louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06506734: Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
Official title: Prevalence of Dental Dyschromia and Impact on the Quality of Life of Participants with Prolonged Hyperbilirubinemia During Their Early Years
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Diseases
Keywords: Hyperbilirubinemia
Biliary Atresia
Progressive Familial Intrahepatic Cholestasis (PFIC)
Alagille Syndrome
Tooth Discoloration
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 12 to 18 years

Brief summary: The main objective of this study is to assess the prevalence of dental discoloration (dental dyschromia) in children who experienced high levels of bilirubin in their blood (hyperbilirubinemia) during their early years. The study will also examine risk factors associated with this condition, such as the duration and severity of hyperbilirubinemia, underlying diseases, and treatments received.

The researchers hypothesize that the quality of life of individuals with dental dyschromia is lower than that of individuals without dyschromia. The results of this study will be used to discuss coverage for dental care with health insurance for children affected by this condition.


Eligibility criteria: Inclusion Criteria:

* A patient with biliary atresia, progressive familial intrahepatic cholestasis, or Alagille syndrome
* Patient or legal representative not opposed to participating in this research.

Exclusion Criteria:

* Inability to understand and respond to quality of life questionnaires

Primary outcomes:
measure: Prevalence of dental dyschromia
timeFrame: from birth to study completion, a maximum of 19 years
Secondary outcomes:
measure: Presence or absence of dental dyschromia
timeFrame: through study completion, an average of 18 months
Other outcomes:
measure: Quality of life score by patient group
timeFrame: through study completion, an average of 18 months
Locations:
city: Bordeaux
country: France
facility: University Hospital Bordeaux
city: Caen
country: France
facility: University Hosptial Caen
city: Lille
country: France
facility: University Hospital Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: University Hospital Marseille
city: Paris
country: France
facility: Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, FHU Hépatinov
city: Paris
country: France
facility: Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris
city: Paris
country: France
facility: Assistance Publique-Hôpitaux de Paris, Hôpital Necker
city: Rennes
country: France
facility: University Hospital Rennes
Study officials:
affiliation: University Hospital, Toulouse
name: Nolwen LABORDE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130634: The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Colorectal Cancer
Keywords: CPT-11(irinotecan)
silymarin
GI toxicity
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.

Detailed description: Primary Objective:

Use both listed and relatively safe drug, Silymarin, to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.

Patient Selection and Enrollment:

Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.

Plan of the Study:

Study Design This is an open-label, randomized, comparative, double arm, single center study to assess efficacy of Silymarin as adjuvant therapy on metastatic colorectal cancer patients undergoing FOLFIRI chemotherapy in Taiwan.

Subject Number Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.

Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB) Duration of study: From the date of the IRB was approved till the 70th patient was collected.

Duration of Enrollment: From the date of the IRB was approved till the 70th patient was collected.

Duration of treatment: From the 1st patient starting chemotherapy till the 70th patient finishing the 6th cycle chemotherapy.

Duration of follow-up: From the 1st patient starting chemotherapy till 3 months after the 70th patient finishing the 6th cycle chemotherapy

Eligibility criteria: Inclusion Criteria:

1. The patient who is between 20 to 80 years old
2. The patient who is diagnosed metastatic colorectal cancer and received chemotherapy with FOLFIRI regimen
3. The female patient should not be pregnant or breast-feeding
4. The patient who has no severe co-morbidity, such as cardiovascular, cerebrovascular, malignant hypertension, renal and hepatobiliary disease.
5. The patient who has no associated drug allergy to this trial.
6. The patient who is in compliance with prescribed medication.
7. The patient who is willing to sign the permit of the clinical trial.

Exclusion Criteria:

1. The patients who do not meet the main inclusion criteria or are not willing to sign the permit.
2. The patient who has viral hepatitis or carrier with impaired liver function.

Primary outcomes:
measure: GI associated adverse events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Study officials:
References:
Clinical trial NCT02373917: Characterization of Methylation Patterns in Lung Cancer
Official title: Characterization of Methylation Patterns in Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-27
Enrollment: 683
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who come to the medical center for the diagnosis of lung cancer.

Brief summary: In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Detailed description: Lots of information about the relationship between changes in methylation patterns and various diseases are accumulated in recent years. Characterization of methylation changes that occur in cancer may contribute to the development of methods for early detection of cancer by detecting cancer cells in liquids. Early detection of such changes and their correlation examining different cancers may lead to a diagnostic tool for the early detection of cancers and improve the treatment of these patients. Detection by molecular analysis can be a sensitive method and non-invasive early diagnosis of the disease In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected lung tumor

Exclusion Criteria:

* Patients who have active disease other than lung cancer during the sample collecting

Primary outcomes:
measure: Characterization of Methylation Patterns in lung Cancer
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Sha'are Tzedaek Medical Center
Study officials:
affiliation: Nucleix Ltd.
name: Eilon Ganor, MD
role: STUDY_DIRECTOR
References:
citation: Gaga M, Chorostowska-Wynimko J, Horvath I, Tammemagi MC, Shitrit D, Eisenberg VH, Liang H, Stav D, Levy Faber D, Jansen M, Raviv Y, Panagoulias V, Rudzinski P, Izbicki G, Ronen O, Goldhaber A, Moalem R, Arber N, Haas I, Zhou Q. Validation of Lung EpiCheck, a novel methylation-based blood assay, for the detection of lung cancer in European and Chinese high-risk individuals. Eur Respir J. 2021 Jan 14;57(1):2002682. doi: 10.1183/13993003.02682-2020. Print 2021 Jan.
Clinical trial NCT05573217: The Utility of Cell-free DNA Methylation Markers for Hepatocellular Carcinoma
Official title: The Utility of Cell-free DNA Methylation Markers for the Response Prediction of Systemic Treatment for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cell-free Methylation Markers
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with liver cancer by AASLD clinical criteria or pathological slides Patients planning to receive systemic drug therapy for liver cancer at National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yevoy.

Brief summary: The subjects of this study were patients with liver cancer diagnosed by physicians according to AASLD clinical criteria or pathological biopsy.

Those who plan to receive systemic drug treatment for liver cancer in National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yervoy. Weak and uncooperative patients were excluded from blood tests, which were performed with full informed consent for relevant tumor markers (AFP ,PIVKA-II and methylation analysis). The data are then counted and compared.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with liver cancer by AASLD clinical criteria or pathological slides Patients planning to receive systemic drug therapy for liver cancer at National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yevoy.
2. Over 20 years old.
3. In the case of informed consent, willing to sign the consent form of the subjects.

Exclusion Criteria:

1. Patients who are weak and unable to cooperate with blood test.
2. Kidney dysfunction, serum creatinine greater than 1.5 x UNL (normal value) and no hemodialysis treatment, who are judged to be unwell for computed tomography or MRI contrast agent injection.

Primary outcomes:
measure: Evaluate efficacy
timeFrame: 3 month after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02912117: Determining the Etiology of Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay
Official title: Determining the Etiologic Diagnosis in Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Neutropenia
Lead sponsor: Karius, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2016-09-23
Enrollment: 57
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: Patients who are admitted for fever and neutropenia at the Stanford University Hospital or patients who are admitted for chemotherapy who develop fever and neutropenia at Stanford University Hospital.

Brief summary: Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Are or will be admitted to Stanford University Hospital for fever and neutropenia
* Neutropenia - an absolute neutrophil count of \<500 per cubic mm
* Documented fever or report of fever ≥38.3 or ≥38.0 on two episodes separated by at least one hour, resulting in hospitalization for febrile neutropenia

Exclusion Criteria:

* Inability to understand instructions and comply with study-related procedures
* Any condition that in the opinion of the treating physician will prevent the subject from completing the study

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
Study officials:
affiliation: Stanford University
name: Stanley C Deresinski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jose G Montoya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benamu E, Gajurel K, Anderson JN, Lieb T, Gomez CA, Seng H, Aquino R, Hollemon D, Hong DK, Blauwkamp TA, Kertesz M, Blair L, Bollyky PL, Medeiros BC, Coutre S, Zompi S, Montoya JG, Deresinski S. Plasma Microbial Cell-free DNA Next-generation Sequencing in the Diagnosis and Management of Febrile Neutropenia. Clin Infect Dis. 2022 May 3;74(9):1659-1668. doi: 10.1093/cid/ciab324.
Clinical trial NCT05035017: Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses
Official title: Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 35
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: The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.

Detailed description: This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.

Eligibility criteria: Inclusion Criteria:

* Has had a self-reported oculo-visual examination in the last two years.
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is an adapted soft contact lens wearer, having worn contact lenses for a minimum 4 weeks prior to the study
* Has spectacle cylinder ≤1.00D in both eyes.
* Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
* Wears CLs in both eyes (monovision acceptable, but not monofit)
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination
* Is willing to wear the study contact lenses for a minimum 8 hours on at least two consecutive days for each study pair.

Exclusion Criteria:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any concomitant systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye-related clinical or research study.

Primary outcomes:
measure: Overall Comfort With Lens
timeFrame: 2 days
Secondary outcomes:
measure: Overall Vision Quality
timeFrame: 2 days
measure: Overall Lens Fit Acceptance
timeFrame: 2 days
measure: Overall Lens Handling
timeFrame: 2 days
measure: Anterior Ocular Health - Corneal Staining Extent
timeFrame: 2 days
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Optometry
state: Indiana
Study officials:
References:
Clinical trial NCT06351917: Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain
Official title: Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Joint Pain
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration.


Eligibility criteria: Inclusion Criteria:

* Adults over 20 years
* Generally healthy
* Able to provide informed consent
* Undertaking regular exercise
* Experiencing post exercise knee pain of at least 3 (on a 0-10 scale) at least 2 times in previous 4 weeks
* Agree not to change current diet and/or exercise frequency or intensity

Exclusion Criteria:

* Serious illness( 1 ) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Unstable illness( 2 ) e.g., diabetes and thyroid gland dysfunction
* Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
* Active smokers, nicotine use, alcohol( 3 ) or drug (prescription or illegal substances) abuse
* Allergic to any of the ingredients in the active or placebo formula
* Pregnant or lactating women
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

Footnotes

( 1 )A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

( 2 )An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.

( 3 )Chronic past and/or current alcohol use (\>14 alcohol drinks/week)

Primary outcomes:
measure: Joint pain
timeFrame: Up to 5 knee pain treatment events for up to 4 weeks
Secondary outcomes:
measure: Time to pain relief
timeFrame: Up to 5 knee pain treatment events for up to 4 weeks
measure: Number of Adverse Events
timeFrame: Enrolment period
measure: Severity of Adverse Events
timeFrame: Enrolment period
measure: Rescue medication use
timeFrame: Up to 5 knee pain treatment events for up to 4 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical Pty Ltd
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05327517: Surgery or Chemoradiotherapy for Cervical Esophageal Cancer
Official title: Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Esophageal Cancer
Keywords: Esophageal neoplasm
Chemoradiotherapy
Esophagectomy
Overall survival
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0);
* Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included;
* Aged 18-75 years;
* Without any contraindication of operation;
* Hemoglobin \>=90 g/L; Leukocytes \>=4.0x10\^9/L; Absolute neutrophil count \>=1.5x10\^9/L; Platelet \>=100x10\^9/L;Total bilirubin \<=1.5 ULN; ALT \<=2.5 ULN; AST \<=2.5 ULN; Serum creatinine \<=1.5 ULN or creatinine clearance rate \>=50 mL/min (Cocheroft-Gault);INR \<=1.5 ULN; APTT \<=1.5 ULN;
* Without other malignancies;
* Expected R0 resection;
* ECOG PS 0-1;
* Volunteered to participate in the study, signed the informed consent form.

Exclusion Criteria:

* Without other malignancies;
* With mental diseases;
* With hemorrhagic disease;
* Inoperable patients;
* Pregnant or lactating women;
* Has a history of allergy to paclitaxel or cisplatin

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years after surgery or definitive Chemoradiotherapy is completed
Secondary outcomes:
measure: Laryngo-esophageal dysfunction free survival
timeFrame: 5 years after surgery or definitive Chemoradiotherapy is completed
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
name: Jie He, MD
role: STUDY_DIRECTOR
affiliation: Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
name: Yin Li, MD
role: PRINCIPAL_INVESTIGATOR
References: