louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04982536: Assessment of VMCore Biopsy Versus Standard of Care Biopsy
Official title: A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Uro-1 Medical
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will have biopsy performed with both the study needle and a standard of care needle
Primary purpose: DIAGNOSTIC

Brief summary: Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.

Detailed description: This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.

Eligibility criteria: Inclusion Criteria:

* Male
* Scheduled for a prostate biopsy
* Able and willing to provide verbal assessment of his condition 5 days post-procedure

Exclusion Criteria:

* Unable or unwilling to provide consent

Primary outcomes:
measure: Procedure Success
timeFrame: 1 Day of the procedure
measure: Adverse Events
timeFrame: 1 Day of the procedure
measure: Patient Pain During use of the biopsy needles
timeFrame: 1 Day of the procedure
Secondary outcomes:
measure: Mean Tissue volume for each sample taken
timeFrame: 1 Day of the procedure
Other outcomes:
Locations:
city: Cartersville
country: United States
facility: Georgia Urology
state: Georgia
Study officials:
affiliation: Uro-1 Medical
name: Thomas Lawson
role: STUDY_DIRECTOR
References:
Clinical trial NCT03201536: ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study
Official title: ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wounds and Injuries
Keywords: ZipLine3 device vs. conventional sutures
Lead sponsor: ZipLine Medical Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.

Detailed description: The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.

Eligibility criteria: Inclusion Criteria:

1. Patients between 18 and 75 years of age

   * In generally good health
   * Willing to be evaluated in 5-14 days and 3-months post op
2. Patient requiring a non-emergent skin incision or biopsy

   * Maximum excision size 1.5x3.0 cm
   * Requiring 4-0 or smaller suture for closure
   * In area of body trunk or extremities with low mobility and tension

Exclusion Criteria:

1. Facial Incisions or incisions in high stress or tension areas
2. Previously diagnosed peripheral vascular disease
3. Insulin-dependent diabetes mellitus
4. Known bleeding diathesis
5. Known personal or family history of keloid formation or scar hypertrophy
6. Known allergy or hypersensitivity to adhesives
7. Presently taking steroids, immune stimulants, beta blockers, or anticoagulants
8. Atrophic skin deemed clinically prone to blistering
9. Any skin disorder affecting wound healing
10. Incisions requiring dermal sutures
11. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Primary outcomes:
measure: Wound healing
timeFrame: 3-month
Secondary outcomes:
measure: time of procedure
timeFrame: immediately
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: San Francisco
country: United States
facility: Plastic Surgery Institute of Northern California
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
Study officials:
affiliation: Plastic Surgery Institute of Northern California
name: Brian M Parret, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palo Alto Medical Foundation
name: Landon Clark, MD,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: California Pacific Medical Center
name: Stanley P Leong, MD,FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542736: Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)
Official title: Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Medulloblastoma
High Risk Supratentorial PNET
Metastatic PNET
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the efficacy of the combination of reduced dose craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine administration for metastatic classical histology medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.


Eligibility criteria: Inclusion Criteria:

* Age greater than 3 years and less than 25 years
* Patients with classic histology or desmoplastic histology metastatic medulloblastoma by histological diagnosis and by head and spine MRI.
* Patients with high-risk supratentorial, non-metastatic, PNET
* Patients with metastatic PNET
* Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision
* Only patients who are expected to survive at least 6 weeks will be eligible for this study.

Exclusion Criteria:

* Patients who are pregnant may not be treated on this study
* Patients with anaplastic histology

Primary outcomes:
measure: Event-free Survival
timeFrame: Up to 60 months.
measure: Overall Survival
timeFrame: up to 5 years
measure: Intellectual Competence Measured by IQ Score: Week 8
timeFrame: Week 8
measure: Intellectual Competence Measured by IQ Score: Month 24
timeFrame: Month 24
measure: Intellectual Competence Measured by IQ Score: Month 60
timeFrame: Month 60
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer Madden, RN, CPNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05979636: Novamin on Streptococcus Mutans Count in Dental Plaque of High Caries Risk Children
Official title: Effect of Toothpaste Containing Novamin on Streptococcous Mutans Count in Dental Plaque of High Caries Risk Children (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Dental Caries
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans in the plaque of high caries-risk children.


Eligibility criteria: Inclusion Criteria:

* Medically healthy children.
* No erupting first permanent molars.
* High caries risk children; Have visible cavities or have a visible plaque on their teeth.
* Cooperative (Positive or definitely positive), according to Frankl's Behavior Rating Scale

Exclusion Criteria:

* History of intake of antibiotics for the past 3-4 weeks.
* History of professional fluoride treatment over 2 weeks before the study.
* Children with tooth structure defects.
* Children unable to return for recall visits

Primary outcomes:
measure: Change in bacterial count in dental plaque
timeFrame: 1 week, 2 weeks and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04136236: Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using pCLE With AI
Official title: Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using Probe-based Confocal Laser Endomicroscopy With Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Artificial Intelligence
Confocal Laser Endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who receive the upper gastrointestinal tract pCLE examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

Brief summary: Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes. Probe-based confocal laser endomicroscopy (pCLE) can diagnose ESN accurately.However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 80;
* agree to give written informed consent；

Exclusion Criteria:

* advanced esophageal squamous cell carcinoma or esophageal stenosis;
* having no suspicious lesion of ESN found by WLE and IEE
* known allergy to fluorescein sodium;
* having coagulopathy or impaired renal function;
* being pregnant or breastfeeding.

Primary outcomes:
measure: The diagnosis efficiency of Artificial Intelligence
timeFrame: 3 years
Secondary outcomes:
measure: Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists
timeFrame: 1 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531036: 3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy
Official title: Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Breast Tumours
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-02-10
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. This could be particularly useful in patients with large breast tumors under pre-operative chemotherapy

Detailed description: 3D breast ultrasound elastography provides volumetric lesion stiffness details in real time. 3D acquisition is compared to breast MRI in order to evaluate volume measurements calculated in ultrasound. Lesion elasticity is calculated in 3 planes with immediate reconstruction. The purpose of this prospective study is to evaluate the feasibility of this technique and compare the results to those of Breast MRI. For women receiving preoperative chemotherapy, this technique will be evaluated with regard to tumour shrinkage and lesion elasticity modifications under treatment.

Eligibility criteria: Inclusion Criteria:

* Patients having already undergone a breast MRI
* Patients presenting with breast lesions measuring between20-50mm in ultrasound

Exclusion Criteria:

* Multifocal lesions
* History of breast cancer
* Breast implants
* Inflammatory breast disease
* Pregnancy

Primary outcomes:
measure: 3D volumetric elasticity measurements
timeFrame: 10min
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Curie Cancer Institute
Study officials:
affiliation: Curie Cancer Institute
name: Alexandra Athanasiou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Athanasiou A, Tardivon A, Tanter M, Sigal-Zafrani B, Bercoff J, Deffieux T, Gennisson JL, Fink M, Neuenschwander S. Breast lesions: quantitative elastography with supersonic shear imaging--preliminary results. Radiology. 2010 Jul;256(1):297-303. doi: 10.1148/radiol.10090385. Epub 2010 May 26.
Clinical trial NCT02685436: Role of Pepsin Assay in Wheezy Infants
Official title: Role of Bronchoalveolar Lavage Pepsin Assay in Wheezy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and exacerbations recurrence.

Detailed description: Wheezy infants were tested for gastro-esophageal reflux disease using combined MII-pH, EGD, LLMI and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole for 12 weeks then re-evaluated for symptoms control and wheeze exacerbations recurrence.

Eligibility criteria: Inclusion Criteria:

* Infants with physician documented 3 attacks of wheezing episodes over the last 6 months or persistent wheeze over the last one month

Exclusion Criteria:

* Wheezy infants with atopy (allergic rhino-conjunctivitis or eczema), prematurity (less than 34 weeks), abnormal neurological examination, congenital heart diseases, airspace opacity on chest radiography, tracheal-bronchial malformations, immune deficiency and anatomical esophageal or gastric malformations

Primary outcomes:
measure: Number of Participants in Each Level of Wheeze Control
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty if medicine, Mansoura University
name: Tarek El-Desoky
role: STUDY_DIRECTOR
References:
Clinical trial NCT03124836: Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of the noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to blood measurements from a laboratory analyzer.


Eligibility criteria: Inclusion Criteria:

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
6. The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
7. The subject has any other serious systemic illness.
8. The subject is a current smoker.
9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject has a history of migraine headaches.
16. Th subject is currently taking antidepressants.
17. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
18. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Primary outcomes:
measure: Accuracy of Methemoglobin Measurement by Arms Calculation
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of San Francisco
state: California
Study officials:
References:
Clinical trial NCT05749536: Pharmacokinetics of Procaterol in Elite Athletes
Official title: Procaterol in Elite Athletes - a PK Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: elite athletes
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Asthmatic and healthy volunteers

Brief summary: The purpose of the study is to find blood and urine concentrations of procaterol administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet intake versus inhalation.

Detailed description: Doping study

Eligibility criteria: Inclusion Criteria:

* Doctor diagnosed asthma for the asthmatic group
* GINA 1-3 for the asthmatic group
* Use of beta2-agonist for at least 12 months for the asthmatic group
* age 18-45
* males
* informed consent

Exclusion Criteria:

* smoker or former smoker
* airway infection to weeks prior to the study or during the study
* other chronic diseaes than asthma and allergy
* Use of beta2-agonist 6 days prior to the study
* Allergy to the study medicine

Primary outcomes:
measure: urine concentration of drug 0-24 h
timeFrame: 7 days
measure: serum concentration of drug 0-24 h
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Vibeke Backer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02951936: The Utility of Regional Bioimpedance in Chronically Ventilated Patients
Official title: The Utility of Regional Bioimpedance in Chronically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Respiratory Failure
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronically ventilated patients will be hemodynamically measured by bioimpedance (NiCAS by NI medical ltd.) for cardiac output, Total peripheral resistance and other NICAS derived parameters.

Patients fluid balance will be planned according to these parameters and the rate of liberation from ventilator and rate of worsening renal function will be measured

Detailed description: Patients will be divided into two groups , the study group and the control group randomly assigned by a computer program .

After obtaining written informed consent , cardiac monitoring will be carried out by means of a NiCAS patients in both groups.The physician will not be exposed to the measurement data of the patients in the control group. For the research group : Monitoring will be carried out once a day , preferably at the same time the first three days . An increase in time interval is possible in accordance with an improvement in the patient . Patients will be treated according to the protocol described in Figure 1. Also , a graphic description of the various treatment zones and the exclusion zone is presented in Figure 2 .

For the control group patients will be treated according to the usual ward protocols.

The basic rules are:

Avoiding over- drying by using parameter TBW .

* Avoidance of renal dysfunction by maintaining the cardiac output above 2.3 , and avoiding the use of beta-blocker overdose in cases of low cardiac output and bradycardia as a result of maintaining an average blood pressure over 70 .
* In cases of high peripheral resistance - Reduction of resistance while maintaining normal blood pressure .

Eligibility criteria: Inclusion Criteria:

* All chronically ventilated patients (ventilated for more than 14 days)
* Age between 18-90

Exclusion Criteria:

* Non ventilated patient
* Total body water \>80%

Primary outcomes:
measure: number of days ventilated
timeFrame: 90 days
Secondary outcomes:
measure: kidney function
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References: