Kornimate/medical-research-clean huggingface dataset:
intranasal insulin for treatment of alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: this is a randomized controlled trial (rct), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with alcohol use disorder (aud) (n=40, 50% female) randomized to in insulin or placebo. in a bar laboratory setting, randomized participants will receive a single dose of in insulin (80iu) or an in matched placebo (0.9% saline). participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (brac) to 0.08g/dl.

aims in this rct testing the effect of in insulin, compared to placebo, in individuals with aud include the following: aim 1: to assess the safety, tolerability and acceptability of in insulin as a pharmacological intervention for aud. the data collected in this aim will monitor possible adverse events and yield qualitative and quantitative data to finalize the feasibility and acceptability of in insulin as an aud pharmacotherapy. aim 2 (alcohol-drug interaction): to assess the safety and tolerability of in insulin when administered with alcohol. the investigators will use a battery of physiological/psychological assessments that measures potential adverse events, alcohol subjective response and alcohol pharmacokinetics endpoints.

Eligibility criteria:
inclusion criteria: * ≥21 years * meet any dsm-5 criteria score for aud * individuals who, in the last month, have consumed at least the same amount of alcohol that will be administered in the laboratory procedure (i.e. to reach brac levels of 0.08g/dl, \~two drinks in one occasion) * brac=0.00g/dl at each visit * good health as confirmed by medical history, physical examination and lab tests * willing to adhere to the study procedures * understand informed consent and questionnaires in english at an 8th grade level * willing to have glucose monitored by finger stick during the laboratory procedures exclusion criteria: * • female identifying who are breastfeeding or pregnant (assessed by a urine screen) * individuals with diabetes * history of suicide attempts in the last three years * current diagnosis of other substance use disorder (other than nicotine or cannabis) * use of drugs (e.g. stimulants/opioids) at each alcohol administration session (by urine tox screen) * cannabis intoxication (by clinical assessments) * use of medications that may interact with insulin and alcohol (by micromedex database) * hypersensitivity to insulin * any nasal disease/congestion that may interfere with intranasal drug absorption; * baseline hypoglycemia (blood glucose ≤65mg/dl) or hyperglycemia (blood glucose \>200mg/dl) (by finger stick)
vitamin d, genes and colorectal cancer

Conditions: Colorectal Cancer

Summary: the aim of this study is to investigate the interaction between intake of vitamin d and polymorphisms in gc and cyp2r1 in relation to risk of colorectal cancer in a danish prospective cohort study.

the association between vitamin d and incidence of colorectal cancer (crc) has been thoroughly investigated in both observational and experimental studies, but the results are conflicting. genetic epidemiology is an advantageous alternative to randomized, clinical trials for ethical and economic reasons. the aim of this study is to investigate whether polymorphisms in gc and cyp2r1 that predicts 25-hydroxycholecalciferol (25(oh)d) concentrations after both ultraviolet b radiation and consumption of vitamin d3-fortified bread and milk in danes are associated with risk of crc; and further, to examine whether intake of vitamin d through diet and supplementation alter the risk of crc. data are retrieved from the danish prospective "diet, cancer and health" study encompassing 57,053 persons which were recruited between 1993 to 1997. between 1994 and 31th december 2009, 1038 crc cases has been diagnosed. a sub-cohort of 1857 persons has been randomly selected within the full cohort at time of entry into the cohort. the study design is a nested case-cohort study.

Eligibility criteria:
inclusion criteria: * born in denmark * no previous cancers at study entry * age between 50-64 exclusion criteria: * previous or present cancer(s) at study entry

Keywords: vitamin d gc cyp2r1 gene-environment interaction prospective case-cohort study single nucleotide polymorphisms colorectal cancer
safety and efficacy of chronic hypnotic use 2

Conditions: Chronic Insomnia

Summary: this proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. the investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.

persons with dsm-v diagnosed insomnia disorder, aged 18-65 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency will be entered to the trial. following a screening npsg and mslt, participants will be randomized to zolpidem xr 12.5 mg (n=60), eszopiclone 3 mg (n=60), or placebo (n=50) nightly for 6 months. after 6 months of nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned "blinded" medication (zolpidem xr 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). nightly sleep at home will be recorded by actigraphy for one week after the screening npsg and mslt and before treatment is initiated and actigraphy again during the two week discontinuation.

Eligibility criteria:
inclusion criteria: * dsm-5 diagnosis of insomnia exclusion criteria: * acute or unstable medical disease, * current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
effects of montelukast on occult exercise-induced bronchospasm in athletes

Conditions: Exercise-Induced Bronchospasm

Summary: the purpose of this study is to determine if treatment of exercise-induced bronchospasm with montelukast will help college athletes train more effectively and thus become more competitive in a non ergogenic manner.

exercise-induced bronchospasm (eib) affects between 7-30% of highly trained athletes. the first phase of this study is to screen varsity level college athletes for eib using eucapnic hyperventilation (evh). those athletes who screen positive, will be enrolled in phase two, a randomized double-blinded placebo controlled double crossover study. at enrollment, athletes will undergo a cardiopulmonary stress test (cpst) and induced sputum sampling and will then be prescribed daily montelukast/placebo for a three week period. athletes will return after three weeks and repeat the evh, cpst, and induced sputum. they will then have a one week washout period followed by crossover once again to daily montelukast/placebo for another three weeks. after the second three weeks they will once again return for a final evh, cpst, and induced sputum. the goal of this study is to demonstrate that effectively blunting the eib response with montelukast, indices of ventilation,exercise tolerance, and perhaps overall physical fitness improve, allowing athletes to train more effectively, in a nonergogenic manner.

Eligibility criteria:
inclusion criteria: * college level varsity athlete * age 18yr or older * healthy. * able to swallow pills * no prior history of asthma exclusion criteria: * younger than 18yr * smoker * prior history of asthma * unable to swallow pills

Keywords: exercise-induced bronchospasm asthma cardiopulmonary stress test eucapnic voluntary hyperventilation induced sputum
lexapro for the treatment of traumatic brain injury (tbi) depression & other psychiatric conditions

Conditions: TBI; Major Depression; Other Psychiatric Disorders

Summary: this research is being done to see if a drug called escitalopram (lexapro) is helpful to people who are suffering from depression after traumatic brain injury (tbi).

despite it's high prevalence, little is known about the pharmacological treatment of depression following traumatic brain injury (tbi). this is because of a lack of randomized controlled studies in the treatment of post-tbi depression. this study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-tbi depression. it will also investigate metabolic changes and neural pathways associated with post-tbi depression and metabolic alterations after treatment through neuroimaging.

Eligibility criteria:
inclusion criteria: * closed head injury * fulfill diagnostic and statistical manual diploma in social medicine (dsm) iv criteria "major depressive disorder" * 18 years of age or older * able to provide informed consent * stable medical history exclusion criteria: * history of stroke, encephalitis, seizures, or any other pre-tbi neurological diseases * history of mental retardation * alcohol or substance dependence in the last 1 year * inability to undergo mri scan * pregnancy * current use of any psychotropic medications including any antidepressants, antipsychotics, anxiolytics, or sedative hypnotics * poor response to escitalopram in the past * acutely suicidal or requiring inpatient psychiatric hospitalization, as determined by the study psychiatrist * good medication response to another antidepressant in the past

Keywords: tbi depression mood behavior
laser treatment of basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: laser treatment of basal cell carcinoma

the purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (bcc) with laser technology. the laser modality that we plan to use is the long-pulse nd:yag 1064nm laser, which is a non-ablative laser already shown to effectively treat bcc.

Eligibility criteria:
inclusion criteria: 1. healthy subjects 18 years of age or older 2. lesion is biopsy-proven superficial bcc \<= 2.0 cm in largest diameter 3. bcc is on trunk or extremities 4. seeks and is scheduled for treatment of bcc 5. willing to have photographs taken of the treatment area 6. ability to understand and the willingness to sign a written informed consent document 7. agrees to adhere to the treatment and follow-up schedule and post treatment care instructions exclusion criteria: 1. subjects with a bcc lesion that requires excision. this would include relatively larger lesions (\>2.0 cm in diameter), high risk lesions as defined by american academy of dermatology as recurrent and sclerosing subtype bcc, or metastases. 2. pregnancy 3. subjects unable to follow-up for the full 12-months 4. subjects not willing to have biopsy taken from the treatment area 5. subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome

Keywords: superficial basal cell carcinoma
increased risk of severe coronavirus disease 2019 in patients with vitamin d deficiency

Conditions: Coronavirus Disease 2019 (COVID-19)

Summary: in this prospective observational study we aim to study the association of vitamin d deficiency with adverse clinical outcomes in patients infected with coronavirus disease 2019

coronavirus disease 2019 (covid-19) can induce an exaggerated inflammatory response. vitamin d is a key modulator of the immune system. we hypothesized that vitamin d deficiency (vdd) could increase the risk of developing severe covid-19 infection. the covit-d study (increased risk of severe covid-19 infection in patients with vitamin d deficiency) is a prospective cohort study recruiting patients with confirmed covid-19 seen at the emergency department of a tertiary hospital. a measurement of 25-hydroxyvitamin d is obtained at admission and follow-up obtained. the primary outcome is a composite of death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. the primary association between vdd - categorised in groups - and the primary outcome will be evaluated with univariate analyses and multivariable logistic regression including the following prespecified confounders: age, gender, obesity and chronic kidney disease. the estimated sample size is n=500 and the expected inclusion time lapse 3 months.

Eligibility criteria:
inclusion criteria: * \>18 years old * symptoms suggestive of covid-19 * positive reverse-transcriptase polymerase chain reaction or antibodies for sars-cov-2 exclusion criteria: * bacterial community acquired pneumonia

Keywords: coronavirus disease 2019 (covid-19) vitamin d deficiency severe acute respiratory syndrome angiotensin converting enzyme 2
a study of tarceva (erlotinib) monotherapy in patients with advanced non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: this study will evaluate the efficacy and safety of oral tarceva in patients with advanced nsclc for whom tarceva monotherapy is considered the best therapeutic option. the anticipated time on study treatment is 3-12 months.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * locally advanced or metastatic nsclc (stage iiib or iv); * not a candidate for curative surgery or radical chemotherapy; * no brain metastases, or clinically stable metastases for \>=2 months. exclusion criteria: * radiotherapy over the previous 2 weeks; * weight loss \>10% in the previous 6 weeks.
evaluation of the diabeo system in poorly controlled dm1 or dm2 patients treated with a basal-bolus insulin regimen

Conditions: Diabetes

Summary: the aim of the telesage study is to demonstrate 1. the superiority of follow up with the diabeo system (software alone) versus usual follow up in terms of improvement in hba1c after 1 year in dm1 or dm2 patients treated with a basal-bolus insulin regimen. 2. the superiority of follow up with the diabeo system (software + telemonitoring) compared to usual follow up in terms of improvement in hba1c after 1 year in dm1 or dm2 patients treated with a basal-bolus insulin regimen. the diabeo software alone is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system. the diabeo software added by paramedical telemonitoring is the electronic diary combined with remote paramedical monitoring of data (telemeonitoring)


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetic patients * performing auto-glycaemic control (at least 2 glycemias a day) * treated with insulin by a basal-bolus regimen for at least 1 year and using the same method of administration for at least 3 months (insulin pen or pump) * who have an apple® or androïde® smartphone compatible, or intend to acquire one before their participation in the study * whose hba1c dating of less 1 month and more than 3 months is ≥ 8% * who are able to understand and follow the study protocol * who have given their signed consent to take part in the study * subject affiliated to the french national health insurance funds or benefiting from such insurance exclusion criteria: * age \< 18 years old * patients who have used the diabeo system within 6 months before inclusion * participation in a clinical study within 6 months, except for the meos (or télédiab 3) study after a participation period of 6 months * patients who are pregnant or who wish to become pregnant during the study. * patients treated with human insulin a patient pre-screening register will be set up in each centre to establish the reasons for dm1/dm2 patients treated with a basal-bolus insulin regimen who are not taking part in the study.
an observational study of xeloda (capecitabine) and oxaliplatin prior and concurrent to preoperative pelvic radiotherapy in patients with locally advanced rectal cancer

Conditions: Colorectal Cancer

Summary: this observational study is a follow-up study of protocol ml18280. survival data of patients who took part in and concluded study ml18280 will be collected for up to 5 years after lplv of ml18270.


Eligibility criteria:
inclusion criteria: * patients who took part in and concluded study ml18280 according to protocol exclusion criteria: * n/a
assessment of clinical trial experiences of alzheimer's disease patients

Conditions: Alzheimer Disease

Summary: taking part in medical trials usually favors a particular demographic group. but there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. this study will admit a wide range of data on the clinical trial experience of alzheimer's disease patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future alzheimer's disease patients.


Eligibility criteria:
inclusion criteria: * patient is at least 50 to 80 years of age * participant has a diagnosis of alzheimer's disease * patient has self-identified as planning to enroll in an interventional clinical trial for alzheimer's disease exclusion criteria: * no diagnosis of alzheimer's disease confirmed * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form

Keywords: alzheimer disease alzheimer's
prevention of incontinence-associated dermatitis and maintenance of local skin microclimate

Conditions: Incontinence-associated Dermatitis

Summary: to explore the feasibility of jefcare sterile medical sheets in preventing incontinence-associated dermatitis and maintaining a stable local skin microclimate in adult patients in the intensive care unit.

jefcare sterile medical sheet is an incontinence care product designed by researchers following the expert consensus on the clinical application of disposable absorbent care products for adults with incontinence. the product has good laboratory test indicators and has the potential to prevent incontinence-associated dermatitis and maintain the stability of the local skin microclimate. still, there is a lack of high-quality clinical studies.

Eligibility criteria:
inclusion criteria: 1. intensive care unit incontinent patients (incontinence time ≥2 days) 2. age ≥18 years 3. patients at high risk of iad (perineal assessment tool ≥ 7) 4. voluntarily participate in the study and sign an informed consent form. if the subject is unable to read and sign the informed consent form due to incapacitation or other reasons, their guardian is required to represent the informed process and sign the informed consent form. if the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness will be required to witness the informed process and sign the informed consent form. exclusion criteria: 1. patients who have developed iad 2. expected subsequent stay in the intensive care unit \<5 days 3. use of nappies, pull-ups, incontinence pads, etc. 4. simple urinary incontinence with indwelling catheterization, external urinary bag without leakage; simple fecal incontinence with built-in drainage device, external ostomy bag, ob tampon without leakage; double incontinence with indwelling catheterization, external urinary bag, built-in drainage device, external ostomy bag, ob tampon without leakage. 5. the iad may affect the skin area within the scope of the disease that affects the iad judgment. 6. the iad may affect the skin area within the scope of the skin breaks, infection 7. patients who are not suitable for turning and cannot tolerate the side-lying position. 8. patients with known allergies or keloid scarring 9. women who are known to be pregnant or breastfeeding or who are planning to have a baby during the study period. 10. patients who have participated in a clinical trial of another drug or medical device within 3 months. 11. patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial.
armolipid plus and metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. such findings appear to be associated with a decrease in insulin sensitivity. management of metabolic syndrome is currently aimed at treating individual components of the disease without addressing this underlying pathophysiologic mechanism; this translates into multidrug regimens, high costs and patient compliance issues. armolipid plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin k,policosanol 10 mg,coenzyme q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on indices of insulin resistance. aim of the study is to evaluate the effects of armolipid plus on insulin sensitivity and on the diagnostic parameters of metabolic syndrome. 60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial; active treatment will consist of armolipid plus (1 tbl qd). primary end point will be the reduction of the insulin/glucose ratio, both after overnight fast (homa index) and after an oral glucose tolerance test (ogtt).


Eligibility criteria:
inclusion criteria: male and female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference \> 102 cm (m) or \>88 cm(f), and two or more of these criteria: * fasting blood glucose \>100 mg; * systolic blood pressure \>135 or diastolic blood pressure \>85 mmhg or patients in treatment with antihypertensive drugs; * triglyceridemia \>150 mg/dl; * hdl cholesterolemia \< 40 mg/dl(m), \< 50 mg/dl(f). exclusion criteria: * pregnancy * diabetes mellitus in pharmacologic treatment; * hepatic failure; * creatininemia \>2 mg/dl; * triglyceridemia \> 500 mg/dl; * heart failure.

Keywords: metabolic syndrome insulin-resistance endothelial function
orismilast for the treatment of mild to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (hs) in adults.


Eligibility criteria:
inclusion criteria: 1. male or female adult patients, 18 years of age or older. 2. have mild to severe hs for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history. 3. have hs lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal). 4. has a total inflammatory lesions (an) count of greater than or equal to 2. 5. total draining fistula count of less than or equal to 30. 6. a stable analgesic dose for 2 weeks prior to baseline. exclusion criteria: 1. presence of active skin lesions other than hs that could interfere with the assessment of hs. 2. receipt of prescription topical therapies for hs within 7 days prior to the baseline visit (visit 2). 3. receipt of systemic therapies for hs, within 28 days prior to the baseline visit. 4. any oral antibiotic within 28 days prior to baseline visit. 5. receipt of a live vaccine within 14 days prior to screening. 6. biologic use for indications other than hs within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline. 7. treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.