louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01981421: Usefulness of Multi-parametric, Quantitative MR Imaging for Staging of Hepatic Fibrosis in the Patients With Chronic Hepatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Fibrosis
Keywords: Liver fibrosis
Elastography
MR Elastography
Quantitative imaging
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have chronic liver disease and who are planned to receive anti-viral treatment.

Brief summary: Liver fibrosis has been considered as irreversible change. However, recent study showed that early stage liver fibrosis could be reversible and a lot of new drugs are now developing or developed including anti-viral treatment. Liver biopsy is considered as golden standard for the evaluation of liver fibrosis. But biopsy specimen through biopsy only consists of 1/50000 of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver fibrosis is still challenging. Furthermore, its invasive nature, repeated biopsy is practically almost impossible. Hence, non-invasive diagnosis of liver fibrosis is important. In this study we hypothesized that multi-parametric MR imaging including MR elastography, conventional DWI, and IVIM can predict changes of liver stiffness after anti-viral therapy in patients with chronic liver disease. We will enroll 60 biopsy-proven patients and perform multi-parametric MR imaging at the enrollment and one year later to evaluate changes in quantitative values in MR.


Eligibility criteria: Inclusion Criteria:

* Patients who had chronic hepatitis
* Patients who underwent liver biopsy within 6 months
* Patients older than 18 years old

Exclusion Criteria:

* patient who had pregnancy
* patient 18 or below 18 years old

Primary outcomes:
measure: Changes in quantitative values measured from Multi-parametric MRI before and after anti-viral treatment
timeFrame: 1 year after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Radiology, Yonsei University Health System
Study officials:
References:
Clinical trial NCT06059521: Software Refraction With Mobilerone Versus Retinoscopy
Official title: Randomized Controlled Study on Subjective Refraction by Software Eye Test Technology Versus Retinoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Myopia, Moderate
Astigmatism
Keywords: software
refraction
subjective refraction
mobilerone
myopia
astigmatism
Lead sponsor: Beijing Airdoc Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Notre Dame Australia
First posted: 2023-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Software refraction in the mobilerone for myopia and astigmatism is a novel medical device for myopia adults and elder children with or without astigmatism. And the investigators would like to test its accuracy and efficacy as well as safety.

Detailed description: It's a software installed in a mobilerone with subjective guide on screen for testing myopic refractive error with or without astigmatism for adults or elder children. The investigators would like to compare its refraction results with retinoscopy.

Eligibility criteria: Inclusion Criteria:

* • subject with ametropia on each eye ≤-12.00D

  * subject with best corrected visual acuity ≥ 20/25, no amblyopia
  * subject with normal transparency of eyes
  * subject with a healthy fundus that does not reveal major abnormalities that may affect vision due to the fluctuate situations
  * subject able to cooperate with the screen and the operator
  * subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
  * non-diabetic subject
  * non nystagmus subject
  * non-strabismus subject
  * subject who has not had eye surgery less than 1 year old

Exclusion Criteria:

* • subject with a topography showing an anomaly (keratoconus type or other)

  * subject with hyperopia or presbyopia
  * subject with mild myopia ≥ -1.00D
  * subject who cannot speak with the operator including those staff of local optometrists or ophthalmologists

Primary outcomes:
measure: Spherical Equivalence(D)
timeFrame: 1-day and within 2 weeks
measure: Astigmatism Power(D)
timeFrame: 1-day and within 2 weeks
measure: Astigmatism axial
timeFrame: 1-day and within 2 weeks
measure: pupil distance (mm)
timeFrame: 1-day and within 2 weeks
Secondary outcomes:
measure: Efficacy of test time (minutes)
timeFrame: 1-day and within 2 eeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Airdoc MPC Opthalmology Clinics
state: Beijing
city: Beijing
country: China
facility: Jenny QIU
state: Beijing
city: Beijing
country: China
facility: Qiu Jenny
state: Haidian District
Study officials:
References:
Clinical trial NCT04905121: Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Official title: An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3-[2-(Dimethylamino)Ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL-PSILO) on Cognition in Patients With Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Short Lasting Unilateral Neuralgiform Headache Attacks
Lead sponsor: Beckley Psytech Limited
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An exploratory open-label phase 1b, ascending dose study
Primary purpose: TREATMENT

Brief summary: This exploratory open-label phase 1b, ascending dose study is to evaluate the effects of psilocybin on cognition in patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

Detailed description: The study aims to:

Determine the safety and tolerability of psilocybin when administered to patients with chronic SUNHA

Determine the effects of psilocybin on cognition when administered to patients with chronic SUNHA

Explore the change in frequency, duration, and intensity of headache attacks with escalating doses of psilocybin in patients with chronic SUNHA

Eligibility criteria: Inclusion Criteria:

\* Diagnosed with chronic SUNHA

Exclusion Criteria:

\* Other comorbidities

Primary outcomes:
measure: Percentage of patients with treatment emergent AEs (TEAES)
timeFrame: From first dose administered through to the last follow up visit, approximately 39 days
measure: Treatment-related changes in Paired Associates Learning (PAL) scores and evaluation of dose response
timeFrame: From first dose administered until the las dose administered, approximately 11 days
measure: Treatment-related changes in Spatial Working Memory (SWM) scores and evaluation of dose response
timeFrame: From first dose administered until the las dose administered, approximately 11 days
measure: Treatment-related changes in Reaction Time Index (RTI) scores and evaluation of dose response
timeFrame: From first dose administered until the las dose administered, approximately 11 days
measure: Treatment-related changes in Rapid Visual Information Processing (RVP) scores and evaluation of dose response
timeFrame: From first dose administered until the las dose administered, approximately 11 days
measure: Change in frequency of headache attacks
timeFrame: From screening until the follow up visit, approximately 39 days
measure: Change in duration of headache attacks
timeFrame: From screening until the follow up visit, approximately 39 days
measure: Change in intensity of headache attacks
timeFrame: From screening until the follow up visit, approximately 39 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
Clinical trial NCT00148421: Study for the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.
Official title: A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Non-myeloid malignancy
Chemotherapy-induced anemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-09-08
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: Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Detailed description: The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Eligibility criteria: Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable / uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance

Primary outcomes:
measure: Reduced incidence of transfusions
Secondary outcomes:
measure: Change in hemoglobin concentration
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 20030125 Study Group Trial; Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol. 2006 May 20;24(15):2290-7. doi: 10.1200/JCO.2005.03.8570.
Clinical trial NCT04253821: Relationship Between Head Posture Muscles, Pulmonary Capacity and Functional Capacity: a Myotonometric Assessment
Official title: Relationship Between the Tonus, Stiffness, and Elasticity of Head Posture Muscles and Pulmonary Capacity and Functional Capacity: a Myotonometric Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forward Head Posture
Muscle Tone
Muscle Stiffnes
Muscle Elasticty
Vital Capacity
Keywords: forward head posture
muscle elasticity
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Forward head posture (FHP) is known to have a large influence on respiratory function by weakening the respiratory muscles. This cross-sectional study is designed to examine the relationship between the tonus, stiffness, and elasticity of head posture muscles and pulmonary capacity. Sixteen FHP individuals and seventeen NFHP individuals were evaluated. The muscle tonus, stiffness and elasticity of upper trapezius (UT), semispinalis capistis (SSC), pectoral muscles (PM) and sternocleidomastoideus muscles (SCM) were measured by using MyotonPro® device. Functional capacity was measured with six-minute walk test. Pulmonary function tests was evaluated with spirometer. The neck disability index (NDT) was applied. The forward head posture was determined by measurements of craniovertebral angle (CVA). Physical activity levels of participants were evaluated by Physical Activity Index (FIT).


Eligibility criteria: Inclusion Criteria:

- the participants do not have any known pulmonary, systemic and muscular system disease and, any neurological symptoms and neck pain that affects daily living activities.

Exclusion Criteria:

* have headache and dizziness
* steroid use or muscle relaxants

Primary outcomes:
measure: muscle tonus, stiffness and elasticity
timeFrame: 1 day
measure: six-minute walk test.
timeFrame: 1 day
measure: Vital Capacity
timeFrame: 1 day
measure: Forced Vital Capacity (FVC)
timeFrame: 1 day
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 1 day
measure: Peak Expiratory Flow (PEF)
timeFrame: 1 day
measure: The neck disability index
timeFrame: 1 day
measure: Physical Activity Index
timeFrame: 1 day
measure: Forward head posture assessment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu Universty
state: Şahinbey
Study officials:
References:
Clinical trial NCT01178164: Prevalence of Fabry's Disease in a Population of Patients With Chronic Pains
Official title: Prevalence of Fabry's Disease in a Population of Patients With Chronic Pains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fabry's Disease
Keywords: chronic pains
unknown aetiology
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 137
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Fabry disease (FD) is a rare X-linked multisytemic lysosomal disorder caused by alpha-galactosidase deficiency. Globotriaosylcéramide (Gb3) deposits are observed in almost all tissues examined. Signs of the disease appear earlier and are more severe in affected males than in females. Myocardiopathy, renal failure and neurological signs including chronic pain and peripheral neuropathies are the most frequent signs. The availability of two enzymatic replacement therapies now provides a specific and effective treatment for patients. The prevalence of FD is estimated between 1/40,000 and 1/117,000. The frequency of Fabry disease has previously been estimated in several series of patients presenting one single sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. However, no data are available about the prevalence of FD in populations of patients suffering from chronic pains of unknown origin.

The diagnosis of FD will be performed by standard procedures following international recommendations. These require the search for a deficiency of alphagalactosidase A activity on leucocytes in males and genetic analysis of the GLA gene in females (Lidove et al. 2007).

The patients in whom the diagnosis of FD is established during this study, will be call in for an additional visit in the Investigating Centre in order to confirm the diagnosis and propose suitable assessment and care.


Eligibility criteria: Inclusion Criteria:

* patients of both sex
* aged from 6 to 65
* with chronic pains of unknown aetiology including:
* acroparesthesias
* and/or pain crises evolving more than 3 months
* continued neuropathic evolving more than 3 months
* and/or multiple pains evolving more than 3 months
* and/or recurrent abdominal crises of pain who come for a clinical visit in the Centre Douleurs Chroniques in the CHU of Bordeaux.

Exclusion Criteria:

* chronic pain of known cause

Primary outcomes:
measure: Diagnosis of Fabry disease in one patient suffering from chronic pains
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux Cedex
country: France
facility: Centre Douleurs Chroniques, Hopital Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Virginie DOUSSET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441864: Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
Official title: Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Nightmare
Nightmare Disorder With Associated Other Sleep Disorder
REM Sleep Behavior Disorder
Keywords: Imagery Rehearsal Therapy
Cognitive Behavioral Therapy for Nightmares
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple baseline single case experimental design
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their romantic partners. All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their partners will attend 2 of those sessions with them.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease
* Age 18 or older
* Speak, read, and write English
* Live in the United States
* Nightmare frequency ≥3 times per week
* Disturbing Dream and Nightmare Severity Index score indicative of nightmare disorder
* Sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study
* Live with a romantic partner who is willing to participate in the study

Exclusion Criteria:

* Possible dementia
* Narcolepsy
* Posttraumatic stress disorder
* Previous behavioral treatment for nightmares
* Currently engaged in sleep- or trauma-focused psychotherapy
* Taking a medication that could cause RBD, if the medication was started prior to onset of RBD symptoms

Inclusion Criteria (Partners):

* Live with a romantic partner who meets all of the above criteria
* Age 18 or older
* Speak, read, and write English
* Live in the United States

Primary outcomes:
measure: Disturbing Dream and Nightmare Severity Index (DDNSI)
timeFrame: Baseline and posttreatment
measure: Nightmare frequency (sleep diary)
timeFrame: Baseline and posttreatment
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT05139264: Glucose, Activity, Diet, & Sleep Assessment Study
Official title: GLADS Study: Glucose, Activity, Diet, & Sleep Assessment Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolism Disorder, Glucose
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men and women willing to record food intake with their smartphone, complete online questionnaires, and wear body sensors to measure physical activity, sleep, and glucose.

Brief summary: GLADS is a cross-sectional, observational study assessing free-living diet, physical activity, sleep, and glucose profile over a 2-week period in healthy adult men and women.

Detailed description: Monitoring free-living lifestyle behaviors can provide important information on behavioral determinants of health. New technologies have improved accessibility of ambulatory assessment of diet, biomarkers, physical activity, and sleep. The study will assess the effects of free-living diet assessed by questionnaire and sleep and physical activity measured by actigraphy on interstitial glucose measured by continuous glucose monitoring in healthy adult men and women over a 2-week period.

Eligibility criteria: Inclusion Criteria:

* Age: 18-75 y old
* In possession of a smartphone
* English speaking
* Live in New York City metro area

Exclusion Criteria:

* Active food intake disorder

Primary outcomes:
measure: Glucose
timeFrame: 2 weeks
Secondary outcomes:
measure: Sleep duration
timeFrame: 2 weeks
measure: Sleep fragmentation
timeFrame: 2 weeks
measure: Diet composition
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Russ Berrie Medical Science Pavilion
state: New York
Study officials:
affiliation: Columbia University
name: Blandine Laferrere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00127621: Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients
Official title: Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Insufficiency
Keywords: ICU patients needing prolonged ventilatory support
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-08-08
Enrollment: 468
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: This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.


Eligibility criteria: Inclusion Criteria:

* Patients under ventilation support for at least 4 days
* Patients needing ventilatory support for \> 7 days
* Age \> 18 years
* Informed consent signed

Exclusion Criteria:

* Patients previously tracheotomised
* Major hemorrhagic risk
* Patients previously randomised in a trial

Primary outcomes:
measure: 28 days mortality
measure: cumulated incidence of nosocomial pneumonia between days 1 and 28
measure: number of ventilatory free days between days 1 and 28
Secondary outcomes:
measure: time in the ICU
measure: time on mechanical ventilation
measure: 60 days mortality
measure: number of septic episodes
measure: accidental extubation
measure: amount of sedation
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: François BLOT, Dr
role: PRINCIPAL_INVESTIGATOR
References: