louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03611387: Artificial Intelligence Screening on Patients With Primary Angle Closure Glaucoma
Official title: Artificial Intelligence Screening on Patients With Primary Angle Closure Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ophthalmopathy
Keywords: Primary Angle-Closure Glaucoma
Artificial Intelligence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: University of California
First posted: 2018-08-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients ≥18 years old with or without glaucoma

Brief summary: The Tomey CASIA (Tomey Corporation, Nagoya, Japan) is a novel rapid imaging device that captures high-quality imaging of the entire anterior chamber of the eye over detailed imaging of a single section. In this prospective study, we want to investigate and compare the anatomical structure of the drainage angle of the eye in patients with different types glaucoma using Tomey machine. This study gives us a better understanding of the predictability, validity and accuracy of Tomey machine in the diagnosis of different types of glaucoma. Moreover, the data collected here will be used to create an artificial intelligence (AI) platform to screen certain type of glaucoma.

Detailed description: Patients ≥18 years old from ophthalmic clinics with or without glaucoma were enrolled to this respective observational clinical study. However, patients with any history of eye surgery (except cataract surgery) including laser procedure were excluded. The investigators will review patients' medical chart and update any medical history in your medical record. If new scans are needed, investigators will do them at the time of patients' current visit and it will require about 30 mins. CASIA SS-OCT (CASIA 2) is a non-contact scan of the front of the eye with higher resolution and provides deeper, wider and three- dimensional views. It is the newest scan machine. It is not FDA-approved but is approved in many other countries including Japan for patient use. We may perform the scan in the light and dark condition. We may also perform the routine scan to capture images of the anterior part of the eye for comparison purpose. The results of the scanned data will be among patients' medical records. Age, sex and ethnicity within your medical records will also be used for the analysis.

Eligibility criteria: Inclusion Criteria:

* Patient with or without glaucoma

Exclusion Criteria:

* Patients with any history of eye surgery (except cataract surgery) including laser procedure.
* Age \< =18 years

Primary outcomes:
measure: The accuracy of the CASIA 2 OCT
timeFrame: baseline
measure: The sensitivity and specificity of the AI
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00189787: Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma, Bronchial
Bronchial Asthma
Keywords: Tacrolimus
Immunosuppressant
Anti-asthmatic drug
Administration, inhalation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2005-09-19
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma
* Patients treated with inhaled corticosteroid
* FEV1 (forced expiratory volume in 1 second)\>60% to 80%

Exclusion Criteria:

* Respiratory infection within 2 weeks
* Asthma exacerbation within 90 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Brno
country: Czech Republic
city: Krhanice
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Sumperk
country: Czech Republic
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Deggendorf
country: Germany
city: Dusseldorf
country: Germany
city: Hannover
country: Germany
city: Munchen
country: Germany
city: Potsdam
country: Germany
city: Rudersdorf
country: Germany
city: Solingen
country: Germany
city: Wiesbaden
country: Germany
city: Budapest
country: Hungary
city: Csorna
country: Hungary
city: Fuzesabony
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szombathely
country: Hungary
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Tarnow
country: Poland
city: Wroclaw
country: Poland
city: Ekaterinburg
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Rostov-na-Donu
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kiev
country: Ukraine
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: R.G.M.vom Amsterdam, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03343587: A Study of LY3375880 in Healthy Participants
Official title: A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3375880 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.

This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
* Are women who are of childbearing potential or who are lactating

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Pre-dose to 3 months after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880
timeFrame: Pre-dose to 3 months after administration of study drug
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880
timeFrame: Pre-dose to 3 months after administration of study drug
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel Early Phase Unit at Glendale
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03301987: Chronic Kidney Disease & Therapeutic Exercise
Official title: Therapeutic Exercise in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney
Exercise
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the therapeutic exercise effects in patients with chronic kidney disease. An interventional prospective study is carried out. A sample of 9 patients with chronic kidney disease is recruited. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic kidney disease

Exclusion Criteria:

* Cognitive impairment and non signed consent inform form.

Primary outcomes:
measure: Kidney function
timeFrame: Change from Baseline creatinine clearance at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Galdakao
country: Spain
facility: Pierre Neyra Bohórquez
state: Bizkaia
Study officials:
References:
citation: Calvo-Lobo C, Neyra-Bohorquez PP, Seco-Calvo J. Aerobic exercise effects in renal function and quality of life of patients with advanced chronic kidney disease. Rev Assoc Med Bras (1992). 2019 Jun 3;65(5):657-662. doi: 10.1590/1806-9282.65.5.657.
Clinical trial NCT00519987: Multiple Dose Pharmacokinetics of Intranasal Ketamine
Official title: An Open Label, Single Center Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Administrations of 30 mg PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is an open label, single-center study of the pharmacokinetic and safety profile of repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Detailed description: To examine safety and characterize the repeat dosing plasma profile, effect on absorption, and accumulation following repeated administration of 30 mg doses of PMI-150 (intranasal ketamine) to healthy adult volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* under 18 years

Primary outcomes:
measure: pharmacokinetics
timeFrame: multiple
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Javelin Pharmaceuticals
name: Javelin Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04131387: The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence
Official title: The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Stress Urinary Incontinence
Keywords: Female Stress Urinary Incontinence
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: First Affiliated Hospital of Wenzhou Medical University
First posted: 2019-10-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Trail

Detailed description: 1. Study purpose: To evaluate the safety and efficacy of micro-energy ultrasound therapy in the treatment of female stress urinary incontinence
2. Study design: This is a randomized, double-blind, controlled, multi-center clinical trial
3. Study subjects: Females with mild to moderate stress urinary incontinence
4. Number of subjects: 60
5. Study center: The Second Affiliated Hospital, School of Medicine, Zhejiang University
6. Treatment methods:

Test group: After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.

Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Eligibility criteria: Inclusion Criteria:

1. patients diagnosed as mild to moderate female stress urinary incontinence in our hospital;
2. other conservative treatments are ineffective or have poor results, and the operator is not considered for the time being;
3. volunteer to participate in this clinical trial, complied with the requirements of this study and signed the informed consent form.

Exclusion Criteria:

1. other types of urinary incontinence;
2. blood routines indicate acute and chronic blood system diseases;
3. B-ultrasound suggests other gynecological diseases;
4. combine uncontrollable diseases such as diabetes, hypertension, and cardiovascular diseases;
5. previous or current history of pelvic surgery and radiotherapy and chemotherapy;
6. the investigator determined that it is not suitable for this clinical trial.

Primary outcomes:
measure: The score of ICI-Q-SF
timeFrame: change from baseline level at 2 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT00865787: Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function
Official title: Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Olivi Agri Team Srl- Grosetto, Italy
name: University of Florence
First posted: 2009-03-19
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic Patients

Brief summary: This study is being done to determine if the use of EGCG-Enhanced Extra Virgin Olive Oil in a daily diet will improve endothelial function.

Detailed description: Patients will be randomized to receive either placebo ROO (refined olive oil) or study solution EGCG-EVOO (EGCG enhanced extra-virgin olive oil) over the four month study period.

Eligibility criteria: Inclusion Criteria:

* Patients will be included in the study if they have an abnormal endothelial function study. This is defined at our institution as an RH-PAT index of less than 2. Patients will undergo two RH-PAT analyses and included abnormal values are obtained on either one or both tests. Only patients who provide written informed consent will be included.

Exclusion Criteria:

* Patients with normal baseline endothelial function studies defined as RH-PAT index \>2 will be excluded. Patients with uncontrolled hypertension \>180/100 while on medication on initial evaluation will also be excluded.

Primary outcomes:
measure: Supplementation with enhanced olive oil will improve endothelial function as assessed by the reactive hyperemia peripheral arterial tonometry (RH-PAT) in patients with coronary artery disease (CAD) risk factors and endothelial dysfunction
timeFrame: Baseline and post 4 month
Secondary outcomes:
measure: Supplementation of EGCG enhanced olive oil will reduce peripheral markers of endothelial dysfunction and inflammation, oxidative stress and inflammation
timeFrame: Baseline and post 4 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: St Marys Hospital
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Widmer RJ, Freund MA, Flammer AJ, Sexton J, Lennon R, Romani A, Mulinacci N, Vinceri FF, Lerman LO, Lerman A. Beneficial effects of polyphenol-rich olive oil in patients with early atherosclerosis. Eur J Nutr. 2013 Apr;52(3):1223-31. doi: 10.1007/s00394-012-0433-2. Epub 2012 Aug 8.
Clinical trial NCT02524587: Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Replacement
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 62
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: DIAGNOSTIC

Brief summary: The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.


Eligibility criteria: Inclusion Criteria:

* patients aged men and women 18 to 75 years
* with a primary or secondary osteoarthritis or osteonecrosis
* having a functional disorder requiring the installation of a total hip prosthesis of primary

Exclusion Criteria:

* patients aged 76 years or more
* pregnant or desiring to be for the duration of the study
* minors or adults protected
* repeated hip replacement
* cephalic prosthesis recovery or intermediate
* repeated cupules
* primary or secondary malignant tumor of the hip

Primary outcomes:
measure: penetration of the metal femoral head in acetabular
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Département d'orthopédie - traumatologie, CHU de Caen
Study officials:
References:
citation: Rochcongar G, Remazeilles M, Bourroux E, Dunet J, Chapus V, Feron M, Praz C, Buia G, Hulet C. Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial. Acta Orthop. 2021 Apr;92(2):151-155. doi: 10.1080/17453674.2020.1852785. Epub 2020 Dec 2.
Clinical trial NCT04410887: Neoadjuvant Chemotherapy With PISOXO for Locally-invaded-gastric Cancer (LIGC)
Official title: Neoadjuvant Chemotherapy With Pressurized Intra Peritoneal Aerosol Chemotherapy(PIPAC) Plus SOX Plus Olaparib (PISOXO) for Locally-invaded-gastric Cancer (LIGC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Stomach Cancer
Gastric Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 30
Sex: ALL
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: TREATMENT

Brief summary: The main purpose of this study is to compare the safety and efficacy of PIPAC+SOX+OLAPARIB for locally-invaded-gastric cancer (LIGC) patients in China. To obtain preliminary results for designing a new phase II/III randomized controlled trial.

Detailed description: Peritoneal metastases is the main cause of relapse and death after surgery in patients with serosa positive or locally-invaded-gastric cancer (LIGC). Recent researches showed that PIPAC and Olaparib are effective to control peritoneal metastases in different malignant diseases but it has not been tested for gastric cancer patients. The main purpose of this study is to compare the safety and efficacy of PIPAC+SOX+OLAPARIB for locally-invaded-gastric cancer (LIGC) patients in China. To obtain preliminary results for designing a new phase II/III randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
* Clinical stage: cTNM: T4b and or N0-3 M0
* Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
* Written informed consent

Exclusion Criteria:

* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
* Distant metastases
* Locally advanced inoperable disease (Clinical assessment)
* Relapse of gastric cancer
* Prior chemo or radiotherapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy

Primary outcomes:
measure: Pathological response rate
timeFrame: Upto three months after curative resection of the primary tumor
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Five years
measure: Disease free survival (DFS)
timeFrame: Three years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Birendra K Sah, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Chen Li, PH D
role: STUDY_DIRECTOR
affiliation: Ruijin Hospital
name: Zhenggang Zhu, PH D
role: STUDY_CHAIR
References: