cyrilzakka/clinical-trials huggingface dataset:
Combination of Sorafenib and Radiation for Brain Metastases and Primary Brain Tumors

Sorafenib™ has the potential to inhibit tumor growth, tumor angiogenesis , and enhance radiation response. This study will test the combination of Sorafenib™ and radiation therapy with or without temozolomide to determine tolerance of the combined treatments. Defining safe dosing of Sorafenib™ in this combination therapy will be achieved.

The current standard of care for patients with brain metastatic malignancies is to receive radiation therapy alone, while the standard of care for patients with high grade primary brain malignancies, astrocytomas, is to receive to receive concurrent temozolomide with radiation therapy. In this phase I study, based on the range of efficacy of kinase inhibitors and its ability to cross the blood-brain barrier we will conduct two parallel studies. The first is to combine sorafenib and radiation therapy for the treatment of patients with brain metastases and the second is to combine sorafenib with temozolomide for primary brain tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring a minimum 2-week course of radiation therapy
2. Age \> or = 18
3. All tumors of the central nervous system, or metastasis to the central nervous system.
4. Measurable disease preferred but not required for eligibility
5. Histologically or cytologically documented evidence of malignancy (for infratentorial and supratentorial glioma patients only).
6. Radiographic evidence of brain metastasis
7. ECOG performance status of 0 or 1
8. Life expectancy of \> or = 3 months

Exclusion Criteria:

1. Patients receiving chemotherapy or other investigational drugs must be discontinued 14 days prior to enrollment.
2. Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
4. Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
5. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
6. Active clinically serious infection \> CTCAE Grade 2
Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients

An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Of adult age (18 years or older)
* ICU patients in which enteral nutrition is planned to be initiated and are expected to stay at least 1 day in ICU on enteral feeding.
* Patients should be mechanically ventilated or have an endotracheal tube or tracheostomy in place.

Exclusion Criteria:

* Contra-indication for (re-) placement of nasogastric feeding catheters.
* History of gastric or esophageal surgery
* Any gastrointestinal surgery or trauma that could significantly increase the risk related to the investigational medical device in the opinion of the investigator
* Fed by mouth or enterally prior to inclusion
* Patient is moribund
* Known pregnancy or breastfeeding women
* Receives gastroprokinetic medication (e.g., erythromycin, metoclopramide, domperidone)
Roflumilast In-Vitro Basophil Release

This study is looking for allergic asthmatics. Lung and allergy testing will be done to verify. If qualified, blood will be drawn for laboratory studies.

Non-smoking allergic asthmatics will be verified using pulmonary function, skin prick testing, exhaled nitric oxide and serum IgE. If qualified, blood will be drawn, treated with study medication and then stimulated with the allergen to which the subject is allergic. Mediators including Histamine, IL-13, IL-4, and leukotrienes will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 and above Allergic Asthma Serum IgE greater than 30iu/ml Exhaled Nitric Oxide greater than 17ppb

Exclusion Criteria:

* smoking history
Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer

Exploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with SBRT in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (IC).

The question of how to administer adequate chemotherapy to synchronize SBRT treatment strategy to maximize the benefits of neoadjuvant therapy for improved prognosis of patients with borderline resectable (BRPC) and locally advanced (LAPC) pancreatic cancer is a challenging and debatable issue. No studies have yet evaluated the efficacy of split-course SBRT as the neoadjuvant chemoradiotherapy regimen. The investigators aimed to study whether neoadjuvant chemotherapy plus split-course SBRT results in better outcomes in BRPC and LAPC patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old and ≤ 70 years old.
* Histologically or cytologically confirmed adenocarcinoma of the pancreas.
* Borderline resectable or locally advanced pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines
* No prior chemotherapy or radiotherapy
* ECOG performance status of 0 or 1.
* Without distant metastasis
* The maximum diameter of the tumor must not exceed 5 cm
* Acceptable hematology parameters: a. Absolute neutrophil count (ANC) ≥1500 cell/mm3 b. Platelet count ≥100,000/mm3 c. Hemoglobin (Hgb)≥9 g/dL
* Acceptable blood chemistry levels: a. AST/SGOT and ALT/SGPT≤2.5× upper limit of normal range (ULN) b. Total bilirubin≤1.5 ULN c. Alkaline phosphatase≤2.5× ULN d. Serum albumin\>3 g/dL e. Serum creatinine≤1.5 ULN
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.

Exclusion Criteria:

* Age \< 18 years old and \> 70 years old. Prior anticancer therapy for pancreatic carcinoma.
* Presence of or history of metastatic pancreatic adenocarcinoma.
* Patients who had surgeries, chemotherapy, or other treatments before inclusion.
* Any other malignancy within 5 years prior to enrollment
* History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients.
* Peripheral sensory neuropathy Grade \> 1
* Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders.
* Pregnant or breast feeding.
* Patients enrolled in other clinical trials or incompliant with regular follow-up
* Unwillingness or inability to comply with study procedures.
Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study

This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data.

This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data. The objectives of this study are to establish the largest collection of explanted mesh materials in the country; demonstrate by common testing utilized by materials engineers, that in vivo exposure of mesh to the oxidants produced by phagocytosis may lead to chain scission, production of free radicals, and overall degradation of the material both physically and chemically; test mesh materials for a decrease in compliance, which would account for a tendency of mesh to stiffen while in the body reducing abdominal mobility and leading to chronic pain; characterize the histologic reaction of tissues to mesh; and utilize de-identified patient demographics to identify possible clinical characteristics which affect mesh degradation.

Eligibility Criteria:
Inclusion Criteria:

* Adults (persons 18 and older)
* Previous placement of hernia mesh material
* Current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure

Exclusion Criteria:

* No retained mesh prosthetic
* Non surgical candidate
Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety

The purpose of this protocol is to determine how band fill volumes that are based on intraband pressure readings can influence the comfortability of the band and to compare weight loss with this methodology to weight loss with the conventional approach recommended in existing product labeling.


Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend, follow and give informed consent.
* Be at least 18 years of age at time of trial enrollment.
* Had a pre-implantation BMI between 35 and 55 kg/m2.
* Have received a SAGB VC implant 1) 30-60 days (and not undergone first band adjustment yet)prior to the date of enrollment.
* Willingness to be randomized to intraband-based or conventional adjustments
* Willingness to consent to monthly visits and possible measurements of intraband pressure (requiring access to the injection port).
* Willingness to undergo up to 7 band adjustments within the 6-month period of the study.
* Able to sit approximately at a 90 degree-angle, from the floor, for IBP measurements.
* Willingness to return to office visits around the same time of the first in-study adjustment (plus or minus 2 hours)
* Willingness to consent to a limited UGI series if the investigator suspects the presence of a band-related complication or if the intraband pressure recordings deviate from expected.
* Willingness to refrain from taking medications or supplements indicated for or known to induce weight loss.

Exclusion Criteria:

* Females currently known to be pregnant.
* Ongoing or unresolved band perforation or band leakage.
* Ongoing (unresolved) slippage, erosion, or pouch dilation.
* Documented esophageal dysmotility/dyskinesia.
* Ongoing (unresolved) port obstruction or tube kinking.
* Current injection port infection.
* History of band revision or replacement.
* Previously documented or ongoing esophageal dilatation.
* Any condition that, in the opinion of the Investigator, may jeopardize the subject's well-being or the soundness of this study.
* Current use of medications or supplements indicated for or known to induce weight loss at any point during the study.
Further Validation of the Memory Orientation Screening Test (MOST):A 5-minute Screening Test for Dementia in Primary Care Practice

The purpose of this study is to apply a recently developed screening test for dementia, the Memory Orientation Screening Test (MOST) to two additional groups. Group one is composed of 150 elders who do not have dementia and are residing in the community so that we can determine what is a "normal" MOST score. These subjects will also be individually administered a one-hour battery composed of other commonly used tests of memory and information processing. Group two is composed of 150 elders who are administered the MOST by a nurse as part of their regular visit to the primary care doctor's office, and their scores will be compared against a rating of their cognitive ability made independently by the doctor or another nurse. Their scores will also be compared with a list of their medical problems and medications. Our hypothesis for the first group is that the MOST scores will be higher in the normal group than in the previous clinical groups and that MOST scores will correlate significantly with other neurocognitive tests. Our hypothesis for the second group is that the MOST can be administered quickly and easily by briefly trained nurses, that it will compare highly with doctor opinions, and that patients with known medical conditions related to dementia, such as hypertension or diabetes, will have lower MOST scores than patients in better health.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older

Exclusion Criteria:

* Younger than 65,
* diagnosed with dementia,
* blind,
* non-English speaking
Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia

cricopharyngeal achalasia refers to incomplete or non-open functional opening of the cricopharyngeal muscle, and after repeated swallowing of food, it still cannot pass through the cricopharyngeal muscle, remaining in the epiglottic valley and the piriform fossa, and even regurgitated into the nasal cavity . Neurogenic diseases, myogenic diseases and head and neck tumors are the common causes. Patients with chronic underfeeding lead to malnutrition, reduced quality of life, affecting the outcome of the disease. At present, the treatment measures for cricopharyngeal achalasia at home and abroad include balloon dilation technique, surgical incision, botulinum toxin injection. The dilation of the balloon is easy to cause mucosal edema and damage. Local infection, massive hemorrhage, local nerve injury and other complications often occur in cricopharyngotomy. Botulinum toxin injection relieves muscle spasms and is now widely used to treat dystonia. Common injection localization methods include CT, ultrasound, electromyography and endoscopy. Ultrasound-guided injection is a new technique of visualization, simple and non-radiation injection guidance, which can observe the injection process and drug injection position in real time. Fixation with a balloon can further improve the accuracy of the injection. In this study, botulinum toxin was injected into the cricopharyngeal muscle by ultrasound combined with balloon.

Under the ultrasound combined with balloon fixation, two injection sites were selected from the left upper esophageal sphincter, and 30U was injected respectively, and one injection site was selected from the right side, and 30U was injected. In addition, the patient also received routine swallowing training once a day for 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* The videofluoroscopic swallowing study (VFSS) confirmed that the cricopharyngeal muscle was not open/closed
* Patients with no significant improvement in swallowing function after more than 2 weeks of standardized rehabilitation therapy (FOIS unchanged or decreased)
* In the presence of swallowing initiation, VFSS is seen in swallowing with an upward motion of the hyoid greater than half the height of the C3 cone
* Vital signs stable, conscious, treatment cooperative
* The patient himself or his family members sign the written informed consent voluntarily

Exclusion Criteria:

* Patients with severe cognitive impairment, mental illness, and severe cardiopulmonary disease
* The structure of the throat is abnormal
* Malignant tumor patient
* Infection or wound at the injection site
* People allergic to botulinum toxin
* Bleeding tendency and coagulation disorder
Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.

Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 3-48 months (have not yet reached their fourth birthday); AND
2. Presence of 3 or more watery stools within 24 hours of screening; AND
3. Duration of vomiting or diarrhea less than 7 days; AND
4. Symptoms consistent with acute intestinal infectious process.

Exclusion Criteria:

1. Presence of an indwelling vascular access line; OR
2. Presence of structural heart disease excluding non-pathological heart murmurs; OR
3. Receiving immunosuppressive therapy or history of immunodeficiency; OR
4. Hematochezia in the preceding 48 hours; OR
5. Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); OR
6. Patients with known pancreatitis; OR
7. History of abdominal surgery; OR
8. Critically ill patients; OR
9. Family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; OR
10. Bilious emesis; OR
11. Probiotic use (supplement) in the preceding 2 weeks; OR
12. Oral or intravenous steroid use in the preceding six months; OR
13. Previously enrolled in this trial; OR
14. Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR
15. Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR
16. Not available for daily follow-up while symptomatic; OR
17. Parent/guardian not speaking English or Spanish; OR
18. Under 6 months old AND premature (\<37 weeks).
Regulation of Hepatic Insulin Extraction

* This study is in the area of Type 2 diabetes and genetics
* Healthy Volunteers and those with mild type 2 diabetes may be eligible to participate
* This study is searching for genes that may affect the body's processing/digestion of glucose/sugar

This study is looking at the genetic influences of type 2 diabetes. It also is investigating the various gastric hormones including but not limited to: insulin, C-peptide, GIP, GLP, \& Xenin.

Eligibility Criteria:
Inclusion Criteria:

* ages 18-65
* non-diabetic
* diabetes controlled with diet or with pills
* no family history of diabetes
* family history of type 2 diabetes
* personal history of gestational diabetes

Exclusion Criteria:

* \< 18 or \> 65 years of age
* medications that affect glucose (sugar) levels
* kidney disease
* liver disease
* heart/cardiovascular disease
The Neural Mechanisms of Imaginal Extinction

Imaginal exposure is a widely used and effective psychological treatment technique in which patients are exposed to fearful stimuli and situations using mental imagery. This study examines imaginal extinction, an experimental analogue of imaginal exposure that allows the study of this treatment technique under controlled circumstances. During imaginal extinction, conditioned fear is diminished through repeated exposure to mental imagery of the feared (conditioned) stimulus. The neural underpinnings of imaginal extinction is not known, and hence, this study examines neural activations during imaginal extinction using psychophysiology and brain imaging.

In this study, participants undergo threat conditioning to two pictures (CS+, CS-) in order to acquire a conditioned threat response. After this, the conditioned threat response is diminished through imaginal extinction (i.e extinction to the mental imagery of CS+ and CS-). Functional magnetic resonance imaging (7T) is used to measure neural activations during threat conditioning and imaginal extinction. Skin conductance is used to measure arousal response. Subjective fear and mental imagery vividness ratings will also be collected. In this way, this study aims to characterize the neural underpinnings of imaginal extinction.

Note that this study employs participants fearful of spiders. This is because data collection is shared with a related study (ClinicalTrials.gov ID 2020-06930a).

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent and complete study procedures
* Fear of spiders (due to data collection together with ID 2020-06930a)

Exclusion Criteria:

* Current psychiatric disorder other than spider phobia. Current use of psychotropic medication. Current neurological conditions. MRI-contraindications (i.e metal implants in skull).
Right Ventricular Outflow Tract Study

This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction prevention.

Ventricular pacing is unavoidable in many patients because of unreliable or absent AV conduction, or permanent AF. In recognition of this need, interest has focused on alternative site(s) ventricular pacing to maximize pumping function. These sites include the RV septum, His bundle, various LV sites, and combination of LV and RV (biventricular \[BiV\]). The RV outflow tract septum (RVOTs) seems to be the most promising site within the RV.

However, small enrollment and inconsistent experimental methods hinder the interpretation of these studies. Locations of alternative pacing sites were not clearly specified, were largely topographic, and lacked consistent anatomic designation. And what is more, there was no prospective, double-blind randomized, multi-center clinical trial which is design to test whether RVOTs pacing is superior to right ventricular apical pacing in preserving left ventricular systolic function and avoiding adverse left ventricular remodeling in patients with a normal left ventricular ejection fraction, ventricular synchrony and standard indications for pacing (sinus node dysfunction) in China. There was also no prospective, double-blind randomized, multi-center clinical trial which is design to test whether RVOTs pacing is not inferior to AAIR pacing in preserving left ventricular systolic function and avoiding adverse left ventricular remodeling in patients with a normal left ventricular ejection fraction, ventricular synchrony and sinus node dysfunction in the world.

So SJM China will sponsor a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction prevention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with only sinus-node dysfunction and meet pacing indication
* Patients with LVEF≥60% and with ventricular synchrony.
* Patients signed the written informed consent for the study
* Patients can endure the required follow up

Exclusion Criteria:

* Patients with atrial fibrillation
* Patients with atrial-ventricular block
* Patients with LBBB
* Patients with significant valvular disease
* Patients with severe hematopathy or severe renal inadequacy
* Patients with life expectancy \< 1.5 year
* Patients who are in the period of pregnant or lactation
* Patients who are younger than 18 years old
* Patients who are ongoing other devices or agents study
Transpyloric Feeding for Prevention of Micro-aspiration

To determine the effect of transpyloric (TP) feeding on microaspiration and lung inflammation in ventilated preterm infants.

Specific Aim 1): To determine the effect of TP feeding on microaspiration and lung inflammation. Hypothesis: TP feeding will reduce the microaspiration and pulmonary inflammation in ventilated preterm infants. Evaluate markers of microaspiration (pepsin A) and lung inflammation \[total cell counts, nuclear factor-kB (NF-kB) activation, tumor necrosis factor-α (TNF-α), IL-1β, IL-6, IL-8, angiopoietin 2 (Ang2), high-mobility group box-1 protein (HMGB1), macrophage migration inhibitory factor (MIF) and interferon-γ (IFN-γ)\] in TA samples obtained from preterm ventilated infants with and without TP feeding.

Specific Aim 2): To determine the effect of TP feeding on respiratory support. Hypothesis: TP feeding will decrease the respiratory severity score (RSS) \[Fraction of inspired oxygen (FiO2) X mean airway pressure (MAP)\] and number of infants requiring ventilator support. Evaluate respiratory support in preterm ventilated infants with and without TP feeding.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with birth weight \<1500 grams
* Requiring ventilatory support

Exclusion Criteria:

* Culture-proven sepsis
* Ventilator associated pneumonia (VAP).