louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04399863: ETOILE : A Feasibility Study in Pediatric Patient Education
Official title: Feasibility Study of the ETOILE Program, a Therapeutic Education Program in Pediatric Hematology About Acute Lymphoblastic Leukemia and Allogenic Hematopoietic Steam Cells Transplantation, for Patient and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia, Lymphoblastic
Keywords: therapeutic education
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital ( Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will be assessed.

Detailed description: This is a pilot feasibility study, of the quasi-experimental before-after, non-randomized, mono-centric type. Feasibility is assessed on process criteria (adoption, reach implementation, satisfaction). Intermediate effectiveness is assessed on the skill level of patients and their caregivers, before, after and at a distance from education. Patients' anxiety levels will also be assessed before, after and at a distance from the program. The level of health literacy will be assessed at the start of the study.

Eligibility criteria: Inclusion Criteria:

* Criteria relating to the population studied: child between 0 and 18 years old, followed at Robert Debré hospital (Paris), by a doctor from the hematology and immunology department

  * Of which the 2 holders of parental authority have been informed and have signed the consent
  * Having 1 or 2 caregivers available to accompany him during FTE sessions
  * 1 to 2 of their adult caregivers will be eligible for the ETOILE program and will be included in the study after their consent.
  * Child with acute lymphoblastic leukemia, treated at Robert Debré Hospital (Paris), in the induction or consolidation phase
  * Child going to receive or having received an allograft of hematopoietic stem cells at the Robert Debré hospital (Paris)
  * Beneficiaries of a social security scheme or entitled to it,

Exclusion Criteria:

* Child not mastering the French language,
* Child with physical or cognitive disability to participate in the program,

Primary outcomes:
measure: Feasibility of the ETOILE program
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: APHP
name: Julie ROUPRET-SERZEC, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02707263: Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
Official title: Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Venous Thromboembolism
Keywords: heparin
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to demonstrate that a continuous infusion of intravenous (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore prophylactic levels of heparin in high-risk critically ill medical patients as compared with guideline recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to measure the anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used to demonstrate that Intravenous administration is more effective.


Eligibility criteria: Inclusion Criteria:

* Admission to the medical ICU (MICU)
* High-risk for Venous Thromboembolism (VTE) ≥ 1 of the following:
* Body Mass Index (BMI) ≥ 30 kg/m2
* Personal or family history of VTE
* Receiving vasopressors

Exclusion Criteria:

* Indication for therapeutic anticoagulation
* Evidence of deep vein thrombosis (DVT) on ultrasonography at admission
* Indwelling intrathecal, epidural, or other indwelling deep catheters
* Recent (\< 3 months) International Society of Thrombosis and Haemostasis (ISTH) major bleeding13
* Recent (\< 3 months) major trauma
* Recent (\< 3 months) neurosurgery or orthopedic surgery Pregnancy
* Contraindication to heparin or heparin products

Primary outcomes:
measure: Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin
timeFrame: 3 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: John Papadopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04086563: Effects of Motor Imagery in Pain Modulation and Median Nerve Mechanosensitive in Healthy Patients
Official title: Effects of Motor Imagery in Pain Modulation and Median Nerve Mechanosensitive in Healthy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Median Nerve Injury
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study are 1) to determinate the effectiveness of motor imagery or strength training in differens aspects of pain modulation. 2) evaluate the functional improvement of the hand by a motor imagery protocol.


Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* be under 18
* any pathology which provoke pain.

Primary outcomes:
measure: Conditioned pain modulation
timeFrame: Change from baseline at 2 weeks
measure: Pressure pain threshold
timeFrame: Change from baseline at 2 weeks
measure: Cold hyperalgesia
timeFrame: Change from baseline at 2 weeks
measure: Neural mechanosensitive
timeFrame: Change from baseline at 2 weeks
Secondary outcomes:
measure: Strength_grip
timeFrame: Change from baseline at 2 weeks
measure: Imagine movement capacity
timeFrame: Change from baseline at 2 weeks
measure: Psychological factors_Anxiety
timeFrame: Change from baseline at 2 weeks
measure: Psychological factors_Depression
timeFrame: Change from baseline at 2 weeks
measure: Psychological factors_Kinesiophobia
timeFrame: Change from baseline at 2 weeks
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References:
citation: Matesanz-Garcia L, Caceres-Pajuelo JE, Cuenca-Martinez F, La Touche R, Goicoechea-Garcia C, Fernandez-Carnero J. Effects of neural mobilizations through movement representation techniques for the improvement of neural mechanosensitivity of the median nerve region: a randomized controlled trial. Somatosens Mot Res. 2021 Dec;38(4):267-276. doi: 10.1080/08990220.2021.1964463. Epub 2021 Aug 17.
Clinical trial NCT00369863: A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Cystoid macular edema
Diabetic macular edema
Hard exudates
Intravitreal triamcinolone
Macular thickness
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-08-30
Enrollment: 76
Sex: ALL
Minimum age (years): 44
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.

Detailed description: Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the main cause of decreased visual acuity is macular edema.

According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema (DME) is laser therapy, which may be neither effective nor curative in some patients.There are many cases which are refractory to laser treatment or not suitable candidates for it.

Corticosteroids might have a beneficial effect on DME. They have been used with different doses and routes (periocular,intravitreal,and slow released implants) for a variety of retinal diseases.

Recently, a few prospective randomized studies, concerning the effect of intravitreal triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies et al. concluded that IVT improved vision and reduced macular thickness in eyes with refractory diabetic macular edema. They showed that this beneficial effect persisted for up to 2 years with repeated treatment.

We also conducted a randomized placebo-controlled clinical trial to determine the safety and efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this intervention on angiographic findings of these patients.

Eligibility criteria: Inclusion Criteria:

* Clinically significant macular edema(CSME)
* Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation

Exclusion Criteria:

* Mono-ocular patients
* History of vitrectomy
* Glaucoma or ocular hypertension
* Significant media opacity
* Traction on the macula

Primary outcomes:
measure: Central macular thickness
Secondary outcomes:
measure: Visual acuity
measure: intraocular pressure
measure: Cataract progression
measure: Cystoid macular edema
measure: Macular hard exudates
measure: Macular leakage severity in FA
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad Medical Center
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Mohammad - Hossein Dehghan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05416463: Clinical Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
Official title: A Single-blinded Randomized Control Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: Grand River Hospital
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development of a provincial healthcare innovation pathway.


Eligibility criteria: Inclusion Criteria:

* Receiving primary THA
* Elective THA
* Provision of informed consent

Exclusion Criteria:

* Unable to obtain informed consent
* Receiving revision THA
* THA is to treat trauma (i.e. hip fracture and/or dislocation)
* Patient is undergoing simultaneous bilateral hip replacement
* Performing surgeon is not participating in the study
* Hip fracture
* Hip dislocation
* Severe osteoporosis
* Trochanteric osteotomy
* Suspected or actual infection
* Existing implanted hardware
* Severe deformities of the femoral or pelvic bone
* High Body Mass Index (BMI)\*

Primary outcomes:
measure: Activities of Daily Living
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04952363: Whole-body Vibration on Mucus Clearance, the Quality of Life, and Exercise Capacity for Patients With Chronic Obstructive Pulmonary Disease
Official title: The Effect of Whole Body Vibration Training on Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 26
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although whole body vibration (WBV) is mainly designed to promote neuromuscular function, however, because of its vibration characteristics, whether it can provide additional effects on the sputum clearance for chronic obstructive pulmonary (COPD) disease patients, thereby improving the quality of life, and exercise capacity is still unknown.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of COPD at the outpatient thoracic medicine clinic
* Need HFCWO as judged by the doctor

Exclusion Criteria:

* Acute COPD exacerbation within the previous 4 weeks,
* Contraindication for WBVT (e.g., artificial joint replacement, a history of deep vein thrombosis, or known aortic aneurysm)
* Inability to perform squatting exercises
* Acute disc disease
* Inability to complete the 6MWT

Primary outcomes:
measure: FVC
timeFrame: 8 weeks
measure: FEV1
timeFrame: 8 weeks
measure: FEV1/FVC
timeFrame: 8 weeks
measure: FVC(% pred)
timeFrame: 8 weeks
measure: FEV1(% pred)
timeFrame: 8 weeks
measure: 6 min walk distance
timeFrame: 8 weeks
measure: Predicted distance
timeFrame: 8 weeks
measure: Distance-Saturation Product (DSP)
timeFrame: 8 weeks
measure: 1 min STST
timeFrame: 8 weeks
measure: 5-rep STST
timeFrame: 8 weeks
measure: Muscle strength test1
timeFrame: 8 weeks
measure: Muscle strength test2
timeFrame: 8 weeks
measure: Sputum self-assessment scale
timeFrame: 8 weeks
measure: X-ray score
timeFrame: 8 weeks
measure: modified Medical Research Council (mMRC)
timeFrame: 8 weeks
measure: chronic obstructive pulmonary disease assessment test (CAT)
timeFrame: 8 weeks
measure: Saint George Respiratory Questionnaire (SGRQ)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
Clinical trial NCT02313363: Patient-Centered Smartphone-Based Diabetes Care
Official title: Feasibility of a Patient-Centered Smartphone-Based Diabetes Care System: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Health care systems
Mobile applications
Self-care
Diabetes mellitus
Smartphone
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS). This study was aimed to test the feasibility of the PSDCS.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* HbA1c levels ≥ 6.5%

Exclusion Criteria:

* severe diabetic complication including severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy, chronic kidney disease stage 4-5, severe diabetic neuropathy, history of diabetic foot, history of angina pectoris, myocardial infarction, and cerebrovascular disease, and peripheral arterial disease
* type 1 diabetes
* insulin therapy other than insulin glargine
* subjects with insulin pump
* history of drug addiction
* history of psychotic disorder
* pregnancy

Primary outcomes:
measure: change of HbA1c
timeFrame: baseline and the end of 12 week
Secondary outcomes:
measure: change of fasting plasma glucose
timeFrame: baseline and after 12 weeks (within 3 days)
measure: change of lipid profile
timeFrame: baseline and after 12 weeks (within 3 days)
measure: change of body weight
timeFrame: baseline and after 12 weeks (within 3 days)
measure: change of the scores of Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: baseline and after 12 weeks (within 3 days)
Other outcomes:
measure: number of events of serious hyperglycemia
timeFrame: 12 weeks
measure: number of events of hypoglycemia
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Young Min Cho, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01868763: TeleLifestyleCoaching for Weight Loss
Official title: TeleLifestyleCoaching Use of Telemedicine for Weight Loss and Care of Weight Associated Illnesses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: telemedicine
coaching
lifestyle change
weight loss
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: HMM Holding AG
First posted: 2013-06-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial was to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.

Detailed description: In an occupational health care setting overweight employees were randomized into a three arm 12-week trial. Participants in the telemedical (TM) and telemedical coaching (TMC) group got a weighing machine and a step counter, with automatic transfer into a personalized online portal, which could be monitored from both, the participant and the study centre. The TMC group weekly got care calls from the study centre aiming to discuss measured data and to fix target agreements. The control group remained in routine care. Wilcoxon signed rank test was used to determine if differences (baseline vs. after 12 weeks) were significantly different from 0 and ANOVA test for determination of inter group differences.

Eligibility criteria: Inclusion Criteria:

* BMI ≥27 kg/m2

Exclusion Criteria:

* Hypoglycemia inducing medication
* severe disease with hospital stay during the last 3 months
* smoking cessation for less then 3 months
* planned smoking cessation during study phase
* acute infects
* chronic diseases

Primary outcomes:
measure: weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: cardiometabolic risk factors
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West-German Centre of Diabetes and Health
Study officials:
affiliation: West-German Centre of Diabetes and Health
name: Stephan Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kempf K, Rohling M, Stichert M, Fischer G, Boschem E, Konner J, Martin S. Telemedical Coaching Improves Long-Term Weight Loss in Overweight Persons: A Randomized Controlled Trial. Int J Telemed Appl. 2018 Sep 9;2018:7530602. doi: 10.1155/2018/7530602. eCollection 2018.
Clinical trial NCT04051463: Rhopressa for Corneal Edema Associated With Fuchs Dystrophy
Official title: Prospective Randomized Study to Determine Whether Use of Rhopressa™ Can Ameliorate Corneal Edema Associated With Fuchs Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fuchs Endothelial Dystrophy
Lead sponsor: Price Vision Group
Sponsor class: INDUSTRY
First posted: 2019-08-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.
* Patient is able and willing to administer eye drops.
* Patient is able to comprehend and has signed the Informed Consent form.

Exclusion Criteria:

* Active intraocular inflammation, corneal ulceration, keratitis, or conjunctivitis.
* Known sensitivity to any of the ingredients in the study medications.
* Abnormal eyelid function.
* History of herpetic keratitis.
* History of non-compliance with using prescribed medication.
* Current or planned pregnancy within the study duration.
* Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study.
* Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.

Primary outcomes:
measure: Change in Central Corneal Thickness
timeFrame: 1 month
Secondary outcomes:
measure: Change in Corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
Study officials:
affiliation: Price Vision Group
name: Francis W Price, Jr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price MO, Price FW Jr. Randomized, Double-Masked, Pilot Study of Netarsudil 0.02% Ophthalmic Solution for Treatment of Corneal Edema in Fuchs Dystrophy. Am J Ophthalmol. 2021 Jul;227:100-105. doi: 10.1016/j.ajo.2021.03.006. Epub 2021 Mar 15.