louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04654221: Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery
Official title: Evaluation of eGFR, Determined by Cystatin C and Creatinine, and mGFR, Measured by Iohexol Clearance, in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Surgery
Keywords: GFR
Acute Kidney Injury
AKI
Lead sponsor: Quark Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have undergone non-emergent cardiac surgery and were at high risk of developing AKI, who meet all of the Inclusion and none of the Exclusion criteria, will be eligible.

Brief summary: To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute kidney injury (AKI) approximately 90 days following cardiac surgery

Detailed description: This is an open label, single-visit study to evaluate the relationship between mGFR and eGFR based either on serum creatinine (eGFRcreat) or cystatin C (eGFRcys) approximately 90 days following cardiac surgery. No investigational study drug will be administered.

Eligibility criteria: Key Inclusion Criteria:

* Male or female, age ≥ 45 years old
* At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:

  1. Reduced renal function
  2. Diabetes with ongoing insulin treatment
  3. Albuminuria
* Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

Key Exclusion Criteria:

* Emergent surgeries, including aortic dissection, and major congenital heart defects
* Past cardiac surgery off CPB
* Have a known allergy to iohexol

Primary outcomes:
measure: Correlation between eGFR and mGFR
timeFrame: at 90 days post cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: CB Flock Research
state: Alabama
city: Covina
country: United States
facility: Valley Clinical Trials
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Advance Medical Research
state: Florida
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Quark Pharmaceuticals
name: Nitsan Halevy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02939521: Reconstructive Surgical Approach for Pincer Nail
Official title: Reconstructive Surgical Approach for Pincer Nail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pincer Nail
Keywords: Pincer Nail
Surgery
Lead sponsor: Clínica María del Mar Ruiz
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective design that studies the effects of a new technique for the treatment of pincer nails. The technique consists of a flattening of the bone of the distal phalanx with a frontal skin lifting that is performed in patients with a pincer nail deformity. Visual Analog Scale (VAS) will be measure before surgery, one month and one year after surgery.


Eligibility criteria: Eligibility Criteria:

* Pincer nail deformity
* At least 5 years of pain in the nail
* Prior unsuccessful conservative treatments

Exclusion Criteria:

* Medical or mental conditions that contraindicate surgical treatment of the condition.

Primary outcomes:
measure: Change in Pain - 10 points Visual Analog Scale (VAS)
timeFrame: Change in Pain will be measured with a VAS: at baseline, after 1 month of treatment and after 1 year after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mª del Mar Ruiz Clinic
name: Mª del Mar Ruíz-Herrera, DPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT00513721: Retrospective Study of Positive Biopsy Specimens on Patients Undergoing a Prostatectomy
Official title: Do Positive Lateral Biopsy Cores on TRUS Directed Biopsies Predict Capsular Penetration and Positive Surgical Margins?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate
prostate cancer
surgical margins
gleason score
positive lateral biopsies
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2007-08-09
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males having undergone surgery for prostate cancer at William Beaumont Hospital-Royal Oak, Michigan

Brief summary: This is a review of prostate biopsy specimens which show capsular penetration or positive surgical margins. Patients had surgery performed at William Beaumont Hospital-Royal Oak, Michigan.


Eligibility criteria: Inclusion Criteria:

* Males having undergone surgery for prostate cancer at William Beaumont Hospital-Royal Oak, Michigan

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Fadi Eliya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04090021: Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.
Official title: Genotypic Resistance-guided Triple Therapy Versus Empirical Concomitant Therapy for First-line H. Pylori Eradication.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: H. pylori
genotypic resistance
tailored therapy
concomitant therapy
Lead sponsor: Konstantopoulio-Patission General Hospital of Nea Ionia
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 304
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 investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.

Detailed description: Empiric eradication of H. pylori becomes steadily more challenging because of increasing antibiotic resistance. In high-resistance countries where bismuth and/or tetracycline are unavailable (eg; Greece), non-bismuth quadruple therapies are currently recommended as first-line therapeutic options; however, eradication rates \>95% are infrequently achieved and even \>90% are disputed. Antimicrobial susceptibility-guided therapy is a promising alternative in order to maintain high therapeutic efficacy. However, traditional culture-based susceptibility testing methods have several shortcomings, including they are time-consuming and they do not 100% reflect in vivo eradication. Recent guidelines also recommend the use of molecular testing for evaluation of H. pylori antibiotic susceptibility. Nevertheless, the efficacy of genotypic resistance-guided treatment of H. pylori has been seldom appraised. Therefore, the investigators conducted this prospective randomized controlled trial aiming to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of H. pylori.

Eligibility criteria: Inclusion Criteria:

* Consecutive outpatients aged ≥18 years with documented H. pylori infection. Mental and legal ability to provide written informed consent.

Exclusion Criteria:

* previous history of H. pylori eradication therapy
* history of allergies to the medications used
* previous esophageal or gastric surgery
* serious systemic disease
* pregnancy or lactation.

Primary outcomes:
measure: Rate of H. pylori eradication
timeFrame: At least 6 weeks after treatment completion
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: At least 6 weeks after treatment completion
measure: Compliance rates
timeFrame: At least 6 weeks after treatment completion
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Konstantopoulio-Patision General Hospital
state: Nea Ionia
Study officials:
References:
Clinical trial NCT06898021: The 3D Stent Study
Official title: Diagnostic Performance of 3DStent to Assess Stent Expansion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention (PCI)
Lead sponsor: CoreAalst BV
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 200
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: Patients presenting with chronic or acute coronary syndromes (ACS) and a clinical indication for PCI

Brief summary: The goal of this observational study is to assess the diagnostic performance of 3D Stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention.

The main question it aims to answer is:

The study hypothesis is that 3DStent technology will offer a comparable assessment of stent expansion compared to intravascular imaging.


Eligibility criteria: Inclusion Criteria:

* Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.

Exclusion Criteria:

1. Age \<18 years
2. Coronary lesions requiring total stent length \> 48 mm.
3. Body mass index \>35 kg/m2
4. Uncontrolled recurrent ventricular tachycardia
5. Cardiogenic shock
6. Unable to provide written informed consent (IC).

Primary outcomes:
measure: Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference.
timeFrame: Periprocedural timeframe
Secondary outcomes:
measure: Agreement on minimal stent area (MSA) between 3DStent and Intravascular Ultrasound (IVUS).
timeFrame: Periprocedural timeframe
measure: Clinical utility of 3DStent for guiding stent optimisation with Intravascular Ultrasound (IVUS) as a reference.
timeFrame: Periprocedural timeframe
measure: Feasibility of 3DStent acquisition during the procedure
timeFrame: Periprocedural timeframe
measure: Agreement on stent expansion between 3DStent and IVUS.
timeFrame: Periprocedural timeframe
measure: Impact of lesion location (vessel and segment) on 3DStent diagnostic accuracy.
timeFrame: Periprocedural timeframe
measure: Agreement on maximal calcium arc as assessed by 3DStent, with IVUS as the reference in cases where 3DStent is acquired pre-PCI.
timeFrame: Periprocedural timeframe
measure: Impact of calcifications on 3DStent diagnostic accuracy.
timeFrame: Periprocedural timeframe
measure: Agreement on stent underexpansion and MSA between site and core laboratory.
timeFrame: Periprocedural timeframe
measure: Radiation exposure associated with 3DStent
timeFrame: Periprocedural timeframe
measure: Procedural time of the 3DStent workflow
timeFrame: Periprocedural timeframe
Other outcomes:
Locations:
Study officials:
affiliation: Cardiovascular Center Aalst
name: Carlos Collet Bortone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Center Aalst
name: Adriaan Wilgenhof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06549621: Cardiotoxicity of Carbon Monoxide in Patients Treated With Hyperbaric Oxygen Therapy
Official title: Cardiotoxicity of Carbon Monoxide in Patients Treated With Hyperbaric Oxygen Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carbon Monoxide Poisoning
Keywords: cardiac injury
cardiac toxicity
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated for CO poisoning with HBOT following European and French recommendations in our department from 2015/01/01 to 2021/12/31

Brief summary: Carbon monoxide poisoning is a frequent domestic accident and the leading cause of death from unintentionnal poisoning. Its toxicity is based on the CO binding to hemoglobin and myoglobin, inhibition of mitochondrial cytochrome oxidase, resulting in tissue hypoxia and reduced adenosine triphosphate synthesis and ischemia-reperfusion injury.

This study aims to investigate the early and late cardiologic effects of CO in patients treated with hyperbaric oxygen (HBOT) for CO poisoning

Detailed description: This is a single-center retrospective study on health data. The methodology includes a collection of data on health and history data of patients treated by HBOT fo CO poisoning between 01/01/2015 and 31/12/2021 and carrying out a telephone interview of patients who have had early cardiovascular manifestations of CO poisoning.

One month between the start of theses interviews, an information letter on the study is sent by post, giving the possibility of opposing it.

Eligibility criteria: Inclusion Criteria:

Patients treated for CO poisoning with HBOT in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2021/12/31

Exclusion Criteria:

* refusal

Primary outcomes:
measure: early and late cardiac injury due to CO poisoning description
timeFrame: enrollment (inclusion)
Secondary outcomes:
measure: relationship between the source of CO poisoning and cardiac injury
timeFrame: enrollment (inclusion)
measure: relationship between context of poisoning (domestic, professionnal or intentional poisoning) and cardiac injury
timeFrame: enrollment (inclusion)
measure: relationship between other possibly associated poisoning and cardiac injury
timeFrame: enrollment (inclusion)
measure: relationship between severity of neurological symptoms and cardiac injury
timeFrame: enrollment (inclusion)
measure: relationship between cardiovascular risk factors or preexisting cardio vascular abnormality and cardiac injury
timeFrame: enrollment (inclusion)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT02056821: Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: stroke
transcranial doppler
cerebral blood flow
cardiac output
non-invasive hemodynamic monitoring
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2014-02-06
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute (\< 12 hours) ischemic stroke patients presenting to the Emergency Department

Brief summary: This study investigates if there are hemodynamic alterations in acute stroke that predispose patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.


Eligibility criteria: Inclusion Criteria:

* Suspected ischemic stroke within 12 hours of symptom onset
* NIHSS ≥ 4
* Age 18 to 90 years

Exclusion Criteria:

* Baseline modified Rankin Scale \> 3
* Pregnancy
* Intracranial hemorrhage on head CT
* Mechanical ventilation prior to enrollment
* Inadequate temporal windows for TCD analysis

Primary outcomes:
measure: Change in cerebral blood flow velocities
timeFrame: initial 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT03636321: Stented Biliary Anastomosis in Living Donor Liver Transplantation
Official title: Randomized Controlled Clinical Trial Of Stented Versus Stentless Biliary Anastomosis In Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant
Keywords: living donor liver transplantation
intraductal stent
biliary complications after liver transplantation
Lead sponsor: Minia University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2018-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determination of biliary complications in stented group compared to duct to duct anastomosis without stent

Detailed description: 30 patients included in the study. patients will be randomly allocated in two equal groups. In group A anastomosis will be done on intraductal stent and in group B anastomosis done without stent .the patients will be followed for one year to compare the result of two groups as regard biliary complications.

Eligibility criteria: Inclusion Criteria:

* adult patients eligible for a liver transplantation
* patients' written informed consent signed.

Exclusion Criteria:

* biliary reconstruction requires a hepatico-jejunostomy for anatomical/biliary disease reason.

Primary outcomes:
measure: biliary complications after living donor liver transplantation
timeFrame: one year
Secondary outcomes:
measure: biliary complications
timeFrame: one year
measure: biliary related mortality
timeFrame: one year
measure: rate of cholangitis
timeFrame: 3 months
measure: hospital stay
timeFrame: one month
measure: time 2 biliary complications
timeFrame: one year
Other outcomes:
measure: skeletonization of duct
timeFrame: 10 hours
Locations:
city: Cairo
country: Egypt
facility: Air force spcialized hospital
Study officials:
References:
Clinical trial NCT05195021: The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain (PP)
Official title: The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain in Mandibular Molars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Apical Periodontitis
Keywords: diode laser
EDDY
post-operative pain
sypmtomatic apical periodontitis
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: The aim of this study was to examine post-operative pain (PP) severity after conventional irrigation and sonic activation methods, with and without laser disinfection in mandibular molar teeth diagnosed with symptomatic apical periodontitis.

Methods: In total, 80 patients with symptomatic apical periodontitis were included in this randomized clinical study. There were four different irrigation and disinfection groups. In group 1, conventional irrigation only was applied. In group 2, EDDY (VDW, Munich, Germany), a sonic irrigation activation system, was applied. In groups 3 and 4, irradiation with a 980-nm diode laser was performed, following irrigation with the conventional method (needle irrigation) and EDDY (VDW) irrigation system, respectively. PP was assessed using a visual analogue scale (VAS). The patients were instructed to record their PP using this scale 8, 24, 48 hours and 7 days post-procedure, in addition to their analgesic intake. A chi-square test, Fisher's exact chi-square test and Fisher-Freeman-Halton exact test were used to assess qualitative data. Inter-group and intra-group parameters were assessed using the Kruskal-Wallis test and Wilcoxon's test at a significance level of p \< 0.05 (for both).


Eligibility criteria: Inclusion Criteria:

1. Healthy adult patients aged between 18 and 65 years
2. Moderate to severe pain (4-10) according to a visual analogue scale (VAS)
3. Mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation)

Exclusion Criteria:

1. Pregnancy or lactation
2. Taking analgesics or anti-inflammatory drugs 12 hours before the treatment
3. Taking antibiotics in the month prior to the treatment
4. Teeth with calcified root canals, greater than grade I mobility and a 4 mm pocket depth, non-restorable damage, occlusal trauma and previous root canal treatment or an open apex
5. Allergy to articaine or non-steroid anti-inflammatory drugs

Primary outcomes:
measure: Post-operative pain
timeFrame: 7 days
measure: Anaglesic intake
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Sema Sönmez Kaplan, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: