louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04733014: Perceptions of Ophthalmologists Regarding Contemporary Presbyopia Management.
Official title: Perceptions of Greek Ophthalmologists Regarding Contemporary Presbyopia Management.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Presbyopia
Keywords: Presbyopia, disease management, ophthalmologist, attitudes
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our study's sample will be representative in terms of age, gender, geographic location.

Brief summary: Different attitudes and perceptions are encountered concerning contemporary presbyopia management. Exploration of ophthalmologists' attitudes on diagnostic and therapeutic management of presbyopia is essential for the development of disease management interventions by the Hellenic Ministry of Health and Welfare. Within this context, Greek ophthalmologists' perceptions on presbyopia will be explored by means of a custom questionnaire.

Detailed description: Different attitudes and perceptions are encountered concerning contemporary presbyopia management. Exploration of ophthalmologists' attitudes on diagnostic and therapeutic management of presbyopia is essential for the development of disease management interventions by the Hellenic Ministry of Health and Welfare. Within this context, Greek ophthalmologists' perceptions on presbyopia will be explored by means of a custom questionnaire (DePrePer31).

Eligibility criteria: Inclusion Criteria:

* Valid license to practice ophthalmology in European Union.
* Adequate literacy of Greek language.

Exclusion Criteria:

* Pediatric ophthalmologist.

Primary outcomes:
measure: Perceptions on presbyopia
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05353114: Clinical Efficacy of a 3D Foot Scanner for the Therapeutic Footwear Fitting
Official title: Clinical Efficacy of a 3D Foot Scanner App for the Fitting of Therapeutic Footwear in Persons With Diabetes in Remission: A Randomized and Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Orthopedic Disorder
Foot Ankle Injuries
Keywords: Prevention
Therapeutic footwear
New technologies
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with diabetes at high risk of ulceration require a perfect fitting shoe to avoid high shear and pressure forces. Neuropathy skews sensory perceptions and can alter the proper selection of the therapeutic footwear.

The aims of study were to evaluate the ability of high-risk patients with diabetes in remission to select the proper therapeutic footwear and to validate a novel 3D foot scanner app for selecting the proper fitting therapeutic footwear.

Detailed description: A Randomized Controlled Clinical Trial in 30 patients with a previous healed diabetic foot ulcer.

After parallel randomization (1:1) patients will be enrolled into two different groups:

1. Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences;
2. Patients that will acquire a specific size and model according to result of a novel mobile app 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).

Validation of proper therapeutic footwear fitting will be performed by a specialized podiatrist after acquisition of shoes in both groups.

Therapeutic Footwear will be recommended to change when following ill fitting reason been found: excessive length or tight, or compromise with toes

Eligibility criteria: Inclusion Criteria:

* High risk patients according to the International Working Group Diabetic Foot Guidelines (IWGDF-risk 3).
* Healed diabetic foot ulcer at the moment of inclusion.
* Capability to walk autonomously without walking aids.
* Diabetic Peripheral neuropathy.

Exclusion Criteria:

* Major amputation in the contralateral limb (below or above the knee).

Primary outcomes:
measure: The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting.
timeFrame: 1 week
Secondary outcomes:
measure: Number of participants with an ulcer occurrence event
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Study officials:
References:
Clinical trial NCT03863314: Virtual Reality vs Inperson Simulation: A Non-inferiority Study
Official title: Virtual Reality vs Inperson Simulation: A Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Work-Related Condition
Keywords: Virtual Reality
Simulation
Workplace
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if Virtual Reality (VR) can elicit emotional responses that are captured via physiological biometrics such as heart rate variability and skin conductance levels. As a non-inferiority study the investigators anticipate the technologies will elicit an emotional not inferior to those responses of an in-person simulations of workplace scenarios (i.e medical error and workplace harassment).


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* Personnel working or volunteering at Lucile Packard Children's Hospital (LPCH) or Stanford Health Care (SHC) facilities

Exclusion Criteria:

* Patients who do not consent
* Are currently taking beta blockers or other chronotropic heart medication(s)
* Have a history of severe motion sickness
* Currently have nausea
* Currently experiencing seizures
* Are clinically unstable

Primary outcomes:
measure: Respiratory sinus arrhythmia
timeFrame: Throughout duration of simulation, approximately 15 minutes
Secondary outcomes:
measure: Skin conductance levels
timeFrame: Throughout duration of simulation, approximately 15 minutes
measure: Emotional levels
timeFrame: Throughout duration of intervention, two minutes before and after the intervention
measure: VR Simulation Questionnaire
timeFrame: Three months post study, approximately 5 minutes
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
citation: Bernardo A. Virtual Reality and Simulation in Neurosurgical Training. World Neurosurg. 2017 Oct;106:1015-1029. doi: 10.1016/j.wneu.2017.06.140.
citation: Kyaw BM, Saxena N, Posadzki P, Vseteckova J, Nikolaou CK, George PP, Divakar U, Masiello I, Kononowicz AA, Zary N, Tudor Car L. Virtual Reality for Health Professions Education: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. J Med Internet Res. 2019 Jan 22;21(1):e12959. doi: 10.2196/12959.
citation: Fan YC, Wen CY. A Virtual Reality Soldier Simulator with Body Area Networks for Team Training. Sensors (Basel). 2019 Jan 22;19(3):451. doi: 10.3390/s19030451.
Clinical trial NCT06659614: Prostate Tissue BioBank
Official title: Prostate Tissue Biobank for People At Genetic Risk for Aggressive Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Genetic Predisposition
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 200
Sex: MALE
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: People assigned male at birth, undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

Brief summary: Prostate cancer is also the most common cancer in men with inherited pathogenic variants in BRCA1 and BRCA2. Beyond BRCA1/2, other genes are known to increase the risk of prostate cancer, including ATM, TP53 and HOXB13. We have shown that 5% of men diagnosed with prostate cancer localized to their prostate gland and up to 10-15% of patients with metastatic prostate cancer gland are carriers of an inherited gene mutation.

The Prostate Tissue BioBank is a prospective study which aims to create a biorepository of prostate tissue samples from prostate biopsies and prostatectomies and matched germline DNA from pathogenic mutation carriers in addition to age-matched control samples. Our primary goal is to investigate prostate cancer development and treatment response in carriers of germline DNA repair mutations, as compared to non-carrier controls.


Eligibility criteria: Inclusion Criteria:

Carriers (Group 1):

1. Confirmed pathogenic or likely pathogenic variant in a known prostate cancer risk gene.
2. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

Controls (Group 2):

1. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Clinical and pathological data for patients with prostate tissue samples
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kara N Maxwell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04131114: Glaucoma After Congenital And Infantile Cataract Surgery
Official title: Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Congenital Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 241
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2016 was performed.

Brief summary: Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.

Detailed description: A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 was performed.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of congenital/infantile cataracts without any surgical intervention;
* age younger than 10 years;
* cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment

Exclusion Criteria:

* a preoperative IOP above 21 mm Hg;
* the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;
* the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.

Primary outcomes:
measure: the incidence of suspected glaucoma/glaucoma after congenital cataracts
timeFrame: 3 years
measure: Risk Factors of suspected glaucoma/glaucoma after congenital cataracts
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT02568514: Study of the Effect on Clinical Outcomes Using Secure Text Messaging
Official title: Study of the Effect on Clinical Outcomes Using Secure Text Messaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congestive Heart Failure
Diabetes
Renal Failure
Copd
Keywords: mhealth
text messaging
secure text messaging
communication
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.

Detailed description: Inpatient health care providers such as physicians and nurses spend up to one-third of their time communicating with other health care providers. Many of these communications have shifted mediums from handwritten notes and face-to-face conversations to phone calls and paging systems. More recently the rapid adoption of smartphones has led to the use of mobile-enabled technologies using smartphones such as text messaging and email. While these technologies may offer ease and fit better within the clinical workflow, they often send patient information through unsecure cellular or internet connections. Mobile secure text messaging may address these issues by encrypting data and allowing for asynchronous or synchronous communication between individual providers or groups of providers. In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Admission to one of the hospital floors or services in the study at the Hospital of the University of Pennsylvania

Exclusion Criteria:

* Discharges against medical advice
* Discharges to hospice

Primary outcomes:
measure: Change in length of stay
timeFrame: 6 months
measure: Change in 30 day hospital readmissions
timeFrame: 6 months
measure: Change in inpatient mortality
timeFrame: 6 months
Secondary outcomes:
measure: Change in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAPs) scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00292214: Comparing Intravenous and Oral Paracetamol for Cholecystectomy
Official title: Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Cholecystectomy
Keywords: paracetamol
acetaminophen
pharmacokinetic
intravenous
oral
analgesia
pain
opioid
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2006-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 18-75
* Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia

Exclusion Criteria:

* Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available.
* History of allergy or sensitivity to paracetamol
* Administration of oral paracetamol within previous 8 hours
* American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity
* Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)

Primary outcomes:
measure: Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
Secondary outcomes:
measure: Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Malcolm Hogg, Anaesthetist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05583214: Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia
Official title: Comparing the Efficacy of Ondansetron, Dexamethasone, and Placebo for the Reduction of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Caesarean Section
Spinal Anesthesia
Lead sponsor: Akhtar Saeed Medical and Dental College
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are:

Which drug is the best at reducing the incidence of intraoperative nausea and vomiting.

Which drug is the best at reducing intraoperative pain.

Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C.

A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded.

Data collected from the three groups will be analyzed using SPSS software.


Eligibility criteria: Inclusion Criteria:

* Age above 20 but less than 35 years old
* Given informed consent
* No contraindication to spinal anesthesia
* ASA I or II

Exclusion Criteria:

* Age less than 20 or more than 35 years old
* Non-consenting
* Contraindication to spinal anesthesia
* ASA III or IV

Primary outcomes:
measure: Intraoperative nausea
timeFrame: 20 minutes after initiation of procedure
measure: Intraoperative vomiting
timeFrame: 1 hour
Secondary outcomes:
measure: Intraoperative pain
timeFrame: 20 minutes after the initiation of procedure
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Akhtar Saeed Trust Hospital
state: Punjab
Study officials:
affiliation: House Officer
name: Muhammad Mubariz, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01515514: Confocal Endomicroscopy for GI Neoplasia Study
Official title: Confocal Endomicroscopy for GI Neoplasia Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Polyps
Keywords: polyps
inflammatory bowel disease
associated neoplasia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Bankhead-Coley
First posted: 2012-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 40 patients with polyps

Brief summary: The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard "free-hand" image acquisition.

Detailed description: The aim of this study is to optimize and validate in-vivo imaging systems capable of highly accurate, real-time classification of colorectal neoplasia.

Eligibility criteria: Inclusion Criteria:

* Those patients undergoing colonoscopy for screening or surveillance of colon polyps will be included in this study.

Exclusion Criteria:

* Patients with known polyposis syndromes, inflammatory bowel disease, allergy to fluorescein, or refusal to provide informed consent.

Primary outcomes:
measure: Quality of the confocal image
timeFrame: 1 yr
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael B Wallace, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01471314: MRA/fMRI Study of Spontaneous Migraine
Official title: Functional MRI and MR Angiography Used in Spontaneous Migraine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Headache Versus Non-headache Day
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2011-11-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Migraine without aura

Brief summary: The purpose of this study is to examine migraineurs during spontaneous migraine attacks without aura, using high resolution magnetic resonance imaging (MRI), to study following:

* Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using functional MRI (fMRI).
* Changes in circumferences of intra- and extracranial arteries using MR-angiography (MRA).
* Changes in regional and global cerebral blood flow (CBF) using the arterial spin labeling (ASL) method.

Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.

The migraine specific drug sumatriptan will be given to relieve pain and the effect will be registered using MRA and fMRI if possible.


Eligibility criteria: Inclusion Criteria:

* Migraine without aura according to IHS criteria.

Exclusion Criteria:

* Other primary headaches.
* Tension-type headache more than 5 days/month.
* Use of anti-pain medication before the scanning on the examination day.
* Pregnant or nursing women.
* Contraindication for MR scan.
* Anamnestic or clinical signs of cardiovascular or cerebrovascular disease, unregulated psychiatric disease or drug misuse.
* Other clinical conditions assessed by the examining doctor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
Study officials:
References:
citation: Amin FM, Asghar MS, Hougaard A, Hansen AE, Larsen VA, de Koning PJ, Larsson HB, Olesen J, Ashina M. Magnetic resonance angiography of intracranial and extracranial arteries in patients with spontaneous migraine without aura: a cross-sectional study. Lancet Neurol. 2013 May;12(5):454-61. doi: 10.1016/S1474-4422(13)70067-X. Epub 2013 Apr 9.