cyrilzakka/clinical-trials huggingface dataset:
Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies

In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed for increasing cure rates for childhood malignancies. This success has led to an emerging understanding of the kinds of effects that treatments can have on the pediatric population and how such effects can influence pediatric cancer survivor's functioning and quality of life. It has become tremendously important to assess the long-term complications due to therapy in this growing sector of survivors and to tailor our treatments so as to minimize these late effects.

The Investigators at MGH are committed to improving the delivery of radiotherapy to our patients and improving the outcome for these patients. MGH has an on-site cyclotron for proton radiotherapy in order to provide the most advanced care for patients in need. Proton therapy possesses a clinical advantage over standard photon therapy in that its optimal dose distribution delivers the bulk of radiation to the tumor site. This method spares the greatest volume of normal tissue, resulting in decreased short-term and long-term morbidity.

Through open pediatric protocols for patients treated with proton radiotherapy, the investigators aim to define and report the acute and late effects associated with treatment.

The investigators also treat a number of patients off-protocol with both proton and photon radiotherapy, and are interested in reporting these patients' QOL outcomes in conjunction with other clinical data that may be pertinent to the site of tumor treatment. This research is significant in that it will allow us to delineate the positive and negative effects of radiation treatment on patients' QOL, highlighting points of success and exposing areas that are in need of improvement. Such knowledge will be used to improve the experience of pediatric cancer survivors in the future.

The aims of this study are: 1) to prospectively collect and report the QOL outcomes in patients treated with radiotherapy and 2) to correlate the QOL data with pertinent clinical information.

You will be asked to complete a series of questionnaires during your treatment and annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Any patient being treated with radiation therapy with curative intent
* Patients between the ages of 2 and 25
* Patients who speak either English or Spanish
* Patients who agree to fill out the questionnaire

Exclusion Criteria:

* Patients younger than 2 years of age or over 25
* Patients receiving treatment with palliative intent
* Patients who do not wish to participate
The IRIS-Resolute Integrity (IRIS-Integrity)

This is a prospective, observational, cohort study to evaluate the relative efficacy and safety of Resolute Integrity stent compared to other (drug eluting stents) DES.

Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.

Eligibility Criteria:
Inclusion Criteria:

* Patients with significant coronary artery disease and receiving Resolute Integrity stent.
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Patients with a mixture of other DESs
* Terminal illness with life expectancy \<1 year
* Patients presented with cardiogenic shock
Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis

The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary assessments on the effects of IFN-gamma 1b on lung function and other indicators of health will be made.


Eligibility Criteria:
* At least 6 years of age
* Diagnosis of cystic fibrosis (against certain criteria)
* Able to perform pulmonary (lung) function tests and participate in induced sputum procedures
* Pulmonary function values must meet certain minimal requirements
* Must have acceptable laboratory test results
* Cannot be on certain medications during and immediately prior to study
* Cannot have a history of unstable or deteriorating cardiac or neurologic disease
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. It is the most expensive healthcare condition to treat in United States and has a mortality rate of nearly 30%. It is widely known that exaggerated inflammation and imbalance between sympathetic and parasympathetic arms of the autonomic nervous system (ANS) contribute to progression and adverse outcomes in sepsis. The role of unchecked inflammation and unregulated ANS as a potential treatment target is an important gap in our knowledge that should be explored.

Cholinergic anti-inflammatory pathway (CAP) is an intricate network where the ANS senses inflammation by vagus nerve afferents and tries to regulate it by vagus nerve efferents to the reticuloendothelial system. The central hypothesis of this pilot clinical trial is that transcutaneous vagus nerve stimulation (TVNS) at tragus of the external ear can activate the CAP to suppress inflammation and improve autonomic imbalance as measured by inflammatory cytokine levels and heart rate variability (HRV) analysis. The investigators plan to randomize patients with septic shock into active and sham stimulation groups and study the effects of vagal stimulation on inflammatory cytokines, HRV and a clinical severity score of sepsis. Both groups will continue to receive the standard of care treatment for sepsis irrespective of group assignments. The investigators hypothesize that 4 hours of TVNS will suppress inflammatory markers and improve the balance between sympathetic and parasympathetic arms of ANS as measured by HRV, resulting in improved Sequential Organ Failure Assessment Score (SOFA). The preliminary data generated from this pilot study will lay the foundation for a larger clinical trial.


Eligibility Criteria:
Inclusion Criteria:

Septic shock (meeting severe sepsis and having persistent systolic blood pressure \<90mmHg despite adequate fluid resuscitation).

Exclusion Criteria:

* Unilateral or bilateral vagotomy
* History of myocardial infarction or stroke in the last 1 year
* Recurrent vasovagal syncope
* Sick sinus syndrome without pacemaker
* Bifascicular heart block
* 2nd or 3rd-degree heart block
* Hypotension due to autonomic dysfunction
* Pregnant women
* Prisoners and patients with suicidal ideation
Impact of Intracoronary Versus Intravenous Epinephrine Administration During Cardiac Arrest .

In hospital cardiac arrest (IHCA) is a major challenge imposed on almost all health care systems worldwide. Despite significant progress in cardiopulmonary resuscitation in the past few years, outcomes remain relatively poor with an approximate 49 % survival rate.

Epinephrine administration remains a cornerstone in the treatment of cardiac arrest. However, the preferred route of administration remains a matter of debate within the medical community .

Various routes of administration, including intravenous, intramuscular, intraosseous and endotracheal routes have been studied.

Initially, American guidelines for the treatment of cardiac arrest recommended injection of 0.5 mg of epinephrine directly into the right ventricle through the parasternal approach, aiming to achieve higher peak intracardiac concentrations and a more central effect, however the intravenous route remained preferable due to its feasibility and safety .

To our knowledge, intra-coronary epinephrine administration for intraprocedural cardiac arrest has not been evaluated or compared with other routes of administration.


Eligibility Criteria:
Inclusion Criteria:

* Aged above 18 years old
* Diagnosed with non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)
* Received dual antiplatelet therapy (acetylsalicylic acid and ticagrelor), or triple therapy (oral anticoagulant, acetylsalicylic acid and clopidogrel)
* Event of cardiac arrest during percutaneous intervention

Exclusion Criteria:

* cardiac arrest documented prior to being transported to cardiac catheterization laboratory.
* Patients who suffered cardiac arrest for less than 60 seconds were excluded from the study.
* Received mechanical circulatory support such as intra-aortic balloon pump, temporary percutaneous ventricular assist devices, or extracorporeal membrane oxygenation (ECMO) during hospitalization.
* Presenting with any cardiac rhythm on admission other than sinus rhythm or atrial fibrillation/flutter
* Signs of infection or a history of hepatic, oncologic or allergy to contrast media and end stage renal failure
* Patients who underwent primary fibrinolysis.
* Furthermore, patients who received atropine, amiodarone, lidocaine, or any other antiarrhythmic prior to CPR
* who received targeted temperature management post CPR .
The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic

This study will investigate the influence of needle gauge on pain during injection of local anaesthetic. Healthy volunteers will be recruited, who will each receive three injections with either 21G, 23G or 27G subcutaneously on the abdomen. After each injection, the participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain will decrease with decreasing thickness of the needle. The aim of this study is to find a simple method for pain reduction that can be used in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years

Exclusion Criteria:

* Kidney, heart or liver disease
* Eczema or psoriasis on injection site
* Neuropathy
* Regular use of painkillers
* Hypersensitivity of Lidocaine
* Pregnancy
* Diabetes
Comparison of the Results of Bronchoalveolar Lavage Culture and Endotracheal Aspirate Culture in Intubated Critically Ill COVID-19 Patients

Introduction: Secondary pneumonia is frequently seen in COVID-19 cases followed up intubated, and high mortality rates can be observed. Isolation of the agent with bronchoalveolar lavage (BAL) culture or endotracheal aspirate (ETA) culture may increase the success of treatment. This study aimed to retrospectively analyze the results of BAL and ETA cultures in intubated COVID-19 cases.

Methods: We routinely apply BAL culture with bronchoscopy or ETA culture within the first 48 hours after intubating. We retrospectively screened cases who underwent BAL and ETA. They were divided into two groups: Group B and E. Evaluated parameters were compared in both groups.

Results: Demographic data and blood test results were similar in both groups. Intensive care unit (ICU) and intubation durations, and culture positivity were statistically significantly higher in Group B. Although not statistically significant, the mortality rate was higher in Group E. The most growth microorganisms were Candida species.

Conclusion: Mortality rates were consistent with the literature. Since the microorganism isolation rate is higher with BAL and antimicrobial treatment is applied more effectively; early deaths were prevented and stay periods were prolonged. In contrast, these durations were shorter in the ETA group due to higher mortality. In intubated COVID-19 cases, a more effective treatment process can be carried out by clearing the airway with fiberoptic bronchoscopy and by specifically planning the treatment according to the BAL culture. This may have a positive effect on prognosis and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Intubated COVID-19 patients
* Above 18 years old patients

Exclusion Criteria:

* Non COVID-19 patients
* Non intubated COVID-19 patients
* Below 18 years old patients
Coronary Flow Reserve (CFR) in Cardiovascular Risk Stratification

CFR has been studied for few years using 82 Rubidium PET (positron emission tomography) /CT. CFR has shown to be correlated with cardiovascular events occurring in the 10 following years. CFR also helps to identify multivessel coronary disease. Few studies have shown the possibility to calculate CFR during myocardial perfusion SPECT on new ultrafast CZT cameras.

Evaluate the contribution of CZT SPECT CFR in cardiovascular risk stratification: correlation with clinical scores, with calcium score, and when pathological with coronarography findings especially fractional flow reserve (FFR).

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for myocardial ischemia screening

Exclusion Criteria:

* Patient already suffering from coronary disease with angioplasty, bypass surgery or myocardial infarction.
* Contraindications related to the stress test:

Acute Coronary Syndrome \<5 days Unstable angina Stenosis of left main artery untreated Uncontrolled severe rhythm disorders Uncontrolled heart failure

* Contraindications to dipyridamole and regadenoson:

Hypotension (systolic \<90mmHg) Severe pulmonary arterial hypertension Bradycardia \<40 beats / minute Sinusal Dysfunction and 2nd or 3rd degree Atrioventricular block Decompensated Heart Failure with Ejection Fraction \<25% Stenosis of supra-aortic trunks unilateral\> 70% or bilateral\> 50% Dipyridamole and regadenoson allergy

* Patients with pacemaker, or who have had valvular surgery,
* Well-known dilated cardiopathy
* Pregnant or breastfeeding women,
* Minor people
* Persons under guardianship or under guardianship
High Flow in Infants With Bronchiolitis

In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal Prongs in children \< 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea.

In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal Cannula with Low Flow Nasal Prongs in children \< 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea. The study will take place on the pediatric (Non intensive care) units of 5 different hospitals in the Netherlands.

Eligibility Criteria:
Inclusion Criteria:

* bronchiolitis PEWS (Pediatric Early Warning Score 0-28) \>= 6 oxygen saturation \< 92%

Exclusion Criteria:

* chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities
A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome After Radical Gastrectomy

1. Analysis of preoperative and postoperative metabolite changes: Through metabolomics technology, the changes of preoperative and postoperative metabolites in patients with gastric cancer complicated with metabolic syndrome were systematically analyzed, and the key metabolites related to the remission of hypertension, hyperlipidemia, and diabetes after surgery were found.
2. Explore the influencing factors of postoperative remission of metabolic syndrome: Combined with clinical data, the association between various metabolites and the degree of postoperative remission was evaluated, and the main factors affecting postoperative remission were determined.
3. Reveal the mechanism of postoperative remission of metabolic syndrome: through multi-level metabolomics analysis, to clarify the metabolic pathways and mechanisms involved in the process of postoperative remission, and provide a new theoretical basis for the development of tumor metabolic surgery.

This project will last 2-3 years. All patients who meet the inclusion and exclusion criteria will be divided into three groups according to the type of metabolic syndrome, including hypertension, diabetes and hyperlipidemia, with 50 cases in each group. Blood and feces of all patients were collected before surgery, 3 days after surgery, 6 months after surgery, and 1 year after surgery. The collected samples will be subjected to untargeted metabolomics analysis, using NMR-IVDr technology to detect the dynamic changes of all small molecular metabolites (mainly endogenous small molecular compounds with relative molecular weight within 1000 Da) in blood and feces before and after stimulation or disturbance without bias. The differential metabolites of blood glucose, blood lipid, cholesterol, insulin, renin, aldosterone, and angiotensin were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the potential physiological mechanism of postoperative hypertension, diabetes, and hyperlipidemia

Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>18 years old. 2. Patients with hypertension or diabetes for more than 1 year before surgery. 3. Patients undergoing radical gastrectomy for gastric cancer.

Exclusion Criteria:

* 1. Gastric stump cancer. 2. Patients with distant metastasis. 3. Patients who underwent combined resection of other important organs. 4. Severe postoperative complications. 5. Patients who are using drugs that may significantly affect metabolic status (such as hormonal drugs, potent immunosuppressants, etc.). 6. Incomplete clinical data.
Post Stroke Epileptic Seizures Risk Forecast

Improve the effectiveness of treatment and prognosis in patients with cerebrovascular accident by early detection of the risk of developing epileptic seizures.


Eligibility Criteria:
Inclusion Criteria:

* informed consent to participate in the study signed by the patient / relative of the patient / the legal representative of the patient
* age over 18 years
* stroke, confirmed by neuroimaging
* light to moderate stroke (score on National Institutes of Health Stroke Scale).

Exclusion Criteria:

* recanalization therapy
* previous epileptic seizures and history of epilepsy
* psychiatric diseases in history
* previous stroke
* traumatic brain injury
* brain tumors.
* inflammatory and infectious diseases
* decompensated physical illness.
* pregnancy.
Lipidome and Microbiome Profile of Acne

Lipidome and microbiome analysis in subjects with acne on doxycycline. Investigators will look at the skin lipidome, blood lipidome, gut micro biome and skin micro biome.

Investigators will look at the changes between acne subjects and control participants, but also the changes that occur after the use of antibiotics and how this is altered.

We will look at acne subjects, and controls.

We will look at four things

1. skin lipidome
2. skin microbiome
3. gut microbiome
4. blood lipidome

Investigators will assess this in acne participants before and after doxycycline and compare them to controls.

Eligibility Criteria:
Inclusion Criteria:

* Aged 15 and older
* Subjects/parents/legal guardian is able to read and comprehend study procedure and consent forms.
* Have already been prescribed Doxycycline by their physician for acne or to be eligible to be prescribed Doxycycline for acne
* Have acne that is diagnosed by a board certified dermatologist.

Exclusion Criteria:

* Those who have received systemic antibiotics within four weeks of starting the study.
* Those who have received systemic isotretinoin within six weeks of starting the study.
* Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
* Those who are pregnant, prisoners or cognitively impaired.
* Those subjects who are currently using proton pump inhibits (as studies have shown this may impact the gut microbiome) (4)
* Those who have a BMI greater than \>30 kg/m2, as studies have shown a reduction in the variability of intestinal microbes within this population (5).
* Those who have initiated or changed brand of oral contraceptive pill within 4 weeks of starting the study.
* Those who have autoimmune disorders as this group has been shown to have an altered microbiome (6)
* Those who have diabetes (6), immunodeficiencies (7), inflammatory bowel disease (6), hypercholesterolemia, as these groups have been shown to have altered gut microbiomes
* Those who have taken oral probiotic supplements (8) within 4 weeks of starting the study
* Given the nature of the instructions that need to be adhered to for accurate collection of samples and this data, non-English speaking individuals will be excluded from this pilot study.
* Allergies to the tetracycline group of antibiotics
* Those who do not fit the inclusion criteria
The New Laryngeal Tube Suction-Disposable for Childrens

The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural changes in design. As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.

The LTS-D, is a second generation supraglottic airway device, made from the medical polyvinyl chloride introduce in 2005. It is used for maintaining the airway during spontaneous and controlled ventilation during general anesthesia . It has been advocated for prehospital emergency airway management and serves as a useful tool during failed intubations The LTS-D has recently undergone considerable changes in design based on clinical studies and investigators feedback. The new LTS-D is available to adult and pediatric sizes.For childrens the devices is presented in the size 3 for patients of \< 155 cm (\> 30 Kg.), the size 2.5 for patients 125-150cm. (20-30 Kg.), the size 2 for patients of 12-25 Kg, the size 1 for patients of 5-12 Kg and the size 0 for patients \< 5 Kg.

As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version.

The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.

Eligibility Criteria:
Inclusion Criteria:Pediatric patients, ASA I and II, normal airway, for minor elective surgery

Exclusion Criteria: Weigth \<10Kg or \> 30 Kg, known difficult airway, active esophagial reflux
Five and Ten Year Results of the CMK21 Hip System

Five and ten year results of the CMK21 Hip system

This study is being conducted to collect long term retrospective and prospective clinical and radiological data to evaluate the safety of revision rate and adverse events, and efficacy of clinical and patient assessment of the CMK21 hip stem in primary total hip arthroplasty.

Eligibility Criteria:
Inclusion:

* The patients enrolled in the study were already operated at the time of the screening.
* All the patients with osteoarthritis of the hip who received CMK21 hip stem between 2005 and 2007.
* Skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.