louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06985238: Stratagen Quantitative Prostate MRI Platform Pilot Study
Official title: A Pilot Study to Determine Safety and Feasibility of the Stratagen Quantitative Prostate MRI Platform as an Adjunct to Standard of Care MRI When Evaluating for Clinically Significant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Stratagen Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-22
Enrollment: 45
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this clinical trial is to assess the safety and feasibility of the Stratagen Quantitative Prostate MRI Platform when used in addition to the standard scans conducted during the existing prostate MRI sessions.

* What severe problems, if any, occur because of the use of the Stratagen Quantitative Prostate MRI Platform?
* Can the data collected be used to measure quantitative MRI parameters?

Participants will:

- Receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.


Eligibility criteria: Inclusion Criteria:

* Subject has a prostate that would be considered for biopsy
* Age 40-90 years
* PSA ≥ 2.5
* Subject has been informed of the nature of the study and has provided written informed consent

Exclusion Criteria:

* Contraindication for MRI
* Prostate biopsy within the previous 12 weeks
* Implant in the pelvis that may cause artifact on MRI (e.g. hip replacement)
* History of prostatectomy or other local prostate cancer therapy (e.g., cryotherapy or brachytherapy), or previous pelvic irradiation
* Currently enrolled in another investigational drug or device study that clinically interferes with this study
* Unable to comply with the study requirements or follow up schedule
* Any condition the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject

Primary outcomes:
measure: Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines
timeFrame: Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
measure: • Feasibility: collection of the data necessary to produce measurable quantitative T1 and T2 relaxation times (milliseconds) maps (images) for at least 80% of pixels fully contained within the prostate for at least 80% of subjects
timeFrame: Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00222638: Influenza Vaccination and Oral Anticoagulant Therapy
Official title: Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anticoagulants
Influenza Vaccines
Keywords: Oral anticoagulants
Influenza virus
Influenza vaccine
Pharmacological interference
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 100
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 is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination

Detailed description: The pharmacokinetic and the pharmacodynamic interactions and the possible clinical events connected with the simultaneous administration of Oral Anticoagulants (OA) and the influenza virus vaccine were evaluated in several small studies which yielded conflicting results, thus encouraging additional investigations with prospective studies in order to obtain a more consistent evidence about the safety and efficacy of vaccination against influenza virus in patients on OA Treatment.

Eligibility criteria: Inclusion Criteria:

* OA Treatment
* Stable anticoagulation (previous two controls in range)
* Presence of indication for Influenza Vaccination
* Life expectancy \> 6 months
* Signed Informed consent

Exclusion Criteria:

* Absence of stable anticoagulation
* Absence of indication for Influenza Vaccination
* Life expectancy \< 6 months
* Denied Informed Consent

Primary outcomes:
measure: 1.Variations in INR value and in OAT weekly dosage after IV
Secondary outcomes:
measure: 1.Efficacy of IV in patients on OAT
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: University of Perugia
Study officials:
affiliation: University Of Perugia
name: Alfonso Iorio
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Sanitary Agency (ASL2-Perugia)
name: Maria Vecchioli
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Virology - University of Perugia
name: Anna Maria Iorio
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iorio A, Basileo M, Marcucci M, Guercini F, Camilloni B, Paccamiccio E, Vecchioli M, Iorio AM. Influenza vaccination and vitamin K antagonist treatment: a placebo-controlled, randomized, double-blind crossover study. Arch Intern Med. 2010 Apr 12;170(7):609-16. doi: 10.1001/archinternmed.2010.49.
Clinical trial NCT02371538: Human Breastmilk in Young Children With Norovirus Infection of the Gut
Official title: A Pilot Study of Enteral Donor Human Milk in Young Children With Norovirus Infection of the Gut
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Norovirus Infections
Keywords: stem cell transplant
human breastmilk
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Mothers' Milk Bank Northeast
First posted: 2015-02-25
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Human Breast milk in young children with Norovirus Infection

Detailed description: The investigators hypothesize that children with clinically significant norovirus infection of the gut who receive enteral human milk will more successfully clear the virus or experience improved symptoms compared to children not receiving human milk.

Eligibility criteria: Inclusion Criteria:

* Children with at least two stool samples taken at least 7 days apart that are positive for norovirus
* Child has an underlying disease or has received immunosuppressive medication or chemotherapy such that clearance of norovirus is expected to be impaired.

Exclusion Criteria:

* The presence of other pathogens causing diarrhea that have specific treatments does not preclude enrollment. However, specific treatment should be offered in addition to human milk.

Primary outcomes:
measure: Loose/Unformed/Liquid Stools or Abdominal Cramping
timeFrame: Up to 12 weeks
measure: Norovirus
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Javier El-Bietar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01677338: Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects
Official title: A Multi-center, Open-label Comparison Study of a 13C-uracil Breath Test Versus 99mTechnetium Sulfur Colloid Gastric Emptying Scintigraphy to Evaluate Normal, and Delayed Gastric Emptying Time in Dyspeptic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyspeptic Subjects
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2012-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a multi-center, open-label comparison study and aimed to evaluate the preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying abnormal (delayed) gastric emptying rates in subjects.

Detailed description: Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10 subjects per group.

The subjects will first have their gastric emptying rates investigated by scintigraphy using the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for evaluation of the 13C-uracil GEBT.

Eligibility criteria: Inclusion Criteria:

* Body mass index \[range is 18.0 to 33.0 kg/m2
* Subjects with any upper GI symptoms
* Stable creatinine

Exclusion Criteria:

* History of known peptic ulcers or stomach cancer.
* History of stomach surgery or resection
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food or other substance, unless approved by the investigator
* History of alcoholism or drug abuse
* History or presence of clinically significant GI, cardiovascular, central nervous system, hepatic, or renal disease; or other conditions
* History of eating disorders
* History or presence of an abnormal ECG, which, in the opinion of the investigator, is clinically significant

Primary outcomes:
measure: Expired 13CO2 concentrations
timeFrame: 6 hours
Secondary outcomes:
measure: Concentrations of 13C-uracil and its major metabolites in plasma and urine
timeFrame: 6 hours
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology
state: New Hampshire
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kimiyoshi Sudoh
role: STUDY_DIRECTOR
References:
Clinical trial NCT03748238: Endometrial Injury In Recurrent Implantation Failure
Official title: Systematic And Standardized Hysteroscopic Endometrial Injury For Treatment Of Recurrent Implantation Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Endometrial Diseases
Keywords: Recurrent implantation failure
Endometrial injury
Implantation
Hysteroscopy
Lead sponsor: Gurgan Clinic
Sponsor class: NETWORK
First posted: 2018-11-20
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.

Detailed description: This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.

Eligibility criteria: Inclusion Criteria:

* Women under the age of 40 who met the RIF definition
* Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL

Exclusion Criteria:

* Patients with congenital uterine anomalies
* Patients with Asherman's syndrome
* Patients with uterine cavity distorted by myoma or endometrial polyps
* Patients with confirmed endometriosis or endometrioma
* Patients with BMI of \<18.5 and \>29.9

Primary outcomes:
measure: Positive Pregnancy
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gurgan Clinic IVF and Women Health Center
state: Cankaya
Study officials:
affiliation: Gurgan Clinic IVF and Women Health Center
name: Ziya Kalem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GurganClinic IVF and Women Health Center
name: Halil Ruso, Embryologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Greek University
name: Antonis Makrigiannakis, MD,Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00907738: A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)
Official title: A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.


Eligibility criteria: Inclusion Criteria:

* Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
* Patient did not withdraw from the base protocol
* Patient agrees to practice effective birth control during the study

Exclusion Criteria:

* Patient is receiving other standard and/or investigational anticancer therapy
* Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug

Primary outcomes:
measure: Percent of Participants With a Serious Drug-related Adverse Event (AE)
timeFrame: From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. doi: 10.3816/CLM.2009.n.082.
Clinical trial NCT03940638: Management of Septic Non-union of the Tibia Using the "Induced Membrane" Technique
Official title: Management of Septic Non-union of the Tibia Using the "Induced Membrane" Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Tibial Non-union
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with septic non-union of the tibia managed using the induced membrane technique

Brief summary: The aim of the study was to assess clinical and radiological results with the "induces membrane" technique, described by A. C. Masquelet in 1986, in a series of patients with septic non-union of the tibia

Detailed description: Septic tibial non-union is a therapeutic challenge that may even lead to amputation. Treatment often necessitates several chirurgical steps. It is agreed that resection must extend to several tissues (osteitis zone ans macroscopically pathological soft tissue), with associated non-union site stabilization ans effective antibiotic therapy.

In 1986, Pr A. C. Masquelet described a 2-step procedure called the induced membrane technique, to manage bone defects of varying severity. Initial results were encouraging but there have been few large homogeneous series specific to this technique in septic non-union.

Eligibility criteria: inclusion criteria :

* Patients with septic non-union of the tibia
* managed using the induced membrane technique between novembrer 2007 and novembre 2014 in Reims University hospital
* Patients who agree to participate to the study
* Major patient

exclusion criteria :

* Patient under law protection
* Minor patient

Primary outcomes:
measure: Presence of Bone union
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
citation: Siboni R, Joseph E, Blasco L, Barbe C, Bajolet O, Diallo S, Ohl X. Management of septic non-union of the tibia by the induced membrane technique. What factors could improve results? Orthop Traumatol Surg Res. 2018 Oct;104(6):911-915. doi: 10.1016/j.otsr.2018.04.013. Epub 2018 Jun 7.
Clinical trial NCT01188538: Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel
Official title: Anti P. Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel in the Treatment of Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: P. acnes, Acne vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.


Eligibility criteria: Inclusion Criteria:

* Subjects with facial acne,
* Subjects with high levels of P. acnes counts on the forehead

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
* Subjects with acne conglobata, acne fulminans, secondary acne
* Subjects with known or suspected allergy to one of the test product

Primary outcomes:
measure: Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes
timeFrame: Week 12
Secondary outcomes:
measure: Percent Change (%) in Inflammatory Lesion Counts
timeFrame: Week 12
Other outcomes:
Locations:
city: Iwonicz Zdrój
country: Poland
facility: Dermatologiczna Klinika Uzdrowiskowa
Study officials:
affiliation: Dermatologiczna Klinika Uzdrowiskowa, IWOLANG Sp. z o.o. , Zespół Naukowo-Kliniczny, IWONICZ ZDRÓJ - POLAND
name: Andrzej LANGNER, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05110508: Active KC: a Text Message Based Intervention for Physical Activity
Official title: Active KC: a Text Message Based Intervention for Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Patient Engagement
Keywords: text message
technology
Garmin
physical activity
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 210
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Active KC will involve delivering PA support tools to individuals interested in increasing their physical activity. The tools involve provision of a Garmin wearable activity monitor and participant-tailored behavior change supports (e.g., goal setting and monitoring) delivered through text messaging and a corresponding study website.


Eligibility criteria: Inclusion Criteria:

* Individual has a smart device with internet or data and app downloading and texting capability
* Can read or write in English
* At least 8 years old (there is no upper age limit)
* Willing to complete study measures, participate in intervention, and share data collected in Active KC with the main study

Exclusion Criteria:

* Does not meet the above inclusion criteria
* Non-adherent to study measurement (wearing the Garmin less than 4 days) during baseline period
* Averaging over 60 minutes per day of physical activity (children) or 30 minutes of physical activity per day (adults) during the baseline period as measured by the Garmin
* Participant has a disability that interferes with their ability to carry out daily activities

Primary outcomes:
measure: Changes in Physical Activity Minutes Over Time
timeFrame: 8 weeks
measure: Changes in Physical Activity Steps Over Time
timeFrame: 8 weeks
Secondary outcomes:
measure: Participant Engagement of Text Messages
timeFrame: 8 weeks
measure: Views of Participants on Intervention Preferences via Participant Survey
timeFrame: Baseline, End of Study (8 weeks)
measure: Participant Engagement of the Garmin Monitor
timeFrame: 8 weeks
measure: Views of Participants on intervention via Focus Groups
timeFrame: Week 4, Week 8
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy
state: Missouri
Study officials:
References:
Clinical trial NCT00546208: Unilateral Cutaneous Ureterostomy - Long Term Follow up
Official title: Bladder Function Following Temporary Unilateral Cutaneous Ureterostomy - Long Term Follow up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Function
Keywords: bladder function
cutaneous ureterostomy
hydronephrosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-10-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adolescents and adults who had been operated in our institution for severe bilateral congenital hydro-ureteronephrosis

Brief summary: This observational study is aimed at exploring bladder function following temporary unilateral low loop cutaneous ureterostomy carried out in newborns suffering from severe congenital hydro-ureteronephrosis


Eligibility criteria: Inclusion Criteria:

* Living patients
* Bilateral functioning kidneys
* Unilateral ureteral cutaneous diversion

Exclusion Criteria:

* Dead patients
* Single kidney
* High percutaneous ureteral diversion (e.g: cutaneous pyelostomies, bilateral cutaneous urinary diversion)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center, Tel Hashomer
Study officials:
affiliation: The Chaim Sheba Medical Center
name: Dorit E Zilberman, MD
role: PRINCIPAL_INVESTIGATOR
References: