louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02529475: Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
Official title: Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Meniere Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: * This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in healthy subjects
* MR Perfusion Imaging will be assess in both cochlea as well
* Primary auditory brain pathways will be evaluated through MR diffusion imaging


Eligibility criteria: Inclusion Criteria:

* Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years)
* Informed consent signed
* Medical examination performed prior to participation in research
* Patients without history of inner ear disease
* Recipient of a French social security scheme

Exclusion Criteria:

* Patients minors
* Patients on a legal protection regime type guardianship
* Respiratory pathologies, cardiovascular, renal, diabetes
* Claustrophobia
* Contraindications to exposure to a magnetic field
* Contraindications to injecting Dotarem ®

Primary outcomes:
measure: Gadolinium enhancement in inner ear structures as measured by MR T1 Weighted Imaging
timeFrame: One MR scan (4 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: GrenobleUniversityHospital
city: Paris
country: France
facility: Hôpital Lariboisière
city: Rouen
country: France
facility: Hôpital Charles Nicolle
Study officials:
affiliation: University Hospital, Grenoble
name: Arnaud ATTYE, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eliezer M, Maquet C, Horion J, Gillibert A, Toupet M, Bolognini B, Magne N, Kahn L, Hautefort C, Attye A. Detection of intralabyrinthine abnormalities using post-contrast delayed 3D-FLAIR MRI sequences in patients with acute vestibular syndrome. Eur Radiol. 2019 Jun;29(6):2760-2769. doi: 10.1007/s00330-018-5825-0. Epub 2018 Nov 9.
Clinical trial NCT05758675: Study on the Antibody Level Against SARS-CoV-2 （COVID-19）in Dazhu County in 2023
Official title: Study on the Antibody Level Against SARS-CoV-2 in Dazhu County in 2023
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 20000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Screening by sampling from natural communities.

Brief summary: About 15,000 to 25,000 subjects will be screened. Their information will be collected, venous blood will be sampled, their serum antibody levels will be detected, and the incidence of COVID-19 wil be followed up.

Detailed description: Data of the following will be collected:

1. Demographic data,including Name, Gender, Ethnic groups, ID Card number (age automatically calculated), Height/weight (automatic BMI calculation);
2. Previous disease/surgical history; 3. Previous COVID-19 infections; 4. COVID-19 vaccination history; 5. Infection after this screening; 6. Screening information for COVID-19 antibodies.

Atibody level against SARS-CoV-2 will be test.

Eligibility criteria: Inclusion Criteria:

* The age when signing ICF should be ≥3 year, male or female.
* The Subject and/or guardian or client of both parties are able to sign a written ICF and voluntarily participate in the trial, fully understand the trial procedure, the risks of participating in the study.
* Healthy subjects or subjects with stable underlying diseases. Stable underlying diseases were defined as those who were in stable condition at least 3 months before inclusion in the study, had no significant change in treatment regimen and had not been admitted to hospital due to disease progression.

Exclusion Criteria:

* a history of contraindications for venous blood collection such as thrombocytopenia or other clotting disorders.
* Current severe or uncontrollable cardiovascular disease, endocrine disease, blood and lymphatic system disease, liver and kidney disease, respiratory system disease, metabolic and skeletal system disease, or malignancy.
* If it is not in line with the benefit maximization of the subjects, the investigator determines that it is not suitable to participate in clinical research.

Primary outcomes:
measure: Concentration of antibody against SARS-CoV-2
timeFrame: From Day 0 to Day 180
Secondary outcomes:
measure: Relation between collected information and antibody concentration
timeFrame: From Day 0 to Day 180
Other outcomes:
Locations:
city: Dazhou
country: China
facility: Dazhu County Center for Disease Control and Prevention
state: Sichuan
Study officials:
affiliation: Dazhu County Center for Disease Control and Prevention
name: Bo Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04379375: Nudges to Improve Health Behaviors That Limit COVID-19 Spread
Official title: Using Behavioral Nudges to Improve Preventive Health Behaviors That Limit COVID-19 Spread
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Health Behavior
COVID-19
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Advancing a Healthier Wisconsin Endowment
First posted: 2020-05-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation is a randomized intervention trial that evaluates behavioral nudges (BN) to increase hand washing behavior and subsequently reduce COVID-19 spreading to a targeted high-risk patient population based in Wisconsin.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Provision of signed and dated informed consent form
* Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
* Has at least 1 risk factor associated with COVID-19 documented in their electronic medical record
* Followed by (i.e., actively receiving care) from targeted MCW specialties (Internal Medicine, OBGYN, Surgery)
* Access to necessary resources for participating in a technology-based activities (i.e., internet access + mobile phone or computer to complete online survey)
* Maintains a personal address where study materials can be shipped and where participant lives full time

Exclusion Criteria:

* Previous COVID-19 diagnosis or positive COVID-19 test result documented in their electronic medical record
* Current participation in another treatment or intervention study associated with COVID-19
* Previous documented Obsessive-Compulsive Disorder diagnosis in their electronic medical record
* Non-English speaker
* Patients hospitalized or incapacitated at onset of potential enrollment
* No access to electronic platform with internet (e.g., smartphone, tablet, computer)

Primary outcomes:
measure: Hand Washing Behavior
timeFrame: 8 weeks post-enrollment
Secondary outcomes:
measure: Clinical Outcomes - General/Internal Medicine
timeFrame: 12 weeks post-enrollment
measure: Clinical Outcomes - Obstetrics & Gynecology
timeFrame: 12 weeks post-enrollment
measure: Clinical Outcomes - Surgery
timeFrame: 12 weeks post-enrollment
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Nicholas D Young, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06009575: Local Culture-Based Nutrition Education Intervention on Iron Supplement Tablets (IST) Consumption Compliance in Female Adolescents at Ogan Komering Ilir Regency: A Quasi-Experimental Protocol Study
Official title: Local Culture-Based Nutrition Education Intervention on Iron Supplement Tablets (IST) Consumption Compliance in Female Adolescents at Ogan Komering Ilir Regency: A Quasi-Experimental Protocol Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Iron Deficiency Anemia
Keywords: anemia
Iron Supplement Tablets
Lead sponsor: Universitas Sriwijaya
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2023-08-24
Enrollment: 126
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the impact of a local culture-based nutritional education intervention on IST consumption compliance among female adolescents in the Ogan Komering Ilir Regency. The main questions it aims to answer are:

a To identify information for the development of a local culture-based nutrition education model and to build a ready-to-implement local culture-based nutrition education model.

b. To evaluate the implementation of the Anemia Prevention and Control Program among female adolescents in Ogan Komering Ilir Regency.

c. To test the impact of the local culture-based nutrition education model on the improvement of knowledge, attitude, and IST consumption compliance among female adolescents.

Participants will received IST and local culture-based nutrition education. Researchers will compare control group received IST as the Ministry of Health's program for the prevention of anemia with a subsidy for providing IST


Eligibility criteria: Inclusion Criteria:

* public schools have received the IST program from the government, and the distance between schools is at least 10 kilometers
* students enrolled in grade 11, age range 15-17 years, menstruating, owning a smartphone, having an Instagram account, and obtaining parental approval to participate in this study

Exclusion Criteria:

* schools that are currently the object of another study and are difficult to reach (remote areas)
* students who have a BMI value≤ -3 SD and do not watch complete educational videos for the sample in the intervention group

Primary outcomes:
measure: Educational Intervention
timeFrame: 12 Weeks
measure: Iron Supplement Tablet (IST) Administration
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palembang
country: Indonesia
facility: Anita Rahmiwati
state: South Sumatera
Study officials:
References:
Clinical trial NCT00933075: Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Frutal (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.


Eligibility criteria: Inclusion criteria:

* Phototype Skin II and III Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Diseases which can cause immunosuppresion, such as diabetes, HIV
* Use of photosensitivity drugs
* History of sensitivity or photosensitivity for topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
timeFrame: From the treatment start to the end of the study (treatment period 5 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT04355975: Clinical Outcomes After Acute Pulmonary Embolism
Official title: Clinical Outcomes After Acute Pulmonary Embolism - The Bern Acute Pulmonary Embolism Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients with Acute PE
* Patients developing CTEPH

Brief summary: To investigate safety and effectiveness of PE treatment according to the decision of the multi-disciplinary pulmonary embolism response team (PERT) and to define and optimize treatment indications, institutional algorithms and interventional techniques for PE.

Detailed description: This single-center cohort study is designed to retrospectively and prospectively collect treatment and outcome data related to patients with PE and after activation of the PERT. Treatment information and outcomes after advanced treatment modalities, including systemic thrombolysis, catheter directed thrombolysis and surgical embolectomy, will be collected.

Retrospective patient data will consist of treatment and health related outcomes of consecutive patients treated for acute and chronic PE between October 2017 and April 2020 (to assess the learning curve of the PERT) and of patients receiving surgical embolectomy between January 2001 and April 2020. The retrospective data will be derived from the local institutional dataset and will be transferred to the study database. Prospective patients will be included after May 2020.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT.
* Written informed consent

Exclusion Criteria:

* High probability of non-adherence to the follow up requirements

Primary outcomes:
measure: In-hospital death
timeFrame: 30 days
Secondary outcomes:
measure: Peri-procedural adverse events
timeFrame: 30 days
measure: Recurrent VTE during follow-up
timeFrame: up to 5 years
measure: Respiratory and functional deterioration after treatment
timeFrame: 6 months
measure: Development of chronic thromboembolic pulmonary hypertension (CTEPH)
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern - Inselspital
state: BE
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Switzerland
name: Stefan Stortecky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06975475: SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases
Official title: SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast caner
HER2 positive
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this project is to evaluate whether the sequence of Trastuzumab，pyrotinib and Nab-Paclitaxel in first line followed by SHR-A1811 in second line is superior to the sequence of SHR-A1811 in first line followed by Trastuzumab，pyrotinib and Nab-Paclitaxel in second line for HER2 positive breast cancer brain metastases.


Eligibility criteria: Inclusion Criteria:

1. Females ≥18 yrs old
2. Pathologically confirmed HER2-positive advanced breast cancer;
3. Newly diagnosed brain metastes,At least one measurable intracranial lesion
4. Not received any systemic treatment for advanced stage
5. Radiotherapy was allowed in patients with an urgent need for control of intracranial symptoms
6. Adequate function of major organs
7. Willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up.

Exclusion Criteria:

1.Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture; 2.Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage; 3.Has received whole brain radiotherapy, chemotherapy, surgery within 2 weeks before first dose of study therapy; 4.Has known clinically significant lung disease, that is, moderate-to-severe lung disease which severely affects respiratory function, including but not limited to: idiopathic pulmonary fibrosis, pneumonitis. Prior ≥ grade 3 interstitial lung disease is not allowed to enrolment; 5.Has received full-dose anticoagulants or thrombolytics within 10 days before enrolment, or non-steroid anti-inflammatory drugs with platelet inhibition 6.Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 7.Participated in other drug clinical trials within 4 weeks before admission; 8.Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.

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Primary outcomes:
measure: PFS2
timeFrame: 2 years
Secondary outcomes:
measure: overall survival(OS)
timeFrame: 4 years
measure: Intracranial CNS progression-free survival
timeFrame: 2 years
measure: Progression-free survival
timeFrame: 2 years
measure: adverse event
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04751175: Management of Pain in Lumbar Arthrodesis
Official title: Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, controlled, prospective and randomized clinical trial, phase IV, to determine the effect of perioperative intravenous administration of ketamine and dexamethasone in patients undergoing lumbar arthrodesis
Primary purpose: TREATMENT

Brief summary: KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.

Detailed description: The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age\> 18 years
* ASA I-III.
* Lumbar arthrodesis.
* Patients who have signed the preoperative informed consent for participation in the study.

Exclusion Criteria:

* Unstable coronary heart disease
* Glaucoma
* History of allergy to ketamine, dexamethasone, or morphic chloride
* Dementia or inability to understand IC and study
* Pluricomplicated diabetes mellitus difficult to control
* Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug

Primary outcomes:
measure: Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated
timeFrame: 4 hours post operative
Secondary outcomes:
measure: Incidence of postoperative nausea and vomiting (PONV).
timeFrame: 4 hours post operative
measure: Efficay of study treatment regarding pain at 3 postoperative months
timeFrame: 3 months
measure: Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)
timeFrame: 4 hours post operative
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Dr Josep Trueta
Study officials:
affiliation: Hospital Dr Josep Trueta and Hospital Santa Caterina
name: Emili Leon, MD
role: PRINCIPAL_INVESTIGATOR
References: