louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01032967: Surgery or Chemoradiation for Esophageal Cancer
Official title: Multicenter Prospective Randomized Trial Comparing Standard Esophagectomy With Chemoradiotherapy for Treatment of Squamous Esophageal Cancer: Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal Cancers
Keywords: squamous cell carcinoma
esophagectomy
chemoradiotherapy
chemoradiation
Squamous cell carcinomas of the esophagus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).


Eligibility criteria: Inclusion Criteria:

* Eligible patients had mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable.

Exclusion Criteria:

* The investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
* Those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also excluded.

Primary outcomes:
measure: Overall survival and disease-free survival
timeFrame: 2 year and 5 year
Secondary outcomes:
measure: Quality of life and function outcomes
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Philip W Chiu, FRCSEd (Gen)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.
citation: Teoh AY, Yan Chiu PW, Wong TC, Liu SY, Hung Wong SK, Ng EK. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: results from a randomized trial. Ann Surg. 2011 Jan;253(1):1-5. doi: 10.1097/SLA.0b013e3181fcd991.
Clinical trial NCT03453567: Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice
Official title: Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Valve Disease
Aortic Valve Stenosis
Keywords: TAVR
SAVR
TAVI
Conventional AVR
Sutureless AVR
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2018-03-05
Enrollment: 900
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with aortic valve replacement

Brief summary: This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Patient with aortic valve replacement

Exclusion Criteria:

* Combined with mitral stenosis requiring surgery or aorta stenosis
* Acute bacterial endocarditis within 1 month of valve replacement

Primary outcomes:
measure: All-cause death
timeFrame: 1 year
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 5 years
measure: All stroke and transient ischemic attack
timeFrame: 5 years
measure: Bleeding
timeFrame: 5 years
measure: Access site complication
timeFrame: 5 years
measure: Acute kidney injury
timeFrame: 5 years
measure: Permanent pacemaker insertion
timeFrame: 5 years
measure: TAVR-related complication
timeFrame: 5 years
measure: Prosthetic valve dysfunction
timeFrame: 5 years
measure: Composite event
timeFrame: 5 years
measure: Structural valve deterioration
timeFrame: 5 years
measure: NYHA class
timeFrame: 30 days and 1 year
measure: The change of valve area
timeFrame: 30 days and 1 year
measure: New onset atrial fibrillation
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Asan Medical Center
name: Suk-Jung Choo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04381767: EYE-SYNC Concussion Classification Study
Official title: EYE-SYNC Concussion Classification Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Mild
Concussion; Eye
Concussion, Brain
Concussion, Severe
Brain Injuries
Concussion, Cerebral
Lead sponsor: Sync-Think, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-11
Enrollment: 1303
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include all patients evaluated for potential traumatic brain injury presenting to the sports medicine clinicians in an athletic environment.

Brief summary: The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.


Eligibility criteria: Inclusion Criteria:

* Men and women actively engaged in competitive athletics
* Eye tracking measurements and SCAT5 evaluations are collected within 3-day window
* Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury

Exclusion Criteria:

* Prior enrollment (subjects may only enroll once)
* POOR eye tracking data quality
* Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: "Difficulty Remembering" ≥ 4 or "Confusion" ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS)
* EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores \< 2.0

Primary outcomes:
measure: A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Sync-Think, Inc.
state: California
Study officials:
References:
Clinical trial NCT05454267: Early Detection of Vaping-related Vascular Diseases
Official title: Early Detection of Vaping-related Vascular Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaping
Blood Vessel Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2022-07-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy non smokers and vapers residing in Florida

Brief summary: The purpose of this study is to determine how vaping affects blood vessels, in particular if early damage occurs in the lung vessels.


Eligibility criteria: Inclusion Criteria:

Vapers Group:

1. Current electronic cigarette (EC) Puff Bar users defined as using EC either daily or occasionally in the past 30 days for at least 6 months, and with 5% nicotine concentration pods.
2. Adults aged 18-40 years

Healthy Group:

1. Healthy never smokers, never vapers
2. Adults aged 18-40 years

Exclusion Criteria:

1. Current or past smoking of tobacco cigarette (TC) or other tobacco/nicotine products (e.g., smokeless tobacco, Hookah) or marijuana will be excluded from the study.
2. Subjects with self-reported history of chronic health problems including asthma, chronic obstructive pulmonary disease (COPD), morbid obesity (BMI\>40 kg/m2), hypertension or diabetes
3. Pregnant or breastfeeding women

Primary outcomes:
measure: Airway blood flow reactivity (QAW)
timeFrame: Up to 1 week
measure: Pulmonary vascular resistance (PVR)
timeFrame: Up to 4 weeks
measure: Flow-mediated vasodilation (FMD)
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
Study officials:
affiliation: University of Miami
name: Adam Wanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234167: The Swedish Prison Program is an Intervention Prevention Program Targeting Injecting Drug Users Risk Behaviours and Infectious Diseases
Official title: Svenska Häktesprogrammet, Prevention, Risk Behaviour and Infectious Diseases Among IDU.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Having Ever Injected Drugs
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Sweden
name: Swedish Prison and Probation Service
name: Linkoeping University
First posted: 2014-09-09
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Primary purpose: PREVENTION

Brief summary: The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was called "The Social Medicine Remand Prison Project" is to target injecting drug users (IDU) with primary and secondary health interventions with regards to injecting and sexual risk behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted infections (STI).

The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk behaviour and disease outcome among IDUs over time.

Detailed description: Risk behaviour for IDU is sexual risk taking, i.e., sex without a condom, buying or selling sex and injection risk taking, i.e., sharing needle, syringe or paraphernalia.

Eligibility criteria: Inclusion Criteria:

* Defined as an injecting drug user, in the prison and probation service and agree to anonymously participate

Exclusion Criteria:

* Being defined as a non-drug user, non-injecting drug user

Primary outcomes:
measure: Number of participants with injection risk behaviour
timeFrame: 2002-2012
Secondary outcomes:
measure: Number of participants with infectious diseases
timeFrame: 2002-2012
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: SHP
Study officials:
References:
citation: Karlsson N, Santacatterina M, Kall K, Hagerstrand M, Wallin S, Berglund T, Ekstrom AM. Risk behaviour determinants among people who inject drugs in Stockholm, Sweden over a 10-year period, from 2002 to 2012. Harm Reduct J. 2017 Aug 16;14(1):57. doi: 10.1186/s12954-017-0184-8.
Clinical trial NCT05695040: Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery
Official title: Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery on the Protein Intake of the Patient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 88
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: The objective of the study was to improve protein intake after the implementation of a dietary workshop performed on the 15th postoperative day following bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Over 18 years of age
* Scheduled for bariatric surgery such as sleeve gastrectomy or bypass surgery.
* Able to give informed consent to participate in the research.
* Enrolled in a Social Security system.

Exclusion Criteria:

* Inability to travel to participate in the workshop.
* Patients with a diet excluding animal proteins (vegetarians, vegans).
* Pregnant and lactating women.
* Inability to comply with protocol recommendations.
* Incapacitated patients.
* Major deprived of liberty
* Refusal to participate.

Primary outcomes:
measure: Protein intake
timeFrame: 1, 3, 6, and 12 months
Secondary outcomes:
measure: Patient's biometric parameters. Muscle function The patient's muscle mass. Undernutrition Nitrogen balance (ancillary ) Medico-economic evaluation
timeFrame: 3, 6 and 12 months
measure: Qualitative evaluation of the workshop at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jessica RODA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594840: Changing Chat: Diaper Tips to Improve Language Development
Official title: Changing Chat: Diaper Tips to Improve Language Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Infants
Keywords: language development
parental interaction
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial has two sets of diapers-- a normal one and one that has tips for how to talk to and engage your toddler. The investigators are hoping that the intervention improves language development.


Eligibility criteria: Inclusion Criteria:

16-18 months of age developmentally normal English speaking

Exclusion Criteria:

-

Primary outcomes:
measure: Language development as measured by the Mcarthur Bates CDI
timeFrame: 6 months after
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Odessa Brown
state: Washington
Study officials:
References:
Clinical trial NCT06009640: Integration of Intraoperative Neuromonitoring Into Decompression Surgery
Official title: Integration of Intraoperative Neuromonitoring Into Laparoscopic Pelvic Nerve Decompression Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Entrapments
Pelvic Pain
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-24
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To describe a novel technique by integrating the intraoperative neurophysiological monitoring (IONM) into laparoscopy to protect pelvic nerves by continuously monitoring when they are at risk during surgery.

Detailed description: We integrated intraoperative neuromonitoring system into laparoscopic lumbosacral plexus nerve decompression surgery and simultaneusly recorded nerve roots from lumbar 5 to sacral 4 during the operation. Diseases that cause pelvic nerve compression such as abnormal vascular conflict, aberrant priformis muscle, and endometriosis have settled in hard-to-reach deep areas of the pelvis. Sacral and sciatic nerves might be damaged when performing decompression surgery in these deep pelvic areas. We described a novel technique by integrating the intraoperative neurophysiological monitoring (IONM) into laparoscopy to protect pelvic nerves by continuously monitoring when they are at risk during surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with symptoms of chronic pelvic pain , dyspareunia, dysmenorrhea and severe, burning sharp pain on the lower extremity dermatomes, which had been present for at least one year were included.

Exclusion Criteria:

* Patients who underwent laparoscopic decompression surgery but did not give informed consent were not included in the study.

Primary outcomes:
measure: Pain score assessment with visual Analogic Scale (VAS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr. Lutfi Kirdar City Hospital
state: Kartal
Study officials:
affiliation: Kartal Dr. Lutfi Kirdar City Hospital
name: Elif Gundogdu, M.D.Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03438240: Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations
Official title: Adding Dexmedetomidine Versus Fentanyl to Bupivacaine for Epidural Analgesia in Combination With General Anesthesia for Elective Lumbar Disc Operations: Prospective, Randomized Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.


Eligibility criteria: Inclusion Criteria:

* Physical status American Society of Anesthesiologist (ASA) I or II.
* First time elective lumbar dicsectomy or laminectomy

Exclusion Criteria:

* Patients who refuse to participate
* Body mass index (BMI) \> 30
* Need an emergency lumbar disc operation
* ASA physical status \> II
* Major illnesses (e.g. cardiac, respiratory, renal, liver)
* Coagulation abnormalities
* Hypovolemia
* History of increased intracranial pressure
* Convulsions
* Spinal stenosis
* Infection at needle insertion site
* Other contraindications to epidural procedure
* Allergy or contraindications to the drugs used in the study
* History of addiction or alcohol abuse
* Psychiatric illness or mental retardation

Primary outcomes:
measure: First time to analgesic requirement
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Total opioid consumption
timeFrame: First 24 hours postoperatively
measure: Visual analogue scale (VAS)
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT06439940: Oncoliq: Early Breast Cancer Detection Based on Liquid Biopsies and microRNAs
Official title: Pilot Test for an Early Diagnosis Kit for Breast Cancer Based on Liquid Biopsies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Breast Cancer
Breast Carcinoma
Keywords: early diagnosis
early detection
cancer
breast cancer
miRNAs
liquid biopsies
pilot study
pilot test
liquid biopsy
Oncoliq
machine learning
AI
RT-qPCR
Lead sponsor: Oncoliq US Inc
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 364
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This protocol includes female volunteers over 35 years old with no personal history of oncological disease who visit the gynecology unit at \&amp;#34;Hospital Posadas\&amp;#34; for a gynecological and mammographic check-up.

Brief summary: Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test aims to improve the accuracy of cancer detection, thereby reducing patient mortality and healthcare costs.

To develop this test, the discovery and validation phases have been completed. In addition, Machine learning and AI were used to determine the algorithm for breast cancer detection.

The overall objective of this protocol is to implement a pilot test to enroll 1,000 women without a previous cancer diagnosis who are attending their annual medical check-up.

To achieve this, we will develop the following specific objectives:

Enroll women over age 35 who attend the gynecological annual check-up. Test the plasma of the enrolled volunteers for specific miRNA biomarkers using RT-qPCR.

Perform an analysis based on artificial intelligence techniques in collaboration with IMAGO Systems (USA) on mammogram images.

Compare the results obtained from the clinical check-up (BiRad from mammogram), IMAGO Systems and RT-qPCR (Oncoliq breast test). Conduct a 5-year follow-up on volunteers with pathological results from Oncoliq breast test.

Participants who meet the inclusion and exclusion criteria and agree to take part in the protocol will be required to sign both pages of the Informed Consent Form and complete the Annex and Survey. Subsequently, a small blood sample of 3-5 mL will be drawn via venipuncture.


Eligibility criteria: Inclusion Criteria:

* Patients over 35 years old who visit the gynecological clinic for their annual mammographic check-up

Exclusion Criteria:

* Personal history of cancer

Primary outcomes:
measure: BIRADS mammography
timeFrame: From July 14 2021 to December 31 2024
Secondary outcomes:
measure: Level of miRNAs in blood sample detected with RT-qPCR
timeFrame: From March 2023 to December 2024
Other outcomes:
Locations:
city: El Palomar, Morón
country: Argentina
facility: Hospital Nacional Profesor Alejandro Posadas
state: Buenos Aires
Study officials:
References: