louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04988451: Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of ASL
Official title: Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of American Sign Language (ASL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deafness
Hearing Loss
Keywords: language
sign language
language development
child language
child, preschool
parents
caregivers
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Design - interrupted time series. Participants will receive intervention in 6-week on/off blocks. Measurements are taken in both on and off weeks.

The Bayesian procedure developed by Swaminathan et al. (2014) involves fitting piece-wise linear or curvilinear trends across the phases, modeling dependencies in the observations with a suitably chosen autoregressive error scheme, and using the Markov Chain Monte Carlo (MCMC) method to obtain the posterior distributions of the model parameters and effect size measures
Primary purpose: TREATMENT

Brief summary: This study examines the development of American Sign Language by deaf and hard of hearing (DHH) children and their parents.

Detailed description: After being informed about the study and potential risks, adult participants who give written informed consent and children whose parents who give written permission will be enrolled in the study. They will participate in preliminary language tasks to assess baseline performance on American Sign Language (ASL) measures. Subsequently they will have weekly sessions with an ASL Specialist to support their development of ASL, following a 6-week on/6-week off ABABABAB sequence.

Eligibility criteria: Inclusion Criteria:

Children:

* Children ages 2;00 - 2;11 at the start of the longitudinal project
* Child is Deaf/ Hard-of-Hearing
* Participating in a program utilizing a bimodal bilingual philosophy

Adults:

- One adult caregiver for each child

Exclusion Criteria:

* Children with previously-diagnosed conditions other than deafness known to affect language and cognitive development
* Families without access to internet (at home or other locations)

Primary outcomes:
measure: Change from Baseline in ASL Phonological Production Accuracy over 12 Months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from Baseline in ASL Production Frequency over 12 Months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut - Department of Linguistics
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Diane C Lillo-Martin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05888051: Assessment of Lower Extremity Isokinetic Muscle Strength and Balance in Individuals With Chronic Low Back Pain
Official title: Assessment of Lower Extremity Isokinetic Muscle Strength and Balance in Individuals With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Keywords: balance
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants; Questions will be asked in total, including information such as age, gender, height, weight, dominant hand.

Brief summary: Low back pain is one of the common problems that 80% of people experience at least once in their lifetime. Between 60% and 90% of the adult population are at risk for low back pain at some point in their lives. While most resolve within six weeks, relapses are common. Pain that lasts longer than 12 weeks is defined as chronic pain, and causes significant limitation in daily life and a high psychosocial burden due to pain. Chronic low back pain significantly limits occupational activities due to a decrease in functional status.

Detailed description: Although chronic low back pain is a problem locally related to the lumbar and sacroiliac joints, it is also affected by changes in the joint and muscle structure of the lower extremity or affects these structures biomechanically. It has been shown that the endurance of the gluteus maximus muscle and the flexibility of the knee and hip flexors are decreased in individuals with chronic low back pain. Studies investigating knee extensor muscle strength in individuals with low back pain in the literature have shown that the maximum voluntary contraction of the knee extensors and the isokinetic strength of the knee extensors are decreased.

Eligibility criteria: Inclusion criteria;

* Being between the ages of 18 - 65,
* Volunteer. Exclusion criteria;
* Having a musculoskeletal or neuromuscular disease that limits mobility,
* Presence of lower extremity sequelae,
* Having undergone surgery on the Lumbar Region, having a history of systemic, inflammatory or cancer
* Participants of both genders will be included in the study.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: one day
measure: Lower Extremity Muscle Strength
timeFrame: one day
measure: Balance
timeFrame: one day
measure: Disability
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: HAZAL genç
state: None Selected
Study officials:
References:
citation: Kim DH, Kim TH. Comparison of the effects of stability exercise and balance exercise on muscle activity in female patients with chronic low back pain. J Exerc Rehabil. 2018 Dec 27;14(6):1053-1058. doi: 10.12965/jer.1836438.219. eCollection 2018 Dec.
Clinical trial NCT01776151: Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
Official title: Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
HIV
Keywords: HIV
cardiovascular diseases
vascular stiffness
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ \> 500 cells/mL randomized to the START trial.

Brief summary: The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.


Eligibility criteria: Inclusion Criteria:

* Simultaneous co-enrollment in the START study
* Signed informed consent

Exclusion Criteria:

* Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation

Primary outcomes:
measure: Change from baseline in large artery elasticity (LAE
timeFrame: baseline, Months 1, 4, 8, 12, annually thereafter
measure: Change from baseline in small artery elasticity (SAE)
timeFrame: baseline, Months 1, 4, 8, 12, annually thereafter
Secondary outcomes:
measure: Changes in plasma markers of thrombosis and fibrinolysis
timeFrame: baseline, months 4, 8, 12, annually thereafter
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: University of Minnesota
name: Jason V Baker, MD
role: STUDY_CHAIR
affiliation: University of Minnesota
name: Daniel Duprez, MD, PhD
role: STUDY_CHAIR
References:
citation: Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):109-18. doi: 10.1111/hiv.12239.
Clinical trial NCT00223951: Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis
Keywords: Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 900
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers


Eligibility criteria: Inclusion Criteria:

healthy normal volunteers age \>=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better

-

Exclusion Criteria:

intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female \< 18 years of age -

Primary outcomes:
measure: Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination
Secondary outcomes:
measure: No additional endpoints
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Bel Air
country: United States
state: Maryland
city: North Andover
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: Charlotte
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Ophthalmic Research Associates, North Andover, MA
name: Jack V Greiner, OD, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01672151: Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia
Official title: Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenic Purpura
Keywords: Refractory Immune Thrombocytopenic Purpura
rapamycin
regulatory T cells
Lead sponsor: First Affiliated Hospital of Suzhou Medical College
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 35 patients using rapamycin therapy were observed before and after treatment,who did not response to any other administrations including prednisone and immunosuppressive drugs, even splenectomy .

Brief summary: The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism.

Detailed description: Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and autoimmune diseases. Many studies have shown that the drug contributes to the expansion of regulatory T cells and preserves the highly suppressive function of autoreactive T cells. Patients with RITP often display a decreased proportion of regulatory T cells by flow cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnoses of idiopathic thrombocytopenic purpura
* Hormone and immune suppression, splenectomy is invalid

Exclusion Criteria:

* patients had a bad tolerance to rapamycin
* platelet counts \< 10\*10E9/L during the treatment of rapamycin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Jiangsu Institute of Hematology
state: Jiangsu
Study officials:
name: zhaoyue wang, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00966251: Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
Official title: Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Primary Hepatocellular Carcinoma
Keywords: Primary Hepatocellular Carcinoma
Lead sponsor: CureTech Ltd
Sponsor class: INDUSTRY
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2009-08-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged 18 years and above, both genders.
2. Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
3. No fibrolamellar subtype HCC
4. Not eligible for any other systemic anti-neoplastic treatment approved for HCC
5. Not eligible for Transarterial chemoembolization (TACE ).
6. No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.
7. Not a candidate for curative surgical resection or liver transplantation
8. Measurable disease defined by the identification at least 1 measurable lesion by MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging post-procedure to be considered measurable disease.
9. Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)
10. Child's Pugh classification A
11. ECOG performance status 0-1

Exclusion Criteria:

1. Patients progressing to liver failure.
2. No core biopsy within the past 7 days
3. Patients who are eligible for Transarterial Chemoembolization (TACE)
4. Patients on concurrent anti-neoplastic therapy (including interferon)
5. Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.
6. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
7. Presence of metastasis.

Primary outcomes:
measure: To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Yaron Ilan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02485951: Central Versus Peripheral Air Injection for DALK (Deep Anterior Lamellar Keratoplasty)
Official title: Big-bubble Deep Anterior Lamellar Keratoplasty: Central Versus Peripheral Air Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: deep anterior lamellar keratoplasty
big-bubble technique
peripheral air injection
keratoconus
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to create a uniform recipient bed, thereby reducing complications, such as interface irregularity and opacification encountered with conventional lamellar keratoplasty. The big-bubble technique provides a planned, safe, quick and consistent baring of Descemet membrane (DM) by injection of air deep into the stroma. Nevertheless, this technique has a long learning curve with a low success rate of big-bubble formation and a high rate of DM perforation when performed by surgeons in training. Different modifications to the original technique using intraoperative instruments such as corneal pachymetry, anterior segment optical coherence tomography (OCT), and femtosecond laser, have been used to increase the chances of achieving a successful DM detachment from the deep stroma by air injection. Even with these innovations, the rate of successful big-bubble formation did not reach 100%. Recently, the investigators described a modification to the original big-bubble DALK in which a 27-gauge needle was inserted into the stroma peripherally from the trephination site towards the limbus. The investigators found that air injection peripheral to the trephination can effectively and reproducibly separate the corneal stroma from the Descemet membrane (DM). This study was aimed to compare the success rate and complications of big-bubble DALK using central versus peripheral air injection performed by senior cornea fellows under the supervision of an experienced faculty member in an academic hospital.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate (48 D \< mean keratometry \< 55 D) to advanced (mean keratometry ≥ 55 D or immeasurable keratometry) keratoconus were enrolled.

Exclusion Criteria:

* History of ocular surgery, concomitant ocular pathologies, such as vernal keratoconjunctivitis, cataract, glaucoma, and retinal abnormalities.

Primary outcomes:
measure: The rate of successful big-bubble formation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT01180751: 18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
Official title: 18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Tumors
Keywords: Positron Emission Tomography
Fluorodeoxyglucose
FDG (18F-Fluorodeoxyglucose)
Oncology
Neurology
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Winnipeg Regional Health Authority
First posted: 2010-08-12
Enrollment: 1000
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: This clinical trial is being conducted to study the use of a radioactive glucose tracer as an imaging test \[Positron Emission Tomography (PET)scan\] in adults who have or are suspected of having cancer and in another group of adults to assess for neurologic conditions.


Eligibility criteria: Inclusion Criteria:

* Known or suspected primary or metastatic tumours
* A neurological presentation consistent with the list of indications
* 18 years of age or older of either sex
* Able to provide written informed consent
* Able to tolerate the physical and logistical requirements of completing a Positron Emission Tomography (PET)scan
* Karnofsky score \> 60
* Women who are nursing may be included in the study if they are able to discontinue breast feeding for 12 hours

Exclusion Criteria:

* Age \<18 years
* Pregnant women; if there is a possibility of pregnancy, bloodwork will be drawn to definitively establish pregnancy status
* Women who are unwilling or unable to discontinue breast feeding for 12 hours post 18F-Fluorodeoxyglucose(FDG) administration
* Subjects who are medically unstable
* Subjects unwilling to provide informed consent.
* Subjects who exceed the safe weight limit of the Positron Emission Tomography (PET) imaging bed or who cannot fit through the PET scanner bore

Primary outcomes:
measure: To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Great West Life PET/CT Centre
state: Manitoba
Study officials:
affiliation: Winnipeg Regional Health Authority
name: Daniel P Levin, BSc,MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04623151: Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
Official title: Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Health Behavior
Foot Diseases
Keywords: Foot care
narrative
diabetes
health behaviour
health psychology
Lead sponsor: University of Chichester
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Online leaflet about foot care in a narrative format
2. Online leaflet about foot care in a non-narrative format
3. No leaflet (control)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study explores the role of health messages (narrative, non-narrative vs. control condition \[no message\]) to enhance good foot care practices among people with diabetes and the general population.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age at the time of consent;
* able to read and speak the English language;
* able and willing to give written informed consent prior to study entry;
* able to complete the protocol requirements

Exclusion Criteria:

* has a cognitive impairment or acute psychopathology (self-reported formal diagnoses of down syndrome, traumatic brain injury, brain tumour, autism, dementia, schizophrenia, and/or schizoaffective disorder), ie that which could interfere with his or her ability to provide written consent and complete the study
* has taken part in any other research on foot care with the University of Chichester in the past year

Primary outcomes:
measure: 5-item Foot Care Detection Behaviour Scale
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Chichester
country: United Kingdom
facility: University of Chichester
state: West Sussex
Study officials:
affiliation: University of Chichester
name: Susan Churchill, PhD
role: STUDY_DIRECTOR
References: