louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02761525: Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients
Official title: Topical Application of Silver Nanoparticles Reduced Oral Pathogens in Mechanically Ventilated Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: silver nanoparticles antimicrobial activity
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether oral topic silver nanoparticles are effective to reduce potential pathogen microbial loads in mechanical ventilation patients.

Detailed description: All patients were performed with oral hygiene as recommended by the clinical practice guidelines for the prevention, diagnosis and treatment of pneumonia associated with mechanical ventilation. After that, placed the treatment of an innocuous gel compound with 12ppm of silver nanoparticles or gel alone according to randomization. Then obtain and plant samples taken before the treatment 6 hours after. Comparing the results of the baseline sample with the final.

Eligibility criteria: Inclusion Criteria:

1. Patients with at least 24 hrs application endotracheal tube and ventilator support were nasogastric tube ,in the ICU of Hospital Central "Dr. Ignacio Morones Prieto"
2. Patients with at least 24 hours of ICU admission.
3. Sedo - analgesia patients in a coma or induced coma.
4. Over 15 years old
5. Informed consent signed by a family member or legal guardian of the patient.

Exclusion Criteria:

1. The patient is not taking part in another study that cause conflict with the present test.
2. Patients who develop bronchiectasis , severe or massive hemoptysis , cystic fibrosis.
3. Patients with known sensitivity to silver.
4. Patients who had reported difficult intubation in the record.
5. Patients whose physical condition does not allow the completion of the oral examination, proper sampling or application of gel.
6. Pregnant women
7. Patients with oral mucositis

Primary outcomes:
measure: Compare Colony Forming Units after the intervention. Unique dosis.
timeFrame: Comparison of microbial colony forming units at 6 hr of treatment with gel application
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01347125: ImCardia for DHF to Treat Diastolic Heart Failure (DHF) Patient a Pilot Study
Official title: ImCardia for DHF - Safety and Functionality
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Heart Failure With Normal Ejection Fraction
Keywords: DHF (diastolic heart failure)
HFNEF (heart failure with normal ejection fraction
Lead sponsor: CorAssist Cadiovascular Ltd.
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the ImCardia safety and to demonstrate system functionality in patients undergoing AV replacement with respect to 36 months follow up.


Eligibility criteria: Inclusion Criteria:

1. Male or female able to understand and sign a informed consent
2. Be 50 years of age or older
3. NYHA class III, IV
4. EF \>55%
5. Candidates for aortic valve replacement due to aortic stenosis.
6. Agrees to attend all follow- up evaluations

Exclusion Criteria:

1. Free wall thickness less than11.5mm
2. Adhesions are expected from a previous surgery or medical condition (e.g. s/p chest radiation therapy etc.)
3. Presence of significant myocardial scars (e.g. postinfarction) at proposed site for implant of ImCardia™device Attachment screw.
4. Likely to be need CABG following the implantation of the ImCardia™
5. Intra-cardiac thrombus/mass
6. Myocarditis
7. Acute/chronic pericarditis
8. Not a candidate for sternotomy
9. Active infection
10. Stroke, surgery or ICD within 3 months
11. Acute coronary syndrome during the past 6 months
12. Left ventricular regional wall motion abnormalities
13. Significant valvular disease other that aortic stenosis
14. Significant pulmonary disease
15. A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator
16. Participating in another trial (other than non-therapeutic or interventional observation) within the last 60 days.
17. History of noncompliance to medical therapy

Primary outcomes:
measure: Safety: Adverse event reporting
timeFrame: 36 month
Secondary outcomes:
measure: Functionality - Successful Device implantation
timeFrame: Immediately post implantation day
Other outcomes:
Locations:
Study officials:
affiliation: CorAssist Cardiovascular
name: Lea Lak, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00727025: Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure
Official title: Closing Linear Incisions in Plastic Surgery: A Randomized Clinical Trial Comparing a New Coaptive Film Device Versus Standard Subcuticular Sutures for Scar Quality, Patient Comfort, and Closure Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Hypertrophy
Abdominal Elastosis
Breast Reconstruction
Keywords: skin closure devices
linear scars
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2008-08-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Purpose: The aims of this randomized clinical trial are:

1. to assess scar quality from the patient and surgeon perspectives
2. to assess patient comfort in the days immediately following surgery
3. to assess the time taken to complete closure in the operating room.
4. the financial benefit or cost for the institution of using Steri Strip S will also be estimated.

Two closure methods will be compared, a new coaptive film device (Steri Strip S) versus standard subcuticular sutures. The linear incisions will include the standard incision segments utilized for an inverted-T closure for bilateral breast reduction and the transabdominal incision segments utilized for abdominoplasty or TRAM flap harvest.

Our hypothesis is that incisions segments closed with Steri Strip S compared to standard subcuticular closure, will yield scars of better cosmetic quality, in shorter time to closure, with novice and expert surgeons, for both bilateral breast reduction and abdominoplasty surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible for enrollment if they agree to provide informed consent, are at least 18 years of age, in generally good health, and available for follow-up in the 5-7 month time frame.

Exclusion Criteria:

* Women known to be pregnant, minors, patients potentially incompetent to provide informed consent or complete the surveys described in our protocol will be excluded from this trial.

Primary outcomes:
measure: Scar Quality at 6 Months Postoperative
timeFrame: 6 months
measure: Time to Perform Wound Closure
timeFrame: intraoperatively
Secondary outcomes:
measure: Patient Postoperative Incisional Comfort
timeFrame: 10 days
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Carolyn L Kerrigan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerrigan CL, Homa K. Evaluation of a new wound closure device for linear surgical incisions: 3M Steri-Strip S Surgical Skin Closure versus subcuticular closure. Plast Reconstr Surg. 2010 Jan;125(1):186-194. doi: 10.1097/PRS.0b013e3181c2a492.
Clinical trial NCT03796325: Depressive State After Sleeve Gastrectomy
Official title: Effect of Laparoscopic Sleeve Gastrectomy in Obese Patients With Depressive State
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Depression
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 300
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 18 years and older with BMI at less 40 or 35-40 with co-morbidities

Brief summary: Obesity is an epidemic disease that continues to increase causing morbidity and mortality to those who suffer. Obese patients suffer, frequently, from a depressive state, anger, and emotional disturbances. It cannot be recognized and depression causes obesity affecting eating habits or obesity causes depression based on physical, social and occupational limitations. Many times we see that obese patients are discriminated in every sense of daily life increasing their depressive state. The best treatment for obesity is bariatric surgery that causes a sufficient weight loss to correct sleep apnea, diabetes, hypertension, and many other co-morbidity. The study is based on elucidating the effect of sleeve gastrectomy in obese patients suffering from depression

Detailed description: The patients were classified as suffering from a depressive state before the bariatric surgery and followed until 3 years after surgery, the data was collected by personal interview or telephone survey.

Eligibility criteria: Inclusion Criteria: 18 years and older No any type of complication after surgery No difficult to drink, eat or take medicaments

Exclusion Criteria:

Any surgical complication Previous gastrointestinal surgery schizofrenia

Primary outcomes:
measure: Weight loss 3 years after laparoscopic sleeve gastrectomy
timeFrame: 36 month
Secondary outcomes:
measure: Depression state changes after Sleeve gastrectomy
timeFrame: 36 month
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta MC
Study officials:
References:
citation: Griauzde DH, Ibrahim AM, Fisher N, Stricklen A, Ross R, Ghaferi AA. Understanding the psychosocial impact of weight loss following bariatric surgery: a qualitative study. BMC Obes. 2018 Dec 3;5:38. doi: 10.1186/s40608-018-0215-3. eCollection 2018.
Clinical trial NCT01939925: Communicating Evidence From Systematic Reviews to the Public
Official title: Communicating Evidence From Systematic Reviews to the Public: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult
Keywords: patient education
Health Knowledge, Attitudes, Practice
comprehension
consumer health information
Lead sponsor: Norwegian Knowledge Centre for the Health Services
Sponsor class: OTHER_GOV
Collaborators: name: McMaster University
name: University of Ottawa
name: Asociacion Colaboracion Cochrane Iberoamericana
name: University of Milan
First posted: 2013-09-11
Enrollment: 193
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this randomised controlled trial is to compare a new standardised summary format for presentation of synthesised evidence from systematic reviews for the public (a new plain language summary format) to the current format used in Cochrane systematic reviews. The study will evaluate if the new presentation improves understanding about the benefits and harms of an intervention, if it improves the accessibility of the information, and if it is preferred over other versions by the public over the current format.


Eligibility criteria: Inclusion Criteria:

* patients or members of the public 16 years or older

Primary outcomes:
measure: Understanding of benefits and harms
timeFrame: After reading summary - time 0
Secondary outcomes:
measure: Number of questions answered correctly
timeFrame: After reading summary - time 0
Other outcomes:
measure: Understanding of the purpose of the summary
timeFrame: after reading summary - time 0
measure: Understanding the producer of the summary
timeFrame: after reading summary - time 0
measure: Usability and accessibility
timeFrame: after reading summary - time 0
measure: Preference for the new format or the old format
timeFrame: after reading both summaries - time 0
Locations:
city: Buenos Aires
country: Argentina
facility: Argentine Cochrane Centre, Instituto de Efectividad Clínica y Sanitaria (IECS)
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Milan
country: Italy
facility: University of Milan
city: Oslo
country: Norway
facility: Norwegian Knowledge Centre for the Health Services
city: Barcelona
country: Spain
facility: Centro Cochrane Iberoamericano - Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Norwegian Knowledge Centre for the Health Services
name: Claire Glenton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Holger J Schunemann, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Nancy A Santesso, RD PhD cand
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05932225: Systane® Complete Preservative Free Lubricant Eye Drops
Official title: Systane® Complete Preservative Free Lubricant Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) lubricant eye drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by Dry Eye Disease (DED) group.

Detailed description: Subjects will participate in the study for approximately 30 days, with a Screening/Baseline visit scheduled on Day 1, a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete the Impact of Dry Eye on Everyday Life - Symptom Bother \[IDEEL-SB\]) questionnaire on Day 1 and Visit 3. In addition, subjects will be instructed to document Systane Complete PF dosing information on a daily basis using a subject diary.

Eligibility criteria: Inclusion Criteria:

* Subject must be able to understand and sign an informed consent form
* Subject with mild to moderate dry eye
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Has suffered any ocular injury to either eye in the past 3 months prior to screening.
* Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group
timeFrame: Baseline (Day 1 pretreatment), Day 30
measure: Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects
timeFrame: Baseline (Day 1 pretreatment), Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Integra Eye Care
state: British Columbia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: North York
country: Canada
facility: Eyes on Sheppard Clinic
state: Ontario
city: Waterloo
country: Canada
facility: University of Waterloo Centre for Contact Lens Research
state: Ontario
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT05504525: Fascia Iliaca Versus Quadratus Lumborum Block for Pain Management in Total Hip Replacement.
Official title: Fascia Iliaca Versus Quadratus Lumborum Block for Postoperative Pain Management in Total Hip Replacement: A Comparative Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Opioid Requirements in Patients With Traumatic Fracture Hip
Keywords: opioid requirements
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative analgesia is essential for early ambulation of patients with hip arthroplasties as well as decreasing hospital stay time. Fascial plane blocks are emerging as a gold standard for postoperative analgesia instead of opioids and NSAIDs, with all there side effects.

The investigators aim to compare postoperative pain levels and opioid analgesic needs of fascia iliaca block versus quadratus lumborum block in patients undergoing primary total hip arthroplasty under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* All patients aging between 40-60 years ASA II, III with no known hypersensitivity for local anesthetics

Exclusion Criteria:

* Patient refusal
* Known allergy to local anesthetics
* Previous femoral artery surgery
* Local infection at the site of injection
* Those on anticoagulation therapy

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Total rescue analgesic requirements
timeFrame: 24 hours
measure: Functional recovery
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university hospitals
Study officials:
References:
Clinical trial NCT00552825: Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children
Official title: Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloblastic Leukemia
Solid Tumors,
Hodgkin's Disease
Non-Malignant
Keywords: acute lymphoblastic leukemia
long-term lung function
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-11-02
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit at the Safra children's hospital, Sheba medical center, Ramat-Gan, Israel, to perform lung function tests, as a part of a 3-year follow-up study.

Brief summary: The aim of this study was to investigate the occurrences of respiratory symptoms risk factors and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic diseases at presentation (before treatment) and up to 3 years follow-up (study period).

Detailed description: Pulmonary function tests (PFTs) are a part of the routine follow-up of patients receiving anti-cancer treatment. Treatment is frequently associated with diverse pulmonary damage which may become functionally and clinically evident many years later. PFTs may help to quantify the damage in the lungs; help to evaluate the point at which lung function deviates from normal to allow early intervention before irreversible lung damage occurs and thereby to reduce morbidity and mortality.

Reliable PFTs in the preschool age have traditionally been difficult to perform, but recent publications have demonstrated that the majority of preschool children can produce reproducible forced expiratory flow volume (FEVC) curves with proper coaching techniques. This recent development may enable studying the long term effect (years) of treatment on lung function in young children suffering from hemato-oncologic diseases.

Eligibility criteria: Inclusion Criteria:

* All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical CenterPediatric pulmonary unit, Pulmonary function laboratory
state: Ramat Gan
Study officials:
affiliation: Sheba Medical Center
name: Ori Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05661825: Cardiac Rehabilitation for the Patients With Acute Myocardial Infarction
Official title: The Efficacy and Related Factors in Phase II Cardiac Rehabilitation for the Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Cardiac rehabilitation
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 850
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute myocardial infarction

Brief summary: The benefits of cardiac rehabilitation include improving exercise tolerance and quality of life. However the attending rate of the patients with acute myocardial infarction was low according to the previous studies. This is a retrospective chart review study collecting the basic characteristics of the patients diagnosed with acute myocardial infarction of Wang-Fang Hospital (from Jan 1, 2012 to June 30, 2021). The aims of the studies are to investigate the related issues of cardiac rehabilitation including (1) attending rate (2) the efficacy of exercise training (3) the factors that limit the participation of the training programs.


Eligibility criteria: Inclusion Criteria:

1. Cased diagnosed with acute myocardial infarction at emergent department and admitted
2. Age over 20 years old

Exclusion Criteria:

1. AAD cases after admission to ER or the general ward
2. Cases died within admission.
3. Cases refused the treatments.-

Primary outcomes:
measure: Changes of maximal oxygen consumption after intervention
timeFrame: Baseline, 6 weeks after training, 16 weeks after training
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan-Fang hospital
Study officials:
affiliation: Department of physical medicine and rehabilitation, Wan Fang Hospital
name: Shiauyee Chen, Master
role: PRINCIPAL_INVESTIGATOR
References: