louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03561805: Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation
Official title: Prolonged Continuous ECG Monitoring Prior to TrAnscatheter AoRtic ValvE Implantation: the PARE Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Arrythmia
Keywords: TAVI
ECG monitoring
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.

Detailed description: This is a prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 1 year post-TAVI, and yearly thereafter up to 5-year follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.

Exclusion Criteria:

* Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure.
* Prior permanent pacemaker.

Primary outcomes:
measure: Arrhythmic events
timeFrame: Within 3 months prior to the TAVI procedure
measure: Therapeutic changes
timeFrame: Within 3 months prior to the TAVI procedure
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: Within 3 months prior to the TAVI procedure
measure: Atrial fibrillation
timeFrame: Within 3 months prior to the TAVI procedure
measure: Atrioventricular block
timeFrame: Within 3 months prior to the TAVI procedure
measure: Severe bradycardia
timeFrame: Within 3 months prior to the TAVI procedure
measure: Left bundle branch block
timeFrame: Within 3 months prior to the TAVI procedure
measure: Permanent pacemaker
timeFrame: Within 3 months prior to the TAVI procedure
measure: Anticoagulation therapy
timeFrame: Within 3 months prior to the TAVI procedure
Other outcomes:
Locations:
city: Québec
country: Canada
facility: IUCPQ
state: Quebec
Study officials:
References:
Clinical trial NCT03180905: ImPACT Normative Extension
Official title: ImPACT Normative Extension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Concussion
Lead sponsor: ImPACT Applications, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 800
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time. ImPACT Online is a computer-based neurocognitive test for concussion management. The test was designed to help measure the effects of concussion on cognitive processes (for example, memory, attention, brain speed) and visual functioning.


Eligibility criteria: Inclusion Criteria:

1. Age: 60-80
2. Primary English speaking or fluent in English.
3. Currently does not reside in a skilled nursing facility.
4. Currently not suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.
5. No known physical, neurological, behavioral or psychological impairment that would affect their ability to perform the test.
6. Hearing or vision impairments that have not been corrected within normal limits.
7. A score of 24 or greater on the MMSE (Mini-Mental State Examination).

Exclusion Criteria:

1. English is not their primary language nor are they proficient in the English language.
2. Currently resides in a skilled nursing facility.
3. Currently suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.
4. Known physical, neurological, behavioral, or psychological impairment that would affect their ability to take or complete the test.
5. Hearing or vision impairments that would affect their ability to perform the test.
6. Score of 23 or below on the MMSE(Mini-Mental State Examination).

Primary outcomes:
measure: Validity
timeFrame: 12 Months
measure: Validity
timeFrame: 12 Months
measure: Validity
timeFrame: 12 Months
measure: Validity
timeFrame: 12 Months
Secondary outcomes:
measure: Reliability
timeFrame: Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Comprehensive Med Psych Systems, Inc.
state: Florida
city: Albany
country: United States
facility: University of Albany
state: New York
city: Pittsburgh
country: United States
facility: ImPACT Applications Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01357005: Expanding Rapid Ascertainment Networks of Schizophrenia Families in Taiwan
Official title: Expanding Rapid Ascertainment Networks of Schizophrenia Families in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2011-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schizophrenia patients and their biological parents

Brief summary: This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications that propose to enrich pre-existing resources for schizophrenia in the NIMH Human Genetics Initiative and to apply genomic methods to further our understanding of the molecular etiology of the disorder. The overarching aims of this proposal are to quickly and cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to discover causal variants for the disorder in the first family-based genome-wide association study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this kind of GWAS study as it is a very expensive study, including collecting large family samples and genome-wide SNP scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang and his intended subcontracted researchers to apply for this project. The investigators, the research team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia.

The investigators will meet the overarching goals of this project by accomplishing several Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending all clinical data and biomaterials to the appropriate repositories; 3) Assess the association of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes such as age at onset ; 5) Perform a genome-wide survey for copy-number variations related to schizophrenia; 6) Test for gene-gene interactions (epistasis); and 7) Test for gene-environment interactions, such as the well-established effect of season of birth.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of schizophrenia and their parents,and parents are still alive

Exclusion Criteria:

* person with Mental Retardation

  * persons with epilepsy
  * alcohol or substance abuse combined
  * in combination with other organic brain damage syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Chi Shin Wu
role: STUDY_DIRECTOR
References:
Clinical trial NCT07009405: Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During
Official title: Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IV Infiltration
IV Extravasation
Lead sponsor: Rhaeos, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.


Eligibility criteria: Inclusion Criteria:

1. Scheduled to receive an infusion therapy of at least 30 minutes in length
2. Region of intact skin proximal to the infusion catheter insertion site that is appropriate in size for application of the study device
3. Signed informed consent
4. Available for 15 minutes of post-measurement monitoring following removal of the study device

Exclusion Criteria:

1. Patient is under 12 years of age
2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives or Tegaderm
3. Use of the study device would interfere with standard patient care that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
4. Investigator judges that the intravenous

Primary outcomes:
measure: Thermal skin measurements
timeFrame: Up to 12 hours of monitoring with a 15-minute follow-up period.
Secondary outcomes:
Other outcomes:
Locations:
city: Skokie
country: United States
facility: Infusacare
state: Illinois
Study officials:
affiliation: Rhaeos, Inc.
name: R. Chad Webb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03126305: Initial Development and Dissemination of OC-Go
Official title: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-Compulsive Disorder
Keywords: exposure
response prevention
web-based application
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Virtually Better, Inc.
First posted: 2017-04-24
Enrollment: 8
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents

Brief summary: The clinical component of Phase I application development examines the clinical utility, feasibility, and functionality of the OC-Go application via an 8-month pilot trial consisting of 50 standard CBT sessions augmented with OC-Go in OCD-diagnosed children who are receiving treatment through the pediatric OCD treatment programs in the UCLA Division of Child and Adolescent Psychiatry

Detailed description: This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for Obsessive Compulsive Disorder (OCD), a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. Once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of EBTs, and therapist confidence and expertise.

Eligibility criteria: Inclusion Criteria:

* Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents

Exclusion Criteria:

* None

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: 6 weeks
measure: Usability Evaluation for e-Learning Applications (UELA),
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univ. of California / Los Angeles / Semel Inst.
state: California
Study officials:
affiliation: University of California, Los Angeles
name: John Piacentini, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Virtually Better, Inc.
name: Peter Tuerk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03442205: Treatment of Common Bile Duct Stones
Official title: Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Common Bile Duct Stone
Keywords: Common Bile Duct Stone;
Laparoscopic Common Bile Duct Exploration;
ERCP;
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease.

Methods/design: This is a prospective, randomized, controlled multicenter trial with three treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire trial is two years including prearrangement, follow-up and analyses.

Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these approaches would appear comparable. It is hopeful to fully address which would be the better approach with this RCT design.


Eligibility criteria: Inclusion Criteria:

* Patients with age between 18 - 80 years.
* Patients diagnosed with gallstones.
* Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).
* Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
* Patients understood the trial and accepted one of the three managements.

Exclusion Criteria:

* Combined with Mirizzi syndrome and intrahepatic bile duct stones
* Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
* History of upper abdominal surgery.
* Serious heart, brain, lung, metabolic diseases history.
* Pregnant women.
* Unwillingness or inability to consent for the study.

Primary outcomes:
measure: Rate of Adverse outcomes
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Renyi Qin, pHD
role: STUDY_CHAIR
References:
Clinical trial NCT02022605: Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees
Official title: Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees: a Prospectively Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Selective Cannulation Rate of Trainees Receiving ERCP Training
Keywords: ERCP, trainning, trainees, EMS
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Previous studies have demonstrated that coached EMS practice at the beginning of ERCP training could improve the trainees' skill. However, it is not known whether continuously coached practice using EMS can provide additional benefit.


Eligibility criteria: Inclusion Criteria:

* consecutive inpatients with naive papilla undergoing ERCP.

Exclusion Criteria:

* history of partial or total gastrectomy (Billroth I/II, Roux-en-Y);
* duodenal stricture (benign or melignant);
* ampullary carcinoma;
* previously failed selective cannulation;
* chronic pancreatitis with PD stone;
* minor papilla cannulation;
* servere diseases of heart, lung, brain and kidney;
* hemodynamical unstablility;
* pregnant women;
* refusal or unable to give written informed consent.

Primary outcomes:
measure: Success rate of selective cannulation in 10min by trainee
timeFrame: 2 years
Secondary outcomes:
measure: Total time of successful cannulation
timeFrame: 2 years
measure: Cumulative success rate of each month
timeFrame: 2 years
measure: Performance score of selective cannulation
timeFrame: 2 years
measure: Performance score of EST
timeFrame: 2 years
measure: Complication rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
name: Yanglin Pan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao WC, Leung JW, Wang HP, Chang WH, Chu CH, Lin JT, Wilson RE, Lim BS, Leung FW. Coached practice using ERCP mechanical simulator improves trainees' ERCP performance: a randomized controlled trial. Endoscopy. 2013 Oct;45(10):799-805. doi: 10.1055/s-0033-1344224. Epub 2013 Jul 29.
citation: Lim BS, Leung JW, Lee J, Yen D, Beckett L, Tancredi D, Leung FW. Effect of ERCP mechanical simulator (EMS) practice on trainees' ERCP performance in the early learning period: US multicenter randomized controlled trial. Am J Gastroenterol. 2011 Feb;106(2):300-6. doi: 10.1038/ajg.2010.411. Epub 2010 Oct 26.
Clinical trial NCT01457105: Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent
Official title: PARTIALLY COVERED NITINOL "ComVi" STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Biliary Strictures
Keywords: Malignant strictures of the main biliary duct
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: self-expandable metal stents for palliation of malignant biliary strictures

Detailed description: The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker axial force than other stents.

Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.

Eligibility criteria: Inclusion Criteria:

* Patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable.
* Patients without liver metastases and 6 months life expectancy
* Patients at the first attempt of endoscopic biliary drainage.
* Negative history for biliary tract surgery.

Exclusion Criteria:

* Patients with ampullary cancer.
* Patients with hilar and/or intra-hepatic ducts malignancy.
* Patients with haemobilia.
* Patients with acute cholangitis at the time of stenting.
* Patients with previous percutaneous, endoscopic or surgical biliary drainage.

Primary outcomes:
measure: patency and effectiveness of the ComVi stent in palliation of jaundice in patients with malignant biliary strictures
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University
state: RM
Study officials:
References: