louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03891342: Effect of Fluid Challenge on Glycocalyx
Official title: Comparing of Two Regimes (Fast and Slow) of Fluid Challenge on Glycocalyx Assessed by Perfused Boundary Region in Septic and Elective Major Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Endothelial Dysfunction
Sepsis
Septic Shock
Surgery
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
Collaborators: name: University Hospital Pilsen
First posted: 2019-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interventional study comparing effect of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery on glycocalyx by using perfused Boundary Region in sublingual microcirculation.

Detailed description: Effect of two regimes of fluid challenge on GCX in patients with sepsis and during elective surgery under general anesthesia.

Hypothesis to be tested: Administration of 500 ml of balanced solution as a bolus impairs GCX more than prolonged administration.

The aim of the study: Comparison of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery.

Type of the study: Open, randomized, interventional.

Subjects:

Part A: Patients with sepsis within 48 hours before admission to ICU requiring fluid challenge based on clinical or echocardiographic assessment.

Part B: Patients during major elective surgery requiring fluid challenge based on clinical or echocardiographic assessment.

Sample size calculation (based on expected difference in PRB, alpha error I =0,05 and study power = 0,99) = 52 patients. Investigators plan enrolment of 60 patients for each part, totally 120 patients.

Intervention:

* 500 ml of balanced crystalloid solution within 5 minutes (group "fast")
* 500 ml of balanced crystalloid solution within 30 minutes (group "slow") Data to be recorded and analysed: Demographics, severity score, fluid response assessment, sublingual microcirculation by SDF imaging will be recorded at time points: baseline, after intervention, after 60 minutes, after 120 minutes, plasma syndecan-1 will be analysed before intervention and 120 minutes thereafter, microcirculatory data and Perfused Boundary Region.

Eligibility criteria: Inclusion Criteria:

arm A: age over 18, diagnosis sepsis, fluid bolus administration indicated, arm B: age 18-70, ASA status I-III, major surgery

Exclusion Criteria:

none.

Primary outcomes:
measure: Influence of balanced crystalloid infusion time on endothelial glycocalyx
timeFrame: baseline and at 20, 40, 60 and 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Plzen
country: Czechia
facility: FN Plzen
Study officials:
affiliation: Charles University hospital in Plzen, Czech Republic
name: Jan Benes, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02136342: Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer
Official title: Phase 1 Trial Evaluating Tolerability and Pharmacokinetics of Chlorogenic Acid for Injection in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: no available effective treatment
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
First posted: 2014-05-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.


Eligibility criteria: Inclusion Criteria:

* advanced cancer with no effective treatment
* Karnofsky performance status no less than 70
* adequated organ function
* informed consent

Exclusion Criteria:

* allergic to chlorogenic acid
* persistent toxicities from previous treatment (no less than grade 2)

Primary outcomes:
measure: Number of adverse events
timeFrame: within the first 60 days after the first dose of chlorogenic acid
Secondary outcomes:
measure: dose-limiting toxicity
timeFrame: within the first 30 days after the first dose of chlorogenic acid
measure: maximum tolerated dose
timeFrame: within the first 30 days after the first dose of chlorogenic acid
measure: Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid
timeFrame: within the first 30 days after the first dose of chlorogenic acid
measure: improvement in cancer-related symptoms and quality of life
timeFrame: within 1 year after the first dose of chlorogenic acid
Other outcomes:
measure: Change in number of red blood cell and level of hemoglobin
timeFrame: within 1 year after the first dose of chlorogenic acid
measure: change in the diameters of lymph node metastasis
timeFrame: within 1 year after the first dose of chlorogenic acid
measure: change in levels of tumor markers
timeFrame: within 1 year after the first dose of chlorogenic acid
Locations:
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yuankai Shi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00777842: Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
Official title: Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.


Eligibility criteria: Key Inclusion Criteria:

* Patient has discrete de novo lesion of a coronary artery with symptomatic ischemic heart disease
* Planned treatment of one lesion with a single stent
* Denovo type A, B1 lesions with a Reference diameter between 3.0 and 3.5mm and a lesion length between 5 and 16mm

Key Exclusion Criteria:

* Diabetic (HbA1C \>6.0)
* Platelet count \< 100000 cells/mm3 or \> 700000 cells/mm3; WBC \< 3000 cells/mm3; or a hemoglobin \< 10 g/dl
* Renal dysfunction with creatinine \> 2.0 mg/dl
* Patient has a known pre-dilatation ejection fraction (EF) less than forty five (\<45%)
* Myocardial infarction (MI) less than 3 months prior to intervention
* Patient has type B2, C lesion
* Reference artery diameter \<3.0 or \>3.6 mm
* Target lesion length \< 5mm and \>16 mm
* Other stenosis \>50% in target vessel
* Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, or cobalt chromium, or a sensitivity to contrast agent that, in the opinion of the investigator, cannot be adequately premedicated.

Primary outcomes:
measure: Vessel Lumen Patency
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
Study officials:
References:
Clinical trial NCT02423642: Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 study the effect of anticoagulation in immune response with Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).


Eligibility criteria: Inclusion Criteria:

* Systemic inflammatory response syndrome; SIRS \> or = 2 meets definition
* Patients with acute kidney injury in the intensive care ward.
* Requiring continuous renal replacement therapy.

Exclusion Criteria:

* Pregnancy
* Cirrhosis
* End stage renal disease
* HIV infection
* Serum creatinine in male \> 2 mg/dl and female \> 1.5 mg/dl
* Bleeding

Primary outcomes:
measure: Functions of inflammatory cells
timeFrame: 24 hours
measure: Regulation of inflammatory reactions and and opsonization in microorganisms
timeFrame: 24 hours
measure: Activity of acute phase protein during acute inflammation
timeFrame: 24 hours
Secondary outcomes:
measure: survival rate
timeFrame: 28 days
measure: length of ICU stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sasipha Tachaboon
state: Pathumwan
Study officials:
References:
citation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Clinical trial NCT00927342: BioGlue or Vivostat in the Control of Air Leak in Thoracic Surgery
Official title: A Comparison of BioGlue and Vivostat in the Prevention of Air Leak in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Air Leak
Keywords: Air leak
Thoracic Surgery
Sealants
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-06-24
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Following lung surgery air may continue to leak from the surface of the lung. Chest drains are placed to allow this air to be removed safely and prevent the lung from collapsing. Drains need to remain until the air leak from the lung has ceased.

Air which continues to leak results in longer chest drainage times which cause increased discomfort and immobility for patients. These patients are at risk of secondary complications such as infection. Longer hospital stays and increased costs ensue. A randomised controlled trial (RCT) conducted at The Royal Brompton Hospital has shown clear benefits in the management of difficult air leak with the use of BioGlue. BioGlue is a surgical sealant applied to the surface of the lung at the time of surgery.

BioGlue is of bovine origin. Concerns exist regarding the potential risk of transmission of blood borne diseases with bovine derived medical products. Should a surgical adhesive without these potential risks prove as effective as BioGlue then its use could be commended.

The Vivostat System is a medical system that derives a sealant from the patient's own blood. A small study has shown that it may also be of benefit in the management of difficult air leaks. The principal aim of our RCT is to compare the duration of air leak, length of chest drainage and hospital stay associated with BioGlue to that of Vivostat.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years and over)
* Males and females
* Patients undergoing any thoracic surgical procedure likely to result in alveolar air leak.
* Written informed consent

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Breast feeding
* Previous treatment with BioGlue or Vivostat
* Inability to give informed consent
* Pneumonectomy
* Empyema
* Grade 0 air leak

Primary outcomes:
measure: Duration of air leak
timeFrame: Days post-operatively
measure: Duration of intercostal drainage
timeFrame: Days post-operatively
measure: Duration of hospital stay
timeFrame: Days post-operatively
Secondary outcomes:
measure: Post-operative complications
timeFrame: Days and weeks following discharge
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Thoracic Surgery, The Royal Brompton Hospital
Study officials:
References:
Clinical trial NCT01678742: Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients
Official title: Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Obesity
Keywords: Diet
Incretins
Gastrointestinal Hormones
Fish Proteins
Lead sponsor: Jeju National University Hospital
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* Subjects signed a written informed consent form

Exclusion Criteria:

* Liver cirrhosis
* Chronic renal disease (serum creatinine \> 2mg/dL)
* Severe congestive heart failure
* Significant infectious or inflammatory diseases
* intractable malignant neoplasm
* Pregnancy

Primary outcomes:
measure: Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
Secondary outcomes:
measure: Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
measure: Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
measure: Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
measure: Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
Other outcomes:
measure: Difference in the iAUC for glucose after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
measure: Difference in the iAUC for insulin after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
measure: Difference in the iAUC for C-peptide after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
measure: Difference in the iAUC for glucagon after food ingestion between high-protein and standard diet groups
timeFrame: 3 hours
Locations:
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
Study officials:
affiliation: Jeju National University Hospital
name: Gwanpyo Koh, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06552442: Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Glucocorticoid Treatment for No-Reflow in STEMI
Official title: Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Reflow Phenomenon in STEMI Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemia-reperfusion Injury
No-reflow
Keywords: acute coronary syndrome
STEMI
No-reflow
Intracoronary
Glucocorticoids
Lead sponsor: Amosov National Institute of Cardiovascular Surgery
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The main study group receives intracoronary methylprednisolone for the no-reflow phenomenon. The control group does not receive any pharmacological intervention. Considering that this complication is very rare, the control group was selected retrospectively.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to improve reperfusion therapy in STEMI patients with no-reflow phenomenon. Based on literature review and pathological studies, the investigators believe that myocardial ischemia-reperfusion injury is primarily due to myocardial edema, which is angiographically manifested by the no-reflow. To restore blood flow, high-dose intracoronary methylprednisolone was applied. The main idea is to stabilize cell membranes and stop the progression of edema. It is local, not systemic, single administration that avoids serious side effects. The primary hypothesis is that hormone administration will improve blood flow to TIMI 2/3 in TIMI 0/1after stenting infarct-related artery.

Detailed description: The study involves comparing the main group receiving intracoronary methylprednisolone with a group of patients without intracoronary pharmacotherapy. Preliminary results: the use of methylprednisolone allows for the restoration of coronary blood flow but does not affect mortality.

Eligibility criteria: Inclusion Criteria:

* TIMI 0/1 flow after successful artery obstruction stenting
* Men and women aged 40 years and older

Exclusion Criteria:

* Coronary artery dissection
* Abrupt intraoperative coronary artery closure
* Intraoperative thrombosis

Primary outcomes:
measure: Restoration of coronary blood flow
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Amosov National Institute of cardiovascular surgery
state: Amosov Street, 6
Study officials:
References:
Clinical trial NCT02922842: A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
Official title: A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urge Incontinence
Overactive Bladder
Keywords: transcutaneous electrical nerve stimulation
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer.
* Patients with urge predominant mixed incontinence.
* Patients will need to have answered at "Yes" to "leakage related to feeling urgency" on the UDI 6 questionnaire.
* Female
* Over 18 years of age.
* English speaking who are able to give informed consent to participate in the study.
* Patients who have four urinary incontinence episodes.

Exclusion Criteria:

* Stress incontinence desiring surgical management.
* Previous treatment of refractory urge incontinence such as PTNS, SNS, or Intradetrusor onabotulinumtoxin A injections.
* Neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair.
* Urethral diverticulum.
* Daily catheterization due to urinary retention.
* The use of anticholinergic medications for less than 6 weeks.
* Patients who have pacemakers in place.
* Patients with limited mobility requiring a wheelchair.
* Elevated PVR \> 200 cc
* Untreated urinary tract infection, defined as symptoms and a urine culture with greater than 100,000 cfu/ ml within the last 1 month prior to treatment.
* Uncorrected Stage 3 prolapse.

Primary outcomes:
measure: Number of incontinence episodes per day
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of bladder voids per day
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01988142: The Effect of Continuous Passive Motion Training on Neuromuscular Adaptation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury(SCI)
Keywords: Spinal Cord Injury
Passive motion
Fatigue index
Hypertonia
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After spinal cord injury (SCI), the muscular property altered due to the immobilization adaptation. The purpose of this study was to investigate the effect of remobilization with continuous passive exercise on the adapted paralyzed muscle properties after SCI.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic spinal cord injury

Primary outcomes:
measure: Muscle tone tests
timeFrame: Baseline, 1, 2,3, and 4 months.
measure: Fatigue index of muscle
timeFrame: Baseline, 1, 2,3, and 4 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References:
Clinical trial NCT00095342: Study Evaluating TMI-005 in Active Rheumatoid Arthritis
Official title: A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-11-03
Enrollment: 390
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: The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).


Eligibility criteria: Inclusion Criteria:

* Meet American College of Rheumatology (ACR) criteria for RA
* Have active RA
* Disease duration of at least 6 months
* Disease onset at \> 16 years of age.

Exclusion Criteria:

* Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra)
* Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care
* Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
city: Syracuse
country: United States
state: New York
city: Duncansville
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Montreal
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References: