Kornimate/medical-research-clean huggingface dataset:
opioid treatment program (otp)-pharmacy collaboration for methadone maintenance treatment

Conditions: Opioid-use Disorder

Summary: the overarching goal of this pilot study is to explore the feasibility, acceptability, and patient/provider satisfaction of pharmacy-based administration and dispensing of methadone for opioid use disorder. the results gained will inform the development of a future multisite randomized clinical trial.

the study will use a non-randomized, prospective, single group design. twenty long-term, clinically-stable methadone maintenance treatment (mmt) patients who receive between 6- and 13-days methadone take-home doses will be enrolled in the study where their methadone take-home administration and dispensing will be transferred to a community pharmacy for 3 months. participants will also complete three follow-up assessments at 1-month, 2-months, and 3-months after the baseline visit to collect clinical and safety information since the previous assessment. primary outcomes will be focused on feasibility measures (recruitment, accessibility to methadone treatment, substance use, medication call back success, and retention in treatment). secondary outcomes will be focused on self-reported satisfaction measures from mmt providers (e.g., physician, physician assistant, nurse, and counselor) pharmacists, and patient participants.

Eligibility criteria:
inclusion criteria: * patient aged 18 or older receiving methadone treatment at morse clinic in raleigh or zebulon, nc. * able to provide informed written consent to participate in the pilot study. * receiving a stable methadone dose between 5 mg and 160 mg. * having all negative drug tests (except for prescribed methadone and ethanol) at the otp for the past 12 months. * no missed call-backs in the past 12 months. * no signs/symptoms of a co-occurring major mental illness (i.e., thought disorder, thoughts of harm to self or others, delusions or hallucinations, cognitive impairment compromising informed consent to study procedures and requirements). * meeting the federal and state regulations for eligibility to receive between 6- and 13-days of take-home methadone and receiving this level of take-home doses at the time of study enrollment. * if female, using adequate birth control methods. exclusion criteria: * have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study. * have chronic pain requiring ongoing pain management with opioid analgesics. * prisoner status or pending legal action that could prevent participation in study activities * legal order for treatment (e.g., parole, probation, or pre-trial) * pregnant or breastfeeding at the time of screening.
the effect of virtual reality exercises on patients with post-sars-cov-2 syndrome

Conditions: Covid19

Summary: the aim of this study is to investigate the effectiveness of virtual reality exercises on pain, cardiopulmonary capacity, mood and quality of life in patients with post-covid syndrome.

this study, which will be conducted in sivas cumhuriyet university, physical medicine and rehabilitation clinic, was diagnosed with covid-19 from an oropharyngeal or nasopharyngeal swab sample more than 90 days ago with polymerase chain reaction, whose symptoms have continued since the diagnosis of covid-19, and inpatient treatment. 63 adult female and male post-covid syndrome patients who did not develop pneumonia or organ failure findings will be included. those who have had acute myocardial infarction in the last 6 months, have cardiovascular system disease such as uncontrolled hypertension, arrhythmia, aneurysm, cardiac failure, have undergone fracture or orthopedic surgery in the last 3 months, have a known chronic respiratory system disease, cause widespread pain such as fibromyalgia syndrome those who have a disease or cannot be mobilized independently will not be included in the study. the sample size was determined as d=0.80 α=0.05 p=0.80410 n=54 using the g\*power 3.1.9.4 program. considering the 15% drop-out risk, 63 patients were planned to be included. demographic data of all participants, including age, gender, height, weight and body mass index, and the time elapsed since the diagnosis of covid-19 will be recorded. in addition, participants' pain intensity, functional capacity, general health status, mood, and fatigue levels will be evaluated.

Eligibility criteria:
inclusion criteria: * diagnosed with covid-19 by polymerase chain reaction from an oropharyngeal or nasopharyngeal swab sample more than 90 days ago, whose symptoms have continued since the diagnosis of covid-19 exclusion criteria: * have been hospitalized due to covid-19, * have developed pneumonia or organ failure findings. * have had an acute myocardial infarction in the last 6 months, * have cardiovascular system disease such as uncontrolled hypertension, arrhythmia, aneurysm, cardiac failure, * have undergone fracture or orthopedic surgery in the last 3 months, * have a known chronic respiratory system disease, * have widespread pain such as fibromyalgia syndrome
long term treatment of patients with major depressive disorder with mk0869 (0869-065)(completed)

Conditions: Major Depressive Disorder

Summary: a clinical study to determine the efficacy and safety of an investigational medication (mk0869) in the treatment of depression.

the duration of treatment is 20 months.

Eligibility criteria:
patients with major depressive disorder
real-world outcomes of aplastic anemia patients treated with eltrombopag: a medical claims database study

Conditions: Anemia, Aplastic

Summary: the main goal of this study was to investigate the effectiveness and safety of eltrombopag (etb) when compared to other treatments in japanese aplastic anemia (aa) patients using data from the medical data vision (mdv) hospital-based database.


Eligibility criteria:
inclusion and exclusion criteria for the safety population: inclusion criteria: * patients with: * at least one confirmed diagnosis of aa registered during the baseline period, or * at least one confirmed diagnosis of idiopathic thrombocytopenic purpura (international classification of diseases, 10th revision \[icd10\] code: d69.3) registered before the index date and at least one confirmed diagnosis of aa during the follow-up period. * had at least 6 months of continuous enrolment prior to the index date. confirmed diagnosis was defined as having ≥1 inpatient or ≥2 outpatient claims with a relevant icd-10 code and without any doubtful flag. continuous enrolment (being continuously followed in the database) was defined as having at least one claim every semester. exclusion criteria: * not receiving atg, csa, etb or romiplostim (rom) during the selection period, * had a diagnosis of acute myeloid leukemia (aml), chronic myelomonocytic leukemia (cmml), myelofibrosis, other hematological malignancies, or cataract before the index date. inclusion and exclusion criteria for the effectiveness population: inclusion criteria: * had at least one confirmed diagnosis of aa registered before the index date, * had at least one procedure for any type of transfusion such as red blood cell transfusion, platelet transfusion, or granulocyte transfusion registered during the baseline period or within 4 weeks after the index date, * had at least 6 months of continuous enrolment prior to the index date, * had at least a 6-month follow-up period. exclusion criteria: * not receiving atg, csa, etb or rom during the selection period, * had at least one prescription of atg, csa, etb or rom before the index date, * had a diagnosis of aml, cmml or other hematological malignancies before the index date.

Keywords: eltrombopag effectiveness safety treatment patterns
an extension study to evaluate the efficacy and safety of elagolix in premenopausal women with heavy menstrual bleeding associated with uterine fibroids

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

Summary: this is an extension study for women who have already received six months of treatment in the phase iii clinical trial m12-815 (nct02654054) or m12-817 (nct02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.


Eligibility criteria:
inclusion criteria: * participant has completed the 6-month treatment period of their respective pivotal study (either study m12-815 or study m12-817). * participant did not meet removal criteria in bone mineral density (bmd) decrease in the spine, total hip and femoral neck at month 6 of the treatment period of their respective pivotal study * participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the treatment period of their respective pivotal study and prior to first dose in this study. * participant's endometrial biopsy from the month 6 visit of their respective pivotal study shows no clinically significant endometrial pathology. exclusion criteria: * participant met criteria for removal from therapy in her respective pivotal study. * participant is planning a pregnancy within the next 18 months. * participant has current suicidal markers as noted at the month 6 visit of her respective pivotal study. * participant has any new medical conditions that may be unsuitable for participation. * participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.

Keywords: uterine fibroids elagolix heavy menstrual bleeding elagolix sodium elagolix plus norethindrone acetate
watch laser acupuncture with nasal radiation for prevention of coronary artery disease

Conditions: Cardiovascular Risk Factor; Coronary Artery Disease

Summary: this study will evaluate the effect of low level laser blood radiation applied to all participants for prevention of coronary artery disease in patients with high risk (hypertension,high blood viscosity, hypercholesterolemia as well as related immune issues)

the areas of low - intensity laser use have expanded in several conditions by different mechanisms and ways. hypertension as one of coronary artery disease risk factors and early indicator of future cardiovascular events with high blood viscosity and elevated blood cholesterol levels with immune-pathological basis became necessary issue to be handled. low level laser irradiation effects on blood is very essential way in revealing the mechanisms of the action of laser radiation on biological tissues by means of changes in metabolism, leading to molecular, cellular and systemic changes.

Eligibility criteria:
inclusion criteria: * stage i hypertensive patients * patients from 30 to 34.9 kg/m2 body mass index * medically stable patients * all participants have sufficient cognition enough to understand the requirements of the study exclusion criteria: * history of malignant disease * smoking * history of progressive fatal disease * history of drug or alcohol abuse * blood donation within at least 30 days * pregnant, trying to be pregnant or breast feeding * cognitive impairment that will make it difficult to partake in the study

Keywords: hypertension high blood viscosity hypercholesterolemia
clinical trial of the use of tocilizumab for treatment of sars-cov-2 infection (covid-19)

Conditions: COVID-19

Summary: covid-19 is a respiratory disease caused by the new coronavirus (sars-cov-2) and causes considerable morbidity and mortality. currently, there is no vaccine or therapeutic agent to prevent and treat a sars-cov-2 infection. this clinical trial is designed to evaluate the use of tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with covid-19.


Eligibility criteria:
inclusion criteria: * subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure. * understand and agree to abide by the study procedures. * adult #18 years of age at the time of inclusion in the study. * confirmation of sars-cov-2 infection by a microbiological test performed before randomization, no longer than 72 hours. * severity 3-4 according to the who 7-point ordinal scale. exclusion criteria: * alt / ast\> 5 times the normal limit * stage 4 chronic kidney disease (gfr \<30) or requiring dialysis. * presence of comorbidities that imply a poor prognosis (according to clinical judgment). * advanced dementia. * pregnancy or breastfeeding. * anticipation of transfer to another center in the 12 hours at the beginning of the study. * allergy to study medication. * serious or active bacterial infections or documented sepsis by pathogens other than sars-cov-2. * streptococcus pneumoniae antigenuria positive before study start. * neutropenia \<500 / mm3. * thrombocytopenia \<100,000 / mm3. * history of diverticulosis. * ongoing skin infection (eg, pyodermitis). * transplanted patient under immunosuppressive treatment. * previous evidence of latent untreated tuberculosis.

Keywords: tocilizumab
nicotine lozenge or tobacco-free snuff for smokeless tobacco reduction

Conditions: Tobacco Dependence

Summary: smokeless tobacco (st) is a known human carcinogen. long-term st use is known to increase the risk for oropharyngeal cancer. extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. the overarching goal of this line of research is to develop a st reduction intervention among st users not interested in quitting tobacco. our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing st use or facilitating st abstinence among st users not interested in quitting.

in this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their st use over 8 weeks with follow-up at 12 weeks. forty subjects will be recruited at mayo clinic in rochester, mn, and 40 subjects will be recruited at the oregon research institute in eugene, oregon.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age; 2. no intention of quitting in the next one month; 3. report st as their primary tobacco of use; 4. have used st daily for the past 12 months; 5. have been provided with, understand, and have signed the informed consent 6. are able to complete all study visits; 7. are in general good health as determined by medical history. exclusion criteria: 1. currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program; 2. currently enrolled in another research study; 3. describe having a medical history of: (a) unstable angina; (b) myocardial infarction within the past 6 months; (c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia; or (d) medically-treated or untreated hypertension with bp ≥ 180 systolic or ≥ 100 diastolic; 4. have phenylketonuria (pku) \[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with pku\]; 5. have another member of their household already participating in this study; 6. have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators; 7. have a score of ≥ 15 on the patient health questionnaire (phq-8) on the phone call pre-screen; 8. are currently pregnant are trying to become pregnant; 9. are currently breast-feeding and unwilling to stop during this study.

Keywords: tobacco dependence tobacco reduction chewing tobacco snuff moist snuff
evaluation of cognitive dysfunction and psychiatric comorbidities

Conditions: Wilson Disease

Summary: primary objective * collection of patients with wilson disease either presented with neurological or hepatic symptoms * assessment of psychiatric and cognitive disorders in both groups by using specific scales secondary objective * correlation of mri brain findings with cognitive \& psychiatric symptoms found in the patients ,if possible.

wilson's disease is an autosomal recessive disorder of copper metabolism caused by atp7b mutations. originally described as hepatolenticular degeneration, it classically presents with the combination of liver disease and a movement disorder during adolescence or early adulthood, albeit with a highly variable phenotype. up to 60% of patients have neurological or psychiatric symptoms at onset, and are referred to as having neurological presentations (1). chelating agents are used to 'de-copper' patients but neurological outcomes are unpredictable; symptoms usually improve however, a minority have persistent or progressive neurological disability (2, 3). it is clinically relevant that the severity of neurologic symptoms commonly fluctuates, sometimes during the same day. symptoms may be exacerbated by stress, concurrent illnesses, or medications (4). wd has been associated with multiple cognitive, emotional, or psychiatric disorders, which may occur at any stage of disease (5 ). the first psychiatric manifestation of wd could occur in childhood and appear as a decline in school performance, inappropriate behavior or impulsiveness(6). it is common to observe classic psychiatric syndromes in later early adulthood, including behavioral and personality changes, anxiety, depression, manic and hypomanic syndrome, cognitive deficits (7-10). personality and behavioral disorder due to brain disease, damage and dysfunction' (11).the bg are a structure capable of generating diverse psychiatric syndromes under dysfunctional conditions. cognitive impairment in wd patients with neuropsychiatric presentation is well described (12) and probably related to the cerebral lesions detected by mri (13). wd patients will firstly experience prospective memory related to the planning or goal-making of daily activities (14), which is associated with gray matter loss in the basal ganglia and structural changes in frontal and occipital whiter matter (15).

Eligibility criteria:
inclusion criteria: * age 8-70, both sexes, diagnosed as wilson disease. exclusion criteria: * • patients with neurological symptoms due to neurological disease other than wilson disease such as patients with cerebrovascular stroke or parkinson disease, ...... * patients with hepatic encephalopathy or severe neurological impairments (disabling dysarthria, tremor or dystonia) or severe psychiatric disorders incompatible with neuropsychological examination * patients with liver transplant
effect of a self-care intervention on depression in people with age-related macular degeneration or diabetic retinopathy

Conditions: Depression; Age-related Macular Degeneration

Summary: the purpose of this trial is to determine the short-term effect of a self-care intervention on depression in patients with age-related macular degeneration or diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of wet or dry amd or diabetic retinopathy * age 50 years and older * at least mild depressive symptoms (a score of 5 or more on the phq-9) * no legal blindness (visual acuity better than 20/200 in better eye). exclusion criteria: * the current use of cognitive behavioural therapy * suicidal intent * ocular surgery during the study period (intravitreal anti-vegf injections will be allowed, e.g. lucentis) * cognitive impairment * inability to speak and understand french or english * profound hearing impairment.

Keywords: depression age-related macular degeneration self-care self-help
comparison of dietary fats on vascular parameters

Conditions: Healthy

Summary: the purpose of the study is to examine the effect of consuming 50g of fat from 5 different sources (coconut, canola, grapeseed, chia, and butter) on arterial stiffness, blood pressure and blood glucose levels. it is hypothesized that butter will have the most detrimental effect on acute vascular function. canola, grapeseed and chia oil with their decreased content of sfa are hypothesized to impair vascular function to a lesser extent.


Eligibility criteria:
inclusion criteria: * healthy * age 18-65 years * bmi \< 30 kg/m2 * brachial systolic blood pressure ≤ 140 mmhg * brachial diastolic blood pressure ≤ 90 mmhg exclusion criteria: * women of childbearing age must not be pregnant or breastfeeding at the time of the study * bmi \>35kg/m2 * hypertensive as defined by brachial sbp \>140mmhg and/or dbp \>90mmhg * sensitivity to the study product or its sources * presence of chronic conditions or illnesses * having any gastrointestinal complication or condition * chronic use of dietary supplements that alter fat absorption

Keywords: healthy arterial stiffness blood pressure blood glucose vascular function
the effect of injection rate of local anesthetic in caesarean section

Conditions: Anesthesia, Spinal; Anesthesia, Obstetrical

Summary: this randomized double-blind study aimed to compare the effects of two different subaracnoid lokal anesthetic injection rate in cesarean section. totally 67 patients were included. the groups were compared in terms of maximum sensory and motor block level, time to reach t6 level, hemodynamic changes and nausea- vomiting saved.

a total of 67 patients 18-40 years undergoing cesarean, who were graded as american society of anesthesiologists physical status were randomly allocated into two groups, 120-sn injection time (n=34, group f), 15-sn injection time (n=33, group s). when the level of the sensory block achieve the t6 level the surgery was let to begin. the groups were compared in terms of hemodynamic values, use of efedrin, the time to achieve sensory block to the t6 level, maximum sensory block level and motor block level.

Eligibility criteria:
inclusion criteria: * anesthesiologists risk score (asa) i-ii risk status * singleton pregnancy aged * between 18-40 years exclusion criteria: * pregnant women with contraindications for spinal anesthesia; * placental anomaly; * hypertension * cardiac disease * vascular disease * hepatic disease * renal disease * hemodynamic instability * spinal deformity; * severe mental retardation * weight \ 110 kg; height \ 180 cm * metabolic and acid-base balance disorders * emergency patients
efficacy mydrane ® for cataract surgery in patients with concomitant primary open angle glaucoma.

Conditions: Cataract Surgery

Summary: the aim of this study is to compare mydrane ®, mydriatic eye drops and mydriasert ® in terms of pupil site stability, surgical time, visual field and anterior chamber configuration modifications among primary open angle glaucoma (poag) patients during cataract extraction surgery.

60 patients with coexisting poag and cataract who underwent elective cataract extraction. all patients underwent ophthalmic routine examinations including automatic visual field examination, anterior chamber configuration, specular microscopy and arterial blood pressure measurement prior to surgery, 24 hours and 30 days postoperatively. all cataract surgeries were videorecorded, and all measurements were performed using media player. 20 patients received topical mydriatic eye drops, 20 patients received mydriasert ® whereas 20 patients received intracameral injection of mydrane ® just after the first incision.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age * diagnosed with age-related cataract with concomitant poag well controlled by pharmacological therapy (iop within its target during the entire day in a minimum of 12-month follow-up with constant use of anti-glaucoma medications) * required cataract extraction under local anesthesia * no history of previous surgery in the study eye exclusion criteria: * patients with poag requiring glaucoma surgery * ocular trauma or infection * other forms of glaucoma * pseudo-exfoliation and exfoliation syndrome

Keywords: mydriasis and intraocular anaesthesia