louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05168982: Development of Non-Invasive MRI Applications for Liver Fibrosis and Inflammation
Official title: Development of Fully Automated Non-Invasive MRI Applications for Diagnosis and Staging of Liver Fibrosis and Inflammation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Fibrosis
Keywords: MRI, liver fibrosis, liver inflammation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic liver disease (CLD) patients at different stages of liver inflammation (A0-3) and liver fibrosis (F0-4)

Brief summary: Chronic liver disease is a major healthcare problem in Hong Kong and worldwide. The diagnosis of liver fibrosis and inflammation in patients with chronic liver disease has important prognostic and therapeutic implications. The current gold standard to evaluate and stage the severity of liver fibrosis and inflammation is based on liver biopsies, which are invasive and impractical for screening and monitoring the disease. The existing non-invasive methods still have significant limitations to meet the challenge.

Magnetic resonance effect can be used to obtain the molecular-level information on the biochemical properties of human tissues. The investigators will develop non-invasive quantitative MRI technologies to evaluate and stage liver fibrosis and inflammation. Our approaches are based on the endogenous contrast mechanism and thus do not need to inject an MRI contrast agent. Our approaches can be implemented on a regular MRI scanner and do not need any extra hardware. To enable the technology for routine clinical use, the investigators will develop fully automated post-processing techniques for the proposed MRI acquisition approaches. The investigators will perform multi-center clinical studies in Hong Kong and mainland China to validate our imaging measurements by histopathologic results from liver biopsies on patient cohorts.


Eligibility criteria: Inclusion Criteria:

* Between the age of 18 and 65.
* Chronic liver disease (CLD) patients at different stages of liver inflammation (A0-3) and liver fibrosis (F0-4).
* CLD patients who have indications and are scheduled to undergo liver biopsy.

Exclusion Criteria:

* Patients diagnosed with HCC or other types of cancers.
* Patients who had undergone liver transplantation before enrollment.
* Any contraindications to either liver biopsy or MRI scan.

Primary outcomes:
measure: To compare the measurement between subjects with different grades of liver inflammation and stages of liver fibrosis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong, Prince of Wale Hospital
state: Shatin
Study officials:
References:
Clinical trial NCT03486782: Dual Site-dual Channel Non-invasive Brain Stimulation for Language and Cognitive Function in Stroke Patients
Official title: Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Language and Cognitive Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Cognitive Impairment
Keywords: transcranial direct current stimulation
dual stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of language and cognitive function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on ipsilesional inferior frontal cortex, ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex. 2) Single stimulation 1: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional inferior frontal cortex; 3) Single stimulation 2: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional supraorbital area.


Eligibility criteria: Inclusion Criteria:

* left hemisphere involved stroke patients
* patients diagnoses as post stroke aphasia

Exclusion Criteria:

* history of psychiatric disease
* patients with metal implants
* history of epilepsy
* pregnancy
* skin defect at the site of electrode attachment

Primary outcomes:
measure: Changes in Korean Boston naming test
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: Changes in Korean Western Aphasia Battery
timeFrame: Baseline and after intervention (approximately 2 weeks)
Secondary outcomes:
measure: Digit span test
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: Korea Montreal Cognitive Assessment
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: Korean Color Word Stroop test
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: Controlled Oral Word Association Test
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: Changes of Cortical activation
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: Changes in brain activation of resting-state and task functional MRI
timeFrame: Baseline and after intervention (approximately 2 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00621582: Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities
Official title: Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 4918
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of varying severities over 8 weeks.

Detailed description: Study Design:

Eligibility criteria: Inclusion Criteria:

Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline.

Patients over 40 years old

Exclusion Criteria:

Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva® Patient with known narrow-angle glaucoma

* Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction
* Patient with known moderate to severe renal impairment (i.e.,creatinin clearance\<=50ml/min)
* Pregnant or nursing women
* Patient with any significant disease other than COPD which would exclude him/her from participating in the study
* Patients with any conditions listed in \[special precautions\], \[drug interactions\], and \[contraindication\] of Spiriva® China package insert
* Patients with signed informed consent of any other study

Primary outcomes:
measure: Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
timeFrame: 0 weeks (Visit 1) and 8 weeks (Visit 3)
measure: Patient Tolerability Assessment at Visit 3
timeFrame: 8 weeks (Visit 3)
Secondary outcomes:
measure: Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
timeFrame: 2 weeks (Visit 2 and 8 weeks (Visit 3)
measure: Physician Tolerability Assessment at Visit 3
timeFrame: 8 weeks (Visit 3)
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00599482: Far Infrared Radiation for Sickle Cell Pain Management
Official title: Phase 1 Study to Examine the Use of Far Infrared Radiation for Pain Management During Sickle Cell Crisis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Anemia, Sickle Cell
Keywords: HEMOGLOBIN SC DISEASE
HEMOGLOBIN C DISEASE
SICKLE CELL TRAIT
THALASSEMIA
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Most patients with sickle-cell disease have periodic intensely painful episodes. To manage this pain, we are proposing the drinking of at least 500 mL of water followed by far infrared radiation.

Detailed description: Painful sickle cell crises are treated with hydration and analgesics. Ischemia is an absolute or relative shortage of the blood supply to an organ. Relative shortage means the mismatch of blood supply (oxygen delivery) and blood request for adequate oxygenation of tissue.

It is hereby postulated that far infrared radiation of the body will promote blood and oxygen supply to the affected tissues. In addition, the analgesic properties of far infrared will alleviate pain due to the crisis.

Eligibility criteria: Inclusion Criteria:

* People with sickle cell disease

Exclusion Criteria:

* None

Primary outcomes:
measure: Pain Management
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: STUDY_CHAIR
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01801982: A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
Official title: A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension, Persistent, of the Newborn
Keywords: PPHN; development progress after PPHN; developmental progress after sildenafil.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil

Brief summary: This single center study will monitor the developmental progress of PPHN patients who received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months following the end of study drug infusion.

Detailed description: This study will monitor developmental progress of PPHN patients for 2 years following study treatment, using Bayley III and Hammersmith tools. Data will be explored with descriptive statistics.

Eligibility criteria: Inclusion Criteria:

* Any subject who received sildenafil treatment in study A1481276.
* Signed and dated informed consent document by legal guardian.

Exclusion Criteria:

* Any subject who did not receive sildenafil treatment during study A1481276.

Primary outcomes:
measure: Number of Participants With Physical Examination Abnormalities at Month 12
timeFrame: Month 12
measure: Number of Participants With Physical Examination Abnormalities at Month 24
timeFrame: Month 24
measure: Number of Participants With Clinically Significant Medical History at Month 12
timeFrame: Month 12
measure: Number of Participants With Clinically Significant Medical History at Month 24
timeFrame: Month 24
Secondary outcomes:
measure: Overall Survival at Month 12
timeFrame: Month 12
measure: Overall Survival at Month 24
timeFrame: Month 24
measure: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital, Paediatric Intensive Care
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01275482: Effectiveness of Transverse Friction Massage in Latent Myofascial Trigger Points in Anterior Deltoid Muscle
Official title: Effectiveness of Transverse Friction Massage Causing or Not Local Twitch Response in Anterior Deltoid Muscle Latent Myofascial Trigger Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Myofascial Trigger Points
Myofascial Pain
Keywords: Latent Myofascial trigger point.
Transverse friction massage
Local twitch response
Effectiveness
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether Transverse Friction Massage (TFM) in Latent Myofascial Trigger points (MTrP) is more effective making this technique in two different ways.

Detailed description: The investigators divide in two groups. The investigators apply the TFM in similar way in both, but the investigators cause local twitch response (isolated contraction of muscle fibers containing the latent trigger points)just in one group. So the investigators want to know whether the effectiveness of this technique is due to those local twitch responses, comparing both groups. The investigators asses Strength, range of motion, and overall, pressure pain thresholds to evaluate the pain sensitivity progress.

Eligibility criteria: Inclusion Criteria:

* Having latent myofascial trigger points in anterior deltoid
* Visual local twitch response

Exclusion Criteria:

* Having active Myofascial trigger points in anterior deltoid
* Having suffered injuries or surgery in upper limb.
* Pain in the first evaluation session.
* Not obtaining local twitch response

Primary outcomes:
measure: Change from Baseline in Pressure pain Threshold (PPT)during treatment.
timeFrame: Pre and post treatment every session and 1 week after last session
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: UCLM
Study officials:
affiliation: UCastilla-La Mancha
name: Jose Miota, PhT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06514482: Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness
Official title: Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea
Keywords: CPAP, residual sleepiness, OSA
Lead sponsor: Hospital San Pedro de Logroño
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to the sleep unit with suspected obstructive sleep apnea dream.

Brief summary: Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out.

OSA patients will be evaluated at baseline, 6, 12, and 24 months.


Eligibility criteria: Inclusion Criteria:

* Patients who come to the sleep consultation for sleep study results for suspected OSA.
* Patients older than 18 years.
* Signature of the informed consent.

Exclusion Criteria:

* Psycho-physical inability to complete questionnaires.
* Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleep deprivation (less than 6h/day), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) and restless legs syndrome.
* Patients with \> 50% central apnea or presence of Cheyne-Stokes respiration (CSRsp).
* A medical history that may interfere with the objectives of the study or that in the judgment of the investigator compromises the conclusions.
* Any medical, social or geographical factor that may endanger the patient compliance. (eg, alcohol consumption (more than 80 g/day in men and more than 60 gr / day in women), absence of stable habitual residence, disorientation or non-compliance history).
* Any process, cardiovascular or not, that limits life expectancy to less than one year.

Primary outcomes:
measure: Primary Outcome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
Study officials:
References:
Clinical trial NCT01721382: Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis
Official title: Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
CF
CFRD
sitagliptin
incretins
GLP1
GIP
beta cell function
adolescents
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 6
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT), will be performed at baseline and again \~4 weeks after treatment with study drug. We will also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before each time the MMTT/OGTT are performed. Several hormones that may affect the way the body regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine has on the hormones measured during the OGTT and MMTT.


Eligibility criteria: Inclusion Criteria:

* Patients with CF between 13 and \<21 yrs old
* Known impaired or indeterminate glucose tolerance (based on a prior OGTT)
* No history of CFRD

Exclusion Criteria:

* Insulin use in the last two months
* Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks
* History of pancreatitis in the last 12 months
* Skin rashes or conditions that may affect CGM placement and wear
* Pregnancy or intent on becoming pregnant
* Patients on growth hormone therapy
* Renal insufficiency with creatinine clearance \<50 ml/min (based on Schwartz formula)

Primary outcomes:
measure: Response to sitagliptin
timeFrame: Change from baseline to ~4 weeks of study drug
measure: Response to sitagliptin
timeFrame: Change from baseline to ~4 weeks of study drug
measure: Response to sitagliptin
timeFrame: Change from baseline to ~4 weeks of study drug
measure: Response to sitagliptin
timeFrame: Change from baseline to ~4 weeks of study drug
Secondary outcomes:
measure: Beta-cell function
timeFrame: Change from baseline to ~4 weeks of study drug
measure: Continuous glucose monitoring (CGM)
timeFrame: change from baseline to ~4 weeks of study drug
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Larry A Fox, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03276182: Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery
Official title: Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including parameters of dry eye syndrome and MGD. Dry eye syndrome parameters included TBUT, Schirmer's test type I, Oxford staining score, and the Ocular Surface Disease Index (OSDI) Questionnaire. MGD parameters consisted of lipid layer thickness (LLT), lid margin abnormality, meibum quality, meibum expressibility, MG orifice obstruction, MGD stage, and MG dropout.


Eligibility criteria: Inclusion Criteria:

* Patients with cataract surgery planning with phacoemulsification and intraocular lens implantation with or without mild dry eye syndrome

Exclusion Criteria:

* the previous use of eye drops, except artificial tears within 3 months before cataract surgery
* a history of previous ocular surgery or trauma
* the presence of ocular comorbidities such as glaucoma, uveitis, cystoid macular edema, and any surgical complications including rupture of the posterior capsule during cataract surgery.

Primary outcomes:
measure: the change of parameters associated with dry eye syndrome
timeFrame: baseline and 1 month after POD(postoperative day)
measure: the change of parameters associated with meibomiangland dysfunction
timeFrame: baseline and 1 month after POD(postoperative day)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
References: