louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00070317: Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
Official title: Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Stage I Cervical Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-10-07
Enrollment: 102
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.

Detailed description: OBJECTIVES:

I. Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using preoperative or intraoperative lymphatic mapping, in patients with stage IB1 cervical cancer.

II. Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients.

OUTLINE: This is a multicenter study.

Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of carcinoma of the cervix of 1 of the following cellular types:

  * Squamous cell carcinoma
  * Adenocarcinoma
  * Adenosquamous cell carcinoma
* Stage IB1 disease (no greater than 4 cm)
* No unequivocal evidence of metastases
* Adequate surgical candidate
* No known allergy to triphenylmethane compounds
* No prior pelvic irradiation
* No prior retroperitoneal surgery
* More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy
* Prior cone biopsy allowed provided current disease is stage IB1

Primary outcomes:
measure: Sensitivity
timeFrame: At the time of surgery
measure: False Negative Predictive Value (FNPV)
timeFrame: At the time of Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Charles Levenback
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03160417: Doppler Ultrasound in Rewarming After Targeted Control Management in Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Doppler Ultrasound
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac arrest with GCS\<8

Brief summary: The aim of the study is to describe CBF modifications during rewarming after targeted temperature management in cardiac arrest patients


Eligibility criteria: Inclusion Criteria:

Major Cardiac arrest Targeted temperature management

Exclusion Criteria:

GCS\>8 after cardiac arrest Neurologic cause of cardiac arrest

Primary outcomes:
measure: Changes in TCD estimates of CBF measurements
timeFrame: day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
state: Finistère
Study officials:
References:
Clinical trial NCT02324517: Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders
Official title: Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Hemophilia
Keywords: response to various potential therapies as managed by lab assays
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-12-24
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coagulopathies (see brief description)

Brief summary: Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Validated coagulation disorder

Exclusion Criteria:

* Not consenting to participate
* Multiple coagulopathies and comorbidities

Primary outcomes:
measure: Thrombin Generation Parameters pre and post therapy / spiking assays
timeFrame: 1 year from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Mediacl Center
Study officials:
References:
Clinical trial NCT03693417: Heated Circuit on Sore Throat
Official title: Heated Breathing Circuit on Postoperative Sore Throat After Endobronchial Tube Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Keywords: pharyngitis
intubation
heat
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 92
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: PREVENTION

Brief summary: This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing endotracheal intubation for general anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Mallampatti scores greater than 2
* Recent sore throat
* Cervical spine disease
* Recent upper respiratory infection
* Recent analgesics
* History of head and neck surgery
* Friable teeth
* Multiple intubation attempts

Primary outcomes:
measure: Number of participants with postoperative sore throat for postoperative 24 hour
timeFrame: At 24 hour
Secondary outcomes:
measure: Number of participants with postoperative sore throat
timeFrame: At 2, 4, and 24 hour
measure: Number of participants with postoperative hoarseness
timeFrame: At 2, 4, and 24 hour
measure: Wound pain scores
timeFrame: At 2, 4, and 24 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04771117: Defiances to Face COVID-19 Pandemic in Mexico
Official title: Defiances to Face COVID-19 Pandemic in Mexico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Risk-Taking
Covid19
Keywords: Health Behavior
Pandemic
Risk-Taking
Mexico
Covid-19
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-02-25
Enrollment: 4004
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample was the Mexican general population currently living in the covid-19 pandemic.

Brief summary: The aim of this study is to identify the risk factors favoring the contagion of COVID-19 by studying the quarantine behavior and preventive measures in the Mexican population. As a secondary aim, the investigators sought to identify areas that need reinforcement, to help develop strategies for a successful plan to face an upcoming pandemic.


Eligibility criteria: Inclusion Criteria:

* Being Mexican or residents of the country
* Participants over 15 years

Exclusion Criteria:

* Participants under 15 years of age
* Participants with incomplete surveys
* Being a tourist currently staying in the country or being Mexican residing in another country

Primary outcomes:
measure: Risk Factors
timeFrame: Baseline
Secondary outcomes:
measure: Fear of Covid-19
timeFrame: Baseline
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Jalisco
Study officials:
References:
Clinical trial NCT00780234: Pioglitazone for Lung Cancer Chemoprevention
Official title: Pioglitazone for Lung Cancer Chemoprevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Endobronchial Dysplasia
Keywords: chemoprevention
lung cancer
pioglitazone
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-10-27
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.

Detailed description: This trial evaluates the oral peroxisome proliferator-activated receptor gamma (PPARgamma) agonist pioglitazone in a double-blind placebo controlled trial. The high risk current and former smokers qualify based on tobacco exposure, airflow limitation on lung function testing, and sputum cytologic atypia. Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy at study entry and after 6 months on drug or placebo. Biologic samples are collected at both time points. The primary outcome is endobronchial histology and determining if pioglitazone can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway will also be analyzed.

Eligibility criteria: Inclusion Criteria:

* Current or former smoker (at least 10 pack years);
* One or more of the following:
* Mild or worse sputum atypia
* Airflow Limitation (FEV1/FVC\<70% predicted)
* Biopsy proven airway dysplasia

Exclusion Criteria:

* myocardial infarction (MI) with ejection fraction \< 50%;
* severe/unstable angina;
* history of coronary or peripheral arterial bypass grafting;
* New York Heart Association (NYHA) class III or IV congestive heart failure;
* hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
* life expectancy \< 6 months; history of bladder cancer
* pregnant or breast feeding; inability to give informed consent

Primary outcomes:
measure: 6-month Histology Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver, CO
state: Colorado
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
state: Tennessee
Study officials:
affiliation: VA Eastern Colorado Health Care System, Denver, CO
name: Robert L. Keith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05894317: Vascular Access Complications for Therapeutic Apheresis in Nephrology
Official title: Vascular Access Complications for Therapeutic Apheresis in Nephrology : a Retrospective Observational Study in North-East France.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Access Complication
Apheresis Related Complication
Keywords: Apheresis
DFPP
ANCA associated vasculitis
Goodpasture syndrome
Arterio veinous fistula
Arterio veinous graft
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in nephrology receiveing apheresis treatment by filtration or double filtration with arterioveinous fistula or arterioveinous graft or central veinous catheter

Brief summary: The aim of this study is to describe vascular access complications which are used for therapeutic apheresis in Nephrology.

Detailed description: The aim of this study is to describe vascular access complications which are used for therapeutic apheresis in Nephrology.

Complications may include arterio-veinous fistula or graft (AVF or AVG) thrombosis with or without known stenosis; AVF or AVG or central veinous catheter (CVC) infections and CVC dysfunctions.

The investigators may enroll all patients receveing therapeutic apheresis for nephrologic indications in North East France.

Nephrologics indications include :

* acute or active antibody mediated rejection (ABMR),
* Goodpasture disease,
* ANCA vasculitis,
* thrombotic microangiopathy (TMA),
* Focal segmental glomerulosclerosis (FSGS),
* HLA or ABO desensitization for kidney transplantation.

Data inclusion period is from June 2020 to June 2022.

The aim of the study is to describe the proportion and type of complication in the population of patient receving therapeutic apheresis for nephrologic disease in the North East France. Te investigators will study the risk factors that are associated with this complications.

The second aim of the study is to describe the population of patient receving therapeutic apheresis in our unit and in our region.

Eligibility criteria: Inclusion Criteria:

* patients in nephrology receiveing apheresis treatment by filtration or double filtration

Exclusion Criteria:

* apheresis treatment for other indications
* centrifugation apheresis treatment

Primary outcomes:
measure: Vascular access Complication (catheter or AVF/AVG thrombosis/infection) rate in therapeutic apheresis among nephrological diseases
timeFrame: june 2020 june 2022
Secondary outcomes:
measure: Description of population enrolled
timeFrame: june 2020 june 2022
measure: Comparison of complications rate with literature datas
timeFrame: june 2020 june 2022
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: CHRU NANCY DRCI
name: Luc Frimat, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032317: Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
Official title: EZ Steer™ THERMOCOOL® With CF Sensing Capability (THERMOCOOL SMARTTOUCH™) for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atrial Fibrillation
Ischemic Ventricular Tachycardia
Keywords: Arrhythmia
Electrophysiology
Fibrillation
Tachycardia
Ablation
Atrial Fibrillation (AF)
Ischemic Ventricular Tachycardia (VT)
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-15
Enrollment: 22
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 study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.


Eligibility criteria: Inclusion Criteria:

* Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion Criteria:

* Longstanding persistent AF
* Idiopathic VT
* Congestive Heart Failure

Primary outcomes:
measure: The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: IKEM
Study officials:
References:
Clinical trial NCT05978817: Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)
Official title: Clinical Effectiveness of Damon Ultima Vs Conventional Brackets (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skeletal and Dental CL I Malocclusion Moderate Crowding
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 34
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets.

Detailed description: Damon Ultima System was introduced and claimed to be the first true full expression orthodontic system designed for faster and more precise finishing. The brackets were completely reengineered to virtually eliminate play for precise control of rotation, angulation and torque. Moreover, the system used specially designed archwires regarding wire dimensions and shape to fulfill the manufacturers claim.

Eligibility criteria: Inclusion Criteria:

* 15-35 years of age patients who are healthy and without medications such as non-steroidal anti-inflammatory analgesics.
* Patients with Class I normal occlusion with moderate dental irregularity (with 4-6 irregularity index) requiring non-extraction treatment.
* Presence of all the permanent teeth apart from the third molars.
* Patients with good oral hygiene and periodontal health.
* Without previous orthodontic treatment/ functional appliances

Exclusion Criteria:

Patients will be excluded from recruitment if he had sever skeletal discrepancy that requires orthognathic surgery.

• Patients who have cleft lip or palate, hypodontia, or hyperdontia

Primary outcomes:
measure: Occlusal outcomes assessment
timeFrame: 1 year
measure: Little Irregularity index:
timeFrame: 6 months
measure: Arch parameter measurement:
timeFrame: 1 year
measure: Root alingment
timeFrame: 1 year
measure: Root resorption
timeFrame: 1 year
Secondary outcomes:
measure: Patient experience and satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Nawar A jebory
Study officials:
affiliation: University of Baghdad
name: Dheaa H Al-Groosh, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02637817: MRI-based Biomarkers for Predicting Punctate White Matter Lesions in Neonates
Official title: MRI-based Biomarkers for the Prognosis Judgement of Punctate White Matter Lesions in Neonates: a Longitudinal Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Diseases
Amblyopia
Brain Damage, Chronic
Cerebral Palsy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Shenzhen Children's Hospital
name: General Hospital of Ningxia Medical University
name: Xijing Hospital
name: Shengjing Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Zunyi Medical College
name: Shaanxi Provincial People's Hospital
name: Baoji Central Hospital
name: Children's Hospital of Fudan University
name: Hainan People's Hospital
First posted: 2015-12-22
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PWML and non-PWML neonates

Brief summary: As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it is lack of certain methods in identifying the prognosis of PWML. Through using various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal study would be conducted to follow-up the PWML neonates with varying spatial-position and degree lesions. Through tracking the variations in WM microstructures from neonate period to childhood (2 years old and 3 years old), this study aims to explore (1) the potential relations between varying PWMLs and motor and visual disorders (2) the relations between WM MRI-metrics and neurodevelopmental assessment results, and thus determine the early biomarkers to identify CP and amblyopia.


Eligibility criteria: Inclusion Criteria:

-(1) Age: 1-28 days (2) PWML (3) High quality MRI scan

Exclusion Criteria:

-(1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol

Primary outcomes:
measure: Cerebral Palsy
timeFrame: At age 2
Secondary outcomes:
measure: Amblyopia or movement disorder
timeFrame: At age 3
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
citation: Wang M, Liu H, Liu C, Li X, Jin C, Sun Q, Liu Z, Zheng J, Yang J. Prediction of adverse motor outcome for neonates with punctate white matter lesions by MRI images using radiomics strategy: protocol for a prospective cohort multicentre study. BMJ Open. 2019 Apr 3;9(4):e023157. doi: 10.1136/bmjopen-2018-023157.