louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01022216: Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
Official title: A Randomized, Controlled Trial of the Procellera™ Wound Dressing Used With Negative Pressure Wound Therapy (NPWT) in the Healing of Diabetic and Pressure Ulcers of the Foot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wound Healing
Keywords: Wound
Skin lesion
Antimicrobial
Bioelectric
Diabetic foot
Pressure Ulcer
Lead sponsor: Vomaris Innovations
Sponsor class: INDUSTRY
First posted: 2009-12-01
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 determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.


Eligibility criteria: Inclusion Criteria:

* Wound size greater than 1x1 cm
* Wounds must be ≥5 cm away from all other wounds
* Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
* Participant must be candidate for negative pressure wound therapy
* Participant agrees to participate in follow-up evaluations
* Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
* Participant is to receive another topical agent (antimicrobials, enzymes, etc.) other than the study dressing (granufoam)
* Participant is to receive Silver granufoam for their wound
* Participant with sensitivity or adverse reactions to silver or zinc
* Pregnancy or nursing an infant or child
* Immunosuppression
* Active or systemic infection
* Participant undergoing active cancer chemotherapy
* Chronic steroid use

Primary outcomes:
measure: Wound healing over time
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Pain reduction
timeFrame: 3 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Wyckoff Heights Medical Center
state: New York
Study officials:
affiliation: Wyckoff Heights Medical Center
name: Ronald M Guberman, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05702216: Non-inferiority Study of a Cardiac Tele-rehabilitation in Hybrid Form Compared to a Cardiac Rehabilitation
Official title: Étude de Non-infériorité d'un Programme de télé-réadaptation Cardiovasculaire Sous Une Forme Hybride Par Rapport à Une rééducation réadaptation Cardiovasculaire Classique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Tele-rehabilitation
Keywords: Cardiac tele-rehabilitation, cardiac rehabilitation
Lead sponsor: Clinique de la Mitterie
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in two groups: a Hybrid Tele-pulmonary Rehabilitation group and a classic Rehabilitation group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cardiac tele-rehabilitation in a hybrid form can be a choise for the management of cardiovascular diseases. The aim is to increase the participation rate of patients in cardiac rehabilitation.

This new form of care can be as effective as traditional care.

Detailed description: The Covid-19 pandemic has had indirect effects on the health system, particularly in the management of cardiovascular diseases. Rehabilitation centres had to adapt their operation to the recommendations of health authorities. The choice appeared to be unavoidable: tele-rehabilitation care in a hybrid form. Moreover, Many patients do not participate at this kind of care. Many identified factors can explain this low rate of participation : a lack of proximity facilities does not promote patient participation.

The objective of this study is to demonstrate a comparable effectiveness between a cardiac telerehabilitation programme in hybrid form and a cardiac classic rehabilitation programme.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 ans
* Patients with heart disease
* Inclusion in the rehabilitation program

Exclusion Criteria:

* Cardiac decompensation
* No stabilised acute coronary syndrome
* Decompensated heart failure
* Severe ventricular rhythm disorders
* Severe functional limitation

Primary outcomes:
measure: 6-minute walk test
timeFrame: 6 weeks before baseline
Secondary outcomes:
measure: Stress test
timeFrame: 6 weeks before baseline
measure: Wall Squat Test
timeFrame: 6 weeks before baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinique la Mitterie
Study officials:
affiliation: CLINIQUE LA MITTERIE
name: Michaël RACODON, Ph.D
role: STUDY_DIRECTOR
References:
citation: Racodon M, Peze T, Masson P. Analysis of physical exercise in cardiac patients following cardiovascular rehabilitation. Acta Cardiol. 2020 Nov;75(7):598-603. doi: 10.1080/00015385.2019.1639269. Epub 2019 Jul 17.
Clinical trial NCT01157416: Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth
Official title: Effect of D-cycloserine on Treatment of PTSD in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorders
PTSD
Keywords: Cognitive Behavior Therapy
Children
Pharmacotherapy
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-07-07
Enrollment: 33
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 7-12 year old children.

Detailed description: While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances.

D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up assessment.

Eligibility criteria: Inclusion Criteria:

* Certain number of PTSD symptoms plus functional impairment
* Must be able to swallow pills

Exclusion Criteria:

* Serious kidney or liver disease
* Epilepsy
* Bipolar
* Psychosis

Primary outcomes:
measure: Child PTSD Symptom Scale (CPSS)
timeFrame: After 12 therapy sessions, up to 28 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center, 1440 Canal St.
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: Michael S Scheeringa, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheeringa MS, Lilly ME, Staiger AB, Heller ML, Jones EG, Weems CF. Do Children and Adolescents Have Different Types of Trauma Narratives and Does It Matter? Reliability and Face Validation for a Narrative Taxonomy. J Trauma Stress. 2017 Jun;30(3):323-327. doi: 10.1002/jts.22190. Epub 2017 Jun 1.
citation: Scheeringa MS, Weems CF. Randomized placebo-controlled D-cycloserine with cognitive behavior therapy for pediatric posttraumatic stress. J Child Adolesc Psychopharmacol. 2014 Mar;24(2):69-77. doi: 10.1089/cap.2013.0106. Epub 2014 Feb 7.
Clinical trial NCT01661816: Breast Cancer and Quality of Life
Official title: Impact of Breast Cancer on Quality of Life of the Young Women, Her Life Partner and Her Couple
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
everyday issues
couple
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with breast cancer, diagnosed before aged 45, having a life partner

Brief summary: The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.


Eligibility criteria: Inclusion Criteria:

* age \< 45
* non metastatic breast cancer
* at least 6 months of relationship

Exclusion Criteria:

* no life partner
* inclusion criteria failure

Primary outcomes:
measure: quality of life at different time of medical follow up
timeFrame: 6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: François Baclesse Center
city: Lille
country: France
facility: Oscar Lambret Center
city: Paris
country: France
facility: Gustave Roussy Institut
city: Valenciennes
country: France
facility: Hospital
Study officials:
References:
Clinical trial NCT01369316: Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps
Official title: Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Resection for the Removal of Large Laterally Spreading Tumours and Sessile Polyps of the Colon
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonic Polyps
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon.

Detailed description: The investigators have recently developed a new, and the investigators believe safer and more effective technique for endoscopic mucosal resection (EMR). Utilising the new method the investigators make small cuts around the polyp to isolate it. Subsequently the Gelofusine solution is injected beneath the polyp and provides greater elevation. This allows us to improve the chance of removal of the entire polyp with one attempt in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. Our team has recently completed an animal study comparing our newly developed technique to conventional EMR. The investigators have found significant improvements in our ability to completely remove the polyp in one attempt. There have also been recent studies overseas that have shown this new technique to be quite effective.

Eligibility criteria: Inclusion Criteria:

* Can give informed consent to trial participation
* Age greater than 18
* Adenomas that have not have previously been attempted for resection (i.e. naïve lesions)
* Adenoma size greater than 20 mm

Exclusion Criteria:

* Age less than 18
* Previous resection or attempted resection of target adenoma lesion
* Pregnant patients

Primary outcomes:
measure: Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: Westmead Hospital - Endoscopy Unit
name: Michael J Bourke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02804516: Recognition and Management of Early Mobilization in ICUs : Practice Patterns in China
Official title: Recognition and Management of Early Mobilization in ICUs : Practice Patterns in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Mobilization
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite evidence to support early mobilization（EM）for critically ill patients,current status in Chinese ICUs is unknown.Understanding current practice patterns and challenges is essential to inform future research and strategies.

Detailed description: Practice guideline recommend EM in ICU,feasibility, safety and efficacy are confirmed by evidence-based data.However,the prevalence of EM in ICU patients is still low.Moreover,most of the prevalence studies come from developed countries, such as: Australia and New England the United States and Europe. Many ICUs in non-western countries are suffering from a lack of medical resources including health care personnel and medical equipment.

A retrospective observational study.To access the implementation of Chinese intensive care units and hospitals to early mobilization.Secondary objectives were to evaluate structure and process parameters of Chinese hospitals that were associated with implementation.

Eligibility criteria: Inclusion Criteria:Participating ICUs at least six beds ,they could be medical ,surgical or mixed

-

Exclusion Criteria:

* pediatric ICUs

Primary outcomes:
measure: the implementation rates for early mobility
timeFrame: within the first 2 to 5 days of critically illness or injury
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02952716: Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
Official title: Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Delayed Encephalopathy After Carbon Monoxide Poisoning
Keywords: carbon monoxide poisoning
delayed encephalopathy
Lead sponsor: Liaocheng People's Hospital
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after carbon monoxide poisoning

Detailed description: To evaluate the effect and mechanism of human cord blood mononuclear cell transplantation for delayed encephalopathy after carbon monoxide poisoning

Eligibility criteria: Inclusion Criteria:

* 35-60 years old.
* No serious infection, chronic diseases, diabetes and tuberculosis.
* Written informed consents were obtained from all subjects.
* Symptomatic Delayed Encephalopathy After Carbon Monoxide Poisoning.

Exclusion Criteria:

* The heart, liver, kidney and other viscera serious organic disease.
* Allergic constitution, clotting disorders, autoimmune diseases and tumors.
* Pregnancy.
* Moribund patient.
* History of prior brain injury.
* History of central nervous system disease.

Primary outcomes:
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline, 4, 8, 12 and 24 weeks
Secondary outcomes:
measure: Chang from baseline in head CT
timeFrame: Baseline, 6 and 12 months
measure: Cerebrospinal levels of IL-2,IL-4,IL-6,IL-10,TNF,IFN-γ，IL-17A，IL-8，IL-12p70，MIG，MCP-1(ng/ul)
timeFrame: Baseline, 1 and 2 months
measure: Serum levels of IL-2,IL-4,IL-6,IL-10,TNF,IFN-γ，IL-17A，IL-8，IL-12p70，MIG，MCP-1(ng/ul)
timeFrame: Baseline,1 and 2 months
measure: Change From Baseline in Activities of Daily Living (ADL)
timeFrame: Baseline, 4, 8, 12 and 24 weeks
Other outcomes:
Locations:
city: Liaocheng
country: China
facility: Liaocheng city people's hospital
state: Shandong
Study officials:
affiliation: Liaocheng People's Hospital
name: Shuangfeng Chen, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01254916: The Sinonasal Outcome Test - 22, Validated for Danish Patients
Official title: The Sinonasal Outcome Test - 22, Validated for Danish Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis
Keywords: Chronic Rhinosinusitis
Sinonasal Outcome test 22
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 44
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic rhinosinusitis diagnosed by a medical doctor

Brief summary: Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in both incidence and prevalence. It calls into attention consensus about diagnosing, assessing symptoms and treatment of patients with CRS. Therefore a validated Danish measure of health-related quality of life in sinonasal disease is needed.

Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the SNOT-22.

Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the initial test and 0.92 in the retest. Pearson was 0.70 (p\<0.001) revealing good correlation between the initial scores and the retests scores. Kappa was calculated for each item with a mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant difference in the subscales.

Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and researches as a patient-reported measure of outcome in sino-nasal disorders such as rhinosinusitis and nasal polyposis.


Eligibility criteria: Inclusion Criteria: Persons diagnosed with Chronic Rhinosinusitis -

Exclusion Criteria: Change of treatment or acute change of symptoms due to common cold/influenza in the time between completing the test and the retest. If SNOT-score was very low. Persons who left before offered test or declined testing.

-

Primary outcomes:
measure: Reproducibility of Sinonasal Outcome test 22
timeFrame: From the time of fullfilling the first SNOT-22 to fullfilling the second SNOT-22 after 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Otorhinolaryngology, Odense University Hopsital
Study officials:
References:
citation: Lange B, Thilsing T, Al-kalemji A, Baelum J, Martinussen T, Kjeldsen A. The Sino-Nasal Outcome Test 22 validated for Danish patients. Dan Med Bull. 2011 Feb;58(2):A4235.
Clinical trial NCT00974116: Trial of the MEND Childhood Obesity Treatment Program
Official title: MEND Childhood Obesity Treatment Programme: An RCT to Improve Body Composition and Cardiovascular Health in Overweight and Obese Children.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The number of children who are obese in the UK is steadily increasing with both short and long term consequences for health. The aim of this study is to determine whether the MEND Programme (a new national initiative for the treatment of childhood obesity) is a successful and sustainable treatment for childhood obesity and obesity related health problems.

300 overweight and obese children will be randomly assigned to start immediately on the MEND Programme for 6 months or join a waiting-list control group for 6 months. Measurements of health outcomes will be taken at baseline, and at 6, 12 and 24 months after the Programme. After 6 months of waiting-list time, the control group will follow the same protocol as the immediate starters. The researchers will be unaware (blinded) to which group each child has been assigned to. The study will examine the effects of the MEND Programme on body composition, cardiovascular health and psychological health.

Detailed description: The Study is a Randomised Controlled Trial.

Eligibility criteria: Inclusion Criteria:

* Children enrolled in the MEND Programme who are yet to be given a start date for the programme.
* Aged between 7-13 years old.
* Overweight or obese as defined by a BMI which falls above the 91st centile on the boys/girls BMI chart UK cross-sectional reference data:1997/1).
* Clinically well with no known chronic illness.

Exclusion Criteria:

* Age less than 7 years or older than 13.
* Known chronic illness.

Primary outcomes:
measure: Body Mass Index z-score
timeFrame: 6 months
Secondary outcomes:
measure: Body fat, waist circumference, blood pressure, arterial stiffness, heart rate control, fitness, physical activity and sedentary behaviour status, self esteem and health related quality of life.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Child Health
name: Prof Atul Singhal
role: PRINCIPAL_INVESTIGATOR
References: