cyrilzakka/clinical-trials huggingface dataset:
Ethical Dilemmas in Anaesthesiology in the Netherlands; a Qualitative Interview Study.

This study will describe which ethical dilemmas are experienced by anesthesiologist in the Dutch Healthcare system and what the current solving strategies are for these issues. Semi- structured interviews will be conducted with anaesthesiologists employed in different hospitals in the Netherlands..

Ethical considerations are part of a doctors daily practice. The development of anaesthesiologists as ' perioperative' doctors is increasingly giving anaesthesiologists a treatment function. As the third largest medical specialty, they are also involved in ethical dilemmas. Examples of common themes in the literature include:' informed consent' and professionalism. Nevertheless, good research into ethical dilemmas in the field of anaesthesiology is lacking.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Employed as anaesthesiologist
* Employed in an academic or non-academic hospital in the Netherlands

Exclusion Criteria:

* Other medical specialists
* language barrier
Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer

This protocol is a single-institution feasibility study to identify the molecular and epidemiological risk factors in the development of gastric cancer in high-risk predominantly Hispanic South Texas population. The study is broken down into two main parts: 1) To identify molecular differences in gastric adenocarcinoma (GAC) between Non-Hispanics and Hispanics, stratified by age, and in benign, pre-malignant, and malignant gastric lesions; and 2) To identify environmental and clinicopathological factors in Hispanics associated with specific molecular changes linked to the development of GAC.

The first part of the study will be accomplished by performing molecular testing on formalin-fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with GAC. Germline testing will be done on both retrospectively and prospectively identified cohort of patients with diagnosis of GAC. The second part of the study will be accomplished via survey administration on retrospectively and prospectively identified patients with diagnosis of GAC and to test Helicobacter pylori (H. pylori) and Epstein-Barr virus (EBV) infection status, which are known risk factors for the development of GAC, on their FFPE gastric specimen. The data from part 1 and part 2 will be analyzed and correlated. The overall goal of the study is to identify molecular markers and environmental risk factors in GAC unique to Hispanics relative to Non-Hispanics in South Texas, and to define molecular alterations in pre-malignant gastric lesions associated with the development of GAC. The long-term goal is to improve racial disparities by defining prognostic and therapeutic molecular markers and environmental risk factors in Hispanics and ultimately for all patients with GAC. Identification of high-risk molecular markers and environmental factors in the development of GAC will help future deployment of improved prevention and surveillance modalities.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Patient with histologically confirmed diagnosis of gastric adenocarcinoma
* Able to understand English or Spanish (only for the prospective cohort)
* GEJ adenocarcinoma Type II (within 1 cm above and 2 cm below the GEJ) and Type III (2-5 cm below the GEJ)
* Hyperplastic polyps

Exclusion Criteria:

* Clinically AND genetically confirmed diagnosis of well-established hereditary cancer syndrome
* Gastroesophageal junction (GEJ) adenocarcinoma Type I (1-5 cm above the GEJ) as they are treated as esophageal cancer
* Other benign or malignant histology types (i.e. leiomyoma, gastrointestinal stroma tumors, fundic gland polyps, etc.)
Prospective Randomized Trial of Navigated and Conventional TKA

Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.

1. Component position, kinematics After skin closure lateral x-rays were done in different flexion angles in order to evaluate the kinematic behaviour of the TKA.

   A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge.
2. clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* primary or secondary osteoarthritis of the knee
* indication to TKA
* a mechanical axis between 20° varus and 5° valgus
* signed informed consent

Exclusion Criteria:

* previous hemi- or total arthroplasty
* severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

The purpose of this current study is to examine the sensation of the corneal and conjunctiva sensation before and after pterygium surgeries by Cochet bonnet esthesiometer and to examine epidemiological, clinical and imaging factors the influence the sensation


Eligibility Criteria:
Inclusion Criteria:

* Patients that suppose to undergo pterigyum surgery

Exclusion Criteria:

* Patients with anterior segment diseases Patients that underwent anterior segment surgeries Patients with 7th nerve palsy
Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome

This study is aimed to investigate the effects of upper extremity manual lymphatic drainage, which is applied to remove edema from the carpal tunnel region in addition to conventional exercise therapy in Carpal tunnel syndrome patients on findings of clinical, ultrasonographic, and electrophysiological.

Thirtyfour volunteer participants between aged 40 and 60 years, who met the inclusion criteria, will be included in the study. Participants will be randomly divided into two groups experimental and control groups. While the control group will receive only conventional exercises, the experimental group will receive both conventional exercises and upper extremity manual lymphatic drainage. A total of 3 measurements will be made before the treatment, after the treatment and 1 month after the end of the treatment. Symptom severity will be evaluated via Boston carpal tunnel syndrome questionnaire, grip strength via hand dynamometer, pressure pain threshold via digital algometer device, cross-sectional area of the median nerve via ultrasound, and median nerve conduction velocity via superficial EMG device.

Eligibility Criteria:
Inclusion Criteria:

* People aged between 40-60 years
* Having been diagnosed with carpal tunnel syndrome (CTS) at least 6 months ago or having symptoms related to carpal tunnel syndrome for at least 6 months
* Having mild (median nerve sensory conduction velocity below 40 m/sec) and moderate (median nerve sensory conduction velocity below 40 m/sec and median motor distal latency 4 ms and above) CTS according to electrophysiological findings
* Not having received medical treatment and/or physiotherapy for CTS in the last 6 months

Exclusion Criteria:

* Having cervical radiculopathy
* Having thoracic outlet syndrome
* Presence of systemic disease that may lead to CTS, such as diabetes or thyroid disease
* Pregnancy
* Presence of anemia
* Having a history of CTS surgery
* Presence of radial or ulnar nerve sensory-motor lesions accompanying the present condition
* Presence of lymphedema
* Having severe (Sensory nerve action potential cannot be obtained) and severe (Sensory nerve action potential cannot be obtained, but combined muscle action potential is not present) CTS according to electrophysiological findings
Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis

Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic
* Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period.

Exclusion Criteria:

* Any patient \<18 years of age
* Patients with hepatocellular carcinoma
* Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)
* Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence
* Patients currently on statin therapy
* Patients with a history of statin intolerance
* Patients on the waitlist for liver transplantation
* Patients taking medications with known drug interactions with statins
* Patients not able to give informed consent or patients belonging to vulnerable categories as the Federal Regulations or Common Rule
Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit

The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.


Eligibility Criteria:
Inclusion Criteria:

* Consent form signed
* Acute hypercapnic respiratory failure defined as PaCO2 \> 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU

Exclusion Criteria:

* Age \< 18 years old
* Known or suspected neuromuscular diseases
* Pregnancy
* Iatrogenic respiratory failure (i.e. drug overdose, AHRF after starting opiates or increasing opiates dose)
* Life expectancy \< 3 months
* Confusion or major psychiatric illness
* Patient unable to be weaned from NIV
Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices

This is planned as a feasibility study. The objective is to evaluate a specially designed patient adherence and monitoring software on standard mobile devices in remote monitoring of heart failure patients.

Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system.

Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender above the age of 18 years
* The subject is able and willing to provide written informed consent prior to enrollment in the study
* New York Heart Association (NYHA) classification class of II-IV
* Left ventricular ejection fraction (LVEF) less than 40%
* One or more prior hospitalization within the last six months for symptoms, management of heart failure.

Exclusion Criteria:

* Disability of fingers or upper limbs (unable to use devices)
* Visually impaired
* Those unable to read and write
* Hearing dysfunction
* Significant cognitive disabilities, mental illness
* Those who are unable to handle electronic devices
* Those residing in places outside the local mobile phone coverage
* Chronic renal failure on renal replacement therapy
* Patients who may not come for follow up or likely to drop out of the study
* Those awaiting cardiac transplantation
* Any illness which may preclude regular follow up
Predictors of Non-invasive Ventilation Failure in Patients With Acute Cardiogenic Pulmonary Edema

The aims of our study was to identify early predictors of non-invasive ventilation failure, so as to alert clinicians early that endotracheal intubation and mechanical ventilation might be appropriate.


Eligibility Criteria:
Inclusion Criteria:

* Presence of ACPE diagnosed based on SpO2 below 90% with \>5 L/ min oxygen via reservoir face mask
* Acute respiratory distress as evidenced by severe dyspnea
* Breathing frequency of \>30 breaths/min, and use of accessory respiratory muscles or paradoxical abdominal motion in association with tachycardia
* Cardiac gallops, bilateral rales, and typical findings of congestion on chest radiography, without a history suggesting pulmonary aspiration or evidence of pneumonia.

Exclusion Criteria:

* Patients were excluded from the study if they were intubated before ICU admission, or required immediate intubation without prior NIV, or presented a respiratory or cardiac arrest
* Severe hemodynamic instability (systolic arterial pressure \<70 mmHg despite adequate fluid repletion and use of vasoactive agents) or life-threatening ventricular arrhythmias.
* Patients were also excluded if they were unresponsive, agitated, and unable to cooperate; or if they had any condition that precluded application of a face mask including upper airway obstruction
* Recent oral or facial trauma or surgery
* Recent gastric or esophageal surgery
* Inability to clear respiratory secretions or high risk for aspiration.
* In addition, patients were excluded if they had a "do not intubate" order or refused research authorization.
Biomarkers & Infection After Prophylactic Antibiotic in Cardiac Implantable Electronic Device Implantation

Effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers


Eligibility Criteria:
Inclusion Criteria:

* Indication of CIED implantation
* No infection at the time of implantation

Exclusion Criteria:

* Refuse to participate in the study
* Allergy to ampicillin sulbactam
* CIED debridement
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction

Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a component of vagal hypertonia. Nevertheless, there is currently a paucity of literature about the results according to the type of presentation (VV, AVB or SND). The investigators aim to assess the safety and efficacy of cardioneuroablation for the treatment of symptomatic SND.

Sinus node dysfunction (SND), also known as sick sinus syndrome, comprises a wide spectrum of sinoatrial dysfunctions, ranging from sinus bradycardia, sinoatrial block, and sinus arrest to bradycardia tachycardia syndrome. An additional manifestation of SND is an inadequate chronotropic response to exercise, reported as chronotropic incompetence. Since the first cardiac denervation was reported in 2005, several registries and retrospective studies using this therapeutic approach for reflex syncope, SND and functional atrioventricular block have been published. However, due to the lack of randomized studies, current guidelines recommend permanent pacemaker implantation for patients with symptomatic SND in order to improve symptoms. Therefore, the purpose of the present study is to assess the safety and efficacy of cardioneuroablation versus permanent pacemaker implantation for the treatment of symptomatic SND.

This is a multicenter, randomized, open, interventional study. After being informed of the study and potential risks, participants will undergo a one week screening period to determine eligibility for the study entry. During this week, participants will undergo an exercise test, atropine test, and a 24 hour-holter electrocardiogram. Then, participants who meet the eligibility criteria, will be randomized 1:1 to receive permanent pacemaker implantation (control group) or cardioneuroablation (interventional group).

The primary endpoint (improve in quality of life assessed with 36-Item Short Form Survey (SF-36)) will be evaluated at six months since randomization.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (\<40 bpm) or chronotropic incompetence in the exercise test).
* Absence of structural cardiopathy

Exclusion Criteria:

* Left ventricular ejection fraction \<50%
* Severe valvular disease
* Any type of cardiomyopathy such as hypertrophic cardiomyopathy
* Previous ischemic heart disease
* QRS interval \>130 ms
* Atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block Mobitz II, advanced atrioventricular block, complete atrioventricular block)
* Lifetime expectance \<12 months
Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure

The purpose of this study is to determine if exenatide will improve global cardiac function in patients with type 2 diabetes mellitus and congestive heart failure, by favorable effects on cardiac metabolism leading to improvement of cardiac efficiency.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Male and postmenopausal female
* Age 18 years an above
* Metformin therapy (stable, maximum tolerable dose for 2 months)
* HbA1c 6.5-10%
* Confirmed congestive heart failure (NHYA functional class II-IV)
* Ejection fraction \< 50%
* Patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study

Exclusion Criteria:

* Type 1 diabetes mellitus
* Serious renal or liver impairment
* (Receiving treatment for) malignant disease
* Cardiovascular event \< 3 months prior to inclusion
* Acute congestive heart failure
* Any reason for not being able to sustain the imaging studies
* Pacemaker/ICD
* Contraindications for the use of exenatide/ insulin
* Use of insulin, thiazolidinediones, incretin-based therapies within 4 months of screening
* Chronic use of glucocorticoids, NSAIDs or centrally acting drugs (\> 2 weeks) within 2 weeks immediately prior to screening
[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children

The first phase of the study will investigate if there is increased uptake of \[F-18\]FDOPA in pediatric brain tumors when compared to normal brain tissue.

The first phase of the study will investigate if there is increased uptake of \[F-18\]FDOPA in pediatric brain tumors when compared to normal brain tissue. Tne subjects between ages 5 and 17 years will be studies, to determine if there is increased uptake of \[F-18\]FDOPA in pediatric brain tumors when compared to normal brain tissue. Drug safety will also be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Documented brain tumor at diagnosis or relapse, including high grade glioma, low grade glioma, medulloblastoma including PNET, optic pathway glioma, brainstem glioma, ependymoma.

Exclusion Criteria:

* Pregnancy
* Requirement for sedation
* Lack of informed consent
Administration of GnRH Antagonist to Oocyte Donation Recipients

This prospective and randomized study was performed to evaluate whether the replacement of GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial preparation has any impact on pregnancy and implantation rates.

This was a prospective and randomized study undertaken between January 2004 and December 2007. One hundred patients with an indication for oocyte donation with functioning ovaries and IVF with or without intracytoplasmatic sperm injection (ICSI) were recruited for the study. After assignment to IVF or IVF/ICSI randomization was performed to 1 of the 2 treatment groups (GnRH agonist or GnRH antagonist during endometrial preparation in oocyte donation recipients) using a computed-generated randomization schedule assigned via numbered sealed envelopes.

In our program, we used excess oocytes from IVF that were voluntarily donated by patients after informed consent.

The indications for oocyte donation were reduced ovarian reserve (59%), recurrent IVF failures (21%), premature ovarian failure (16%), and genetic anomaly (4%).

This study was performed according to the declaration of Helsinki and the European Community note on Good Clinical Practice for trials on medical products in the European Community (CPMP Working Party on Efficacy of Medical Products, 1990). Furthermore, the local ethics committee approved the study protocol, and written informed consent was obtained from all patients.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-34 years
* Body mass index between 19-30 kg/m2;
* History of regular menstrual cycles, ranging from 25-35 days
* No relevant systemic disease (all patients were screened for hepatitis B and C, human immunodeficiency viruses I and II, syphylis, and vaginal infection), genetic disease, severe endometriosis or pelvic inflamatory disease
* No more than two previous IVF cycles; and
* No previous IVF cycles with poor response (less than three oocytes in a previous IVF cycle) or severe ovarian hyperstimulation syndrome.

Exclusion Criteria:

* Patients without inclusion criteria.