louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02808039: Is There a Transient Rebound Effect of Platelet Reactivity Following Cessation of Dual Antiplatelet Therapy With Ticagrelor - a Single Center Prospective Observational Trial
Official title: Is There a Transient Rebound Effect of Platelet Reactivity Following Cessation of Dual Antiplatelet Therapy With Ticagrelor - a Single Center Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dual Antiplatelet Therapy
Platelet Reactivity
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 60
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: Patients who underwent coronary stent implantation and completed 12 months of DAPT regimen with Ticagrelor with no clinical or adverse events.

Brief summary: to assess whether cessation of 12 months DAPT regimen containing Ticagrelor results in a hyperreactive phase of platelet function

Detailed description: the study will be composed of a cohort of patients , who completed 12 months of DAPT with Ticagrelor (standard recommended dose for ACS - 90 mg BID), did not experience any clinical or adverse event during this time period and are about to discontinue Ticagrelor. We intend to measure the platelet reactivity for each patient on 4 time points - prior to cessation of Ticagrelor (i.e. while still on DAPT) and 1,4 and 12 weeks post discontinuation of therapy. There will not be a control group.

Eligibility criteria: Inclusion Criteria:

* Age\>18
* underwent coronary stent implantation due to ACS
* completed 12 month of DAPT regimen containing Ticagrelor at standard dose (90 mg BID)

Exclusion Criteria:

* any ischemic or bleeding events while under Ticagrelor
* any other Ticagrelor associated adverse effects
* planned for continuation of Ticagrelor for more than 12months post stenting according to the judgment of the attending physician.
* Unable to make informed consent .

Primary outcomes:
measure: platelet reactivity
timeFrame: from 1 week prior to 12 weeks post DAPT cessation
Secondary outcomes:
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center - Hsharon Campus
Study officials:
affiliation: Rabin Medical Center, Department of Cardiology
name: Guy Witberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin Medical Center, Department of Cardiology
name: Eli Lev, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06849739: Study on the Correlation and Consistency of Measuring Biologic Drug Plasma Concentrations Based on Different Detection Methods
Official title: Study on the Correlation and Consistency of Measuring Biologic Drug Plasma Concentrations Based on Different Detection Methods
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on the treating physician's judgment, IBD patients require biologic therapy with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) .

Brief summary: In recent years, biologics (such as infliximab, adalimumab, vedolizumab, and ustekinumab) have shown great potential in the treatment of inflammatory bowel disease (IBD), transforming the traditional treatment model for IBD. Despite achieving good efficacy, some patients do not respond to biologics, which may be related to low drug concentrations in the blood. Guidelines recommend therapeutic drug monitoring (TDM) during the treatment of IBD. Currently, many commercial testing methods are available to detect the trough levels of biologics; however, data on the diagnostic accuracy and practicality of these methods remain limited. This study compares the detection of blood samples from IBD patients after administration using ELISA, PICA, and CLIA methods, aiming to provide more accurate guidance and evidence for TDM in Chinese IBD patients undergoing biologic therapy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) .

Exclusion Criteria:

* Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.

Primary outcomes:
measure: plasma concentration
timeFrame: During hospitalization for biologic injections，an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT06598839: Immuno-effect of Tα1 for Stage I NSCLC
Official title: Assessment of the Efficacy of Immunomodulatory Therapy With Thymosin Alpha 1 (Tα1) Following Surgical Resection in Patients With Stage I Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
Thymosin alpha1
CTC
Immunosenescence
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effect of thymosin alpha 1 (Tα1) on postoperative peripheral blood circulating tumor cells and immunosenescence in patients with early-stage non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed stage I (per AJCC 8th edition) invasive NSCLC
* Resectable tumor
* undergoing lobectomy and systemic lymph node dessection
* Without a previous history of malignant tumors or other concurrent malignancies
* Naïve to any anticancer therapies or other immunostimulatory agents
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1, with cardiac, pulmonary, hepatic, cerebral, and renal functions capable of withstanding surgery
* Aged ≥18 years and ≤75 years
* Having signed written informed consent and capable of adhering to the visit schedule and related procedures outlined in the study protocol

Exclusion Criteria:

* With a pathologically confirmed non-invasive NSCLC, including preinvasive lesions, small cell lung cancer, and benign lesions
* Post-diagnostic use of immunosuppressive medications or other immunostimulatory agents
* With known or suspected active autoimmune disease
* Allergic to thymopeptides
* With other uncontrolled serious illnesses or having acute or chronic conditions that may confound test outcomes, including active severe clinical infections ( \&gt;NCI-CTCAE grade 2 infection); diagnosed with epilepsy requiring antiepileptic treatment; on renal dialysis; with non-healing wounds, ulcers, or fractures; with a history of arteriovenous thrombotic events, including cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, within six months prior to the first dose

Primary outcomes:
measure: Number of CTCs
timeFrame: 4 months after sugery
Secondary outcomes:
measure: Number of immune cells
timeFrame: 4 months after sugery
measure: Peripheral blood immune cells profile
timeFrame: 4 months after sugery
measure: AE
timeFrame: within 4 months after sugery
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
name: Yousheng Mao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03320239: Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men
Official title: Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men in Beijing: a Social Media-based Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
HIV Infections
Social Media
Keywords: HIV
risk assessment
HIV testing
unprotected anal intercourse
Social medica
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
First posted: 2017-10-25
Enrollment: 4500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to evaluate the effectiveness of a HIV risk assessment tool to promote HIV testing and to reduce high risk sexual behaviors among men who have sex with men (MSM). It hypothesizes that the social media-based HIV risk assessment tool can increase 20% HIV testing proportion during the six months follow-up period.


Eligibility criteria: Inclusion Criteria:

* Male at birth.
* Having had homo-sexual behaviors (anal/oral) in the past 6 months before enrollment.
* An age of 18 years or older.
* Living in Beijing, China.
* Self-reporting HIV negative or unknown.
* Willingly participating into the baseline survey and the six months follow ups.
* Agreeing not to share the research link to others.
* Owning a mobile phone and having had downloaded the social networking Application Blued before enrollment.

Exclusion Criteria:

* Not accepting blood sampling within the study period.
* Reporting injecting drugs use in the past six months before enrollment.
* Being currently involved in other HIV behavioral interventions for MSM.
* Having a specific plan to leave from Beijing in the next 6 months.
* Self-reporting female.
* Other reasons the investigators deem make participation either detrimental to the participants or the study.

Primary outcomes:
measure: The proportion of HIV testing during the study period
timeFrame: 1 month
Secondary outcomes:
measure: unprotected anal intercourse
timeFrame: 6 months
measure: Post exposure prophylaxis (PEP)
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: national center for AIDS control and prevention
state: Beijing
Study officials:
affiliation: NATIONAL CENTER FOR HIV/STD CONTROL AND PREVENTION
name: Wu Z You, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02255539: Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
Official title: Bioburden and Usability Study of the Geelong Mask System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep
sleep apnea
OSA
CPAP
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. The mask system will be assessed according to objective data recordings and user questionnaires. It is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver CPAP treatment.


Eligibility criteria: Inclusion Criteria:

* Participants willing to give written informed consent
* Participants who can read and comprehend written and spoken English
* Participants who are over 18 years of age
* Participants who have been diagnosed with OSA
* Participants who have been established on CPAP for ≥ 6 months
* Participants currently using a ResMed nasal pillows mask

Exclusion Criteria:

* Participants who are not able to provide written informed consent
* Participants who are unable to comprehend written and spoken English
* Participants who are pregnant
* Participants who are unsuitable to participate in the study in the opinion of the researcher
* Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury)
* Participants who cannot participate for the duration of the trial
* Participants who are established on bi-level support therapy
* Participants who are not established on a ResMed nasal pillows mask

Primary outcomes:
measure: Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResMed Ltd
state: New South Wales
Study officials:
affiliation: Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
name: Klaus Schindhelm, BE PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00959439: Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)
Official title: A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Osteoarthritis
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 55 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PharmaKinetics Laboratories Inc.
name: Ronald Goldwater, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04981639: TAP and IMS for HIPEC
Official title: Effects of Transabdominal Plane Block and Electrical Twitch Obtaining Intramuscular Stimulation on the Postoperative Pain in Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytoreductive Surgery
Keywords: hyperthermic intra-peritoneal chemotherapy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 81
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is important to decrease the postoperative pain in patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy. We will compare the Transversus abdominis plane block with the Transversus abdominis plane block plus intramuscular electrical stimulation in patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy.


Eligibility criteria: Inclusion Criteria:

-Patients who are able to do daily activity and walk independently.

Exclusion Criteria:

1. Patients with history of preoperative abdominal surgery
2. Patients who are unable to walk independently due to musculoskeletal disorder
3. Patients who are allergic to local anesthetics
4. Patients with chronic pain
5. Patients with pacemaker
6. Patients with endotracheal tube postoperatively
7. Patients with history of substance abuse
8. Pregnancy
9. Patients who are unable to communicate due to mental disorder

Primary outcomes:
measure: Pain score
timeFrame: At postoperative day 1
Secondary outcomes:
measure: Pain score
timeFrame: At postoperative day 2, 3, 5, 7, 14 and 28
measure: IVPCA consumption
timeFrame: At postoperative day 1, 2, and 3
measure: Nausea will be evaluated using 2 point scale (yes, no)
timeFrame: At postoperative day 1, 2, 3, 5 and 7
measure: Vomiting will be evaluated using 2 point scale (yes, no)
timeFrame: at postoperative day 1, 2, 3, 5 and 7.
measure: Peak cough flow
timeFrame: At postoperative day -1, 4, 7, 14, and 28
measure: Gait speed
timeFrame: day -1, 4, 7, 14, and 28
measure: Quality of life will be evaluated using QoR40 questionnaire (0-200)
timeFrame: At postoperative day 4 and 7
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeveranceHospital
Study officials:
References:
Clinical trial NCT03913039: Reduction of Prostate Biopsy Morbidity
Official title: Reduction of Prostate Biopsy Morbidity and Hospitalization Through a Modified Biopsy Protocol Bundle and Region-specific Antibiogram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 157
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males with clinical indication for a prostate biopsy.

Brief summary: Prostate biopsy is typically performed via either the transrectal or transperineal approach. This study is a case-control study being done to determine if a novel prostate biopsy protocol incorporating a transperineal approach, rectal swab to detect resistant bacteria and broad antibiotic prophylaxis will reduce infectious complications and hospital readmission compared to current biopsy practices.

Detailed description: This will be a prospective multi-center cohort case-control study comparing a novel transperineal prostate biopsy protocol integrating measures to reduce post procedural infection (Cases) to traditional transrectal prostate biopsies (Controls). Eligible subjects will be identified through administrative records in the Urology clinics affiliated with Maimonides Medical Center. Eligible patients will be counseled about the risks and benefits of participation and offered enrollment into the study. Demographic data including age, comorbidities and past medical history will be extracted from the medical record.

Men meeting inclusion/exclusion criteria will be prospectively enrolled. The novel transperineal protocol will include the following: (Cases)

1. Transperineal biopsy approach with avoidance of rectal flora
2. MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
3. Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
4. Multi-antibiotic prophylaxis
5. Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

Traditional biopsy protocol includes: (Controls)

1. Transrectal approach
2. Standard 12-core template
3. Surgeon-specific antibiotic prophylaxis
4. Urine culture, prostate tissue culture and FQR rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

Eligibility criteria: Inclusion Criteria:

* Male patients greater than 18 years of age
* Indication for prostate biopsy

Exclusion Criteria:

* Female patients
* Male patients under 18 years of age
* No indication for prostate biopsy

Primary outcomes:
measure: Rate of clinically significant post-biopsy complications
timeFrame: 30 Days
Secondary outcomes:
measure: 1. Number of individual complications within 30 days
timeFrame: 30 Days
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02917486: EC-MOTION : ExtraCorporeal Membrane Oxygenation and Therapeutic Drug Monitoring of Drugs of infectION
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Keywords: ExtraCorporeal Membrane Oxygenation
patient in intensive care
pharmacokinetic modeling
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in intensive care treated with ECMO or without ECMO

Brief summary: The objective of the study is to investigate the exposure difference between antibiotic studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients without Extracorporeal Membrane Oxygenation.

The exhibition is evaluated by population pharmacokinetic modeling.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Hospitalisation in intensive care
* Treatment with ECMO or without ECMO
* Introducing sepsis treated with an anti-infective molecule studied (piperacillin) for less than 48 hours
* With an arterial catheter
* Patient Information or their next of kin according to the patients status.

Exclusion Criteria:

* Pregnancy
* Major person under legal protection (backup justice, trusteeship, quardianship), person deprived of liberty

Primary outcomes:
measure: Measure exposure to piperacillin
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Pierre Fillatre
role: PRINCIPAL_INVESTIGATOR
References: