louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02425540: Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
Official title: Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Undetermined Ovarian Mass
Keywords: Pelvic MRI
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 74
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ovarian mass not able to classify by gynecological ultrasound

Brief summary: The aim of the study is to prospectively evaluate the value of pelvic MRI including diffusion- and perfusion-weighted sequences in the selected group of patients that have an undetermined ovarian mass at ultrasound.


Eligibility criteria: Inclusion Criteria:

\*Any woman with an adnexal mass undetermined by gynecological ultrasound

Exclusion Criteria:

* Any lesion with definite diagnosis by gynecological ultrasound
* Denial or withdrawal of oral informed consent.
* Contra-indication for MRI

Primary outcomes:
measure: Correlation of MRI findings with histopathology or 2-years follow-up
timeFrame: 03/2015 to 03/2017 (up to 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals UZ Leuven, Gasthuisberg
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT00320840: Internal and Familial Resources and Motherhood. Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants
Official title: The Contribution of Internal and Familial Resources to the Development of Motherhood. Long Term Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Twins
Preterm Infants
Keywords: preterm infants
twins
motherhood
internal resources
familial resources
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-05-03
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To evaluate the contribution of internal and familial resources on the development of motherhood in a population of mothers having preterm twin infants and comparing this population to a population of mothers giving birth to single (or twins) full term infants.

Detailed description: 150 mothers will participate in this study. The study is using 4 questionnaires at infants ages of 1 month, 1 year, 2 years and 4 years. The questionnaires are involving communication skills,grandparents support, stress feelings, psychological parameters, parity functioning, infant temperament, self assessment, maternal and infant medical background and twins and brotherhood evaluation.

a comparison will be done between mothers to preterm twins and mothers to single full term infants.

Eligibility criteria: Inclusion Criteria:

* preterm infants
* twins

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat -Gan
country: Israel
facility: Sheba medical center - Neonatal Department
Study officials:
affiliation: Sheba Medical Center
name: Jacob Kuint, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00743340: Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
Official title: A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1 Infection
Keywords: HIV-1 infection
emtricitabine
pediatrics
pediatric patients
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objectives of this trial are to provide FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine (FTC), following completion of the FTC-203 study and to collect long-term safety information in participants receiving emtricitabine in combination with other antiretroviral agents.


Eligibility criteria: Key Inclusion Criteria:

* Complete or have previously completed at least through the Week 96 Visit (i.e., 96 weeks on study) for the FTC-203 study.
* Complete all End-of-Study Visit procedures for the FTC-203 study.
* Either (a) have a plasma HIV-1 RNA viral load of ≤ 400 copies/mL at the End-of-Study Visit for the FTC-203 study, or (b) if the subject's plasma HIV-1 RNA viral load at the End-of-Study Visit for FTC-203 study is \> 400 copies/mL, their viral load is \< 1.0 log10 above the nadir recorded after Week 8 of the FTC-203 study and there is reliable genotypic evidence showing a lack of resistance to emtricitabine.
* A parent or other legal guardian has provided written informed consent to the subject participating in the rollover protocol. As applicable, based on the subject's age and normal institution practice, the subject should additionally provide their written informed consent or assent to participate in the rollover protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants Who Had Access to, and Received the Intervention
timeFrame: Up to 586 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Themba Lethu Clinic, Helen Joseph Hospital, Westdene
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02196740: Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis
Official title: Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periapical Diseases
Keywords: periapical periodontitis,primary teeth
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in the treatment of periapical periodontitis of deciduous teeth is superior to other drugs currently in use as creosote.

Detailed description: We design to collect a group of patients presenting primary teeth with periapical periodontitis in certain criterion. We will divide the patients into two groups randomly.One group will get treated with triple antibiotic paste while the other with creosote.We want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of triple antibiotic paste.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of periapical periodontitis
* must be primary teeth
* must be 3\~8 years old
* the permanent tooth germ is complete and didnot be involved

Exclusion Criteria:

* blood disease
* residual root that is advised to extract
* serious periodontitis
* allergy to the triple antibiotic paste

Primary outcomes:
measure: Evidence of lesion healing confirmed by cone beam computed tomography and X-rays
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jicheng Lin
state: Guangdong
Study officials:
affiliation: Guanghua hospital of stomotology,Sun Yat-sen University
name: Jiacheng Lin
role: STUDY_CHAIR
References:
citation: Bezgin T, Yilmaz AD, Celik BN, Sonmez H. Concentrated platelet-rich plasma used in root canal revascularization: 2 case reports. Int Endod J. 2014 Jan;47(1):41-9. doi: 10.1111/iej.12144. Epub 2013 Jun 17.
citation: Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.
citation: Nagata JY, Soares AJ, Souza-Filho FJ, Zaia AA, Ferraz CC, Almeida JF, Gomes BP. Microbial evaluation of traumatized teeth treated with triple antibiotic paste or calcium hydroxide with 2% chlorhexidine gel in pulp revascularization. J Endod. 2014 Jun;40(6):778-83. doi: 10.1016/j.joen.2014.01.038. Epub 2014 Apr 29.
Clinical trial NCT03769740: Cerebral Oximetry and NIRS in Cardiac Arrest Patients
Official title: Cerebral Oximetry and NIRS in Cardiac Arrest Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Death
Cardiac Arrest
Emergencies
Keywords: cardiac arrest, cardiac death, CPR, neurologic prognostication, emergency medicine,
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 500
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: Patients presenting to the Emergency Department experiencing non-traumatic cardiac arrest or arriving post non-traumatic cardiac arrest

Brief summary: This is an observational study to define the role and future applications of cerebral oximetry in cardiac arrest patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Non-traumatic cardiac arrest or post non-traumatic cardiac arrest
* No purposeful response to verbal or noxious stimuli

Exclusion Criteria:

* Age \< 18 years
* Open head injury/trauma

Primary outcomes:
measure: ROSC
timeFrame: During ED resuscitation
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: DMC Detroit Receiving Hospital - Wayne State University
state: Michigan
city: Detroit
country: United States
facility: DMC Sinai-Grace Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT05324540: A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
Official title: A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: MediCool Technologies
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: An assessment of the use of cold therapy to terminate atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Subject must be ≥ 18 years or older
* Male of female
* Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration
* Must be in AF at time of surgery, or inducible using manual or electrical stimulation
* Subject is willing and able to provide written informed consent
* Subject has a life expectancy of at least 1 yearExclusion Criteria:

Exclusion Criteria: • Long-standing AF (duration \> 1 year)

* Prior AF ablation
* Left main coronary artery occlusion \> 70%
* Critical aortic stenosis (gradient \> 50mm HG)
* Inability to induce patient into AF without drugs at time of surgery
* Female subjects who are pregnant at time of surgery
* Subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study
* Permanent pacemaker or implantable cardioverter defibrillator
* Current cancer treatment that includes radiation of the heart
* Inability to give informed consent
* Significant intra-cardiac thrombus
* Subjects not eligible for or considered high risk for anticoagulation

Primary outcomes:
measure: Termination of atrial fibrillation
timeFrame: Termination will be measured within 3 minutes of application of cool therapy. No longer term data will be collected.
Secondary outcomes:
measure: Time to termination
timeFrame: Time to termination will be assessed only during each application. No longer term data will be collected.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04376840: Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia - COVID-19
Official title: Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe SARS-CoV2 Pneumonia
Keywords: SARS-CoV2
long term
complication
pneumonia
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Studies performed after coronavirus epidemics (severe acute respiratory syndrome coronavirus, SARS-CoV and Middle East respiratory syndrome coronavirus, MERS-CoV) have shown a long-term impact on respiratory morbidity, musculoskeletal and psycho-social repercussions.

Patients with SARS-CoV pneumonia had fibrotic pulmonary sequelae at 45 days (lower DLCO in 27.3% of cases and radiological lesions in 21.5% of cases). In the MERS-CoV pneumonia study, patients had radiological sequelae in 33% of cases and the 12-month evaluation showed persistence of radiological abnormalities in 23.7% of the cases despite an improvement in respiratory function.

Clinical presentation and therapeutic management of severe SARS-CoV-2 infection are in part similar to those induced by SARS-CoV and MERS-CoV. Long-term respiratory complications are therefore expected.

Detailed description: Objective is to evaluate prevalence of long-term respiratory complications after severe SARS-CoV2 pneumonia.

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient with with severe SARS-CoV2 pneumonia
* Patient consenting to participate to the study
* Patient enrolled in the national healthcare insurance program

Exclusion Criteria:

* Patient under 18 years

Primary outcomes:
measure: medium-term respiratory complications
timeFrame: 3 months
Secondary outcomes:
measure: long-term respiratory complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
citation: Perotin JM, Gierski F, Bolko L, Dury S, Barriere S, Launois C, Dewolf M, Chouabe S, Bongrain E, Picard D, Tran E, N'Guyen Y, Mourvillier B, Servettaz A, Rapin A, Marcus C, Lebargy F, Kaladjian A, Salmon JH, Deslee G. Cluster analysis unveils a severe persistent respiratory impairment phenotype 3-months after severe COVID-19. Respir Res. 2022 Aug 2;23(1):199. doi: 10.1186/s12931-022-02111-9.
Clinical trial NCT04821440: A 3D Tablet Sensor Approach to the Measurement of a Lymphedema
Official title: A 3D Tablet Sensor Approach to the Measurement of an Upper and Lower Limb Volume in the Monitoring of a Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: 3D sensor
Lower Extremity
Upper Extremity
Body Regions
Measurement
Monitoring
Water displacement
Volume
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Up to now, the diagnosis of lymphedema remains hard and delayed. It suffers from many limitations such as lack of coordination and formation of the health-care network. The diversity of used tools is another obstacle because all provided solutions on the market are either costless with poor accuracy, or highly expensive but with excellent accuracy. Therefore, we decided to evaluate an affordable and open-source 3D iPad sensor sharing the same technology used in Kinect sensors.


Eligibility criteria: Inclusion Criteria:

- Unilateral lymphedema

Exclusion Criteria:

* Minor patient,
* Bilateral lymphedema,
* Trophic disorders: Acute or recent skin infection (\<1 month after the end of antibiotic therapy), unhealed wounds.
* Predictable difficulties in carrying out the measurements due to the patient's physical limitations (maintenance of orthostatic or sitting position \<5 minutes)
* Single or bilateral edema with a different etiology than lymphedema.

Primary outcomes:
measure: Accuracy of a 3D sensor for lymphedema volumetry
timeFrame: One hour
Secondary outcomes:
measure: Reproducibility of measurements made with a 3D sensor for lymphedema volumetry
timeFrame: One hour
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
city: Pont-l'Abbé
country: France
facility: CH Pont l'Abbé
Study officials:
References:
Clinical trial NCT06138340: The Effects of Anesthetics on Brain Network Connectivity in Patients With Supratentorial Glioma
Official title: The Alterations of Brain Network Connectivity Under Sedation and Anesthesia in Patients With Supratentorial Glioma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Network Connectivity
Postoperative Delirium
Dexmedetomidine
Propofol
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population will be selected from patients who schedule to receive elective surgery in Beijing Tiantan Hospital.

Brief summary: Perioperative anesthesia can affect postoperative cognitive function. In our previous study, intraoperative dexmedetomidine (Dex) infusion reduced the incidence of delirium within the first 5 days after brain tumor. However, the mechanism is still unclear. With the development of neuroimaging, multimodal neuroimaging technology provide a new method to explore the underlying mechanism. Therefore, the purpose of this study is to analyze the alterations of brain network under sedation and anesthesia by different anesthetics in patients with supratentorial glioma and their association with cognition.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as unilateral supratentorial glioma by MRI
* Selective operation
* Age over 18 years old
* ASA I-II
* Right handedness

Exclusion Criteria:

* History of cerebrovascular disease, brain trauma, chemotherapy and radiotherapy, or psychotropic drugs
* History of intracranial surgery
* Drug and/or alcohol abuse
* History of dementia or mental illness
* Pregnant or lactating women
* Contraindications for MRI
* Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block
* Severe hepatic or renal dysfunction

Primary outcomes:
measure: The alterations of brain network connectivity.
timeFrame: Before sedation, 30 minutes after sedation，and 30 minutes after surgery.
Secondary outcomes:
measure: Postoperative delirium.
timeFrame: Day 1-5 after surgery.
measure: Electroencephalogram changes
timeFrame: From patients admission to operation room until 10 minutes after surgery
measure: rScO2 changes.
timeFrame: From patients admission to operation room until 10 minutes after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT04047940: A Study of LY900020 in Healthy Chinese Participants
Official title: A Relative Bioavailability Study of Three LY900020 Tablet Formulations in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-08-07
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate three new formulations of LY900020; a fixed dose, combination drug developed for people with type 2 diabetes mellitus. The study will be conducted in healthy participants to investigate the effect of different tablet formulations on the amount of LY900020 in the bloodstream. Side effects and tolerability will be documented. The study will last about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
* Have a body mass index (BMI) of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Had blood loss of more than 400 milliliters (mL) within the last 3 months

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020
timeFrame: Predose through 72 hours postdose on Day 4 in each study arm
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY900020
timeFrame: Predose through 72 hours postdose on Day 4 in each study arm
Secondary outcomes:
measure: PK: Time to Maximum Observed Drug Concentration (tmax) of LY900020
timeFrame: Predose through 72 hours postdose on Day 4 in each study arm
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: