louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06682377: Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma
Official title: Evaluation of Clinical Efficacy of Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma: a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 159
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate, through a prospective multicenter trial, the procedural time, safety, technical success rate for achieving a safety margin of at least 5 mm around the tumor, and the clinical efficacy (local and remote recurrence rates: estimated local recurrence rate at 12 months) of radiofrequency ablation using the "No-touch" technique. This approach employs Octopus electrodes and combined radiofrequency energy delivery (dual switching monopolar and bipolar mode) for the treatment of hepatocellular carcinoma.


Eligibility criteria: \*\*Inclusion Criteria\*\*

1. Agreement to the protocol requirements and provision of informed consent.
2. Age between 20 and 85 years.
3. Child-Pugh Class A or B7.
4. Patients with liver cirrhosis who are candidates for radiofrequency ablation (RFA) based on multi-detector computed tomography (MDCT) or multi-detector computed tomography (MRI) within 60 days, with a suspected hepatocellular carcinoma (HCC) lesion of 1-3 cm.

   * \*\*HCC Diagnostic Criteria:\*\* A. Presence of risk factors (e.g., hepatitis B virus (HBV) positive, hepatitis C virus (HCV) positive, liver cirrhosis).

   B. Findings consistent with HCC on at least one imaging modality (MDCT, dynamic MRI, or Primovist MRI) according to the Korean Liver Cancer Association (KLCA) criteria.

   C. Histological diagnosis of HCC.
5. No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years.

\*\*Exclusion Criteria\*\*

1. Presence of three or more malignant liver tumors.
2. Diffuse infiltrative type tumors with unclear boundaries.
3. Recurrent HCC within two years of previous treatment.
4. Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm.
5. Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance.
6. Vascular invasion by malignant liver tumors.
7. Severe coagulopathy (platelets \<50,000/mm³ or International Normalized Ratio (INR) \>50% prolongation).
8. Presence of extrahepatic metastasis.
9. Situations where obtaining appropriate data for the study is unlikely.

Primary outcomes:
measure: Estimated local tumor progression rate
timeFrame: 12 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03115177: Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
Official title: Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure of total shoulder arthroplasty as well as other shoulder surgeries. This study is investigating adding an FDA approved antibiotic that is commonly used for treatment of this bacteria and many common infections. The investigators will take intraoperative cultures to look for the presence or absence of specific bacteria. The investigators are conducting this trial to see if adding another antibiotic to specifically target this common bacteria found around the shoulder will be effective.

Detailed description: Patients undergoing total and reverse shoulder arthroplasty for primary glenohumeral arthritis will be invited to participate in this study if patients meet inclusion and exclusion criteria. Patients will be randomized to receive either standard perioperative antibiotics with cefazolin or to the treatment group to receive doxycycline in addition to cefazolin. Patients will then undergo routine surgical treatment. 3 cultures from the superficial tissue, dermis, and glenohumeral joint will be taken and cultured for 14 days to detect any bacterial growth.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary total shoulder arthroplasty at Rush University Medical Center

Exclusion Criteria:

* Patients with prior shoulder surgery of any kind
* Patients with a known infection or history of infection with clinical signs such as elevated erythrocyte sedimentation rate, C-reactive protein, positive culture aspiration
* Patients with a known allergy to doxycycline
* Patients with a known allergy to cefazolin or penicillin

Primary outcomes:
measure: Bacterial Culture
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Allison Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02474277: How Well Does the 30-Second Chair Stand Test Predict Rehabilitation Needs in Acutely Admitted Elderly Patients
Official title: How Well Does the 30-second Chair Stand Test Predict Rehabilitation Needs in Acutely Admitted Elderly Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Disease
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 156
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aims are to identify predictive indicators of hospitalized elderly medical patients' need for rehabilitation and to validate (known group validity) the Chair Stand Test

Detailed description: In the emergency department the assessment of acutely admitted elderly medical patients' need for rehabilitation is difficult as it has to been performed within 48 hours. Is it possible to use the the Chair Stand Test in combination with admission complaints and identified risk factors to predict the need for rehabilitation? An investigating of the Chair Stand Test is needed, as its validity with hospitalized patients is undocumented.

Eligibility criteria: Inclusion Criteria:

* Can speak and understand Danish
* Can report personal data
* Within the first 48 hours of admission are able to sin on an ordinary chair

Exclusion Criteria:

* Patients ordinarily unable to walk

Primary outcomes:
measure: 30-Second Chair Stand Test
timeFrame: 14 days after admission at the hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Lillebaelt hospital
Study officials:
affiliation: University of Southern Denmark
name: Christian B Mogensen, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruun IH, Maribo T, Norgaard B, Schiottz-Christensen B, Mogensen CB. A prediction model to identify hospitalised, older adults with reduced physical performance. BMC Geriatr. 2017 Dec 7;17(1):281. doi: 10.1186/s12877-017-0671-5.
Clinical trial NCT03964077: Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study
Official title: Turkish Version of the Neurogenic Bladder Symptom Score Questionnaire: a Cross-cultural Adaptation, Reliability and Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: Neurogenic Bladder
Quality of life
Spinal Cord Injury
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2019-05-28
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 70 spinal cord injury patients

Brief summary: Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study

Detailed description: Turkish version of the Neurogenic Bladder Symptom Score questionnaire: a cross-cultural adaptation, reliability and validity study in spinal cord patients.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury patients
* aged \> 18 years old

Exclusion Criteria:

* spinal shock patients
* urinary tract operation in the last month
* Quality of life changes in the last month
* urinary tract infections in the last month
* bladder management changes or drug changes in the last month

Primary outcomes:
measure: Life quality: Short-form 36
timeFrame: 4 months
measure: Neurogenic Bladder Symptom Score Questionnaire
timeFrame: 4 months
measure: The King's Health Questionnaire
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Mehmet Akif Guler
state: İ̇stanbul
Study officials:
References:
citation: Guler MA, Dogan D, Yilmaz Yalcinkaya E. Validity and reliability of the Turkish version of the neurogenic bladder symptom score. Disabil Rehabil. 2022 Jun;44(12):2889-2895. doi: 10.1080/09638288.2020.1846216. Epub 2020 Nov 24.
Clinical trial NCT04468477: EVALECGcardio Study
Official title: An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrhythmia
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. We wanted to test whether a novel handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment.

Detailed description: The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple screener to identify patients who do not need a 12 lead ECG.

Eligibility criteria: Inclusion Criteria:

* Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)

Exclusion Criteria:

* Patients who do not consent to the study

Primary outcomes:
measure: Difference between the 6 lead and the 12 lead Electrocardiogram
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT00260377: Aspirin Resistance Following Coronary Bypass Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Aspirin treatment
Aspirin resistance
Coronary bypass surgery
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-01
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical outcome after coronary artery bypass surgery. It appears to be effective when being prescribed as early as first 48 hr. after the operation without increasing the incidence of bleeding complications. the exact effective dose is not known.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing Coronary artery bypass surgery
* Patients who signed Informed Consent Form

Exclusion Criteria:

* Concomitant valve surgery or carotid surgery or off-pump surgery
* Need for anticoagulation therapy for any reason
* Another antiplatelet medications at least 7 days prior to surgery
* Contra-indication for aspirin treatment
* Thrombocytopenia / thrombocytopathia
* NSAIDs treatment for chronic medical conditions
* Reluctance to participate in the study

Primary outcomes:
measure: Ventilation
measure: Inotropic support
measure: Mortality
measure: Perioperative MI
measure: Perioperative stroke
measure: Bleeding / reopen / transfusion
measure: Dysrhythmias
Secondary outcomes:
measure: ICU stay
measure: In-hospital stay
measure: Non-fatal cardiac events - MI, recurrence of angina, dysrhythmias
measure: Need for repeat revascularization
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: jacob.lavee@sheba.health.gov.il
name: Jacob Lavee, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04781777: Effect of Ultrasonographic Guided Insulin Injection With Dexamethasone and Local Anesthetic Mixture in Diabetic Patients With Mild to Moderate Carpal Tunnel .
Official title: Effect of Ultrasonographic Guided Insulin Injection With Dexamethasone and Local Anesthetic Mixture in Diabetic Patients With Mild to Moderate Carpal Tunnel .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Relief
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insulin as an adjuvant to local anesthetic and cortisone to decrease pain recurrence


Eligibility criteria: Inclusion Criteria:

- Diabetic patients with mild to moderate carpal tunnel syndrome

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: pain neuropathy
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02358577: Early In-bed Cycling in Critically Ill Children
Official title: Early Exercise in Critically Ill Youth and Children, a preLiminary Evaluation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Critical Illness
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children.

Detailed description: This is a single centre, Pilot RCT that will evaluate in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children. We will conduct a qualitative substudy to evaluate caregiver impressions of the intervention, and to understand barriers and facilitators to implementing early mobilization in critically ill children.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 3 years to \< 18 years;
2. Limited to bed-rest or bed mobility at time of screening
3. expected PICU stay for an additional 48 hours minimum, at time of screening
4. informed consent and or assent where appropriate;
5. agreement of the most responsible PICU physician.

Exclusion Criteria:

1. Contraindications: e.g. Hemodynamic instability, unstable or uncontrolled arrhythmia, ICP, unstable airway, unstable fractures/spine
2. Contraindication to mobilizing upper/lower limbs, e.g. femoral sheath
3. Cycle ergometer does not fit body dimensions
4. Already mobilizing well/expected to mobilize out of bed within 24h
5. not expected to survive current admission - i.e. predicted hospital mortality of \> 90%;

Primary outcomes:
measure: Feasibility - enrolment (75% consent rate target) and protocol adherence
timeFrame: 7 days
Secondary outcomes:
measure: Adverse event rate
timeFrame: 7 days
Other outcomes:
measure: Functional outcome (functional recovery, as measured by the Pediatric Overall Performance (POPC), the Pediatric Cerebral Performance Category (PCPC) Scores, and the Pediatric Disability Inventory)
timeFrame: PCCU discharge, 3 and 6 months post PCCU discharge
measure: Workload (physiotherapist and nursing workload, as measured by set up and take down times)
timeFrame: 7 days
measure: Organ Dysfunction severity as measured by PELOD-2
timeFrame: 30 days
measure: PCCU-acquired morbidities
timeFrame: 30 days
measure: Mortality
timeFrame: 6 months
measure: Duration of Mechanical Ventilatory support
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Caregiver perception
timeFrame: 7 days
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Karen Choong, MB, BCh, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02783677: The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease of the Lower Extremities
Official title: The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Disease
Diabetes Mellitus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 230
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with DM

Brief summary: Peripheral artery disease (PAD) is highly prevalent. It occurs most often in the lower extremities. Symptoms include intermittent claudication, ischemic pain, ulceration and necrosis. Amputation may be necessary in severe cases. PAD is also an indicator of future cerebrovascular and cardiovascular events. Diabetes mellitus (DM) is one of the major risk factors of PAD. Approximately 5% to 10% of diabetic patients have had foot ulceration, and 1% have undergone amputation. Other risk factors include smoking, old age, male gender, hypertension, dyslipidemia, hyperhomocysteinemia and renal insufficiency. Ankle-brachial index (ABI) is the most popular tool used to screen PAD. Doppler-derived ankle and brachial systolic pressure is obtained. If the ratio is abnormal, further confirmation studies will necessary. Although ABI is recommended as one of the screening tests for diabetic complications in guidelines, its utility is limited in calcified non-compressible vessels, which are common in DM and renal failure patients.

Digital infrared thermal imaging (DITI) is used to detect surface temperature because objects of absolute temperatures higher than zero would radiate electromagnetic waves of certain wave lengths according to Plank's law. DITI examination is non-invasive, non-contact and fast. Theoretically, temperature of the perfusion area of the occlusive arteries will decrease. Investigators will analyze DITI of PAD, and observe the relationship between DITI, ABI and vascular duplex examination. The dynamic change of DITI before and after percutaneous transluminal angioplasty of PAD will also be observed. Investigators would like to evaluate the possibility of the clinical application of DITI for PAD screening.


Eligibility criteria: Inclusion Criteria:

* Age: 20\~85 years old
* Diagnosed with DM

Exclusion Criteria:

* History of lower extremities disease or underwent leg surgery
* Pregnancy
* Fever
* Leg edema
* Autoimmune disease

Primary outcomes:
measure: Digital infrared thermal imaging (DITI)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Taipei, Taiwan
Study officials:
References:
Clinical trial NCT03399877: A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
Official title: A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enuresis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Children who meet the inclusion criteria and no exclusion criteria are assigned to perform one of the three test protocols in order of registration according to a computer gererated randomization list. Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again. Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry. Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
Primary purpose: DIAGNOSTIC

Brief summary: Uroflowmetry(UF) has been the standard first-line diagnostic tool for the evaluation of pediatric voiding dysfunction. But recently, UF combined with pelvic flow electromyography(EMG) is emphasized and recommended to analyze the separate contributions of the detrusor and bladder outlet and sole UF is discouraged except for the follow-up study after abnormal UF/EMG result(Bauer et al., 2015). However, electrode itself can disturb pelvic floor relaxation and there is no evidence about necessity of consecutive UF/EMG test. Therefore, the investigators are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG, UF/EMG-sole UF, sole UF-UF/EMG)


Eligibility criteria: Inclusion Criteria:

1) children aged 5 to 11.9 who visit pediatric urology department for enuresis.

Exclusion Criteria:

1. If children have experience of performing uroflowmetry or uroflowmetry-electromyography.
2. If children do not cooperate on performing the test
3. If enuresis is caused by neurological or anatomical problem.

Primary outcomes:
measure: maximum flow rate(Qmax=cc/s)
timeFrame: One day
Secondary outcomes:
measure: Uroflow curve pattern
timeFrame: One day
measure: post void residual
timeFrame: One day
measure: synergy or dyssynergy between the bladder and the pelvic floor.
timeFrame: One day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology,
Study officials:
References: