louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06969378: Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease
Official title: Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Tachycardia
Atrial Flutter
Congenital Heart Disease
Pulmonary Vein Isolation
Pulsed Field Ablation
Catheter Ablation
Keywords: atrial fibrillation
atrial tachycardia
atrial flutter
pulsed field ablation
congenital heart disease
adult congenital heart disease
pulmonary vein isolation
catheter ablation
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2025-05-13
Enrollment: 30
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: This is a prospective, single-arm intervention trial whereby we will test the safety and efficacy of performing pulmonary vein isolation (PVI) using pulsed field ablation (PFA) in adult patients with congenital heart disease (CHD) who are presenting for atrial tachycardia (AT) ablation.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>= 18 years of age) with repaired or unrepaired congenital heart disease and a history of sustained (\>30 seconds) AT

Exclusion Criteria:

* History of sustained AF and/or previous catheter or surgical pulmonary vein isolation.

Primary outcomes:
measure: Acute pulmonary vein isolation
timeFrame: Acute (immediate intraoperative).
measure: Time to atrial tachycardia or atrial fibrillation recurrence
timeFrame: 12 months
measure: Major adverse event
timeFrame: 1 month
Secondary outcomes:
measure: AT/AF Burden
timeFrame: 12 months
measure: Left atrial/pulmonary venous atrial dwell time
timeFrame: Acute (immediate intraoperative)
measure: Case duration
timeFrame: Acute (immediate intraoperative).
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05107778: Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV
Official title: A Phase II Multi-center, Randomized, Single-blind, Placebo-controlled to Evaluate Safety and Efficacy of ASC42 Tablets in Combination With Entecavir and Pegylated Interferon α-2a in Subjects With Chronic Hepatitis B Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B, Chronic
ASC42
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-11-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old (including 18 and 65 years old);
* Chronic HBV infection confirmed by serological, etiological and clinical diagnosis (HBsAg positive for more than 6 months);
* HBV-DNA negative after nucleoside (acid) treatment;
* Laboratory test values meet the following requirements :

  * Liver function : AST, ALT ≤ 3×ULN; serum total bilirubin≤2×ULN; direct bilirubin≤1.5×ULN; serum albumin≥35 g/L (blood collection is not within 2 weeks before transfusion of albumin);
  * Hematology: white blood cell count\>3.0×109/L, ANC\>1.5×109/L; platelet\>1×ULN; hemoglobin 120g/L. (No blood transfusion (including transfusion of red blood cells and platelets) and EPO, TPO, leukocyte-stimulating factor were required within 2 weeks before blood collection) ;
  * Renal function: serum creatinine≤1×ULN;
  * Thyroid function: TSH and T4 in normal range or thyroid function can be completely controlled ;
  * Determination of serum immunoglobulin : IgM≤ULN;
  * Coagulation function: International normalized ratio: INR≤1×ULN;

Exclusion Criteria:

* Chronic HBV with unexplained portal hypertension;
* Subjects with liver cancer or serum AFP \>1×ULN;
* Previously received FXR therapy;

Primary outcomes:
measure: Serum HBsAg change compared with baseline
timeFrame: Week 12 of intervention\Week 24 of follow-up
measure: Serum HBV pgRNA change compared with baseline
timeFrame: Week 12 of intervention\Week 24 of follow-up
Secondary outcomes:
measure: Serum HBsAg change compared with baseline
timeFrame: Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
measure: Serum HBV pgRNA change compared with baseline
timeFrame: Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT01571778: Hand Hygiene Before Non-sterile Glove Use
Official title: The Utility of Hand Hygiene Before Non-sterile Glove Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Hygiene
Keywords: Hand Hygiene
Non-sterile Glove Use
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The importance of healthcare worker hand hygiene in decreasing bacterial transmission between patients is well documented. Healthcare workers may don non-sterile gloves in routine care of patients, particularly for those patients known or suspected to harbor epidemiologically important microorganisms. Governing bodies currently recommend performing hand hygiene prior to donning gloves and after glove removal. The importance of hand hygiene post glove removal is well shown, however few studies exist to show utility of hand hygiene prior to donning gloves. In fact, data suggests that glove use is an impediment to hand hygiene and may reduce compliance with hand washing. In light of this and the fact that no evidence exists that washing hands BEFORE glove use is important, the aim of the study is to asses the utility of routine hand hygiene prior to donning non-sterile gloves before a patient contact.


Eligibility criteria: Inclusion Criteria:

* Healthcare worker engaging in direct patient contact on Contact Precautions (e.g. expected glove use)
* \>= 18 years of age

Exclusion Criteria:

* Visibly soiled hands requiring hand washing (cannot randomize)
* Non-compliance with glove use as indicated for care of patient on Contact Precautions

Primary outcomes:
measure: Difference in Total Aerobic Colony Counts
timeFrame: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2).
Secondary outcomes:
measure: Pathogen Identification
timeFrame: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to perform hand hygiene and don gloves (group 1) or don gloves (group 2).
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT05339178: Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy
Official title: Evaluation of the Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy - A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Periodontal Diseases
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: periodontitis patients undergoing supportive treatment

Brief summary: The present prospective study aims to assess the QoL of periodontitis patients during supportive treatment and to relate it to periodontal health (clinical and radiographic data) and treatment stability. Follow-ups after the first cross-sectional assessment are planned after approximately 2.5, 5, 7.5, and 10 years.


Eligibility criteria: Inclusion Criteria:

* All patients returning for supportive therapy on a regular basis after active periodontal treatment will be asked for participation if they are in supportive therapy for at least 1 year.

Primary outcomes:
measure: disease specific OHRQoL (ParoQoL)
timeFrame: at baseline
measure: disease specific OHRQoL (ParoQoL)
timeFrame: after 2.5 years
measure: disease specific OHRQoL (ParoQoL)
timeFrame: after 5 years
measure: disease specific OHRQoL (ParoQoL)
timeFrame: after 7.5 years
measure: disease specific OHRQoL (ParoQoL)
timeFrame: after 10 years
Secondary outcomes:
measure: Oral Health Impact Profile (OHIP)
timeFrame: at baseline
measure: perceived stress scale (PSS)
timeFrame: at baseline
measure: overall health status of the patients (EQ5D-5L)
timeFrame: at baseline
measure: Oral Health Impact Profile (OHIP)
timeFrame: after 2.5 years
measure: perceived stress scale (PSS)
timeFrame: after 2.5 years
measure: overall health status of the patients (EQ5D-5L)
timeFrame: after 2.5 years
measure: Oral Health Impact Profile (OHIP)
timeFrame: after 5 years
measure: perceived stress scale (PSS)
timeFrame: after 5 years
measure: overall health status of the patients (EQ5D-5L)
timeFrame: after 5 years
measure: Oral Health Impact Profile (OHIP)
timeFrame: after 7.5 years
measure: perceived stress scale (PSS)
timeFrame: after 7.5 years
measure: overall health status of the patients (EQ5D-5L)
timeFrame: after 7.5 years
measure: Oral Health Impact Profile (OHIP)
timeFrame: after 10 years
measure: perceived stress scale (PSS)
timeFrame: after 10 years
measure: overall health status of the patients (EQ5D-5L)
timeFrame: after 10 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Division of Oral Surgery, School of Dentistry, Medical University of Vienna
Study officials:
References:
Clinical trial NCT01017978: Quantitative MR Biomarkers for Sarcoma Treatment
Official title: Quantitative MR Biomarkers for Sarcoma Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Tumors
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-11-23
Enrollment: 11
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To determine if MRI imaging can be used to accurately determine if a sarcoma is responding to the type of chemotherapy being used.

Detailed description: The purpose of this study is to determine if MRI imaging can be used to accurately determine if a sarcoma is responding to the type of chemotherapy being used or if it is ineffective early on in the treatment; instead of finding this out 2-3 months later. If it is determined that MRI can accurately diagnose tumor response, medications can be switched early on potentially improv8ing the patients'chances of recovery.

Eligibility criteria: Inclusion Criteria:

1. Biopsy proven primary bone or soft tissue tumor
2. No previous treatment for this malignancy
3. Will be given chemotherapy before having surgery or radiation on the tumor.
4. Are able to undergo a MRI examination
5. If your tumor measures at least 1/2 inch in length.

Exclusion Criteria:

1. Younger than 3 yrs. of age or need general anesthesia(sedation that puts you to sleep) to have a MRI performed.
2. History of Renal Failure
3. Are not able to have a MRI performed for any reason such as you have a pacemaker or other implanted device that may malfunction or move because of the magnetic field inside the MRI room and scanner.
4. Have any history of an allergic reaction to gadolinium based contrast agents (a medication injected in a vein that helps create clearer MRI images.

   -

Primary outcomes:
measure: To determine if MRI imaging can accurately determine if a sarcoma (tumor)is responding to the type of chemotherapy being used.
timeFrame: Baseline prior to chemo
Secondary outcomes:
measure: MRI Scan
timeFrame: 3 weeks post start of chemo and end of chemo
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: Universityof Michigan Health Systems
name: Gary Luker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846378: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
Official title: The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Acute Myocardial Infarction
Keywords: ST segment elevation myocardial infarction (STEMI)
timed balloon inflations
post conditioning
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Cardiology Research UBC
First posted: 2009-02-18
Enrollment: 30
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 size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.

Detailed description: The intervention of "post conditioning" at the time of reperfusion, in patients with acute myocardial infarction (AMI), will attenuate the degree of ischemia-reperfusion injury, as manifested by infarct size. This intervention is hypothesized to be safe in humans.

Eligibility criteria: Inclusion Criteria:

* STEMI
* Onset of symptoms within 6 hours
* TIMI 0 to TIMI 1 flow in infarct related artery

Exclusion Criteria:

* collaterals to infarct related artery
* previous infarct in related territory
* thrombolytics
* cardiogenic shock
* TIMI 2 to TIMI 3 flow

Primary outcomes:
measure: Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software
timeFrame: 6 weeks
measure: Echocardiograms will be analyzed to evaluate left ventricular function. Standard techniques will be used to quantitate ejection fraction and the percentage of left ventricular circumference that is hypokinetic or dyskinetic.
timeFrame: 6 weeks
measure: Venous blood samples troponin, creatine phosphokinase (CPK). This will be done to follow enzyme release and washout, and area data will be available and infarct size/risk area ratios in control and post-conditioning subjects will be compared.
timeFrame: baseline, every 8 hours x 3
measure: ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3.
timeFrame: baseline, up to 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Tarek Helmy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02377778: Comparative Effect of Theipoental and Propofol in IVF Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subfertility
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the aim is to compare the effect of the type of anaesthetic drug used during oocyte retrieval on fertilization rates of oocytes retrieved after ovarian stimulation for in-vitro fertilization.


Eligibility criteria: Inclusion Criteria:

* women undergoing oocyte retrieval for IVF under general anesthesia
* age ≤45 years

Exclusion Criteria:

* women with a known hypersensitivity to the active substance of the investigating drugs or any of their excipients

Primary outcomes:
measure: Fertilization rate
timeFrame: First 24h after oocyte retrieval
Secondary outcomes:
measure: Number of MII oocytes
timeFrame: 12h after oocyte rertieval
measure: Pregnancy rate
timeFrame: 14 days after embryo transfer
measure: Implantation rate
timeFrame: 40 days after embryo traansfer
measure: The concentration of propofol or thiopental in the follicular fluid of the dominant (larger) follicle aspirated at oocyte retrieval
timeFrame: 12 hours after oocyte retrieval
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit for Human Reproduction, 1st Dept of OB/Gyn, Medical School, Aristotle UNiversity of Thessaloniki
Study officials:
References:
citation: Goutziomitrou E, Venetis CA, Kolibianakis EM, Bosdou JK, Parlapani A, Grimbizis G, Tarlatzis BC. Propofol versus thiopental sodium as anaesthetic agents for oocyte retrieval: a randomized controlled trial. Reprod Biomed Online. 2015 Dec;31(6):752-9. doi: 10.1016/j.rbmo.2015.08.013. Epub 2015 Sep 4.
Clinical trial NCT00240578: Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Iodine I 131 Tositumomab
Official title: A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKIN'S LYMPHOMA PREVIOUSLY TREATED WITH IODINE I 131 TOSITUMOMAB IN STUDIES CP-97-011, CP-98-025, CP-99-032, or CP-99-036
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Non-Hodgkin
Keywords: Long-Term Follow-up
BEXXAR
Iodine I 131 Tositumomab
Low-grade lymphoma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 88
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: The study population consists of subjects which have been previously treated with Iodine I 131 Tositumomab in Studies 104505, 93229/023, 393229/007, 104514 and 393229/028.

Brief summary: This is a multi-center study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on Studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long-term safety. Additionally Laboratory evaluations consisting of a TSH level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.


Eligibility criteria: Inclusion Criteria:

* Patients must have enrolled in one of the following Corixa sponsored clinical trials: CP-97-011, CP-98-025, CP-99-032, or CP-99-036 and are \>2 years post treatment with Iodine I 131 Tositumomab.
* Patients must give written informed consent by signing an IRB/ethics committee approved consent form prior to entry on this follow-up study.

Exclusion Criteria:

* Inability to meet above referenced inclusion criteria.

Primary outcomes:
measure: long term followup data
timeFrame: every 3 months at Months 6, 9, 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01974778: A Role for Brown Adipose Tissue in Postprandial Thermogenesis?
Official title: A Role for Brown Adipose Tissue in Postprandial Thermogenesis?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Diabetes
Cardiovascular Disease
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2013-11-03
Enrollment: 4
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Brown adipose (fat) tissue (BAT) is a type of fat tissue found in certain small rodents and human babies that is capable of extremely high rates of energy burning. We now know that in adult humans it is present and also able to burn energy.

In addition to increased energy expenditure during cold exposure, energy burning is also increased after consuming a meal. Animal studies have shown that part of this additional energy consumption is contributed by BAT. In the present study we will aim to examine whether BAT activity is increased after a meal.

Detailed description: The purpose of this project is to measure whether BAT activity (during which BAT increases energy burning) increases in response to ingestion of a meal.

BAT is one of two types of fat, (the other being white fat), which is found in humans and other mammals. In this study we aim to further our understanding of how BAT works in humans. Studies in animals show that in addition to cold exposure, BAT is also activated by ingestion of a meal, and to different amounts depending on the meal composition, and more importantly, total energy content. However we have only a very limited understanding of BAT function in response to meals in humans. Since BAT function is defective in obesity, and its activity and function are impacted by diet, here we will find out whether a single high energy meal composed entirely of lipid (fat) can increase BAT activity. In future these findings and those of subsequent studies may have important implications for the management of obesity and related diseases.

A total of 20 people will participate in this project. Participation will involve a total of 3 visits, including a screening visit, 2 experimental visits consumption of the treatment meal on one visit, and the placebo (dummy) on the other in a randomised order.

Eligibility criteria: Inclusion Criteria:

* Males aged 19 - 35 years
* Unmedicated for the previous 2 months
* No major illness
* BMI 17-40 kg/m2

Exclusion Criteria:

* Unable to give informed consent
* Smokers
* Participant in research projects involving ionising radiation within the past 5 years, excluding dual energy x-ray absorptiometry scans conducted in prior studies
* Claustrophobia
* Fasting plasma glucose \> 6.0 mmol/L

Primary outcomes:
measure: BAT activity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Baker IDI Heart & Diabetes Institute
name: Bronwyn Kingwell, Professor
role: PRINCIPAL_INVESTIGATOR
References: