louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00537992: Blue-Blocking IOLs in Combined Surgery
Official title: Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membranes
Macular Holes
Cataract
Keywords: combined surgery,
cataract surgery,
vitrectomy,
blue light-filter iols
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although commonly used in cataract surgery, the use of the blue light-filter IOLs in vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter IOL on the surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.

Detailed description: Sixty patients were randomly assigned to receive a UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure.

Outcome measures were intraoperative conditions for the surgeon, complication rates, the functional outcome and vitreoretinal diagnoses.

Eligibility criteria: Inclusion Criteria:

* Diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema)
* Coexisting significant cataract
* The need for combined surgery ( pars plana vitrectomy, phacoemulsification and IOL implantation)
* Age over 50 years.

Exclusion Criteria:

* Pseudophakia on the non-study eye
* The need for silicone oil tamponade
* Optic atrophy.

Primary outcomes:
measure: intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome
Secondary outcomes:
measure: complication rates and vitreoretinal diagnoses
Other outcomes:
Locations:
Study officials:
affiliation: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
name: Susanne Binder, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
name: Christiane I Falkner-Radler, MD
role: STUDY_DIRECTOR
References:
citation: Hayashi K, Hayashi H. Visual function in patients with yellow tinted intraocular lenses compared with vision in patients with non-tinted intraocular lenses. Br J Ophthalmol. 2006 Aug;90(8):1019-23. doi: 10.1136/bjo.2006.090712. Epub 2006 Apr 5.
citation: Olson RJ, Werner L, Mamalis N, Cionni R. New intraocular lens technology. Am J Ophthalmol. 2005 Oct;140(4):709-16. doi: 10.1016/j.ajo.2005.03.061. Epub 2005 Jul 18.
citation: Falkner-Radler CI, Benesch T, Binder S. Blue light-filter intraocular lenses in vitrectomy combined with cataract surgery: results of a randomized controlled clinical trial. Am J Ophthalmol. 2008 Mar;145(3):499-503. doi: 10.1016/j.ajo.2007.10.021. Epub 2008 Jan 11.
Clinical trial NCT06287892: Diagnosis of HCM With AI-ECG
Official title: Diagnosis of Hypertrophic Cardiomyopathy With Artificial Intelligence-enhanced Electrocardiogram
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes patients with HCM, and subjects without HCM as control.

Brief summary: The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with HCM

Exclusion Criteria:

* Patients with ventricular pacing

Primary outcomes:
measure: Diagnosis of HCM with AI-ECG
timeFrame: 1 year within the time frame of ECG data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Fudan University
name: Yixiu Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06125392: Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition
Official title: A Multicenter RegIstry on the Diagnosis of Patients with Chronic Angina and No Angiographic CoRonary Artery Stenosis (international Retrospective Collection of Anonymized Patient Data) - Searching a New Ach Spasm Definition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Microvascular Disease
Coronary Vasospasm
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with angina but no epicardial disease.

Brief summary: The MICRO-SNAPE registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in Europe and North America.

Detailed description: Microvascular dysfunction is an important determinant of patients´quality of life and prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear understanding and diagnosis has a potentially large clinical importance. It is therefore important to better describe the phenotype of these patients. The MICRO-SNAPE registry will allow investigating these associations. Patient data as collected during the local clinical practice and at the operator's discretion, will be retrospectively entered in this non-interventional registry in anonymous form.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent combined measurements of coronary pressure and flow in at least 1 native coronary artery in response to endothelium dependent and independent vasodilators.

Exclusion Criteria:

* Hemodynamic instability
* Age \<18 years

Primary outcomes:
measure: Identification of endotypes of coronary vasomotor function
timeFrame: immediately after the invasive measurement
Secondary outcomes:
measure: Accuracy of clinical criteria for the diagnosis of microvascular and epicardial spasm
timeFrame: immediately after the invasive measurement
measure: Normal values expressing endothelium-dependent coronary flow reserve
timeFrame: immediately after the invasive measurement
measure: Sex impact on coronary vasospasm measures
timeFrame: immediately after the invasive measurement
measure: Coronary bridge and epicardial spasm
timeFrame: immediately after the invasive measurement
measure: Acetylcholine versus adenosine responses
timeFrame: immediately after the invasive measurement
measure: Normal values and associations of resting microvascular resistances
timeFrame: Immediately upon measurment
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Center of Cardiology, Cardiology I, university hospital Mainz
state: Rheinland-Pfalz
Study officials:
References:
Clinical trial NCT06233292: A Study of ZG005 in Patients With Advanced Solid Tumors
Official title: A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.


Eligibility criteria: Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Male or female 18-70 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
* Life expectancy ≥ 3 months;
* Histologically or cytologically confirmed diagnosis of advanced solid tumors.

Exclusion Criteria:

* Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
* Any other malignancy within 5 years.

Primary outcomes:
measure: Dose Limiting Toxicities (DLT)
timeFrame: Up to 21Days
measure: Adverse Event (AE)
timeFrame: Up to 24 Months
measure: Objective Response Rate
timeFrame: Up to 24 Months
measure: Maximum tolerated dose (MTD)
timeFrame: Up to 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT02365792: Professional Development in Emergency Medical Services
Official title: Efficacy of a Clinical Decision Support System in Prehospital Care: Single Blind, Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Clinical Decision Support
Clinical Practice Guidelines
Emergency Medical Services
Keywords: Clinical Decision Support
Clinical Practice Guidelines
Emergency Medical Services
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 112
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The ProDEms-trial focuses on nurses and ambulance drivers working in prehospital care, taking care on the one hand of patients suffering from time-sensitive critical conditions like STEMI, acute stroke or severe traumatic brain injury, and on the other hand of patients whose lives are not in immediate danger but suffer from acute exacerbation of chronic conditions or suffer from acute pain.

In the current study the investigators will use a multistage approach to test the hypothesis whether the use of a CDSS in prehospital emergency care will: 1. Improve protocol adherence, 2. Reduce emergency department length of stay, 3. Improves diagnostic accuracy; without impeding the workflow of the prehospital team or impairing patient safety.


Eligibility criteria: Inclusion Criteria:

* Patients who receive treatment from the Paramedic Intervention Team (PIT) in the prehospital Emergency Medical Services (EMS) area of the University Hospitals, Leuven.

Exclusion Criteria:

* Patient-related interventions not dispatched by the Emergency Medical Dispatch center (EMD)
* Patient related interventions during transport between two healthcare facilities or in mass casualty situations.

Primary outcomes:
measure: Treatment protocol adherence
timeFrame: Up to 12 months
Secondary outcomes:
measure: Length of Stay in the ED
timeFrame: Up to 12 months
measure: Prehospital Patient Time Interval
timeFrame: Up to 12 months
measure: Consistency in reported diagnose and the choice of PIT standing order (-s) or procedure (-s)
timeFrame: Up to 12 months
measure: Alignment between diagnostic accuracy and interventions taken.
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Academic Center for General Practice
state: Vlaams-Brabant
Study officials:
affiliation: Academic Center for General Practice
name: Bert mr Aertgeerts, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04224792: Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
Official title: Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Thyroid Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients.


Eligibility criteria: Inclusion Criteria:

* Adults ≥18yrs of age with well-differentiated thyroid cancer and self-reported fatigue any time after initial treatment of thyroid cancer.
* English speaking
* Able to provide consent

Exclusion Criteria:

* Pregnant
* Medullary thyroid cancer
* Anaplastic thyroid cancer
* Physical limitations to perform exercise

Primary outcomes:
measure: Fatigue symptoms
timeFrame: Baseline, 12 weeks
measure: Physical activity
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Regina Castro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00719992: Diagnostic Value of HS-CRP in Stable Angina.
Official title: Diagnostic Value of HS-CRP in Stable Angina Patients With Positive Exercise Test as Compared With Coronary Angiography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Positive ETT
Keywords: Exercise tolerance test
HS-CRP
Coronary angiography
Patients
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 97
Sex: ALL
Minimum age (years): 43
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to assess the amount of additive value of HS-CRP levels to a positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using coronary angiography as the gold standard. The investigators concluded that HS-CRP can be used as a single predictor of coronary vessel involvement in patients with stable angina and positive ETT.

Detailed description: the investigators included 97 patients with positive ETT and stable angina and saw that Hs-CRP is the only predictor of severity of CAD as compared with coronary angiography in stable angina patients.

Eligibility criteria: Inclusion Criteria:

* Stable angina
* Positive ETT

Exclusion Criteria:

* Unability to perform ETT
* Contraindications for ETT and angiography study

Primary outcomes:
measure: significant coronary lesion
Secondary outcomes:
measure: severity of CAD
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Cardiology Ward Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: javad kojuri, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03901092: A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation
Official title: A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 PET Scan Interpretation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: flortaucipir F 18
Positron Emission Tomography
18F-AV-1451
Diagnostic imaging
Tau imaging
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 242
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Physician PET scan readers are participants, blinded to demographic and clinical data from the source PET scans.
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.


Eligibility criteria: Scan Reader Criteria (5 total):

* Board-certified in radiology or nuclear medicine
* Professional experience interpreting PET scans
* Naive to study protocol
* No previous training or exposure to Avid Flortaucipir F 18 read methodology

Scan Criteria:

- Previous enrollment in Study A05 confirmatory cohort (NCT02016560), or A16 (NCT02516046)

Scan Study Population Criteria for FR01 (A05 confirmatory cohort):

* Cognitively-impaired
* mild cognitive impairment (MCI) or dementia with suspected neurodegenerative cause
* mini-mental status exam (MMSE) score of 20-27, inclusive

Scan Study Population Criteria for FR01 (Study A16):

* Subjects at end of life (less than or equal to 6 months)
* Imaged with flortaucipir F18 and came to autopsy

Primary outcomes:
measure: Primary Objective 1 Analysis 1: Diagnostic Performance of Individual Readers (NFT Score)
timeFrame: baseline scan
measure: Primary Objective 1 Analysis 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis)
timeFrame: baseline scan
measure: Primary Objective 2: Inter-reader Reliability of Reader Interpretation of Flortaucipir-PET Imaging
timeFrame: baseline scan
Secondary outcomes:
measure: Secondary Objective 1 Analysis 1: Diagnostic Performance of τAD++ Flortaucipir PET Images to Detect B3 NFTs
timeFrame: baseline scan
measure: Secondary Objective 1 Analysis 2: Diagnostic Performance of τAD++ Flortaucipir PET Images to Detect High ADNC
timeFrame: baseline scan
measure: Secondary Objective 2: Inter-reader Reliability of Reader Interpretation of τAD++ Flortaucipir PET Images
timeFrame: baseline scan
measure: Secondary Objective 3: Inter-reader Reliability of Flortaucipir PET Scan Interpretation in the Population of Intended Use
timeFrame: baseline scan
measure: Secondary Objective 4: Intra-reader Reliability of Reader Interpretation of Flortaucipir-PET Imaging
timeFrame: baseline scan
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: American College of Radiology
state: Pennsylvania
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05860192: Virtual Reality Mindfulness in Preoperative Anxious Patients
Official title: Virtual Reality Mindfulness in Preoperative Anxious Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Test Anxiety
Anxiety State
Preoperative Period
Lead sponsor: Ospedale Regionale di Mendrisio
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to reduce preoperative anxiety by Virtual Reality mindfulness.

Population: all adults, able to give their consent and scheduled for surgery with high preoperative anxiety defined by Amsterdam Preoperative Anxiety and Information Scale (APAIS) score \> 10. The study will recruit 100 patients in one university teaching hospital.

The main question it aims to answer is: may mindfulness by Virtual Reality reduce preoperative anxiety in patients particularly anxious for the surgery? Participants will be asked to undergo to a single mindfulness virtual reality session before the surgery.


Eligibility criteria: Inclusion Criteria:

* adults able to give their consent, scheduled for elective surgery and with high preoperative anxiety defined by Amsterdam Preoperative Anxiety and Information Scale (APAIS) \> 10

Exclusion Criteria:

* Pregnancy
* Epilepsy
* Pacemaker wearers
* Mental diseases
* Alcohol or drug addiction
* Severe hearing loss or blindness
* Simultaneous participation to other studies

Primary outcomes:
measure: Change from one week before surgery in anxiety on STAI score some hours before the intervention
timeFrame: Up to two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mendrisio
country: Switzerland
facility: Andrea Polito
Study officials:
affiliation: Ospedale Beata Vergine
name: Andrea Polito
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00743392: HPV Infections in Older Women
Official title: HPV Infections in Older Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillomavirus Infections
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2008-08-28
Enrollment: 503
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 to 65 year old women who date online

Brief summary: The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year.

Detailed description: Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a longitudinal study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 300 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect four sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. We will identify behavioral and health predictors of type-specific HR HPV infections, predictors of repeatedly-detected HR HPV infections, and evaluate study participants' experiences with self-collecting vaginal specimens and attitudes towards HPV vaccination and cervical cancer screening. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women.

Eligibility criteria: Inclusion Criteria:

* Have had sex with men
* Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)

Exclusion Criteria:

* Pregnant, breastfeeding, or planning a pregnancy in the next 6 months
* Hysterectomy

Primary outcomes:
measure: High-risk HPV DNA
timeFrame: Every 4 months for 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Rachel L Winer, PhD
role: PRINCIPAL_INVESTIGATOR
References: