Kornimate/medical-research-clean huggingface dataset:
effect of formoterol on the counterregulatory hormonal response to hypoglycemia in type 1 diabetes.

Conditions: Type 1 Diabetes

Summary: insulin treatment often causes the blood glucose levels to fall too low. the body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. however, this hormone response can be altered in people with diabetes. currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). the aim of this study is to determine whether a formoterol inhaler can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.

note: below is the original detailed description submitted in 2010. the recruitment for this study was stopped at 7 subjects in each study arm. the study design and outcome measures did not change for this study. see below for further details. original: 15 subjects with well controlled type 1 diabetes and regular hypoglycemia and 15 healthy volunteers will be recruited for this study. if you agree to participate in this study, you will be asked to participate in a screening at yale new haven hospital. each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) in these hypoglycemic clamp studies, the subject will be given an inhaler. on one visit the inhaler will contain formoterol capsules and on the other visit, the subject will be given 'dummy' capsules. subjects will be required to be admitted to the hru the night before the study so that glucose levels can be stabilized and hypoglycemia avoided.

Eligibility criteria:
inclusion criteria: * type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) * age 18-50 * bmi 18-30 exclusion criteria: * pregnancy * significant diabetes complications * liver disease, cirrhosis * cardiac disease * neurological disorder * autonomic neuropathy * kidney disease * lactose intolerance

Keywords: type 1 diabetes hypoglycemia formoterol
evaluation of a decision aid about life-sustaining therapies

Conditions: Decision Making; Resuscitation; Intensive Care Unit; Goals-of-care; Shared-decision Making

Summary: introduction: clinical practice guidelines recommend shared decision making (sdm) to facilitate goals-of-care discussions. this study will train clinicians about how to use a context-adapted decision aid (da) and sdm to conduct goals-of-care discussions with the elderly. the objectives of this study are to: 1) determine if the use of the da and sdm training program: a) increase clinicians' engagement of patients in decision making regarding their goals of care; b) increase adoption of evidence-based behaviours regarding goals-of-care decision making; and 2) identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the skills in goals-of-care decision making. methods: this study will have three phases. phase i (may-june 2017) will be a baseline evaluation of the current goals-of-care decision making process with elderly patients in a single icu setting (levis, quebec). phase ii (july-august 2017) will be an evaluation of the goals-of-care decision making process in the same icu using a da. phase iii (september-december 2017) will be the delivery of an online and in-person training session about the use of the da and about how to conduct discussions about goals-of-care. the study will then evaluate the goals-of-care decision making process after completion of the training program and using the da. the investigators will observe and audio- or video-record all eligible elderly-intensivist dyads discussing goals of care during each phase. two investigators will analyse the recordings using the option 12 scale (measuring the extent that clinicians engage patients in sdm) and the accept quality indicators (measuring the extent to which intensivists engage in best practice goals-of-care discussions). the investigators will conduct qualitative content analysis of the video and audio records to identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills. deliverables: this study will produce evidence regarding the impact of a context-adapted da and training program on clinicians' adoption of sdm and other best practice behaviors regarding goals-of-care decision making with the elderly, and evidence regarding the most frequent patients' incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.


Eligibility criteria:
inclusion criteria: 1. aged 65 and older, 2. capable of making their own healthcare decisions as determined by the attending intensivist's clinical judgment, 3. in need of a discussion about goals of care as determined by the attending intensivist's clinical judgment. exclusion criteria: 1. intubated patients, 2. patients facing urgent decisions, 3. patients cared by the principal investigator, 4. patients who do not read or speak french.

Keywords: decision aid icu goals-of-care videotaping shared-decision making
the effect of growth hormone replacement on liver fat

Conditions: Growth Hormone, Recombinant; Fatty Liver

Summary: we will examine a cohort of growth hormone deficient adults starting growth hormone (gh) replacement. the purpose of this study is to determine whether gh replacement reduces the fat content of the liver. to compare the results we will include growth hormone deficient patients who do not start gh replacement as controls.

adults with untreated growth hormone deficiency (ghd), a condition mostly due to pituitary disease, often show metabolic features similar to those described in the 'metabolic syndrome'. growth hormone (gh) replacement has been shown to reverse many of these unfavorable changes, with a particular evident reduction of visceral fat. in recent years, a strong correlation between fat accumulation in the liver and features of the metabolic syndrome (particularly visceral fat) has been identified, and 'fatty liver' is now being referred as the hepatic feature of the 'metabolic syndrome'. the effect of gh replacement on liver fat, however, has never been systematically studied. we will assess 15 patients with ghd before and 6 months after starting gh replacement. we will also assess 15 control patients with ghd but who don't go on gh replacement for various reasons. liver fat will be assessed using mr spectroscopy. changes in liver fat will be correlated to changes in insulin sensitivity and changes in various inflammatory markers.

Eligibility criteria:
inclusion criteria: * 20-70 years of age * growth hormone deficiency, with (cohort 1) or without (cohort 2) planned growth hormone (gh) replacement * clinically stable exclusion criteria: * known hepatic disease * acromegaly * diabetes mellitus * growth hormone replacement within the last 12 months * cushing's disease, if not cured for at least 12 months * any contraindication to mr studies as set out in the mr safety questionnaire

Keywords: growth hormone growth hormone deficiency liver fat liver steatosis growth hormone replacement
covid-19 close contact self-testing study

Conditions: Covid19

Summary: widespread testing and contact tracing are critical to controlling the covid-19 epidemic. distribution of covid-19 self-test kits can augment public health contact tracing efforts, as individuals with covid-19 can distribute self-testing to close contacts. this approach can increase case detection by facilitating testing among exposed individuals, and potentially ameliorate stigma, fear, and medical mistrust associated with covid-19 among vulnerable populations. the central hypothesis of this study is that distribution of sars-cov-2 self-tests to close contacts of among individuals with covid-19 infection can increase case detection compared with a standard contact referral strategy.

strategies to increase testing among individuals exposed to covid-19 are needed. one approach to increase testing and case detection is to distribute home test kits to close contacts of individuals with covid-19. this approach decreases logistic barriers to testing, potential exposures to covid-19, and reduces potential stigma and fear associated with facility-based covid-19 testing. the investigators will conduct a cohort study of individuals diagnosed with covid-19 in the c-strand trial (nct04797858), in order to determine if distribution of self-test kits to close contacts of of individuals with covid-19 can increase case detection compared with a standard contact referral strategy among. individuals diagnosed with covid-19 who were randomized to the self-test (intervention) arm or received self-test kits will be assigned to receive additional self-test kits to distribute to close contacts. individuals diagnosed with covid-19 who were randomized to the test referral (control) arm or received test referrals will be assigned to receive text message referrals to give their close contacts to seek testing if needed. covid-19 case detection and test uptake will be measured in both arms.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * has a working telephone number * willing and able to provide informed consent exclusion criteria: * severe symptoms requiring immediate medical attention * younger than 18 years of age * does not have a working telephone number * unable or unwilling to provide informed consent
diode laser and srp in chronic periodontitis

Conditions: Periodontitis

Summary: the purpose of this study is to compare the efficacy of photoablative and photodynamic diode laser in adjunct to scaling-root planing (papd+srp) and srp alone for the treatment of periodontitis.

the present study is a randomized, blinded, controlled clinical trial, which used a split-mouth design. all patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed. twenty-four patients were studied. maxillary left or right quadrants were randomly assigned to papd laser treatment or sham-treatment and srp. papd consisted of: i) photoablative gingival epithelium with diode laser (λ 810 nm, 1 w); ii) photodynamic treatments (4-10 weekly) with diode laser (λ 635 nm, 100 mw) and 0.3% methylene blue as photoactive antiseptic, performed after srp. sham-treatment was similar but with switched off laser. efficacy evaluations, including probing depth (pd), clinical attachment level (cal), bleeding on probing (bop) was performed at baseline ,1year, and year 3 using a conventional manual periodontal probe. polymorphonuclear leukocytes (pmn), erythrocytes (rbc), damaged epithelial cells (dec) and bacteria were assayed by cytofluorescence on gingival exfoliative samples at baseline, 6 month and 1, 3, 5 years.

Eligibility criteria:
inclusion criteria: 1. periodontitis:presence of at least two teeth with at least one site with pocket probing depth (pd) ranging from 4 to 10 mm in each upper maxillary quadrant and with bleeding on probing (bop) 2. a minimum of five natural teeth in each studied quadrant. exclusion criteria: 1. history of systemic diseases (diabetes mellitus, cancer, hiv, metabolic and endocrine diseases) 2. pregnancy or lactation 3. chronic high-dose steroid use 4. previous or current radiation or immunosuppressive therapies 5. ongoing orthodontic treatments 6. extensive carious lesions 7. recurrent antibiotic medications during the 6 months preceding the study 8. class iii tooth mobility 9. heavy contamination by spirochetes and fungal pathogens on tongue and oral mucosa

Keywords: laser periodontitis scaling root planing bacteria pmn
utility of urinary beta2 microglobulin as an early marker of renal dysfunction in vietnamese hiv-infected patients

Conditions: HIV Infection; Renal Function Disorder; Renal Tubular Disorder

Summary: this study is to investigate clinical utility of beta2 microglobulin as an early marker for renal dysfunction caused by tenofovir in vietnamese hiv-infected patients.

an observational study to investigate clinical utility of beta2 microglobulin as an early marker for renal dysfunction caused by tenofovir in vietnamese hiv-infected patients.

Eligibility criteria:
inclusion criteria: * hiv-infected patients in the nhtd -acc cohort who are under cart or will start cart and can provide written informed consents. exclusion criteria: * hiv-infected patients who drop out of treatment within 6 months from the entry.

Keywords: tdf:tenofovir, urine beta2microglobulin
clinical outcome in view of surgical site infection (ssi) with antibacterial skin sutures

Conditions: Wound Infection, Surgical

Summary: background: poor wound healing and the development of surgical site infection (ssi) continue to occur and remain a significant cause of disability among operated patients. in spite of the substantial advances in our understanding of the epidemiology, pathogenesis and prevention it remains one of the most common complications in conventional abdominal surgery with an incidence in the literature between 4% and 17%. as it is known that surgical sutures potentiate the development of wound infection the search for an ideal suture material, suitable for all purposes has been pursued by surgeons for decades. hypothesis: in line with in-vitro results the investigators hypothesize that the use of antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of ssi after open abdominal surgery methods: to prevent microbial colonization of suture material in operative wounds and therefore to prevent ssi, triclosan-coated poliglecaprone 25 suture materials with antibacterial activity will be tested against un-coated suture material for skin closure after open abdominal surgery of 200 patients. the study is planed as a single center, randomized controlled trial. after ethical approval the patients will be consecutively enrolled from 2011 to 2012 in the department of visceral surgery, university hospital basel, switzerland. the patients will be followed for 30 days (day 3,7 and 30) to detect and document wound complications. wound complications will be classified according to center for disease control and prevention standard guidelines. data will be collected and the rate of ssi will be analysed in both groups. expected value of the proposed project: if the investigators can confirm the proposed hypothesis in our study this could be a promising and feasible approach to lower ssi after open abdominal surgery and might be also used in other surgical fields. by lowering the rate of ssi the investigators might offer a new and cost saving procedure to the surgical community.


Eligibility criteria:
inclusion criteria: * all patients from the visceral department of basel university hospital requiring open abdominal surgery. open abdominal surgery is defined as: opened peritoneal cavity exclusion criteria: * factors limiting the ability to co-operate in the study; * absence of signed informed consent before entering the study; * people with mental disorders; * pregnant women; * participants under 18 years
the study of rhutpo/rhuil-11 in the treatment for chemotherapy-induced thrombocytopenia in patients with nsclc

Conditions: Thrombocytopenia

Summary: purpose: to evaluate the efficacy and safety of rhutpo/rhuil-11 in the treatment for chemotherapy-induced thrombocytopenia in patients with nsclc receiving gemcitabine and cisplatin or carboplatin chemotherapy.

inclusion criteria: 1. patients aged 18 years -75 years, male or female; 2. histologically or cytologically confirmed non-small cell lung cancer; 3. consistent with the indication of chemotherapy 4. the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 \* 109/ l; 5. the expected survival was more than 3 months; 6. patients must have the ability to understand and the willingness to sign a written informed consent; 7. to be able to follow the study and follow-up procedures exclusion criteria: 1. pregnant or lactating women; 2. patients who had severe allergic history on biological preparation; 3. the existing serious acute infection without control; 4. patients receiving radiotherapy; 5. more than 3 metastatic tumor of bone were found in the screening period, and the platelet count did not restore to 100 \* 109/ l on the screening period on the seventeenth day of the screening period; 6. with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months; 7. sepsis, disseminated intravascular coagulation (dic); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy; 8. tumor metastasis was found in the central nervous system;

Eligibility criteria:
inclusion criteria: * age\>18 years, male or females * patients with nsclc for whom treatment with gemcitabine and cisplatin or carboplatin * platele counts ≤ 50×109/l during screening chemo cycle * ecog ps score is ≤ 2 * the predicted life expectancy ≥3 months * written informed consent exclusion criteria: * pregnant or nursing women * known history of severe anaphylactic reaction to biologics * uncontrolled severe infection * history of bone or central nervous system metastasis * history of platelet disorder * active bleeding

Keywords: nsclc chemotherapy thrombocytopenia rhtpo
follow-up study of autologous cultured adipose-derived stem cells for the crohn's fistula

Conditions: Crohn's Disease; Fistula

Summary: this is an open follow-up clinical trials to evaluate a sustained efficacy and safety of adipoplus inj. for 10 months (12 months after final dose injection)after phase ii clinical trial.


Eligibility criteria:
inclusion criteria: * the patients who have participated in antg-asc-202 clinical trial * the patients who have experienced with adipoplus in antg-asc-202 trials * the patients who submit written consents and is able to obey requirements of trials exclusion criteria: * pregnant or breast feeding * autoimmune disease other than crohn's disease * infectious diseases including hbv, hcv or hiv * who is not willing to use effective contraceptive methods during the study. * active tuberculosis * moderate to severe active or worsened crohn's disease * who have received infliximab during or after antg-asc-202 trial

Keywords: crohn's fistula autologous adipose derived stem cell
the brain app: building relationships using artificial intelligence and nostalgia

Conditions: Dementia; Dementia, Vascular; Alzheimer Disease; Dementia, Mixed

Summary: this study will involve testing of an alpha version of an app called "building relationships using artificial intelligence and nostalgia" or brain. the brain app will be the first -ever artificial intelligence infused cst app for pwd. the app has two main goals: (1) to foster positive relationships between the care triad, and (2) to promote qol while reducing responsive behaviors in pwd. testing will examine the app's impact on engagement/affect for both pwd and professional care partners.

a quasi-experimental pretest / posttest design will be used. during a four-week baseline period, researchers will collect data on engagement, quality of life, neuropsychiatric symptoms, and quality of the care-patient relationship. participants will then use the brain app for four weeks, during which engagement data will be collect. after the intervention period, researchers will collect data again on quality of life, neuropsychiatric symptoms, and quality of the carer-patient relationship.

Eligibility criteria:
pwd inclusion criteria: * diagnosed with dementia (any type) * resident in alf or nh * 65+ years old * read and speak english * exhibit at least one responsive behavior on the npi-nh or score below maximum score on the demqol pwd exclusion criteria: * bed-confined * completely unable to communicate verbally * have serious visual or hearing impairments * show signs of rapid decline or over the last six months staff and family member inclusion criteria * 18+ years old * speak and read english staff and family member exclusion criteria -n/a

Keywords: psychosocial non-pharmacological
avacopan in crescentic immunoglobulin a nephropathy (igan)

Conditions: IgA Nephropathy (IgAN)

Summary: the purpose of this study is to evaluate the efficacy and safety of avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic imunoglobulin a nephropathy (igan) and high risk of progression.


Eligibility criteria:
inclusion criteria * age \> 18 years * kidney biopsy showing crescentic iga nephropathy within 6 months of enrolment (mest-c-score =c1/c2). * quantified creatinine clearance \>20 ml/min/1.73m2 * quantified proteinuria \> 750 mg/24h based on a 24h urine collection while on maximum tolerated dose of ras blockade * hematuria defined as \>10 rbc/hpf or hemoglobinuria \>1+ * patients need to be in adequate supportive care (blood pressure \<125/85mmhg, lifestyle advice, and maximum doses tolerable of ras blockade) at least 4 weeks prior to enrollment * patients would receive dietary and lifestyle counseling prior enrollment: low protein (0.8-1.0 g/kg/day) diet, low sodium (2 grams/day) intake, indication for smoke cessation, during the 4 weeks run-in period * has signed an informed consent form prior to any study-related procedures * patients with documented use of ras blockade and adequate blood pressure control (\<125/85 mmhg) for ≥4 weeks, can be enrolled in the study and randomized without repeating a 4-week run-in period. exclusion criteria * creatinine clearance \<20 ml/min/1.73 m2 * liver function tests \> 2x upper limit of normal. (serious cases of hepatotoxicity have been reported in patients with avacopan during first approval and advocate study (29) (30) * severe interstitial fibrosis and tubular atrophy (ifta \> 70% on renal biopsy) * active cancer or acute non-controlled infection (including hiv, hbv, hcv) * women who are pregnant or breastfeeding * immunosuppression treatment: * rituximab less than 12 months prior to enrollment * mmf, cyc, or immunomodulatory agents within 3 months prior to enrollment * aza within 3 months prior to enrollment. * glucocorticoids \>20 mg/day within 1 month prior to enrollment * secondary iga nephropathy (associated with gastrointestinal diseases, infection, autoimmune, malignancy, respiratory tract, or skin) * anca-associated vasculitis or other vasculitis diagnostic defined by acr criteria/chapel hill consensus conference * contraindication to use any of the protocol treatments (glucocorticoids, avacopan) * use of a strong/moderate cyp3a4 inducer * initiation of sglt2 inhibitors is not allowed once patient has been enrolled in the study. patients who have been on an sglt2 inhibitor prior to enrollment on the study may continue on this therapy, at the same dose. no dose increase is allowed. * active, untreated and/or uncontrolled chronic liver disease (chronic active hepatitis b, untreated hepatitis c, uncontrolled autoimmune hepatitis, cirrhosis * unable to give written consent form * as a safety measure patients who are pregnant or lactating will not be enrolled in the study.