louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02799836: The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
Official title: The Effect of Light Deprivation on Visual Functions in Adult Amblyopes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amblyopia
Anisometropia
Visual Impairment
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Amblyopia is a significant health problem, affecting up to 4% of the population in the United States. Amblyopia, commonly known as "lazy eye," is a developmental visual disorder in which one or both eyes suffer from poor vision as a result of being disadvantaged in early life. Strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering eyes (exotropia), and anisometropia, or a power difference between the eyes, are the most common causes of amblyopia. If conventional treatment, such as patching the better seeing eye, is not initiated during the critical period of visual development, lasting visual impairment may persist throughout life. This critical period of visual development has been thought to end around age 10. However, recent research has demonstrated that the critical period of visual development can be extended into adulthood. Complete light deprivation in animal models has restored plasticity in the visual cortex and has demonstrated drastic recovery of vision in amblyopic eyes. The objective of this pilot study is to evaluate the impact of complete light deprivation on visual function in a cohort of human adults with severe amblyopia from anisometropia.


Eligibility criteria: Inclusion Criteria:

* Amblyopia, defined as decreased vision, less than or equal to 20/100, in one eye secondary to anisometropia
* Age 18-50 years

Exclusion Criteria:

* Strabismus
* Eye pathology, such as cataract, corneal disorder, maculopathy, glaucoma,
* Mental health diagnosis, such as depression, schizophrenia, bipolar disorder or anxiety disorder

Primary outcomes:
measure: Logmar visual acuity
timeFrame: Measured at 60 minutes after blindfold is removed
measure: Logmar visual acuity
timeFrame: Measured at one week after blindfold is removed
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01858636: Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Closure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that will be included in the study will be indicated for the procedure according to the Instructions for Use. Physicians should carefully select patients based on the IFU including a consideration of all warnings and precautions.

Brief summary: To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.


Eligibility criteria: Inclusion Criteria:

* Patient requires closure of femoral artery puncture resulting from arterial access procedure.
* Patient is ≥18 years of age.
* Patient is willing to provide written informed consent prior to study device use.
* Patient is willing and able to adhere to data collection and follow-up requirements.

Exclusion Criteria:

* Patient is participating in another clinical trial which has the potential to impact hemostasis.
* Patient has an active groin infection or systemic infection.
* Patient has undergone a vascular access procedure within the past 90 days.
* Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)

Primary outcomes:
measure: The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication
timeFrame: 30 days post procedure
measure: The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.
timeFrame: within 5 minutes of device deployment
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Frankfurt
country: Germany
facility: Institut für Diagnostiche und Interventionelle Radiologie
city: Homburg
country: Germany
facility: Univ. des Saarlandes
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GMBH
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
Study officials:
References:
Clinical trial NCT05796336: Two Methods of Lip Taping as a Presurgical Orthopedic Appliance
Official title: Effectiveness of Two Methods of Lip Taping as a Presurgical Orthopedic in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial to compare the effectiveness of two methods of lip taping as a presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

Detailed description: It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Eligibility criteria: Inclusion Criteria:

1. Non-Syndromic infants with complete bilateral cleft lip and palate.
2. Both sexes.
3. Age range from 1-30 day

Exclusion Criteria:

1. Infants with systemic syndromes.
2. infants with unilateral cleft
3. infants whom parents refuse to consent.

Primary outcomes:
measure: Assessment of maxillary arch dimension change
timeFrame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Secondary outcomes:
measure: Assessment of Linear measurement change
timeFrame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
measure: Assessment of Angular measurement change
timeFrame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
measure: Assessment of Parents Perception and experience
timeFrame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry
state: Al-Rusaffa
Study officials:
References:
Clinical trial NCT05137249: The Glycocalyx in COVID-19 Patients. A Pilot Study
Official title: The Glycocalyx in COVID-19 Patients. A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Endothelial Dysfunction
Coagulation Disorder
Keywords: glycocalyx, covid-19, ards, icu, coagulation,
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 30
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 diagnosed and hospitalized with COVID 19 due to clinical symptoms.

Brief summary: The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS. We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.

Detailed description: The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS. We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.Circulating plasma syndecan-1 is measured as surrogat parameter for the extent of the glycocalyx damage.

Eligibility criteria: Inclusion Criteria:

* COVID-19 detected by PCR measures going along with clinical symptoms
* age \> 18 years

Exclusion Criteria:

* refusal of study participation

Primary outcomes:
measure: extent of endothelial damage
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of Anesthesia, Intensive Care Medicine and Pain Medicine
name: Judith Schiefer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00244049: CHIPs or College Health Intervention Projects
Official title: "Primary Care Alcohol Intervention in College Students"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Abuse
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-10-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The goal of the study is to test the efficacy of brief clinician advice in reducing the frequency of high-risk drinking and alcohol-related harm in a population of college students seeking care at five university health care clinics. High-risk drinking is defined as 1) 8 or more episodes of heavy drinking (5 or more drinks in a row) in the past 28 days for male and female students, and/or 2) 50 drinks for male and 40 drinks for female students in the past 28 days, and/or 3) 15 drinks for male and 12 drinks for female students in the past 7 days, and/or 4) One or more episode(s) of heavy drinking which includes 15 or more drinks in a row.


Eligibility criteria: Inclusion Criteria:

* subjects who screen positive for high risk drinking on the Health Screening Survey (HSS) and Baseline interview

Exclusion Criteria:

* Students who will be leaving campus due to graduation or for an extended absence prior to the first face to face intervention Female students who are pregnant at the time of randomization Students who are currently suicidal at the time of the baseline interview Students under 18 years of age Students who drink more than 200 drinks in 28 days (referred for treatment).

Primary outcomes:
measure: Reduction in binge/high-risk drinking in college-aged students.
timeFrame: 6-months
Secondary outcomes:
measure: c) fr. of accidents, d) fr. of campus vandalism and interaction police; e) academic perf; f) fr. of unwanted sex; g) fr. of high-risk sex; h) fr. of physical altercations i) ER visits and hospital days; and j) cost vs. benefit of the intervention.
timeFrame: 6-months
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Fleming, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05211349: Comparison of Dual-Task Timed Up and Go Test (Cognitive) and 3-m Backwards Walk Test
Official title: Psychometric Evaluation of Dual-Task Timed Get Up and Go Test (Cognitive) and 3-m Backwards Back Test in Community-dwelling Stroke Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
Falling
Reliability and Validity
Postural Balance
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the participants will consist of stroke individuals who receive inpatient or outpatient treatment in the Physical Therapy and Rehabilitation Polyclinic. All assessments will be done face to face. Men and women aged 50-85 years who have had a stroke for at least 6 months will be included in the study.

Brief summary: Two balance assessment tools that have been used recently have attracted considerable attention: the Dual-Task Timed Up and Go Test (cognitive) (DTUG) and the 3-m Backward Walk Test (3MBWT). The aim of this study is to compare the psychometric properties of two clinically proven balance assessment tools.

Detailed description: There are unidimensional and multidimensional scales used to evaluate gait balance after stroke. Unidimensional scales (DTUG, 3MBWT) can be useful in clinical practice and in screening for basic balance problems. Two balance assessment tools that have been used recently have attracted considerable attention: the Dual-Task Timed Up and Go Test (cognitive) (DTUG) and the 3-m Backward Walk Test (3MBWT). The aim of this study is to compare the psychometric properties of two clinically proven balance assessment tools. In the study, construct validity, concurrent validity, reliability, and cut-off score (for determining falling risk) of the two tests will be calculated.

Eligibility criteria: Inclusion Criteria:

* Single stroke with unilateral hemiparesis at least 6 months prior to the study,
* Be in the age range of 50-85 years
* Able to walk at least 10 meters independently with or without a walking aid,
* Getting at least 24 points from the Standardized Mini-Mental Test
* It is to be able to follow two-stage commands and perform subtraction.

Exclusion Criteria:

* Presence of additional orthopedic or neurological diseases that may affect balance and walking,
* Having uncorrected vision and hearing problems

Primary outcomes:
measure: Dual-Task Timed Up and Go Test (cognitive)
timeFrame: 5 minutes
measure: 3-m Backward Walk Test
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Science University
Study officials:
affiliation: AFSU
name: EMEL TAŞVURAN HORATA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926549: Ocular Imaging With Spectral Domain Optical Coherence Tomography
Official title: Posterior and Anterior Ocular Imaging With Spectral Domain Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Myopia
Hypermetropia
Keywords: spectral domain-OCT
macular thickness
myopia
hypermetropia
normal
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to analyze macular retinal thickness and macular volume using the spectral domain - optical coherence tomography (SD-OCT) in normal eyes and in eyes with various ocular diseases.

Detailed description: Assessment of macular thickness is important for the treatment and follow-up of a variety of ocular diseases. The introduction of optical coherence tomography (OCT) has enabled clinicians to reliably detect small changes in macular thickness and to quantitatively evaluate the efficacy of different therapeutic modalities. In this study using the spectral domain-OCT, we examined the variations of macular retinal thickness and macular volume in normal eyes and in eyes with various ocular diseases.

Eligibility criteria: Inclusion Criteria:

* normal eyes
* myopic eyes
* hypermetropic eyes

Exclusion Criteria:

* systemic illness
* cataract
* previous ocular trauma or surgery(other than cataract surgery or refractive surgeries)

Primary outcomes:
measure: macular retinal thickness and volume
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Gangnam Severance Hospital
Study officials:
affiliation: Department of Ophthalmology, Yonsei University College of Medicine, Gangnam Severance Hospital
name: Sung Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05458349: Acellular Dermis in Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Keywords: rotator cuff
shoulder
surgery
acellular dermal graft
acellular dermis
rotator cuff augmentation
Lead sponsor: The Royal Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a Level 1 study, a prospective double blind, randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient

Detailed description: Rotator cuff healing poses a significant clinical problem with re-tear rates between 20-50%. The final functional outcome following surgery correlates with healing, with those that completely heal performing best. Failure of repair is mainly due to tendon failure both mechanically and biologically. If the healing and the structural properties of the tendon can be improved then significant functional gains may be achieved. This study will therefore utilise acellular dermal grafts to determine whether they could be used for to improve patient outcomes following surgery

Eligibility criteria: Inclusion Criteria:

1. Symptomatic rotator cuff tear that warrants operative intervention.
2. A Tear measuring between 1-5cm at arthroscopy.
3. An arthroscopic rotator cuff repair.
4. Written consent.

Exclusion Criteria:

1. Rotator cuff tears greater than 5cm and less than 1cm
2. Clinical or radiological evidence of osteoarthritis affecting the index side.
3. Patients involved in a Compensation claim related to the shoulder.
4. Inability to attend follow-up for 1 year and to a repeat MRI scan.
5. Previous shoulder surgery or proximal humeral fracture on the index side.
6. Patients that are recruited in a current study

Primary outcomes:
measure: rotator cuff healing
timeFrame: 12 month post-surgery
Secondary outcomes:
measure: Western Ontario Rotator cuff score
timeFrame: 12months
measure: Constant Murley score
timeFrame: 12 months
measure: American shoulder and elbow surgeons standardized form
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital NHS Trust
Study officials:
affiliation: The Royal Orthopaedic Hospital NHS Foundation Trust
name: Martyn Mr Snow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02925949: Duo Partnership Adherence Commitment Therapy
Official title: A Couples-based Approach to Improving Engagement in HIV Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Treatment
Adherence
Intervention
Sexual and Gender Minority Couples
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-10-06
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized controlled trial of a new behavioral intervention designed to improve engagement in HIV care for couples. Investigators will compare the HIV viral load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to an individual adherence intervention (LifeSteps).

Detailed description: The investigators will test the intervention to improve HIV care engagement by enrolling 150 sexual or gender minority couples and randomizing 75 couples each to one of two conditions: 1) DuoPACT, a newly-developed couples intervention; or 2) LifeSteps, a standardized antiretroviral adherence intervention for HIV+ individuals. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention effects via behavioral indicators of engagement in HIV care, the couple's relationship dynamics, and the primary outcome of HIV viral load.

Eligibility criteria: Inclusion Criteria:

1. 18+ years old;
2. Identifies as a sexual or gender minority;
3. In a primary romantic relationship for at least 3 months;
4. At least one partner is HIV+;
5. English-speaking;
6. Able to provide informed consent; and
7. For HIV+ participants: Evidence of suboptimal engagement in HIV care.

Exclusion Criteria:

1. Must be able to consent to and follow study protocol;
2. Evidence of severe cognitive impairment or active psychosis;
3. Lives outside California or plans to relocate from the state of California in the next 6 months; or
4. Participation in the DuoPACT pilot.

Primary outcomes:
measure: Change from Baseline HIV viral load at 3, 6 and 9 months
timeFrame: 3, 6 and 9 months
Secondary outcomes:
measure: Change from Baseline behavioral indicators of engagement in HIV care at 3, 6 and 9 months
timeFrame: 3, 6 and 9 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Center for AIDS Prevention Studies
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mallory O. Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tabrisky AP, Coffin LS, Olem DP, Neilands TB, Johnson MO. Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 22;11(3):e037468. doi: 10.1136/bmjopen-2020-037468.