Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of coronary amphilimus-eluting stent in diabetic patients

Conditions: Coronary Artery Disease; Diabetes Mellitus

Summary: more recently a polymer-free drug eluting stent (amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. however, to date there are no direct comparisons of these two type of drug eluting stents.

drug eluting stent is the cornerstone of treatment in diabetic patients with coronary artery disease (cad) undergoing percutaneous coronary intervention (pci). however, there are a considerable number of patients who continue to have major adverse event despite this treatment. more recently a polymer-free drug eluting stent (amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. these more favorable effects translate into reduced event rates, but to date there are no existing data comparing directly the mid-long term effect of this new polymer-free drug eluting stent with the other drug eluting stents in a larger cohort of patients.

Eligibility criteria:
inclusion criteria: * diagnosis of insulin or non-insulin dependent diabetes mellitus treated from at least 1 month * if basal blood sugar at the admission is above 200 mg / dl or hemoglobin levels glycated\> 6.5% (\> 48 mmol / mol) exclusion criteria: * inability to provide informed consent or unable to guarantee the possibility of be contacted in the following 12 months; * age under 18 years or over 80 years

Keywords: polymer free drug eluting stent
utilization of different virtual reality experiences

Conditions: Surgery; Pain, Postoperative; Anxiety; Otolaryngological Disease

Summary: this trial studies differences between a mindfulness and a gaming virtual reality (vr) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.

optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. in addition to facilitating with postoperative pain control, vr may have a role in reducing preoperative anxiety. however, it is unclear whether different vr experiences may be more beneficial for different clinical applications. this study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different vr experiences. patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming vr experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing head and neck surgery * are able to provide informed consent exclusion criteria: * isolation precautions * active eye discharge * active nausea or vomiting * history of seizure, epilepsy, or hypersensitivity to flashing light * expected to have wounds or wound care that prevent comfortable and safe use of the vr headset
study of the intestinal microbiota of patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the term gut microbiota describes the entire intestinal microbial communities. studies have established the important role played by the gut microbiome in modulating vital functions of the healthy host. the physiological effects of the microbiota for the host are, for the most part, beneficial. in several pathologies, an imbalance in the composition of the microbiota has been demonstrated. systemic sclerosis is an autoimmune, disorder of the connective tissue, characterized by vascular lesions, immunological abnormalities, and fibrosis of skin and internal organs as in many inflammatory diseases, there are painful digestive manifestations in systemic scleroderma that affect up to 90% of patients. the exact pathophysiology of the digestive involvement in systemic sclerosis is uncertain. the digestive manifestations of systemic sclerosis are frequent and can affect the entire digestive system. however, there are few studies of the intestinal microbiota in this disease, which seems to be part of the same continuum of diseases with abnormalities of innate immunity. by analogy with chronic inflammatory bowel diseases, particularly crohn's disease, we have raised the question of the existence of dysbiosis during scleroderma which could lead to episodes of acute, severe and recurrent inflammation of the peritoneum under the influence of triggering factors. the long-term prospects would be to look for ways to prevent attacks or to treat them more rapidly and effectively by using therapeutic targets in the intestinal microbiota. the study population will be seen in the usual care setting, identically to all patients with systemic sclerosis treated in the department. in case of an inflammatory disease outbreak, and depending on its severity, the patient will be seen again in consultation or hospitalized. appropriate complementary examinations (biology, imaging, endoscopy) will be carried out and the treatment adapted.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patient with a confirmed diagnosis of systemic sclerosis according to international criteria, before or after the start date of this study. * non-opposition of the patient exclusion criteria: * subject under guardianship, curatorship or safeguard of justice * subject with state medical aid (ame) * subject does not speak french * subject unable to answer questions or express himself/herself * taking antibiotics or a colonic preparation within 6 weeks prior to stool collection will be a temporary contraindication to stool collection. the patient may be included, other usual care samples may be taken, but the stool sample will be deferred and taken at a later date.

Keywords: gut microbiota systemic sclerosis
acute concussion therapy intervention training in healthy and concussed participants

Conditions: Cerebral Concussion

Summary: healthy (non-injured) and concussed college-aged participants will complete two testing sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a progressive exercise session to establish symptom exacerbation or maximal exercise capacity. individuals randomized to the control group will receive no intervention between sessions, while individuals randomized to the intervention group will complete 30 minutes of stationary bike exercise at least 3 days/week.

healthy and concussed participants will be randomized to active training (intervention) or control (no intervention) groups. participants, regardless of group assignment, will receive clinical symptom, balance, and cognitive evaluations as well as a progressive exercise assessment at study outset. concussed participants will enroll into the study within three days of injury and study participation will termination following 24 consecutive hours with no reported concussive symptoms. healthy participants will have arbitrary start dates and will terminate the study 10-14 days later to approximate the general length of concussion recovery and, therefore, make the time between session in the healthy and concussed cohorts as equivalent as possible. participants in the intervention group will complete stationary cycle ergometer workouts for 30 mins at least 3 days per week between testing sessions. healthy participants will complete six active training sessions, while concussed participants will complete active training at least three days per week until asymptomatic. concussed control participants will follow physician guidelines for rest and activity, while healthy control participants will be asked to follow their typical routines for rest and activity. participants will repeat the identical testing session assessments prior to study termination.

Eligibility criteria:
inclusion criteria: * diagnosed as having a concussion by a physician within three days of study enrollment (concussed participants only) * glasgow coma scale \>13 (concussed participants only) * participants must be active, which is defined as 30 or more minutes of moderate to vigorous physical activity 3 or more days per week. all healthy participants must met this definition and concussed participants should have met this definition prior to injury. * good cardiovascular health (subject to approval from study physician) exclusion criteria: * recreational drug use over the course of study participation * associated injuries (broken bones, etc.) that would limit the ability to successfully complete active training * for healthy participants, no history of concussion within the last year * for concussed participants, skull fracture or brain bleed at time of the injury * unc varsity athletes

Keywords: concussion exercise
efficacy and safety study of nab-paclitaxel combined with cisplatin in second or later-line treatment in advanced biliary tract cancers

Conditions: Advanced Biliary Tract Cancers

Summary: to verify the role of nab-paclitaxel in second or later-line treatment in advanced biliary tract cancers, the investigators designed a prospective, exploratory, single arm,single center phase ii trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as second or later-line treatment in advanced biliary tract cancers.


Eligibility criteria:
inclusion criteria: * age ranges from 18 to 75 years * radiographically, histologically or/and cytologically diagnosed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer. * received at least one first-line systemic treatment for advanced or metastatic diseases and failed, with imaging evidence of disease progression. * ecog performance status 0-1 * according to the recist1.1 standard, at least one measurable objective lesion should be judged. * expected survival more than 12 weeks * the laboratory test meet the following requirements: bone marrow function: neutrophils ≥ 1.5×10(9)/l, platelets ≥ 100×10(9)/l, hemoglobin ≥ 90 g/l liver function：total bilirubin ≤ 1.5x uln；ast and alt) ≤ 2.5x uln renal function：cr ≤ 1.5x uln，ccr ≥ 45 ml/min coagulation function：inr≤1.5×uln, pt≤1.5uln, aptt within the normal range * not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver). * during the non-lactation period, contraceptive measures should be taken in patients of child-bearing age during this trial. the test ofβ- hcg was negative. * the patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form exclusion criteria: * with chemotherapy contraindication, known to be allergic, highly sensitive or intolerable to research-related drugs or excipient. * pregnant or lactating women. * refuse or fail to sign informed consent to participate in the trial * grade 2 or above peripheral neuropathy or hemorrhage according to nci ctcae 4.03 * combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(bp≥160/95mmhg), unstable angina, a history of myocardial infarction in the past 6 months,congestive heart failure\>nyha grade ii, severe arrhythmia, pericardial effusion, etc. * patients with severe systemic infections or other serious diseases. * combined with other primary tumors * patients not suitable for the group according to the judgement of the researcher, with mental disease. * patients with symptomatic central nervous system (cns) metastases who require radiotherapy, surgery or sustained corticosteroid use, and untreated brain metastases that cause any symptoms * prior exposure to nab-paclitaxel * the investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent.
influenced the type of laryngoscopy the intraoperative nerve monitoring during thyroid surgery

Conditions: Thyroid; Airway Morbidity

Summary: a randomized controlled prospective study of laryngoscopy and evaluation of the intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the c-mac videolaryngoscope.

intraoperative nerve monitoring (ionm) is used in addition to the visual the nerve in thyroid surgery. here, the ionm can be done by placing electrodes on an endotracheal tube. in order to guarantee a sufficient signal quality of the ionm, the electrode must be adequately positioned on the glottis. the present study pursued the question of whether the conventional direct laryngoscopy compared with video laryngoscopy allows a visually adequate tube placement.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years no concurrent participation in another study * capacity to consent * present written informed consent of the research participant * elective surgery under general anesthesia exclusion criteria: * age \<18 years * existing pregnancy * lack of consent * inability to consent * emergency patients * emergency situations in the context of a difficult airway management * asa classification 4 * situations where the possibility of accumulated gastric contents * participation in another study

Keywords: intraoperative nerve monitoring, airway management
correlation between rmi of degenerative disk disease and reduction of pain after disk-infiltration treatments

Conditions: Discopathy; Lumbago

Summary: the primary objective of the study is to demonstrate the difference in the reduction of pain at 1 month after intradiscal infiltration of corticosteroids depending on symmetrical or asymmetrical active discopathies with mri examination. the difference should be judged significant if it ⩾ 2 points.

as secondary objective, the study aims to study the correlation between pain reduction which will be assessed by numerical scale at 1 month and 6 months after intradiscal infiltration of corticosteroids and following parameters: the duration of chronic lumbago, the presence of associated root pains, the morphological characteristics with rmi examination of active discopathies, the co-existence of scoliosis, the sign of inter-somatic instability, the muscular trophicity of muscle erector of low back, the pelvic incidence, degree of lumbar lordosis, cobb angle, wearing a corset.

Eligibility criteria:
inclusion criteria: * age ⩾ 18 years. * chronic growing lumbago with duration \> 3 mois. * disabling lumbago with an average ⩾ 4/10 defined by numerical scale. * common chronic low back pain that has been evolving for more than 3 months. * disabling lumbalgia defined by an average numerical scale greater than or equal to 4/10 in the month preceding the inclusion. * failure or intolerance to drug treatments (nonsteroidal anti-inflammatory drugs and systemic corticosteroids). * absence of biological inflammatory syndrome. * recent mri of less than 6 months with active disc disease (modic 1) defined by degenerative disc disease associated with mirror rearrangements of the subchondral bone of the adjacent vertebral endplates in hyposignal t1 and hypersignal t2. * signed informed consent obtained. * affiliation to social security. exclusion criteria: * pregnancy woman. * immunosuppression. * history of allergy to iodinated contrast agents and / or prednisolone acetate. * local or general infection. * fever (temperature\> 38). * history of disc surgery of less than 6 months. * history of infectious spondylodiscitis. * unbalanced psychiatric disorders. * severe coagulation disorders or impossible cessation of anticoagulation or anti platelet aggregation. * impossibility to obtain signed consent form. * patient under guardianship and/or curatorship.

Keywords: discopathy chronic lumbago degenerative modic 1
community-based health coach to improve access to germline genetic testing among african american men with prostate cancer

Conditions: Prostate Carcinoma

Summary: this clinical trial studies barriers to genetic testing in african american men with prostate cancer and whether tailored, culturally relevant genetic testing education provided by a community-based health coach is beneficial in improving knowledge, attitudes, and awareness of genetic testing. information gained from this study, may help researchers better understand and learn more about how to increase access to germline genetic testing in underrepresented populations.

primary objective: i. to assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach. secondary objective: i. to assess decisional conflict among african american men receiving tailored education strategies and culturally relevant cancer resources on genetic testing delivered by a community-based health coach. tertiary objective: i. to assess the germline mutation rate among african american men with prostate cancer. outline: patients are assigned to 1 of 2 cohorts. cohort a: patients complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. patients may also undergo genetic testing. cohort b: patients participate in educational session with health coach over 60 minutes. patients also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. patients may undergo genetic testing.

Eligibility criteria:
inclusion criteria: * age \>= 18 years old * speak and read english * have no known cancer risk genetic mutation * self-identify as black or african american * self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per national comprehensive cancer network (nccn) guidelines exclusion criteria: * prior germline genetic test * age \< 18 years old * unable to read or answer forms
safety and efficacy study of icotinb in non-small cell lung cancer (nsclc) patients

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine whether icotinib is at least non-inferior to gefitinib in the treatment of advanced non-small cell lung cancer (nsclc) patients after one or two chemotherapies.

lung cancer is the rapidest increased type of cancer in china with over 5 times incidence rate increase during the past 30 years . it is the leading cause of death of cancer in man and 2nd in women. with the development of gefitinib and erlotinib, egfr-tki (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for nsclc patients in asia including china. icotinib is a novel egfr-tki developed by a group of chinese scientists and clinician. it appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase i/ii trials. in this study, a randomized, double-blind, gefitinib as control, multi-center phase iii trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced nsclc patients after failure of 1 or 2 chemotherapy. pfs (progress free survival) is the primary end-point with os (overall survival), orr (objective response), ttp (time to progress), hrqol and safety as the secondary end-point. a total of 400 patients will be recruited. egfr and k-ras gene mutational analysis as well as a population pk study have also been proposed.

Eligibility criteria:
inclusion criteria: 1. confirmed nsclc with histology or cytology; advanced （iiib/iv). 2. must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =. exclusion criteria: 1. previous usage of egfr-tki or antibody to egfr: gefitinib, erlotinib, herceptin, erbitux.

Keywords: efficacy safety egfr-tki phase iii nsclc
open label study of long term evaluation against ldl-c trial

Conditions: Hypercholesterolemia

Summary: the primary clinical hypothesis is that long-term exposure of evolocumab (amg 145) will be safe and well tolerated in adults with hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * complete a qualifying evolocumab (amg 145) parent study protocol, including: 20101154 (nct01375777), 20101155 (nct01380730), 20090158 (nct01375751), 20090159 (nct01375764), and 20110231 (nct01652703) exclusion criteria: * experienced a treatment-related serious adverse event that led to investigational product (ip) discontinuation in the parent study * have an unstable medical condition, in the judgment of the investigator * known sensitivity to any of the products to be administered during dosing * currently enrolled in another investigational device or drug study (excluding evolocumab (amg 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Keywords: high cholesterol raised cholesterol cholesterol elevated cholesterol