louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03006588: EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients
Official title: Fine Needle Aspiration of Retropharyngeal Lymph Node Guided by Endoscopic Ultrasound for the Diagnosis of Patients With Suspected Recurrent Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: FNA,EUS,retropharyngeal lymph node (RPLN),NPC
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: EUS-FNA for RPLN in NPC

Detailed description: To evaluate the safety and efficacy of a novel minimally invasive sampling technique -- fine needle aspiration (FNA) guided by endoscopic ultrasound (EUS), which aims to sample tissues from retropharyngeal lymph nodes (RPLN) for the diagnosis of patients with suspected recurrent nasopharyngeal carcinoma (NPC).

Eligibility criteria: Inclusion Criteria:

1. had undifferentiated, non-keratinizing carcinoma at the initial diagnosis (WHO, 1991 criteria) and no evidence of distant metastasis obtained before radiotherapy;
2. received regular chemotherapy with cytotoxic agents such as cisplatin, carboplatin, 5-fluorouracil, paclitaxel, etc, and coordinated with radiotherapy with standard doses (approximate 50-70 Gy) in nasopharynx and neck respectively. Within 3 months after radiotherapy, no local and distant lesions were found;
3. during regular follow-up , the enlarged RPLN was detected by MRI more than 6 months later since radiotherapy accomplished;
4. didn't receive chemotherapy radiotherapy, immunotherapy or salvage surgery from completion of radiotherapy to suspicious recurrent lesion in RPLN detected;
5. no recurrent lesion in nasopharynx was found by white light endoscopy as well as cancer cell negative in pathology by bite biopsy;
6. single lesion in RPLN, and no other recurrent or metastatic lesion was found in local region or distant organ.
7. the minimum axial diameter of RPLN was more than 5mm.

Exclusion Criteria:

* (1) patients with nasal stenosis; (2) patients with coagulation dysfunction; (3) patients with distant metastasis

Primary outcomes:
measure: Accuracy
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jian-jun Li, MD & Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00896688: Ultrasound Guided Diagnostic Cervical Medial Branch Block
Official title: Ultrasound Guided Diagnostic Cervical Medial Branch Block
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Facet Joint Pain
Neck Pain
Keywords: cervical branch block
fluoroscopic guidance
ultrasound guidance
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2009-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been well established. However, recently some studies have shown that the diagnostic cervical and lumbar medial branch block can be done under ultrasound guidance.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* patients who have headache, neck pain, and shoulder pain due to possible facet joint disease

Exclusion Criteria:

* patients/volunteers with BMI \> 35
* patients/volunteers with short thick neck
* coagulopathy
* allergy to local anesthetic, ultrasound gel
* patient unable to fill out post procedure pain diary

Primary outcomes:
measure: To determine the efficacy of the use of ultrasound for diagnostic cervical medial branch block on pain patients who have developed neck pain, cervicogenic headache, or shoulder pain.
timeFrame: At time of procedure
Secondary outcomes:
measure: Interventional pain procedure studies on chronic pain patients
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Joseph Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fishman SM, Smith H, Meleger A, Seibert JA. Radiation safety in pain medicine. Reg Anesth Pain Med. 2002 May-Jun;27(3):296-305. doi: 10.1053/rapm.2002.32578. No abstract available.
citation: Greher M, Scharbert G, Kamolz LP, Beck H, Gustorff B, Kirchmair L, Kapral S. Ultrasound-guided lumbar facet nerve block: a sonoanatomic study of a new methodologic approach. Anesthesiology. 2004 May;100(5):1242-8. doi: 10.1097/00000542-200405000-00028.
Clinical trial NCT02889588: Visual and Optics Impact of Refractive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Disorders
Keywords: Refractive Surgery
higher order aberrations
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing refractive surgery

Brief summary: Refractive surgery includes interventions to correct refractive errors, using a medical device such as a laser or an implant (intraocular lenses) or surgical instruments. The study distinguishes corneal interventions, carried on the surface of the eye, and intraocular interventions, performed on the lens or in the anterior or posterior chamber of the eye. The number of procedures in refractive surgery is growing significantly. They seem to offer satisfactory visual results but a number of issues remains unresolved. In order to get emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower orders (ie spherical refractive error and astigmatism). This increases high-order aberrations (the most common is a bright halo on the edge of the image). The cutting of the flap to the surface of the cornea in the case of LASIK increases high-order aberrations, which have the effect of reducing post-surgical visual performance (ie visual acuity and contrast sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a post-operative cornea is more complex. It is therefore necessary to limit these post-surgical aberrations and to identify their possible sources. Indeed, some authors have provided insight into the effects of some high-order aberrations, but the influence of several factors characterizing the preoperative eye on refractive surgery are still unknown, such as pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.


Eligibility criteria: Inclusion Criteria:

* patient candidate for Laser in Situ Keratomileusis (LASIK) refractive surgery
* 18 to 40 years old
* corrective glasses or lenses ranging from -9.00 to + 6.00 diopter
* astigmatism less than or equal to 5 diopter

Exclusion Criteria:

* patient opposition to participate in the study
* patient under legal protection
* Pregnant or breast feeding patient
* no health insurance coverage

Primary outcomes:
measure: number of high order aberrations after refractive surgery
timeFrame: 3 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Imène SALAH
role: STUDY_DIRECTOR
affiliation: Fondation OPH A de Rothschild
name: Damien GATINEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05080088: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies
Official title: A Pilot Study: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy: Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS ™ System, the Artificial Intelligence GI GENIUS ™ Alone and Colonoscopy Alone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoma Colon
Colorectal Cancer
Colorectal Polyp
Colonic Adenocarcinoma
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients are recruited during a pre-colonoscopy consultation, carried out by the gastroenterologist in current practice

Brief summary: Retrospective study, single blind (patient), allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit, to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm :

* Colonoscopy Only Group
* Artificial intelligence only group (IA GI GENIUS ™ alone)
* Endoscopic Cap and Artificial Intelligence Group (endoscopy cap associated with the GI GENIUS ™ IA System)


Eligibility criteria: Inclusion Criteria :

* 18 years \< Patient \< 85 years
* Need to perform a primary and / or secondary screening colonoscopy for colorectal cancer
* Patients candidates for outpatient care

Exclusion Criteria :

* History of inflammatory digestive tract disease
* Failed previous colonoscopy
* Known familial polyposis
* Biopsy / polypectomy contraindication (coagulation disorder, treatment with CLOPIDOGREL / Anticoagulant)

Primary outcomes:
measure: Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software
timeFrame: 4 months
Secondary outcomes:
measure: Adenomas Rate according to their morphology
timeFrame: 4 months
measure: Adenomas Rate according to their size
timeFrame: 4 months
measure: Adenomas Rate according to their histology
timeFrame: 4 months
measure: Caecal Intubation Rate
timeFrame: 4 months
measure: Withdrawal time
timeFrame: 4 months
measure: Adverse effects
timeFrame: 4 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nîmes
state: Gard
Study officials:
References:
Clinical trial NCT00600288: Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)
Official title: A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-01-24
Enrollment: 261
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: The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent prior to any study procedures being performed.
* Have a best corrected visual acuity (BCVAof +0.7 or better.
* Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
* Have ongoing dry eye disease, in the same qualifying eye or both eyes.

Exclusion Criteria:

* Have previously had LASIK refractive surgery.
* Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
* Have had penetrating intraocular surgery in the past 90 days.
* Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.
* Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
* Any serious ocular systemic disease or uncontrolled medical condition.
* Exposure to any investigational drug within 30 days of study start.

Primary outcomes:
measure: Change in fluorescein staining scores of the cornea
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Saiid Davari
role: STUDY_DIRECTOR
References:
Clinical trial NCT05914688: A Study to Compare Two Formulations of LY3209590 in Healthy Participants
Official title: A Bioequivalence Study of Subcutaneous Injections of LY3209590 in Two Formulations in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Formulation
Bioavailability
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 67
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated.

Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.


Eligibility criteria: Inclusion Criteria:

* Male or female participants who are overtly healthy as determined by medical evaluation
* Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
* Contraceptive use by participants should be consistent with local regulations

Exclusion Criteria:

* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have known allergies to LY3209590, related compounds, or any components of the formulation
* Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Are lactating or pregnant

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590
timeFrame: Predose up to 65 days post dose
measure: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
timeFrame: Predose up to 65 days post dose
measure: PK: Maximum Observed Concentration (Cmax) of LY3209590
timeFrame: Predose up to 65 days post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
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 NCT02352688: RCT on Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Care
Official title: A Randomised Controlled Trial on Preoperative Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Input
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: elderly
enhanced recovery after surgery
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 74
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of enhanced geriatric input on elderly patients undergoing colorectal cancer surgery. Half of the participants will received additional pre, peri and post-operative care from the geriatric team, while the other half will receive standard surgical care.

Detailed description: Additional geriatric care involves appropriate assessments and interventions by a multidisciplinary team involving geriatricians, physiotherapist, occupational therapist, surgical team, dietician and social worker. It is divided into three stages of care: 1) preoperative assessment, 2) perioperative care and 3) discharge or rehabilitation. In preoperative assessment, a comprehensive geriatric assessment will be carried out which encompasses patients medical and social backgrounds, cognitive status, nutritional assessment and risk factors identification. Perioperative care includes a joint care by surgical and geriatric teams aiming to prevent and treat any postoperative complications. Discharge and rehabilitation aim to identifies and facilities any potential discharge problem or accelerates patients for rehabilitation to the appropriate locations.

Standard surgical care will be given to patients who are undergoing colorectal cancer surgery but without the additional input mentioned above.

Eligibility criteria: Inclusion Criteria:

1. Consecutive colorectal cancer patients (aged 70 and over) undergoing elective colorectal cancer surgery at the Prince of Wales Hospital, Shatin, Hong Kong
2. American Society of Anaesthesiologists fitness score of I, II or III

Exclusion Criteria:

1. Colorectal cancer patients aged 69 or under undergoing colorectal surgery
2. Patients undergoing emergency colorectal cancer resection
3. Patients with benign pathology
4. Patients with evidence of locally advanced or metastatic spread of their primary disease
5. Patient who are unable to give informed consent

Primary outcomes:
measure: Length of postoperative hospital stay
timeFrame: up to 90 days
Secondary outcomes:
measure: 30-day morbidity
timeFrame: 30 day from time of surgery
measure: 30-day mortality
timeFrame: 30 day from time of surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China
name: Tony Mak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03448588: Research on Association Between Selenium Deficiencies and Change of Thyroid Function
Official title: Effect of Selenium Deficiency on Thyroid Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Selenium Deficiency
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from volunteers who undergo health examination in Peking Union Medical College Hospital and meet the inclusion criteria.

Brief summary: As one of the essential micronutrients, selenium has important biological functions. However, an effective and convenient method for evaluation of selenium nutritional status has not yet been established. Previous literature has disclosed effect of selenium deficiency on inactivating glutathion peroxidase and deiodinase, which may cause decreased conversion from thyroxine ( T4) to triiodothyronine (T3). A case-control study is designed to demonstrate the association between selenium deficiency and abnormally elevated T4 or T4/T3, which may provide more clues for establishing effective selenium assesment methods.


Eligibility criteria: Inclusion Criteria:

* with normal free triiodothyronine( FT3), free thyroxine (FT4) and thyroid-stimulating hormone (TSH).
* without thyroid hormone replacement therapy
* without medical history of thyroid surgery
* without iodine radiotherapy;

Exclusion Criteria:

* acute critical illness in the latest 1 year;
* weight fluctuation by more than 5% in the latest 3 months;
* eating disorders
* neuropsychological disorders
* allergy to corn or yeast
* fail to give informed consents.

Primary outcomes:
measure: between-group difference in serum selenium
timeFrame: up to 24 weeks
Secondary outcomes:
measure: between-group difference in serum deiodinase activity
timeFrame: up to 24 weeks
measure: between-group difference in erythrocyte glutathione peroxidase activity
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03390088: Heart Failure Management in Azerbaijan
Official title: The Clinical Profiles and Treatment Management of Chronic Heart Failure in Azerbaijan
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Keywords: Heart failure
Lead sponsor: World Heart Failure Society
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: outpatients with chronic heart failure

Brief summary: This study is proposed to determined a national database of the etiologies, clinical and the demographic profile, using diagnostic tests and treatment of outpatients with chronic heart failure in Azerbaijan population.

Detailed description: Chronic heart failure remains the leading cause of hospitalization for those over the age of 65 and expected to increase over the next 25 years with advancing life span. Being a progressive syndrome, CHF decreases the quality of life and place an economic burden on health care system.

Advanced technologies in interventional cardiology, better organization of angiographic laboratories and primary prevention of coronary artery disease as the leading cause of HF, allowed warning its development in CAD patients. But the incidence and prevalence of CHF continue to increase with age as heart failure with preserved ejection fraction predominates in elderly patients. For the moment more than 23 million people over the world suffer from heart failure.

The prevalence of these patients remains very high even in USA - over 5.8 million.However, there is no any database for heart failure patient in Azerbaijan.The purpose of this study is to compose a national database of the etiologies, clinical and demographic characteristics, using diagnostic tests and management of outpatients heart failure in Azerbaijan population.

Eligibility criteria: Inclusion :

* Patients \>18 years olds
* Clinical diagnosis of heart failure
* NYHA class II-IV heart failure

Exclusion :

* Patients \<18 years old
* Failure to obtain informed consent
* Pregnant or lactating

Previous cardiac transplantation

Primary outcomes:
measure: Heart failure related hospitalization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: Yasmin Rustamova
Study officials:
References: