louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03268239: Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions
Official title: Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Central Nervous System
Brain
Multiple Sclerosis
Demyelinating Diseases
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-08-31
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of enhanced MRI to detect active lesions may vary according to the acquisition strategy used (e.g., delay between injection and image acquisition, contrast dose, field strength, and frequency of MRI sampling). Selection of the most appropriate T1-weighted sequence after contrast injection may also influence sensitivity. Several clinical studies performed at 1.5 Tesla have shown that conventional 2D spin-echo (SE) sequences perform better than gradient recalled-echo (GRE) sequences for depicting active MS lesions after gadolinium injection. As relates to MS, 3.0 Tesla systems offer some advantages over lower field strengths, such as higher detection rates for T2 and gadolinium-enhancing brain lesions, an important capability for diagnosing and monitoring MS patients. Recent studies have shown that at 3 Tesla, 3D GRE or 3D fast SE sequences provide higher detection rates for gadolinium-enhancing MS lesions, especially smaller ones, than standard 2D SE, and better suppress artefacts related to vascular pulsation. However, the comparison of the performance of 3D GRE versus 3D SE sequences has not been investigated yet.

Objectives To compare the sensitivity of enhancing multiple sclerosis (MS) lesions in gadolinium-enhanced 3D T1-weighted gradient-echo (GRE) and turbo-spin-echo (TSE) sequences.


Eligibility criteria: Inclusion Criteria:

* Equal or more than 18 years of age
* Able to provide written informed consent.
* Known central nervous system inflammatory disease
* Magnetic Resonance exam needed for evaluation after a clinical event in the last 3 weeks

Exclusion Criteria:

* Current treatment with dimethylfumarate (Tecfidera®), natalizumab (Tysabri®) or fingolimod (Gilenya®)
* Contraindications either to 3 Tesla Magnetic Resonance Imaging (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency).

Primary outcomes:
measure: Number of gadolinium-enhanced brain lesions
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
References:
Clinical trial NCT01240239: Comparison of Telemedicine Evaluation to Standard Evaluation Methods for Pre-Anesthesia Consultation
Official title: Comparison of Telemedicine Evaluation to Standard Evaluation Methods for Pre-Anesthesia Consultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ENT Patients Scheduled for Surgery
Keywords: Pre anesthesia consultation
telemedicine
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects scheduled for ENT surgery.

Brief summary: The purpose of the study is to evaluate different methods of pre-anesthesia consultation, with the aim of improving the day of surgery experience for the patient. In this study, we will use a telephone consultation, an in-person consultation, and a telemedicine consultation, which involves television cameras and monitors that allow live two-way communication for the pre-anesthesia consultation. The reason for this study is to evaluate the use of telemedicine for the pre-anesthesia consultation. Patients and anesthesiologists have been highly satisfied in previous studies using pre-anesthesia telemedicine consultation. In this study, we will examine a larger group of patients, as previous studies have studied smaller groups of patients.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 89 who are scheduled for otolaryngologic procedures and pre-anesthesia consultation.

Exclusion Criteria:

Lack of consent; inability to understand English-

Primary outcomes:
measure: Comparison Of Telemedicine Evaluation To Standard Evaluation Methods For Pre-Anesthesia Consultation
timeFrame: about 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Redlands
country: United States
facility: Orange Tree Lane Otolaryngology Offices
state: California
Study officials:
References:
citation: Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.
Clinical trial NCT02848339: Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity
Official title: Aspirin DesensitizAtion in PatienTs With Coronary artEry Disease: Results of a Multi Center Registry: the ADAPTED Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspirin Hypersensitivity
Lead sponsor: Italian Society of Cardiology
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 330
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 a history of aspirin hypersensitivity presenting with either an acute coronary syndrome or known/suspected stable coronary artery disease scheduled for coronary angiography with intent to undergo PCI

Brief summary: Data about aspirin desensitization for patients with coronary artery disease undergoing percutaneous coronary intervention are sparse.

This is a prospective, multicenter, observational study including 7 italian centers, to assess safety and feasibility of a standard desensitization protocol in patients with aspirin sensitivity undergoing coronary angiography. Patients with history of aspirin sensitivity undergoing coronary angiography are prospectively enrolled.All patients underwent the desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg) administered orally at predefined intervals, with the procedure lasting 5.5 hours.All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure, and in hospital major adverse cardiac events (MACE). All patients are also followed-up for 12 months in order to assess their long-term risk of MACE, compliance with ASA therapy, and late occurrence of side reactions due to ASA sensitivity.


Eligibility criteria: Inclusion Criteria:

* history of aspirin hypersensitivity
* acute coronary syndrome or known/suspected stable coronary artery disease
* intent to undergo percutaneous coronary intervention

Exclusion Criteria:

* withdrawal of consent

Primary outcomes:
measure: Percentage of patients with successful desensitization procedure
timeFrame: 12 months
measure: Major adverse cardiac events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rossini R, Iorio A, Pozzi R, Bianco M, Musumeci G, Leonardi S, Lettieri C, Bossi I, Colombo P, Rigattieri S, Dossena C, Anzuini A, Capodanno D, Senni M, Angiolillo DJ. Aspirin Desensitization in Patients With Coronary Artery Disease: Results of the Multicenter ADAPTED Registry (Aspirin Desensitization in Patients With Coronary Artery Disease). Circ Cardiovasc Interv. 2017 Feb;10(2):e004368. doi: 10.1161/CIRCINTERVENTIONS.116.004368.
Clinical trial NCT05137639: Free Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting
Official title: Free Skin Grafting to Reconstruct Donor Sites After Radial Forearm Flap Harvesting: A Prospective Study With Platelet-rich Fibrin (PRF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reconstruction of the donor site after radial forearm flap harvesting is a common procedure in maxillofacial plastic surgery. Unfortunately, free skin graft transplantation faces wound healing impairments such as necrosis, (partial) graft loss, or tendon exposure. Several studies have investigated methods to reduce these impairments and demonstrated improvements if the wound bed is optimized. However, these methods are device-dependent, expansive, and time-consuming. Therefore, the application of platelet-rich fibrin (PRF) to the wound bed could be a simple, cost effective, and device-independent method to optimize wound-bed conditions instead. In this study, PRF membranes were applied between the wound bed and skin graft.

Detailed description: Reconstruction of the donor site after radial forearm flap harvesting is a common procedure in maxillofacial plastic surgery. It is normally carried out with split-thickness or full-thickness free skin grafts. Unfortunately, free skin graft transplantation faces wound healing impairments such as necrosis, (partial) graft loss, or tendon exposure. Several studies have investigated methods to reduce these impairments and demonstrated improvements if the wound bed is optimized, for example through negative pressure wound therapy or vacuum-assisted closure. However, these methods are device-dependent, expansive, and time-consuming. Therefore, the application of platelet-rich fibrin (PRF) to the wound bed could be a simple, cost effective, and device-independent method to optimize wound-bed conditions instead. In this study, PRF membranes were applied between the wound bed and skin graft. Growth factor release could stimulate fibroblast migration, wound healing and angiogenesis. Further more PRF act as a lubricant layer to protect skin graft from tendon motion. This could improve graft in-growth.

Eligibility criteria: Inclusion Criteria:

* \>18 years, donor site on the forearm after radial forearm flap surgery, free skin graft reconstruction of this skin defect, informed consent

Exclusion Criteria:

* \<18 years, inclusion criteria were not met

Primary outcomes:
measure: Coverage rate
timeFrame: 10-14 days
Secondary outcomes:
measure: Evaluation Score (ES)
timeFrame: 10-14 days
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University Hospital of Würzburg
state: Bavaria
Study officials:
affiliation: Dep. of Oral and Maxillofacial Plastic Surgery
name: Anton Straub, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01613339: Body Awareness Therapy for People With Stroke
Official title: Body Awareness Therapy for People With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
postural control
body awareness therapy
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: Norrbacka-Eugenia Foundation
First posted: 2012-06-07
Enrollment: 46
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: Affected balance capacity is common after a stroke due to paresis and sensory disturbances. The affected balance capacity may cause walking disturbances, falls and decreased mobility. Balance may be improved by physical therapy. A possible method for balance training is body awareness therapy, that was introduced in Sweden by Jacques Dropsy and Gertrud Roxendal. Earlier body awareness therapy was mostly used in psychiatric care but in the recent years the method has been used for people with long-tern pain, amputations and multiple sclerosis. Body awareness therapy includes exercises in lying, sitting and standing. Focus of the exercises are awareness of one´s movement behaviour, breathing patterns, resources and limitations. Postural control is an essential part in the exercises. Body awareness therapy could be used for people with stroke as a way to improve postural control. The aim of this study is to investigate if balance training using body awareness therapy can improve balance and walking in people after stroke. The interventions consists of body awareness therapy once a week for 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosed stroke more than 6 months ago. Walking capacity of 100 meter with or without assistive device.

Exclusion Criteria:

* Medical or cognitive impairment that prohibits participating in the intervention.

Primary outcomes:
measure: Bergs Balance Scale
timeFrame: Change from baseline in Bergs balance scale at 9 weeks
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: Change from baseline in Timed Up and Go test at 9 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: Change from baseline in Activities-specific Balance confidence scale at 9 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Primary Health Care Centres
Study officials:
affiliation: Family Medicine Research Centre, Örebro county council
name: Mialinn Arvidsson Lindvall, RPT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Medicine Research Centre, Örebro county council
name: Anette Forsberg, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00327639: Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto
Official title: Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thalassemia
Fertility
Pregnancy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2006-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Treatment of patients with beta thalassemia in North America has altered dramatically during the past 40 years, with improvements in transfusion therapy and introduction of iron chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth and sixth decades of life, with fertility and childbearing becoming important issues. Data regarding this important topic remain limited, without clear data regarding iron control including serial assessment of hepatic iron concentration, the need for assistance in becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy increases and overall health improves in thalassemia, clear data on fertility, pregnancy complications, and the effect of pregnancy on maternal health in thalassemia patients are necessary since these will have a direct impact on patient care, quality of life, and patient expectations.


Eligibility criteria: Inclusion Criteria:

* Thalassemia, thalassemia intermedia or E-thalassemia patients in Toronto
* Subject has attempted conception

Exclusion Criteria:

* Subject has any other form of blood disease
* Subject has not attempted conception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto General Hospital
name: Nancy F Olivieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04576039: Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes
Official title: Ultrasonographic Appearance of the Endometrium After Saline Infusion in Women Presenting With a Thickened Endometrium After the Use of Ulipristalacetate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroid
Endometrial Cyst
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: If endometrial thickening is visualised (\>10mm) after the use of ulipristalacetate in case of medical treatment for uterine fibroids a saline infusion and sonographic examination will be performed to evaluate the endometrium and exclude intra-uterine pathology.

Detailed description: When ultrasonographic examination during follow up of a treatment with ulipristalacetate shows a thickening of the endometrium of 10mm or more ( thickening described in 10% of ulipristalacetate users and is completely benign), a saline infusion can help to exclude pathology in the uterine cavity. Saline infusion helps to better delineate the uterine cavity and endometrium. If fibroids or polyps are present in the uterine cavity they will clearly be seen.

This study was set up to describe how the endometrial changes after Esmya use appear on saline infusion sonography. This study can help to recognize ultrasonographic images in women presenting with thickened endometrium after Ulipristalacetate use.

Eligibility criteria: Inclusion Criteria:

* Women with thickened endometrium on ultrasound (defined as double endometrium thickness of ≥10mm) at the end of their treatment with ulipristalacetate.
* Normal double endometrium thickness before the use of ESMYA (\<10mm)
* BMI \>18 - \< 30

Exclusion Criteria:

* Known type 0 or 1 fibroids
* Known intrauterine pathology

Primary outcomes:
measure: ultrasonographic morphology of the endometrium at saline infusion sonography
timeFrame: 1 week
Secondary outcomes:
measure: diagnostic ability to exclude intrauterine pathology
timeFrame: 1week
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis UZBrussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Catherine Degreef, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02216539: Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Diseases
Keywords: All terminal
leading
indication
lung transplantation
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2014-08-15
Enrollment: 5
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: SUPPORTIVE_CARE

Brief summary: Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.

The study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.


Eligibility criteria: Inclusion Criteria:

* patients over 15 years of age
* indication of lung transplantation

Exclusion Criteria:

* patient unable to receive training in self-hypnosis (for cognitive, linguistic or cultural reasons)

Primary outcomes:
measure: Average Pain Score (Visual Analog Scale) One Month After Surgery
timeFrame: one month after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch, Suresnes, France
name: Mireille Michel-Cherqui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Foch, Suresnes, France
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06533839: Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh
Official title: Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parastomal Hernia
Keywords: Parastomal hernia
end colostomy
prophylactic mesh
Lead sponsor: Consorci Sanitari Integral
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.

Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.

The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a definitive colostomy confection
* Terminal colostomy confection
* ASA index III or inferior
* Patients who have given legat authorization to participate in the study

Exclusion Criteria:

* Lateral colostomy or a colostomy that will be removed posteriorly

Primary outcomes:
measure: Postoperative parastomal hernia prevention
timeFrame: up to one year post-intervention
Secondary outcomes:
measure: Postoperative parastomal hernia prevention
timeFrame: 5 years after surgery
measure: readmissions for complications
timeFrame: up to one year post-intervention
measure: morbidity
timeFrame: up to one year post-intervention
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Hospital Sant Joan Despí Moisès Broggi
state: Barcelona
Study officials:
References: