louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02008253: Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)
Official title: Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectasia
Keywords: INTRASTROMAL CORNEAL RING
ASTIGMATISM
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients residents in Brazil with ectasia after refractive surgery

Brief summary: To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery.

Detailed description: Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series. Mean age at the time of ICRS implantation was 30,5 years.

Eligibility criteria: Inclusion Criteria:

* Patients 19 to 48 years old
* Keratoconus (ectasia) on eyes with prior refractive surgery

Exclusion Criteria:

* Diabetes
* Autoimmune diseases

Primary outcomes:
measure: Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery
timeFrame: Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).
Secondary outcomes:
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Instituto de Olhos de Goiânia
state: Goias
Study officials:
affiliation: Instituto de Olhos de Goiânia
name: Larissa Rossana S Stival
role: STUDY_CHAIR
References:
Clinical trial NCT04525053: Dosimetric Validation of Scans Generated by GAN From Pre-therapeutic MRI in Stereotactic Cerebral Radiotherapy
Official title: Dosimetric Validation of Scans Generated by GAN From Pre-therapeutic MRI in Stereotactic Cerebral Radiotherapy (SBRT-IRM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Metastases
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Restrospective inclusion of all patients treated with intra-cranial SRT for brain metastases from 2014 to 2018 in our single institution

Brief summary: Stereotactic radiotherapy (SRT) is being widely accepted as a treatment of choice for patients with a small number of brain metastases and an acceptable size, allowing a better target dose conformity resulting in high local control rates and better sparing of organs at risk. Currently, imaging for such a delivery technique requires both a recent magnetic resonance imaging (MRI) brain study for volume definition and a computed tomography (CT) scan for SRT planning. An MRI-only workflow could reduce the risk of misalignment between the two imaging modalities and shorten the delay of planning. Given the absence of a calibrated electronic density on MRI, the investigators aim to assess the equivalence of synthetic CTs generated by a generative adversarial network (GAN) for planning in the brain SRT setting.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years old
* SRT treatment for one or more brain metastasis(ses)
* brain MRI and planning CT scans realized less than 14 days prior to the treatment delivery

Exclusion Criteria:

* MRI's field of view (FOV) judged insufficient for tumour(s) and OAR visualization

Primary outcomes:
measure: Local Gamma Analysis Passing Rate
timeFrame: Once, at the time of treatment delivery
Secondary outcomes:
measure: Global Gamma Analysis Passing Rate
timeFrame: Once, at the time of treatment delivery
measure: Planning Target Volume's coverage values
timeFrame: Once, at the time of treatment delivery
measure: Organs at risk Dose Constraints
timeFrame: Once, at the time of treatment delivery
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT06059053: Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
Official title: Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Aneurysm
Endovascular Aortic Repair
Stent-Graft Endoleak
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft.

Brief summary: The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.

Detailed description: The main question it aims to answer are:

* Patency of the semibranch
* Feasibility of the technique regarding cannulation and stentgrafting

The participants will treated with the custom made semibranch device and enrolled in the registry if they consent. No change in treatment will be made when enrolled.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Presence of pararenal or thoracoabdominal aortic pathology
* Treatment planned a semibranch device branch from Artivion
* Availability of the patients during the follow up period
* Informing patients about the study and providing written informed consent

Exclusion Criteria:

* Women of childbearing age
* Patients under 18 years

Primary outcomes:
measure: Freedom from target vessel instability
timeFrame: 30 days after intervention
measure: Mortality
timeFrame: 30 days after intervention
measure: technical success
timeFrame: During intervention
Secondary outcomes:
measure: Morbidity
timeFrame: During follow up period (up to 3 years)
measure: freedom Endoleak Type I and III
timeFrame: During follow up period (up to 3 years)
measure: Long term mortality
timeFrame: During follow up period (up to 3 years)
measure: Branch patency
timeFrame: During follow up period (up to 3 years)
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Muenster University Hospital
Study officials:
affiliation: Department of Vascular and Endovascular Surgery University Hospital Münster
name: Alexander Oberhuber, MD,PhD
role: STUDY_CHAIR
affiliation: Department of Vascular and Endovascular Surgery University Hospital Münster
name: Alexander Oberhuber, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00776451: Usability of the PreView PHP for Home Use in Intermediate AMD Patients
Official title: Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: AMD
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dry AMD subjects

Brief summary: To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.

Detailed description: The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.

Eligibility criteria: Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study Subjects diagnosed as intermediate AMD in at least one eye
* Age ≥65 years
* VA with habitual correction better than 20/60 in the study eye
* Ability to speak, read and understand instructions in English or Hebrew
* Qualified to use the device by health care professional

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
* Any non-macular related ocular surgery or macular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study
* Patients diagnosed with geographic atrophy (GA)

Primary outcomes:
measure: The proportion of subjects who successfully completed the test by themselves, in a home simulated environment
timeFrame: 2 clinic visits
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Belinson Medical Center
Study officials:
affiliation: JHMC
name: Neil Bressler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02627651: The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury
Official title: The Cardiac Autonomic System Response to Activity and Cognitive Tasks in Children Post Acquired Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 18 children post acquired brain injury and 18 typically developed controls matched for age and gender.

All children aged 10-18 yrs who understand simple commands.

Tools:

1. Heart rate monitor
2. Six minute walk test
3. The behavior rating inventory

Method:

1. At the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds.
2. At the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; After a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .


Eligibility criteria: Inclusion Criteria:

aged 10-18 understand simple commands walk independently

Exclusion Criteria:

Canot understand simple commands

Primary outcomes:
measure: Heart rate
timeFrame: 5 min
measure: Heart rate variability- time domain measures
timeFrame: 5 min
measure: Heart rate variability- frequency domain measures
timeFrame: 5 min
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Alyn Pediatric and Adolesencent Rehabilitation Center
Study officials:
References:
Clinical trial NCT00175851: Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy
Official title: An Open-label, Multicenter, Follow-up Trial to Evaluate the Long-term Safety and Efficacy of Seletracetam Used as Adjunctive Treatment Using a Flexible Dosing Scheme of 4 to 80 mg b.i.d. in Subjects Aged 16 Years or Older Suffering From Epilepsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Epilepsy
Keywords: Partial onset, primary generalized seizures, seletracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study


Eligibility criteria: Inclusion Criteria:

* A signed and dated IRB/IEC approved written informed consent form
* Male/female age 18 years (16 years where permitted) to 65 years
* Minimum body weight of 40 kg
* Patients having participated in a previous seletracetam study
* Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.

Exclusion Criteria:

* Ongoing psychiatric disease other than mild controlled disorders
* Subject with clinically significant abnormalities in laboratory tests or ECG
* Poor compliance with visit schedule or medication intake in a previous seletracetam study
* Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment

Primary outcomes:
measure: Safety profile of seletracetam
Secondary outcomes:
measure: Reduction in seizure frequency
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: Barbara Bennett, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00938951: Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Symptoms
Visual Performance
Keywords: Dry Eye
Visual Performance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to compare visual degradation in a stressed (forced stare) environment in patients before and after acute administration of Systane Ultra.


Eligibility criteria: Inclusion Criteria:

* Player/ Coach must answer "Yes" to the survey eligibility question.
* Player/Coach must voluntarily agree to participate in survey

Exclusion Criteria:

* None.

Primary outcomes:
measure: Effectiveness of eye drop basd on athlete's opinion/experience during a one hour practice session
timeFrame: 60 minutes post-dosing with test article
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04766151: Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial)
Official title: A Randomised, Double-blind, Parallel Group, Efficacy and Safety Study of Transdermal Patch Nitroglycerin in the Prevention of Coronary Artery Spasm, During Coronary Angiography/ Angioplasty (NURSE-TTS - Nitrate Use to Obtain Radial Spasm Embarrassment)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radial Artery Spasm
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2021-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Transradial cardiac catheterization and percutaneous coronary intervention are increasingly being performed worldwide in elective and emergency procedures, with many centres adopting the transradial route as their first choice of arterial access. One of the most common complications encountered during transradial procedures is radial artery spasm. The aim of this study is to evaluate the Efficacy and Safety of the use of transdermal Glyceryl trinitrate patches applied to skin before cardiac catheterization to prevent the occurrence of radial artery spasm during transradial access cardiac catheterization.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery

Exclusion Criteria:

* Prior same radial artery catheterization
* Positive Allen test
* Severe Hypotension (SBP\<100 mmHg)
* Pregnancy
* Ongoing Acute Myocardial Infarction
* Ongoing cardiogenic shock
* Known History of Nitrates intolerance/allergy

Primary outcomes:
measure: Radial Spasm occurrence
timeFrame: Immediately after the end of the procedure
measure: Successful radial puncture
timeFrame: During radial puncture and catheterization
Secondary outcomes:
measure: VRS-4 pain scale
timeFrame: During the whole procedure
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: During the whole procedure
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 424 GeneralMH
Study officials:
References:
Clinical trial NCT01046851: A Study of Nopan Treatment of Acute Suicidality
Official title: Phase 3 Study of the Effects of Nopan as add-on Treatment to Antidepressants in Treating Depression and Suicidality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Suicidality
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2010-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Depression, suicidality, and overall functioning will be assessed before, during and after a four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.


Eligibility criteria: Inclusion Criteria:

* suicidal behavior or ideation (BSI\>6)

Exclusion Criteria:

* ECT history within the last month
* psychotic features within the last 3 months
* history of schizophrenia, substance or alcohol abuse within the last two years
* benzodiazepine dependence within the last two years
* any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician
* pregnant women
* patients who currently suffer from severe impairment or severe dysfunction of liver, kidney, adrenal, gall, closed brain injury, urinary retention or respiratory system.

Primary outcomes:
measure: Reduction in Suicidality as expressed by the score on the BSI
timeFrame: 4 weeks
Secondary outcomes:
measure: Reduction in depression as measured by the BDI
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bat-Yam
country: Israel
facility: Abarbanel MHC
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Tel Aviv
country: Israel
facility: Brill Community Mental Health Center
Study officials:
affiliation: University of Haifa, Institute for the Study of Affective Neuroscience
name: Yoram Yovell, MD, PhD
role: STUDY_CHAIR
affiliation: Abarbanel MHC
name: Mordechai Masiah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edith Wolfson Medical Center
name: Jack Asherov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv- Brill Community Mental Health Center
name: Nathaniel Laor, MD, PhD, Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03761251: Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
Official title: Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Adolescent Behavior
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the short-term effects of incorporating the structured care of a pet fish into a diabetes self-care routine on glucose control in early adolescents with type 1 diabetes.

Detailed description: Efficacy of treatment for Type 1 diabetes mellitus (T1DM) is dependent on adherence to self-care behaviors and collaborative parental involvement. Adolescence is a vulnerable time for the deterioration of glycemic control in patients with T1DM. In particular, parental monitoring declines during early adolescence. This often occurs before the child has developed self-efficacy and competence in independently performing diabetes-related tasks, including blood glucose monitoring. Consequently, there is a great need for innovative strategies in early adolescents that promote self-efficacy development and facilitate parental involvement.

Eligibility criteria: Inclusion Criteria:

* age 10-13 years
* diagnosis of T1DM
* duration of T1DM for at least one year
* fluency in English
* two recent consecutive HbA1c values 8.0 - 13%

Exclusion Criteria:

* clinical or laboratory characteristics suggestive of type 2 diabetes mellitus
* involvement in foster care
* dual-home living situation
* severe psychiatric disorders
* developmental delay or cognitive impairment
* current participation in another study that may impact glycemic control
* regular usage of a continuous glucose monitor
* HbA1c \> 13% (because these individuals may need a more intensive intervention than this is intended to provide).

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT03570151: Medical Care at a Mass-gathering Music Festival
Official title: Medical Care at a Mass-gathering Music Festival: A Retrospective Study Over Seven Years (2011 - 2017) of the Frequency Festival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Health Problems Occurring During a Music Festival
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 18684
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Visitors and staff at an Austrian music festival

Brief summary: Key Objective is to describe Patient Presentation Rate and Transport to Hospital rate at an Austrian Music Festival. If significant changes in specific incidence rates are found, a causal explanation will be looked for.


Eligibility criteria: Inclusion Criteria:

* All persons seeking help from the local ambulance service at the music festival

Exclusion Criteria:

* Incomplete Data

Primary outcomes:
measure: Patient Presentation Rate
timeFrame: 2011-2017
measure: Transfer to Hospital Rate
timeFrame: 2011-2017
Secondary outcomes:
measure: Changes in the Incidence of single Illnesses
timeFrame: 2011-2017
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: