louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05080010: Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma
Official title: Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Retinoblastoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of 3 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

Detailed description: This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will receive 3 cycles of chemotherapy(CEV) oon a monthly basis. Patients will be followed for 60 months.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
* Received enucleation in the study eye.
* Monocular retinoblastoma.

Exclusion Criteria:

* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* History of chemical intervention for retinoblastoma in the study eye.

Primary outcomes:
measure: disease-free survival
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Huasheng Yang, M.D, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03198910: Retrospective Data Analysis of Data From the Zurich PH Registry
Official title: Efficacy of Medical Therapy for Pulmonary Arterial and Inoperable Chronic Thromboembolic Pulmonary Hypertension in a Real Life Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Artery Hypertension
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PAH and CTEPH patients diagnosed with a right heart catheter

Brief summary: The collected data from the Zurich Registry for pulmonary Hypertension (PH) are evaluated in a retrospective analysis. This study examines the number of patients and their exact diagnoses who are treated at the University Hospital of Zurich and potentially other participating in the Zurich Registry. Other demographic parameters such as age, gender and body-mass-index are also part of the evaluation. Furthermore, the analysis will focus on the newest guidelines on PH. Therefore, it will be checked how many patients would fulfill the therapeutic goals in terms of New York Heart Classification (NYHA), 6-minute walk distance, sign of right heart failure and N-terminal pro-brain-natriuretic peptide(NTproBNP). Additionally, the study examines on how the patients are treated. Despite the different kind of Drugs, the focus lies on the combination therapy (single, double, triple) and the impact the therapy had on the patients.


Eligibility criteria: Inclusion Criteria:

* Patients with pulmonary arterial hypertension (PAH)
* Patients with chronic thromboembolic pulmonary hypertension (CTEPH)
* All prevalent patients (diagnosed \>12 month ago) with PAH or distal CTEPH who had a consultation at the PH centre in Zurich between November 2015 and November 2016)

Exclusion Criteria:

-

Primary outcomes:
measure: Change in NYHA/WHO functional class
timeFrame: Baseline, 3 months, 6 months, 1 year
measure: Change in 6 minute walk distance
timeFrame: Baseline, 3 months, 6 months, 1 year
measure: Change in NT-proBNP
timeFrame: Baseline, 3 months, 6 months, 1 year
Secondary outcomes:
measure: Percentage of patients that are in NYHA/WHO functional class <= II
timeFrame: Baseline, 3 months, 6 months, 1 year
measure: Percentage of patients with a 6 minute walk distance > 440m
timeFrame: Baseline, 3 months, 6 months, 1 year
measure: Percentage of patients with a NT-proBNP < 300 ng/l
timeFrame: Baseline, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
References:
Clinical trial NCT02918110: Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour
Official title: Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Induced Deliveries
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karlstad Central Hospital
First posted: 2016-09-28
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.

Detailed description: To compare orally administrated solution of misoprostol (Cytotec®) with vaginal slow release misoprostol (Misodel®) regarding efficacy and safety during labour Design: Randomised controlled trial (RCT)

Settings:

Obstetric departments of Sodersjukhuset, Stockholm Obstetric departments of Women's clinic, Karlstad.

Eligibility criteria: Inclusion Criteria:

Primipara BS ≤ 4p Gestational week \>37

Exclusion Criteria:

Multipara Multiples Gestational week \<37 BS \>4 IUFD Previous uterine surgery

Primary outcomes:
measure: Cesarean section rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eva Wiberg-Itzel
Study officials:
affiliation: Karolinska Institutet
name: Per Tornvall, Prof
role: STUDY_DIRECTOR
References:
citation: Strandberg M, Wallstrom T, Wiberg-Itzel E. Women's expectations and experiences of labor induction - a questionnaire-based analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2021 May 4;21(1):355. doi: 10.1186/s12884-021-03786-6.
Clinical trial NCT05158010: Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort
Official title: Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure
Health Behavior
Environment
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: ATHLETE will set up a prospective Europe-wide exposome cohort covering the first 2 decades of the life course, which will integrate data on the external, chemical, physical,behavioral, and social domains of the exposome, as well as on health outcomes and biological omics responses, from preconception until adolescence. As part of ATHLETE, the investigators will follow up a unique existing exposome cohort into adolescence (the HELIX Subcohort).


Eligibility criteria: Inclusion Criteria:

For the adolescent :

* Subject of the EDEN cohort included in the Helix cohort in 2014-2015 in Poitiers (16-19 years old)
* Subject benefiting from a Social Security scheme or benefiting through a third party

For the person legally responsible :

* The legal guardian, if possible the mother, of the adolescent included in Athlete ;
* Subject benefiting from a Social Security scheme or benefiting through a third person;
* Free subject, without tutorship or guardianship or subordination.

Exclusion Criteria:

* Concomitant participation in another clinical research study.
* Persons not benefiting from a Social Security scheme or not benefiting through a third party.
* Adolescents who are incapable or who do not give their consent to follow the study procedures

Primary outcomes:
measure: Urinary biomarkers exposure
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: C.H.U. de Poitiers
Study officials:
References:
Clinical trial NCT02611310: A Study to Observe Treatment Patterns and Outcomes in Participants in Saudi Arabia With Human Epidermal Growth Factor Receptor 2 (HER2-Positive) Unresectable Locally Advanced or Metastatic Breast Cancer (LA/mBC)
Official title: Saudi Arabia - A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with HER2-positive unresectable LA/mBC

Brief summary: This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. These participants will be prospectively followed for at least 5 years after study enrollment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.


Eligibility criteria: Inclusion Criteria:

* Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
* Able to comply with the study protocol

Exclusion Criteria:

None

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 5 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen
timeFrame: Up to 5 years
measure: Duration of Response (DoR) Per Anti-Cancer Treatment Regimen
timeFrame: Up to 5 years
measure: Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D)
timeFrame: Up to 5 years
measure: Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Holy Makkah
country: Saudi Arabia
facility: King Abdullah Medical City-Holy Makkah
city: Riyadh
country: Saudi Arabia
facility: National Guard King Abdulaziz Medical City; Oncology
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City; Gastroentrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06573710: Correlation Between Postoperative Pain and Apical Extrusion of Different Irrigation Activation Techniques
Official title: Correlation Between Postoperative Pain and Apical Extrusion of Different Irrigation Activation Techniques (Randomized Controlled Trial - an In Vitro Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: irrigant , ultrasonic, LASER , sonic
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this clinical trial is :

To evaluate effect of different techniques of irrigant activation:

1. LASER activation
2. sonic activation
3. ultrasonic activation
4. passive needle irrigation

On:

1. Postoperative pain in vital teeth (Randomized controlled trial)
2. Amount of apical extrusion (In vitro study) Participants will describe their preoperative pain and postoperative pain level at fixed time interval Research will compare postoperative pain accompanied with different irrigant activation techniques and correlate it to amount of debris extrusion


Eligibility criteria: Inclusion Criteria:

* Age group 18-50 years
* Males and females
* Lower molars with symptomatic irreversible pulpitis without apical periodontitis

Exclusion Criteria:

* Patients with uncontrolled health conditions
* Immunocompromised patients
* Teeth with periodontal diseases
* Teeth with calcified canals
* pregnant patients

Primary outcomes:
measure: Evaluation of postoperative pain
timeFrame: 8,24,48 hours and one week
Secondary outcomes:
measure: Frequency of analgesic intake
timeFrame: 8,24,48 hours and one week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT02443610: Haemorrhages and Thromboembolic Venous Disease of the Postpartum
Official title: Hémorragies et Maladie Veineuse Thromboembolique du Post-partum : Epidémiologie, Etudes Des déterminants Cliniques et Biologiques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Venous Thromboembolism
Keywords: Postpartum Hemorrhage
Venous Thromboembolism
Pregnancy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 20241
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women admitted for delivery in a maternity Finistère

Brief summary: The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France)

Detailed description: This is an analytical observational prospective multicenter cohort study , conducted on all the maternity hospitals in Finistère (Bretagne - France), with a biological collection.

This protocol allows to study all women at risk of PPH (Postpartum Hemorrhage) and postpartum venous thromboembolic disease, including maternity level 1-3 without case selection. The prospective nature of the study should provide a more detailed analysis of exposures in this particular population of women (risk factors related to the field, childbirth, the postpartum events ...).

The events of interest were PPH and venous thromboembolic disease.

Eligibility criteria: Inclusion Criteria:

* Any woman giving birth and supported in one of Gynaecology Obstetrics services of a maternity Finistere.
* Women ≥ 16 at the time of the collection of non-opposition.
* For minor patients: understanding the patient and at least one parent.
* All births ≥ 15 weeks gestation.

Exclusion Criteria:

* Home Birth
* Expressed opposition to participation in this study.
* Childbirth under X.
* Parent (s) uninformed of the pregnancy of their child.

Primary outcomes:
measure: Postpartum Hemorrhage
timeFrame: 2 days
measure: Symptomatic thromboembolic events
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Carhaix-Plouguer
country: France
facility: CH de Carhaix
state: Finistère
city: Brest
country: France
facility: CHRU de Brest - Service de Gynécologie-obstétrique
city: Brest
country: France
facility: Clinique Keraudren
city: Landerneau
country: France
facility: CH de Landerneau
city: Morlaix
country: France
facility: CH de Morlaix
city: Quimper
country: France
facility: CH Quimper
Study officials:
affiliation: Unité d'Hémostase , Centre Régional de traitement de l'hémophilie et des maladies hémorragiques, CHRU de Brest (France)
name: PAN PETESCH Brigitte
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02933710: Postmarketing Surveillance Study for IMOJEV® in Republic of Korea
Official title: Postmarketing Surveillance Study for a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Republic of Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Japanese Encephalitis
Keywords: Japanese encephalitis
IMOJEV®
Japanese encephalitis chimeric virus vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who receive IMOJEV® (either primary or booster dose) during a routine health-care visit

Brief summary: The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.

Primary objective:

* To describe the safety profile of the first dose of IMOJEV® administered under routine health care visit as primary vaccination or as booster.

Detailed description: Subjects aged 12 months of age and older and who are given study vaccine during routine health-care visits will be enrolled in the study.

No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Eligibility criteria: Inclusion Criteria:

* Informed consent form signed by the subject (for subjects 19 years old and above) or the parent(s) or other legal representative (for subjects under 19 years of age)
* Receipt of the first dose of IMOJEV® (on the day of inclusion) according to approved local insert paper.

Exclusion Criteria:

* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure.
* Subjects who already participated in this study.

Primary outcomes:
measure: Number of participants reporting solicited injection-site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during the trial
timeFrame: Day 0 up to Day 42 post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 001
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kim HS, Oh Y, Korejwo J, Castells VB, Yang K. Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev(R)) in South Korea, 2015-2019. Infect Dis Ther. 2020 Sep;9(3):589-598. doi: 10.1007/s40121-020-00305-6. Epub 2020 May 30.
Clinical trial NCT00290381: The Effects of OC000459 on Nasal Mediators
Official title: The Effects of OC000459 on Nasal Th2 Cytokine Release, Eosinophil Responses, and Nasal Symptoms After Nasal Allergen Challenge (NAC) With Timothy Grass Pollen in Subjects With Allergic Rhinitis Out of Season
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Oxagen Ltd
First posted: 2006-02-13
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Nasal Allergen Challenge Study
Primary purpose: TREATMENT

Brief summary: This is the first proof of concept study for OC000459 and is undertaken to assess the effects of the compound on the development of inflammatory cytokines in a model (nasal allergen challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be compared with placebo in the study.

The study will be a randomised, double blind, placebo controlled, crossover evaluation of the effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects with a known history of allergic rhinitis and screening positive to allergen will be included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety parameters will be monitored throughout.


Eligibility criteria: Inclusion Criteria:

1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.

Exclusion Criteria:

1. Medical conditions likely to affect the outcome of the study.

2 History of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.

3. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.

Primary outcomes:
measure: The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13
timeFrame: 1 to 9 hours after nasal allergen challenge
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Heart & Lung Institute Clinical Studies Unit
Study officials:
affiliation: National Heart & Lung Institute
name: Trevor T Hansel, FRCPath
role: PRINCIPAL_INVESTIGATOR
References: