louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00804934: Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis
Official title: Phase II Study Intravitreally Admininstered Ranibizumab in 50 Subjects With AMD Having Received at Least 3 Doses of Intermittent Anti-VEGF Therapy in the Preceding 18 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet AMD
Lead sponsor: Retina Institute of Hawaii
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.

Detailed description: To determine mean change in visual acuity at 6 and 12 months

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age greater then and equal 50 years
* Patients with active neovascular AMD
* Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months
* If the patient has bilateral disease and qualifies for the study, both eyes may be included

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from this study:
* Pregnancy or lactation
* Premenopausal women not using adequate contraception.
* Participation in another simultaneous medical investigation

Primary outcomes:
measure: Mean change in visual acuity at 6 and 12 months
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Retina Institute of Hawaii
state: Hawaii
Study officials:
affiliation: Retina Institute of Hawaii
name: Debra L Shimabukuro, RN
role: STUDY_CHAIR
References:
Clinical trial NCT05141734: Correlation Tests for Patients With Benign Paroxysmal Positional Vertigo
Official title: Evaluation of Patients With Benign Paroxysmal Positional Vertigo With vHIT (Video Head Impulse Test) and VNG (Videonystagmography)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Positional Vertigo
Reflexes, Vestibo-Ocular
Nystagmus Vestibular
Keywords: vestibular function tests
Head Impulse Test
semicircular canals
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included in the study group were diagnosed with isolated benign paroxysmal positional vertigo (BPPV) according to clinical symptoms.

Brief summary: This study aimed to investigate whether there is a relationship between nystagmus intensity and vestibular-ocular reflex gains by comparing Videonystagmography and video head impulse test in patients with posterior semicircular canal-benign paroxysmal positional vertigo.

Detailed description: The aim of this study is to investigate the relationship between the vestibulo-ocular reflex (VOR) gains obtained by video Head Impulse Test (vHIT) and the slow phase velocity (SPV) of nystagmus in patients with benign paroxysmal positional vertigo (BPPV) originating from the posterior semicircular canal (PSCC).

The patients were included in two groups. The study group consisted of patients with isolated PSCC BPPV (PSCC-BPPV), and the control group consisted of age and gender-matched healthy individuals. VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.

Eligibility criteria: Inclusion Criteria:

* Patients with isolated benign paroxysmal positional vertigo were included in the study group.
* The patients included in the control group were composed of those who did not complain of vertigo.

Exclusion Criteria:

-Participants with a history of neuro-otologic disease, an orthopedic disease that prevents neck movements, and any disease or surgery that causes impairment in ocular movements were excluded from the study.

Primary outcomes:
measure: Comparison of nystagmus intensity and vestibulo-ocular reflex gains in patients with benign paroxysmal positional vertigo
timeFrame: 2019-2010 (15 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Merih Onal
Study officials:
affiliation: Selcuk University
name: Merih Onal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04924634: Stress Levels and Mental Well-Being Among Slovak Students During e-Learning
Official title: Stress Levels and Mental Well-Being Among Slovak Students During e-Learning in The COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety State
Depression
Keywords: depression
e-Learning
COVID-19
anxiety
Lead sponsor: The Opole University of Technology
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 3051
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Students participating in active learning

Brief summary: Introducing restrictions on human contact has been effective in preventing the uncontrolled spread of COVID-19, however, it appears to have negatively impacted mental health. Psychological problems in different age groups occur with different intensity and duration of the pandemic. This study was aimed to assess the impact of introducing distance learning (e-Learning) on the stress levels and mental well-being among Slovak Students.

Detailed description: Socially isolated young people, condemned to constant contact with the Internet, find themselves in sorrowful situations where their basic need were impossible. Previous studies report that university students report high levels of stress, anxiety, and depression, which affects student motivation and attitudes toward learning; however, to date, no such studies have been conducted on a population of Slovakian Students. This study considered 4 Slovak universities. Using standardized questionnaires, students' mental status during e-Learning was assessed at the beginning of the summer semester (February, March 2021).

Eligibility criteria: Inclusion Criteria:

* Students attending the course cycle

Exclusion Criteria:

* Inability to self-complete the research questionnaires;
* Psychiatric or psychological treatment, likewise taking medications that affect the psyche during the research project;

Primary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: 20 minutes
measure: BDI
timeFrame: 20 minutes
measure: Authors survey
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Opole
country: Poland
facility: Faculty of Physical Education and Physiotherapy, Opole University of Technology
Study officials:
References:
Clinical trial NCT03783234: Triage Assessment and NEWS-score as Risk Predictor in Older Frailty Adults in the ED
Official title: 3-level Triage Assessment and National Early Warning Score as Predictor for Mortality, Hospital Admission and ED Readmission for Older Frailty Patients in the ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Aged
Triage
Keywords: Emergency triage
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: City of Espoo
name: University of Helsinki
First posted: 2018-12-20
Enrollment: 1711
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of aforementioned counties, aged over 75 years, who attend the Emergency department and have clinical frailty scale minimum 4.

Brief summary: Emergency Department Triage Systems have not been shown to sufficiently recognize frail elderly patients in need of urgent assessment and care. In this prospective, observational study the performance of the 3-level triage system and the National Early Warning Score (NEWS) 2 are assessed (separately and combined) for predicting adverse outcomes in older frailty patients visiting in the ED. Observational data for this study is gathered as part of GAOPS - main study (ClinicalTrials.gov Identifier: NCT03751319).


Eligibility criteria: Inclusion Criteria:

* "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse

Exclusion Criteria:

• Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Hospital admission
timeFrame: Day 0
measure: ICU/HDU admission
timeFrame: Day 0
measure: Readmission in the ED
timeFrame: Hour 72, Day 30
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Central Hospital, Jorvi
Study officials:
affiliation: Department of Emergency Medicine and Services, Helsinki University Hospital
name: Veli-Pekka Harjola
role: STUDY_DIRECTOR
affiliation: Department of Emergency Medicine and Services, Helsinki University Hospital
name: Janne Alakare, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kemp K, Alakare J, Harjola VP, Strandberg T, Tolonen J, Lehtonen L, Castren M. National Early Warning Score 2 (NEWS2) and 3-level triage scale as risk predictors in frail older adults in the emergency department. BMC Emerg Med. 2020 Oct 28;20(1):83. doi: 10.1186/s12873-020-00379-y.
Clinical trial NCT06905717: The T2D Profile - Studies of the Omics Profile in Type 2 Diabetes
Official title: The T2D Profile - Studies of the Omics Profile in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with newly diagnosed Type 2 Diabetes identified from population-based cohorts.

Brief summary: The T2D Profile study examines the longitudinal molecular profiles of newly diagnosed type 2 diabetes (T2D), before and during guideline-based diabetes treatment.

Detailed description: The study included a total of 3 visits: At baseline and after 1 and 3 months of diabetes treatment according to standard of care. Visits included clinical examinations, questionnaires and clinical chemistry. In addition, samples were collected at each visits for comprehensive molecular profiling including proteomics, genomics, transcriptomics, metabolomics, lipidomics, antibody profiling, mass cytometry and gene profiling of fecal microbiota.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent to participate in the study.
* Age 50-65 years.
* T2D diagnosis (fasting p-glucose ≥7.0 mmol/L or an oral glucose tolerance test 2 hour p-glucose ≥11.1 mmol/L \[or ≥12.2 mmol/L if measured capillary\] at two separate occasions).

Exclusion Criteria:

* Diabetes medication before study start.
* Severe hyperglycemia requiring hospitalization or immediate insulin treatment, as judged by the investigator.
* Presence of any clinically significant disease which, in the opinion of the investigator, may interfere with the subject´s ability to participate in the study.
* Any major surgical procedure or trauma within 4 weeks of the first study visit.

Primary outcomes:
measure: Molecular profiles during diabetes treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Göteborg University
name: Göran Bergström, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gummesson A, Bjornson E, Fagerberg L, Zhong W, Tebani A, Edfors F, Schmidt C, Lundqvist A, Adiels M, Backhed F, Schwenk JM, Jansson PA, Uhlen M, Bergstrom G. Longitudinal plasma protein profiling of newly diagnosed type 2 diabetes. EBioMedicine. 2021 Jan;63:103147. doi: 10.1016/j.ebiom.2020.103147. Epub 2020 Dec 3.
Clinical trial NCT05330117: Nerve Stimulation Using a TENS to Provide Pain Relief During Surgery for Overactive Bladder
Official title: Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Operative Cystoscopy for Overactive Bladder: A Randomized Control Trial (TENSOB Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Overactive Bladder
Pain, Acute
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 100
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: This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Subjects will be identified by the University of Rochester Urologists and Urogynecologists participating in the study who currently oversee urinary urge incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia and the second group will have cystoscopy with placebo TENS.


Eligibility criteria: Inclusion Criteria:

* Men and Women, Age ≥18 years
* Diagnosis of OAB/UUI,
* Scheduled to undergo intravesical Botox injections in the office
* Able to read/write English

Exclusion criteria:

* Currently undergoing Sacral Neuromodulation
* Cutaneous damage such as ulcers or broken skin on target treatment area
* Currently implanted cardiac pacemaker or defibrillator
* Pre-procedural use of opioids for pain management, less than 8 hours from last dose
* Participants with altered sensation below the umbilicus

Primary outcomes:
measure: Mean pain measured by Visual Analog Scale (VAS)
timeFrame: Baseline (Before procedure)
measure: Mean pain measured by Visual Analog Scale (VAS)
timeFrame: Approximately 2-5 minutes into the procedure
measure: Mean pain measured by Visual Analog Scale (VAS)
timeFrame: within 10 minutes after procedure
Secondary outcomes:
measure: Mean pain measured by Likert scale
timeFrame: before procedure
measure: Mean pain measured by Likert scale
timeFrame: Approximately 2-5 minutes into the procedure
measure: Mean pain measured by Likert scale
timeFrame: within 10 minutes after procedure
measure: Number of participants with side effects
timeFrame: within 10 minutes after procedure
measure: Mean satisfaction with the procedure
timeFrame: within 10 minutes after procedure
measure: Number of participants who guessed correctly whether they were given the active TENS or placebo TENS
timeFrame: within 10 minutes after procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02645617: Safety Evaluation of Advantage Anti-Caries Varnish
Official title: Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Lead sponsor: Advantage Dental Services, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 36
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.

Detailed description: This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium Fluoride \[Therametrics Technologies, Inc, Noblesville, IN, USA\]. The oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. The child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the follow-up, a qualified dental provider will ask questions focused on adverse events.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Weight less than 15 kg or hypersensitivity to iodine

Primary outcomes:
measure: Soft Tissue
timeFrame: within 48 hours
Secondary outcomes:
measure: Adverse Events
timeFrame: within 48 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Regional Clinical Dental Research Center
state: Washington
Study officials:
affiliation: Advantage Dental
name: Peter Milgrom, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02909517: The Role of Inflammation in Ocular Tumours
Official title: The Role of Inflammation in Ocular Tumours
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ocular Melanoma
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential study subjects will be identified from within the circle of care of the attending physicians. Subjects must be 18 years of age or older, be able to understand the study protocol, and provide informed consent. They must be able to attend all three visits

Brief summary: This prospective, non-therapeutic study will determine whether a novel imaging technique can identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours.

The investigators will evaluate 5 groups:

1. Choroidal nevus
2. Choroidal indeterminate melanocytic lesion
3. Choroidal melanoma
4. Suspected metastatic tumour (ie, primary tumour elsewhere)
5. Locally treated ocular tumours


Eligibility criteria: Inclusion Criteria:

Any tentative clinical diagnosis of:

1. Choroidal nevus (low-risk features):
2. Choroidal indeterminate melanocytic lesion (high-risk features)
3. Choroidal melanoma
4. Suspected metastatic tumour (ie, primary tumour elsewhere)
5. Locally treated ocular tumours

Note that a patient can enroll in this study twice, once before treatment and once after, provided that at least one month has passed since initiation of treatment. This patient will count twice (ie, once in each of two study arms)

Male and female age 18 years and older Ability to provide informed consent

Exclusion Criteria:

* Allergy to angiography dye
* Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
* Patients not able to provide consent for the study.
* Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
* Patients \< 18 years of age. Any concurrent unrelated eye diagnosis

Primary outcomes:
measure: Identification of macrophages
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre, Ontario
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Shelley Boyd, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940417: Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer
Official title: Cumulative Summation Analysis of Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasms
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients were scheduled to undergo minimally invasive gastric cancer surgery and meet the above conditions

Brief summary: The investigators prospectively collected the clinical data of Da Vinci robot-assisted radical gastrectomy patients conducted by the same group of physicians from October 2017 to October 2018. The learning curve of the surgery was analyzed with the moving average method and the cumulative sum analysis (CUSUM). The short-term efficacy was then validated by comparing the perioperative and pathologic outcomes of patients in the two stages of the learning curve.


Eligibility criteria: Inclusion Criteria:

* 1.Patients were 18-90 years old
* 2. Patients with a documented diagnosis of gastric adenocarcinoma
* 3. patients were scheduled to undergo minimally invasive gastric cancer surgery
* 4.patients with no preoperative evidence of serosal invasion or extraperigastric lymph node metastasis on preoperative computed tomography scans, upper endoscopy, and endoscopic ultrasound

Exclusion Criteria:

* 1. Patients with neoadjuvant treatment
* 2. Patients procedure concurrent with the gastrectomy
* 3.Patients with palliative surgery
* 4. Patients with the contraindications for general anesthesia
* 5. Patients were pregnant or mentally incompetent
* 6. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension

Primary outcomes:
measure: Operation time,min
timeFrame: 1 week
measure: Docking time,min
timeFrame: 1 week
Secondary outcomes:
measure: Evaluated blood loss ,ml
timeFrame: 1 week
measure: Number of retrieved lymph nodes
timeFrame: 1 week
measure: Day of ﬁrst ﬂatus,day
timeFrame: 2 week
measure: Day of ﬁrst ﬂuid diet,day
timeFrame: 2 week
measure: the rate of postoperative complications
timeFrame: 30 days after the operation
measure: postoperative hospital stay, days
timeFrame: 30 days after the operation
measure: cost
timeFrame: 30 days after the operation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
Study officials:
References: