louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06426992: Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies
Official title: Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Malignant Tumors
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 62
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 determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.


Eligibility criteria: Inclusion Criteria:

* Child-Pugh Class A or B
* Patients with suspected hepatocellular carcinoma or residual/recurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered

Exclusion Criteria:

* In cases where there are three or more malignant liver tumors
* When the maximum size of the tumor exceeds 4 cm
* Diffuse infiltrative type of cancer with unclear tumor boundaries
* When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more
* Severe liver failure (Child-Pugh Class C)
* In cases of vascular invasion by malignant liver tumors
* Severe coagulopathy (platelet count below 50,000/mm³ or INR prolonged by more than 50%)
* In cases of multiple extrahepatic metastases
* Situations where it is highly unlikely to obtain appropriate data for research purposes

Primary outcomes:
measure: Technical success
timeFrame: Immediately after ablation
measure: Local tumor progression rate
timeFrame: 12 months after ablation
Secondary outcomes:
measure: Complication after ablation
timeFrame: Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation
measure: Recurrence-free survival
timeFrame: 12 months after ablation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00565292: A Study of MK0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia (MK-0859-011)(COMPLETED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Hyperlipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL cholesterol in blood) This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Patient is between 18 and 75 years of age
* Patient can be on a stable diet for the study
* Patient has a stable weight for more then 6 weeks before the study and has not participated in a weight loss program

Exclusion Criteria:

* Patient has chronic heart failure or a history of heart disease
* Patient has blood, digestive, or central nervous system disorders
* Patient is pregnant or nursing
* Patient is HIV positive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Krishna R, Anderson MS, Bergman AJ, Jin B, Fallon M, Cote J, Rosko K, Chavez-Eng C, Lutz R, Bloomfield DM, Gutierrez M, Doherty J, Bieberdorf F, Chodakewitz J, Gottesdiener KM, Wagner JA. Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomised placebo-controlled phase I studies. Lancet. 2007 Dec 8;370(9603):1907-14. doi: 10.1016/S0140-6736(07)61813-3.
Clinical trial NCT00332592: Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)
Official title: Intragastric and Intraperitoneal Microdialysis in Infants With NEC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Enterocolitis
Keywords: Necrotizing Enterocolitis
Intragastric microdialysis
Peritoneal microdialysis
Infants
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2006-06-01
Enrollment: 14
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature children with NEC

Brief summary: NEC is a serious inflammatory bowel disease, which almost only strikes infants with low birth weight and low gestational age. The morbidity and mortality rates are high, and early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of intragastric microdialysis and whether it is able to select patients, who may benefit from either medical or surgical therapy. The aim of intraperitoneal microdialysis is to evaluate whether changes in intraperitoneal microdialysis reflect the clinical outcome after laparotomy.

Detailed description: Neonates who are hospitalized because of suspicion of NEC are subjected to intragastric microdialysis during the observation period. The catheter is placed in the stomach via the naso-oesophageal route. If surgery is necessary a microdialysis catheter is placed in the peritoneal cavity prior to wound closure. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

A total of 20 patients will be included in this pilot study. The results of the intragastric and peritoneal microdialysis will be compared with the clinical course, s-lactate, radiological and pathological findings in each patient.

Eligibility criteria: Inclusion Criteria:

* Neonates who are hospitalized because of suspicion of NEC.
* Neonates who has surgery because of NEC.

Exclusion Criteria:

* Non-acceptance from the child's parents or custody holder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Surgical department A, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Niels Qvist, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen ME, Dahl M, Qvist N. Intraperitoneal microdialysis in the postoperative surveillance after surgery for necrotizing enterocolitis: a preliminary report. J Pediatr Surg. 2011 Feb;46(2):352-6. doi: 10.1016/j.jpedsurg.2010.11.015.
Clinical trial NCT06403592: The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter
Official title: The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Pressure Increase
Keywords: Laryngeal airway mask
Optic Nerve sheath Diameter
Intracranial Pressure
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA I-II patients scheduled for surgery under general anesthesia

Brief summary: The goal of this observational trial is to study the effect of a laryngeal airway mask on the optic nerve sheath diameter, as a surrogate for intracranial pressure.

The optic nerve sheath diameter of participants will be measured under general anesthesia, before, during and after insertion of a laryngeal airway mask.


Eligibility criteria: Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria: aged 18 years or older, ASA I or ASA II, scheduled for elective surgery under general anesthesia, with a planned duration of \> 30 minutes, that can be routinely performed with a LMA.

Exclusion Criteria:

* Scheduled for head or neck surgery
* Scheduled for neurosurgery
* Scheduled for laparoscopic or thorascoscopic procedures
* Scheduled for procedures that require Trendelenburg or anti-Trendelenburg positioning
* Neurological disorders
* Glaucoma
* History of bilateral eye related trauma
* Intellectual disability

Primary outcomes:
measure: Effect of insertion of a laryngeal airway mask on optic nerve sheath diameter
timeFrame: During surgery
Secondary outcomes:
measure: Effect of laryngeal ariway mask after insertion on optic nerve sheath diameter
timeFrame: During surgery
measure: Effect of layngeal airway mask on optic nerve sheath diameter interna vs optic nerve sheath diameter externa
timeFrame: During surgery
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
Study officials:
References:
Clinical trial NCT01477892: Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population
Official title: Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infant, Preterm
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ajou University School of Medicine
name: Severance Hospital
First posted: 2011-11-23
Enrollment: 14
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.


Eligibility criteria: Inclusion Criteria:

* preterm infants mechanically ventilated
* requiring peripherally induced central catheterization
* with informed consent of their parents

Exclusion Criteria:

* major congenital anomalies
* cardiopulmonary instability
* use of sedative, antiepileptic drugs or anesthetic drugs
* grade III or IV intraventricular hemorrhage

Primary outcomes:
measure: Premature Infant Pain Profile
timeFrame: first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop
Secondary outcomes:
measure: Adverse Reaction
timeFrame: during and after 10min of remifentanil continous infusion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
References:
Clinical trial NCT02018289: Effect of Triclosan-coated Suture on Superficial SSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Site Infection
Keywords: Triclosan coated suture
Surgical site infection
Fecal peritonitis
Superficial
incisional
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The abdominal closure with triclosan coated suture will reduce superficial surgical site infection.


Eligibility criteria: Inclusion Criteria:

* Fecal peritonitis

Exclusion Criteria:

* Perioperative mortality

Primary outcomes:
measure: Superficial surgical site infection (SSI)
timeFrame: 60 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: General University Hospital Elche
state: Alicante
Study officials:
affiliation: Hospital General Universitario de Elche
name: Jaime Ruiz-Tovar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00988689: Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake
Official title: The Effect of Different Types of Starch on Glycemic Response, Subjective Appetite and Short-term Food Intake in Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Prevention
Diabetes Prevention
Keywords: starch
carbohydrates
blood glucose
food intake
satiety
appetite
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ingredion Incorporated
First posted: 2009-10-02
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that different types of starch vary in their effects on appetite, blood sugar and food intake. In this study, subjects consumed five soups containing 50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added starch at one week intervals. The investigators measured food intake at 120 minutes, appetite and blood sugar.


Eligibility criteria: Inclusion Criteria:

* Healthy males with a BMI of 20-24.9 kg/m2

Exclusion Criteria:

* Females
* Smokers
* Breakfast skippers
* Individuals with diabetes or other metabolic diseases

Primary outcomes:
measure: Blood glucose
timeFrame: 0-200 min
measure: Food Intake
timeFrame: at 120 min
measure: Appetite
timeFrame: 0-200 min
Secondary outcomes:
measure: Palatability of treatments
timeFrame: 0-200 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Studies, University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson GH, Cho CE, Akhavan T, Mollard RC, Luhovyy BL, Finocchiaro ET. Relation between estimates of cornstarch digestibility by the Englyst in vitro method and glycemic response, subjective appetite, and short-term food intake in young men. Am J Clin Nutr. 2010 Apr;91(4):932-9. doi: 10.3945/ajcn.2009.28443. Epub 2010 Feb 17.
Clinical trial NCT05471089: Long-term Effects of the Addition of Diathermy by Emission of Radiofrequency to Therapeutic Exercise in Patellofemoral Pain Syndrome Patients
Official title: Non-invasive Radiofrequency Diathermy and Supervised Therapeutic Exercise in Patellofemoral Pain Syndrome. A Single Blind Randomized Controlled Trial With a Six-month Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Patellofemoral Pain
Patello Femoral Syndrome
Keywords: knee pain
electrophysical agents
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 86
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Introduction: the management of Patellofemoral Pain (PFP) is focused on therapeutic exercise (TE) to improve muscle strength and motor control. Recent studies suggest that the addition of radiofrequency diathermy (RFD) obtain greater short-term improvements in knee pain than TE alone. As there is no follow up data, the aim of this research is to assess the long-term effects of adding RFD to TE on pain, function and quality of life on PFP patients.

Methods: a single-blind randomized controlled trial will be conducted. Participants diagnosed of PFP will be allocated in either a TE group or a RFD+TE one. Sociodemographic data, knee pain, and lower limb function will be collected. Each group will performed 20 min of daily knee and hip supervised TE along three weeks with the addition of ten sessions of RFD for the RFD+TE group.


Eligibility criteria: Inclusion Criteria:

* Subjects between 30 and 50 years old without radiological findings of osteoarthritis.
* Subjects referring during the last month almost three points of pain in the anterior surface of knee measured with Visual Analogue Scale.

Exclusion Criteria:

* Subjects with contraindications for the treatment with radiofrequency diathermy (tumors, use of pacemakers or any other implanted electronic device, thrombophlebitis or deep venous thrombosis, pregnancy, fever, active tuberculosis, infections and rheumatoid arthritis).
* Subjects who have received corticoid or hyaluronic acid or platelet-rich plasma injections treatment in the knee.

Primary outcomes:
measure: Knee pain
timeFrame: Baseline
measure: Knee pain
timeFrame: At three weeks
measure: Knee pain
timeFrame: Through study completion, an average of 6 months
measure: Knee function
timeFrame: Baseline
measure: Knee function
timeFrame: At three weeks
measure: Knee function
timeFrame: Through study completion, an average of 6 months
measure: Knee function
timeFrame: Baseline
measure: Knee function
timeFrame: At three weeks
measure: Knee function
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Centro de Salud San José de la Rinconada
Study officials:
References:
Clinical trial NCT00883389: Med-alert Bracelet in Chronic Kidney Disease
Official title: Safe Kidney Care Med-Alert Bracelet/Keytag
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: patient safety
chronic kidney disease
med-alert
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 26
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: Patients with chronic kidney disease and impaired kidney function

Brief summary: This is a pilot observational study to evaluate subjects with chronic kidney disease acceptance of an alert device linked to an informational website intended to increase recognition of chronic kidney disease, and to guide patients and providers to the safe delivery of care required for this disease. Primary device was a bracelet with the alternative of a key fob with same information supplied when requested. Patients usage of the device was evaluated by survey with Likert scale as to whether the device is 0 = not useful, 1 = somewhat useful, 2 = extremely useful

Detailed description: No need for more extensive description

Eligibility criteria: Inclusion Criteria:

* Persons with chronic kidney disease defined as estimated glomerular filtration rate of \< 60 ml/min/1.73m2.

Exclusion Criteria:

* Persons expected to be on dialysis within 6 months.
* Less than 18 years of age

Primary outcomes:
measure: Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland, College Park
name: Jeffrey C Fink, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02354989: Rate RESPONSIVe Pacing in Patients With Permanent AF Underwent AV Node ABLation and bivEntricular Pacing (RESPONSIBLE)
Official title: Effect on Exercise Capacity of Fixed Rate Vs Rate RESPONSIve Pacing in Patients With Permanent AF and Left Ventricular Dysfunction Underwent Radiofrequency Atrioventricular Junction aBLation and bivEntricular Pacing (RESPONSIBLE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Dysfunction
Atrial Fibrillation
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 60
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 the effect on distance covered in a 6 minute walking test of Rate Responsive pacing in patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing.

Detailed description: Patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing will be enrolled. Two 6' walking test (6WT), one during VVI 70/min biventricular pacing (RR off) and the other during VVIR 70-120/min biventricular pacing (RR on), will be performed one week apart; patients will be randomly and blindly assigned with a 1:1 ratio to group A (first 6WT RR off) or B (first 6WT RR on). The difference between the two tests will be recorded.

Eligibility criteria: Inclusion Criteria:

* Permanent, refractory atrial fibrillation treated with atrio-ventricular node ablation and biventricular pacing
* Left ventricular systolic dysfunction
* Ability to perform a 6-minute walking test
* Completion of the 18th year of age

Exclusion Criteria:

* Contraindications to 6 minute walking test
* IV NYHA Class

Primary outcomes:
measure: The distance covered during the 6-minute walking test
timeFrame: 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tricase
country: Italy
facility: Azienda Ospedaliera "Card. G. Panico"
state: Lecce
city: Ancona
country: Italy
facility: Università Politecnica delle Marche
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Catanzaro
country: Italy
facility: AO Pugliese-Ciaccio
city: Naples
country: Italy
facility: Seconda Università Napoli - A.O. Monaldi
city: Novara
country: Italy
facility: AOU "Maggiore della Carità"
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
Study officials:
affiliation: Azienda Ospedaliera "Card. G. Panico" - Tricase
name: Pietro Palmisano, MD
role: PRINCIPAL_INVESTIGATOR
References: