cyrilzakka/clinical-trials huggingface dataset:
The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis

This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis.

The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis.

Signed informed consent was obtained from a parent of each child. And the human ethics committee of our hospital approved the study according to the principles of the Declaration of Helsinki.(Approved - 2002)

Patients:

65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider Children's Medical Center because of bronchiolitis during winter in two consecutive years 2004-2005.

The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after informed consent was signed with clinical presentation of mild to moderate bronchiolitis according to a clinical score .Exclusion criteria were as follows: prematurity, congenital lung or cardiac disease, infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score\>7 with a range scale 0-10).

All eligible patients were randomly assigned to one of two groups: Group 1 (control) received inhalation of epinephrine 1mg, in 2cc of 0.9% saline solution four times a day, and nasal drops of 0.9% saline for each nostril every twelve hours. Group 2 - the study group received four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL to each nostril twice a day. This treatment continued until the patient was ready for discharge.

Patients were examined and evaluated at the study entry and were re-evaluated every 10-12 hours. Length of hospital stay,time to improve Oxygen saturation, time to the need of IV fluid and clinical score between the two groups of treatment were compared.

Eligibility Criteria:
Inclusion Criteria:

* Full term previously healthy Infants
* Ages 1-12 months
* After informed consent was signed with clinical presentation of mild to moderate bronchiolitis

Exclusion Criteria:

* Prematurity, congenital lung or cardiac disease
* Infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score \>7 with a range scale 0-10)
RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF)

The purpose of this prospective, non-randomized, single-arm, research study is to evaluate the accuracy of acutely extracting respiratory rate and tidal volume from implanted cardiac device impedance in subjects with heart failure.

In addition, to assess the feasibility of extracting respiratory rate from device EGM under various conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have heart failure and be undergoing implant of a new or replacement/upgrade Medtronic dual-chamber Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator device for approved indications;
* Subject must be implanted with an right ventricle lead that supports bipolar pacing and sensing (i.e. a true bipolar defibrillation lead);
* Subject must receive a light conscious sedation or no sedation where breathing maneuvers can be performed and evaluated during the implant;
* Subject must be willing to provide Informed Consent for their participation in the study;
* Subject must be ≥ 18 years of age.

Exclusion Criteria:

* Subjects who are unable or unwilling to voluntarily participate in any visit required by the study and to provide consent;
* Subject has congenital heart disease;
* Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure;
* Subject has unstable coronary artery disease;
* Subject requires cardiac pacing at rest for rate support;
* Subject presents any concomitant conditions which in the opinion of the investigator would not allow a proper execution of the respiratory exercises as per protocol;
* Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study;
* Subject is pregnant or breast feeding;
* Subject is legally incompetent;
* Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager.
Effectiveness of an Intervention for Prevention and Treatment of Burnout in Primary Care

Background: Burnout syndrome is an important health problem that affects many professionals and must be addressed globally, with both organizational measures and personal interventions. Burnout of health professionals can be prevented in order to avoid personal, familial, and social consequences, as well as repercussions for patients.

Methods/Design: This work describes a protocol for a controlled, pragmatic, randomized clinical trial in 2 parallel groups: intervention and control. All health professionals from 7 health care centers (HCCs) will form the intervention group, and all health professionals from 7 different HCCs will form the control group. The intervention group will receive 16 hours of training at their work place. The Maslach's burnout inventory (MBI), burnout physician Questionnaire (CDPM) or burnout nurse Questionnaire (CDPE), and the 28-item Goldberg's General Health Questionnaire (GHQ-28), validated for our setting, will be used as measurement tools. Change in the average scores from the MBI emotional exhaustion scale will be compared between the intervention and control groups, measured as intention-to-treat, and the intervention will be considered effective if a minimum increase of 20% is achieved.

Discussion: Due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work, it is necessary to evaluate the effectiveness of certain interventions for its prevention. Organizational measures are important for preventing burnout syndrome, but so is providing professionals with coping strategies, as this group intervention intends to do.


Eligibility Criteria:
Inclusion Criteria:

* All health professionals (family physicians, pediatricians, and nurses) who are part of the health care centers at the moment of the trial.

Exclusion Criteria:

* No one.
Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC

The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).

Moderate to severe traumatic brain injury frequently results in persistent problems with memory, attention span, mood and more complex brain functioning such as planning and organizing. There are currently no drugs available to reduce the brain damage or the persisting symptoms that result from TBI. The longer term goal of this study is to provide physicians with a safe and effective treatment for TBI

Eligibility Criteria:
Inclusion Criteria:

* Non-penetrating TBI.
* Age 16-75 years.
* Admission to hospital.
* Post resuscitation GCS 4-12.
* Have at least one reactive pupil.
* Able to receive investigational product within 8 hours of injury.
* Hemodynamically stable after resuscitation (systolic blood pressure (SBP) \>100 mm Hg).
* Able to read and write English and have sufficient motor dexterity prior to injury to undertake the neuropsychological and activities of daily living (ADL) testing, in the opinion of the investigator, at 1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks) post injury.

Exclusion Criteria:

* Penetrating brain injury.
* Spinal cord injury.
* Presence or known history of prior cerebral injury requiring hospitalization that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
* Non-traumatic brain injury.
* Known history of any medical or psychiatric disorder, or any severe concomitant disease that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
* Significant non-central nervous system (CNS) injuries sustained at the time of the TBI would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
* Weight \>150 kg.
* Participation in another clinical trial within the previous 4 weeks.
* Clinical state requiring greater than 6 L blood, colloid or crystalloid fluid resuscitation prior to randomization.
* Pregnant or nursing mothers. Women of child-bearing potential must have a negative urine or blood test prior to randomization.
* Prior enrollment in this study.
* QTc Exclusions. The study will use the exclusion criteria as defined in ICH Guideline E14 to exclude patients with a risk of QT/QTc prolongation, as follows:

  * A marked baseline prolongation of corrected QT/QTc interval \>450 ms.
  * History of risk factors for torsade de pointes (e.g. heart failure, hypokalemia (serum potassium at screening \<3.0 mmol/L)or family history of long QT syndrome).
Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time

It is a randomized, single-blind clinical trial, whose population to be studied will be randomized patients with a diagnosis of dehiscence and infection of a cesarean surgical wound who meet the inclusion and exclusion criteria.

H0: Sucrose does not reduce hospital days in patients with surgical wound dehiscence.

HA: Sucrose reduces hospital days in patients with surgical wound dehiscence.

Cesarean section is one of the most performed surgical interventions at the Maternal and Child Hospital. Infection and dehiscence of the surgical site are some of the most common complications in post-cesarean section patients. The Honduran population, like those around the world, is susceptible to surgical site infections due to several risk factors and depends on each patient. Regarding the patients treated at the Maternal and Child Hospital, a surgical site risk of approximately 2-3% is estimated. Therefore, the investigators consider it beneficial to look for alternatives to treating surgical infections that help to reduce hospital time. Granulated sucrose has previously been used as a method for treating surgical wounds, however, no trial has been conducted to determine the benefits of its use.

Therefore, the investigators consider that it will be beneficial for the Gynecology and Obstetrics service of the Maternal and Child Hospital, especially the Septic ward, to carry out a study that helps to determine if the use of granulated sucrose reduces the hospitalization time of patients with infection and dehiscence of the surgical site due to cesarean section, as well as replacing the use of other methods that must be paid for by the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Delivery of a signed and dated informed consent form.
2. Declared willingness to comply with all study procedures and availability for the duration of the study.
3. Women from 18 to 45 years old
4. Enjoy good general health, as demonstrated by your medical history, and have been diagnosed with post-cesarean surgical wound dehiscence and fascia integra.
5. Ability to take oral medication and be willing to comply with the sucrose regimen.
6. Agreement to comply with Lifestyle Considerations

Exclusion Criteria:

1. Known allergic reactions to sucrose components.
2. Treatment with another investigational drug or other intervention within the previous 7 days.
3. Current smoker or tobacco consumption within the previous 3 months.
4. Treatment with antibiotics at least 2 weeks before hospitalization
5. Reinterventions before hospitalization

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Altitude Related Illness In Patients With Respiratory Disease

Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute mountain sickness in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in reducing the incidence of acute mountain sickness in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
* Living at low altitude (\<800m)

Exclusion Criteria:

* COPD exacerbation
* severe COPD, GOLD grade 3 or 4
* arterial oxygen saturation \<92% at low altitude (\<800 m)
* Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea.
* Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day).
* pregnant or nursing patients
De Novo Lipogenesis of Sebaceous Glands in Acne

There are two purposes of this study:

1. First, the investigators want to see what the differences are in de novo sebaceous lipid production of people with and without acne.
2. Secondly, the investigators want to know what happens to sebaceous gland de novo lipid production before and after treatment with topical tretinoin and oral isotretinoin.

The primary objective of this study is to understand how de novo lipid production of sebaceous glands are altered in acne and with acne directed therapy.

Hypothesis 1: The overall de novo lipogenesis will be increased in those with acne

Hypothesis 2: Treatment with topical tretinoin and systemic isotretinoin will reduce de novo lipogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Age 15 to 45 years of age
* Subject/Parents/Legal Guardian be able to read and comprehend study procedure and consent forms
* Have acne that is diagnosed by a board certified dermatologist
* Meet one of the following criteria:

  * already been prescribed oral isotretinoin for treatment of acne
  * have already been prescribed a topical retinoid
  * eligible for prescription of topical tretinoin

Exclusion Criteria:

* Those who have already initiated or completed a course of systemic isotretinoin
* Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
* Those who are pregnant in female participants
* Those who do not fit the inclusion criteria
A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes

This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A.


Eligibility Criteria:
Part A: Inclusion Criteria:

* Subject has a body mass index (BMI) between ≥18.0 and \<32.0 kg/m2
* In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
* Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day-1 or Day 1 (predose).
* Agreement to comply with protocol-specified contraceptive requirements.

Part B: Inclusion Criteria:

* Subject has a body mass index (BMI) between ≥18.0 and \<32.0 kg/m2
* Other than HSV infection, is in good health (as determined by the investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
* Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 (predose).
* Agreement to comply with protocol-specified contraceptive requirements

Part A and B: Exclusion Criteria:

* Current infection of human immunodeficiency virus (HIV), hepatitis B virus, (HBV), hepatitis C virus (HCV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV).
* History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or condition known to interfere with the absorption /distribution/ elimination of drugs.
* History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson Syndrome, urticaria, or multiple drug allergies.
* History of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening.
* Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whatever is longer.
Comparison of the Performance of ICM and CIED in Detecting AF

The aim of this project is to study the performance of the two most commonly used Implantable Cardiac Monitors in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care.

Atrial fibrillation (AF) is the most common abnormal heart rhythm disturbance, affecting 1-2 million people in the UK. The irregular heartbeat caused by AF can make the heart pump blood less efficiently. As a result, AF significantly increases the risk of having a stroke, heart failure and dementia. However, a significantly proportion of people have no symptoms, and they may be only found to be in AF after having a stroke. Therefore, diagnosis largely relies on accurate electrocardiogram (ECG) monitoring.

AF episodes can be unpredictable and easily missed unless continuous ECG monitoring is undertaken. Pacemakers can continuously record the heart's electrical activity and detect AF with a high degree of confidence. However, they are invasive and rely on electrical wires implanted inside the heart, and hence less suited to be used as primary monitoring devices. To overcome these difficulties, implantable cardiac monitors (ICM) have been designed to be placed under the skin.

The new generation of ICMs can now be injected under the skin. Moreover, they connect with the patient's smartphone and transmit recordings. Despite these significant improvements, their ability to reliably capture AF has never been tested against pacemakers.

The aim of this project is to study the performance of the two commonly used ICMs in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care. The investigators plan to inject an ICM in 30 patients with AF and pre-existing pacemaker. After a period of 6 months, the investigators will compare how many episodes were detected in each device. With the information collected the investigators will try to understand the pitfalls in the current technology and develop strategies to improve it.

Accurate, minimally invasive long-term ECG monitor can have far reaching benefits for patients, both in routine clinical practice and research.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial.
* Male or Female.
* Aged 18 years or above.
* History of paroxysmal and persistent AF.
* Dual-chamber pacemaker, Implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy (CRT) device with a functioning atrial lead, able to record electrograms and remote monitoring.

Exclusion Criteria:

* Diagnosis of permanent AF.
* Contra-indications for implantable cardiac monitor.
* Unable to comply with the follow-up schedule.
Improving Engagement With a Process Measure Dashboard Through Precision Feedback

The study seeks to assess the impact of e-mailing specific, targeted, practice-pattern based information ("precision feedback") on provider engagement with a dashboard for a quality process measure (showing stent omission after pre-stented ureteroscopy), compared with generic information ("one size fits most" feedback).

The Michigan Urological Surgery Improvement Collaborative (MUSIC) is a state-wide, physician-led quality improvement collaborative comprised of over 40 urology practices representing varied practice sites within Michigan and nationally, designed to evaluate and improve the quality of urologic care.

A recently identified area for quality improvement within MUSIC is avoidance of placing ureteral stents following uncomplicated ureteroscopy and lithotripsy for kidney stones. Such unnecessary stents do not measurably increase post-operative safety, but rather have been shown to contribute to unnecessary emergency department visits. This process measure (stent omission after uncomplicated ureteroscopy) is the subject matter for the dashboard and will serve as the focus of precision feedback.

The study team hypothesizes that a behavior change intervention bundle consisting of "precision feedback" along with communication strategies to simplify access to feedback will increase dashboard engagement (measured via click-through rate and dashboard logins) compared with standard "one size fits most" e-mail messages. Knowledge gained from this study will inform the development of other precision feedback programs within our urology quality improvement collaborative (MUSIC), and provide a framework for rapid, pragmatic trials for small to mid-sized collaborative quality initiatives nationally.

Eligibility Criteria:
Inclusion Criteria:

-Urologists participating in MUSIC that were in the top one hundred individuals in annual case volume from 2023 for "pre-stented ureteroscopy", the case for which the dashboard contents are most relevant.

Exclusion Criteria:

- Urologists that are not in the top one hundred individuals in annual "pre-stented ureteroscopy" case volume, urologists in the study team, or that opt out from the study at the individual or site level.
Audit of Management of First Stage of Labour in Assiut University Hospitals : a Quality Improvement Project

auditing the current management of first stage of normal vaginal deliveries at Assiut university hospitals emergency obstetric care

Clinical auditing is a quality improvement process that involves reviewing the delivery of healthcare to ensure the best practice is being carried out . it is agreed that caesarean section rates are above the nationally accepted in Egypt . This can be related to many factors and can be associated with risks to morbidities and mortalities

Eligibility Criteria:
Inclusion Criteria:

* term 37- 41 weeks primigravida single vertex presentation living fetus spontaneous onset no contraindications for vaginal delivary

Exclusion Criteria:

* women with associated co morbidities pre eclampsia and diabetes IUFD previous uterine scar intrauterine growth restriction