louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06203314: Epstein-Barr Virus and Cancer Risks
Official title: Prospective Cohort Study on Epstein-Barr Virus Antibody and Cancer Risks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: EBV
Prospective study
Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Wuzhou Red Cross Hospital
name: Zhongshan People's Hospital, Guangdong, China
First posted: 2024-01-12
Enrollment: 100000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30-69 years old healthy residences in Zhongshan City and Wuzhou City.

Brief summary: The goal of this prospective cohort study is to investigate the associations between Epstein-Barr Virus (EBV) antibody levels and the risk of overall and site-specific cancer types in Southern China. The main questions it aims to answer are:

Question 1: In addition to the established EBV-associated cancer types, such as lymphomas, nasopharyngeal carcinoma, and stomach cancer, whether EBV is associated with other cancer types? Question 2: What's the cancer burden attributed to EBV in Southern China?

Detailed description: Growing molecular evidence suggests the involvement of EBV in various cancers, however, comprehensive epidemiological evidence is still lacking. In this study, researchers conducted a population-based prospective cohort study to investigate the associations between EBV antibodies and the risk of overall and site-specific cancer types in Southern China. All the participants underwent EBV antibody tests at enrollment and were subsequently followed up annually for cancer incidence, vital status, and immigration status. The primary objective of this study was to provide prospective evidence for the role of EBV in multiple cancers, shedding light on the etiology of a broad range of common EBV-associated cancers.

Eligibility criteria: Inclusion Criteria:

* Subject residents in Zhongshan or Wuzhou City;
* Subject has no medical record of prevalent cancer;
* Subject has psychical condition and well consciousness, and willingness to accept and cooperate with the study\&amp;#39;s follow-up procedures.

Exclusion Criteria:

* Subject has heavy cardiovascular, liver, or kidney disease;
* Subject has prevalent cancer.

Primary outcomes:
measure: Cancer incidence
timeFrame: 10 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 10 years
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
city: Wuzhou
country: China
facility: Wuzhou Red Cross Hospital
state: Guangxi
Study officials:
References:
Clinical trial NCT00333814: A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Intermediate Uveitis
Posterior Uveitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 229
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: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.


Eligibility criteria: Inclusion Criteria:

* 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Any active ocular infections

Primary outcomes:
measure: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
measure: Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)
timeFrame: Week 8
measure: Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score
timeFrame: Week 8
Locations:
city: Dallas
country: United States
state: Texas
city: Sydney
country: Australia
city: Vienna
country: Austria
city: São Paulo
country: Brazil
state: São Paulo/SP
city: Montreal
country: Canada
state: Quebec
city: Prague
country: Czech Republic
city: Paris
country: France
city: Heidelberg
country: Germany
city: Holargos
country: Greece
city: Hyderabad
country: India
city: Petah Tikva
country: Israel
city: Seoul
country: Korea, Republic of
city: Gdansk
country: Poland
city: Coimbra
country: Portugal
city: Johannesburg
country: South Africa
city: Madrid
country: Spain
city: Lausanne
country: Switzerland
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Lightman S, Belfort R Jr, Naik RK, Lowder C, Foster CS, Rentz AM, Cui H, Whitcup SM, Kowalski JW, Revicki DA. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. 2013 Jul 18;54(7):4864-70. doi: 10.1167/iovs.12-10981.
citation: Naik RK, Rentz AM, Foster CS, Lightman S, Belfort R Jr, Lowder C, Whitcup SM, Kowalski JW, Revicki DA. Normative comparison of patient-reported outcomes in patients with noninfectious uveitis. JAMA Ophthalmol. 2013 Feb;131(2):219-25. doi: 10.1001/2013.jamaophthalmol.102.
citation: Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
Clinical trial NCT02452814: Long Term Extension Study is Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
Official title: Long-term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCV
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include null responder subjects with Chronic hepatitis C (CHC) genotype 1 virus infection who have participated in Study SPC3649-205.

Brief summary: Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection


Eligibility criteria: Inclusion Criteria:

- Participated in Study SPC3649-205 (this would include those who completed study SPC3649-205, those who discontinued or terminated the study early for whatever reason (including treatment failure) and those who opted to receive approved therapy for the treatment of HCV infection).

Exclusion Criteria:

* Those unwilling to provide informed consent for participation in this study.
* Subjects who have received investigational drug therapy after discontinuation, termination, or successful completion of Study SPC3649-205.

Primary outcomes:
measure: Number of Participants with adverse changes in liver ultrasound results
timeFrame: Up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Transplant Physicians
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06924814: Technology-Based Distractions for Minor Procedures
Official title: Technology-Based Distractions for Minor Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Procedural Anxiety
Keywords: Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.


Eligibility criteria: Inclusion Criteria:

* Pediatric patient age between 4-17
* English speaking
* Parental consent/patient assent
* Undergoing minor procedure(s) at LPCH or Stanford Hospital

Exclusion Criteria:

* Patient does not consent
* Legal guardian not present to obtain consent
* Patient with a significant neurological condition or major developmental disability
* Patient experiencing nausea
* Patient with active infection of the face or hand
* A history of severe motion sickness
* A history of visual problems
* A history of seizures caused by flashing light
* Major surgery within the last 48 hours
* Patients who are clinically unstable or require urgent/emergent intervention
* Patient or parental preference for general anesthesia

Primary outcomes:
measure: Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures
timeFrame: baseline, immediately after the intervention
Secondary outcomes:
measure: Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures
timeFrame: baseline, immediately after the intervention
measure: To evaluate pain levels pre- and post-intervention, participants will complete the Numerical Rating Pain Scale (NRPS) for patients 12-17 years old.
timeFrame: baseline, immediately after the intervention
measure: To evaluate patient's, clinician's, and caregiver's satisfaction levels
timeFrame: immediately after the intervention
measure: To evaluate the patient's affect during the intervention using HRAD
timeFrame: during minor procedure
measure: To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC)
timeFrame: during minor procedure
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
Clinical trial NCT05605314: Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye
Official title: Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 500
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: pSS and DED patients who visited the dry eye clinic of Peking University Third Hospital from January 2021 to January 2028.

Brief summary: Primary Sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body.

Detailed description: Patients usually first seek for the ophthalmologist for severe dry eye symptoms, and most clinicians are ill-informed about Sjögren's syndrome dry eye disease (SS-DED), which can lead to missed diagnoses and misdiagnoses. Clinically, there are not many types of patients with pSS and the number of in-depth studies is small. Meanwhile, there are no specific drugs for the treatment of SS-DED, and most patients need to be treated with multiple methods to understand which methods are most effective. In this study, by establishing a clinical cohort of patients with different subtypes of dry eye with pSS, we explored the association between the primary organs affected by pSS and various biomarkers related to tear fluid and blood, and the association between the primary organs affected by pSS, tear components and blood markers and the severity of ocular involvement, symptom progression and prognosis. This study initially constructs a special cohort of patients with pSS ocular involvement, which may explain its pathogenesis from a new perspective in diagnose, classification and treatment.

Eligibility criteria: Inclusion Criteria:

* All enrolled DED participants met the criterion of TFOS DEWS II Definition and Classification Report and pSS-DED group also met 2016ACR/EULAR pSS diagnosis and classification consensus.

Exclusion Criteria:

* (1) patients were diagnosed as any rheumatic or systematic diseases that would probably affect tear function except for pSS and DED. (2) had a history of ocular trauma or surgery. (3) had a history of wearing contact lens. (4) had concomitant ocular lesions such as acute inflammation or infection, glaucoma or eyelid abnormalities. (5) cannot cooperate properly or finish related examinations.

Primary outcomes:
measure: ESSDAI
timeFrame: 2021.1~2028.1
Secondary outcomes:
measure: Schirmer
timeFrame: 2021.1~2028.1
measure: BUT，TMH
timeFrame: 2021.1~2028.1
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Liyuan Tao, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00619814: Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
Official title: Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colon polyps
Fecal occult blood test
Double contrast barium enema
Colonoscopy
Lead sponsor: VA Caribbean Healthcare System
Sponsor class: FED
First posted: 2008-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The research protocol aim is to compare diagnostic tools for the proper evaluation of patient with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl carcinoma. The purpose of this study is to determine if Double Contrast Barium Enema (DCBE), a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation of patients with positive fecal occult blood as compared to colonoscopy, which is considered the best evaluation method. Colonoscopy involves the direct visualization of the colon using a flexible instrument. This permits the removal of polyps and to obtain biopsies. It involves additional risks, discomfort and costs. In fact the DCBE is the experimental procedure in this protocol.

Additional aims of this study are: to determine the localization, number, size and pathologic characteristics, if applicable, of findings in colonoscopy and/or DCBE and to determine the patient preference between both studies.

This study is limited to those patients 50 years or older who are at average risk for colon cancer and who had a positive fecal occult blood screening test.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic patients older than 50 years of age, with at least one positive FOBT
* Without history of colon cancer and/or polyps
* Gross gastrointestinal bleeding or prior colonoscopy or DCBE
* Who were willing to participate in the study
* Were included in the investigation.

Exclusion Criteria:

* Patients with poor cardio-respiratory condition
* Coagulation deficiency, use of anticoagulants or other drugs affecting coagulation
* Severe renal or liver disease
* Hospitalized patients and palpable abdominal or rectal mass were excluded from the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00921414: Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
Official title: Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mantle Cell Lymphoma
Keywords: Mantle cell lymphoma
R DHAP
ASCT
Rituximab Maintenance
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Lymphoma Study Association
First posted: 2009-06-16
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.

Detailed description: Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.

Eligibility criteria: Inclusion Criteria:

* mantle cell lymphoma
* Initial immunophenotyping with CD20 and CD5.
* CD20+.
* t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
* Patient no previous treated.
* At least one tumor site accessible for assessment
* Aged \> 18 years \< 65
* ECOG \< or = 2.
* No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
* signed informed consent
* FEVG 50%

Exclusion Criteria:

* other type of lymphoma
* ECOG \> or = 3
* relapse
* serology VIH + Hepatite +
* diabetis

Primary outcomes:
measure: event-free survival (EFS) post Rituximab maintenance therapy
timeFrame: EFS post 4 years after maintenance
Secondary outcomes:
measure: duration of PFS of the entire group of patients.
timeFrame: Safety/efficacy of maintenance treatment
measure: duration of OS of the entire group of patients
timeFrame: safety/efficacy of treatment
measure: complete, partial and overall response rate after induction with R-DHAP and after ASCT.
timeFrame: safety/efficacy of all the treatment
Other outcomes:
Locations:
city: Nantes
country: France
facility: Regional University Hospital
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Steven LE GOUILL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Gouill S, Thieblemont C, Oberic L, Moreau A, Bouabdallah K, Dartigeas C, Damaj G, Gastinne T, Ribrag V, Feugier P, Casasnovas O, Zerazhi H, Haioun C, Maisonneuve H, Houot R, Jardin F, Van Den Neste E, Tournilhac O, Le Du K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Bene MC, Salles G, Tilly H, Lamy T, Gressin R, Hermine O; LYSA Group. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769.
Clinical trial NCT05123014: Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease
Official title: Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adenoviral Keratoconjunctivitis
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 45
Sex: ALL
Minimum age (years): 24
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: LENTICULE IMPLANTATION AND AUTOLOGOUS SERUM NEW APPROACH IN TREATMENT OF ADENOVIRAL KERATITIS DISEASE
Primary purpose: TREATMENT

Brief summary: Adenoviral keratitis(caused by adenovirus) is one of the most frequently diagnosed eye diseases. Most of these infections have symptoms like (Ocular itchiness and irritation, chemosis (conjunctival edema),photophobia, epiphora, foreign body sensation, epithelial keratitis etc.Adenoviral subepithelial infiltration is one of the most difficult complication to treat. Our purpose is to evaluate corneal transparency, recurrence, and visual acuity in patients with adenoviral subepithelial infiltration by first removing the infiltrative stroma with a smile and implanting the same volume of fresh lenticule in the prepared stromal pocket.

Detailed description: Our treatment of adenoviral keratitis using lenticule implantation and autologus serum it has been applied to patients who have received medical treatment(Antiviral medications, topical corticosteroids ,compresses, artificial tears, and topical cycloplegic) for a long time but have not been successful.

In OCT, firstly, the thickness of the adenoviral subepithelial infiltration in the cornea is calculated in microns, and extraction is performed accordingly with Small Incision Lenticule Extraction( SMILE )and fresh lenticule implanted stromal in the same volume. AS-OCT was evaluated using corneal topography and glass-corrected best visual acuity (BSCVA) measurements and electron microscopy. Postoperative complications were recorded during the follow-up period.

The patients were followed for one year. No complications were observed in the patients. After the operation, there was an increase in satisfaction and vision. They returned to their daily lives very quickly.

Postoperatively, uncorrected vision increased to 6 lines in 12 eyes, seven lines in 11 eyes, and eight lines in 3 eyes.

Eligibility criteria: Inclusion Criteria:

* low transparency of cornea
* low visual acuity
* recurrence keratitis

Exclusion Criteria:

* active anterior segment pathology
* previous corneal or anterior segment surgery
* any infection

Primary outcomes:
measure: Increasing corneal transparency
timeFrame: 12 months
Secondary outcomes:
measure: Increase of visual acuity
timeFrame: 12 months
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References: