louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01457859: Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery
Official title: Effectiveness of Triclosan Coated VICRYL\MONOCRYL Sutures in Preventing Leg Wound Infection Compared to POLYSORB\ BIOSYN Sutures in Patients After Coronary Bypass Surgery- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Complication of Coronary Artery Bypass Graft
Surgical Wound Infection
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 410
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: The purpose of this study is to assess whether triclosan-coated sutures reduces wound infections compared to regular non-coated sutures, after saphenous vein harvesting in CABG patients.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older with written informed consent
* Male and female subjects
* Subjects scheduled for an elective and urgent CABG surgery that includes saphenous vein harvesting.

Exclusion Criteria:

* Known allergy or intolerance to triclosan
* Different surgical prophylactic antibiotic regimen than common in the department.
* Continuous preoperative and predicted postoperative antibiotic treatment.

Primary outcomes:
measure: leg wound infection
timeFrame: Up to 45 days postsurgery
Secondary outcomes:
measure: Antibiotics administration
timeFrame: Up to 45 days postsurgery
measure: Hospital Length of stay
timeFrame: Average of 7 days postsurgery
measure: Incidence of hospital re-admission due to leg wound infection
timeFrame: Within 45 days postsurgery
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus, Depatment of cardiac surgery
Study officials:
affiliation: Rambam Health Care Campus
name: Liran Shani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05036759: 68Ga-FAPI PET/MR for Atherosclerosis
Official title: 68Ga-FAPI PET/MR for Intracranial and Carotid Atherosclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Atherosclerosis
Keywords: atherosclerosis
68Ga-FAPI
PET/MR
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 68Ga-FAPI PET/MR
Primary purpose: DIAGNOSTIC

Brief summary: A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

Detailed description: A thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. Fibroblast activating protein (FAP) is an active serine protease, which can degrade type I collagen, potentially thinning the fibrous cap. Previous ex vivo analysis of human aortic atheromata revealed that FAP was expressed in atherosclerotic plaques, and higher FAP expression was detected in thin fibrous caps than thick caps. Constitutive Fap deletion in atherosclerosis-prone mice models could reduce plaque formation and improve plaque stability with increased fibrous cap thickness. Thus we speculate that atherosclerotic plaque could be imaged with 68Ga-FAPI PET/MR.

Eligibility criteria: Inclusion Criteria:

* intracranial or carotid atherosclerosis patients
* signed informed consent

Exclusion Criteria:

* pregnancy, breastfeeding
* contradictions of MRI
* unstable vital signs

Primary outcomes:
measure: Diagnostic performance
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: SUVmax
timeFrame: through study completion, an average of 2 years
measure: FAPI expression
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Qiao Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Meiqi Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02103400: Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia
Official title: Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional capacity, peripheral muscle strength and quality of life. Despite the high incidence and severity has not yet been demonstrated whether a physical training program can change these outcomes. Objectives: To evaluate the effects of an exercise training program in patients hospitalized for CAP, to compare this effects with traditional physical therapy and assess whether the inflammatory markers correlate with the functional status of the patient and type of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk test, Glittre test, measurement of peripheral muscle strength, spirometry, and the application of quality of life questionnaire Shor Form 36 will be held. The measurement of inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held. Patients will be randomized into two groups: one will perform a program of physical training (stretching, active resistance exercises and aerobic exercises) and the other group held the traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight days. On the tenth day the same assessment will be carried out initially described.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pneumonia
* Must be able to walk
* Time less than 48 hours of hospitalization
* Age above 18 years
* Conscious and oriented
* Hemodynamically stable

Exclusion Criteria:

* Patients with other respiratory diseases
* Osteoarticular or cognitive disorders
* Patients who refuse to participate or complete the procedures

Primary outcomes:
measure: Glittre test
timeFrame: up to 9 months
Secondary outcomes:
measure: Shuttle test
timeFrame: up to 9 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Simone Dal Corso, PhD
role: STUDY_DIRECTOR
References:
citation: Jose A, Dal Corso S. Inpatient rehabilitation improves functional capacity, peripheral muscle strength and quality of life in patients with community-acquired pneumonia: a randomised trial. J Physiother. 2016 Apr;62(2):96-102. doi: 10.1016/j.jphys.2016.02.014. Epub 2016 Mar 17.
Clinical trial NCT00401700: Influenza Vaccine Postpartum Questionnaire
Official title: Acceptability and Feasibility of Influenza Vaccine Administration on the Post-partum Floor Prior to Discharge Home During Flu Season
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Vaccine
Pregnancy
Keywords: influenza
influenza vaccine
pregnancy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2006-11-20
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: The purpose of this trial is to assess the knowledge and attitudes of post-partum women regarding influenza and the use of the influenza vaccine in pregnancy.

Detailed description: Women on our post-partum floor will be approached to complete a questionnaire which will assess their knowledge and attitudes regarding influenza and the use of the influenza vaccine in pregnancy. The study will take place over a 2-month period during influenza season, and at the time when the influenza vaccine becomes available.

Eligibility criteria: Inclusion Criteria:

* women admitted to the postpartum floor during the study period

Exclusion Criteria:

* inability to read or understand English

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital (Toronto, Canada)
name: Mark H Yudin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03272100: Influence of Two Different Flap Designs for Sinus Floor Elevation
Official title: Influence of Two Different Flap Designs for Sinus Floor Elevation. A Split-mouth Randomised Controlled Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Involvement in Diseases Classified Elsewhere
Keywords: lateral approach
bone augmentation
sinus lift
flap
Lead sponsor: University of Firenze and Siena, Napoli, Italy
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all the involved patients were edentulous in the maxillary posterior area , bilaterally, with a residual bone heigh of less then 4 mm; for this reason they required a surgical bone reconstruction for implant placement.

Brief summary: It is assumed that the reduction of the flap dimension could provide a reduction of surgical time, post surgical complications and patient's discomfort when compared with the traditional surgical approach.

Detailed description: 16 edentulous patients in maxillary posterior area were treated with a bilateral sinus lift procedure. Once enrolled in the study impressions were realised and the radiographic stent prepared, with radio-opaque references fixed in the positions where the implants should be inserted. Pre-surgical CT scan was executed after placing the stent in its proper position in patient's mouth. If no surgical contra-indications were detected at CT evaluation, patients were involved in the study.

Eligibility criteria: Inclusion Criteria:

* patient edentulous in the maxillary posterior area on both left and right side
* residual bone height in the maxillary premolar and molar region less than 4mm

Exclusion Criteria:

* history of systemic diseases that would contraindicate surgical treatment

Primary outcomes:
measure: height of augmented bone obtained
timeFrame: 6 months
Secondary outcomes:
measure: Duration of the surgery
timeFrame: 1 day
measure: Post surgical patient's discomfort
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
city: Siena
country: Italy
facility: Tuscan School of Dentistry
Study officials:
affiliation: tuscan school of dental medicine, university of Firenze and Siena
name: marco ferrari, clinical director
role: STUDY_CHAIR
References:
Clinical trial NCT01183000: Closure of Peritoneum at Cesarean Section and Postoperative Adhesion
Official title: Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Adhesions
Keywords: Formation of adhesions assessed at subsequent cs
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 533
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To determine the effect of non-closure of the visceral and parietal peritoneum during Cesarean section on the formation of adhesions.

Study design: A prospective randomized trial of 533 women undergoing primary Cesarean section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a subsequent cesarean,he presence of adhesions and their severity was evaluated at several sites: between the layers of the abdominal wall, between the bladder and the abdominal wall, between bladder and uterus, between the uterus and the abdominal wall, and between the bowels and the pelvic organs. A cumulative adhesion score was calculated.


Eligibility criteria: Inclusion Criteria:

* Women undergoing primary CS

Exclusion Criteria:

* Lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent
* Previous pelvic or abdominal surgery

Primary outcomes:
measure: Adhesion score
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Ashkelon
country: Israel
facility: Barzilay University Medical Center
Study officials:
affiliation: Barzili Medical Center
name: Ofer Gemer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700700: Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF)
Official title: Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Cardiac Resynchronization Therapy
Dyspnea
Exercise Tolerance
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 2
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: A new therapy for patients with advanced heart failure (HF) involves the implantation of a specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to restore the synchronized contraction of the ventricular chambers of the heart. In some people, CRT improves exertional breathlessness and allows them to exercise for longer periods. However, to date, the mechanisms by which CRT improves symptoms and exercise tolerance is unknown. This study will use in-depth cardiopulmonary exercise testing and pulmonary function testing to explore these mechanisms in greater detail.


Eligibility criteria: Inclusion Criteria:

* clinically stable
* being considered for implantation of biventricular pacemaker for CRT
* LVEF \<35%
* QRS duration \>120 msec
* NYHA III-IV functional class
* optimized pharmacologic management of CHF
* no recent (\<1 month) episodes of decompensated CHF

Exclusion Criteria:

* inability to perform cycle ergometry or comply with testing
* uncontrolled ischemic heart disease
* coronary revascularization within 3 months of study entry
* concurrent primary lung disease
* current use of ambulatory oxygen
* rhythm other than sinus
* dependency on pacemaker therapy as a consequence of bradyarrhythmias
* severe valvulopathy

Primary outcomes:
measure: Exercise endurance time
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Chris M. Parker, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05415800: Quality Improvement Pilot
Official title: Facilitation of Cancer Prevention and Screening Guideline Implementation: Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of this study is to develop and pilot test the use of practice facilitation as an intervention for healthcare providers and staff, with the goal of improving the implementation of cancer prevention and screening guidelines in primary care settings.


Eligibility criteria: Inclusion Criteria:

* Normal Volunteers

Exclusion Criteria:

* None

Primary outcomes:
measure: Colorectal Cancer: Screening Rate (Patient Population)
timeFrame: 6 months
measure: Lung Cancer: Screening Rate (Patient Population)
timeFrame: 6 months
measure: Tobacco: Treatment Rate (Patient Population)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Pamela C Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290700: Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life
Official title: Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life Quality
Functional Status
Keywords: functional status
life quality
mothers
Pregnancy
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life.

Detailed description: This was a single blind randomised controlled experimental study. The sample size of the study was calculated using the G\*Power 3.1.7 program, considering a 5% margin of error and 95% confidence interval, and was determined to be at least 61. Therefore, the sample was planned to consist of 122 pregnant women, including 61 pregnant women in the intervention group and 61 pregnant women in the control group.

Study Inclusion Criteria Being at least a primary school graduate. Being a primiparous pregnant woman. Being able to provide feedback. Study Exclusion Criteria Being a multiparous pregnant woman. Being a high-risk pregnant woman. Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.

Eligibility criteria: Inclusion Criteria:

* Being at least a primary school graduate.
* Being a primiparous pregnant woman.
* Being able to provide feedback.

Exclusion Criteria:

* Being a multiparous pregnant woman.
* Being a high-risk pregnant woman.

Primary outcomes:
measure: severity of maternal function by Barkin Index of Maternal Functioning
timeFrame: 10 weeks after after the intervention
Secondary outcomes:
measure: Maternal Postpartum Quality of Life Instrument
timeFrame: 10 weeks after after the intervention
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Yonca ÇIÇEK OKUYAN
Study officials:
References:
Clinical trial NCT05222100: Effect of Breast Implants om Mammography Screening
Official title: Effect of Breast Implants om Mammography Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
plastic surgery
breast implant
mammography screening
health economy
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-02-03
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women participating in the mammography screening program in Gothenburg, Sweden.

Brief summary: The purpose of the study is to survey how many women have breast implants in the mammography screening population and the effect of implants on the number and type of examinations and on costs.


Eligibility criteria: Inclusion Criteria:

* Women participating in the mammography screening program.

Exclusion Criteria:

* None

Primary outcomes:
measure: Costs
timeFrame: 1 year post-operatively
Secondary outcomes:
measure: Prevalence
timeFrame: 1 year
measure: Frequency of need for additional examinations
timeFrame: 1 year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
References: