louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03806218: Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC
Official title: Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: RFA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.


Eligibility criteria: Inclusion Criteria:

* radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment
* HCC nodules measuring 1 cm or larger and smaller than 5 cm

Exclusion Criteria:

* more than three HCC nodules
* tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter \> 5mm
* extrahepatic metastasis
* Child-Pugh class C
* severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)

Primary outcomes:
measure: Minimum diameter of ablation zone per unit time
timeFrame: 3 days after RFA
Secondary outcomes:
measure: Technique efficacy
timeFrame: 1 month after RFA
measure: IDR rate
timeFrame: 12 months, 24 months after RFA
measure: EM rate
timeFrame: 12 months, 24 months after RFA
measure: Local tumor progression (LTP)
timeFrame: 12 months, 24 months after RFA
Other outcomes:
measure: Complication
timeFrame: 1 month after RFA
measure: Volume of ablative zone
timeFrame: 3 days after RFA
measure: Ablation time
timeFrame: 1 day
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study. PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.
Clinical trial NCT00679718: A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease
Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 150
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Best corrected visual acuity of at least +0.7 ETDRS
* Six month history of dry eye disease
* Mild severity in two out of five symptoms
* Unanesthetized Schirmer score of less than or equal to 7mm
* Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

Exclusion Criteria:

* Nasal stimulated Schirmer score of less than 3mm
* Have ongoing ocular infection
* Have congenitally absent meibomian or lacrimal glands
* Have had punctal occlusion within a specified time prior to study
* Wear contact lens and refuse to remove them
* Have other excluded eye conditions.

Primary outcomes:
measure: Schirmer scores
measure: Corneal staining
measure: Conjunctival staining
measure: Tear break-up time
measure: Change in artificial tear usage
measure: Patient-reported improvement of foreign body sensation
Secondary outcomes:
measure: Visual acuity
measure: Investigator global severity assessment
measure: Patient-reported dry eye symptoms other than foreign body sensation
measure: Biomicroscopy
measure: Ophthalmoscopy
measure: IOP
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Clinical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06428318: Diagnostic Value of the Biofire®in Community Acquired Pneumonia
Official title: Diagnostic Value of the Biofire® Filmarray Pneumonia Panel Compared to Conventional Sputum Culture in Critically il Patients With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed to determine the impact value of the BioFire FilmArray Pneumonia panel compared to conventional sputum culture in critically ill patients with pneumonia.

Detailed description: the BioFire® FilmArray Pneumonia Panel (BFPP) emerges as a promising candidate for a rapid and multifaceted diagnostic approach.

This study compare the diagnostic accuracy, turnaround time, and impact on antibiotic management decisions of BFPP versus conventional sputum culture in critically ill patients admitted to the ICU with suspected pneumonia.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU with community acquired pneumonia

Exclusion Criteria:

* Age less than 18 years old.
* End stage malignant patients,
* Patients admitted to the ICU with Acute Lung Injury (ALI).
* Patients admitted to the ICU with Acute Respiratory Distress Syndrome (ARDS).
* Patients with radiological findings suggesting atypical pneumonia.
* Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids \> 20mg/day Prednisone equivalent, other immunosuppressants.
* Solid organ or bone marrow transplant patients, cystic fibrosis.
* Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements.

Primary outcomes:
measure: the ICU length of stay
timeFrame: Five days after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abassia
Study officials:
References:
Clinical trial NCT02965118: CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis
Official title: Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase III Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Detailed description: PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 12 - 70 years.
* Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
* Whose affected TBSA is over 5% and below 30%, and IGA score is 2 (mild) to 3 (moderate).
* Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
* Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
* Who has used systemic steroids, antibiotics, immunosuppressants, or received phototherapy within 28 days before study drug administration.
* Who has used topical steroids, topical calcineurin inhibitors or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.

Primary outcomes:
measure: Success rate of Investigator's Global Assessment (IGA)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change of Investigator's Global Assessment (IGA) score
timeFrame: 8 weeks
measure: Success rate of ≥2-grade Investigator's Global Assessment (IGA)
timeFrame: 8 weeks
measure: Percent of change in Eczema Area and Severity Index (EASI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyuhan Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01409941: The Relation Between Preoperative ScO2 and the Postoperative Course of Humoral Organ Dysfunction Markers.
Official title: The Prognostic Relevance of N-terminal Pro B-type Natriuretic Peptide(NTproBNP), Cerebral Oxygen Saturation (ScO2), and Preoperative Creatinine Clearance in Cardiac Surgery Patients - Amendment 2: the Role of NTproBNP and ScO2 in Predicting Mortality and Postoperative Organ Dysfunction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing Cardiac Surgery
Keywords: cerebral oxygen saturation,
NTproBNP
hsTNT
GDF-15
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 765
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 scheduled for cardiac surgery

Brief summary: Cerebral oxygen saturation (ScO2) is a measure of cerebral and systemic oxygen delivery to demand ratio. An observational trial in a heterogeneous cohort of 1078 patients patients revealed that a ScO2 below 50% absolute during oxygen insufflation is an independent predictor of short and long term mortality in patients undergoing on-pump cardiac surgery. Comparably, a low ScO2 was a predictor of postoperative morbidity determined as a combined endpoint of a high dependency unit stay of more than 9 days and/or at least 2 of the major postoperative complications. low cardiac output syndrome, stroke, need of renal replacement therapy or reintubation.

The primary objectives of the present prospective observational study is to determine, if there is an association between preoperative ScO2 and postoperative organ dysfunction determined by sensitive markers of organ dysfunction (N-Terminal pro B-type natriuretic peptide, high sensitive troponin T, growth-differentiation factor 15, soluble -FLT1, and placental growth factor)


Eligibility criteria: Inclusion Criteria:

* all patients scheduled for cardiac surgery

Exclusion Criteria:

* age less than 18 years

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Morbidity
timeFrame: Within hospital
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology, University of Luebeck
name: Matthias Heringlake, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960841: Effectiveness of Intracavitary Manual Lymphatic Drainage
Official title: Effectiveness of Intracavitary Manual Lymphatic Drainage Versus Conventional Treatment in the Prevention of Perineal Trauma During Labor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphatic Diseases
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the effectiveness of Intracavitary Manual Lymphatic Drainage (IMLD) in the reduction of the perineal trauma and the symptoms of vaginal edema, the prevention of complications during the expulsive and the improvement in the postpartum recovery, compared to conventional treatment during the gestation, in women with the second partum. The weekly treatment is performed from the 25th gestational week in women with vulvar edema.


Eligibility criteria: Inclusion Criteria:

* A sample of 49 second-trimester pregnant women with gestational edema with more than 18 years of age

Exclusion Criteria:

* Primiparous women

Primary outcomes:
measure: Pain intensity assessed by the Visual Analogue Scale
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01580241: Serum DCAMKL1 Pre and Post Treatment in Patients With Pancreatic Cancer
Official title: Expression Patterns of Stem Cell Marker Doublecortin and CaM Kinase-Like-1 (DCAMKL-1) in Human Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 60
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: Human patients with pancreatic cancer undergo various treatments for pancreatic cancer. We will examine the expression of Dcamkl-1 pre and post therapy (including, chemotherapy only, surgery only, neoadjuvant and adjuvant therapies) to correlate treatment with a change in DCAMKl-1 expression.

Brief summary: The investigators believe DCAMKL-1 is a stem cell tumor marker and is elevated in patients with pancreatic cancer. The investigators would like to analyze its expression pre and post treatment, to gauge the correlation between current pancreatic cancer therapies and the expression of DCAMKL-1

Detailed description: Pancreatic adenocarcinoma has the worst prognosis of any major malignancy with a 3% 5 year survival. Major obstacles in treating pancreatic cancer include extensive local invasion and early metastasis. The incidence of pancreatic adenocarcinoma (PAC) has been increasing steadily. Epithelial-mesenchymal transition (EMT) plays a key role in cancer invasion and metastasis. Recently, a direct link between EMT and the gain of epithelial stem cell properties has been described. We have recently determined that DCAMKL-1, a microtubule-associated kinase expressed in post mitotic neurons, is a putative intestinal stem cell marker. We have also demonstrated that DCAMKL-1, a protein expressed in both normal stem cells and in cancer, likely promotes tumorigenesis through the regulation of pri-let-7a microRNA and c-Myc. We have recently demonstrated evidence that DCAMKL-1 is a marker for pancreatic cancer stem cells in surgical specimens. This study will investigate expression of DCAMKL-1 in pancreatic tissue obtained through EUS-FNA. Furthermore expression of DCAMKL-1 will also be investigated in serum obtained simultaneously.

Eligibility criteria: Inclusion Criteria:

* pancreatic cancer

Exclusion Criteria:

* age \< 18, history of other types of cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephensen Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Courtney Houchen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00723541: Breast Lesion Analysis for Tomosynthesis Mammography
Official title: Tomosynthesis Mammography: Computer-Aided Analysis of Breast Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Abnormal Findings on Radiological Examination of Breast
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-28
Enrollment: 872
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, which hopefully will improve breast cancer detection and classification.

Detailed description: The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, and determine if the lesion is a cancer or not for digital tomosynthesis mammography (DTM).

Eligibility criteria: Inclusion Criteria:

* Subjects scheduled for core biopsy of a breast lesion

Exclusion Criteria:

* Pregnant females

Primary outcomes:
measure: Achieve earlier breast cancer detection and characterization
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Heang-Ping Chan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05530941: Online Suicide Prevention Campaign Aimed at Men
Official title: Evaluation of an Online Suicide Prevention Campaign Aimed at Men to Promote Help-seeking and Peer Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Help-Seeking Behavior
Suicide
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 205
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to examine whether the online suicide prevention campaign for men could increase openness about emotions and help-seeking behavior, and decrease hopelessness and adherence to traditional gender norms concerning self-reliance among men. The effectiveness of the campaign will be evaluated in adult men using a pre-post questionnaire study design.


Eligibility criteria: Inclusion Criteria:

* Gender identity: male
* ≥ 18 years old
* Have access to internet and a computer/tablet/smartphone
* Speak Dutch

Exclusion Criteria:

* Gender identity: female or other
* \< 18 years old
* No acces to internet and a computer/tablet/smartphone
* Non-Dutch speaking

Primary outcomes:
measure: Change in self-reliance: self-reliance factor of the Conformity to Masculine Norms Inventory (CMNI)
timeFrame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
measure: Change in Help-seeking behaviour: General Help-Seeking Questionnaire (GHSQ)
timeFrame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
measure: Change in Openness about emotions: scales "Communication and Expression of Emotions" and "Normative Restrictions of Affectivity" of the Dimensions of Openness to Emotions (DOE)
timeFrame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
measure: Change in Hopelessness: Beck Hopelessness Scale (BHS), 4-item version
timeFrame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
Secondary outcomes:
Other outcomes:
measure: General distress: Kessler 10
timeFrame: Baseline (before intervention)
measure: Suicidal ideation and behaviour: Suicidal ideation Attributes Scale & two general questions
timeFrame: Baseline (before intervention)
measure: Campaign evaluation
timeFrame: post-test (after three days of access to the campaign)
Locations:
city: Ghent
country: Belgium
facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University
Study officials:
affiliation: University Ghent
name: Gwendolyn Portzky, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00558441: Prospective Data Collection of IVMRI Cases
Official title: Prospective Data Collection in Clinical Cases Where Coronary Plaque Lipid Characterization by IVMRI Was Performed During Diagnostic or Interventional Catheterization Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Plaque Lipid Characterization
Lead sponsor: TopSpin Medical
Sponsor class: INDUSTRY
First posted: 2007-11-15
Enrollment: 1000
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: The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities.


Eligibility criteria: Inclusion Criteria:

* An adult patient ≥ 18 years old.
* The patient, or legal guardian, has been informed of the nature of the study, agrees to its provisions, and has sign the approved informed consent.
* The patient and the treating physician agree to attend the follow-ups as defined in the study protocol.
* Indication for diagnostic and/or interventional procedure.
* Lesions in a native vessels where IVMRI interrogation may provide additional information beyond angiography and other diagnostic tools.

Exclusion Criteria:

* Culprit lesions within 48 hours following STEMI.
* Tortuous vessels, calcified or thrombotic lesions.
* Significant stenosis of an unprotected left main coronary artery.
* IVMRI interrogation of an unprotected left main coronary artery.
* Patients with pacemaker or cardioverter defibrillator.
* The patient is suffering from transplant mediated coronary artery disease.

Primary outcomes:
measure: LFI - Lipid Fraction Index
timeFrame: 5 years
Secondary outcomes:
measure: correlation between LFI and a set of predefined parameters
timeFrame: 5 years
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: OLV Hospital
name: William Wijns, Prof.
role: PRINCIPAL_INVESTIGATOR
References: