louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01228721: Reproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-10-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma patients and healthy control subjects using Spectralis® SD-OCT.

METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator within one session with a brief rest between measurements. Three measurements were taken with the eye-tracker and retest function, and three were taken without this function, alternating between measurement methods.

* Trial with medical device


Eligibility criteria: Inclusion criteria:

* Visual acuity of more or equal to 0.5 Snellen, refractive error less than ±5.00 diopters (D) spheric and ±3.00 D cylindrical and no history of ocular trauma or of any other severe ocular disease (particularly diseases affecting the optic nerve or surgery other than uncomplicated cataract surgery).
* Additional inclusion criteria for the glaucoma group were a diagnosis of primary open angle glaucoma (POAG) or PEX-glaucoma.

Exclusion criteria:

* Exclusion criteria for the control group were history of glaucoma or intraocular pressure beyond 21 mmHg and optic disc cupping of more than 0.6

Primary outcomes:
measure: retinal nerve fiber layer thickness measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Langenegger SJ, Funk J, Toteberg-Harms M. Reproducibility of retinal nerve fiber layer thickness measurements using the eye tracker and the retest function of Spectralis SD-OCT in glaucomatous and healthy control eyes. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3338-44. doi: 10.1167/iovs.10-6611.
Clinical trial NCT03034421: Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
Official title: Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumothorax
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.

Detailed description: Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 130 patients with advanced emphysema and low collateral ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical care including a 48 bed rest or standard medical care following valve implantation. All patients will undergo treatment at one study centre in Heidelberg.

Eligibility criteria: Inclusion Criteria:

* FEV1 \< 50%, RV\>150%, TLC\>100%
* emphysema confirmed by computed tomography
* pO2 \>60 mmHg (with supplemental oxygen), pCO2 \< 55 mmHg (room condition)
* no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement)
* no COPD exacerbation within the past 8 weeks
* daily use of \< 20 mg Prednisolon
* non-smoking for a minimum of 4 months prior to consent
* Patient has provided written informed consent

Exclusion Criteria:

* BMI \< 18 kg/m²
* clinically relevant bronchiectasis
* failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure
* Prior lung resection (e.g. lobectomy)

Primary outcomes:
measure: Advent of pneumothorax within 90 days following valve implantation
timeFrame: 90 days following valve implantation
Secondary outcomes:
measure: Lung function before and after valve therapy
timeFrame: 30 and 90 days following valve implantation
measure: Excercise capacity before and after valve therapy
timeFrame: 30 and 90 days following valve implantation
measure: Dyspnoe score before and after valve therapy
timeFrame: 30 and 90 days following valve implantation
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
Study officials:
affiliation: Thoraxklinik at University of Heidelberg
name: Daniela Gompelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01943721: A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
Official title: A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ocular Hypertension
Primary Open Angle Glaucoma
Lead sponsor: ForSight Vision5, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Primary open-angle glaucoma or ocular hypertension in both eyes
* Best-corrected distance vision of 20/100 or better
* Stable visual field

Exclusion Criteria:

* Cup-to-disc ratio greater than 0.8
* Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
* Corneal refractive surgery within prior 6 months
* Past history of any incisional surgery for glaucoma at any time
* Corneal abnormalities that would interfere with tonometry readings
* Current participation in an investigational drug or device study or participation in such a study within 30 days of screening

Primary outcomes:
measure: Ocular Tonometry (change from baseline)
timeFrame: Week 2, 6, 12 and Months 4,5,6
Secondary outcomes:
measure: Safety as assessed by Slit Lamp Exam
timeFrame: Weeks 2,6,12 and Months 4,5,6
Other outcomes:
Locations:
city: Contact ForSight VISION5 for Trial Locations
country: Latvia
facility: Contact ForSight VISION5 for Trial Locations
Study officials:
affiliation: ForSight VISION5
name: Anne Rubin
role: STUDY_DIRECTOR
References:
Clinical trial NCT03451864: Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates
Official title: Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Outcome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 88
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 88 full term neonates of both sexes born to 88 healthy women with a mean age was 27.0 ± 5.0 years. Forty-one (46.6%) had normal vaginal delivery and 47 (53.4%) underwent cesarean section

Brief summary: Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA

Detailed description: Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA.Maternal 25 (OH) vitamin D measurement: Blood samples for determination of serum 25 (OH) vitamin D were collected by venipuncture and processed as follows: 3 mL blood were collected into plain tubes and allowed to clot for 30 minutes, then it was centrifuged at 1500 round per minute for 15 minutes at room temperature and the serum was separated into clean, properly labeled tubes and stored at ≤ -20°C till assay. Serum 25 (OH) vitamin D level was assessed by Enzyme-Linked ImmunoSorbent Assay (ELISA) using DRG 25-OH Vitamin D (total) ELISA (DRG International, Inc., USA) according to manufacturer's instructions. Vitamin D deficiency is defined by 25(OH) D levels less than 20 ng/d

Eligibility criteria: Inclusion Criteria:

* Healthy women Term pregnancy

Exclusion Criteria:

any chronic illness as chronic hypertension or pregestational diabetes pregnancy-related illnesses as preeclampsia, gestational diabetes multiple pregnancy

Primary outcomes:
measure: Neonatal intensive care unit admission
timeFrame: 24 hours after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01031264: Chronic Alcohol and Brain Stress Circuit Response
Official title: Chronic Alcohol and Brain Stress Circuit Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Alcoholism
Keywords: social drinkers
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2009-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: social drinkers

Brief summary: Alcoholism is among the top three causes of preventable death and disease in the US (Mokdad et al., 2004; Room et al., 2005). Stress plays an important role in the development of alcoholism and in high vulnerability to alcohol relapse. This study will provide a greater understanding of the mechanism by which stress and alcohol consumption interacts to influence development of compulsive alcohol seeking and vulnerability to stress-induced drinking, and the results will have significant implications for the development of new prevention and treatment interventions for alcoholism.


Eligibility criteria: Inclusion Criteria:

* ages 21-50

Primary outcomes:
measure: Assess differences in reactivity to cue imagery
timeFrame: 2 years from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Rajita Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05390164: Sensory Symptoms in Active Vitiligo
Official title: Sensory Symptoms as an Early Manifestation of Active Vitiligo: a Case-control Clinical and Molecular Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Totest Sensory Symptoms in Active Vitiligo
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Active vitiligo patients

Brief summary: This work aims to assess sensory symptoms in early active vitiligo patients (segmental, non-segmental, or mixed) and to measure 3 neuropeptides expression in their lesional skin \[neuropeptide Y(NPY), calcitonin gene-related peptide (CGRP), and nerve growth factors (NGF)\] to correlate neuropeptide levels, sensory symptoms, and functions, with criteria of disease activity and perceived stress scale.

Detailed description: Study Design: Case-control study Population: 45 patients with active vitiligo and 45 patients with stable vitiligo

Inclusion criteria:

Age: 18 years old and older Sex: both sexes

Exclusion criteria:

Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post-inflammatory hyperpigmentation, and leprosy as excluded by lack of accentuation by wood's light examination. - Cases who received treatment (systemic or topical) in the last 3 months before sampling. - Neurological or other diseases that cause itching. - Medical history of DM, HTN, or other systemic diseases, history of associated autoimmune diseases.

Assessment will be carried as follows: • History of itching or other abnormal neurological sensations as paresthesia and numbness. Aggravating factors (e.g. dryness, hot environment, sun exposure, ..etc), alleviating factors of itching Type of vitiligo (segmental, unilateral, vulgaris). • Assessment of activity by assessing: koebner's phenomenon, confetti depigmentation, trihypochrome areas, poorly defined borders, inflammatory signs (e.g eye inflammation and hearing loss), and leukotrichia. • Assessment of sensory symptoms and signs (fine touch, crude touch, pain, and sweating by starch iodine test) in active vitiliginous patches. • Clinical assessment: the vitiligo area score index (VASI), vitiligo extent scores (VES), vitiligo disease activity score (VIDA) (Feily, 2014) will be assessed in every participant and demographic data

Eligibility criteria: Inclusion Criteria:

* Active and stable vitiligo

Exclusion Criteria:

* Diabetic or other associated disease

Primary outcomes:
measure: Neuropeptide
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02617264: Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery
Official title: Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.

Detailed description: As part of the diagnostic tests for breast cancer sometimes necessary to perform a FNA or Core biopsy to a suspicious axillary lymph node.

Presently there is no possibility to identify the examined gland at the surgery. If the gland was infected it's most important to remove it.

The only technique that exists today is marking with a metal clip and the use of this technique is not profit, partly because of technical difficulties.

In this trial the investigator will use a special ink which will be injected to the axillary lymph node during the biopsy and latter on the surgery the investigator will try to assess the ability to identify the marked gland.

Eligibility criteria: Inclusion Criteria:

* Women with findings suspicious of breast cancer (or known breast cancer) who undergo axillary lymph node biopsy

Exclusion Criteria:

* Inability to sign Informed Consent

Primary outcomes:
measure: Intra operative identification the Spot TM marked node at the time of surgery
timeFrame: Within 1 year of enrollment
Secondary outcomes:
measure: Correlation between Spot TM marked lymph node and sentinel lymph node
timeFrame: Within 1 year of enrollment
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Kaplan Medical Center
name: Tanir Allweis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02171364: Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation, Virtual ablation, electrocardiography, electroanatomical mapping data
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.

Exclusion Criteria:

* AF patients who have severe heart deformations or blood problems.
* The patients who had been performed catheter ablation of atrial ablation.
* The patients who missed out to recording of 3D CT, echo and electrocardiography.

Primary outcomes:
measure: change of hospitalization rate
timeFrame: 1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter.
Secondary outcomes:
measure: occurence of cardiovascular disease
timeFrame: 6 months
measure: recurrence of AF
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Kim IS, Lim B, Shim J, Hwang M, Yu HT, Kim TH, Uhm JS, Kim SH, Joung B, On YK, Oh S, Oh YS, Nam GB, Lee MH, Shim EB, Kim YH, Pak HN; CUVIA-AF1 Investigators. Clinical Usefulness of Computational Modeling-Guided Persistent Atrial Fibrillation Ablation: Updated Outcome of Multicenter Randomized Study. Front Physiol. 2019 Dec 17;10:1512. doi: 10.3389/fphys.2019.01512. eCollection 2019.
Clinical trial NCT04738864: Neuro-ultrasound Assessment in Behcet's Disease
Official title: The Effect of Behcet's Disease on Cerebrovascular Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behcet Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Assessment of structural changes that occur in large extracranial and intracranial arteries in patients with Behcet's disease

Detailed description: Patients will be selected from Rheumatology and Rehabilitation inpatient and outpatient clinics in Assiute University Hospital Patients under 16 years old, patients with hyperlipidemia, hypertension, diabetes mellitus and all other risk factors affecting blood vessel intimal thickness will be excluded from the research.

All patients and control groups underwent a complete extracranial and intracranial ultrasound assessment by 2 experienced neurovascular sonographers .The ultrasound examination was done at the Neurovascular Ultrasound Laboratory in the Neurology department, Assiut University hospitals using a color-coded duplex ultrasound device Philips HD5 (Philips Medical Systems, Nederland B.V.) for the carotid and vertebral arteries and for the intracranial arteries.

Intimal medial thickness (IMT) of the common carotid artery (CCA), peak systolic velocities (PSVs) and end diastolic velocities (EDVs) were measured in the common, internal, and external carotid arteries (CCA, ICA, ECA) with L 3-12 MHz linear transducer probe and when stenosis was detected the velocities were measured at the maximally stenotic area.

The intracranial arteries were evaluated in all patients with transcranial color-coded duplexsonography (TCCS) with the use of a low-frequency (2- to 5-MHz) phased-array probe through the transtemporal acoustic bone window. The middle cerebral artery (MCA), intracranial segment of vertebral artery (V4)and basilar artery (BA) were examined. Peak systolic velocity (PSV) and flow direction (antegrade or reversed) used for the diagnosis of any intracranial atherosclerotic disease (ICAD).

The findings and the atherosclerotic changes in the extracranial and intracranial vessels were interpreted according to the internationally published data Data will be analyzed using the computer program SPSS

Eligibility criteria: Inclusion Criteria:

* patient more than 18 years old
* All patients fulfill the modified International Criteria for Behçet's Disease

Exclusion Criteria:

* Patients under 16 years old,
* patients with hyperlipidemia, hypertension, diabetes mellitus and all other risk factors affecting blood vessel intimal thickness

Primary outcomes:
measure: CNS vascular involving
timeFrame: 6 mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Medicine
Study officials:
affiliation: Assiut University
name: Esraa A Talaat, Lecturer
role: STUDY_CHAIR
References: