louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06948565: Prognosis of Cirrhotic Patients Admitted to the General Intensive Care Unit Between 2014 and 2024: a Regional Retrospective Multicentre Cohort Study
Official title: Prognosis of Cirrhotic Patients Admitted to the General Intensive Care Unit Between 2014 and 2024: a Regional Retrospective Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cirrhosis
Intensive Care Medicine
Acute on Chronic Liver Failure(ACLF)
Keywords: prognosis
cirrhosis
ICU
ACLF
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cirrhosis admitted to intensive care between January 2014 and December 2024.

Brief summary: Ten years after our team's publication, practices have changed considerably in the management of severe cirrhotic patients. This study will analyse these practices in primary care hospitals and in a tertiary centre, and assess the impact of these changes on the prognosis of these patients.

The following hypotheses will be tested:

* Improvement in intensive care and overall prognosis compared with data from the literature prior to 2014
* Improved access to liver transplantation compared with the literature prior to 2014
* Improvement in intensive care unit practices (for example: application of recommendations published by learned societies concerning the intensive care unit management of patients with cirrhosis, access to comfort care, degree of clinical severity on admission to the intensive care unit, etc.).
* Centre' effect: variability in the phenotype of patients admitted to intensive care depending on the technical facilities available and whether or not the hospital centre has access to TH.


Eligibility criteria: Inclusion Criteria:

Patients with cirrhosis over 18 years of age (cirrhosis either histologically proven or diagnosed by hepatologists according to clinical, biological and ultrasound criteria) admitted to intensive care between January 2014 and December 2024.

Exclusion Criteria:

None

Primary outcomes:
measure: 28-day survival
timeFrame: 28 days
Secondary outcomes:
measure: Phenotype of patients admitted to intensive care
timeFrame: baseline
measure: Overall survival
timeFrame: through study completion
measure: Survival without liver transplantation
timeFrame: 12 months
measure: Proportion of patients listed for liver transplantation
timeFrame: through study completion
measure: number of patients receiving LT
timeFrame: through study completion
measure: Prognostic performance of general and cirrhosis-specific organ failure scores
timeFrame: baseline
measure: Comparison of the characteristics of patients on admission in primary care hospitals and in university hospital.
timeFrame: baseline
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT00334165: Auricular Acupuncture for Analgesia During Total Hip Arthroplasty
Official title: Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Pain
Total Hip Arthroplasty
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Humboldt-Universität zu Berlin
First posted: 2006-06-06
Enrollment: 360
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty


Eligibility criteria: Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective hip arthroplasty because of degenerative osteoarthritis under general anesthesia.
2. Surgery time does not exceed 100 minutes.
3. Patients without previous opioid medication.
4. Patients ranged 45-85 years old.
5. Patients who have given informed consent.

Exclusion Criteria:

1. Pregnant or nursing females.
2. Recidivist alcoholics.
3. Local or systemic infection.
4. Age \< 45 and \> 85 years.
5. Surgery time more than 100 minutes.
6. Intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines).
7. Patients consumed opioid medication before surgery.
8. Patients with prosthetic or damaged cardiac valves.
9. Patients who are unable to understand the consent form.
10. History of psychiatric disease.

Primary outcomes:
measure: Intraoperative analgesics requirement
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University of Berlin, Campus Charite
city: Greifswald
country: Germany
facility: Ernst Moritz Arndt University
Study officials:
affiliation: Ernst Moritz Arndt University
name: Taras I Usichenko, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01164865: Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
Official title: The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Keywords: Soft Contact lens
Multi-Purpose Solution
Hydrogen Peroxide
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to assess comfort in soft contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Wear silicone hydrogel contact lenses on a daily wear basis;
* Currently using OPTI-FREE RepleniSH contact lens solution;
* Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
* Read, sign, and date IRB-approved informed consent and the privacy document;
* Be generally healthy and have normal ocular health;
* Be be willing to follow the study procedures and visit schedule;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of additional lens cleaners;
* Known sensitivity to any ingredient in either of the test articles;
* Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
* Prior (within 7 days of enrollment) or current ocular infections;
* Clinically significant lash or lid abnormality;
* History of ocular surgery/trauma within the last 6 months;
* Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Ocular Comfort Rating at 2 Weeks
timeFrame: Baseline (Day 0), 2 weeks
measure: Likert Questionnaire Scores at 2 Weeks
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01014065: A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients (SUnitinib Prospective CardiovasculaR Effect)
Official title: A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Cardiotoxicity
Heart Failure
Hypertension
Keywords: sunitinib
cardiac MRI
maximal exercise testing
biomarkers
pharmacokinetics
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2009-11-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with renal cell carcinoma scheduled to receive sunitinub.

Brief summary: While sunitinib can be very helpful to treat kidney cancer, these medications can also cause side effects, including heart damage. Studies performed in the past did not look at heart function in detail, so the investigators do not know what happens to the heart when people start sunitinib treatment. The aim of the study is to prospectively study acute effects of sunitinib on heart function, overall fitness and blood markers of heart disease.

Detailed description: Participants will undergo cardiac MRI, maximal exercise testing(VO2 peak), blood and urine samples before and after 2 treatments of sunitinib. An extra blood sample will be collected the 2nd week of the first treatment to check blood levels of sunitinib. We will also examine routine CT scans to study body composition.

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of metastatic renal cell carcinoma
* Eligible to receive first-line sunitinib
* Willingness to attend Cross Cancer Institute and University of Alberta for study-related assessments
* Karnofsky Performance Status (KPS)82 ≥ 70
* Age ≥ 18 years of age
* Adequate creatinine clearance to receive gadolinium
* All patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to CPET;
* Fluent in English language
* No contraindication to MRI or other concern eg., metallic implants, claustrophobia

Exclusion Criteria:

* Prior systemic therapy for mRCC
* Documented history of major cardiac event in last year i.e. MI, unstable angina, CABG, symptomatic CHF, CVA or TIA, or pulmonary embolism
* Pregnancy
* Other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate
* Unstable brain metastases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Mark Haykowsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02705365: Patient Navigation for Lung Screening at MGH Community Health Centers
Official title: Patient Navigation for Lung Screening at MGH Community Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Screening
Low-Dose Computer Tomography
Patient Navigation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 1200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To develop and implement a patient navigator (PN) program for lung screening and smoking cessation in community health center primary care practices. This program will be evaluated in a randomized controlled trial of primary care patients who currently smoke.

Detailed description: The specific aims of this study are:

Specific Aim 1: To develop a patient navigator (PN) program for lung screening for patients who are current smokers, aged 55-77 years, potentially eligible for lung screening and are receiving care at community health centers (CHCs) affiliated with MGH.

Specific Aim 2: To evaluate the effectiveness of the new lung screening PN program in improving screening rates and increasing use of tobacco cessation services in a randomized controlled trial.

Specific Aim 3: To demonstrate that equity is maintained in rates of lung screening and in follow up of abnormal chest CT results, comparing eligible smokers from CHCs with eligible smokers from other practices within the MGH primary care network.

Eligibility criteria: Inclusion Criteria:

1. adult patients aged 55-77 years who are current cigarette smokers (according to an algorithm using electronic medical record data), and
2. receive care at one of the five Massachusetts General Hospital community health centers.

Exclusion Criteria:

1. patients who have previously received a diagnosis of lung cancer,
2. have undergone a chest CT within 18 months before enrollment,
3. are subsequently identified as having died prior to the study intervention,
4. deemed by their primary care provider as not eligible for lung screening.

Primary outcomes:
measure: Chest CT Completion
timeFrame: Up to 1 year
Secondary outcomes:
measure: Tobacco Treatment Use
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sanja Percac-Lima, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Percac-Lima S, Ashburner JM, Rigotti NA, Park ER, Chang Y, Kuchukhidze S, Atlas SJ. Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial. Cancer Med. 2018 Mar;7(3):894-902. doi: 10.1002/cam4.1297. Epub 2018 Feb 21.
Clinical trial NCT03927365: Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
Official title: Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: COPD
Copd Bronchitis
Lead sponsor: Liita Care ApS
Sponsor class: INDUSTRY
First posted: 2019-04-25
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants cross over from active to placebo or vice versa in random order
Primary purpose: TREATMENT

Brief summary: Cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in COPD patients as measured by lung scintigraphy.

Detailed description: Stable COPD patients will be examined twice with minimum two, maximum 14 days interval. In randomized order the patients will inhale from a salt particle inhaler with (active) or without (placebo) content.

Eligibility criteria: Inclusion Criteria:

* COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits

Exclusion Criteria:

* Pregnant or lactating women
* Patients exposed to radionuclear isotopes within one month
* Patients under antibiotic treatment
* Patients with known hyper reactive airways

Primary outcomes:
measure: Muco-ciliary clearance
timeFrame: Activity at time zero
measure: Muco-ciliary clearance
timeFrame: Activity at time 30 minutes
measure: Muco-ciliary clearance
timeFrame: Activity at time 90 minutes
measure: Muco-ciliary clearance
timeFrame: Activity at time 120 minutes
Secondary outcomes:
measure: Registering number of coughs
timeFrame: Activity at any time between time zero and 120 minutes
measure: Collection of sputum
timeFrame: Activity at any time between time zero and 120 minutes
measure: Symptoms in the subjects health
timeFrame: Activity at time zero
measure: Symptoms in the subjects health
timeFrame: Activity at time 30
measure: Symptoms in the subjects health
timeFrame: Activity at time 120
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Clin nuclear and physiolog dept.
Study officials:
affiliation: Rigshospitalet, Clin Nuclear & Physiolog dept.
name: Jann Mortensen, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02795065: Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients
Official title: Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Lead sponsor: Al Mouwasat Hospital
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two types of low-molecular-weight heparin, enoxaparin and bemiparin, as regards their efficacy and safety in venous thromboembolism prevention among intensive care unit patients.

Detailed description: A prospective randomized trial to compare thromboprophylaxis using bemiparin and enoxaparin in critically ill patients in ICU. The study included one hundred bedridden patients in intensive care unit who are at high risk for developing venous thromboembolism and require long term anticoagulation

Patients were divided into two groups each one consists of 50 patients. One group received bemiparin 3500 IU subcutaneous once daily and the other group received enoxaparin 40 mg subcutaneous once daily as a prophylaxis against thromboembolism.

Patients were followed up for 60 days for the development of deep venous thrombosis, pulmonary embolism and complications related to the injected anticoagulant.

Eligibility criteria: Inclusion Criteria:

* Sepsis , stroke , major burn , respiratory failure , traumatic brain injury , malignancy and post arrest who are intubated and mechanically ventilated on continuous IV sedation

Exclusion Criteria:

* Hypersensitivity to low molecular weight heparins , hypercoagulability , congenital or acquired bleeding disorder, prolongation of activated partial thromboplastin time or prothrombin time by 20% compared to normal values; thrombocytopenia (platelet count \<100,000/mm3); macroscopic hematuria; uncontrolled hypertension \[systolic blood pressure \>200 mmHg; diastolic blood pressure \>100 mmHg\]; impaired kidney function: serum creatinine \> 2.0 mg/ dL and bleeding gastrointestinal ulcer.

Primary outcomes:
measure: Development of deep venous thrombosis
timeFrame: Within 2 years
measure: Development of pulmonary embolism
timeFrame: Within 2 years
measure: Complications related to the injected anticoagulant
timeFrame: Within 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Navarro-Quilis A, Castellet E, Rocha E, Paz-Jimenez J, Planes A; Bemiparin Study Group in Knee Arthroplasty. Efficacy and safety of bemiparin compared with enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: a randomized, double-blind clinical trial. J Thromb Haemost. 2003 Mar;1(3):425-32. doi: 10.1046/j.1538-7836.2003.00142.x.
citation: Abbas MS. Bemiparin versus Enoxaparin in the Prevention of Venous Thromboembolism among Intensive Care Unit Patients. Indian J Crit Care Med. 2017 Jul;21(7):419-423. doi: 10.4103/ijccm.IJCCM_23_17.
Clinical trial NCT01794065: The Promus Element Rewards Study
Official title: The Promus Element Rewards Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Stenosis
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 500
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: Patients who are scheduled to receive a Promus Element stent implant, and have de novo coronary lesions.

Brief summary: This study is being done to study stent deformation on persons with de novo coronary lesions to determine how much deformation takes place and how often. The information gathered from the group that receives the Promus element stent will be compared to other groups that receive other contemporary drug eluting stents.


Eligibility criteria: Inclusion Criteria:

* Patients, male or female, 18 years or older;
* Patients with de-novo coronary lesions and slated to receive a Promus Element stent;
* Patients who are slated to undergo IVUS after stent deployment during implantation procedure

Exclusion Criteria:

* Patients receiving more than one drug-eluting stent within the same lesion during implantation procedure;
* Patients with in-stent restenosis;
* Patients who had IVUS imaging attained with manual pullback.

Primary outcomes:
measure: Stent length
timeFrame: 1 day
Secondary outcomes:
measure: IVUS stent length
timeFrame: 1 day
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03757065: Cell Surface Marker Expression in Autoimmune Diseases
Official title: A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Sjogren's Syndrome
Multiple Sclerosis
Systemic Sclerosis
Crohn's Disease
Ulcerative Colitis
Inflammatory Myositis
Lead sponsor: Alpine Immune Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 14
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, multiple sclerosis, Crohn's disease, ulcerative colitis, or inflammatory myositis.

Brief summary: This study is designed to explore the expression of cell-surface markers in the following seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g) inflammatory myositis.


Eligibility criteria: Inclusion Criteria:

1. Male or female participants 19 years of age or older.
2. Participant or legal surrogate able and willing to provide written, informed consent.
3. Participant is, or has been undergoing care for one of the specified diseases in a participating centre with a confirmed clinical diagnosis of the specified disease.
4. Participant has or will provide the relevant peripheral blood (required) and normal practice tissue specimens (if available).
5. Participant has one of the following target auto-immune or inflammatory diseases diagnosed according to local clinical practice guidelines:

   1. Crohn's Disease
   2. Inflammatory myositis
   3. Multiple sclerosis
   4. Sjogren's syndrome
   5. Systemic lupus erythematosus
   6. Systemic sclerosis
   7. Ulcerative colitis

Exclusion Criteria:

1. Participants receiving investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to enrolment.
2. Participants suffering from any additional disease that may interfere with the biomarker signals as per the investigator's discretion.

Primary outcomes:
measure: CD28 Expression
timeFrame: At enrollment
measure: ICOS Expression
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: Vancouver
country: Canada
facility: Mary Pack Arthritis Center
Study officials:
affiliation: Alpine Immune Sciences
name: Jan Hillson, MD
role: STUDY_DIRECTOR
References: