Kornimate/medical-research-clean huggingface dataset:
deep learning based mri radiomics in predicting the clinical risk of locally advanced rectal cancer

Conditions: Locally Advanced Rectal Carcinoma

Summary: neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by mri in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. this study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. in order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment.

the patients with locally advanced rectal cancer were collected retrospectively, and the relevant information such as clinical baseline characteristics, imaging data and preoperative/postoperative pathological data were collected and integrated, applying the method of deep learning to construct the model, in order to predict and evaluate the risk factors (invasion of mesorectal fascia, status of cancer nodule, long-term prognosis, tumor recurrence, etc.) which are important in clinical diagnosis and treatment. after the model was established, prospective studies were carried out to validate the model, continue training and enrich the effectiveness of the model.

Eligibility criteria:
inclusion criteria: 1. primary rectal adenocarcinoma was diagnosed before operation 2. preoperative mri staging was diagnosed as stage ct4 rectal cancer 3. receiving neoadjuvant therapy before operation (including but not limited to chemotherapy, radiotherapy, immunotherapy or targeted therapy, etc.) 4. middle and low rectal cancer (the distance between the lower margin of the tumor and the anal margin ≤ 12cm measured by mri) 5. receive radical resection of rectal cancer exclusion criteria: 1. lack of clinical tnm staging information or other key clinical information about mri 2. the imaging quality is poor or the mri image has artifacts
a pilot study of additional chinese formula for concurrent chemoradiotherapy in oral cavity cancer patients

Conditions: Head and Neck Neoplasm; Chemoradiotherapy

Summary: the goal of this clinical trial is to learn about the clinical efficacy of san-zhong-kui-jian-tang (szkjt), a formula of chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (ccrt) treatments. the main questions it aims to answer are: * can szkjt improve the completion rate of ccrt? * can szkjt reduce the adverse effects of ccrt? * how szkjt affect the quality of life in the patients receiving ccrt * how about the safety of using szkjt in the patients receiving ccrt participants will be asked to: * take szkjt for 9 weeks during the whole ccrt course * take questionnaires of quality of life

san-zhong-kui-jian-tang (szkjt) is originated from the secret treasure of the orchid chamber written by gao li (ac1180 - 1251). szkjt contains 16 herbs to treat abnormal swelling or nodules. in the theory of chinese medicine, szkjt can clear heat and resolve toxin, which leads to disperse swelling and binds in nodules. the purpose of this study is to explore the clinical efficacy and safety of szkjt in improving the completion rate of concurrent chemoradiotherapy (ccrt) in patients with head and neck cancer, and to evaluate the prevention and treatment effects of szkjt on the side effects of chemoradiotherapy, as well as the improvement of quality of life. the primary endpoint of the study is the completion rate of ccrt under szkjt treatment. the secondary endpoints are adverse effects of ctcae, body constitution questionnaire (bcq) and the eortc core quality of life questionnaire (qlq-c30). liver and kidney functions are considered as well for adverse effects of szkjt. we hypothesized that additional szkjt with ccrt might improve completion rate of ccrt and reduce severity of adverse effects of ccrt.

Eligibility criteria:
inclusion criteria: * aged from 20- to 65-year-old; * firstly diagnosed as head and neck cancer with stage ii, iii or iv; * adjuvant therapy with chemotherapy of cisplatin or combined with radiotherapy after surgery; * or chemotherapy of cisplatin for those without surgery; * wiliness to sign inform consent. exclusion criteria: * pregnancy; * non-squamous-cell carcinoma; * secondary cancer or carcinoma in situ in 5 years; * any evidence of metastasis; * abnormality of liver, kidney or bone marrow functions before treatments; * unstable vital signs; * episode of acute infection; * unclear consciousness for inform consent; * receiving other herbal, complementary or acupuncture therapy.

Keywords: head and neck neoplasms; chemoradiotherapy complementary therapies medicine, chinese traditional
a study to compare the uptake into the blood of two strengths of somapacitan after injection under the skin in healthy subjects

Conditions: Healthy Volunteers; Growth Hormone Deficiency

Summary: this study will compare two strengths of the new long-acting growth hormone somapacitan. the aim of this study is to test if both strengths are taken up in the blood in the same way. during three separate dosing visits participants will get a total of 3 injections of the study medicine. somapacitan is not yet approved and therefore cannot be prescribed by a doctor outside of this study. the study duration is between 10 and 15 weeks. participants will have 17 visits with the study doctor. three visits will each comprise 6 in-house days with overnight stays. in total, at least 15 overnight stays at the clinic. there will be blood samplings during the study. participants must come to the clinic regularly for these blood samplings. people who have already received growth hormones in the past or who are growth hormone deficient cannot be in the study. people cannot be in the study if the study doctor thinks that there are risks for their health. women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-45 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 18.5 and 24.9 kg/m\^2 (both inclusive). * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * participation in any clinical trial of an approved or non-approved investigational medicinal product within 45 days or 5 times the half-life of the previous investigational medicinal product, whichever is longer, before screening. * body weight above 100.0 kg * subject with any known history of growth hormone deficiency as declared by the subject. * subject who is non-naïve to growth hormone treatment as declared by the subject.
biomarkers in acute abdomen

Conditions: Acute Abdominal Pain

Summary: background: in the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account. objective: to evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors. design: prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain. estimated duration: may 2015 - may 2016 location setting: emergency department (ed) of the hôpital universitaire pitié-salpétrière, paris, france. study population: 200 patients presenting to the ed with acute abdomen eligibility criteria: * inclusion criteria: presentation at ed with acute abdominal pain, aged at least 18 years * exclusion criteria: no informed consent, pregnancy, homeless, no social assurance procedure: patients presenting to the ed with acute abdominal pain will be included after informed consent is given. blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. all diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded final diagnosis and outcome will be assessed by 2-week-telephone interview. measurement of candidate biomarkers will be performed in collected material. copeptin and saa will be measured as potential biomarkers, as a control value, cortisol will be obtained. other biomarkers will be in consideration, depending upon availability and financial aspects. safety evaluations: all recommendations outlined in the ich guidelines for good clinical practice will be adhered to throughout this trial. sample size considerations: the number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency. significance of the study: if a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.


Eligibility criteria:
inclusion criteria: * presentation at ed with acute abdominal pain, aged at least 18 years exclusion criteria: * no informed consent, pregnancy, homeless, no social assurance

Keywords: acute abdomen pain stress biomarker
effects multi-gravitational suspension-based therapy

Conditions: Exercise

Summary: background: multi-gravitational suspension-based therapy (m-gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy. aims: to examine the effects of m-gravity exercise on posture, physical fitness, quality of life, depression, and sleep quality in women without regular exercise habits. methods: this study was designed as a non-randomized controlled trial. this study included 20 women without regular exercise habits, who participated in the exercise with m-gravity and 20 women who did not participate in any exercise program, a total of 40 participants. in this study, the investigators planned to evaluate the effects of m-gravity on women without regular exercise habits. the following outcomes were measured: posture with the new york posture assessment method, the flexibility of the hamstring and pectoral muscles, time is taken to stay in the plank position, depression levels with the beck depression inventory scale, sleep quality is performed with the pittsburgh sleep quality index, and the nottingham health profile (nhp) questionnaire to measure the perceived health levels of the subjects. the measurement of the contraction force of the deep lumbar muscles is performed with the stabilizer pressure biofeedback (chattanooga stabilizer). two evaluations were made before and after 4 weeks of exercise.


Eligibility criteria:
inclusion criteria: * sedentary women exclusion criteria: * individuals with a physical, cardiac, or neurological disease that may interfere with our practices and assessments * pregnancy and post-natal individuals * individuals with scoliosis of 20 degrees or more * glaucoma * recent surgery (3-6 months waiting period according to surgery) * hypertension, exercise in the head-down position can cause an increase in blood pressure and a hypertensive crisis * impaired cerebral circulation * botox treatment in the last 6 hours * spinal fractures * severe osteoporosis * sequestered disc herniation * spinal tumors * inflammatory conditions of the spine * head injuries * previous myocardial infarction * vertigo

Keywords: woman exercise posture physical fitness quality of life
comparison of age-related macular degeneration treatments trials: lucentis-avastin trial

Conditions: Age Related Macular Degeneration

Summary: the purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular amd with lucentis on a fixed schedule, avastin on a fixed schedule, lucentis on a variable schedule, and avastin on a variable schedule. a five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.

age related macular degeneration (amd) is the leading cause of severe vision loss in people over the age of 65 in the united states and other western countries. more than 1.6 million people in the us currently have one or both eyes affected by the advanced stage of amd. lucentis® is the most effective treatment for neovascular amd studied to date. bevacizumab (avastin®) and lucentis® are derived from the same monoclonal antibody. following the encouraging clinical trial results with lucentis®, several investigators began evaluating intravitreal avastin® for the treatment of cnv. given its molecular similarity to lucentis, its low cost, and its availability, the interest in avastin® has been considerable. avastin® has not been evaluated relative to lucentis®. in addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy. only a single eye in each patient was analyzed. at the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.

Eligibility criteria:
inclusion criteria: * active, subfoveal choroidal neovascularization (cnv) * fibrosis \< 50% of total lesion area * visual acuity (va) 20/25-20/320 * age ≥ 50 yrs * at least 1 drusen (\>63μ) in either eye or late amd in fellow eye exclusion criteria: * previous treatment for cnv in study eye * other progressive retinal disease likely to compromise va * contraindications to injections with lucentis or avastin

Keywords: bevacizumab ranibizumab choroidal neovascularization
2nd study to assess isv-305 compared to vehicle for treatment of inflammation and pain associated with cataract surgery

Conditions: Inflammation and Pain Associated With Cataract Surgery

Summary: the purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of isv-305 (dexamethasone in durasite® 2) compared to vehicle in the treatment of inflammation and pain associated with cataract surgery.

the purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of isv-305 (0.1% dexamethasone in durasite® 2) compared with vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.

Eligibility criteria:
inclusion criteria: * are at least 17 years of age * are scheduled for uncomplicated unilateral cataract surgery * signature of the subject or parent(s) or legally authorized representative on the informed consent form, and when appropriate the minor's assent in accordance with local regulations * are willing and able to follow all instructions and attend all study visits * are willing to avoid disallowed medication for the duration of the study * if female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study * male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility) * additional inclusion criteria also apply exclusion criteria: * have known sensitivity or poor tolerance to any component of the study drugs * have any sign of iritis or scleritis in the study eye * have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye * have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease) * have known blood dyscrasia or bone marrow suppression * have any active corneal pathology in the study eye * have had radial keratotomy, corneal transplant, or lasik in the study eye within the last 2 years * be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test * have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device * have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation * use of any medication the investigator feels may interfere with the study parameters * additional exclusion criteria also apply
endurant for challenging anatomy: global experience registry

Conditions: Abdominal Aortic Aneurysms With Challenging Anatomy

Summary: the department of vascular surgery at catharina hospital eindhoven, the netherlands initiates the endurant for challenging anatomy: global experience (eagle) registry. the aim of this study is to collect clinical information on the performance of the endurant stent graft system for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. this study aims at creating a database that can be pooled/ compared with the engage database. this study aims at answering two major questions: 1. is the technical success rate of successful delivery and deployment of the endurant (ii) similar in anatomically challenging aneurysm? 2. is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?


Eligibility criteria:
inclusion criteria: * age ≥ 18 years or minimum age as required by local regulations * indication for elective evar * challenging aaa anatomy * intention to electively implant the endurant or endurant ii stent graft system© * signed informed consent form exclusion criteria: * subjects with intolerance to contrast media * chimneys or fenestrated device procedures * high probability of non-adherence to physician's follow-up requirements * current participation in a concurrent trial that may confound study results
3,4-diaminopyridine use in lambert-eaton myasthenic syndrome(lems) and congenital myasthenic syndromes (cms)

Conditions: Lambert-Eaton Myasthenic Syndrome; Congenital Myasthenic Syndrome

Summary: the purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the lambert-eaton myasthenic syndrome (lems) and congenital myasthenic syndromes (cms).

this is an open-label, non-randomized, non-comparative expanded access study. up to 25 patients with clinically proven paraneoplastic or primary autoimmune lems per emg and positive voltage-gated calcium channel antibody serology, or patients with clinically proven cms per electromyogram (emg), biopsy or genetic testing who meet the selection criteria outlined in sections 3.1 and 3.2 will be enrolled in this study. subjects will receive 3,4-diaminopyridine (3,4-dap) starting with a low dose and titrating up per efficacy and patient tolerance to a maximum daily dose of 100mg . treatment will continue until the subject experiences a treatment-limiting toxicity, voluntarily withdraws consent, transfers to another site, dies, becomes lost to follow-up, is no longer receiving clinical benefit from 3,4-dap (in the opinion of the subject and/or the investigator), or the jacobus pharmaceuticals or the fda discontinues the study.

Eligibility criteria:
inclusion criteria: * lems diagnosis or pre or post synaptic cms diagnosis * 18 years or older * females must have negative pregnancy test and be willing to practice an effective form of birth control * no prolonged qt syndrome as indicated by baseline ekg exclusion criteria: * known sensitivity to 3,4-diaminopyridine * history of seizures and/or severe asthma

Keywords: lems cms 3,4 diaminopyridine 3,4 dap
triple therapy of dexamethasone, palonosetron, and fosaprepitant as ponv prevention

Conditions: Postoperative Nausea and Vomiting; Gynecologic Surgical Procedures; Laparoscopy

Summary: as a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron.

intervention 1. control group (dual therapy) study drug (placebo): normal saline 150ml dexamethasone 5 mg palonosetron 0.075 mg, 2. experimental group (triple therapy) study drug (fosaprepitant): resolved in normal saline 150ml dexamethasone, palonosetron 0.075mg,

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic gynecological surgery. * adults between the ages of 18 and 50 * american society of anesthesiologists physical status (asa physical status i, ii exclusion criteria: * american association of anesthesiologists physical standards (asa physical status iii or higher) * children under the age of 19 * adults over 49 years of age * diabetes mellitus * pregnant or lactating women * patients with a history of allergy or contraindications for use of the study drug * patients who did not understand this study or expressed their refusal. * patients with a history of serious psychologic disease that may affect the patient evaluation * patients taking serotonergic drugs

Keywords: ponv fosaprepitant dexamethasone palonosetron