louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05817695: Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker
Official title: Effect of Different Pacing Sites on Cardiac Synchronization and Tricuspid Regurgitation After Leadless Pacemaker Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bradycardia
Keywords: Leadless pacing
Synchronization
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2023-04-18
Enrollment: 40
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: patients consent to LP implantation surgery

Brief summary: Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site

Detailed description: Right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. Pacing at various sites had different effects on synchrony and tricuspid regurgitation. This study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. Ultrasound and ECG parameter indices are applied.

Eligibility criteria: Inclusion Criteria:

patients consent to LP implantation surgery

Exclusion Criteria:

1. Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava;
2. Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system;
3. Patients with myocardial infarction;
4. Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves;
5. cannot understand or are unwilling to give informed consent.

Primary outcomes:
measure: The evaluation of cardiac electrical synchrony
timeFrame: 1 month
measure: The evaluation of cardiac mechanical synchrony
timeFrame: 1 month
Secondary outcomes:
measure: Age may affect synchronization
timeFrame: 1 month
measure: BMI may affect synchronization
timeFrame: 1 month
measure: Blood pressure may affect synchronization
timeFrame: 1 month
measure: The pacemaker sensing may affect synchronization
timeFrame: 1 month
measure: The pacemaker lead impedance may affect synchronization
timeFrame: 1 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Yi zhou XU
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Yi zhou XU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06848595: Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation
Official title: Effects of Dexmedetomidine Versus Magnesium Sulfate on Cerebral Oxygen Saturation During Spine Surgery: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Cerebral Desaturation Events
Spine Surgeries
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the effects of dexmedetomidine and magnesium sulfate on cerebral oxygen saturation in patients undergoing spine surgeries as adjuvant to general anesthesia guided by cerebral oximetry. The main aims to are Incidence of cerebral desaturation events and duration of cerebral desaturation events.


Eligibility criteria: Inclusion Criteria:

* Age from 21 to 60 years old.
* either gender.
* American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion Criteria:

* Patient refusal to participate in research.
* History of preoperative neuromuscular disease.
* Patients with preexisting cerebral pathology (such as previous episodes of cerebral ischemia or stroke).
* History of psychiatric illness.
* History of orthostatic hypotension, myocardial infarction, uncontrolled hypertension or documented carotid stenosis.
* Coagulopathy disorder.
* Patients receiving magnesium supplementation.
* Chronic use of opioids.
* Current treatment with a β-blocker or calcium channel blocker.

Primary outcomes:
measure: Incidence of cerebral desaturation events.
timeFrame: intraoperative
Secondary outcomes:
measure: Duration of cerebral desaturation events
timeFrame: intraoperative
measure: change in heart rate in beats
timeFrame: intraoperative
measure: change in blood pressure in mmHg
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Tanta University
name: Ahmed Said Elgebaly, professor
role: STUDY_DIRECTOR
affiliation: Tanta University
name: Shimaa Farouk Abdelkader, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04823195: Development Cellular Models of the Ear and Nose to Study the Mechanisms of Hearing
Official title: Development of Cellular Models of the Ear and Nose From Patient Samples to Study the Mechanisms of Hearing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss, GJB2, Cis Regulation, DFNB1
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: over 18 years old full consent With exostosis, or having cochlear implant surgery, or early presbycusis

Brief summary: Development of cells culturesissued from Nose and Ear to study auditory mecanisms.

Study of the cis-Modulation of the gene GJB2 for the patients with early presbycusis to identify the genetic cause of hearing loss.


Eligibility criteria: Inclusion Criteria:

* Hearing loss Presbycusis Exostosis

Exclusion Criteria:

* Genetic hearing loss

Primary outcomes:
measure: GJB2 cis regulation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03615495: Flourish™ Pediatric Esophageal Atresia
Official title: Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Atresia
Digestive System Abnormalities
Esophageal Disorders Congenital
Keywords: Esophageal
Atresia
Congential
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 21
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with esophageal atresia without a tracheoesophageal fistula (TEF) or for whom a concurrent TEF has been closed as a result of a prior procedure.

Brief summary: This study is continued evaluation of the safety and probable benefit of the Flourish Pediatric Esophageal Atresia device through the Humanitarian Device Exemption (HDE) pathway.


Eligibility criteria: Inclusion Criterion:

* Patient treated for esophageal atresia with Flourish device starting May 12, 2017

Primary outcomes:
measure: Rate of Adverse Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Winston-Salem
country: United States
facility: Brenner Children's Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Children's Hospital
state: Virginia
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
city: Montréal
country: Canada
facility: McGill University Department of Pediatric Surgery
state: Quebec
Study officials:
References:
Clinical trial NCT06617481: PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
Official title: RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer (Post Prostatectomy)
Keywords: Rising PSA following cancer prostatectomy surgery
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
First posted: 2024-09-27
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.

The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.

Detailed description: This is not an investigational study drug. Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.

Eligibility criteria: Inclusion Criteria:

* History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy.
* An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5

Exclusion Criteria:

* Patients who are planned to have an x-ray contrast agent or other PET radiotracer \&amp; less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan.
* Patients currently receiving Androgen Deprivation Therapy (ADT).

Primary outcomes:
measure: Cancer Detection Rate
timeFrame: 24 months
Secondary outcomes:
measure: Correlation with biopsy
timeFrame: 24 months
measure: Correlation with other imaging modalities
timeFrame: 24 months
measure: Response to therapy
timeFrame: 24 months
measure: Adverse Events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
Study officials:
References:
Clinical trial NCT03078881: Clinical Assessment Study in Crigler-Najjar Syndrome
Official title: LUSTRO: A Clinical Assessment Study in Crigler-Najjar Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crigler-Najjar Syndrome
Lead sponsor: Audentes Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-03-14
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll Crigler-Najjar syndrome subjects aged equal or greater than 1 year of age requiring daily phototherapy.

Brief summary: This is a Pre-Phase 1 prospective, non-interventional clinical assessment study to evaluate Crigler-Najjar syndrome subjects requiring daily phototherapy, aged 1 year and older.


Eligibility criteria: Key Inclusion Criteria:

* Subject has a diagnosis of Crigler-Najjar syndrome resulting from a confirmed mutation in the UGT1A1 gene
* Subject is aged equal or greater than 1 year of age
* Subject receives daily phototherapy for a minimum of 6 hours within a 24-hour period (daily illumination time)

Exclusion Criteria:

* Subject is currently participating in an interventional study or has received gene or cell therapy
* Subject has received a whole liver, partial liver, or hepatocyte transplant; or subject has a liver transplant scheduled within the planned participation period of this study
* Subject has significant cholestatic disease, in the opinion of the investigator
* Subject is receiving phenobarbital or other known inducer of UGT1A1 within 30 days of screening
* Subject has any clinically significant underlying liver disease (other than Crigler-Najjar syndrome), in the opinion of the investigator
* Subject has a history of, or currently has, a clinically important condition other than Crigler-Najjar syndrome, in the opinion of the investigator

Primary outcomes:
measure: Characterize the disease course and natural history of subjects with Crigler-Najjar syndrome
timeFrame: Up to 2 years
measure: Assess variation in bilirubin levels over the course of the study and the variation of bilirubin levels over a 24-hr period
timeFrame: Up to 2 years
measure: Assess phototherapy usage over the course of the study
timeFrame: Up to 2 years
Secondary outcomes:
measure: Assess the humanistic and clinical burden of disease in Crigler-Najjar subjects and caregivers as measured by PedsQL
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Strasburg
country: United States
facility: Clinic for Special Children
state: Pennsylvania
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: London
country: United Kingdom
facility: King's College Hospital
state: England
Study officials:
affiliation: Audentes Therapeutics
name: Suyash Prasad, MBBS, MRCP,MRCPCH, FFPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT01252381: Supplementary Intake of Vitamin D During 12 Weeks Strength Training in Younger and Older People
Official title: The Importance of Supplementary Intake of Vitamin D on the Efficacy of 12 Weeks of Strength Training in Both Vitamin D Sufficient Younger and Older People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Tendon Elasticity
Muscle CSA
Tendon CSA
VDR Receptor
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Institute of Sports Medicine, Copenhagen
First posted: 2010-12-03
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim is to investigate the importance of vitamin D levels to achieve the effect of strength training. If we can show that vitamin D has an effect of training, the ultimate goal is to find out why and how vitamin D affects muscle.

This would potentially have important implications for public health. Since a large number of populations, including elderly, are shown to have too little vitamin D and also has low muscle strength, it will be essential that these people added vitamin D in relation to training and rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Men 20-30 or 60-75 years old

Exclusion Criteria:

* smokers Knee problems On medication affecting protein synthesis High exposure to sun light (ex. ski holiday) during the trial

Primary outcomes:
measure: Cross-sectional area of thigh musculature and knee tendon
timeFrame: 12 weeks
measure: VDR potential target CYP27b1
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine - Bispebjerg Hospital
Study officials:
References:
citation: Agergaard J, Trostrup J, Uth J, Iversen JV, Boesen A, Andersen JL, Schjerling P, Langberg H. Does vitamin-D intake during resistance training improve the skeletal muscle hypertrophic and strength response in young and elderly men? - a randomized controlled trial. Nutr Metab (Lond). 2015 Sep 30;12:32. doi: 10.1186/s12986-015-0029-y. eCollection 2015.
Clinical trial NCT03903081: The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects
Official title: A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects


Eligibility criteria: Inclusion Criteria:

* Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
* Be able to complete the study according to the trail protocol
* Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures
* Male subjects and must be 18 to 45 years of age inclusive
* Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive
* Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

* Use of \>5 cigarettes per day during the past 3 months
* Allergies constitution ( multiple drug and food allergies)
* History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
* Donation or loss of blood over 450 mL within 3 months prior to screening
* 12-lead ECG with clinically significant
* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
* Subjects deemed unsuitable by the investigator for any other reason.

Primary outcomes:
measure: Adverse Events
timeFrame: From Days 1-12
Secondary outcomes:
measure: Cmax
timeFrame: At pre-defined intervals from Days 1-12
measure: Tmax
timeFrame: At pre-defined intervals from Days 1-12
measure: AUClast
timeFrame: At pre-defined intervals from Days 1-12
measure: AUC0-∞
timeFrame: At pre-defined intervals from Days 1-12
measure: T1/2
timeFrame: At pre-defined intervals from Days 1-12
measure: CL/F
timeFrame: At pre-defined intervals from Days 1-12
measure: Cmin
timeFrame: At pre-defined intervals from Days 1-11 for MAD
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yanhua Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01171781: A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Official title: A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasophayngeal Carcinoma Between Stage II and IVb
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 110
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 study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma


Eligibility criteria: Inclusion Criteria:

* histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II \~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 \~2 good organ function (liver, renal, hematologic)

Exclusion Criteria:

* active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer

Primary outcomes:
measure: progression free survival rate at 3 years
timeFrame: 36 months
Secondary outcomes:
measure: overall survival rate
timeFrame: 36 months
measure: objective response rate
timeFrame: 36 months
measure: toxicity
timeFrame: 36 months
measure: quality of life
timeFrame: 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT04048681: Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
Official title: Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: artificial sweeteners
diet soda
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study seeks to determine whether artificial sweeteners in the context of diet soda may alter the brain's response to food cues and thus impact appetite.


Eligibility criteria: Inclusion Criteria:

* Men and women who are 18-65 years old, with a BMI \>30kg/m2.

Exclusion Criteria:

* Unable or unwilling to participate in the study for any reason
* Metal in the body or other safety concerns which makes patient unable to have an MRI
* Pregnant women will be excluded to protect the fetus against potential effects of a non-medically required MRI on fetal development and difficulty of measuring accurate BMI.

Primary outcomes:
measure: Changes in Brain Response to Food Cues in the Insula
timeFrame: 1 hour
Secondary outcomes:
measure: Neurocognitive Testing (Stop Signal Reaction Time)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center MRI Research Facility
state: Massachusetts
Study officials:
References: