cyrilzakka/clinical-trials huggingface dataset:
Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach

Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is performed primarily by early referral; while at the same time we still struggle with the limited longterm ablation success of endocardial VT ablation. An underestimated number of VTs from ischemic substrate have an epicardial exit. However, one cannot accurately predict who is in need of epicardial ablation. The investigators hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.

Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence.

Study design: Multicenter prospective open randomized controlled trial. Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation.

Intervention: One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.

Main study parameters/endpoints: The main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure success and safety.


Eligibility Criteria:
Inclusion Criteria:

1. clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers
2. history of ischemic heart disease
3. ICD carrier or ICD implantation planned after the ablation
4. informed written consent

Exclusion Criteria:

1. current unstable angina as defined by current european guidelines
2. AMI \< 30 days or in case of incessant VT \< 14 days
3. absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)
4. significant coronary stenosis approachable and clinically relevant for intervention
5. presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or MRI
6. previous pericarditis
7. presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions
8. previous thoracic radiation therapy
9. contra-indication for general anaesthesia
10. age below 18 years
Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition

The current research program aims to study how sleep disordered breathing, age and genetics affect memory in older adult veterans with Posttraumatic Stress Disorder (PTSD).

The study will help researchers and clinicians better understand the relationship among PTSD, sleep disordered breathing, genetics and memory function.

The research project will clarify how sleep disordered breathing and Apolipoprotein (APOE) status affect cognitive decline in a population already at risk for accelerated decline-veterans with PTSD.

To fill this knowledge gap properly, we will conduct a longitudinal study and data include analytic techniques designed specifically to identify moderators and mediators of clinical change.

Eligibility Criteria:
Inclusion Criteria:

1. Age 55 years or older, male or female veterans of any racial or ethnic group.
2. PTSD subjects will be positive for lifetime PTSD, related to any past lifetime traumatic experience and have a diagnosis of current, chronic PTSD by the Clinician Administered PTSD Scale (CAPS) criteria with current CAPS score \> 40
3. Capable of giving informed consent for the study
4. Sufficient visual and auditory acuity for cognitive testing

Exclusion Criteria:

Psychiatric Exclusions:

1. Current or lifetime history of any psychiatric disorder with psychotic features
2. Current or lifetime bipolar disorder or delusional disorder
3. Prominent suicidal or homicidal ideation
4. Current exposure to trauma or recent exposure to trauma in the past 3 months.
5. Currently or have within the past six months met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine).
6. Presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during testing
7. Diagnosis of probable or possible dementia
8. Mini-Mental State Exam (MMSE) \< 23
9. History of seizure disorder.

Medical/Medication Exclusions:

1. Acute illness or unstable chronic illness (e.g., history of severe liver disease (cirrhosis, esophageal varices, ascites, portal hypertension, hepatic encephalopathy). Clinical or laboratory evidence of active hepatic disease will be recorded.
2. History of neurologic (e.g., multiple sclerosis, seizure disorder, stroke, history of transient ischemic attacks) or systemic illness affecting central nervous system (CNS) function (e.g. liver failure, kidney failure, congestive heart failure, systemic cancer)
3. Unstable or severe cardiovascular disease
4. Unstable gastrointestinal disorder
5. Uncontrolled hypertension
6. Head injury within one year
7. Loss of consciousness \>24 hrs
8. Use of systemic steroid medication (with the exception of Estrogen replacement therapy which is permissible)
9. Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol
10. Toxicology evidence of illicit substance use.
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.


Eligibility Criteria:
Inclusion Criteria:

* Age =\>18
* \<8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram

Exclusion Criteria:

* Subject with know hypersensitivity to Alfuzosin hydrochloride or any component of Alfuzosin hydrochloride tablets
* Pregnant/Nursing females
* Solitary kidney
* Renal insufficiency (Creatinine\>1.8)
* Urinary infection (fever \>101, positive urine culture, many bacteria on urinalysis)
* Moderate or severe hepatic insufficiency (Childs-Pugh categories B and C)
* Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since Alfuzosin blood levels are increased
* Other alpha-blockers
* Phosphodiesterase type 5 inhibitors for erectile dysfunction
* Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study
Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial

The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP (nasal continuous positive airway pressure)as the initial respiratory support when using minimal ly invasive surfactant therapy (MIST) in preterm infants.

OBJECTIVE: To determine that affect the rate of (bronchopulmonary dysplasia) BPD and death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for respiratory distress syndrome (RDS).

METHODS: Inborn preterm infants of gestational age 26-32 weeks, with respiratory distress syndrome were enrolled in this single-centered, unblinded randomized prospective controlled trial. They were stabilized with T-piece device in delivery room. Immediately after admission of neonatal intensive care unit (NICU), infants were randomly assigned to receive NCPAP with either nasal prongs or mask. NCPAP was continued by setting at PEEP as 5 to 8 cm H2O .

RESULTS: 160 infants were assessed for eligibility 149 infants were randomized. Finally 75 infants in Group I (nasal prong) and 74 in Group II (nasal mask) were analyzed. Mean gestational ages were 29.3±1.6 vs 29.1±2.0 weeks (p=0.55) and birth weights were 1225±257 vs. 1282±312 grams (p=0.22) respectively in Group I and Group II. The frequency of NCPAP failure within 24 hours of life was higher in Group I compared to Group 2 (respectively 8%, %0 , p=0.09) but difference was not significant. The outcomes of BPD and death rates did not differ among the groups ( Group I 9.3% vs. Group II 9.4 %; p=0.96).

CONCLUSIONS: Applied nasal mask is a feasible method to deliver NCPAP and as effective as nasal prongs for the initial treatment of RDS in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* One hundred sixty infants born at 26-32 weeks' gestation not endotracheally intubated in the delivery room (DR)

Exclusion Criteria:

* Infants with major congenital anomalies, and who required intubation in the DR and no parental consent were excluded.
Survey in a Population of Sickle Cell Disease Patients to Evaluate the Transition Between the Queen Fabiola Children Hospital and the CHU Brugmann Hospital, and the Quality of the Hospital Care Within the CHU Brugmann Hospital.

Sickle cell disease is a genetic disease responsible for an abnormal hemoglobin.The anomaly has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility to infections.

Patients with this disease should be monitored medically continuously from birth. At adulthood, they will pass from a pediatric medical care system to an adult medical care system.This transition can be experienced with more or less ease, depending on the organization within the pediatric and adult hospitals.

This questionnaire aims to assess the quality of the transition between pediatric and adult services.The investigators want to better estimate hospital work and improve the quality of care for this type of patients, throughout their entire medical history.

Sickle cell disease is a genetic disease responsible for an abnormal hemoglobin. It particularly affects populations with an African ascent (300 000 African children are born every year with this genetic anomaly).

The anomaly has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility to infections.

The severity of sickle cell disease is variable among children. Some develop frequent and serious complications, while others don't. A child with sickle cell disease is hospitalized about a week a year in average (for a painful crisis, infection or worsening of anemia).

Patients with this disease should be monitored medically continuously from birth. At adulthood, they will pass from a pediatric medical care system to an adult medical care system.This transition can be experienced with more or less ease, depending on the organization within the pediatric and adult hospitals.

This questionnaire aims to assess the quality of the transition between pediatric and adult services.The investigators want to better estimate hospital work and improve the quality of care for this type of patients throughout their entire medical history.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease patients, beeing admitted in the CHU Brugmann Hospital (Horta site) after having been followed in the Queen Fabiola Children Hospital.

Exclusion Criteria:

* None
Comparing CADe Software for Enhanced Polyp Detection

Purpose \& Research Questions

The purpose of this study is to evaluate whether artificial intelligence (AI) improves the detection of polyps and whether the system can classify the type and severity of detected changes. The investigators will also assess if there are any differences between the various AI systems and whether the polyps that may be missed are benign or malignant.

Materials: Selection, Representativeness, and Grouping

The study is a randomized controlled clinical trial conducted at Västra Götaland region. Patients are randomized to receive either AI or conventional endoscopy, and each endoscopy unit has access to at least one AI device. Informed consent is obtained from patients before the examination.

Before the examination, patients are asked if they want to participate in the study. If the patient wishes to participate, informed consent is obtained. The endoscopist then draws a slip from an envelope, determining whether conventional colonoscopy or AI will be used. During conventional colonoscopy, the patient is examined according to routine practice. After the examination, a questionnaire is filled out, recording various findings from the examination. During AI examinations, the AI system is activated only during instrument withdrawal. The system identifies polyps and alerts the endoscopist. Additionally, two of the AI systems (GI-Genius, CADEYE) have the ability to characterize the detected polyps and provide an interpretation of whether the changes are benign or malignant. After the examination, a similar questionnaire is completed as in conventional colonoscopy.

Method: Data Collection

Basic data will be recorded, including the reason for the examination, other illnesses, medications, demographic data such as gender, age, family history of cancer, and the time of the examination (morning or afternoon). During the examination, the following will be recorded: the number of polyps, macroscopic classification of polyps, AI system's characterization of the polyps, bowel cleansing quality, laxative method, medication during the examination, complications occurring during or after the examination. Withdrawal time is recorded, as well as the number of false-positive polyps and supplementation with histological data of polyps after review by the pathologist.

Three different AI systems will be used at the various hospital sites, namely EndoAid (Olympus), CADEYE (Fujinon), and GI-Genius (Medtronic). All units will randomize each examination to either AI or non-AI.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Elective colonoscopy

Exclusion Criteria:

* Patient declines to participate in the study.
* Age \< 50 years
* Emergency examinations
* Contraindications for biopsy/polypectomy
* Unprepared bowel
The Clinical Effects of Myofascial Trigger Points in Disc Replacement With Reduction

This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. These two groups will be compared for clinical findings, pain severity and limitation of the temporomadibular function.

This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. The participants' ages will be between 18-65 years of both genders.

These two groups will be compared for clinical findings with DC/TMD Axis I- Symptom Questionnaire, pain levels in the last 1 month with DC/TMD Axis II-Graded Chronic Pain Scale, and limitation of the temporomadibular function with DC/TMD Axis II-Jaw Functional Limitation Scale-8.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old of both genders.
* Presence of disc displacement with reduction with/without myofascial trigger points in master muscles.
* Being accepted of the participation in the study.

Exclusion Criteria:

* Lack of cognitive ability to understand test instructions, illiteracy, aphasia, presence of a known psychiatric illness
* Refusal to participate in the study
* Patients under the age of 18 and over the age of 65
* Having other temporomandibular joint disorders other than the diagnosis of RDD and/or myofascial trigger points
A Study to Evaluate SimPull for Lateral Patient Transfer

The purpose of this research is to test an investigational device called SimPull to see if it is a more efficient method of transferring a patient from one bed to another compared to that of current methods. The purpose of this research is to gather information on the safety and effectiveness of the SimPull device.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring lateral transfer for an invasive cardiac procedure to and from gurney to exam table.
* Patients requiring lateral transfer for an invasive cardiac procedure to and from exam table to gurney.
* Patient does not have compound fractures or cervical fractures present.
* Patient does not have skin damage or open wounds to the dorsal cavity.
* Patient or legally authorized representative (LAR) must be able/present to sign consent.

Exclusion Criteria:

* Patients who do not require lateral transfer for an invasive cardiac procedure to and from gurney to exam table.
* Patients who do not require lateral transfer for an invasive cardiac procedure to and from exam table to gurney.
* Patient has compound fractures or cervical fractures present.
* Patient has skin damage or open wounds to the dorsal cavity.
* Patient or legally authorized representative (LAR) are unable/present to sign consent.
Social Transfers for Exclusive Breastfeeding

The goal of this study is to assess the effectiveness of social transfers on exclusive breastfeeding rates in Lao PDR. The main questions it aims to answer are:

1. Are social transfers effective at increasing exclusive breastfeeding rates at 6-months
2. Are social transfers cost-effective
3. What are the long-term impacts of social transfers for breastfeeding on child development

Participants will be randomly assigned to one of three groups: 1) control, no social transfer 2) non-conditional social transfer at 6-months postpartum, and 3) conditional social transfer at six months postpartum; conditional upon the mothers exclusive breastfeeding status.

All participants receive education about the benefits of exclusive breastfeeding and current international recommendations.

Researchers will compare the intervention groups to the control group to see if social transfers are effective at increasing exclusive breastfeeding rates at six months postpartum.


Eligibility Criteria:
Inclusion criteria:

* Given birth in the last four weeks
* Exclusively breastfeeding at time of recruitment
* Lives in Vientiane in one of the following districts: Chanthabury, Sikhottabong, Sangthong, or Parkngum and is included in the VITERBI cohort

Exclusion criteria:

* Plans to move permanently outside study area
* Has a medical, intellectual or psychological disability
* Contraindication for breastfeeding
* Preterm births
* Children born with \< 2500 grams
Evaluation of The Effect of Crowns Applied With Hall Technique on Occlusion

This study aims to evaluate and compare the change on occlusion after placing stainless steel crowns (SCC) using Hall technique and conventional technique in children between the ages of 5-8. In addition, the investigators planned to analyze the change in oral health-related quality of life between SCC applied with the Hall technique and SCC applied with the conventional method, before and after clinical application.

First, the participants who met the inclusion criteria were included in 2 study groups according to age, gender, dental experience, tooth number, applied stainless steel crown technique, Decayed, Missing due to caries, and Filled teeth in the permanent teeth/decayed, missing due to caries, and filled teeth in the deciduous teeth (DMFT/dmft index) values and International Caries Detection and Assessment System (ICDAS II) and radiographic evaluation criteria. In the experimental group, stainless steel crowns were placed on the teeth of 39 participants using the Hall technique. In the control group, stainless steel crowns were placed on the teeth of 39 participants using conventional technique.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with American Society of Anesthesiologists score I (ASA I),
* Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
* Clinically, Black class II enamel-dentin caries in the upper jaw primary second molar is; ICDAS II Scale score 4, score 5 and the accepted values in the evaluation of radiographic dental caries are D1-RA3, D2-RB4, D3-RC5,
* Antagonist of the tooth planned to be processed,
* Lamina dura and periodontal space can be observed normally
* There is permanent tooth germ underneath or the position is normal.

Exclusion Criteria:

* Allergic to the local anesthetics or sulfites,
* Had teeth with pain or sepsis,
* Were uncooperative during clinical examination,
* TMJ disorder,
* Had parafunctional habit
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

The aim of the study is to see if lozenges containing a low dose of interferon-alpha can prevent and/or reduce the severity of colds and flu. Starting about 1 month before the expected start of the winter colds and flu season in Perth, Australia, healthy volunteers will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo), to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of treatment will determine whether interferon was able to prevent infections with cold/flu viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms, medications taken, days of work missed, etc. to see if interferon was able to make their winter colds and flu less severe.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female
* Females of child-bearing potential must practice a medically accepted form of birth control

Exclusion Criteria:

* Currently exhibiting an acute upper respiratory tract infection
* history of chronic respiratory disease requiring regular therapy(i.e. COPD, asthma, bronchitis, etc.)
* any condition likely to increase the risk of severe or complicated influenza (i.e. cardiac disease, chronic renal disease, endocrine diseases, including diabetes and/or immunosuppressive therapy)
* any condition requiring regular treatment with antihistamines, analgesics or antipyretics
* known infection with HIV, hepatitis B virus or hepatitis C virus
* any other serious, uncontrolled disease
* any active infections requiring use of antibiotic or antiviral drugs
* non-ambulatory status
* suspected drug or alcohol abuse
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea
* Brighton Grading of II or III
* Culture-based diagnosis of acute bacterial otitis externa
* Willingness to refrain from swimming through end of the study

Exclusion Criteria:

* Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment.
* Tympanic membrane perforation
* Any condition or situation likely to cause the patient to be unable or unwilling to comply with study treatment or attend all study visits
* Any condition in the patient or parent/guardian that, in the judgment of the principal investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study