louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05779215: Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion
Official title: The Multicenter, Prospective, Real-world Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
large vessel occlusion
medium vessel occlusion
real-world registry
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 50000
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: Patients with acute ischemic stroke due to large- or medium-vessel occlusion will be enrolled and no additional exclusion criteria are set.

Brief summary: This study is designed to observe the treatment options in real-world clinical practice as well as the safety and efficacy of different treatment strategies.

Detailed description: LOMEVO is a prospective, multicenter, real-world registry lasting for 10 years. A total of 50000 patients with large- or medium-vessel occlusion will be enrolled at approximately 30 centers around China.

Eligibility criteria: Inclusion Criteria:

* The clinical diagnosis is acute ischemic stroke with large- or medium- vessel occlusion (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018)
* Informed consent from the patient or surrogate

Exclusion Criteria:

* No additional exclusion criteria

Primary outcomes:
measure: modified Rankin Scale (mRS) score
timeFrame: 90±7 days
Secondary outcomes:
measure: Excellent functional outcome
timeFrame: 90±7 days
measure: Good functional outcome
timeFrame: 90±7 days
measure: mRS 0-3
timeFrame: 90±7 days
measure: Change of National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 24 hours
measure: Change of National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 7 days
measure: Symptom-to-thrombolysis time (STT)
timeFrame: 24 hours
measure: Door-to-Needle Time (DNT)
timeFrame: 24 hours
measure: Door-to-Puncture Time (DPT)
timeFrame: 24 hours
measure: Onset-to-recanalization time
timeFrame: 24 hours
measure: Door-to-Recanalization Time (DRT)
timeFrame: 24 hours
measure: Puncture-to-recanalization time
timeFrame: 24 hours
Other outcomes:
measure: Incidence of clinically significant intracranial hemorrhage
timeFrame: 36 hours
measure: Incidence of any intracranial hemorrhage
timeFrame: 36 hours
measure: All-cause mortality
timeFrame: 90±7 days
measure: Complications related to intravenous thrombolysis
timeFrame: up to 7 days
measure: Complications related to endovascular treatment
timeFrame: up to 7 days
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT06106815: Implementation and Evaluation of the Graded Repetitive Arm Supplementary Program (GRASP) for People With Stroke
Official title: Implementation Science for Bridging the Gap Between Research and Practice: Implementation and Evaluation of the Graded Repetitive Arm Supplementary Program (GRASP) for People With Stroke in the Real-World Hospital Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effect of the Graded Repetitive Arm Supplementary Program (GRASP) with the usual care on upper extremity function in individuals with stroke.

The main questions it aims to answer are:

* Compare the effectiveness of the GRASP program delivered by train occupational therapists
* Explore the patients' and therapists' experiences of the GRASP program using interviews and surveys

Stroke participants will receive either the GRASP program or Usual Care for four weeks (3 sessions/week). Stroke participants will be evaluated before, immediately after, and 3 months after the intervention. Therapist participants will be trained for the delivery of the GRASP program. Interviews and surveys/questionnaires will be administered to understand patients' and therapists' perspectives on the implementation of the GRASP program.


Eligibility criteria: Inclusion Criteria:

* 1) are aged 20 years or older, 2) stroke onset \> 3 months, 3) have upper extremity hemiparesis due to the first-ever stroke, (4) have some voluntary movement in the affected UE, including the ability to lift the affected arm to chest level and hold for 5 seconds, some ability to extend the affected wrist, and some ability to grasp and release an object such as a cup handle, and 5) are able to follow 2-step instructions.

Exclusion Criteria:

* 1) orthopedic conditions affecting the arm/hand or other neurological conditions, 2) severe pain that prevents movement in the affected arm and hand, and 3) unstable medical status.

Primary outcomes:
measure: Fugl Meyer Assessment (upper extremity)
timeFrame: though study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Chieh-ling Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03700515: Exosome Proteomics to Detect EPO
Official title: Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: EPO
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Tasmania
First posted: 2018-10-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The role of exosomes in cell signalling has only recently been appreciated and is a hugely exciting and rapidly growing area, and combined with LC-MS/MS proteomics, can overcome traditional barriers to proteomics in doping applications. To our knowledge, no research has yet been undertaken to explore whether the highly promising combination of exosome proteomics has utility for rhEPO detection. The applications are extensive; the diagnostic value of differentially regulated proteins could be further validated against the existing IEF EPO WADA accredited tests using samples collected during this study, used to study altitude hypoxia versus exogenous EPO administration (WADA current targeted research 2017), investigated as a platform approach to ESA and HIF agents more generally, as well as facilitate development of direct ELISA high throughput tests.


Eligibility criteria: Inclusion Criteria:

* VO2max of at least 55+/-2 for men and 50+/-2 for women
* BMI between 18 and 27
* Resting hematocrit of less than 46%

Exclusion Criteria:

* Chronic disease deemed by the medical doctor to affect the outcome
* Competitive athlete subject to doping control
* Use of other prescription medicine deemed by the medical doctor to interact with the study drug
* Allergy or otherwise unacceptable side effects toward the study drug
* Smoker
* Pregnancy

Primary outcomes:
measure: Blood proteome enrichment pathway analysis in GO annotation
timeFrame: At baseline and after week 3 of treatment
Secondary outcomes:
measure: Blood markers of iron
timeFrame: At baseline and after week 3 of treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT04047615: The Effects of Exercise on Behavior and Fitness in Children With ASD
Official title: The Effects of an Exercise Intervention Programme on Behaviour and Fitness Levels in Children With ASD.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Behavior
Lead sponsor: Institute of Technology, Carlow
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of a school based exercise intervention programme on the behaviour and fitness levels in children with autism.

Detailed description: This study will examine the effects of a school based exercise intervention programme on the behaviour and fitness levels in children with autism. Local primary schools who have an Autism Spectrum Disorder (ASD) class will be approached to participate in the project. The age profile of the children will be 4-12 years of age and they will have mild-sever levels of autism. The exercise intervention programme will be delivered 3 times per week in the schools over an 8 week period.

Children will be fitness tested to assess the change in fitness levels over the 8 week period. Questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in behaviour levels as a result of the exercise intervention programme.

Eligibility criteria: Inclusion Criteria:

• Diagnosis of Autism Spectrum Disorder

Exclusion Criteria:

• Any medical condition which excludes the child from partaking in exercise

Primary outcomes:
measure: Behavior
timeFrame: Change from baseline at Week 4 and Week 8
measure: Behavior
timeFrame: Change from baseline at Week 4 and Week 8
Secondary outcomes:
measure: Fitness Level
timeFrame: Change from baseline at Wkke 4 and Week 8
Other outcomes:
Locations:
city: Carlow
country: Ireland
facility: Institute of Technology, Carlow
Study officials:
References:
Clinical trial NCT03902015: "Nuance Hearing" for Attention Deficit Hyperactivity Disorder
Official title: Technology Efficacy of "Nuance Hearing" Among Students Suffering From Attention Disorders- A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit/Hyperactivity Disorder
Lead sponsor: Nuance Hearing
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 30
Sex: MALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to examine whether the ability to avoid irrelevant auditory stimuli and focus hearing, enabled by the device developed by "Nuance Hearing", may help students with ADHD in classroom listening situations by significantly reducing background distractions.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of attention deficit hyperactivity disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM IV)
* Have fulfilled the "Test of variables of attention"
* with normal hearing

Exclusion Criteria:

* Moderate to severe co-morbid psychiatric disorders
* Neurological chronic disease

Primary outcomes:
measure: Listening inventory for education - revised (L.I.F.E - R) 1 week after baseline
timeFrame: 1 week after baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Geha Mental Health Center
name: Iris Manor, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05277415: Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure
Official title: Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Herat Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure With Reduced Ejection Fraction HFrEF
Keywords: cardiac output
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, parallellel intervention study
Primary purpose: TREATMENT

Brief summary: In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion

Detailed description: In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion (single dose).

The following parameters will be collected: routine clinical parameters, endothelial function, cardiac structure and function by echocardiography, non-invasively assessed cardiac output and hemodynamics, serologic and of cardiac and renal function, sympathetic and RAS activation, metabolism, anabolic hormone function, inflammation, fibrosis, oxidative stress and apoptosis.

15 patients each group in are adequate to detect a difference between groups and before vs after ghrelin administration in metabolism, anabolic function and endothelial function with a power of 90% and two-sided significance of 5%.

Eligibility criteria: Inclusion Criteria:

1. Current or past signs of clinical HF according to the Framingham criteria
2. LVEF\<40%
3. NT-proBNP \> 300 ng/L

Exclusion Criteria:

1. Inability to or unwillingness to provide informed consent,
2. Participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.

Primary outcomes:
measure: Change in cardiac output between treament groups
timeFrame: Procedure (At the end of ghrelin administration)
Secondary outcomes:
measure: Change in endothelial function between treament groups
timeFrame: Procedure (At the end of ghrelin administration)
measure: Change in cardiac function between treament groups
timeFrame: Procedure (At the end of ghrelin administration)
measure: GH biomarker
timeFrame: Procedure (At the end of ghrelin administration)
measure: ghrelin biomarker
timeFrame: Procedure (At the end of ghrelin administration)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05239715: Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract
Official title: Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract: Benefit of Use of the Enhance Retina Visualization Mode
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optical Biometer, Cataracts
Keywords: optical biometer, cataracts
Lead sponsor: OFTALVIST (Oftalmología Vistahermosa S.L)
Sponsor class: INDUSTRY
Collaborators: name: Alcon Research
First posted: 2022-02-15
Enrollment: 51
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: Patients with dense cataracts.

Brief summary: To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts

Detailed description: To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts

Eligibility criteria: Inclusion Criteria:

* LOCS III cataract classification with a grade of ≥3 for nuclear, cortical or posterior subcapsular.
* DLI index, from the ITrace device, should be ≤ 5.

Exclusion Criteria:

* Previous continuous contact lens wear
* Ocular trauma
* Intraocular lens surgery
* Poor fixation
* Corneal disease (i.e. keratoconus)

Primary outcomes:
measure: To describe and compare the acquisition rate between different biometers in eyes To describe and compare the acquisition success rate between different biometers in eyes with advanced cataracts
timeFrame: 6 months
Secondary outcomes:
measure: To describe the correlation of success rate and Dysfunctional Lens Index (DLI, iTrace)
timeFrame: 6 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Oftalmología Vistahermosa SL
Study officials:
affiliation: Oftalmología Vistahermosa SL
name: Pedro Tañá, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tana-Rivero P, Aguilar-Corcoles S, Tana-Sanz P, Tana-Sanz S, Montes-Mico R. Axial length acquisition success rates and agreement of four optical biometers and one ultrasound biometer in eyes with dense cataracts. Eye Vis (Lond). 2023 Sep 1;10(1):35. doi: 10.1186/s40662-023-00352-3.
Clinical trial NCT00250315: DOCICAR: Cardiac Dysfunction in Cirrhosis
Official title: Cardiac Dysfunction in Cirrhosis: Cirrhotic Cardiomyopathy Evaluated by Dobutamin MRI.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Cirrhotic Cardiomyopathy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2005-11-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Patients with cirrhosis have a altered cardiac response to stress. This study evaluate the cardiac response by MRI during dobutamine stress. Hypothesis: impared increase in cardiac output, cardiac index, ejection fraction.


Eligibility criteria: Inclusion Criteria:

* Non alkoholic cirrhosis

Exclusion Criteria:

* Coma hepaticum
* Primary cardiac diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital
name: Søren Møller, DrMsci, MD
role: STUDY_DIRECTOR
References:
citation: Dahl EK, Moller S, Kjaer A, Petersen CL, Bendtsen F, Krag A. Diastolic and autonomic dysfunction in early cirrhosis: a dobutamine stress study. Scand J Gastroenterol. 2014 Mar;49(3):362-72. doi: 10.3109/00365521.2013.867359. Epub 2013 Dec 16.
Clinical trial NCT02704715: Postoperative Pain in Orbital Disease and Ocular Tumor
Official title: Postoperative Pain of General Anesthesia in Orbital Disease and Ocular Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
general anesthesia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the postoperative pain after general anesthesia of orbital diseases and ocular tumor patients.

Detailed description: The purpose of this study is to evaluate patients diagnosed of orbital diseases or ocular tumor over 16 years old of the postoperative pain after general anesthesia , and to analyze the related factors of pain after operation.

Eligibility criteria: Inclusion Criteria:

* over 16 years old
* diagnosed as orbital disease or ocular tumor
* surgery under general anesthesia

Exclusion Criteria:

* any uncontrolled clinical problems

Primary outcomes:
measure: pain
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huijing Ye, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05008315: Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section
Official title: Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Postsurgical Adhesion
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postpartum women with C-section receiving deep and superficial tissue mobilization would have better improvement on pain, lumbopelvic muscle functions, spinal mobility, and posture compare to the superficial tissue mobilization and control group


Eligibility criteria: vaginal delivery

Inclusion Criteria:

* Natural birth without C-section scar
* Postpartum more than 6 months
* Without any pain in the lumbopelvic region

C-section

Inclusion Criteria:

* Healed C-section scar \> six months
* Scar with or without pain

Both mode of delivery

Exclusion Criteria:

* Active infection or infectious disease in the pelvis or abdomen
* Pain medications on days of measurements
* Skin irritation and inflammation at the site of the scar
* Currently pregnant or actively trying to get pregnant
* History of radiation to the area
* Any fracture around spine and pelvis
* Any previous gynecologic and obstetric surgery

Primary outcomes:
measure: Scar Characteristic: Extensibility
timeFrame: 8 weeks
measure: Scar Characteristic: Viscoelasticity
timeFrame: 8 weeks
measure: Scar Characteristic: Irritability
timeFrame: 8 weeks
measure: Muscle function measures of lumbopelvic muscles
timeFrame: 8 weeks
measure: Muscle function measures of pelvic floor muscle control
timeFrame: 8 weeks
measure: Spinal Mobility
timeFrame: 8 weeks
measure: Myofascial Flexibility
timeFrame: 8 weeks
measure: Spinal Alignment and Posture
timeFrame: 8 weeks
measure: Pain intensity measure of Visual Analogue Scale
timeFrame: 8 weeks
measure: Pain intensity measure of pelvic girdle questionnaire
timeFrame: 8 weeks
measure: Pain intensity measure of Oswestry Low Back Pain Disability Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Self-perceived Change Health Status: Global Rating of Change Scale (GROC)
timeFrame: 8 weeks
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References: