Kornimate/medical-research-clean huggingface dataset:
switching from twice-daily to once-daily clozapine dosing in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. however, to date, several randomized controlled trials (rcts) have shown no differences in clinical outcomes between once- and twice-daily dosing of various antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life. this would apply to clozapine as well; however, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. to address this gap in the literature, the investigators shall conduct a pilot, double-blind, rct to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.

plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. to date, however, several randomized controlled trials (rcts) have shown that once-daily dosing of antipsychotics including perphenazine, risperidone, olanzapine, quetiapine, and asenapine is comparable to twice-daily dosing in terms of efficacy and tolerability, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life. this issue applies to clozapine as well, in that it has a relatively short plasma half-life of 12-16 hours; of note, the product monographs recommends that clozapine be administered more than once daily if the dose exceeds 200 mg/day in canada. despite this, in clinical practice clozapine is frequently administered once daily because of convenience and side effects such as a daytime sedation or somnolence, in support of this, a cross-sectional survey done at the investigators' own centre has revealed that clozapine was prescribed once daily in 75.1% of 676 patients, even though \>200 mg/day was administered in 88.6%. however, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. to address this gap in the literature, the investigators shall conduct a pilot, double-blind, rct to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.

Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia or schizoaffective disorder based on dsm-iv criteria * outpatient status * ages 18 years or older * has received clozapine twice a day, one of which is in the evening/bedtime, at the same dose and dosing regimen for at least 3 months * fluent in english and competent to provide written informed consent exclusion criteria: * having significant medical or neurological illnesses * pregnant or lactating

Keywords: clozapine dosing once daily regimen schizophrenia
cannabinoids for taxane induced peripheral neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: taxane-induced peripheral neuropathy (tipn) affects a significant number of women undergoing breast cancer treatment. some patients may need to shorten their course of treatment, and do not receive the full benefit of chemotherapy as a result. rodent studies have shown that the cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. the goal of this study is to investigate the cannabinoids thc and cbd for tipn.

the investigators' goal is to study the efficacy of cannabinoids as a potential treatment for tipn. volunteers with a diagnosis of breast cancer and chemotherapy-induced peripheral neuropathy, secondary to treatment with paclitaxel or docetaxel, will be enrolled. this study involves the administration of cannabinoids in different strength capsules. the primary outcome measures include measures of pain and functional impairment (non-painful symptoms). the scales will include: 1) brief pain inventory-short form (bpi) for pain severity ; and 2) bpi pain interference subscale for functional impairment. the study outcomes will also include secondary measures of perception, which will be performed in the laboratory.

Eligibility criteria:
inclusion criteria: * 1) participants with breast cancer, experiencing tipn due to paclitaxel or docetaxel. * 2) participants must have an ecog score of 2 or better. participants must have a score of 2 or 3 score for sensory neuropathy, as assessed by the common toxicity criteria adverse events (ctcae). * 3) able to give informed consent and comply with all study procedures. exclusion criteria: * 1) diagnosis of a major medical, neurological, or psychiatric disorder that would preclude study participation. * 2) women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, iud) or currently pregnant. * 3) subjects taking warfarin. * 4) subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.
trauma-informed, resilience-based telehealth intervention for improving hiv prevention and hcv care for persons who inject drugs in the deep south (formative phase)

Conditions: HIV Pre-exposure Prophylaxis; HEPATITIS C (HCV)

Summary: explore the perceptions of people who inject drugs (pwid) and healthcare providers and policymakers to identify barriers to and facilitators of prep uptake and persistence as the primary focus, with hcv care and moud uptake as secondary foci, in the context of aces and intersectional stigma.

investigators will recruit 30 pwid (15 in-care for prep, hcv, and/or moud and 15 not-in-care) for in-depth, one-on-one, semi-structured interviews which will include questions on trauma history; intersecting stigmas; hiv and hcv risk perception; current challenges they face in accessing/using prep, daa, and/or moud; how they view service integration in human service settings; knowledge of and preferences for prep, daa, and/or moud; and perceived barriers to and facilitators of prep, daa, and/or moud uptake and adherence. interviews will also include questions on barriers to and facilitators of participating in a telehealth program; and preferred features of a telehealth intervention, i.e., number, length, frequency, contents of the sessions, interface, and online resources.

Eligibility criteria:
inclusion criteria: * people who actively inject drugs verified by visible injection stigmata (needle tracks) * hiv negative * adult (≥18 years) * lives in rural areas exclusion criteria: * living with hiv * lives in urban areas * not proficient in english

Keywords: hiv pre-exposure prophylaxis hepatitis c virus medications for opioid use disorder barriers facilitators people who inject drugs (pwid) deep south
functional electrical stimulation for individuals with secondary progressive multiple sclerosis

Conditions: Secondary Progressive Multiple Sclerosis

Summary: secondary progressive multiple sclerosis (spms) is a subtype of multiple sclerosis (ms) for which there are no existing therapies that alter the disease course. this research will utilize cutting edge functional electrical stimulation (fes) cycling technology with the goal of improving walking in individuals with spms. the investigators hypothesize that fes cycling will improve walking in subjects with spms.

individuals with secondary progressive multiple sclerosis (spms) experience significant impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs. treatment attempts for progressive ms have been disappointing. no therapeutic intervention has been shown to modulate disability in patients with spms. fes cycling has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. more importantly fes may modulate the inflammatory central nervous system (cns) environment in progressive ms. the investigators are proposing a novel, and easy to implement intervention strategy of fes cycling to help improve gait function in individuals with spms. a successful outcome on a larger spms population would have significant impact towards changing ms clinical care. fes is easily transferable to clinical practice and could potentially ameliorate other complications associated with spms such as spasticity, mood and fatigue reducing the burden of health care cost. in addition, the investigators will gain a better understanding of the mechanisms underlying these changes that could be used to design new therapeutic strategies.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of secondary progressive multiple sclerosis * males and females between the ages of 18 and 65 years * expanded disability status scale score between 5.0 and 7.0 * able to consent to participate in study and are willing to undergo a lumbar puncture and blood draws * if on on ampyra or anti-spasticity agent, must be on stable dose for 1 month prior to screening * no functional electrical stimulation use within 4 weeks * participants must be medically stable with no recent (1 month or less) inpatient admission for acute medical or surgical issues exclusion criteria: * uncontrolled hypertension or other significant cardiovascular disease as determined by investigator * history of epileptic seizures * subjects who have a pacemaker * relapse within thirty days prior to screening visit * pregnancy * subjects having a stage 2 or greater sacral decubitus ulcer

Keywords: spms
mayo clinic family medicine resident wellness study

Conditions: Sleep Patterns

Summary: the objectives of this study are to better understand the association between sleep characteristics (sleep disruptions and deprivations) during overnight shifts and mental fatigue among medical residents, and to explore the feasibility of a virtual, tailored exercise program on sleep characteristics, subjective mental fatigue, and burnout level among residents in family medicine.

the purpose of the proposed study is two-fold: 1) to better understand the association between sleep characteristics (sleep disruptions and deprivations) during overnight shifts and mental fatigue among medical residents; and 2) to explore the feasibility of a three-week tailored, virtual exercise program on sleep characteristics, subjective mental fatigue, and burnout level among residents in family medicine. it is hypothesized that: 1) the greater the number of average sleep disruptions, and the greater the sleep deprivation, the greater the acute mental fatigue during overnight shifts reported by the family medicine residents; 2) the number of average sleep disruptions and the magnitude of sleep deprivation are greater during overnight shifts than non-overnight shifts among family medicine residents; and 3) a three-week tailored virtual exercise program will significantly increase the amount of physical activity throughout the day and reduce the levels of mental fatigue and perceived burnout during overnight shifts.

Eligibility criteria:
inclusion criteria: • a family medicine resident at the mayo clinic health system of eau claire in either the pgy-1 year, pgy-2 year, or pgy-2 year (5 residents from each year). exclusion criteria: * participant is not able to wear the devices for the assigned timeframe. * any condition the investigator considers will prevent compliance with study instructions.

Keywords: acute and chronic cognitive fatigue perceived burnout family medicine residency program
arabic version of henry ford hospital headache disability inventory questionnaire : validity, and reliability

Conditions: Headache

Summary: arabic version of henry ford hospital headache disability inventory questionnaire: cross-cultural adaptation, validity, and reliability

this questionnaire will be developed to assess the impact of headache on functional and emotional aspects of daily life. the alpha version of hdi (alpha-hdi) included 40 items, but the newest beta version (beta-hdi) contains 25 items. the beta version of hdi, developed by jacobson (1994) in english, is a generic headache disability questionnaire widely administered in the related research studies. this questionnaire measures the effect of different medical and rehabilitation treatments on the physical and emotional disabilities in patients with different types of headaches. this generic headache questionnaire is not specific to any headache type. therefore, hdi will be applied to follow the general consequences of different headache types and to compare different aspects of disability for a variety of headaches. based on the literature, the original hdi has strong internal consistency/reliability and construct validity. the results of test-retest showed that hdi has an acceptable level of reliability considering the total questionnaire and its subscale scores. the validity and reliability of the non-english versions of hdi, such as spanish, have been previously investigated and confirmed. the arabic researchers and practitioners need valid and reliable tools to measure the emotional and functional states of patients with different headache disorders. so, this study will be carried out to translate and culturally adapt the hdi questionnaire for administration among the egyptian patients with headaches. moreover, this study will assess the validity and reliability of the developed arabic version of this questionnaire. creation of questionnaires in different languages must pass through many steps. questionnaires must be translated, then culturally adapted to the environment in which they will be used.

Eligibility criteria:
inclusion criteria: 1. chronic primary headache to enter the study. 2. patients having chronic daily headaches at least 15 days a month. exclusion criteria: 1. patients with secondary headaches who has underlying serious problems (infection, trauma, tumors, and brain bleedings) 2. severe psychotic and mental dysfunctions
multiplanar lumbopelvic control in patients with low back pain

Conditions: Low Back Pain

Summary: the purpose of this study was to investigate whether combined assessment of lumbopelvic control during sagittal and frontal plane motion (using two common clinical observational assessments) discriminates between people with and without lbp than single plane assessment alone. it was hypothesized that the two tests used in combination (multiplanar) would perform better than each test used independently (single planar) in accurately discriminating patient cases from healthy controls.


Eligibility criteria:
inclusion criteria: * patients with lbp inclusion criteria: * age 18-70 years old * ability to understand and follow written and verbal instruction in english * seeking treatment from a physical therapist for lbp (pain below t12-l1 vertebral segment), prior to initial evaluation (no treatment provided) matched controls: control subjects will be matched for age, gender, and bmi category to patients with lbp. inclusion criteria: * ability to understand and follow written and verbal instruction in english * no history of lbp during the past 5 years requiring: * \> 3 day absence from work/school/recreation * clinical care (md, dc, dpt, mt) for lbp exclusion criteria: patients with lbp * pregnancy within past 12 months * previous spine or hip surgery * serious spinal or systemic pathology * inability to transfer from standing to supine to sidelying to prone * inability to stand \> 20 minutes matched controls exclusion criteria: * pregnancy within the past 12 months * previous spine or hip surgery * inability to transfer from standing to supine to side-lying to prone * inability to stand \> 20 minutes

Keywords: low back pain lumbopelvic assessment active straight leg raise active hip abduction
neoadjuvant endocrine therapy versus chemotherapy in premenopausal patients with er+ & her2- breast cancer

Conditions: Breast Cancer

Summary: this study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal hr positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.


Eligibility criteria:
inclusion criteria: * 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) histologically confirmed primary invasive breast cancer * stage: t2n0m0(ct\>2cm, slnb negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast) * histologically confirmed hr+ (er or pr positive, and \>50% cell in ihc) her2 negative breast cancer by pathological evaluation * no other previous treatment for primary breast cancer * without other tumor or unstable complication or uncontrolled infection * no contradiction for the third generation ais, lhrha, chemotherapy * attend the study voluntarily, sign the informed consent. exclusion criteria: * metastasis disease by pathological or radiological diagnosis * the history of other tumor * contradiction for the third generation ais, lhrha, chemotherapy * contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy * contradiction for proceeding surgery: contradiction for anesthesia, large lesion,t4, lymph node positive * other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem * have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study

Keywords: premenopausal patients estrogen receptor-positive her2 negative
inhalational anesthesia and precipitation of dementia: is there a link?

Conditions: Alzheimer's Disease; Dementia

Summary: many elderly patients undergoing surgical procedures already have impaired cognitive (memory/concentration) status. patients with pre-existing cognitive impairment, or dementia, may benefit from modified anesthesia techniques. it is estimated that one in eight people age 65 and older has alzheimers disease. more so, nearly half of people that are 85 years or older have alzheimers disease. currently, both spinal (regional) and inhalational (general) anesthesia, are used in patients undergoing common urological, orthopedic, and general surgical procedures. inhalational anesthesia has been associated with higher risk of memory impairment in experimental (animal) and human studies. however, currently, there are simply no large or good enough studies to be sure that inhalational anesthesia is responsible for causing dementia and alzheimers disease.the proposed study investigates if elderly patients (65 years and older) undergoing spinal anesthesia (patient is awake or slightly sedated) are less likely to develop dementia and alzheimers disease for up to 2 years after surgery, when compared to inhalational anesthesia (patient is kept asleep with gas anesthetic). the investigators will also test all patients for the presence of apolipoprotein (apoe-îμ4 type of gene that is present in 15-20% of patients), and beta-amyloid tau protein (present in cerebrospinal fluid) that are known risk factors for alzheimers disease. the particular strength of this study is that it takes into account whether the frequency and/or severity of dementia and alzheimers disease is different in patients with and without these markers. the investigators believe that this study will make a major contribution to better understanding of development of alzheimers disease.


Eligibility criteria:
inclusion criteria: * \>65 yrs of age * male or female * scheduled to undergo urologic procedures (e.g., transurethral resection of prostate, transurethral resection of bladder tumor), orthopedic (e.g., total knee replacement, total hip replacement) general (e.g., femoral hernia repair, lower abdominal surgery) or vascular surgery procedures (e.g. lower limb reperfusion amputations) and qualifies to be randomized to receive either local (spinal) or general anesthetic exclusion criteria: * diagnosis of severe dementia * diagnosis of any other significant neurological disease such as parkinson's, multi-infarct dementia, huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain or spinal abnormalities.

Keywords: elderly surgical patients alzheimer's disease dementia elderly surgery
clinical trial in constitutional thinness

Conditions: Individuals With Constitutional Thinness

Summary: the purpose of this study is to evaluate the molecular differences between a group of constitutionally thin (ct) subjects and a group of controls.


Eligibility criteria:
inclusion criteria: * inclusion criteria specific to subjects with constitutional thinness * women: bmi less or equal to 17.5 * men: bmi less or equal to 18.5 * stable weight for at least 3 months inclusion criteria specific to subjects with normal weight * men and women: bmi above or equal to 20 but not more than 25 * stable weight for at least 3 months * no previous family history of first or second-degree obesity inclusion criteria common to both groups * age: between 18 and 35 at the inclusion visit * normal blood sugar, liver function, lipid and coagulation profiles * signed consent form to participate in the study * signed consent form for genetic analysis * acceptance of a moderate weight gain of 2 kg (less than 10% of body weight) * beneficiary or member of a social security system. exclusion criteria: * adults with a legal guardian, or subjects unable to act freely due to a decision by a legal or administrative authority, * pregnancy in the case of women * women without contraception * vegetarian subjects or those with lactose intolerance * subjects with an eating disorder (dsm iv) * significant alcohol consumption equivalent to more than 10 glasses of wine per week * severe progressive disorder (diabetes, for example) * subjects who undertake intensive physical activity (more than 3 sessions of physical activity per week) * significant tobacco consumption equivalent to more than 10 cigarettes per day * depression or psychiatric condition (treated with antidepressant or psychotropic medication), depression questionnaire/score * medical or surgical history considered by the investigator to be incompatible with this study (stomach or intestinal surgery, for example) * subjects receiving treatment that may interfere with the parameters measured: antihypertensives (blockers, centrally acting antihypertensives), anti-hyperlipidemic agents or corticosteroids for more than 8 days * inclusion in a different clinical study within the previous 12 weeks.