cyrilzakka/clinical-trials huggingface dataset:
The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation

The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. The main question it aims to answer is:

• Is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ?

Participants will performed 2 IRMs with injection and completed Quality of Life Questionnaires. They participate in the study for 4 months.

Researchers will compare 2 arms:

* Pulse-Field Ablation
* Cryoablation


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18
* Established diagnosis of paroxysmal fibrillation, with a I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines)
* Episode of AF documented by ECG within the last 12 months
* Patient able to give written informed consent
* If female of childbearing potential, have a negative serum pregnancy test and using effective contraception
* Be affiliated with a French social security system or entitled

Exclusion Criteria:

* Non-paroxysmal atrial fibrillation
* Contraindication to oral anticoagulation
* Intracardiac thrombus
* Previous ablation in the left atrium
* Previous heart surgery
* Significant valvular heart disease defined as any moderate (grade 3) or severe (grade 4) mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or tricuspid stenosis
* Contraindication to perform MRI or using the DOTAREM™ contrast product (pacemaker, defibrillator, foreign body or prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, percutaneous devices for endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic device, severe kidney disease with GFR \< 30 mL/min, documented hypersensitivity to gadoteric acid or to excipients, severe claustrophobia)
* Patient on AME (state medical aid)
* Pregnant or breast-feeding female
* Patient protected by law (guardianship, tutelage measure, deprived of liberty)
* Participation in another interventional study or being in the exclusion period at the end of a previous study.
Radiological Findings in Primary Intestinal Ischaemia

To investigate which findings on a non-specific CT scan that predict acute primary intestinal ischaemia.

48 patients with primary intestinal ischemia admitted in 4 consecutive years (2006-2009) in Department of Gastrointestinal Surgery, Aalborg University Hospital. Control group consists of 82 patients operated in the same department and in the same time range.

Abdominal CT scans are described with respect to intestinal diameter, changes in intestinal wall, extra intestinal changes and vessel pathology.

Eligibility Criteria:
Inclusion Criteria:

* Primary acute intestinal ischaemia in an abdominal operation.
* CT-scan within 48 hours preoperative.

Exclusion Criteria:

* Secondary intestinal ischaemia
* Intestinal ischaemia isolated intestinal mucosa.
* No CT-scan within 48 hours preoperative
Serial Usage of Combitube in Anesthesiology

Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Background: The oesophageal-tracheal Combitube (ETC) was designed for the use in the pre-hospital setting and has proven its value both there and in difficult airway management. The ETC is a double-lumen tube and as such it enables ventilation independent of its position in either the trachea or the oesophagus. Since laryngoscopy is not necessary for positioning the ETC, it is especially favoured in pre-hospital setting, but is also used in clinical setting.

Objectives: Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients ASA class I and II

Exclusion Criteria:

* patients not able to sign informed consent
A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.

The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:

Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ZMC fractures requiring open reduction and internal fixation.
* Adult patients aged between 20 and 50 years with no gender predilection.

Exclusion Criteria:

* An existing laceration in the inferior and lateral periorbital site.
* Infection at the fracture line.
* Comminuted fracture with bone loss.
* Acute and chronic conjunctival diseases.
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy

A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

Eligibility Criteria:
Inclusion Criteria:

1. Males aged 18 years or older at time of informed consent.
2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
3. Grade Group 2-5.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
5. Have adequate organ and bone marrow function at screening.
6. Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document

Exclusion Criteria:

1. Have an invasive malignancy, other than the disease under study.
2. Anticipated to require the use of a drain after radical prostatectomy.
3. Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate.
5. History of allogeneic organ transplant.
6. History of primary immunodeficiency.
7. QTc interval \>470 msec at Screening.
A Distress Screening and Intervention in Cancer Surgery

The goal of this project is to examine initial effectiveness of a brief (2 preoperative, 2 postoperative session) cognitive behaviorally-based telephone intervention compared to standard care on postoperative outcomes for patients who are scheduled to undergo a cancer-related surgery in 12 or more days and screen positive for distress (4 or higher on 0-10 Distress Thermometer). The intervention focuses on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care. Participants will be randomly assigned to receive the intervention or to receive standard care. Outcomes assessed 4 and 6 weeks post-operatively will include: Depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), health-related QOL (SF-36 MCS and PCS), number and type of complications, length of stay, and 30-day readmission.


Eligibility Criteria:
Inclusion Criteria:

* ADULT (18 years of age or older)
* SCHEDULED FOR SURGERY FOR CANCER (excluding non-melanoma skin cancer) 12 OR MORE DAYS IN ADVANCE OF CONSENT
* SIGNIFICANTLY DISTRESSED (\>4 on the 0-10 Distress Thermometer)
* ABLE TO SPEAK ENGLISH

Exclusion Criteria:

* COGNITIVE IMPAIRMENT : \<4 on baseline Mini Cog measure
* SERIOUS MENTAL ILLNESS: a diagnosis of a bipolar or psychotic disorder (noted in medical record)
* NON-ENGLISH SPEAKING: This study only involves participants who can speak English.
Problem Management Plus Mindfulness-informed Legal Education for Addressing Gender-based Violence and Improving Parenting

Gender-based violence and, more specifically, domestic violence is a prevalent problem globally and in Nigeria. Its effect significantly impacts women and also the wellbeing of their families. Limited access to support has posed a constraint in effectively addressing the issues suffered by affected victims in Nigeria. In addition, gender-based violence could affect parenting due to factors such as anxiety, trauma, depression, poor social support, limited awareness of legal channels for complaint and harsh parenting to children. The implication is that it could not only have a negative impact on the affected victim but also on their parenting styles or caring responsibilities, which could be detrimental to the child development, wellbeing and the potential subsequent resort to criminal behaviours. In essence, the current study aims to test the feasibility and acceptability of a novel cross disciplinary intervention titled, Problem Management plus Mindfulness-informed Legal Education (PM+MiLE) for addressing gender-based violence and improving parenting in Nigeria in comparison to the waitlist control group for the purposes of improving social cohesion, legal awareness, wellbeing and reducing depression, including trauma and anxiety as a result of experiencing gender-based violence, in Nigeria.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* Female with child(ren) or with caring responsibilities for child(ren).
* Able to provide full consent for their participation.
* A resident of the study areas (Delta, Jos, Lagos State, etc.)

Exclusion Criteria:

* Less than 18 years
* Unable to consent
* Currently undergoing severe mental healthtreatment
* Unable to speak the English language fl uently
Effect of Milk Warming on the Very Low Birth Weight Infant

This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard method does not keep the breast milk at a consistent temperature during the feeding. A continuous milk warmer maintains the breast milk at body temperature throughout the feeding. It is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.

The aim of this randomized prospective quasi-experimental study is to determine if providing body temperature breast milk feedings to very low birth weight infants through use of continuous milk warmer improves feeding tolerance and weight gain compared to a standard milk warming technique.

Warming breast milk in a hot water bath just prior to feeding prior to feeding in the neonatal intensive care unit is a common practice. However, little evidence is available to support a standard warming method. This method allows inconsistent temperatures at time of feeding and progressive cooling of the milk during the feeding. No published study used a continuous warming device that delivered milk at a consistent physiological temperature throughout the feeding. The continuous warmer externally heats milk in the tubing just posterior to the feeding tube to provide body temperature milk to the infant.

A convenience sample from the Children's Hospital at OU Medical Center of 50 very low birth weight infants will be randomly assigned to either the experimental or control group for ten days. The experimental group will receive warmed feedings through the duration of the feeding through the use of the Guardian Warmer™, a continuous milk warming device. A control group will receive breast milk feedings warmed using the standard milk warming methods. Feeding tolerance and weight gain over the ten-day period will be used to evaluate the effectiveness of continuous milk warming.

Eligibility Criteria:
Inclusion Criteria:

• Gestational age 28-32 weeks on full enteral feeding of breast milk

Exclusion Criteria:

* Mechanical ventilation
* Positive End Expiratory Pressure (PEEP)
* Total parenteral nutrition, or any congenital anomalies
* Severe to moderate respiratory disease
* Previous medical or surgical necrotizing enterocolitis.
Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

The current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy is very heterogeneous among studies published in the literature; in addition, clear outcomes advantages of one strategy over another currently lack.

The goal of this observational study is to describe the current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy (FOB), stratified by baseline respiratory condition, co-morbidities, type of procedure and hospital settings.

Investigators will enroll all adult patients undergoing any fiberoptic bronchoscopy in any clinical settings (from outpatients to critically ill patients). No specific exclusion criteria are indicated for enrollment in this study.

Investigators will record the following data:

* Patient's baseline data.
* Type of FOB procedure: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS). The type and size of bronchoscope (with or without an internal/external camera) and the time of the procedure will be also recorded.
* Type of supportive strategy: no support, Standard Oxygen Therapy, High Flow Nasal Cannula, Continuous Positive Airway Pressure and or non invasive ventilation trough mask or helmet, invasive mechanical ventilation.
* Sedation
* Intra-procedural vital parameters
* Occurrence of adverse events: desaturation (i.e. SpO2\< 90% for at least 10 seconds), severe desaturation (i.e. SpO2\< 80%), need for procedure interruption, hypotensive (systolic blood pressure \<90 mmHg) or hypertensive (systolic blood pressure \>140 mmHg) events, new onset of cardiac arrhythmias (specify the rhythm) or myocardial ischemia or electrocardiographic ST-alterations, neurological events (i.e. severe sensorium depression, psychomotor agitation).
* Post-procedural vital parameters (15 minutes after the procedure).
* Clinical outcomes: need for support escalation, need for admission to ward (for outpatient) or ICU (for outpatients and ward-admitted patient).


Eligibility Criteria:
Inclusion Criteria:

* Need for any procedure with flexible FOB
* Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)

Exclusion Criteria:

* None
A Study in People With Mild Hypertension

The primary objective of this study is to test the hypothesis that LY518674, administered for 6 weeks to patients with mild hypertension, reduces Systolic Blood Pressure, compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Are men and women between 18 and 70 years of age, inclusive
2. Have given signed informed consent to participate in this study
3. Are diagnosed with mild essential hypertension at screening (currently untreated or treated with monotherapy)

Exclusion Criteria:

1. Secondary or malignant hypertension
2. Have or have had a history of hyperlipidemia within 3 months of screening requiring treatment
3. Any previous cardiovascular disease other than hypertension
4. Type 1 or 2 diabetes
Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC);
* High-risk UTUC: \>= pT2, pN+, tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition);
* Aged \>= 18 years old;

Exclusion Criteria:

* With Distant metastases already found at the time of surgery; non-R0 resected ;
* History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy;
* Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception;
* History of malignant tumors (except skin cancer that is not malignant melanoma and in situ cervical cancer, tumors that have been cured for more than 5 years);
* Weight loss \> 10% within 6 months;
* Existing or coexisting bleeding disorders, active infection;
* Terrible condition cannot tolerate the intervention;
* Unable to sign informed consent due to psychological, family, social and other factors.
Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa

The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.

Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge (otorrhea).

Eligibility Criteria:
Inclusion Criteria:

* Aged 3 years to 80 years old.
* Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
* Intact tympanic membrane
* Unilateral disease

Exclusion Criteria:

* Known allergy or sensitivity to Ciprofloxacin or other quinolones.
* Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
* Patient has the non intact tympanic membrane.
* Patient has a serious underlying disease.
* Patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy.
* Patients with history of Diabetes mellitus.
* Patients with more than 80% of the ear canal occluded.
* Pregnant or lactating patients.
* Overt fungal Acute Otitis Externa.
* Local ear canal abnormalities such as abscess, granulation or polyps.
* Congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear.
* Mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear.
* Seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation.
* Current Infection requiring systemic antimicrobial therapy.
* Current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days).
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)

The aim of this study is to investigate the effects of soluble corn fiber (SCF) on bone mineral content (BMC) and bone mineral density (BMD) in pre-pubertal boys and girls. The hypothesis to be tested is: SCF will lead to greater increase of BMD, as measured with densitometry in both low calcium as well as high calcium intakes compared to placebo.

Main objective To investigate the effects of soluble corn fiber (SCF) supplementation on bone mineral content (BMC) and bone mineral density (BMD) in pre-pubertal boys and girls.

Secondary objectives

The secondary objectives are:

To investigate changes in bone formation and bone resorption markers in response to soluble corn fiber supplementation in the diet of prepubertal boys and girls consuming adequate calcium intake vs placebo To investigate changes in body composition in response to soluble corn fiber supplementation in the diet of prepubertal boys and girls consuming adequate calcium intake vs placebo

Hypothesis Soluble corn fiber would lead to improved BMC and BMD accrual in pre-pubertal children compared to placebo.

Study design The proposed study is a double blind, randomized, single center, parallel design trial

Duration of study The duration of the study intervention would be 12 months

Eligibility Criteria:
Inclusion Criteria

* Screened to be generally healthy as determined by standard medical assessment on physical and mental health
* Tanner stage 2 based on breast development for girls, and pubic hair in boys. Girls will have to be premenarcheal
* Having obtained his/her informed consent and parents or legal guardians consent

Exclusion Criteria:

* History of serious medical conditions such as intestinal or severe metabolic diseases, disorders such as diabetes, renal, hepatic or pancreatic diseases, disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition, anaemia
* History or on therapy with medication known to interfere with bone metabolism such as steroids, hormones, diuretics, cortisone or anti-seizure medication
* Taking regularly any nutritional supplements and unwilling to stop for the study