louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02769130: Pilot Trial: the Safety and Feasibility of Losartan for Pulmonary Vein Stenosis
Official title: Pilot Trial: the Safety and Feasibility of Losartan Therapy for Treatment of Pulmonary Vein Stenosis in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Pulmonary Vein Stenosis
Children
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.

It is an open label single arm interventional study. The patient population involves pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given losartan for 1 year. Outcomes include measures of safety/adverse events and progression of pulmonary vein stenosis.

Detailed description: This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis.

Large animal studies have demonstrated that losartan can ameliorate the progression of pulmonary vein stenosis in a surgical model of pulmonary vein stenosis.

There is no safety data for losartan in children \< 6months of age or in children with pulmonary vein stenosis. Therefore, this study will test the safety and feasibility of losartan in children in an open label single arm interventional study.

Patient inclusion criteria includes stenosis involving 2 or more pulmonary veins. Patients who are consented into the trial with be on losartan therapy for one year. They will undergo study visits every 3 months. Patients will be screened for adverse events through biochemical tests, routine clinical tests and questionnaires.

An exploratory efficacy analysis will compare progression of pulmonary vein stenosis in children enrolled in losartan to a contemporary cohort of children with pulmonary vein stenosis, who did not receive losartan.

Eligibility criteria: Inclusion Criteria:

* Stenosis involving 2 or more pulmonary veins
* Consent of parent/legal guardian or child(when appropriate)

Exclusion Criteria:

* History of angioedema or allergic reaction to angiotensin converting enzyme inhibitors
* corrected gestational age of less than 40 weeks
* severe renal dysfunction
* pregnancy

Primary outcomes:
measure: Safety:Number of participants with adverse events
timeFrame: 12 months
measure: Feasibility:Number of participants eligible and recruited
timeFrame: 12 months
Secondary outcomes:
measure: Progression of pulmonary vein stenosis: survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Christopher A Caldarone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05447130: Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome
Official title: Corneal Endothelial Evaluation After Phacoemulsification in Eyes With Pseudoexfoliation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Endothelial Cell Loss
Pseudoexfoliation Syndrome
Keywords: corneal endothelial cell loss, pseudoexfoliation syndrome , cataract
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To study corneal endothelial cells changes after phacoemulsification in patients with senile cataract and pseudoexfoliation syndrome (PEX) compared with control patients with senile cataract using specular microscope.

Detailed description: In a prospective interventional case-control study, 20 eyes with cataract and PEX and 20 control eyes with cataract without PXE were subjected to phacoemulsification and posterior chamber foldable intraocular lens implantation in Minia University Hospital and Genaidy Eye Center between March 2019 and December 2020. Specular microscopy was done preoperatively, 3 and 6 months postoperatively. Endothelium cell density (ECD), coefficient variation (CV), hexagonality, pleomorphism and corneal thickness were evaluated and compares between PXE and control eyes.

Eligibility criteria: Inclusion Criteria:

* senile cataract age more than 55 years

Exclusion Criteria:

* PEX with glaucoma, eyes with cornea guttata or any corneal dystrophy, zonular dehiscence, very dense nuclear cataract (cataracta nigra) history of previous ocular surgery.

Primary outcomes:
measure: corneal endothelial cell loss
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University Hospital
state: Minia
Study officials:
References:
Clinical trial NCT03182530: Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization
Official title: Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization. Randomized Duplex Follow-up Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CARDIAC CATHETRIZATION
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 600
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: Data from literature: transradial access failure sometimes occurs due to inability to cannulate the radial artery due to radial artery spasm1 causing severe difficulties in manipulation of the guide wires and catheters along the tortuous pathways of the arteries. both mechanical stimuli and circulating catecholamines through activation of α1-adrenoreceptors, causing smooth muscle cell contraction \& radial artery spasm


Eligibility criteria: Inclusion Criteria:

* Normal radial artery and of size ≥ 2mm by duplex.
* Normal ulnar artery by duplex.

Exclusion Criteria:

* Pre-procedural duplex detection of radial artery anomalies as hypoplasia, tortousity, severe calcification or radial artery diameter \< 2 mm.
* Severe renal failure (creatinine clearance \< 30 ml/min).
* Known peripheral vascular disease.
* Emergency procedures.
* Failure to successfully cannulate the radial artery was also a criterion for exclusion.
* Patients on warfarin therapy.

Primary outcomes:
measure: The percentage of occurrence of radial artery occlusion
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Tarek nagib, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04239430: Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study
Official title: Evaluation of the Immunogenicity of Meningococcal B (4CMenB) and Meningococcal ACWY (MenACWY Conjugate) Vaccination in a Population With HIV at 18 and 30 Months After Two Doses of Vaccine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS
Meningococcal Disease
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: Public Health England
First posted: 2020-01-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is the same as for the original Propositive study. This study will follow up the same cohort of participants.

Brief summary: The need for and timing of booster doses of meningococcal vaccines in People Living with HIV (PLWHIV) is currently unknown. As such it is impossible for clinicians to recommend booster doses or to know if and when these might be necessary.We propose to follow up a group of participants from the Propositive study who received two doses of both MenB (Bexsero) and MenACWY (Menveo). This was a group of PLWHIV between the ages 18-45 years. We propose following up these participants at 18 and 30 months post completion of two doses of vaccine and investigating their immunological response.


Eligibility criteria: Inclusion Criteria:

* Received vaccination with Bexsero and Menveo during Propositive study
* Able to sign fully informed consent
* Able to comply with study requirements

Exclusion Criteria:

• Unwilling or unable to comply with study requirements

Primary outcomes:
measure: Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo)
timeFrame: The 18 month blood test is taken 548 days (+/-60 days) from completion of vaccination during the Propositive study and the 30 month blood test is taken 912 days (+/- 60 days) after completion of vaccination
Secondary outcomes:
measure: Serum bactericidal Assay responses against relevant MenACWY strains at 18 and 30 months post two doses Menveo (administered concomitantly with Bexsero)
timeFrame: The 18 month blood test is taken 548 days (+/-60 days) from completion of vaccination during the Propositive study and the 30 month blood test is taken 912 days (+/- 60 days) after completion of vaccination
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's University of London
Study officials:
References:
Clinical trial NCT05246930: Evaluating the Use of a Device Called Impulse Oscillometry in Participants With Vocal Cord Disorders or Asthma
Official title: The Study of Impulse Oscillometry in Inducible Laryngeal Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breathing, Mouth
Lung Function Decreased
Vocal Cord Dysfunction
Laryngeal Obstruction
Asthma
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to one hundred (100) human subjects will be recruited from the following University of Rochester locations: Mary Parkes Center for Asthma, Allergy, and Pulmonary Care, the Pulmonary Clinic at Strong Memorial Hospital, and The Voice Center, an Otolaryngology Clinic at Clinton Woods.

Brief summary: This study will determine if airway resistance to airflow and pressure, measured by Impulse Oscillometry, is impacted in subjects with vocal cord disorders and whether these measurements are different when compared to subjects with asthma.


Eligibility criteria: Inclusion Criteria:

* Vaccinated against COVID-19 or testing negative for COVID-19 by viral PCT within 5 days before testing
* Willingness to perform breathing test
* Must be able to speak and understand English
* Documented diagnosis of asthma, documented clinical diagnosis of vocal cord dysfunction, or undergoing evaluation for vocal cord dysfunction

Exclusion Criteria:

* Unable to provide consent or perform oscillometry test

Primary outcomes:
measure: Mean respiratory system impedance
timeFrame: Single measurement, approximately day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mary Parkes Asthma and Allergy Center
state: New York
Study officials:
References:
Clinical trial NCT02767830: Cleveland Kids Run
Official title: Adherence to a Running and Nutrition Program in Children Aged 8-12 Years: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A 12 month long program focused on making good food choices and exercise directed at 8-12 year olds and their caregivers. The program will consist of monthly educational meetings each teaching a new nutritional and exercise concept. Children will be given weekly exercise schedules and their adherence to the program will be assessed. The study will culminate with an annual children's race in May.


Eligibility criteria: Inclusion Criteria:

* Participants must be aged 8-12 years old and enrolled in kindergarten through 6th grade in a Cleveland Public School
* Participants must have at least a B-average or equivalent in the prior academic year
* Participants must have at least one part or guardian who is able to accompany the participant during exercise and educational sessions
* Participants must be willing to participate in the Rite Aid Cleveland Marathon Ringling Bros. and Barnum \& Bailey Red Nose Run® at the end of the study

Exclusion Criteria:

* Children who are younger than 8 years or older than 12 years

  * Children whose parents who are unable or unwilling to provide informed consent,
  * Children whose parents are are illiterate or non-English speaking or reading
  * Children whose parents are unable or unwilling to accompany them to educational and exercise sessions
  * Children with a medical condition that prevents them from unmonitored exercise
  * Children who have not maintained an equivalent of a B-average in the prior academic year

Primary outcomes:
measure: Adherence to program
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01310530: Partial Breast Proton Therapy for Early Stage Breast Cancer
Official title: Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Partial Breast
Proton Beam
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.

Detailed description: Radiation therapy delivered to the whole breast is standard treatment following tumor removal for patients with early stage breast cancer. In selected patients, delivering the radiation treatment to only the part of the breast involved by the tumor may be a viable alternative. This can decrease the amount of normal tissues exposed to irradiation, potentially decrease side-effects and shorten the treatment time. Proton beam can decrease the volume of normal tissues treated compared to standard forms of radiotherapy. This study will recruit patients with early stage breast cancer following surgical removal to undergo partial breast radiotherapy with proton beam and determine the recurrence rates and side-effects of treatment.

Eligibility criteria: Inclusion Criteria:

* Breast carcinoma
* DCIS
* Age 40 years or higher
* Primary tumor 3 cm or less
* Lumpectomy with clip placement
* Axillary node sampling
* Negative margins

Exclusion Criteria:

* Distant metastasis
* Multicentric disease
* Prior radiation or chemotherapy
* Active collagen vascular disease
* Pregnant or lactating
* BRCA mutation
* Lymph nodes with more than microscopic tumor involvement

Primary outcomes:
measure: Rate of recurrence in the breast
timeFrame: 5 years
Secondary outcomes:
measure: Rate of breast recurrence of low versus intermediate risk patients
timeFrame: 5 years
measure: Side-effects related to treatment
timeFrame: 5 years
measure: Disease Free Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Radiation Medicine - Loma Linda University Medical Center
name: David A Bush, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bush DA, Slater JD, Garberoglio C, Yuh G, Hocko JM, Slater JM. A technique of partial breast irradiation utilizing proton beam radiotherapy: comparison with conformal x-ray therapy. Cancer J. 2007 Mar-Apr;13(2):114-8. doi: 10.1097/PPO.0b013e318046354b.
Clinical trial NCT02671630: Computerized Cognitive Training Program for Older Persons With Mild Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Cognitive function
Depression
Quality of life
Community-based computerized cognitive training program
Randomized controlled trial
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Little is known about the effects of computerized cognitive training programs on mild dementia patients' health. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.

Detailed description: Little is known about the effects of computerized cognitive training programs on mild dementia patients' health. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.However, most of these studies were not randomized controlled trial and the samples of these studies were mostly healthy older persons, patients with brain injuries, or with moderate and severe dementia. A lack of studies for effects of these programs on patients with mild dementia using randomized controlled trials was found. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.

Eligibility criteria: Patients' Inclusion Criteria:

* Aged 65 or older,
* Being diagnosed as having mild dementia by a neurologist, and
* Being able to communicate in Mandarin or Taiwanese.

Patients' Exclusion Criteria:

* Vision or hearing impairment.

Caregivers' (proxy) Inclusion Criteria:

* Living with the dementia patient,
* The family member spending the most time on the patient's care, and
* \>20 years old.

Caregivers' (proxy) Exclusion Criteria:

* Terminally ill

Primary outcomes:
measure: Cognitive Abilities as assessed by Cognitive Abilities Screening Instrument.
timeFrame: 3 months
measure: Memory as assessed by Prospective and Retrospective Memory Questionnaire.
timeFrame: 3 months
measure: Cognitive State as assessed by Mini-Mental State Examination
timeFrame: 3 months
Secondary outcomes:
measure: Depression as assessed by Geriatric Depression Scale.
timeFrame: 3 months
measure: Quality of Life as assessed by Chinese Dementia Quality of Life, DQoL.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05782530: Prevalence of Tattoos and Piercings in Healthcare Using the Example of Obstetrics Workers
Official title: Prevalence of Tattoos and Piercings in Healthcare Using the Example of Obstetrics Workers (TattOBS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acceptance, Social
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: medical stuff (nurses, medical doctors, midwives) working in obstetrics

Brief summary: Tattoos and piercings as body decorations have developed into an art form over the last few decades and its social recognition is growing. However, critics also speak of an excessive lifestyle when tattooing or piercing.

The data from the questionnaires should examine how widespread tattoos and piercings are among medical staff and thus make a statement on acceptance.


Eligibility criteria: Inclusion Criteria:

* medical stuff in obstetrics
* minimum 18 years old

Exclusion Criteria:

* language barrier
* uncompleted questionnaire

Primary outcomes:
measure: Prevalence of tattoos and piercings in healthcare using the example of obstetrics workers
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03181230: Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
Official title: Pilot Study of Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Turner Syndrome
Turner Syndrome Mosaicism, 45, X/46, XX or XY
Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X
Turner Syndrome Karyotype 46,X With Abnormal Sex Chromosome , Except I(Xq)
Keywords: Turner syndrome
45,XO
body composition
cardiometabolism
quality of life
fitness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 21
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will enroll adolescent and young adult females with Turner syndrome who will complete all study procedures. One parent will also be enrolled (either mother or father) to complete questionnaires about the daughter.

Brief summary: This study plans to learn more about how the energy system works in girls with Turner syndrome. This is important to know so that the investigators understand how Turner syndrome relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and how this impacts day to day life.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 12-21 years
* 45,XO karyotype in \>50% of cells tested with a diagnosis of Turner syndrome (TS)
* Tanner stage 2-5 for breast development

Exclusion Criteria:

* Growth hormone treatment within the past 3 months
* Diagnosis of type 1 or type 2 diabetes
* Untreated hypertension with blood pressure \> 99%ile for sex, age and height or \>140/90
* Weight \> 300 lbs
* Height \< 54"
* Aortic sinus of Valsalva or ascending aorta z-score \> 2
* Other cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures, including vigorous exercise
* Pregnancy

Primary outcomes:
measure: Peak oxygen consumption
timeFrame: Baseline
Secondary outcomes:
measure: Quality of Life Survey
timeFrame: Baseline
measure: Percent body fat
timeFrame: Baseline
measure: Insulin resistance (IR)
timeFrame: Baseline
Other outcomes:
measure: Qualitative structured interview
timeFrame: Baseline
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colroado
name: Shanlee Davis, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: