cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer

This phase II trial studies how well stereotactic body radiation therapy with HyperArc software technology works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To evaluate local control and toxicity of patients who receive escalated dose stereotactic body radiation therapy (SBRT) reirradiation with HyperArc for recurrent head and neck cancer (rHNC).

SECONDARY OBJECTIVES:

I. To evaluate the clinical benefit of HyperArc through the analysis of overall survival (OS), progression-free survival (PFS) and locoregional progression-free survival (LPFS).

EXPLORATORY OBJECTIVES:

I. To evaluate dosimetric data including dose to target and organs at risk (OAR).

OUTLINE:

Patients undergo treatment planning with both standard radiation treatment software and HyperArc software technology. The most optimal plan will be delivered to a total dose of 55 Gy in 5 fractions, given 2-3 times weekly.

After completion of study treatment, patients are followed up periodically for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery.
* History of radiation therapy for head and neck cancer with minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume.
* Estimated life expectancy \> 12 weeks.
* Karnofsky performance status \>= 70 (Eastern Cooperative Oncology Group \[ECOG\] 0-2).
* Maximum tumor, or tumor bed, diameter \< 5 cm.
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment.
* Ability to understand and willingness to sign a written informed consent.
Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation

Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients under invasive mechanical ventilation more than 24 hours and with a minimum of 48 hours of respiratory signals registered from the ventilator
* Diagnosis of COVID-19

Exclusion Criteria:

* less than 48 hours of data,
* age \< 18 years
* admitted from other centers under invasive mechanical ventilation.
19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease

This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.

Children and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel "free-breathing" technique that will eliminate the need for breath holds during MRI acquisition.


Eligibility Criteria:
Inclusion Criteria:

* 6-17 years old
* Non-smoker and non-vaper
* Cystic Fibrosis (CF) Group: must have a diagnosis of CF
* No use of supplemental oxygen
* They must be able to perform spirometry and have stable lung function (within 10% personal best in the last 6 months) and no exacerbations within the past 4 weeks
* Baseline forced expiratory volume in 1 second (FEV1) \>80% with ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung (FEV1:FVC) ratio \>0.7

Exclusion Criteria:

* Healthy volunteers: with any history of chronic lung disease (i.e. asthma)
* Active or former smoker with less than 1 year of quitting
* Unable to undergo an MRI of the lungs and chest because of contraindications, including:

  * Injury to the eye involving a metallic object
  * Injury to the body involving a metallic object
  * Presence of an implanted drug infusion device that is not MRI safe
  * Bone growth of fusion simulator
  * Presence of cochlear, otologic, or ear implant
  * Shunt (spinal or intraventricular)
  * Any implant held in place by magnet
  * Claustrophobia
* Unable to tolerate the inhalation of the gas mixture
* Facial hair preventing a tight fit of the mask used in the study
* Pregnancy
* Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies
The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study

The purpose of this study is to evaluate the safety and utility of using heliox gas in combination with nasal CPAP in premature infants. The investigators hypothesize that using heliox gas in combination with nasal CPAP will results in decreased early nasal CPAP failure requiring intubation and mechanical ventilation.

Introduction: In recent years there has been an increased use of nasal continuous positive airway pressure (nCPAP) in the management of premature infants with respiratory distress syndrome (RDS). The use of early nCPAP eliminates the need for endotracheal intubation and mechanical ventilation, and their associated morbidities. In clinical practice a significant number of extremely low birth weight (ELBW) infants with RDS fail nCPAP therapy within the first 72 hours of life and require rescue endotracheal intubation. The clinical factors resulting in nCPAP failure are hypoxemia, hypoventilation, muscular fatigue and/or apnea. Helium is a biologically inert gas that is used in medicine as a carrier for oxygen. Heliox (mixture of helium and oxygen) has been used safely in neonates for decades and its use has been consistently been shown to improve oxygenation, enhance ventilation and decrease the work of breathing. Prior studies using heliox in the management of premature infants with RDS have shown clear therapeutic benefits. The use of heliox delivered via a nCPAP device (Hx-nCPAP) has recently been reported in infants with bronchiolitis. Given the prior success of heliox in the management of RDS combined with the recent advent of Hx-nCPAP we intend to investigate the utility of Hx-nCPAP in reducing the incidence of early nCPAP failure in ELBW infants with RDS.

Research design: Prospective, open-label, randomized, pilot study comparing conventional nCPAP to Hx-nCPAP in the management of ELBW infants being treated with nCPAP for RDS.

Methods: All spontaneously breathing infants born at \< 30 wks estimated gestational age (EGA) admitted to the NICU at KMCWC with the diagnosis of RDS and on nCPAP since birth will be eligible for enrollment. Volunteer Infants will be randomly assigned to conventional nCPAP or Hx-nCPAP groups. Hx-nCPAP will be provided to the study group infants for the first 72 hours of life. Primary and secondary outcome measures will be compared between the heliox group and control group to determine if Hx-nCPAP results in a decreased incidence of early nCPAP failure and/or improved clinical outcomes when compared to conventional nCPAP.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 33 weeks
* Receiving CPAP from the time of delivery

Exclusion Criteria:

* Cyanotic congenital heart disease
* Congenital malformation
Postoperative Nasal Irrigation Using Mucolytic Agents

Nasal irrigation techniques have been used for many years and been shown to improve symptoms of rhinosinusitis. Although there is a wealth of literature available, establishing treatment protocols can be difficult because of the great variability in recommended composition (seawater or hypertonic or isotonic saline with or without additives) and irrigation technique (variations in pressure and volume). Nasal irrigation is also used in many centers as part of postoperative treatment protocols and in particular has been recommended following endoscopic sinus surgery (ESS). Nasal crusting and thick nasal discharge have a negative impact on these patients quality of life (QOL). At the time of our study, there are no studies comparing irrigation with mucolysis with saline irrigation following ESS. The investigators aimed to assess whether mucolysis is effective at improving patients QOL and reducing postoperative signs as assessed endoscopically.

The study will take place at Tel Aviv Sourasky medical center, otolaryngology outpatient clinic, a tertiary care academic hospital, for two years. It will be double-arm, open label, randomized controlled trial comparing two different methods of medical therapy following ESS. The allocation ratio is intended to be approximately equal for each arm. The two arms consisted of: a control arm (group A) of generic saline irrigation alone, irrigating with 20 mL per nostril tid for a total of 120 mL daily irrigation; and intervention arm (group B), which included generic N-Acetylcystine of 200 mg dissolved in 200 mL saline irrigated as per group A, 20 mL per nostril given tid daily (for a total of 120 mg). All medications will be used daily for the 3 months duration of the post-operative follow up. Patients will be instructed as to correct irrigation technique prior to discharge home from the hospital, and will be reminded of this technique at each postoperative clinic visit.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or over
2. Patient undergoing endoscopic sinus surgery

Exclusion Criteria:

1. Allergy to N-Acetylcysteine,
2. Any other nasal surgery performed concomitantly
3. Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) nasal pathology
4. Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
5. Unable to give informed consent due to mental impairment
6. Unable to adhere follow up or treatment.
7. Patients requiring any additional nasal sprays (e.g. steroid sprays)
Veteran Primers for CRC Screening

This is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening. This project is for the purpose of quality improvement and has been designated as non-research by the VHA Office of Primary Care, Improvement \& Innovation (VHA Program Guide 1200.21).

Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 4 and 8) to the following interventions:

1. Active arm: Primer

   1. Intervention Type: Other
   2. Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit receipt for annual CRC screening
2. Control arm: No primer a. Intervention Type: No intervention

Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)

Our primary outcome of interest is the return rate at three months post randomization. Our secondary outcome of interest is the return rate at six months post randomization. Enrollment in the trial will occur between May 1, 2021 and January 1, 2022.

Eligibility Criteria:
Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.

Inclusion criteria:

* Veteran
* Assigned to a primary care provider at the VA Puget Sound as of January 1, 2021
* At least 1 year of prior data available (evidence of at least one outpatient visit)
* Due for annual colorectal (CRC) screening

Exclusion criteria:

* Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.
* Not currently receiving hospice care
* No record of recent death in the administrative data.
* No history of CRC or history of prior colectomy.
Intraoperative Implementation of the Hypotension Probability Indicator

Reducing intraoperative hypotension using FlotracIQ with HPI software.

Intraoperative hypotension occurs often. Even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia. Currently treatment of these hypotensive episodes is not proactive. Edwards Lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. Hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours
* Planned to receive general anaesthesia
* Planned to receive an arterial line during surgery
* Aim for MAP of 65 mmHg during surgery
* Being able to give written informed consent prior to surgery

Exclusion Criteria:

* Aim for MAP other than 65 mmHg at discretion treating physician
* Significant hypotension before surgery defined as a MAP \<65
* Right- or left sided cardiac failure (e.g. LVEF\<35%)
* Known cardiac shunts (significant)
* Known aortic stenosis (severe)
* Severe cardiac arrhythmias including atrial fibrillation
* Requiring dialysis
* Liver surgery
* Vascular surgery with clamping of the aorta
* Perioperative Goal Directed Therapy (PGDT) protocol
Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

This study intends to reconstruct intestinal micro-ecology through fecal Microbiome transplantation (FMT) technology, to treat patients with type 1 diabetes, and combine intestinal Metagenomics and 16s rRNA sequencing technology to study the relevant mechanism of intestinal micro-ecology for the treatment of type 1 diabetes.

Type 1 diabetes is an organ-specific autoimmune disease based on islet beta cell-specific destruction and absolute insulin deficiency. Studies on the pathogenesis of intestinal flora and type 1 diabetes have shown that as an "endocrine organ", intestinal microbes play an important role in regulating the secretion of the body. Bacteria in the intestine can not only directly synthesize hormones or hormone-like compounds, but also regulate the synthesis and secretion of corresponding hormones in the widely distributed intestinal endocrine cells, thereby participating in the regulation of various biological functions in the human body. This study uses fecal microbiome transplantation (FMT) to explore another potential treatment for type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* (1) Type 1 diabetes patients.
* (2) Age between 18 and 65 years old, regardless of gender.
* (3) No serious comorbidities.
* (4) Accept and suitable for endoscopic catheterization (TET) and fecal transplantation (FMT).
* (5) Can receive follow-up and follow-up examinations on time. (6) Subjects need to sign an informed consent form.

Exclusion Criteria:

* (1) Systematic application of glucocorticoids, other immunosuppressive drugs or biological immune modulators, antibiotics, probiotics, and other microecological agents to alter intestinal motility within 6 months prior to enrollment.
* (2) An infection that is active.
* (3) Combined with irritable bowel syndrome, inflammatory bowel disease, celiac disease, and other chronic gastrointestinal diseases, the condition has not been controlled.
* (4) Chronic diseases such as cerebrovascular disease, cardiovascular disease, and diabetic autonomic neuropathy.
* (5) Pregnancy or with a pregnancy plan
* (6) severe organ dysfunction (including decompensated cirrhosis, malignant tumors, etc.)
The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aim of this prospective study is to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.

In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days.But, eradication has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Vonoprazan is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs). Several studies previously suggested that vonoprazan containing antibiotic therapy was superior to other PPI-containing therapies for Hp. Most strains of Helicobacter pylori are sensitive to amoxicillin. Bismuth salts, a topical agent, which are available in our country, have a synergistic effect on antibiotics and decrease the bacterial load. Therefore, the investigators performed a prospective, multi-center, randomized trial, to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.

Eligibility Criteria:
Inclusion Criteria:

* Helicobacter pylori infected patients comfirmed by 13C/14C UBT
* age 18\~65

Exclusion Criteria:

* prior Hp eradication therapy including amoxicillin and clarithromycin
* previous gastric resection
* allergic to the drugs used in this study
* previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
* Patients who were pregnant or lactating
* Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy#diabete mellitus, hypertension...) effect the evaluation of this study
* Can't express the complaint correctly
Safety and Efficacy Study of Mix Vaccine in Pancreatic Carcinoma Patient

The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.

Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients diagnosed with pancreatic carcinoma based on histology
* 2.Evaluable lesions on imaging study
* 3.Without known immunodeficiency
* 4.Age \>18 and \<80 years ago

Exclusion Criteria:

* 1.Patients is unable or unwilling to sign informed consent
* 2.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
* 3.Positive HIV and/or RPR (rapid plasma reagin)
* 4.Female patient who is pregnant or breast feeding
* 5.Patients, based on the opinion pf the investigator, should not be enrolled into this study
* 6.Prior anti-cancer vaccine or biological immunotherapy
* 7.Allergic to any known ingredient of the MV compound
Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study

This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of YVOIRE contour injected into the anteromedial malar region in subjects who have completed the LG-HACL014 study.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects who have completed the LG-HACL014 study
* Have anteromedial malar region volume loss at least a one-point worse on the MFAS compared with 2 weeks after treatment in the LG-HACL014 study
* Accept the obligation not to receive any other mid facial procedures or treatments during the study
* Signed informed consent
* Those who fall under one of the following 3 cases

  1. Males or females who are surgically sterile
  2. Post-Menopausal females who are above 45 years of age and 2 years after the last menstruation
  3. Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the repeat treatment of the investigational device to avoid pregnancy

Exclusion Criteria:

* Have a history of hypertrophic scars or keloids
* Other criteria as identified in the protocol