louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01668329: Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)
Official title: Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunocompetent Patient on Septic Shock
Keywords: Septic shock
Inflammatory process
Cytokines
Hormonal response
Oxydative stress
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All immunocompetent patients hospitalised in intensive care from the beginning of the septic shock state.

Brief summary: Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its outcome has not been improved despite the knowledge on inflammatory processes; a reason for these lack of results may lay on the lack of data on the precise dynamics of inflammatory and anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring of the inflammatory process on a small group of non-immunocompromised patients. Our goal is to obtain quality data, repeated over time, by limiting the technical variability.

Detailed description: The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal response on immunocompetent adults during septic shock.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years admitted in ICU.
* Clinical evidence of infection, suspected or proved, during the 48hrs following the hospital entry.
* Systemic inflammatory response syndrome.
* Shock defined as arterial hypotension (\<90mmHg)not responding to adequated filling.

Exclusion Criteria:

* Minors
* Patient under guardianship or trusteeship
* Pregnant or lactating women
* Not affiliated to the social security
* Deprived of liberty by court decision
* Patients hospitalised without their approval
* Shock related to another cause than infection
* Long term corticothérapy
* On-going chemiothérapy, AIDS
* Bedridden patient

Primary outcomes:
measure: Evolutive profile of the inflammatory response during septic shock
timeFrame: Hospitalisation in ICU
Secondary outcomes:
measure: Research for early prognosis factors
timeFrame: Hospitalisation in ICU
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: TIMSIT Jean FRANCOIS, PU/PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03232229: Supplementation in Tennis
Official title: Supplementation in Tennis: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Supplements
Tennis
Nutrition
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The participants will have to be professional tennis players, both male and female.

Brief summary: The aim of this observational study is to examine supplementation (e.g. caffeine or creatin) use in both male and female professional tennis players.


Eligibility criteria: Inclusion Criteria:

* Professional tennis player

Exclusion Criteria:

* Any metabolic disease or a possible pregnancy

Primary outcomes:
measure: Supplementation questionnaire
timeFrame: October 2017 - September 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02666729: Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary Veins
Official title: Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary Veins
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2016-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who are undergoing an intial AF ablation procedure.

Brief summary: The purpose of this study is to collect information about the success rate of atrial fibrillation (AF) ablation procedures using the contact force data from the TactiCath Quartz ablation catheter.

Detailed description: Atrial fibrillation is a condition in which the upper chambers of the heart (the atria) begin to quiver (shake rapidly with small movements) instead of beating in a normal rhythm. This condition can cause blood to remain in the atria instead of moving to the lower heart chambers. AF can cause a number of other health problems and can decrease your quality of life.

Treatments for AF can include surgery, implantable devices, ablation and medication, to name a few. An ablation is a procedure that creates scar tissue in the heart to interrupt irregular heart rhythms and prevent them from coming back. The ablation procedure uses tools called catheters to treat the AF. Ablation catheters are thin, flexible plastic tubes that use electrical energy to create scars in the heart.

The amount of force applied to the heart tissue where the catheter touches (called the contact force) might help determine the success of the ablation procedure. This study would help to determine whether or not the contact force makes a difference in an effective ablation. You will be tested on both sides, at the end of the procedure to see if any problem persists.

Participants will be in this study for about 3 months. All visits in this study will correspond to standard of care visits.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing an initial AF ablation procedure
* Able to sign informed consent and complete the 3 month follow up

Exclusion Criteria:

* Severe COPD and is unable to receive adenosine therapy during the procedure

Primary outcomes:
measure: Rates of dormant conduction
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235129: Six Minute Walking Test and Breath-holding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To compare the relationship between breath-hold time and the distance in a Six Minute Walking Test in chronic obstructive pulmonary disease population.


Eligibility criteria: Inclusion Criteria:

* stable chronic obstructive pulmonary disease

Exclusion Criteria:

* contra-indication for six minutes walking test
* difficulty to walk
* musculoskeletal disorder

Primary outcomes:
measure: six minute walking test
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT00352729: Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites
Official title: Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Keywords: Burns
ACell
Donor Site
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2006-07-17
Enrollment: 0
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 purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds.

Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less than the mean healing time for wounds treated with the Standard of Care dressing.

Detailed description: This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of the ACell Dressing for use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing, which is currently Xeroform.

Eligibility criteria: Inclusion Criteria:

* less than 30% total body surface area burn
* burn wounds do not involve the donor site harvesting areas
* requires excision and grafting of sufficient extent to justify two donor site of roughly equal size on non-dependent body surfaces.
* The scheduled excision and grafting procedure is the first such operation for the subject
* subject agrees to participate in follow-up evaluations

Exclusion Criteria:

* Critical illnesses such as those requiring ventilator support, systemic infection, or hemodynamic instability
* Major acute or chronic medical illness that could affect wound healing
* Cellulitis or other infection of the potential donor sites
* Donor site has been previously harvested for grafting
* Subjects who are pregnant
* Religious objections or allergy to porcine products

Primary outcomes:
measure: The specific aim of this study is to determine if the ACell dressing is superior to the ISR Burn Center's current standard of care dressing with respect to speed of healing, patient comfort or wound cosmesis.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: U.S. Army Insitute of Surgical Research
state: Texas
Study officials:
affiliation: U.S. Army Institute of Surgical Research
name: Michael Albrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Badylak SF. Xenogeneic extracellular matrix as a scaffold for tissue reconstruction. Transpl Immunol. 2004 Apr;12(3-4):367-77. doi: 10.1016/j.trim.2003.12.016.
Clinical trial NCT02933229: The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori
the Operative Link on Gastric Intestinal Metaplasia
Operative Link on Gastric Intestinal Assessment
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By causing progressive damage to the stomach and may eventually result in gastric atrophy, H. pylori infection has been demonstrated to be responsible for more than 95% of gastric malignancies


Eligibility criteria: Inclusion Criteria:

* Patients with H. pylori infection;
* Aged 18-65 years.

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Conditions unsuitable for performance of gastroscopy, such as coagulopathy, impaired renal function;
* Pregnancy or breastfeeding;
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: The proportion of more severe inflammation in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
timeFrame: 15 years
measure: The proportion of more severe atrophy in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
timeFrame: 15 years
measure: The proportion of more severe IM in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
timeFrame: 15 years
Secondary outcomes:
measure: The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link on gastritis assessment (OLGA) system compared with original status.
timeFrame: 15 years
measure: The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link for gastritis intestinal metaplasia (OLGIM) system compared with original status.
timeFrame: 15 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Li Yanqing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05260229: The Observation About the Effects of Internal Carotid Artery Stenosis on Fundus Vessels and the Changes of Fundus Vessels After Interventional Therapy
Official title: The Observation About the Effects of Internal Carotid Artery Stenosis on Fundus Vessels and the Changes of Fundus Vessels After Interventional Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Internal Carotid Artery Stenosis
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with carotid artery stenosis and need surgery.

Brief summary: The investigators plan to collect 30 participants with internal carotid artery stenosis to observed the relationship between the degree of internal carotid artery stenosis and fundus vessels （and blood flow）density before operation, and compared with participants without internal carotid artery stenosis.The fundus blood flow density will be observed after intervention operation in order to see whether the operation is effective to improve the density of fundus vessels and blood flow or not.


Eligibility criteria: Inclusion Criteria:

1. Patients who have been diagnosed with carotid artery stenosis and need surgery;
2. Patients whose vision won't get worse soon;
3. Patients have not had any eye surgeries;
4. Patients with complete profile.

Exclusion Criteria:

1. Patients with severe systemic disease;
2. Patients with poor dioptric stroma;
3. Patients with nystagmus;
4. Patients with incomplete profile.

Primary outcomes:
measure: The differences of perfusion density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
timeFrame: 2022-01-31
measure: The differences of perfusion density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
timeFrame: 2022-02-14
measure: The differences of vessel density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
timeFrame: 2022-01-31
measure: The differences of vessel density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
timeFrame: 2022-02-14
measure: The perimeter and area of the fovea avascular zone（FAZ）in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
timeFrame: 2022-02-14
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of ophthalmology and neurology at Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT06783829: A Study of SHR-4394 Injection in Subjects With Prostate Cancer
Official title: A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. Age range: 18-85 years old, male;
2. ECOG score for physical condition is 0-1 points;
3. Expected survival period ≥ 6 months;
4. Prostate adenocarcinoma confirmed by histological or cytological examination;
5. Patients with at least one metastasis lesion;
6. Disease progression on or after the most-recent prior regimen;
7. Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy;
8. Testosterone was at castration level;
9. Adequate organ function.

Exclusion Criteria:

1. Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
2. Unresolved to CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy;
3. Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
4. Uncontrollable tumor-related pain;
5. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
6. Other serious concomitant disease;
7. Previous or co-existing malignancies;
8. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394;
9. Active hepatitis B or active hepatitis C;
10. Other inappropriate situation considered by the investigator.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 3 weeks.
measure: Maximal tolerable dose (MTD)
timeFrame: 3 weeks.
measure: Adverse events (AEs)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Recommended phase II dose (RP2D)
timeFrame: Screening up to study completion, an average of 1 year.
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to approximately 2 years.
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years.
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years.
measure: overall survival (OS)
timeFrame: Up to approximately 2 years.
Other outcomes:
Locations:
city: ChengDu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT00510029: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
Official title: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arrhythmia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The study will assess the safety, tolerability and pharmacokinetics of single intravenous (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour infusion.


Eligibility criteria: Inclusion Criteria

* Generally healthy men and women of nonchildbearing potential (WONCBP), aged 18 to 50 years.
* Body Mass Index (BMI) range of 18 to 30 kg/m2.
* Blood serum creatinine levels less than or equal to the upper limit of normal.

Exclusion Criteria

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any history of clinically important cardiac arrhythmias and familial history of long QT syndrome or unexpected cardiac death.
* History of drug and alcohol abuse, positive HIV, HCV, and/or HBs Ag test, and any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.

Primary outcomes:
measure: To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects
timeFrame: 3-4 months
Secondary outcomes:
measure: To provide the initial Pharmacokinetic (PK) profile of single ascending IV doses (24 hour and 1-minute) and the initial PK assessment of the bioavailability of an oral formulation of GAP-134 under fasting conditions in healthy subjects
timeFrame: 3-4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06146829: Machine Learning Models for Prediction of Acute Kidney Injury After Noncardiac Surgery
Official title: Development of Interpretable Machine Learning Models for Prediction of Acute Kidney Injury After Noncardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Acute Kidney Injury
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 88367
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: Adult patients who underwent noncardiac surgical procedures at Tongji hospital between July 2018 and October 2022 were included.

Brief summary: Acute kidney injury (AKI) is a common surgical complication characterized by a rapid decline in renal function. Patients with AKI are at an increased risk of developing chronic kidney disease and end-stage renal disease, which has been associated with an increased risk of morbidity, mortality and financial burdens. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies, and prediction models can be helpful in this regard.

The goal of this retrospective study is to develop prediction models for postoperative AKI in noncardiac surgery using machine learning algorithms, and to simplify the models by including only preoperative variables or only important predictors.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age ≥ 18 years) who had a serum creatinine measurement within 10 days before surgery and at least one measurement within 7 days after surgery.
* Eligible surgeries encompassed general, thoracic, orthopedic, obstetric, gynecology, and neurosurgery procedures lasting longer than 1 hour

Exclusion Criteria:

* Patients with concurrent cardiac, vascular, urological, or transplant surgeries.
* Patients with an American Society of Anesthesiologists (ASA) physical status V.
* Patients with end-stage renal disease (i.e., a glomerular filtration rate \[eGFR\] of 15 mL/min/1.73 m² or receiving hemodialysis).

Primary outcomes:
measure: Postoperative acute kidney injury
timeFrame: Within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Rao Sun
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Rao Sun
role: PRINCIPAL_INVESTIGATOR
References: