louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00792259: Topcon 3D OCT-1000 Optical Coherence Tomography System
Official title: Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Disease
Glaucoma
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2008-11-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ophthalmology practice

Brief summary: The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.


Eligibility criteria: Retinal Disease Study

No Retinal Disease:

Inclusion Criteria:

* Male or female
* Between 18 and 80 years of age
* Either eye, but only one eye per subject will be enrolled
* Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.

Exclusion Criteria:

* Any known ocular disease
* Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.
* Topcon image quality factor ≤ 44 or Stratus signal strength \< 5.

Retinal Disease

Inclusion Criteria:

* Male or female
* Between 18 and 80 years of age
* Either eye, but only one eye per subject will be enrolled
* Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study
* A range of retinal thickness will be included
* Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.

Exclusion Criteria:

* Presence of glaucoma
* Topcon image quality factor ≤ 44 or Stratus signal strength \< 5.

Primary outcomes:
measure: Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
timeFrame: 30 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bronxville
country: United States
facility: Retina Consultations
state: New York
city: New York
country: United States
facility: New York Eye and Ear-Glaucoma Associates of New York
state: New York
city: New York
country: United States
facility: Vitreous-Retina-Macula Consultants of NY
state: New York
city: New York
country: United States
facility: SUNY
state: New York
Study officials:
References:
Clinical trial NCT00637559: Barrett's Esophagus - 315 - 3 Way Cross-Over
Official title: A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Barrett's Esophagus
Keywords: Nexium
Barrett's esophagus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.


Eligibility criteria: Inclusion Criteria:

* Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months

Exclusion Criteria:

* A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.
* History of various gastrointestinal diseases - please see investigator for full list.
* Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.
* Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.

Primary outcomes:
measure: To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
timeFrame: pH measured on Day 5
Secondary outcomes:
measure: Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.
timeFrame: pH measured
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT01761500: Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Childhood Non-Hodgkin's Lymphoma
Keywords: Non-Hodgkin's lymphoma;
Childhood and adolescence;
Survival Rate
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol in Chinese children and adolescents with Non-Hodgkin's lymphoma.

Detailed description: Non-Hodgkin's Lymphoma (NHL) in children and adolescents include Burkitt's lymphoma (BL), diffuse large B cell lymphoma (DLBL), anaplastic large cell lymphoma (ALCL) and lymphoblastic lymphoma (LBL). These subtypes of NHL are an aggressive group of diseases. At present, in developed countries, 80 to 90% of children with NHL are cured by intensive, risk-adapted chemotherapy.The best protocols include BFM-90, LMB-89 and FAB/LMB/96. However, in developing countries, such as those with low and moderate incomes, the limited availability of resources is an obstacle for using these complicated and intensive protocols.As such, very simple protocols, such as the CHOP protocol, were often used to treat children and adolescents with NHL, thus resulting in poor survival rates. To improve the survival rate of Chinese children and adolescents with NHL, This study was designed to evaluate the efficacy and toxicity of this modified NHL-BFM -90 protocol in Chinese children and adolescents with NHL.

Eligibility criteria: Inclusion Criteria:

1. Untreated children and adolescents with Non-Hodgkin's lymphoma
2. Age ≤ 20 years
3. The informed consent of their guardians was obtained.

Exclusion Criteria:

1. Recurrence Non-Hodgkin's lymphoma
2. Age \>20 years
3. No abide by the protocol

Primary outcomes:
measure: The event free survival (EFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 5 years
Other outcomes:
measure: the characteristics of Chinese children and adolescents with NHL
timeFrame: Up to 5 years
Locations:
Study officials:
References:
Clinical trial NCT06082700: Correlation Between Missing Posterior Teeth and Vertical Dimension Measurements With Temporomandibular Joint Disorders in a Sample of Adult Egyptian Subjects
Official title: Correlation Between Missing Posterior Teeth and Vertical Dimension Cephalometric Measurements With Temporomandibular Disorders in a Sample of Adult Egyptian Subjects: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Correlation Between Missing Posterior Teeth and Vertical Dimension Cephalometric Measurements With Temporomandibular Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 93
Sex: ALL
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Male and female patients with 2 or more missing posterior teeth seeking treatment at the faculty. Age: 16-49 years.

Brief summary: The goal of this observational study is to learn about the correlation between missing posterior teeth and vertical dimension cephalometric measurements with temporomandibular disorders in a sample of adult Egyptian subjects in. The main questions it aims to answer are:

* Is there a correlation between missing posterior teeth and temporomandibular disorders?
* Is there a correlation between vertical dimension cephalometric measurements and temporomandibular disorders? Participants will be asked for the following:-

  * to give their phone numbers \& it will be collected through the orthodontic department patient's database ensuring complete confidentiality.
  * to fill Personal data chart (name, age, date of birth, mobile number, address).
  * to receive Clinical examination to determine number of missing teeth.
  * to receive Clinical examination to diagnose TMD using the DC/TMD.
  * to do Lateral cephalometric radiograph to measure the vertical dimension.


Eligibility criteria: Inclusion Criteria:

* Male and female patients with 2 or more missing posterior teeth seeking treatment at the faculty.
* Age: 16-49 years.

Exclusion Criteria:

* - Patients who refuse to participate in the study.
* Patients younger than 16 years.
* Subjects who received previous TMD treatment.
* Subjects suffering from systemic conditions which may affect the functioning of TMJ, for example, rheumatoid arthritis, scleroderma, and septic arthritis.
* Subjects with a history of trauma to the maxillofacial area.
* Subjects with a previous history of maxillofacial surgery.
* Subjects with a history of malignancy or current malignancy of the maxillofacial area.

Primary outcomes:
measure: temporomandibular disorder
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
state: Cairo, Manial
Study officials:
References:
Clinical trial NCT02804100: Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients
Official title: A Multi-centre Observational Study on Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients Under Gefitinib Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Keywords: Circulating Tumor DNA
Lung cancer
Plasma DNA
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NSCLC patients with activating EGFR mutations

Brief summary: A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Histologically confirmed stage IIIB/IV NSCLC.
* Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
* Able to comply with the required protocol and followed-up procedures, and able to receive oral medications

Exclusion Criteria:

* Histologically confirmed small cell lung cancer or other metastatic tumors
* Patient had received prior chemotherapy or EGFR-TKIs treatment
* Patients who harbor Exon20 T790M mutation

Primary outcomes:
measure: dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Wenfeng Li, Ph.D
role: STUDY_CHAIR
References:
citation: Yang Z, Li J, Hu Y, Chen M, Peng D, Zong D, Shang Q, Tao L, Zhao Y, Ni Y, Ye J, Xie Y, Yang L, Lin Q, Cai C, Xu N, Huang X, Dong X, Zhou Z, Yu Y, Shangguan Z, Xu Y, Ying W, Weng M, Yuan Z, Dong Z, Li J, Zheng Z, Pan J, Liu L, Ye J, Zhang Z, Li W, Zhu J, Jin S, Li Y, Ding C. Dynamics of Plasma EGFR T790M Mutation in Advanced NSCLC: A Multicenter Study. Target Oncol. 2019 Dec;14(6):719-728. doi: 10.1007/s11523-019-00682-0.
Clinical trial NCT03996200: MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
Official title: A Prospective, Open, Multicentre Clinical Trial Analysing the Efficacy and Safety of Miniject (MINI SO627) in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications Using a Single Operator Delivery Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Glaucoma Eye
Keywords: glaucoma
medical device
MIGS
drainage device
eye
reduction IOP
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2019-06-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MINIject SO627
Primary purpose: TREATMENT

Brief summary: Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.

Detailed description: The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 or grade 4 according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg \< IOP \< 35 mmHg in the study eye at baseline visit.

Exclusion Criteria:

* Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
* Neovascular glaucoma in the study eye.
* Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
* Prior glaucoma surgery in the study eye.

Primary outcomes:
measure: medicated diurnal IOP
timeFrame: 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Clinica Oftalmologica del Caribe
city: Hyderabad
country: India
facility: Maxivision Eye Hospital
state: Telangana
city: Panama City
country: Panama
facility: Panama Eye Center
Study officials:
affiliation: iSTAR
name: Zubair Hussain, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05175300: Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
Official title: Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Arthropathy
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-centre, prospective, randomised, single-blind, comparative, category 2 study of two parallel groups of patients undergoing total hip arthroplasty:

* Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
* Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
Primary purpose: PREVENTION

Brief summary: Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.

Detailed description: A single-centre, prospective, randomised, single-blind, comparative study of two parallel groups of patients undergoing total hip arthroplasty:

* Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
* Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 to 65 years,
* Who have signed their consent to participate in the study,
* For whom an indication for total hip arthroplasty has been given

Exclusion Criteria:

* History of hip surgery
* Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly)
* Hip dysplasia
* Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis
* Sequelae of neurological disease or stroke
* Pregnant or breastfeeding women
* Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
* Patient likely not to return for follow-up visits
* Patient already included in another therapeutic study protocol
* Patient under court protection, guardianship or curatorship.

Primary outcomes:
measure: five-year wear thickness of the two friction pairs
timeFrame: Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
Study officials:
References:
Clinical trial NCT03357900: Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study
Official title: Closed-loop Anaesthesia for Liver Transplantation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Liver Transplant
Keywords: Consciousness Monitor
Clinical Pharmacology
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 12
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: Automated titration of propofol and remifentanil guided by the bispectral index (BIS) has been used for numerous surgical procedures. Orthotopic liver transplantation (OLT) uniquely combines major volaemic changes, an anhepatic phase, and ischaemia-reperfusion syndrome. We assessed the behaviour of this automated controller during OLT


Eligibility criteria: Inclusion Criteria:

Patients scheduled for OLT

Exclusion Criteria:

age younger than 18 years, pregnancy, allergy or hypersensitivity to propofol or remifentanil, a medical history of psychiatric illness, and supraspinal neurological disorders

Primary outcomes:
measure: percentage of time spent in the BIS interval [40-60]
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00522600: Eye Drop Use in Glaucoma Patients Through Patient Surveys and Video Observations
Official title: Evaluation of Eye Drop Administration in Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Dry Eye Syndrome
Conjunctivitis
Keywords: eyedrops
compliance
glaucoma medications
adherence
Lead sponsor: Robin, Alan L., M.D.
Sponsor class: INDIV
Collaborators: name: Alcon Research
First posted: 2007-08-30
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 173 subjects enrolled and 222 video recordings were made. Ages ranged from 21-94 years old (mean:67 yrs) and subjects were 55% female and 70% caucasian.

Brief summary: This study will be used to evaluate how patients put eye drops in their eyes and any problems that may arise from this activity. The information gathered will help identify common problems patients are having with putting in their eye medications. Then doctors can be better informed about the issues and provide better advice to their patients to overcome these problems.

Detailed description: Approximately 100 patients will take part in a one time procedure and survey as part of this project. After appropriate consent patients are asked to complete a short 2 page survey about themselves and their eye drops. Then a video recording will be made of the patient instilling eye drops in their habitual manner. The eye drops used will be sterile saline placed in either Travatan-like or Systane bottles to simulate the corresponding prescribed medication. The videos will be graded for instillation technique and combined with scoring of survey answers.

Patients will be asked to instill the drops to their left eye with their dominant hand as we expect this to be most difficult. Patients with severe (\>20/200) vision loss will instill drops into their better seeing eye.

Eligibility criteria: Inclusion Criteria:

* Currently using topical glaucoma medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: ALan L Robin MD PA
state: Maryland
Study officials:
affiliation: Alan L Robin MD PA
name: Jennifer L Stone, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alan L Robin MD PA
name: Alan L Robin, MD
role: STUDY_DIRECTOR
References:
citation: Stone JL, Robin AL, Novack GD, Covert DW, Cagle GD. An objective evaluation of eyedrop instillation in patients with glaucoma. Arch Ophthalmol. 2009 Jun;127(6):732-6. doi: 10.1001/archophthalmol.2009.96.