louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04816136: Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke
Official title: Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Cerebral Infarct
Sleep Apnea
Periodic Limb Movement Disorder
Keywords: Functional recovery
Ischemic stroke / cerebral infarct
Sleep
Polysomnography
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients selected with computer codes of disease and examination corresponding to the criteria : sleep recording and ischemic stroke

Brief summary: Ischemic stroke is a major public health issue, likely to cause functional disability. It is well known that sleep has an impact on brain plasticity, and after an ischemic stroke, studies have shown subjective sleep quality alterations and sleep architecture abnormalities.

Furthermore, there is no clear guideline showing the usefulness of a systematic sleep investigation following an ischemic stroke.

The aim of the study is to identify retrospectively correlation between polysomnographic abnormalities (sleep apnea, periodic limb movements, disturbed sleep architecture...) and functional recovery after an ischemic stroke. The study also assesses the impact of sleep abnormalities on survival, and the risk of new cardiovascular event.

Detailed description: This study is a retrospective observational study, from a cohort of patients who had a sleep recording (polysomnography or ventilatory polygraphy performed in Montpellier University Hospital) following an ischemic stroke.

Eligibility criteria: Inclusion criteria:

* men and women, more than 18 years old
* medical history of ischemic stroke
* who had a sleep recording following the stroke

Exclusion criteria:

* others types of strokes (bleeding, transient ischemic attack, cerebal veinous thrombosis)
* patients less than 18 years old

Primary outcomes:
measure: Correlation between polysomnographic abnormalities and functional recovery
timeFrame: functional recovery at 6 months
Secondary outcomes:
measure: Correlation between polysomnographic abnormalities and survival, onset of new cardio vascular events, functionnal recovery and quality of life.
timeFrame: survival or onset of new cardio vascular events at one year, quality of life evaluated by self questionnaire at one year and functionnal recovery (modified rankin score and National Institutes of Health Stroke Scale) at one year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Yves DAUVILLIERS, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03504436: Endovascular Treatment of Wide Neck Intracranial Aneurysms With the LEO + Stent : The LEO + II Cohort Study
Official title: Evaluation of the LEO + Stent in the Endovascular Treatment of Wide Neck Intracranial Aneurysms (Fusiform, Saccular or Dissecting), Ruptured or Not Ruptured: Cohort of the Self-expanding Intracranial Stent LEO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Lead sponsor: Balt Extrusion
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with ruptured or not ruptured intracranial aneurysms demonstrated by cerebral arteriography treated with LEO + stent

Brief summary: This is a prospective, multicenter, single-arm observational study to evaluate the efficacy and the morbi-mortality of LEO + in patients with wide neck intracranial aneurysms (fusiform, saccular or dissecting), ruptured or not ruptured.


Eligibility criteria: Inclusion Criteria:

* All patients with ruptured or not ruptured intracranial aneurysms demonstrated by cerebral arteriography treated with LEO + stent
* Patients (or their parents for minors) must be informed and give written consent

Exclusion Criteria:

* Patients (or parents) who refused to give consent.

Primary outcomes:
measure: Total aneurysmal occlusion rate
timeFrame: 18 months
measure: Morbi-mortality
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00965536: Nis Register Study Comparing Seroquel and Seroquel Prolong
Official title: A Local Non Interventional Retrospective Register Study of the Current Clinical Treatment Practices and the Number of Hospitalization Days With Seroquel or Seroquel Prolong.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comparing Hospitalisation Time With Seroquel and Seroquel Prolong
Keywords: Schizophrenia
Bipolar Disorder
Manic Disorder
Register study
Quetiapine
Quetiapine Prolong
Seroquel
Seroquel Prolong
Seroquel XR
In-patient
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: South Karelia Central Hospital in-patients

Brief summary: The general aim of this non interventional study is to clarify what are the current clinical treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The primary objectives of the study are:1.To collect information on the used Quetiapine Immediate Release or Quetiapine Extended Release medication 2.To collect information on duration and number of hospitalisation days 3.Change of GAF points


Eligibility criteria: Inclusion Criteria:

* Medication: Seroquel or Seroquel Prolong
* Diagnosis: F20-F29 or F30-F31 (ICD-10)
* In-patient

Exclusion Criteria:

* None

Primary outcomes:
measure: Hospitalisation time
timeFrame: 2008-2010
measure: Treatment practice
timeFrame: 2008-2010
Secondary outcomes:
measure: Primary diagnosis
timeFrame: 2008-2010
measure: Medication at the end of hospitalisation
timeFrame: 2008-2010
measure: GAF rating points
timeFrame: 2008-2010
Other outcomes:
Locations:
city: Lappeenranta
country: Finland
facility: Research Site
Study officials:
affiliation: Medical Affairs Manager, MD, psychiatrist
name: Yrjö Ovaskainen
role: STUDY_DIRECTOR
affiliation: MD, psychiatrist
name: Kari Hänninen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06641336: Perceptions of RehAtt Mixed Reality System
Official title: Perceptions of Using RehAtt Mixed Reality System in Stroke Motor Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
mixed reality
motor rehabilitation
patients' perspective
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study aims to explore the patients' perspective on usability and feasibility of the RehAtt™ mixed-reality system during upper limb, gait and balance function rehabilitation.

Detailed description: Mixed reality is an immersive technology that can integrate virtual objects into the real world and adaptive scenarios. It offers the opportunity to train physical and cognitive aspects in stroke patients. The patients' perspectives were assessed with a semi-structured interview.

Eligibility criteria: Inclusion Criteria:

* first ischaemic or hemorrhagic stroke,
* one-sided hemiparesis,
* adequate cognitive abilities.

Exclusion Criteria:

* severe cognitive impairment,
* aphasia,
* known presence of an epileptic seizure in the last year,
* other orthopaedic and neurological diseases affecting sensory or motor functions,
* inability to sit independently,
* severe visual impairment,
* severe depression.

Primary outcomes:
measure: Semi-structured interview
timeFrame: On the day of the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Nataša Bizovičar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00506636: Tissue Engineering for Hair Follicle Regeneration
Official title: Study of Tissue Engineering for Hair Follicle Regeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tissue Engineering
Hair Follicle Regeneration
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2007-07-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: This study is to try to maintain cultured dermal papilla cells in spherical structure in vitro before transplanting into dermis in vivo. Also, this study is aimed in clarifying actual mechanism of inducing hair follicle by dermal papilla cells.

Detailed description: Hair transplantation is an well-documented way of treating hair loss. Hair transplantation is based on redistribution of hair follicles without any new follicle formation. It has been long that a lot of researchers have focused on developing skills in regenerating hair follicles. However, cultured dermal papilla cells lose the ability of inducing hair follicle formation after several generations in vitro culture. Our study is aiming in culturing dermal papilla cells in vitro and maintain their spherical structure before transplanting into dermis in vivo. Meantime, this study may help clarify the actual mechanism of inducing hair follicle by dermal papilla cells.

Eligibility criteria: Inclusion Criteria:

* Patients receiving cosmetic surgeries such as removal of moles

Exclusion Criteria:

* No special exclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Sung-Jan Lin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00198536: Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
Official title: Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 159
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 purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome


Eligibility criteria: Inclusion Criteria:

* Agree to avoid systemic \& topical ophthalmic meds \& disallowed meds
* Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
* Diagnosis of moderate dry eye syndrome

Exclusion Criteria:

* Uncontrolled ocular or systemic disease that could interfere with study
* Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
* Contraindications or hypersensitivity to use of study meds or components
* Wear contact lenses
* Secondary dry eye to surgery
* Eye surgery (including laser) within 6 months
* Use of systemic or topical ophthalmic meds within 14 days
* Punctal plugs in one or both eyes in place for \<45 days
* Permanent occlusion of the lacrimal puncta

Primary outcomes:
measure: Ocular discomfort
timeFrame: Day 91
measure: Tear Film Break-up Time (TFBUT)
timeFrame: Day 91
measure: Blink Rate
timeFrame: Day 91
Secondary outcomes:
Other outcomes:
Locations:
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Dover
country: United States
facility: Eyesight Ophthalmic Services, PA
state: New Hampshire
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05438836: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Official title: ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Cancer
Anal Carcinoma
Anal Squamous Cell Carcinoma
Keywords: adaptive radiotherapy
Anal cancer
Online Adaptive radiotherapy (oART)
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 205
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 non-metastatic squamous cell carcinoma of the anus, referred for chemo-radiotherapy with curative intent.

Brief summary: A single-arm, prospective, Phase II, single-center clinical trial that will investigate if daily online adaptive radiotherapy for anal cancer will significantly reduce early treatment-related GI toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).


Eligibility criteria: Inclusion Criteria:

* Biopsy-verified anal cancer
* Eligible for curative intended radiotherapy
* Written and oral consent

Exclusion Criteria:

* Other malignant disease within the past 5 years (excluding basal cell carcinoma)

Primary outcomes:
measure: Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)
timeFrame: from mid-treatment to 3 months after end of treatment
Secondary outcomes:
measure: All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest)
timeFrame: from mid-treatment to 3 months after end of treatment
measure: All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities
timeFrame: From 3 months after end of treatment to 5 years follow-up
measure: Patient Reported Outcomes (PRO)
timeFrame: from baseline to 5 years follow-up
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment
timeFrame: from baseline to 5 years follow-up
measure: Progression Free Survival
timeFrame: From time of inclusion to disease progression, assessed up to 5 years follow-up
measure: Overall Survival
timeFrame: From time of inclusion to death from any cause, assessed up to 5 years follow-up
measure: Disease Free Survival
timeFrame: From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up
measure: Treatment Related Hospitalization
timeFrame: From of start of radiation therapy through 5 year follow-up
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Oncology dept, Herlev and Gentofte Hospital
Study officials:
affiliation: Herlev og Gentofte Hospital
name: Eva S Serup-Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03611036: Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD
Official title: Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, prospective, randomized, open-label study.
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with COPD during a pulmonary rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Patient with stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program (4 weeks)
* Patient aged 18 or over
* Patient able to consent and having signed a consent form

Exclusion Criteria:

* Patient with pain, osteoarthritis or shoulder surgery
* Patient with a history of Pneumonectomy, lobectomy less than 6 months old
* Refusal of participation
* Patient with an inability to complete a pulmonary rehabilitation program in totality
* Pregnant or breast-feeding women
* Patient under tutorship or curatorship

Primary outcomes:
measure: Compare the effect of upper limbs strength training versus the effect of upper limb endurance training on dyspnea in patients with COPD during a pulmonary rehabilitation program.
timeFrame: Change from inclusion at 4 week
Secondary outcomes:
measure: Compare dyspnea in daily life between the 2 groups
timeFrame: At inclusion and week 4
measure: Compare dyspnea in daily life between the 2 groups
timeFrame: At inclusion and week 4
measure: Measuring upper limb endurance
timeFrame: At inclusion and week 4
measure: Compare dyspnea at the end of a functional test using the upper limbs
timeFrame: At inclusion and week 4
measure: Compare upper limbs muscle fatigue at the end of a functional test using the upper limbs
timeFrame: At inclusion and week 4
measure: Compare the evolution of upper limb strength between the 2 groups.
timeFrame: At inclusion and week 4
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: CH Pays de Morlaix
Study officials:
affiliation: CH des pays de Morlaix
name: Marc BEAUMONT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Brest
name: Francis COUTURAUD, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Beaumont M, Peran L, Berriet AC, Le Ber C, Le Mevel P, Courtois-Communier E, Couturaud F. Effect of different form of upper limb muscles training on dyspnea in chronic obstructive pulmonary disease: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22131. doi: 10.1097/MD.0000000000022131.
Clinical trial NCT01770236: Pain Control After Minimally Invasive Coronary Artery Bypass Grafting
Official title: Optimal Method of Pain Control After Minimally Invasive Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Pain
Medication Side Effects
Narcotic Requirement
Lead sponsor: Gundersen Lutheran Medical Foundation
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 41
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare postoperative pain control after minimally invasive coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic medicine injected in an area under the ribs) in the operating room and IV acetaminophen (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon pump attached to 2 small tubes near your procedure site that automatically delivers pain medicine).


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Coronary artery disease requiring surgical intervention
* No prior sternotomy
* Creatinine within normal limits (0.60 - 1.10 mg/dL)

Exclusion Criteria:

* Less than 18 years of age
* Inability to provide consent or complete a written survey
* Previous history of sternotomy
* Contraindications to MICS-CABG or to any of the components of the 2 analgesic regimens

Primary outcomes:
measure: Pain score
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary outcomes:
measure: Medication side effects
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Gundersen Lutheran Health System
state: Wisconsin
Study officials:
affiliation: Gundersen Health System
name: Prem Rabindra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gundersen Health System
name: Kym Culp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gundersen Health System
name: Korey Zellner, PA-C
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walther T, Falk V, Metz S, Diegeler A, Battellini R, Autschbach R, Mohr FW. Pain and quality of life after minimally invasive versus conventional cardiac surgery. Ann Thorac Surg. 1999 Jun;67(6):1643-7. doi: 10.1016/s0003-4975(99)00284-2.
citation: McGinn JT Jr, Usman S, Lapierre H, Pothula VR, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting: dual-center experience in 450 consecutive patients. Circulation. 2009 Sep 15;120(11 Suppl):S78-84. doi: 10.1161/CIRCULATIONAHA.108.840041.
citation: Berger MM, Berger-Gryllaki M, Wiesel PH, Revelly JP, Hurni M, Cayeux C, Tappy L, Chiolero R. Intestinal absorption in patients after cardiac surgery. Crit Care Med. 2000 Jul;28(7):2217-23. doi: 10.1097/00003246-200007000-00006.