louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00579735: Histologic Diagnoses of Incidentally Detected Lesions on MRI
Official title: Histologic Diagnoses of Incidentally Detected Lesions on MRI
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: Breast cancer
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mammography clinic in Northwest Arkansas

Brief summary: Patients who received breast MRI will be evaluated for a variety of indications including : # each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental lesions not detected by any other method that were subsequently subjected to biopsy with the following BIRADS categories 3-# reasons for bx 4-# 5-# Of the lesions detected % of each BIRADS category were postive histologies-ductal, lobular, DCIS, etc. and negative (fibrosis, hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance will be evaluated and a predictive value established.

Detailed description: Patients who received breast MRI will be evaluated for a variety of indications including ? # each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental lesions not detected by any other method that were subsequently subjected to biopsy with the following BIRADS categories 3-# reasons for bx 4-# 5-# Of the lesions detected % of each BIRADS category were postive histologies-ductal, lobular, DCIS, etc. and negative (fibrosis, hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance will be evaluated and a predictive value established. This study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of PHI. To minimize this risk, data collection forms will be identified by subject ID number. A master list of these ID numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. The medical record number will not be recorded on any other form containing subject PHI. The only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised

Eligibility criteria: Inclusion Criteria:

* All patients subjected to biopsy as a result of findings seen only on MRI

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Arkansas
name: Steven E Harms, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02025335: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients
Official title: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients (ACE-KT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation Recipients
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 199
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kindeny transplant recipients

Brief summary: CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of CMV development after solid organ transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant candidates to predict the development of CMV infection after kidney transplantation.

Detailed description: Between Mar 2014 and Mar 2015, all patients admitted in the kidney transplant unit will be enrolled in this study. All patients will receive CMV-specific ELISPOT assay and be prospectively followed for the development of CMV infection.

Eligibility criteria: Inclusion Criteria:

* age 16 or more
* agree with written informed consent

Exclusion Criteria:

* donor CMV IgG (+) and recipient CMV IgG (-)

Primary outcomes:
measure: CMV infection
timeFrame: 6 months after transplantation
Secondary outcomes:
measure: mortality
timeFrame: 6 months after transplantation
measure: rejection
timeFrame: 6 months after transplantation
measure: graft loss
timeFrame: 6 months after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim T, Lee HJ, Kim SM, Jung JH, Shin S, Kim YH, Sung H, Chong YP, Lee SO, Choi SH, Kim YS, Woo JH, Kim SH, Han DJ. Diagnostic usefulness of the cytomegalovirus (CMV)-specific T cell-based assay for predicting CMV infection after kidney transplant. Korean J Intern Med. 2020 Mar;35(2):438-448. doi: 10.3904/kjim.2017.318. Epub 2018 Jun 7.
Clinical trial NCT06930235: Effectiveness of Midodrine as an Adjuvant to Norepinephrine in Weaning Critically Ill Patients From Vasopressors
Official title: Effectiveness of Midodrine as an Adjuvant to Norepinephrine in Weaning Critically Ill Patients From Vasopressors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shock
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 112
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: This study aims to evaluate the effectiveness of midodrine as an adjuvant to norepinephrine in weaning critically ill patients from vasopressors


Eligibility criteria: Inclusion Criteria:

* Patients with refractory hypotension on an intravenous vasopressor for more than 24 h but deemed clinically stable.
* Patients on noradrenaline support \<10 μg/min

Exclusion Criteria:

* Known allergy to midodrine.
* Severe shock state, as evidenced by multiple vasopressor infusions or high vasopressor requirement (i.e. noradrenaline \>10 μg/min)
* Patients with severe organic heart disease (e.g., heart failure, sever aortic stenosis), pregnancy, thyrotoxicosis or pheochromocytoma.
* Those with no enteral route available.

Primary outcomes:
measure: follow up of critically ill patients on vasopressors
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Costa-Pinto R, Yong ZT, Yanase F, Young C, Brown A, Udy A, Young PJ, Eastwood G, Bellomo R. A pilot, feasibility, randomised controlled trial of midodrine as adjunctive vasopressor for low-dose vasopressor-dependent hypotension in intensive care patients: The MAVERIC study. J Crit Care. 2022 Feb;67:166-171. doi: 10.1016/j.jcrc.2021.11.004. Epub 2021 Nov 18.
citation: Hammond DA, Smith MN, Peksa GD, Trivedi AP, Balk RA, Menich BE. Midodrine as an Adjuvant to Intravenous Vasopressor Agents in Adults With Resolving Shock: Systematic Review and Meta-Analysis. J Intensive Care Med. 2020 Nov;35(11):1209-1215. doi: 10.1177/0885066619843279. Epub 2019 Apr 28.
citation: Hamed M, Elseidy SA, Elkheshen A, Maher J, Elmoghrabi A, Zaghloul A, Panakos A, Panaich S, Saad M, Elbadawi A. The Use of Midodrine as an Adjunctive Therapy to Liberate Patients from Intravenous Vasopressors: A Systematic Review and Meta-analysis of Randomized Controlled Studies. Cardiol Ther. 2023 Mar;12(1):185-195. doi: 10.1007/s40119-023-00301-0. Epub 2023 Jan 21.
Clinical trial NCT05320835: A Setting Focus Overdose Prevention Intervention
Official title: A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
HCV
Drug Overdose
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-04-11
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial (RCT)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).

Detailed description: This is a pilot of an injection setting targeted peer-driven intervention to reduce HIV/HCV transmission and overdose risk behaviors. Participants will be randomized to conditions: 1) Peer education and stocking of semi-public injection settings (SPIS) with risk reduction materials, and the standard of care. Based on their SPIS use, 120 index PWID participants will be selected.

A conceptual model for the intervention: The conceptual model is based on social influence, social network, and social cognitive theory. The prior work delineated social influence mechanisms. It is expected that training and modeling of effective communication skills will increase the occurrence of conversations on HIV/HCV and overdose prevention. These conversations will then alter perceived descriptive and prescriptive social norms of risk behaviors. The prior work is being enhanced by increasing the availability of risk reduction materials as well as the cuing and modeling risk reduction behaviors in risk settings. It has been found that PWID are motivated to conduct peer education; it enhances their status and provides them a prosocial role in the community. It is hypothesized that peer outreach and supply of materials to SPIS will lead to reduced sharing of injection equipment and increased naloxone availability.

Eligibility criteria: Inclusion Criteria:

* Current drug user (opioid use in the prior two weeks)

Exclusion Criteria:

* Any mental or physical health impairment that impedes ability to participate

Primary outcomes:
measure: Overdose prevention
timeFrame: 6 months
measure: HIV/HCV prevention
timeFrame: 6 months
Secondary outcomes:
measure: Overdose behaviors
timeFrame: 6 months
measure: Overdose behaviors 2
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Lighthouse Studies at Peer Point
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Carl Latkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462535: An Observational Study to Evaluate Effectiveness and Safety of Amosartan Plus Tablet
Official title: An Observational Study to Evaluate the Efficacy and Safety of Amosartan Plus Tablet in Uncontrolled Essential Hypertension Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension,Essential
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 4785
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Uncontrolled essential hypertension patients

Brief summary: This study was to evaluate the therapeutic effect and safety of Amosartan Plus tablet administration in uncontrolled essential hypertension patients.

During the routine medical visit, Amosartan Plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment.

In this study, effectiveness and safety information of treatment of Amosartan Plus tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.

As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

Detailed description: This study was a multi-center, prospective, non-interventional, observational study of factors affecting blood pressure after treatment with Amosartan Plus tablet in uncontrolled essential hypertension patients.

Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Plus tablet.

This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Eligibility criteria: Inclusion Criteria:

* Uncontrolled essential hypertension patients
* Those who have already decided to administer Amosartan Plus tablet under the medical judgment of the researcher
* Those who voluntarily decided to participate in this study and consented in writing to the consent form

Exclusion Criteria:

* Patients for whom use of Amosartan Plus tablet is prohibited

Primary outcomes:
measure: Change from baseline in SBP/DBP
timeFrame: 24 weeks
measure: Percentage from baseline in SBP/DBP
timeFrame: 24 weeks
measure: Percentage of patients achieving target blood pressure
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanmi Pharmaceutical Company Limited
Study officials:
References:
Clinical trial NCT06068335: Innate Immunity in Allergic Asthma
Official title: Innate Immunity in Allergic Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: allergy
Immunity
Healthy
respiratory
ENT
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will require 100 participants, with a third ideally falling within each category (healthy, allergic, or asthmatic)

Brief summary: The purpose of this study is to determine whether a potential type 2 signature, obtained through stimulation of cell lines with various allergens in vitro, correlates with an allergic or asthmatic disease state ex vivo. This type 2 signature will be multi-hierarchical in nature and will be comprised cell surface receptor expression, pathway activation, and gene upregulation.


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 18 years of age
* no history of allergic disease (healthy controls), have clinically diagnosed allergies, or have clinically diagnosed asthma.

Exclusion Criteria:

* Pregnant women and prisoners will be excluded from the study.
* Individuals currently suffering from any acute infections and those known to suffer from light-headedness will be excluded.

Primary outcomes:
measure: To determine which parameters of the established type-2 signature obtained in vitro is significantly different between healthy controls, allergic individuals, and asthmatic individuals ex vivo.
timeFrame: 1 year
Secondary outcomes:
measure: To determine ex vivo whether any of the identified disease-specific type-2 parameters can be modified (brought back to healthy control levels) through the use of investigational compounds.
timeFrame: 1 year
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Justine T Tigno-Aranjuez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04861935: Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple
Official title: Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacrococcygeal Disorder
Keywords: pediatric, sacral dimple, ultrasound
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups were formed as those with and without dimples in the sacral region.
Primary purpose: DIAGNOSTIC

Brief summary: When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners.

Detailed description: A dimple over the sacrum may be an isolated finding or a sign of underlying spinal abnormality. Therefore, most practitioners are confused to perform a caudal block. Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound guided investigation of the anatomical features of sacral region may play a key role to eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural sac level, distance between dural sac and estimated needle insertion site or needle entry angle. In this study, we will examine whether there is a difference between normal children and children with dimple in the sacral region.

Eligibility criteria: Inclusion Criteria:

-Children aged 1-72 months who are taken to the operating room for any reason

Exclusion Criteria: Patients with

* spinal anomalies,
* history of prematurity,
* neurological disorder
* syndromic illness.

Primary outcomes:
measure: ultrasound measurement-1
timeFrame: 1 min
measure: ultrasound measurement-2
timeFrame: 1 min
measure: ultrasound measurement-3
timeFrame: 1 min
Secondary outcomes:
measure: ultrasound evaluation of sacral region
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Guner Kaya, Prof.
role: STUDY_DIRECTOR
References:
citation: Schwartz D, Al-Najjar H, Connelly NR. Caudal block in a child with a sacral dimple utilizing ultrasonography. Paediatr Anaesth. 2011 Oct;21(10):1073-4. doi: 10.1111/j.1460-9592.2011.03621.x. No abstract available.
citation: Choi JH, Lee T, Kwon HH, You SK, Kang JW. Outcome of ultrasonographic imaging in infants with sacral dimple. Korean J Pediatr. 2018 Jun;61(6):194-199. doi: 10.3345/kjp.2018.61.6.194. Epub 2018 Jun 25.
Clinical trial NCT03928535: Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD
Official title: Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in Patients With Hypercapnic COPD，a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High-Flow Nasal Cannula
COPD
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients with hypercapnic COPD, investigators plan to conduct the participants level, 1:1 randomized trial at the respiratory ICU. Participants were randomized to undergo either high-flow conditioned oxygen therapy or noninvasive mechanical ventilation after extubation. Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Secondary outcomes included length of RICU stay after extubation and mortality; partial pressure of arterial carbon dioxide.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of AECOPD
* Extubation must be performed after 48 hours of invasive ventilation
* Must be treated sequentially with HFNC or NIV after extubation
* PaCO2≥50mmHg when extubation
* Positive End Expiratory Pressure (PEEP) ≤8cmH2O (1cmH2O=0.098 kPa) when extubation

Exclusion Criteria:

* Do-not-intubate
* Tracheostomies
* Accidental extubation
* Self-extubation

Primary outcomes:
measure: Rate of reintubation
timeFrame: Within 72 hours after extubation
Secondary outcomes:
measure: RICU length of stay after extubation
timeFrame: From date of extubation until the date of discharging from the RICU up to 28 days
measure: Mortality
timeFrame: Within 28 days after extubation
measure: Partial pressure of arterial carbon dioxide
timeFrame: Within 24 hours before extubation and within 72 hours after extubation
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
References: