louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04567745: Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
Official title: Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Vascular Dementia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Eyenuk, Inc.
name: Malavika Bhaskaranand PhD
name: Kaushal Solanki
First posted: 2020-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer's disease, and vascular dementia.


Eligibility criteria: Inclusion Criteria:

- Patients older than 18 years and diagnosed with mild cognitive impairment (MCI), Alzheimer's disease (AD), or vascular cognitive impairment and/or dementia (VaD).

Exclusion Criteria:

* Children and subjects with other diagnoses than those mentioned in the inclusion criteria.
* Patients without the means to visit the clinic on the assigned dates.
* Patients who are pregnant or are expecting to become pregnant.

Primary outcomes:
measure: retinopathy features identification
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Oana Dumitrascu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302145: Drug to Drug Interaction Study With ASP1941 and Metformin
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel Design Study, in Patients With Type 2 Diabetes Mellitus, to Investigate the Safety, Pharmacokinetics and Pharmacodynamics Interactions of Multiple Oral Doses of ASP1941 and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: pharmacokinetics
metformin
Drug to drug interaction
ASP1941
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 36
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: BASIC_SCIENCE

Brief summary: A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes
* Stable disease under metformin monotherapy (between 1500-3000

mg/day) or dual therapy with metformin (1500-3000 mg/day) and a Sulfonylureum Derivative (SUD) for at least 3 months

* Fasting Serum Glucose: 7-11.5 mmol/l (after wash-out)
* Stable Fasting Blood Glucose (FBG) at the end of wash-out
* BMI between 18.5 and 40.0 kg/m2, inclusive

Exclusion Criteria:

* Subjects with type 1 diabetes
* Any diabetes related macro-complications, painful diabetic neuropathy, diabetic macular edema or diabetic proliferative retinopathy
* Clinical significant renal disease (CLcr \<60 ml/min as assessed during a 24h creatinine clearance on Day-2
* Recent evidence (e.g. within the last 6 months) of severe hypoglycemia, for example plasma glucose \<3 mmol/l (\<55 mg/dl) or requiring hospitalization
* Pulse \<40 or \>90; Systolic Blood Pressure \>160 mmHg; Diastolic Blood Pressure \> 100 mmHg

Primary outcomes:
measure: Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring
timeFrame: 5 weeks
Secondary outcomes:
measure: Pharmacodynamics assessed by serum glucose change
timeFrame: 5 weeks
measure: Pharmacokinetics assessed by metformin plasma concentration change
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Balatonfured
country: Hungary
city: Budapest
country: Hungary
city: Groningen
country: Netherlands
city: Warsaw
country: Poland
city: Bratislava
country: Slovakia
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Veltkamp SA, van Dijk J, Collins C, van Bruijnsvoort M, Kadokura T, Smulders RA. Combination treatment with ipragliflozin and metformin: a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus. Clin Ther. 2012 Aug;34(8):1761-71. doi: 10.1016/j.clinthera.2012.06.027. Epub 2012 Jul 15.
Clinical trial NCT05909345: Examination of Foot Posture's Change on Balance in Different Disorders
Official title: Examination of Foot Posture's Change on Balance in Different Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Knee Osteoarthritis
Keywords: back pain
Knee Osteoarthritis
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 132
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To evaluate the foot postures and balances of individuals with knee osteoarthritis and nonspecific low back pain.

Brief summary: Foot; It is a terminal joint that opposes external resistance in the lower kinetic chain. It plays a primary role in weight transfer and ground response between the body and the ground.

Detailed description: To investigate the extent to which foot posture affects balance and foot function in different disease groups. The amount of studies examining the effect of the postural structure of the foot and balance seen in different disease groups in the literature is insufficient.

Eligibility criteria: Inclusion criteria;

* Being between the ages of 45 - 65,
* Volunteer. Exclusion criteria;
* Having a musculoskeletal or neuromuscular disease that limits mobility,
* Presence of lower extremity sequelae,

Primary outcomes:
measure: Navicular Drop Test
timeFrame: one day
measure: Foot Posture Index
timeFrame: one day
measure: Y Balance Test
timeFrame: one day
Secondary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: one day
measure: Western Ontario and MacMaster (WOMAC)
timeFrame: one day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol hospital
state: Istanbul Avrupa Kitasi
Study officials:
References:
citation: Sporndly-Nees S, Dasberg B, Nielsen RO, Boesen MI, Langberg H. The navicular position test - a reliable measure of the navicular bone position during rest and loading. Int J Sports Phys Ther. 2011 Sep;6(3):199-205.
Clinical trial NCT05992805: ScanNav Anatomy PNB Data Collection Study
Official title: ScanNav Anatomy PNB Data Collection Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Data Collection
Lead sponsor: IntelligentUltrasound Limited
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers.

Brief summary: Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.

Detailed description: Volunteer study to gather additional ultrasound training and/or validation data for Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.

Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Training and/or validation data (in the form of recorded ultrasound scans)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Hodge House
Study officials:
References:
Clinical trial NCT00515905: One-lung Ventilation: Expression of Pulmonary Inflammatory Mediators
Official title: Lung: One-lung Ventilation: Expression of Pulmonary Inflammatory Mediators After Deflation and Re-expansion of the Lung During Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery With One-lung Ventilation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 76
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: PREVENTION

Brief summary: One-lung ventilation; organ protection; volatile anesthetics

One-lung ventilation has become a common procedure for thoracoscopic surgery. Two hypothesis will be tested in this study:

1. Are inflammatory mediators increased in the re-ventilated lung after short-period pulmonary collapse?
2. Does Sevoflurane influence the production of inflammatory mediators in the re-inflated lung? Therefore, this study will elucidate the potential protective effect of a volatile anaesthetic (sevoflurane) on the production of inflammatory mediators by the respiratory compartment of the lung, i.e. the alveolar epithelium.

   * Trial with immunomodulatory product / biological


Eligibility criteria: Inclusion criteria:

* Thoracic surgery (thoracotomy, thoracoscopy) with one-lung ventilation

Exclusion criteria:

* Immunosuppressive therapy
* Ongoing inflammatory processes

Primary outcomes:
measure: One-lung ventilation measurement in the re-ventilated lung after short-period pulmonary collapse
timeFrame: Sep 07
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT05052905: VR-based Remote Rehabilitation for Pediatric ABI
Official title: Virtual Reality Based Rehabilitation of Vestibular and Oculomotor Function for Pediatric ABI in a Home Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Pediatric
Lead sponsor: Libra At Home LTD
Sponsor class: INDUSTRY
Collaborators: name: Alyn Pediatric & Adolescent Rehabilitation Hospital
First posted: 2021-09-22
Enrollment: 2
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the feasibility and effectiveness of an at-home program of VR-based vestibular and oculomotor rehabilitation on improving postural stability, ocular motility and activities of daily living for children with mild to severe ABI


Eligibility criteria: Inclusion Criteria:

* They are ALYN patients undergoing physiotherapy for mild to severe ABI;
* They experience symptoms of vestibular function such as vertigo, postural instability, or impaired ocular motility;
* They are between the ages of 8 and 18;
* The time since injury/event is between 10 days and 1 year after the injury/event;
* They are able to maintain stable and dynamic positioning of the head;
* They able to walk with or without assistive equipment, or use a wheelchairs with no need for head support, defined by a LSS (level of sitting scale) score of 3 or greater (scale range: 1-8);
* Are able to understand basic instructions;
* Have sufficient visual acuity and visual field to identify and track mid-size objects on a screen.

Exclusion Criteria:

* Psychological, neurological or cognitive disorders which could impede participation, such as a history of epileptic seizures;
* Untreated benign paroxysmal positional vertigo (BPPV);
* Are in early post-operative stages (to avoid risk of bleeding or cerebrospinal fluid leak);
* Hearing impairment.

Primary outcomes:
measure: Vestibular Oculomotor Motor Screening (VOMS)
timeFrame: 6 months
measure: Pediatric Vestibular Symptom Questionnaire (PVSQ)
timeFrame: 6 months
measure: Convergence Insufficiency Symptom Survey (CISS)
timeFrame: 6 months
measure: Dizziness Handicap Inventory (DHI)
timeFrame: 6 months
measure: Dizziness Handicap Inventory for patients caregivers (DHI-PC)
timeFrame: 6 months
measure: Pediatric Quality of Life Inventory (PEDSQL)
timeFrame: 6 months
measure: Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)
timeFrame: 6 months
measure: Berg Balance Scale (Berg)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: ALYN Hospital Pediatric and Adolescent Rehabilitation Center
Study officials:
affiliation: ALYN Hospital Pediatric and Adolescent Rehabilitation Center
name: Naomi Gefen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01163305: PET-CT and Circulating Tumor Cells in Colorectal Cancer
Official title: Identifying an Early Indicator of Drug Efficacy in Patients With Advanced Colorectal Cancer - a Prospective Evaluation of Circulating Tumor Cells, Positron-emission Tomography Scan and RECIST Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Metastasis
Keywords: Identifying an early indicator of drug efficacy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with metastatic colorectal cancer

Brief summary: The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria.

Detailed description: 1. To determine if measuring both tumor metabolic response (via FDG-PET scan) \& circulating tumor cells (CirTC) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (CRC) who are undergoing first-line oxaliplatin-based chemotherapy.
2. To determine if a new method of assessing drug response (measuring tumor metabolic response via FDG-PET \& CirTC at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'Response Evaluation Criteria in Solid Tumors' - RECIST).

Eligibility criteria: Inclusion Criteria:

* Metastatic colorectal cancer patients not received prior drug treatment for metastatic CRC
* Age \>= 18 years
* (ECOG) performance status of 0-2
* Measurable tumor sites by RECIST criteria
* Adequate bone marrow, renal \& hepatic functions

Exclusion Criteria:

* Patients with diabetes mellitus
* presence of hyperglycemia
* Pregnant or lactating patients

Primary outcomes:
measure: Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 4 years
measure: Progression-free survival
timeFrame: 4 years
measure: serum carcinoembryonic antigen (CEA) level
timeFrame: 4 years
measure: Circulating tumor cells level changes at 4 weeks after chemotherapy
timeFrame: 2 years
measure: RECIST-based tumor response at 10 weeks after chemotherapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Brigette Ma, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01295905: Prospective Study of an Investigational Daily Disposable Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-02-15
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.


Eligibility criteria: Inclusion Criteria:

* Subjects with normal eyes who are not using any ocular medications.
* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
* Willing and able to wear spherical contact lenses for at least 5 days per week.
* Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
* Best spectacle-corrected visual acuity greater than or equal to 20/25.
* Manifest cylinder less than or equal to 0.75D.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any active anterior segment ocular disease that would contraindicate contact lens wear.
* Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of refractive surgery or irregular cornea.
* History of pathologically dry eye.
* Eye injury within twelve weeks immediately prior to enrollment for this trial.
* Currently enrolled in any clinical trial.
* Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
timeFrame: 3 months of wear, lenses replaced daily
Secondary outcomes:
measure: Overall Vision
timeFrame: 3 months of wear, lenses replaced daily
measure: Overall Comfort
timeFrame: 3 months of wear, lenses replaced daily
measure: Overall Handling
timeFrame: 3 months of wear, lenses replaced daily
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06761105: Using Anonymous Data from a Digital Tool for Medical History-Taking to Improve Healthcare Services
Official title: Observation of the Use of Digital Tools for Medical History-Taking in Primary Care and Utilization of Anonymous Routine Data for Health Services Research
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Health Services Research
Keywords: digital medical history
anonymized usage data
general practice
GP consultations
GP
health services research
Lead sponsor: University Hospital Goettingen
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lower Saxony, Germany

Brief summary: This study aims to understand how people use a mobile app that helps them record their symptoms before going to the doctor. Patients use the app on a tablet or other digital device. The app guides patients through a series of structured questions tailored to their symptoms. The data collected is then transferred to the practice's electronic record and is available to the treating doctor before and during the consultation.

In this project, anonymized usage data will be analyzed to contribute to the further development of the tool and to provide valuable insights for health services research.

Detailed description: In several studies the usability of digital medical history tools has been demonstrated. These tools allow acute complaints to be recorded using an app before a medical consultation and the data collected to be transferred to the electronic medical record.

The aim of the study is to investigate the effectiveness and use of a digital medical history tool that is becoming increasingly popular in general practice. To this end, it is aimed to evaluate anonymized usage data provided by the company that distributes the app, aidminutes gUG, as part of an observational study with the aim of identifying potential for further development and for questions of health services research (e.g. on the frequency of GP consultations, morbidity and frequency of complaints). This is a retrospective data analysis of anonymous routine data in a cross-sectional design.

Eligibility criteria: Inclusion Criteria:

* all patients that use the app in a general practice that agreed to provide data
* all ages (including children if the app is used by parent or legal guardian)
* all complaints chosen in the app

Exclusion Criteria:

* patients that use the app in a general practice that did not agree to provide data
* patients that use the app in a general practice outside of the federal state Lower Saxony

Primary outcomes:
measure: Use patterns
timeFrame: From enrollment to the end of app use, up to 8 years
Secondary outcomes:
measure: Data quality
timeFrame: From enrollment to the end of app use, up to 8 years
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Department of General Practice
state: Lower Saxony
Study officials:
References: