Kornimate/medical-research-clean huggingface dataset:
safety and pharmacokinetics of extrato de cannabis sativa greencare

Conditions: Healthy

Summary: the goal of this phase i clinical trial is to assess the pharmacokinetic availability and safety and tolerability profile of extrato de cannabis sativa greencare 79.14 mg/ml. the main question it aims to answer is: • is the extrato de cannabis sativa greencare 79,14 mg/ml safe?


Eligibility criteria:
inclusion criteria: * men and women from 18 to 65 years, inclusive; * body weight ≥ 50 kg and bmi between 18.5 and 30 kg/m2, inclusive; * be healthy according to medical history, i.e., have laboratory test results within normal ranges and/or any deviations from normal classified as clinically insignificant; * be exclusively participating in this clinical study during the research period; * understand and comply with the protocol requirements and consent to participate in the study by signing the informed consent form (icf) approved by an ethics committee (ec). exclusion criteria: having participated in any experimental study or ingested any experimental drug within 1 (one) year prior to the start of this study; * inability to use oral medication and/or cooperate with investigators due to cognitive impairment or mental state; * reported allergy to any component of cannabis sativa extract 79.14 mg/ml; * personal or first-degree family history of schizophrenia, bipolar affective disorder, psychotic symptoms, suicidal ideation, planning and/or attempt, and/or severe uncontrolled psychiatric comorbidities, at the discretion of the principal investigator; * donated blood within four (4) months prior to signing the informed consent form (icf); * being pregnant, breastfeeding, intending to become pregnant during the study period, or having a positive result for urinary β-hcg testing; * reported use of cannabis and/or its derivatives for any purpose in the past 6 months; * personal history of cannabis use disorder and/or other illicit drug use disorder; * personal history of alcohol, tobacco, opioid, benzodiazepine, barbiturate, and/or other substance use disorders, such as st. john's wort; * smokers or ex-smokers who quit less than 6 months ago; * consumed alcoholic beverages within 24 hours before the study confinement period; * any condition that prevents participation at the discretion of the investigator; * dietary habits that prevent ingestion of the diet provided during the study; * any clinical or laboratory finding or therapy that, at the investigator's discretion, may place the participant at risk or interfere with study objectives or outcomes; * non-compliance with the complete ingestion of the diet provided - determination at the discretion of the responsible physician.
type 1 diabetes telemedicine

Conditions: Diabetes Mellitus, Type 1

Summary: at the conclusion of this project, investigators will have assessed the effectiveness of home-based telemedicine for improving multiple important clinical and patient-centered outcomes in a high-risk pediatric cohort with t1d. aim 1. to test the hypothesis that home-based telemedicine is a feasible and acceptable method of care delivery for patients with poorly controlled type 1 diabetes (t1d) currently cared for at the university of california, davis (ucd) pediatric endocrinology clinic. specifically: a) patients and families choose to participate in telemedicine visits as a supplement to in-person care; b) patients and families can utilize secure, internet-based platforms to upload and share glucose meter data and to establish an audio-video connection with a diabetes specialist in their home settings; c) patients and families are satisfied with the experience of home-based telemedicine and would choose to receive future diabetes care via this modality. aim 2. to test the hypothesis that using home-based telemedicine, these patients can complete more frequent visits with a diabetes specialist than they previously completed via office visits alone. aim 3. to test the hypothesis that increased contact with a diabetes specialist via home-based telemedicine will lead to significant improvement in glycemic control for these patients. aim 4. to evaluate the effects of increased contact with a diabetes specialist via home-based telemedicine on high-cost health care utilization - specifically emergency department (ed) visits and diabetes-related hospitalizations.


Eligibility criteria:
inclusion criteria: * age 1-17 years * known diagnosis of t1d * \>1 prior visit to the uc davis pediatric endocrinology clinic (to avoid enrolling newly diagnosed patients) * suboptimal glycemic control, defined as most recent hemoglobin a1c level of \>8% * access to the internet via a device with video and audio capability (e.g. computer, tablet, mobile phone) * ability to connect their home glucose meter to an internet-capable device via bluetooth or physical cable for the purpose of data uploading. exclusion criteria: * patients and parents whose primary language is not english * patients who have western health advantage health insurance

Keywords: pediatrics
covid - airpollution

Conditions: COVID-19 Confirmed Cases; COVID-19 Mortality

Summary: epidemiological data have related particulate matter (pm), nitrogen dioxide (no2) and ozone (o3) to covid-19 morbidity and mortality at the population level. air pollution may be related to an increase in the covid-19 severity and lethality through its impact on chronic diseases such as cardiovascular and respiratory diseases and diabetes that are also the main comorbidities associated with covid-19. epidemiological studies using individual data are needed to provide more precise estimate of the association between air pollution exposure and covid-19. in this multicenter prospective study, the investigators will analyze the number of deaths in covid-19 confirmed cases in geriatric patients according to long-term exposure to air pollution, taking into account confounders such as diabetes, hypertension, age, and bmi. exposure to air pollution will be estimated as the mean concentration of air pollutants at the residential address during the previous two years. in addition, the investigators will explore the relationship between short-term variations in air pollutants, relative humidity, temperature, uv radiations, pollen and the occurrence of covid-19.


Eligibility criteria:
inclusion criteria: * patient over 60 years old (or dementia patient over 50 years old) * patient hospitalized in a geriatric department over the period from 2020/01/01 to 2020/06/01 * patient who underwent rt-pcr sars-cov-2 * patient (or trusted person/ legal guardian/curator, if applicable) who has given consent to the re-use of his/her data (patient data) for research purposes exclusion criteria: none

Keywords: air pollution covid-19 respiratory viral diseases pm- no2-ozone
mivetscan: can-coach trial (phase 2)

Conditions: Chronic Pain

Summary: the goal of the mivetscan can-coach trial is to test four coaching sessions to help veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.

all study interactions will be done virtually.

Eligibility criteria:
inclusion criteria: * united states veteran * experiencing chronic pain (pain lasting 3 or more months) * moderate to severe chronic pain * are planning or currently using cannabidiol (cbd) or cannabis products for pain management * able to read and speak english sufficiently to allow for informed consent and active participation in the educational intervention sessions * willingness to attend all study visits (conducted virtually) * willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details) exclusion criteria: * inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in english) * participant states participant is pregnant * current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition) * current diagnosis or past history of bipolar disorder * unable to attend study visits * risk for imminent harm - suicidal ideation or wish to die as assessed with the positive and negative suicide ideation (pansi) questionnaire and further risk assessment by study team members * any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol

Keywords: veteran cannabis cannabidiol
an investigation of ags-009 in patients with systemic lupus erythematosus (sle)

Conditions: Inflammation; Systemic Lupus Erythematosus (SLE)

Summary: this trial is conducted in north america. the aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of ags-009 in patients with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * diagnosis of sle * disease duration longer or equal to 6 months * stable, mild to moderate active sle * receiving stable maintenance therapy exclusion criteria: * significant lupus nephritis * active central nervous system (cns) disease * significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing * active vasculitis requiring treatment * body weight over 120 kg * history of cancer * infections * viral: hiv, hepatitis b or c, epstein-barr virus (ebv), cytomegalovirus (cmv), varicella zoster virus (vzv), or herpes simplex virus (hsv-1 or hsv-2) * tuberculosis (tb) * severe systemic microbial infections within the past 12 months prior to dosing * immunosuppressive and immune modulating therapy
procedural sedation for pediatric patients with spinal muscular atrophy

Conditions: Muscular Atrophy, Spinal; Child, Only; Anesthesia

Summary: background and aim: spinal muscular atrophy (sma) is a neuromuscular disease characterized by progressive symmetrical weakness and atrophy of proximal muscles causing from degeneration of anterior horn cells of spinal cord. nusinersen must be administered intrathecally and this treatment is specially for spinal muscular atrophy. procedural sedation is commonly enough for intrathecal treatment in children. in this retrospective study, the investigators aimed to present our experience in procedural sedation for the intrathecal treatment of patients with sma 1,2 and 3 in our hospital.

design: this research is a retrospective obsevational study. methods: after approval institutional review board, data from anesthesia charts and electronic medical records of 14 patients with sma type i, ii and iii who underwent procedural sedation,such as; the demographics data of the patients (age, gender, weight, american society of anesthesiologist (asa) physical status), which anesthetic agent was used and their doeses, during of anesthesia, presence of scoliosis, by whom the procedure was performed etc. was reviewed. all our patients with sma type ii and iii who underwent intrathecal treatment are given sedation with different combination of anesthetic agent. due to peripheral intravenous line was placed previously, intravenous induction was performed in all of our patients for procedural sedation, anesthesiologists used different combination of midazolam, ketamine, propofol, fentanyl or remifentanyl, depending on the patient's requirement. they were oxygenated with a face mask or nasal cannula while their spontaneous breathing continues. all patients were recovered in the recovery room. statistical analysis: the data were analyzed by using spss statistics software (spss 24, chicago, il, usa) descriptive statistics were used in this study. mean and standart deviation were calculated for age (year), weight (kilogram), midazolam dose (mg/kg), fentanyl dose (mcg/kg), remifentanyl dose (mcg/kg), propofol dose (mg/kg), ketamine dose (mg/kg) and length of stay in recovery room (minute) and frequency analysis were made for the number of intervention.

Eligibility criteria:
inclusion criteria: * pediatric patients younger than 18 years old with sma 1,2 and 3 who were to undergo intrathecal nusinersen treatment were included in this study. exclusion criteria: * patients whose procedures were performed under fluoroscopic guidance in the radiology unit were excluded from the study because their procedures were performed in another hospital. * patients without a diagnosis of sma

Keywords: spinal muscular atrophy procedural sedation children intratechal treatment
the chinese mutation hotspot of enac causing liddle's syndrome and the association of enac variations and hypertension

Conditions: Hypertension

Summary: the variations of enac have an impact on the degradation of epithelial sodium channels and sodium reabsorption, and thus are associated with hypertension and hypokalemia. liddle's syndrome is a rare monogenic form of autosomal-dominant hypertension caused by truncating or missense mutations in the c-termini of epithelial sodium channel β- or γ-subunit encoded by scnn1b or scnn1g. our purpose is to determine the hotspot of mutation causing chinese liddle's syndrome. the second purpose is to determine wether the polymorphisms of enac are associated with hypertension in chinese. some polymorphisms of enac associated with hypertension may be genetic risk factors for chinese hypertension.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypertension and liddle's syndrome * clinical diagnosis of normal controls with no cardiovascular disease exclusion criteria: * hypertension caused by other single gene mutation

Keywords: hypertension, enac, liddle's syndrome, variation
measuring the treatment preferences of participants in japan with moderate-to-severe psoriasis (pso) using discrete choice experiment

Conditions: Psoriasis

Summary: the purpose of this observational study is to identify and weight the treatment attributes from the moderate-to-severe psoriasis (pso) patients' perspective in japan.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate-to-severe psoriasis (pso) by physician (phase 1) or self-reported (phase 2) * currently taking systemic psoriasis treatment * japanese resident aged 20 years and older exclusion criteria: * unable or unwilling to provide informed consent * diagnosis of guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis

Keywords: psoriasis japan bms-986165 observational study moderate-to-severe pso dce (discrete choice experiment) preferences
triple combination therapy in high risk crohn's disease (cd)

Conditions: Crohn Disease

Summary: the purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous \[iv\]), a tumor necrosis factor (tnf) antagonist (adalimumab subcutaneously \[sc\]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed cd stratified at higher risk for complications.

the drug being tested in this study is called vedolizumab. vedolizumab is being tested to treat people who have cd. this study will look at the endoscopic remission and mucosal healing of gastrointestinal tract of people who take vedolizumab as triple combination therapy with adalimumab and methotrexate. the study will enroll approximately 60 participants. participants will receive triple combination therapy which includes: * vedolizumab 300 mg (intravenous) * adalimumab 160/80/40 mg (subcutaneous) * methotrexate 15 mg (oral) all participants will receive vedolizumab intravenous infusion on weeks 0, 2, 6, 14 and 22 along with adalimumab 160 mg, subcutaneous injection at week 0, 80 mg at week 2, then 40 mg once at week 4 and every 2 weeks thereafter until week 26 along with methotrexate tablets orally, once weekly from weeks 0 up to week 34. in monotherapy phase, all participants will receive vedolizumab intravenous infusion once at weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102. this multi-center trial will be conducted in the united states and canada. the overall time to participate in this study is 128 weeks. participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a safety follow-up assessment. participants will also participate in a long-term safety questionnaire, by phone, at 26 weeks (6 months) from the last dose of study drug.

Eligibility criteria:
inclusion criteria: 1. has an initial diagnosis of cd established within 24 months prior to screening with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy. 2. has moderate to severely active cd during screening defined by a centrally assessed simple endoscopic score for crohn disease (ses-cd) score \>=7 (or \>=4 if isolated ileal disease). exclusion criteria: gastrointestinal (gi) exclusion criteria 1. has a diagnosis of ulcerative colitis (uc) or indeterminate colitis. 2. has clinical evidence of a current abdominal abscess or a history of prior abdominal abscess. 3. has a known perianal fistula with abscess. (the participant may have a perianal fistula without abscess.) 4. has a known fistula (other than perianal fistula).

Keywords: drug therapy
geriatrics balance and low back pain study

Conditions: Distorted Balance; Low Back Pain

Summary: this study evaluates the effect of standard of care treatments (physical therapy versus manual therapy) in older adult patients who have balance problems with or without low back pain.

this study uses a randomized controlled research design and will enroll up to three hundred patients. treatment will take place in outpatient facilities. it is hypothesized that among older adults with low back pain manual therapy will reduce low back pain and improve balance more than physical therapy; and that among older adults without low back pain manual therapy and physical therapy will be equally efficacious in improving balance. the results of this study will help to further define effective treatment protocols.

Eligibility criteria:
inclusion criteria: * between ages 60-85 * self reported balance problems * with or with out low back pain. exclusion criteria: * history of recent fracture or surgery of lumbar spine, pelvis, hip or femur * history of recent neoplasm (minor skin cancers are not excluded) * acute infectious disease * chronic low back pain persisting for \>8 weeks * severe disabling health problems so that patient is not ambulatory * non-mechanical low back pain * recent unstable peripheral vascular disease and or cardiac disease requiring recent hospitalization \< 6 months ago * patients with balance problems related to the following: meniere's disease, vertigo, or vestibular disorders * recent history of self reported substance abuse * ongoing treatment for balance problems or low back pain by chiropractor, physical therapist, or orthopedic physician or other physician. * current use of medication from the following categories: antipsychotics, anxiolytics, and sedative/hypnotics

Keywords: balance falls low back pain geriatric
a study to evaluate the effect of act-709478 in photosensitive epilepsy patients

Conditions: Photosensitive Epilepsy

Summary: the main study objective is to assess the effect of act-709478 in male and female subjects with photosensitive epilepsy following single dose administration


Eligibility criteria:
inclusion criteria: * signed informed consent in the local language prior to any study-mandated procedure * male and female subjects aged between 18 and 60 years (inclusive) at screening * photosensitive epilepsy and a generalized ppr in response to ips of at least 4 units on a spr in at least 1 condition (eye closure, eyes closed, or eyes open) on 2 occasions at screening with at least 1 hour interval and reproducible on day -1 (less than 3 units difference in spr between screening and day -1) * healthy on the basis of physical examination, cardiovascular assessments and laboratory tests * women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on day -1. they must consistently and correctly use a reliable method of contraception with a failure rate of \<1% per year, be sexually inactive, or have a vasectomized partner. hormonal contraceptives must be initiated at least 1 month before first study treatment administration exclusion criteria: * lactating women * known hypersensitivity to any of the excipients of the study treatment formulation * history or clinical evidence of any disease other than epilepsy and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed) * relevant history of a suicide attempt or suicidal behavior. any recent suicidal ideation within the last 6 months (categories 4 or 5), or any suicidal behavior within the last 2 years, except for "non-suicidal self-injurious behavior" (item also included in the suicidal behavior section), as judged by the investigator using the columbia-suicide severity rating scale (c-ssrs) at screening * history of status epilepticus during the last 12 months * history of non-epileptic seizures that cannot be differentiated from the participant's epileptic seizures * history of generalized tonic-clonic seizures triggered by ips * previous history of repeated fainting, syncope, orthostatic hypotension, or vasovagal reactions in the past 5 years * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
effect of desflurane versus sevoflurane with recent bio-markers on renal and hepatic functions

Conditions: Postoperative Complications

Summary: studying the effects of both inhalational anesthetics desflurane and sevoflurane on hepatic integrity and renal function, guided by recent blood and urine biomarkers in patients undergoing laparoscopic cholecystectomy surgery.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) class: i\&ii. 2. elective laparoscopic cholecystectomy. 3. age: 25-55 years. 4. gender: both male and female. 5. body mass index (bmi): 18.5-24.9 km2-(normal weight). exclusion criteria: 1. extremes of age. 2. abnormal hepatic function by alanine aminotransferase (alt) and aspartate aminotransferase (ast) values outside the normal range. 3. abnormal renal function by blood urea nitrogen (bun) and creatinine above the normal ranges. 4. hypertension, unstable angina pectoris or myocardial infarction within the last six months. 5. pregnancy and lactation. 6. bronchial asthma. 7. drug allergies. 8. alcohol or drug addiction. 9. general anesthesia within the last three months.
ultrasound-guided erector spinae plane blocks

Conditions: Rib Fractures

Summary: the purpose of this study is to determine the feasibility of using the ultrasound-guided erector spinae plane blocks to provide additional pain relief to patients with rib fractures in the emergency department (ed) and intensive care unit (icu).


Eligibility criteria:
inclusion criteria: * patients 18 years old or older. * patients with one or more acute traumatic rib fractures. exclusion criteria: * inability to position appropriately. * unconscious or heavily sedated. * patients who are critically ill such that care should not be delayed for regional anesthesia. * patients under the age of 18 years old. * vulnerable populations including prison inmates and pregnant patients. * overlying skin infection, wound, or dressing/equipment (i.e., chest tube). * inability to visualize target anatomy or by ultrasound or anatomy prohibitive for other reasons to perform procedure successfully. * known or documented allergy to ropivacaine or other amide local anesthetic.