of subjects presenting with primary safety events which are device- or procedure-related
timeFrame: up to 3-month visit
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Nemocnice Na Homolce
Study officials:
affiliation: Roentgenova 37/2, 150 30 Praha 5 - Motol, Czech Republic
name: Nemocnice Na Homolce
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03510507: Characteristics of Lyme Arthritis
Official title: Characteristics of Positive Lyme PCR Arthritis, Data From CNR Borrelia 2011-2016
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lyme Arthritis
Keywords: Lyme arthritis
Borrelia burgdorferi
vector tick
Arthritis
joints
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient diagnosed with Lyme arthritis and confirmed by PCR of joint fluid at CNR Borrelia between 2011 and 2016

Brief summary: Lyme disease is due to Borrelia burgdorferi sensu lato and is transmitted by a tick vector of the genus Ixodes. One of the clinical forms of this disease in the disseminated phase is the appearance of arthritis, classically mono or oligo-arthritis in the large joints.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Diagnosis of Lyme arthritis confirmed by PCR of joint fluid at CNR Borrelia between 2011 and 2016
* Patient who has agreed to use his medical data for research purposes

Exclusion Criteria:

- Refusal to participate in the study

Primary outcomes:
measure: Retrospective study of clinical and biological data of French patients with Lyme arthritis between 2011 and 2016
timeFrame: The period from 2011 to 2016 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire de Bacteriologie - Ptm
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Benoit JAULHAC, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05859607: Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes , Sohag Experience.
Official title: Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes, Sohag Experience.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Calculous Cholecystitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 50
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: laparoscopic cholecystectomy nowadays is the most common surgery done by General surgery surgeons , so it is necessary to evaluate the difficulty of each case prior to surgery and from the first look ,to avoid complications and improve outcomes , so scoring systems are needed for better assessment of the overall condition and make good decision .


Eligibility criteria: Inclusion Criteria:

* patients with symptomatic gall stones

Exclusion Criteria:

* lap to open conversion due to equipment failure pregnancy common bile duct stone obstructive jaundice unfit for general anesthesia patients refusing lap cholecystectomy.

Primary outcomes:
measure: Validation and applicability of scoring systems
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
Clinical trial NCT02006407: A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors
Official title: A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Tumor, Primary
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 5
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study to assess the changes in white matter, in the brain, in response to radiation therapy and correlate these changes with later declines in cognitive function.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (age 6-21) who will receive cranial radiotherapy for brian tumors. This could include but is not limited to: low grade glioma, high grade glioma (to include grade III but not grade IV glioma), germ cell tumors, primitive neuroectodermal tumors, craniopharyngioma, or medulloblastoma.
* Patients should, in the estimate of the treating physician, be anticipated to have a median survival of greater than 1 year.

Exclusion Criteria:

* Patients with previous Central Nervous System (CNS) radiation or or CNS tumors that, in the judgement of the investigators, are likely to undergo progression during or shortly after radiotherapy are excluded.
* Patients with glioblastoma, multiforme, gliosarcoma, diffuse pontine glioma, or other tumors presumed to have expected median survival per the investigators of less than 1 year.
* Patients who require sedation for Magnetic Resonance Imagining (MRI)are excluded.
* Patients at risk for nephrogenic systemic sclerosis will be excluded as a safety precaution due to the contrast used in the scans.

Primary outcomes:
measure: Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy.
timeFrame: Baseline, 3 weeks, and 6 weeks
Secondary outcomes:
measure: Evaluate the Correlation Between Global COGState Scores and the Perpendicular Diffusivity of Water by Diffusion Tensor Imaging at Baseline, 3 Weeks, and 6 Weeks Into Treatment.
timeFrame: Baseline, 3 weeks, and 6 weeks
measure: Evaluate the Correlation Between Global COGState Scores, Radiation Dose, and the Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Carl Koschmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05498207: Identification of Biomarkers for Stress Vulnerability and Resilience
Official title: Identification of Biomarkers for Stress Vulnerability and Resilience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Mental Health
Mobile application
Cognitive Behavioral Therapy (CBT)
Stress
Fitbit
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Pritzker Consortium
name: Weill Medical College of Cornell University
First posted: 2022-08-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants that have a Android will be assigned to the no intervention arm.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to understand the biological mechanisms of stress vulnerability (being susceptible to stress) and stress resilience (being able to recover readily from stress), obtain biomarkers (a biological indicator) for stress resilience and to devise strategies for prevention and treatment of stress-related disorders.

Detailed description: This study will be using the Maya application (app) for the intervention arm, a mobile cognitive behavior therapy (CBT) program for adolescents and young adults experiencing anxiety symptoms. The Maya app, developed at Weill Cornell, teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.

Eligibility criteria: Inclusion Criteria:

* Incoming Freshmen Students at the University of Michigan

Exclusion Criteria:

* Suicidal Ideation

Primary outcomes:
measure: Change in anxiety symptoms based on the General Anxiety Disorder-7 Scale (GAD-7) between the intervention arm and the no intervention arm
timeFrame: Baseline, up to 12 months
measure: Change in depressive symptoms based on the Patient Health Questionnaire-9 (PHQ-9) between the intervention arm and the no intervention arm
timeFrame: Baseline, up to 12 months
measure: Change in anxiety symptoms based on the Spielberger State and Trait Anxiety Inventory (STAI) between the intervention arm and the no intervention arm
timeFrame: Baseline, up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Huda Akil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04996407: Survival Thermal Blanket Versus Draping Fabric to Prevent Hypothermia in Geriatric Surgical Patients
Official title: Comparison Effect of Using Between Survival Thermal Blanket and Draping Fabric as Substitute for Perforated Blanket With Forced Air Warmer Usage as Perioperative Warmer : Study on Inadvertent Perioperative Hypotermia in Geratric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia; Anesthesia
Keywords: perioperative hypothermia
geriatric
survival thermal blanket
draping fabric
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients.

Detailed description: Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.

Eligibility criteria: Inclusion Criteria:

* Age \> 60 years old
* Physical status ASA 1-3
* Undergo elective surgery under general anesthesia with or without regional anesthesia

Exclusion Criteria:

* Thermoregulation disturbance
* Abnormal thyroid function
* Fever caused by infectious disease in 7 days prior to surgery
* Pre-induction hypothermia with temperature below 36 degree
* On routine antipiretic
* Unstable hemodynamic preoperative and intraoperative

Primary outcomes:
measure: Number of participants with hypothermia in survival thermal blanket group
timeFrame: Before induction
measure: Number of participants with hypothermia in survival thermal blanket group
timeFrame: every 15 minute during anesthesia
measure: Number of participants with hypothermia in survival thermal blanket group
timeFrame: end of surgery
Secondary outcomes:
measure: Number of participants with hypothermia in draping fabric group
timeFrame: Before induction
measure: Number of participants with hypothermia in draping fabric group
timeFrame: every 15 minute during anesthesia
measure: Number of participants with hypothermia in draping fabric group
timeFrame: end of surgery
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT02948907: "Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
Official title: Endobronchial Ultrasound "Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphadenopathy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Several benign and malignant diseases are associated with hilar and mediastinal lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the visualization of tissue elasticity and "Tissue Harmonic Imaging (THI)" might be useful for the differentiation of benign and malignant lymph nodes.

Detailed description: Patient enrolment and data acquisition is to be carried out on a prospective basis. Patients with hilar and/or mediastinal lymphadenopathy and indication for EBUS-TBNA are enroled. It is planned to evaluate 100 lymph nodes by elastography and THI. All patients will undergo diagnostic bronchoscopy at one study centre in Heidelberg.

Eligibility criteria: Inclusion Criteria:

* Indication for EBUS-TBNA
* Patient has provided written informed consent

Primary outcomes:
measure: Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"
timeFrame: Once after bronchoscopic procedure
Secondary outcomes:
measure: Safety of endobronchial use of elastography and "Tissue Harmonic Imaging" assessed by Incidence of adverse events
timeFrame: during diagnostic bronchoscopy procedure
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik
Study officials:
affiliation: Thoraxklinik at University of Heidelberg
name: Felix Herth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gompelmann D, Kontogianni K, Sarmand N, Kaukel P, Krisam J, Eberhardt R, Herth FJF. Endobronchial Ultrasound Elastography for Differentiating Benign and Malignant Lymph Nodes. Respiration. 2020;99(9):779-783. doi: 10.1159/000509297. Epub 2020 Oct 7.
Clinical trial NCT04087707: Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects
Official title: A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteer
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 and body weight is more than 40.0 kg at screening inspection
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
* History of drug and food allergy
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
timeFrame: Day 1 up to Day 14
measure: Area under the concentration-time curve AUC (tau)
timeFrame: Day 1 up to Day 9
measure: Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)
timeFrame: Day 1 up to Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
facility: Sumida Hospital
state: Tokyo
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
citation: Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.
Clinical trial NCT06500507: A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS4131 Injection in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.

Detailed description: Multiple myeloma (MM) is a malignant disease with abnormal proliferation of clonal plasma cell, which is often accompanied by multiple osteolytic damage, hypercalcemia, anemia, and kidney damage. QLS4131 is a novel tri-specific humanized antibody. The study consists 3 periods: screening phase, treatment phase and a post-treatment follow-up phase. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of QLS4131 administered to participants with relapsed or refractory multiple myeloma. Total duration of study is up to 2 years.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, regardless of gender.
2. Subjects should be willing and able to comply with the study schedule and protocols.
3. Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
4. Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal.

Exclusion Criteria:

1. Known hypersensitivity to any of the ingredients of this product.
2. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
3. Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.

Primary outcomes:
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: Approximately 2 years
measure: Incidence of adverse events（AEs）
timeFrame: Up to 2 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Gang An, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: