Kornimate/medical-research-clean huggingface dataset:
study of nitazoxanide in adults with acute uncomplicated influenza

Conditions: Influenza

Summary: this is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a placebo in the treatment of acute uncomplicated influenza in adults. we hypothesize that treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. secondarily, we hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities, and viral shedding.

the study is conducted at approximately 25 sites in the united states. subjects selected based on symptoms will be randomized to receive oral nitazoxanide or placebo twice daily for 5 days. subjects will be monitored by daily by telephone or home visit to monitor symptoms and complications of influenza for safety and will be referred for medical care as required. subjects will complete a diary twice daily to record the presence and severity of symptoms, ability to perform normal daily activities and time lost from work. complications of influenza (including sinusitis, otitis, bronchitis, pneumonia, central nervous system disease) and other adverse events will be reported. nasopharyngeal swabs will be collected at baseline (day 0) and day 7 for all patients and on days 1 through 4 for a subset of patients to test for influenza a (including novel h1n1), influenza b and 17 other respiratory viruses by rt-pcr and culture and to evaluate quantitative viral shedding. the primary analysis will be for patients with confirmed influenza, and secondary analyses will be conducted for subjects with any respiratory virus and for all treated subjects.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years * fever, respiratory symptoms and constitutional symptoms compatible with influenza infection * influenza a or b infection in the local community * onset of illness no more than 48 hours before presentation * willing and able to provide comply with protocol requirements exclusion criteria: * severity of illness requiring or anticipated to require in-hospital care * high risk of complications from influenza per idsa (infectious diseases society of america) guidelines or current cdc (centers for disease control) criteria * females pregnant, breast-feeding or sexually active without birth control * vaccination for seasonal influenza or h1n1 on or after august 1, 2009 * treatment with antiviral medication for influenza within 1 month prior to screening * treatment with nitazoxanide or any investigational drug within 1 month prior to screening * known sensitivity to nitazoxanide or any excipients * unable to take oral medications * chronic kidney or liver disease or known impaired hepatic and/or renal function * other pre-existing chronic infection undergoing or requiring medical therapy * pre-existing illness placing subject at unreasonably increased risk by participation in study * unlikely to comply with the requirements of this protocol

Keywords: influenza influenza like illness
perioperative or adjuvant mfolfirinox for resectable pancreatic cancer

Conditions: Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Adenocarcinoma

Summary: the preopanc-3 study is a randomized, multicenter, phase 3 trial. patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mfolfirinox followed by surgery and 4 cycles of adjuvant mfolfirinox (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mfolfirinox (arm 2). the primary objective of the trial is to determine whether perioperative mfolfirinox improves overall survival compared with adjuvant mfolfirinox in patients with resectable pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically (bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma. * resectable tumor according to dutch pancreatic cancer group criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less * no evidence for metastatic disease * who performance status of 0 or 1 * ability to undergo surgery and mfolfirinox chemotherapy * leucocytes (wbc) ≥ 3.0 x 10\^9/l * platelets ≥ 100 x 10\^9/l * hemoglobin ≥ 6.0 mmol/l * renal function: egfr ≥ 40 ml/min * age ≥ 18 years * written informed consent exclusion criteria: * prior radiotherapy, chemotherapy, or surgery for pancreatic cancer. * prior chemotherapy precluding mfolfirinox. * previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pnet) \<2cm, and gastrointestinal stromal tumor (gist) \<2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion. * pregnancy or lactation. * serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Keywords: neoadjuvant therapy adjuvant chemotherapy oxaliplatin irinotecan leucovorin fluorouracil pancreatic neoplasms pancreatectomy
improvement of the safety of care in cataract surgery teaching on eyesi simulator (e3caps)

Conditions: Surgery-Complications; Cataract

Summary: the aim of this project is to reduce the risks of cataract surgery using the eyesi simulator axis 1: to model the learning curve of novice residents in ophthalmology who follow the training program recommended by the "collège des ophtalmologistes niversitaires de france" (couf) in order to help creating a "licence to operate" axis 2: to evaluate the impact of sleep deprivation on the surgical performance of experienced residents in ophthalmology

axis 1 (15 residents): learning curve each resident will perform four 2-hour learning sessions, under the supervision of an experienced cataract surgery trainer. each resident will perform a standardized assessment at the beginning of the first session with the collection of scores at each surgical stage and the calculation of an average score simulating a complete surgery. this standardized assessment will then be repeated at the end of each of the 4 training sessions. these five points of measurement will make it possible to produce a learning curve for each surgical stage and for the average score simulating a complete surgery. axis 2 (25 residents): sleep deprivation * 1st session: in order to include the "experienced" residents and to limit the bias related to the learning curve of the cognitive tests and the surgical procedure * 3 normed assessments in autonomy to determine the average score for each resident * 3 trials of the test for attentional performance (tap) with parallel versions to limit test-retest learning bias * 2nd session: no sleep deprivation * sleep assessment by actimetry the night before the session (motionwatch 8©, camntech®, validated as an alternative method to the reference method which is polysomnography) * epworth sleepiness score * visual analogue scale for self-rated fatigue * attentional performance tests tap * 3 standardized evaluations on eyesi in the morning and in the afternoon * 3rd session: sleep deprivation (\< 7 hours) after a working day * sleep evaluation by actimetry the night before the session (motionwatch 8©, camntech®) * epworth sleepiness score * self-rated visual analogue scale for fatigue * attentional performance tests tap * 3 eyesi standardized evaluations in the morning and in the afternoon

Eligibility criteria:
inclusion criteria: * novice resident in ophthalmology (axis 1) * experienced resident in opthalmology (axis 2 ) exclusion criteria: * n/a

Keywords: ophthalmologic surgical procedures cataract simulation training eyesi simulator learning curve sleep deprivation professionalism
self-managed intervention for anxiety in parkinson's disease

Conditions: Parkinson Disease; Anxiety

Summary: a mixed methods randomized controlled feasibility and acceptability study will be conducted to determine the effects of a self-managed, focused breathing intervention on anxiety in persons who have been diagnosed with parkinson's disease.

this study is being conducted to determine the feasibility and acceptability of using focused breathing as a self managed, non-pharmacologic intervention for anxiety experienced by those with parkinson's disease. participants meeting eligibility criteria will be randomized to either an intervention or control group. those in the intervention group will be taught how to perform focused breathing and asked to practice it twice daily for six weeks for a minimum of four minutes each time. anxiety, depressive symptoms, sleep, self-efficacy and quality of life with be measured in participants in both the intervention group before beginning to practice focused breathing as well as in the control group. after six weeks of practice the same measurements will be collected from the intervention group. additionally, intervention participants will participate in a brief interview at the end of their six weeks of practice. control group participants will be taught how to perform focused breathing six weeks at the end of a six week wait-period, following collection of data using the aforementioned measures..

Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease * hoehn \& yahr i, ii, \& iii * self report or clinical diagnosis of anxiety * ability to speak and read english exclusion criteria: * montreal cognitive assessment scores less than 26, indicating cognitive impairment * persons under the age of 18 are excluded from this study

Keywords: anxiety self-managed intervention focused breathing
pharmacokinetic study of bupropion hydrochloride products with different release patterns

Conditions: Depression

Summary: the objectives of this project are to determine if the bioavailability and release pattern of bupropion hcl products differ and if the genotype of the metabolic enzymes affects the saturation of intestinal enzymes with different dose strengths within one product line. findings from this project will help the fda center for drug evaluation and research's (cder) office of generic drugs improve policy development and review practice in the future for similar products, e.g. extended release oral drug products being metabolized in the gut wall and having multiple strengths. aim 1: to compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy individuals when they ingest different strengths of bupropion (75-300 mg) with variable release profiles (ir vs xl vs sr) in gi tract. working hypothesis: variation in release rate and mechanism of bupropion formulations in gastrointestinal (gi) tract will impact metabolism and saturation of bupropion in gi tract, which will generate different concentration of bupropion and its metabolites in plasma. aim 2: to investigate pharmacogenomics of cyp 2b6 that influences metabolism, saturation, and pharmacokinetics of bupropion working hypothesis: the gain of function of cyp2b6 variants (allele \*4 and \*22) in patients will increase the metabolism of bupropion in the gi tract and liver, reduce both local concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when bupropion is released earlier in gi tract


Eligibility criteria:
inclusion criteria: * healthy volunteers 25 to 55 years old. * volunteers have a body mass index (bmi), calculated from the ratio of height and weight, within a range of 18.5 to 35. * willing to be medication and supplement free 2 weeks prior to beginning study, and throughout the study. all forms of birth control are okay. exclusion criteria: * individuals unwilling or unable to comply with the study protocol (e.g. unable to remain medication or supplement free during the study). * individuals unwilling or unable to take bupropion or have an allergy to bupropion * any medical or surgical conditions which might significantly alter bupropion absorption (e.g., history of malabsorption, liver disease, gastric bypass surgery ) * individuals with a history of psychiatric or neurological illness, including seizure disorders * nicotine dependence * alcohol dependence * pregnant or nursing women
calcium electroporation for early colorectal cancer

Conditions: Colorectal Cancer

Summary: this is an explorative, phase i clinical trial. the aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery.

this is an explorative, phase i clinical trial. the aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation as a down staging and immune-response enhancing treatment prior to intended curative surgery. the study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. in total the study will involve 24 patients, of these, 12 patients with rectal cancer and 12 patients with sigmoid colon cancer. in relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment. patients will be followed for one month after the elective surgery.

Eligibility criteria:
inclusion criteria: * • patients must be mentally capable of understanding the information given. * patients must give written informed consent. * histologically verified adenocarcinoma of the rectum or sigmoid colon. * tumor described as passable at index endoscopy. * men or women aged at least 18 years. * case reviewed by mdt (surgery, radiology, oncology). case considered curable with standard surgical resection. * asa class i-ii (classification of the american society of anesthesiology) exclusion criteria: * • uncorrectable coagulation disorder. * highly inflamed gastrointestinal tissue which is ulcerated and bleeding * patients with icd or pacemaker units. * ongoing immunosuppressive treatment. * patients with concomitant use of phenytoin. * concurrent treatment with an investigational medicinal product. * patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. * advanced tumor stages, clinical uicc stage iv. * indication for neoadjuvant chemoradiation or chemotherapy prior to surgery * acute surgical resection. * pregnancy
comparison between injection molded peek framework and cobalt chromium framework in removable partial denture regarding retention

Conditions: Mandibular Prosthesis User

Summary: this study is aiming to evaluate the retentive forces in peek framework rpd compared to cobalt-chrome framework rpd during attachment/detachment cycles in mandibular kennedy class i edentulous cases


Eligibility criteria:
inclusion criteria: * . kennedy class i edentulous subjects indicated for framework partial denture exclusion criteria: * uncooperative patients and bad oral hygiene patients
effect of continuous glucose monitoring on hypoglycemia in adults with pancreatogenic diabetes

Conditions: Pancreatogenic Type 3C Diabetes Mellitus

Summary: this study will investigate the effect of continuous glucose monitoring (cgm) (compared to self-monitoring) on hypoglycemia and glycemic control in patients with insulin-treated pancreatogenic diabetes.

the use of cgm in people with type 1 or type 2 diabetes receiving multiple daily insulin injections improves glycemic control and reduces time spent in hypoglycemia compared to self-monitoring. these beneficial effects of cgm are likely also present in people with pancreatogenic diabetes but have only been sparsely investigated. in this study, the investigators, therefore, aim to investigate the effects of cgm (compared to self-monitoring) on hypoglycemia and glycemic control in patients with pancreatogenic diabetes. patients with chronic pancreatitis and insulin-treated diabetes will be randomized 1:1 to receive 50 days of cgm followed by 50 days of self-monitoring or vice versa. each study period is preceded by 20 days of masked cgm assessment, which also serves as the washout period between the two study periods. furthermore, the self-monitoring group will use masked cgm for the last 20 days of the study period to monitor glucose levels for comparison with the unmasked cgm period. thus, each study period lasts a total of 70 days. the investigators hypothesize that the use of cgm vs self-monitoring of blood glucose in patients with pancreatogenic diabetes will lead to decreased time spent with a glucose value \<3.0 mmol/l and increased time in glycemic range.

Eligibility criteria:
inclusion criteria: * signed informed consent before any study specific procedures * able to read and understand danish * male or female age ≥ 18 ≤ 85 years * a definitive diagnosis of chronic pancreatitis based on the m-annheim criteria * a diagnosis of insulin treated pancreatogenic diabetes based on the world health organization criteria for diabetes (hba1c ≥6.5 % (48 mmol/mol) and/or fasting plasma glucose ≥126 mg/dl (7.0 mmol/l)) \>3 months after diagnosis of pancreatitis exclusion criteria: * known or suspected abdominal cancer (incl. intestine, pancreas, and the hepato-biliary system) * severe pre-existing comorbidities (assessed by investigator upon inclusion) * attack of acute on chronic pancreatitis requiring admission within four weeks prior to inclusion * use of glucocorticoid medications within four weeks prior to inclusion, with the exception of inhaled glucocorticoids in the treatment of chronic pulmonary diseases. * presence of autoimmune antibodies suggestive of type 1 diabetes * prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or frey procedure) * prior gastric surgery or vagotomy * autoimmune pancreatitis

Keywords: chronic pancreatitis pancreatic diseases digestive system diseases diabetes continuous glucose monitoring
mechanism of aphasia and recovery of language after the injury of geschwind's territory: a study based on the brain network analysis

Conditions: AVM - Cerebral Arteriovenous Malformation; Language

Summary: at present, functional imaging studies have suggested that the geschwind's territory (the inferior parietal lobe) is an important language area. it is the hub for semantics and phonetic language processing. however, the type and mechanism of aphasia after injury of geschwind's territory and the subsequent recovery of language are still unclear. in our study based on brain injury model of brain arteriovenous malformation (bavms) resection, investigators found that the incidence of aphasia was higher after the injury of geschwind's territory than after injury of the classical language area, and the type of aphasia was complicated, while the recovery rate of language disorder was high during follow-up. investigators hypothesized that the type of aphasia may be associated with the type of brain connectivity damaged, and that reorganization of brain connections and brain network promote the recovery of language function. in this study, we aim to investigate the types of aphasia and their corresponding brain network changes after the resection of bavms located in the geschwind's territory. investigators will evaluate language function and collect multimodality images of the patients before resection of the lesions, as well as 7 days, 3 months and 6 months afterwards. in addition, the anatomical brain connectivity and brain network will also be analyzed. our research will not only be a meaningful exploration for mechanisms of human language function damage and reorganization, but will also provide an important basis for the protection of brain function in neurosurgery.


Eligibility criteria:
inclusion criteria: 1. signed the informed consent form; 2. the dominant hand is the right hand (evaluated by the edinburgh hand scale); 3. bavm located in the left inferior parietal lobe 4. no history of rupture and bleeding and neurosurgical treatment exclusion criteria: 1. there are implants in the body (cardiac pacemaker, artificial femoral head, etc.); 2. the dominant hand is unclear; 3. illiterate or other patients who can not cooperate well with cognitive function tests; 4. the history of bleeding in bavm patients within one month; 5. history of neurosurgical treatment.
a study of rvt-1401 in myasthenia gravis (mg) patients

Conditions: Myasthenia Gravis

Summary: the purpose of the current study is to assess safety/tolerability and key pharmacodynamic (pd) effects that are considered to be associated with clinical benefit (reduction of total igg and anti-achr-igg) in myasthenia gravis patients following treatment with rvt-1401 (also known as imvt-1401) compared to placebo.


Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age. 2. myasthenia gravis foundation of america (mgfa) class ii-iva and likely not in need of a respirator for the duration of the study as judged by the investigator. 3. qmg score ≥12 at screening and baseline. other, more specific inclusion criteria are defined in the protocol. exclusion criteria: 1. use of rituximab, belimumab, eculizumab or any monoclonal antibody for immunomodulation within 6 months prior to first dosing. 2. immunoglobulins given by sc, iv (ivig), or intramuscular route, or plasmapheresis/plasma exchange (pe) within 4 weeks before screening. 3. thymectomy performed \< 12 months prior to screening. 4. total igg level \<6 g/l (at screening). 5. absolute neutrophil count \<1500 cells/mm3(at screening). other, more specific exclusion criteria are defined in the protocol

Keywords: imvt-1401
comparison of dual assignment, cadence, and gait speed in alzheimer's dementia and healthy geriatric individuals

Conditions: Alzheimer Dementia

Summary: tests will be performed in individuals with alzheimer's dementia to compare dual-task and gait with healthy geriatric individuals.

in this study, it was aimed to compare double assignment, cadence and walking speed in alzheimer's dementia and healthy geriatric individuals. individuals who can walk independently and who are diagnosed with alzheimer's dementia over the age of 65 and healthy individuals will be included in the study. it will be done with 50 people who voluntarily participated in the research. as a data collection tool; the demographics formula with patient descriptive features is the timed get up and walk test to turn off double assignment, the 2 minute walk test to evaluate the advertisement, and the footprint method to use cadence. it will be assessed with the mini mental state test and the montreal cognitive assessment test to examine discriminative units.

Eligibility criteria:
inclusion criteria: * 65 years and older, * who volunteered to participate in the research, * able to walk independently, * he was diagnosed with alzheimer's by a physician for the experimental group, * having not been diagnosed with alzheimer's for the control group * individuals who have not undergone surgery in the last 6 months * individuals who do not have cooperation and communication problems. exclusion criteria: * under age 65 * individuals who do not agree to participate in the research, * individuals who have a disability to do physical activity, * individuals who have undergone an operation in the last 6 months, * individuals with problems of cooperation and communication

Keywords: dual task cadance gait speed alzheimer demantia