Kornimate/medical-research-clean huggingface dataset:
short-term intensive insulin therapy induction of long-term glycemic control

Conditions: Type 2 Diabetes

Summary: we designed this prospective, randomized control study to compare the benefits between the insulin therapy and oads after correction of the glucose toxicity with a short period of intensive insulin therapy.

objective-type 2 diabetes is associated with defects in insulin secretion and insulin action. hyperglycemia may aggravate these defects, a feature known as glucose toxicity. previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. the current study attempts to identify any characteristics of patients with newly diagnosed type 2 diabetes (fasting glucose \>300mg/dl) who would have a long-term benefit, in terms of glycemic control, from a brief course of insulin therapy. research design and methods-newly diagnosed type 2 diabetic patients with severe hyperglycemia (fasting blood glucose \>300 mg/dl or random blood glucose \>400 mg/dl) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. oral glucose tolerance will be performed after one week of intensive insulin treatment. after discharge, patients will be randomized to receive insulin injection or oral anti-diabetic drug for further management. patients will be followed in our clinics and adjust their medication according to their blood glucose levels. oral glucose tolerance test will be repeated 6 months later, whereas the insulin sensitivity and beta-cell function will be evaluated again. expected results-we will respect that short-term intensive insulin therapy can induce lone-term glycemic control in newly diagnosed type 2 diabetes with severe hyperglycemia.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed type 2 diabetic patients. 2. hospitalization due to hyperglycemia hyperosmolality syndrome. 3. those who age between 30 and 80 years old and can inject insulin by themselves. exclusion criteria: 1. pregnant women. 2. impaired liver function (alt \> 120 u/l) 3. impaired renal function (serum creatinine \>3.0 mg/dl) 4. recently suffered from mi or cva. 5. patients are acute intercurrent illness. 6. 2-hour c-peptide level \< 1.8 ng/ml.

Keywords: type 2 diabetes oral glucose tolerance test insulin oral anti-diabetic drug ß-cell function
statin-intolerance registry

Conditions: Dyslipidemias

Summary: the statin-intolerance registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ascvd) prevention. patients will be systematically and prospectively included and followed by the registry.

this non-interventional registry based on routine clinical practice will collect data under real-life conditions. the treatment of patients will not be changed by this study. data on patient characteristics and the treatment history will be collected via questionnaires at study entree. yearly follow up visits will re-assess the baseline parameters and document cardiovascular events. the data will be analyzed using descriptive statistics.

Eligibility criteria:
inclusion criteria: 1. patients with dyslipidemia and statin intolerance, defined as: use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued 2. participants are ≧ 18 years old 3. written declaration of consent is available 4. the patient is cognitively, linguistically and organizationally capable to meet the study requirements. the possibility of 1 year follow-up is very likely. exclusion criteria: 1. use of any experimental or investigational drugs within 30 days prior to screening. 2. an employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-investigator, or sponsor.

Keywords: statins muscle symptoms cardiovascular lipid metabolism disorders
observational study in patients with autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary: to collect characteristics of patients with adpkd across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. the economic and quality life impact of adpkd will be assessed. subjects who terminated participation early from clinical trials with tolvaptan may also be followed.


Eligibility criteria:
inclusion criteria: * existing diagnosis of adpkd by modified-ravine criteria * total kidney volume \>= 300 cc/m height by ultrasound or \>= 250 cc/m height by mri exclusion criteria: * current or expected (within the next six months) interventions for the treatment of adpkd affecting kidney volume
exploring oxytocin response to meditative movement

Conditions: Hypertension

Summary: this pilot study is designed to test effects of a single session of meditative movement (tai chi easy) on older adults' blood pressure, perceptions of connection, mood, and oxytocin levels.

endogenous oxytocin (the "cuddle hormone") is associated with lowering blood pressure (bp), suggesting that finding ways to increase oxytocin even in the absence of social connection, may be beneficial. meditative movement emphasizing breath, meditative state and flow-inducing movements holds potential for reducing bp, improving mood and releasing oxytocin. in a single-group pilot study we exposed 21 oas with mild-moderate hypertension to a 50-minute "tai chi easy (tce)" (simplified tai chi/qigong) session, collecting bp, saliva samples for oxytocin, and psychosocial measures (connection, mood) pre/post intervention.

Eligibility criteria:
inclusion criteria: * age 55-80 --bp above 120/80 - exclusion criteria: * having a neurologic disorder such as parkinson's, seizure disorder, multiple sclerosis, alzheimer's disease * answered "yes" to one or more questions on the physical activity readiness questionnaire (par-q). the par-q is a seven-question assessment that determines one's readiness, safety and ability to engage in physical activity and is safely validated for older adults
social support aid for people with dementia

Conditions: Dementia; Memory Loss

Summary: the goal of this study is to determine the acceptability, utility, and preliminary effectiveness of a facial recognition technology for persons with memory concerns and their family care partners.

this project develops a novel social support aid (ssa) to allow persons with memory concerns (pwmcs) to more fully engage in their social network and enhance their quality of life. the ssa will assist people in an early stage of dementia, e.g., alzheimer's disease or related dementia, who desire social interaction, but struggle to remember names and relationships. it provides memory cuing by displaying the names and relationships of the people with whom pwmcs are engaged. the investigators anticipate that the ssa will offer robust support for care partners and pwmcs in various communities. the ssa is not intended to replace caregiver aids, but rather augment them to further improve quality of life. millions of americans have dementia, the loss of mental functions, e.g., thinking, memory, and reasoning, which interferes with their daily functioning. while some cases of dementia are caused by medical conditions that can be treated, most cannot be reversed. hence, the focus switches from treatment to palliative care, i.e., developing a plan to make life easier and more comfortable for individuals with dementia and their caregivers. assistive technologies to enhance living with dementia, let alone studies that evaluate their efficacy, are underdeveloped. the proposed project aims to begin filling this scientific and clinical gap by developing a social support aid and formally evaluating its utility via a sufficiently powered randomized controlled trial. this phase ii small business innovation research project will continue work started in phase i and complete a product. the aim of this human subjects research protocol is to evaluate whether the ssa exerts positive benefits for pwmcs' social connections, communication, and quality of life via an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial (rct) design. the investigators hypothesize that the proposed ssa will exert positive benefits on the social connections, communication, and quality of life of people in early stage dementia.

Eligibility criteria:
inclusion criteria: pwmcs must be: * a physician diagnosis of early-stage alzheimer's disease, mild cognitive impairment, or a self-identified concern of memory loss. * able to complete surveys in english or spanish * slums score of 20 or above care partners of pwmcs must be: * 21 years of age and over; * self-identify as someone who provides assistance to the pwmc because of their memory loss (these individuals are called ''care partners,'' as these individuals may or may not provide the intensive hands-on care typical of ''caregivers''); * indicate a willingness to use the ssa exclusion criteria: * indicates an unwillingness to use the ssa.

Keywords: caregiving technology social support
thiamine as a renal protective agent in septic shock

Conditions: Sepsis; Kidney Injury; Thiamine Deficiency

Summary: this is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin b1) on renal function in septic shock.

this is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin b1) on renal injury in septic shock. patients admitted with septic shock who have a lactate of at least 2.0mmol/l and do not have pre-existing renal failure requiring dialysis will be eligible for the study. enrolled patients will be randomized to intravenous thiamine 200mg twice daily for 6 doses or matching placebo. blood will be drawn at several time points to assess biomarkers of renal injury. secondary endpoints include need for renal replacement therapy, length of icu stay, and hospital mortality.

Eligibility criteria:
inclusion criteria: 1. adult ≥18 years of age 2. suspected or confirmed infection (defined as collection of a blood/fluid culture and provision of an antimicrobial) 3. receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin) 4. serum lactate ≥2mmol/l 5. creatinine \>1.0mg/dl exclusion criteria: 1. clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days 2. renal replacement therapy within the past 30 days 3. comfort measures only or anticipated withdrawal of support within 24 hours 4. protected populations (pregnant women, prisoners) 5. known thiamine allergy
am-101 in the treatment of acute tinnitus 3

Conditions: Tinnitus

Summary: the purpose of this research study is to test the safety and effectiveness of the study drug, am-101. am-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last \>3 to 6 months.

this phase iii study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic am-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (stratum a), or between \>3 and 6 months (stratum b) from onset).

Eligibility criteria:
inclusion criteria: 1. persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (stratum a) or between \>3 months and 6 months (stratum b) prior to randomization, as documented by medical report or by documented medical history. upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally. 2. age ≥ 18 years and ≤ 75 years; 3. negative pregnancy test (woman of childbearing potential); 4. willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured; 5. willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed. other protocol-defined inclusion criteria may apply. exclusion criteria: 1. fluctuating tinnitus; 2. intermittent tinnitus; 3. tinnitus resulting from traumatic head or neck injury; 4. presence of chronic tinnitus; 5. meniere's disease, history of endolymphatic hydrops, or history of fluctuating hearing loss; 6. history of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma; 7. ongoing acute or chronic otitis media or otitis externa; 8. other treatment of tinnitus for the study duration; 9. known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction; 10. women who are breast-feeding, pregnant or who are planning to become pregnant during the study; 11. women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months; 12. concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization. other protocol-defined exclusion criteria may apply.
ilf with/without cisplatin for advanced gastric cancer

Conditions: Stomach Neoplasm

Summary: to compare the combination of irinotecan, leucovorin and 5-fu (ilf) with ilf plus cisplatin (pilf) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

irinotecan, in combination with 5-fu or cisplatin, clearly demonstrated efficacy against gastric cancer. a previous randomized study of ilf regimen versus ip in patients with agc showed that the ilf produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with ip regimen \[pozzo c, et al. ann oncol 2004\]. however, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, fu and cisplatin) seemed to be a promising strategy for advanced agc. we desinged this randomized phase ii study to compare the combination of irinotecan, leucovorin and 5-fu (ilf) with ilf plus cisplatin (pilf) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

Eligibility criteria:
inclusion criteria: * histologically proven gastric adenocarcinoma * advanced, metastatic or recurrent * ecog performance status 0 to 2 * no prior chemotherapy * measurable or evaluable indicator lesion(s) * normal marrow, hepatic and renal functions * provision of written informed consent exclusion criteria: * active infection, bleeding or severe comorbidities * pregnant or breastfed women * active cns metastasis
open label, safety and efficacy study of topical investigational drug to treat patients with psoriasis

Conditions: Psoriasis

Summary: this will be an open label study of ruxolitinib topical cream applied to 2 - 20% bsa in patients with active, stable plaque psoriasis.


Eligibility criteria:
inclusion criteria: * subjects must have psoriatic lesions measuring protocol specific bsa exclusion criteria: * lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face * pustular psoriasis or erythroderma

Keywords: psoriasis
temporary gastric electrical stimulation for gastroparesis

Conditions: Gastroparesis

Summary: this is a prospective study of temporary gastric mucosal electrical stimulation (tges) in 30 patients with gastroparesis (gp). after a 7 day baseline assessment of symptoms, subjects will have an endoscopically-placed tges lead implanted into the mucosa of the antrum. this lead is connected to a thin wire that runs up the esophagus and out the nostril, similar to a nasojejunal feeding tube, although much thinner. it is then attached to a programmable battery pack which provides the desired level of stimulation. patients will then be randomized to 7 days off or 7 days on stimulation in a double-blind fashion. after 7 days, subjects will crossover to the other study arm (ie on patients will be switched off; off patients will be switched on). symptoms and qol measures will be assessed at baseline, on, and off periods. serum ghrelin and other hormones, as well as egg will be assayed after 6 days in each arm.


Eligibility criteria:
inclusion criteria: * age of 18 or older * existing clinical diagnosis of gastroparesis for at least one year as judged by the study gastroenterologist based on past medical history, clinical symptoms * sufficiently symptomatic at time of proposed study (minimum total baseline gcsi score of 1.5 or higher) * delayed gastric emptying (\>10% retention at 4 hours) on standard scintigraphic emptying study with patients off narcotics for at least 48 hours. normal upper endoscopy (with the exception of small bezoars) since the onset of symptoms * medically fit to undergo endoscopy * able and willing to remain in calgary for the duration of the study (baseline period excepted) * able to provide written informed consent exclusion criteria: * clinical evidence (including physical exam and/or ekg) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns * current use of anticoagulants, asa, nsaids, clopidogrel, etc. which cannot safely be stopped for up to 5 days prior to the procedure in the opinion of the investigators * bleeding diathesis * severe immunocompromise * physical, mental, or compliance issues which in the opinion of the investigators may prevent the patient from completing the study * pregnant or breastfeeding females

Keywords: gastroparesis gastric electrical stimulation
microlyte in prevention of ssi after open ventral hernia repair

Conditions: Ventral Hernia

Summary: participants who are scheduled to have open ventral hernia repair (ovhr) will be asked to take part in this study. the purpose of this study is to find out if placing microlyte (which is a dissolvable sheet coated in silver) on the surgical incision is better than placing nothing on the surgical incision when it comes to decreasing the chance of surgical site infections. the study device has been cleared by the food and drug administration (fda) for use on surgical incisions. a total of 280 participants will be included in the study. participation will last for about 90 days.

the aim of our study is to assess the impact of microlyte-ag® (imbed biosciences, fitchburg, wi), a silver-coated bioabsorbable matrix, on surgical site infection (ssi) on patients undergoing clean open ventral hernia repair (ovhr) at carolinas medical center/atrium health (charlotte, nc), prisma health-upstate (greenville, sc), and mission health/hca healthcare (asheville, nc). those who agree to participate in the study will undergo the following: information will be collected, including demographics, past medical and surgical history, and hospital outcomes. on the day of surgery, participants will be "randomized" into one of the study groups listed below. * group 1: the study device will be cut into strips and placed in the surgical incision * group 2: nothing will be placed in the surgical incision for both groups, the surgical incision will then be closed with absorbable sutures, which is the usual treatment. participants will be seen by the study doctor 30 and 90 days after surgery for a checkup. at the 30-day visit, participants will have a physical examination, and the study doctor will check to see if any complications have happened since the last visit. the 90-day follow-up visit can be done in person or over the telephone and will be done to check and see if there have been any problems with the healing of the surgical incision.

Eligibility criteria:
inclusion criteria: * men and women over 18 years of age * patients undergoing open hernia repair with retromuscular or preperitoneal placement of polypropylene mesh in clean (class i) operative fields, and who are candidates for complete skin closure * capable and willing to attend the scheduled postoperative visits * signed icf for study enrollment exclusion criteria: * prisoners * minimally invasive repairs (laparoscopy, robotics) * cdc wound class ii-iv * irrigation of the wound or peritoneal cavity with antibiotic or antimicrobial fluid * inability to completely close the midline fascia * mesh placed as a bridge, onlay, or intraperitoneal position to the fascia * skin left open or packed at the time of the index operation * use of wound wicks at the time of the index operation * use of an investigational product within the preceding 60 days * allergy to silver
proton versus photon radiotherapy for nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.participants will be randomized to 2 arms. arm 1, participants received photon combined with carbon ion radiotherapy group, arm 2, participants received proton combined with carbon ion radiotherapy.

the purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.participants will be randomized to 2 arms. arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 gy/28 fx, plus carbon: 15-17.5 gray equivalent \[gye\]/5 fx for boost). arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 gye/28 fx, plus carbon: 15-17.5 gye/5 fx for boost). adverse events will be documented according to ctcae v4.03.the response of treatment will be evaluated according to recist criteria.

Eligibility criteria:
inclusion criteria: * pathologically confirmed nasopharyngeal carcinoma(who ii/iii type). * age ≥ 18 and ≤ 70 years of age. * eastern cooperative oncology group score: 0-1. * adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \> 2000/mm\^3; 2) platelet \> 100,000/mm\^3; 3) total bilirubin \ 60ml/min. * willing to accept adequate contraception for women with childbearing potential. * willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial. exclusion criteria: * presence of distant metastasis. * received radiotherapy for head and neck before. * received surgery(except for biopsy) for primary lesion or cervical lymph node. * previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors. * presence of diseases (such as sjögren syndrome) that may interfere evaluation of xerostomia. * accompanied with severe major organ dysfunction. * presence of mental disease that may influence the understanding of informed consent.

Keywords: nasopharyngeal carcinoma intensity-modulated radiation therapy proton beam therapy carbon-ion radiotherapy toxicity survival disease control