Kornimate/medical-research-clean huggingface dataset:
a volume, motion, and anatomically adaptive approach to photon and proton beam radiotherapy

Conditions: Biopsy Proven Non Small Cell Lung Cancer; Head and Neck Cancer; Gastrointestinal Cancer; Colorectal Cancer; Rectal Cancers; Gynecological Malignancy Requiring Definitive Radiotherapy

Summary: this pilot study will determine changes over time in tumor volume/motion \& patient anatomy, as well as dose distributions to normal organs. the study will inform medical decision-making about need for (and timing of) re-calibration of radiation dosimetry plans. weekly ct and/or serial mr scans will be employed for those patients receiving 7-8 wks of radiation therapy. the study will enroll 30 patients in each stratum: non small cell lung cancer (nsclc), head \& neck, gastrointestinal (gi) and gynecologic tumor.

this is a pilot study to estimate the degree of tumor volume, tumor motion and patient anatomy change during treatment with photon or proton beam radiotherapy. patients will undergo simulation with an mr scan and/or ct scan per best clinical practices, and 4d imaging will be employed as indicated, at the discretion of the treating radiation oncologist. photon beam treatment plans and proton beam treatment plans will be generated from these images. based on the location of the primary tumor, patients will undergo either up to weekly 3d or 4d ct and/or serial mr scans during treatment. these images will be compared to the initial ct/mr scans used for treatment planning and analyzed for changes in tumor volume and tumor anatomic location. at the end of treatment, the frequent 3d or 4d ct and/or serial mr images will be compared to the initial treatment planning images to quantify the changes in tumor volume and tumor motion during the course of radiation treatment. each ct and/or mr scan will also be used to evaluate the changes in dose distribution to the target volumes and normal tissues that occur with the initial photon treatment plan and initial proton treatment. the changes in tumor volume, tumor motion and dose distribution during the course of radiation treatment will be analyzed to determine the effect of tumor changes on radiation treatment efficacy.

Eligibility criteria:
inclusion criteria: * aged 18 and above. * biopsy proven diagnosis of non-small cell lung cancer, small cell lung cancer, head and neck, esophageal, gastric, pancreatic, anal, hepatic, biliary, colorectal, cervical, endometrial, vaginal, vulvar, ovarian cancer and any other gastrointestinal or gynecological cancers requiring definitive radiotherapy alone with or without concurrent chemotherapy. * able to provide written informed consent and comply with all study procedures. * entire course of radiotherapy will be delivered at the university of pennsylvania perelman center for advanced medicine. exclusion criteria: - pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

Keywords: adult subjects nsclc
late-onset sepsis in term and pre-term neonates and infants up to 3 months of age

Conditions: Neonatal Sepsis

Summary: this study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (los). ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. it is approved for its use to treat adults and children with pneumonia in many european and non-european countries.

this is a multicenter, open-label, single-arm, multiple-dose study of intravenous (iv) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole). it may be combined with ampicillin and/or an aminoglycoside based on the investigator's judgement according to manufacturer's instructions and/or local standard of care. following screening, ceftobiprole will be administered as a 2-hour infusion at a dose of 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, depending on age and weight. the target treatment duration is 3-10 days, which may be extended to 14 days if considered clinically necessary by the investigator.

Eligibility criteria:
key inclusion criteria: * informed consent from parent(s) or other legally acceptable representative (lar) to participate in the study * male or female, with a gestational age of ≥ 24 weeks and a post-natal age ranging from ≥ 3 days to ≤ 3 months * diagnosis of documented or presumed bacterial los requiring administration of systemic antibiotic treatment * sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line key exclusion criteria: * refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment * proven ventilator-associated pneumonia * proven central nervous system infection (e.g., meningitis, brain abscess) * proven osteomyelitis, infective endocarditis, or necrotising enterocolitis * impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, or urinary output \< 0.5 ml/kg/h (measured over at least 8 hours), or requirement for dialysis * progressively fatal underlying disease, or life expectancy \< 30 days * use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication * participation in another clinical study with an investigational product within 30 days of enrollment in the current study

Keywords: late-onset sepsis neonates infants
shock wave vs. on-demand tadalafil for erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the objective of this study is to evaluate the effectiveness and safety of focused li-eswt on 25 participants complaining of ed compared to 25 participants complaining of ed on medical treatment on a prospective clinical trial for 12 weeks.

penile erection is a very complex process which requires a delicate and coordinated equilibrium among the neurological, vascular and the tissue compartments. it also includes arterial dilation, trabecular smooth muscle relaxation, and activation of the corporeal veno occlusive mechanism.erectile dysfunction is defined as persistent inability to achieve or maintain the erection that is sufficient to permit satisfactory sexual intercours. it has a multifactorial pathogenesis, one of them is vasculogenic ed that occurs due to diseases such as diabetes mellitus, hypertension, hyperlipidemia, smoking, or vascular occlusive disease. ed is also the most commonly treated sexual disorder and it affects approximately 20% of adult males over the age of 20. nowadays, there are several treatment solutions for patients with ed, either non-invasive or invasive but the phosphodiesterase 5 inhibitors are still the first-line therapy for ed. however, pde5-is effect is limited due to their inability to improve penile blood flow for a time period that is sufficient to allow optimal oxygenation and recovery of cavernosal vasculature. also, they cannot improve spontaneous erections. moreover, several patients ranging from 40% to 50% will not respond to drug therapy even after optimization approaches such as treatment combinations have been implemented. also, it was proven that the effect of long-term daily use of pde5-is on endothelial function has induced a short-term improvement in erectile function but probably not a longstanding one. another option for ed patients is the use of intracavernosal injections which is considered the second line of treatment. although pde5-is and intracavernosal injections are effective and safe vasodilating agents, they are unable to alter the underlying predominant pathology in patients with vasculogenic ed (eg, cavernosal artery insufficiency). other options include the use of intraurethral injections, or vacuum constrictive devices that could serve as salvage therapy for patients who failed to respond to pde5-is. if the previous options failed or not preferred by the patient, penile prosthesis implantation would be the last resort treatment for ed. many trials were done to find a new treatment modality that would provide a rehabilitative or curative effect for ed. this modality should affect the endothelial function and improve penile hemodynamics. one of these modalities was low-intensity extracorporeal shockwave therapy.

Eligibility criteria:
inclusion criteria: * male patients * ed at least for 6 months * vasculogenic ed * from 25-60 years old exclusion criteria: * psychological patents * neurological patients * younger than 25 years old * older than 60 years old

Keywords: erectile dysfunction shock wave clinical trial
evaluation system for the efficacy of immunologic checkpoint inhibitors in nsclc

Conditions: Non Small Cell Lung Cancer

Summary: inhibitors of programmed cell death protein 1 (pd-1) and programmed cell death ligand 1 (pd-l1) are effective therapies for metastatic nsclc lacking sensitizing egfr or alk mutations. first-line combination regimens that include a pd-1 or pd-l1 inhibitor may maximize the chance of response and lead to prolonged survival. pd-l1 expression is the only validated predictive biomarker for selecting pembrolizumab treatment. however, it is far from being the ideal biomarker and its role in predicting efficacy from icpis remains undefined due to conflicting results from randomized clinical trials. the selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs as well as to prevent inappropriate allocation of health resources. further studies are clearly needed to better understand the mechanism of action of immunotherapy in vivo thus allowing the identification of other predictive biomarkers. therefore, our research team intends to explore advanced non-small cell lung cancer treated with immune checkpoint inhibitors, by combining the evaluation criteria of solid tumor efficacy evaluation criteria (recist1.1), clinical pathological characteristics of patients, and dynamic monitoring of peripheral blood molecular biological markers, finding the correlation with the efficacy of immunotherapy, establish a detection mode for selecting patients with clinical benefits.


Eligibility criteria:
inclusion criteria: ages ≥18 years of age. histologically confirmed stage iiib-iv non-squamous non-small cell lung cancer. life expectancy of at least 3 months. exclusion criteria: * previous treatment . untreated cns metastases. active autoimmune disease. surgery or significant traumatic injury. active infection. history of allergy or hypersensitivity to immunotherapy components. women are breastfeeding or pregnant. requiring systemic treatment with either corticosteroids or other immunosuppressive medications.

Keywords: advanced lung cancer immunotherapy
heated breathing circuit on postoperative sore throat after double-lumen endobronchial tube insertion

Conditions: Lung Surgery

Summary: this investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing double-lumen endotracheal intubation.


Eligibility criteria:
inclusion criteria: * asa i-iii * patients scheduled for double-lumen endotracheal intubation exclusion criteria: * difficult airway * mallampatti scores greater than 2 * recent sore throat * cervical spine disease * recent upper respiratory infection * recent analgesics * history of head and neck surgery * friable teeth * multiple intubation attempts

Keywords: intubation pharyngitis
efficacy of fluoroscopy-guided epidural anesthesia for osteoporotic vertebral compression fracture treated by percutaneous vertebroplasty

Conditions: Vertebral Compression Fractures in Osteoporotic Patients

Summary: vertebral compression fractures in osteoporotic patients is a major healthcare problem. percutaneous vertebroplasty is commonly used to restore stability of the vertebra and to alleviate pain. however, the anesthetic techniques commonly used during these procedures such general anesthesia or a combination of local anesthesia and sedation are not satisfying as they are associated either with side effects or insufficient pain reduction. this study compares the standard procedure of local anesthesia to a new technique of fluoroscopy-guided epidural anesthesia carried out by the radiologist. the investigator's hypothesis is that fluoroscopy-guided epidural anesthesia * provides better pain relief during the injection of high viscosity cement * and thus, reduces the need of additional intravenous analgesia by remifentanil (morphine analogue) * minimizes remifentanil potential adverse effects such as respiratory depression, hypoxemia, pruritus and nausea * improves working conditions and satisfaction of the radiologist * improves the global satisfaction of the patient it is a monocentric, prospective, comparative and randomized study.


Eligibility criteria:
inclusion criteria: * - two osteoporotic vertebra compression fractures in the low thoracic or lumbar spine * men and women \> 18 years old * patients with healthcare insurance * signed and dated informed consent exclusion criteria: * men and women \< 18 years * pregnant or breastfeeding women * patients under trusteeship or guardianship or patients under the protection of court * bad comprehension or cooperation * bleeding disorders * local or general infection * intracerebral or severe cardiac affections
can we safely have our patients eat with cardiac catheterization - nix or allow: the chow now study

Conditions: Chest Pain

Summary: the purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). the study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.

for years it has been common to have patients fast before a cardiac catheterization. it is believed that fasting may lower the risks of upset stomach, vomiting, and aspiration (stomach contents going to the lungs). new findings show that fasting before the procedure may not be needed. this study will look at the safety and possible benefits of not fasting.

Eligibility criteria:
inclusion criteria: * subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients exclusion criteria: * subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery * pregnant women * prisoners
corpus callosum size in patients with pineal cyst

Conditions: Pineal Gland Disorder; Corpus Callosum Atrophy; Cerebral Palsy

Summary: this study aims to determine size of corpus callosum on midsagittal mr scan in patients with a pineal cyst and to compare it with the control group without a pineal cyst.

a pineal cyst (pc) is a benign affection of the pineal gland, its prevalence in population reaches 1-2 %. etiopathogenesis of pc is unknown, several hypotheses have been proposed. one of the hypothesis consider perinatal hypoxia as a causative factor for a development of pc in later life. ozmen et al. showed significantly higher prevalence of pc in patients with cerebral palsy (p\<0.001). bregant et al. studied presence of pc in patients that suffered from a mild to moderate perinatal hypoxia. prevalence of pc reached 36 % in these patients and presence of pc was associated with a atrophy of the corpus callosum (p\<0.005). the atrophy of the corpus callosum is considered to be a sign of a periventricular leukomalacia, i.e. an ischemic insult in a perinatal period. in the present study, we are going to compare an area of corpus callosum on a midsagittal magnetic resonance t2-weighted scan in the group of patients with pc and in the control group without pc. the goal of the study is to determine if there is a relationship between atrophy of the corpus callosum and pc. such finding would support abovementioned theory of etiopathogenesis of pc.

Eligibility criteria:
inclusion criteria: * 3t mr examination of the brain including t2 sagittal scans exclusion criteria: * other intracranial pathology discovered on the mr * other known neurological disease (e.g. multiple sclerosis, stroke, tumor, etc.)
capacity of amylose characterisation compare by immunohistochemistry and proteomic analysis

Conditions: Amyloidosis

Summary: amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. there are approximately 30 proteins involved in amylose's constitution. the therapeutic management varies depending on the type of amyloidosis observed. the application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa). in this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis. the purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.


Eligibility criteria:
inclusion criteria: * upper age to 18 years * amylose diagnosis establish by tissue sample, after "rouge congo" coloration * all patient with amylose identified by the two laboratory of anatomopathology * sample necessary for realized proteomic analysis * no opposition at the participation of the study * patient sign an informed consent for biology collection exclusion criteria: * tissue sample inadequate for apply immunohistochemistry or proteomic identification * patient trust, guardianship, under legal protection measure, deprived of freedom
gingival crevicular il-34 and csf-1 levels in patients with periodontitis and uncontrolled type 2 diabetes

Conditions: Periodontitis; Diabetes

Summary: type 2 diabetes mellitus is a metabolic disorder. there is a bidirectional association between periodontal disease and dm. currently there is no data relationship between csf-1 and il-34, periodontal disease and diabetes.the aim of this study to investigate gcf levels of il-34 and csf-1 in periodontitis subjects with diabetes.

periodontally healthy (h), periodontitis, and periodontitis with diabetes patients, were recruited for this study. 1. inclusion criteria for h groups: individuals with clinically healthy gingiva, no attachment and bone loss, and less than 10% bleeding on probing were included. 2. inclusion criteria for periodontitis groups: systemically healthy individuals with interdental cal ≥ 5 mm and ppd ≥ 6 mm were included. 3. inclusion criteria for periodontitis with diabetes groups: type 2 diabetes patients with interdental cal ≥ 5 mm, ppd ≥ 6 mm, and hba1c ≥ 6.5% were included. the plaque index (pi), gingival index (gi), presence of bleeding on probing (bop), pd, and clinical al were used for clinical periodontal assessments. all assessments were done with a manual probe. gcf samples were obtained and analyzed using an enzyme-linked immunosorbent assay.

Eligibility criteria:
inclusion criteria: * have 20 teeth * have diabetes . exclusion criteria: * individuals have systemic disease * smokers; * pregnant * those using drugs;

Keywords: diabetes, periodontitis cytokines
a study of evorpacept (alx148) in patients with advanced her2+ gastric cancer (aspen-06)

Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Summary: a phase 2/3 study of evorpacept (alx148) in combination with trastuzumab, ramucirumab, and paclitaxel in patients with advanced her2-overexpressing gastric/gej adenocarcinoma.

this is a randomized phase 2 (open-label) / 3 (blinded), international, multi-center study of patients with metastatic her2-overexpressing gastric/gej adenocarcinoma that has progressed on or after prior her2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy (2nd-line or 3rd-line). approximately 450 adult patients are expected to be enrolled in the study across both phases.

Eligibility criteria:
inclusion criteria: * her2-overexpressing advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma that has progressed on or after a prior her2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line) * adequate bone marrow function. * adequate renal \& liver function. * adequate performance status exclusion criteria: * patients with known symptomatic central nervous system (cns) metastases or leptomeningeal disease requiring steroids. * prior treatment with any anti-cd47 or anti-sirpα agent. * prior treatment with ramucirumab.

Keywords: alx148 cd47 sirpα gastric gastroesophageal gej her2 positive ramucirumab evorpacept
voglibose tablets 0.2 / od tablets 0.2 special drug use surveillance "long-term use in patients with impaired glucose tolerance"

Conditions: Impaired Glucose Tolerance

Summary: the purpose of this study is to determine the safety and efficacy of long-term use of voglibose (basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

this is a special drug use surveillance on long-term use of voglibose (basen) designed to determine the safety and efficacy of long-term use of voglibose (basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting. particioants will be patients with impaired glucose tolerance. the planned sample size is 1,000. the usual adult dosage is 0.2 mg of voglibose administered orally three times daily immediately before each meal.

Eligibility criteria:
inclusion criteria: * participants must meet all of the following criteria (\[1\] to \[3\]) to be included in this study: 1. determined as having igt (defined as fasting blood glucose \< 126 mg/dl and 2-hour post 75-g oral glucose tolerance test \[ogtt\] blood glucose of 140-199 mg/dl) without improvement despite treatment with diet therapy and exercise therapy for 3-6 months 2. meets any of the following conditions: (i) concurrently has hypertension\*1 (ii) concurrently has dyslipidemia\*2 (iii) is obese (bmi ≥25 kg/m\^2) (iv) has a family history of diabetes mellitus in relatives to the second degree as defined by japanese law\*3 3. regularly visits the study site and can be observed for 72 weeks * 1: hypertension: patients with systolic blood pressure ≥ 140 mmhg or diastolic blood pressure ≥ 90 mmhg, or patients on oral antihypertensive medication. * 2: dyslipidaemia: participants with any of the following conditions or participants on oral antidyslipidemic medication * hyper ldl cholesterolemia (fasting ldl-cholesterol ≥140 mg/dl) * hypo hdl cholesterolemia (fasting hdl-cholesterol \< 40 mg/dl) * hypertriglyceridemia (fasting triglyceride ≥150 mg/dl) \*3: relatives to the second degree of consanguinity refer to blood relatives who are the subject's "father or mother, grandfather or grandmother, brothers or sisters, children, or grandchildren." note that these do not include spouse's relatives. exclusion criteria: * participants meeting either of the following criteria (\[1\] or \[2\]) will be excluded: 1. previously diagnosed with diabetes mellitus 2. has any contraindications to basen as specified below: (i) severe ketosis, diabetic coma or precoma (ii) severe infection, perioperative state, or serious trauma (iii) history of hypersensitivity to any ingredients of basen

Keywords: drug therapy