Kornimate/medical-research-clean huggingface dataset:
effects of abrocitinib in subjects with atopic dermatitis with an unsatisfactory response after treatment with dupilumab

Conditions: Atopic Dermatitis

Summary: this is a single-arm, open-label study that will examine the effect of abrocitinib in subjects with atopic dermatitis.

this study is being conducted to evaluate the efficacy, safety, and molecular effects of abrocitinib in subjects with an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab. approximately 60 subjects with atopic dermatitis will receive abrocitinib once daily for 12 weeks.

Eligibility criteria:
inclusion criteria: 1. male or female subject 18 years of age or older, at the time of consent. 2. subject has clinically confirmed diagnosis of active atopic dermatitis (ad), according to hanifin and rajka criteria. 3. subject has at least a 1-year history of ad and had no significant flares in ad for at least 4 weeks before screening. 4. subjects who had moderate to severe ad before initiating dupilumab treatment. 5. subject currently has an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab, defined as follows: 1. a global viga-ad ≥ 2, at least 1% bsa with facial erythema, and a modified viga-ad for the face ≥2 at screening and day 1 or 2. a global viga-ad ≥ 2, at least 3% bsa affected by ad on the trunk and/or limbs, and a modified viga-ad for the trunk/limbs ≥ 2 at screening and day 1. exclusion criteria: 1. subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. 2. subject has clinically infected ad. 3. subject has a history of skin disease or presence of skin condition that would interfere with the study assessments. 4. subject has a history of cancer within 5 years prior to day 1. 5. subject has a history of lymphoproliferative disorder, lymphoma, or leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. 6. subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. 7. subject is known to have immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency. 8. subject has a current or recent clinically serious infection. 9. subject has used abrocitinib prior to day 1. 10. subject has a known hypersensitivity to abrocitinib or its excipients. 11. subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to day 1 that in the opinion of the investigator will preclude participation in the study.

Keywords: eczema dupilumab abrocitinib
effect of insulin resistance reducing agents pre and post cabg on post-operative metabolic status and oxidative stress

Conditions: Coronary Artery Disease

Summary: the present study aimed to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood glucose and oxidative stress regulation.

the present study aimed to evaluate the effect of a combination of insulin resistance reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood glucose and oxidative stress regulation. the sample size was estimated to be 92 (23 in each group). the participants of the study were selected from the non-diabetic patients scheduled for cabg. the patients were allocated to four groups using balanced block randomization method: 1. consumption of the supplement (a 20 gram pack of the supplement daily) 7 days before surgery and placebo (a pack of starch) 30 days post surgery 2. consumption of placebo 7 days before surgery and supplement 30 days post surgery 3. consumption of the supplement 7 days before and 30 days post surgery 4. consumption of placebo 7 days before and 30 days post surgery one week before, before the onset of the surgery, after the surgery, 1 week after and 4 weeks after the operation, blood samples were taken and the levels of hemoglobin a1c, glucose, insulin and malondialdehyde were measured. also, body composition indices were assessed in four times: one week before the surgery, before the onset of the surgery, 1 week after and 4 weeks after the surgery.

Eligibility criteria:
inclusion criteria: * mean age of 30-70 years old, having coronary artery disease * undergoing coronary artery bypass grafting surgery exclusion criteria: * positive history of diabetes mellitus, metabolic, hematological, and immune disorders, renal problem, and cerebrovascular accident * taking antioxidant supplements * cases for emergency operations * ejection fraction \< 30%

Keywords: insulin resistance blood glucose cabg oxidative stress
efficacy and safety study of aripiprazole to treat schizophrenia

Conditions: Schizophrenia

Summary: this study design is subject to relevant sfda regulations about clinical trials. patients will be screened for inclusion into the study at the initial visit(240 patients to be recruited) and then undergo a minimum of 3-7 day's placebo washout period(placebo wash out is to eliminate the effect of prior antipsychotic medication with tablets without any active ingredients)(patients without prior antipsychotic medication are exempt from the washout phase). after screening and washout period, eligible patients will be randomly assigned to the two treatment group, aripiprazole or risperidone, for 6 week's treatment. patients will be hospitalized for the entire duration of the study. patients' condition will be assessed weekly.


Eligibility criteria:
inclusion criteria: inclusion criteria for screening 1. schizophrenia or acute schizophrenia-like psychotic disorder(icd 10) 2. panss total of no less than 60 3. age: 18-65; male or female 4. informed consent from the legal guardians of the patients inclusion criteria after washout 1.panss total of no less than 60 2.3-7days washout with placebo is required after discontinuation of other oral antipsychotics; no washout is needed for patients who had never taken any antipsychotics before; in cases that patients's condition is deemed clinically deteriorating and immediate treatment is needed, patients with less than 3 days' placebo washout could be randomized after notifying the sponsor 3.no serious function impairment in heart, liver or kidney. - exclusion criteria: for screening 1. tendency or history of suicide 2. patients with extreme agitation, violent attacking behavior towards people and those who can hardly comply with treatment 3. diagnosis of other mental diseases besides schizophrenia 4. diabetes or other serious unstable diseases or the following neurological diseases, migraine, epilepsy, parkinson's disease, alzheimer's disease, multiple sclerosis, stroke and tia etc 5. patients who take fluoxetine in the past 1-month before screening 6. patients who had participated any other clinical trial in the past 1-month before screening 7. history of alcohol or drug abuse or dependence 8. pregnancy or breast-feeding 9. patients who have had gastrointestinal operations that could affect drug absorption. 10. allergy to risperidone or aripiprazole or hypersensitiveness to any drug 11. patients who discontinued long-acting antipsychotics less than one treatment cycle before screening 12. refractory schizophrenia patients who did not respond to treatments of two different type antipsychotics with adequate dose and course, or patients who did not respond to clozapine 13. patients who had electroconvulsive therapy (ect) in the past 6 months after washout 1. diagnosis of other mental diseases besides schizophrenia during the washout period 2. significant abnormal ecg or laboratory examination results (alt,ast\>1.5 times of higher limit of normal range), not suitable to be enrolled based on the investigator's discretion. -

Keywords: aripiprazole schizophrenia clinical trial risperidone
epidemiology non-cholera vibrio infections

Conditions: Vibrio Infections

Summary: the purpose of this study is to identify the epidemiological and clinical characteristics of patients diagnosed with non-cholera vibrio infection in western france from 2000 to 2019.

vibrios are gram-negative, ubiquitous bacteria of the marine flora and are found particularly in warm waters. for example, the incidence is high in florida and vibrio infections are now reportable in the united states. different species of vibrio are described. a distinction is made between choleric vibrios belonging to serogroups o1 and o139, responsible for cholera epidemics, and non-choleric vibrios. our study will focus on non-cholera vibrios. vibrio infections can occur by eating contaminated raw seafood or by exposure of a wound to the marine environment. they occur mainly during the hot summer months. this can be explained on the one hand by higher water temperature and on the other hand by increased beach use. with global warming, it is possible that vibrio infections may increase in number and location.

Eligibility criteria:
inclusion criteria: * non-cholera vibrio infection exclusion criteria: * vibriosis to vibrio cholerae o1 and o139
study evaluating the safety and tolerability of sca-136 in healthy japanese and non-japanese female subjects

Conditions: Schizophrenia

Summary: this study is being conducted to evaluate the safety and tolerability of ascending multiple oral doses of sca-136 adminstered to healthy japanese and non-japanese female subjects.


Eligibility criteria:
inclusion criteria: * healthy japanese women or non-japanese of child bearing potential using nonhormonal contraceptives. * japanese female subjects are defined as being born in japan but living outside of japan for less than 5 years. exclusion criteria: * any significant disease. * positive urine drug screen, increased liver funtion tests, use of prescription drugs.

Keywords: pharmacokinetics pharmacodynamics
the effect of epidural steroid injections on glycemic control in diabetic patients according to the doses of steroids

Conditions: Low Back Pain

Summary: there has been no reports of the effect of various kinds of steroid or various dose of steroid which are commonly used in the clinical setting. previous studies have simply shown that the blood glucose level is elevated in diabetes patients and did not show or suggest the adequate strategy of epidural steroid injection in diabetes patients regarding steroid type, dosage or injection interval. therefore, the investigators tried to evaluate the effect of different dosage of triamcinolone, which is a commonly used steroid in epidural steroid injection, on the blood glucose level.

it is well known that blood glucose level is elevated in diabetes patients more than non-diabetes patients who underwent the epidural steroid injection. however, there has been no reports of the effect of various kinds of steroid or various dose of steroid which are commonly used in the clinical setting. previous studies have simply shown that the blood glucose level is elevated in diabetes patients and did not show or suggest the adequate strategy of epidural steroid injection in diabetes patients regarding steroid type, dosage or injection interval. therefore, the investigators tried to evaluate the effect of different dosage of triamcinolone, which is a commonly used steroid in epidural steroid injection, on the blood glucose level.

Eligibility criteria:
inclusion criteria: * subjects who undergo epidural steroid injection (caudal epidural injection or selective transforaminal block) in the pain medicine outpatient clinic * subjects older than 20 yrs. exclusion criteria: * asa (american society of anesthesiologists class) iii or more * severe cardiopulmonary disease or brain disorder * subjects diagnosed uncontrolled diabetes with complications * subjects undergoing hormone therapy * subjects with active infection * subjects with pregnancy * subjects with recent stress condition such as surgery or trauma * subjects with active neurologic disorder * those with anticoagulation therapy

Keywords: epidural steroid injection triamcinolone fasting blood glucose diabetes mellitus
incidence of venous thromboembolism in children undergoing elective neurosurgical procedures

Conditions: Deep Vein Thrombosis

Summary: the purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized. the information gained from this study will help us determine when children children need to receive therapy to help prevent this type of blood clot from forming.


Eligibility criteria:
inclusion criteria: * patients age 1 month-12 years undergoing elective neurosurgical procedures. exclusion criteria: * patients undergoing outpatient neurosurgical procedures * patients with known dvt * patients with known hypercoagulable state * patients at high risk for dvt (discretion of surgeon in consultation with the hematology service)

Keywords: deep vein thrombosis children pediatric anti-coagulant neurosurgical procedures blood clot
a study to investigate how effective and safe solifenacin succinate suspension is in treating children/adolescents aged 5 to less than 18 years with symptoms of overactive bladder (oab) compared to a non-active drug

Conditions: Urinary Bladder, Overactive

Summary: solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. for the use in children and adolescent patients a new formulation of solifenacin has been developed. this study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. the 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (non-interventional diary assisted urotherapy consisting of overactive bladder (oab) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for oab), followed by a 12 week daily treatment period. the study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.


Eligibility criteria:
main inclusion criteria: * written informed consent has been obtained * oab (symptoms of urgency) according to international children's continence society (iccs) criteria * daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary main exclusion criteria: * daily voiding frequency less than 5 * extraordinary daytime urinary frequency according to the international children's continence society (iccs) definition * uroflow indicative of pathology other than oab * maximum voided volume (morning volume excluded) \> expected bladder capacity for age \[(age +1) x 30\] in ml or a maximum voided volume (morning volume excluded) above 390 ml * post void residual (pvr) \> 20 ml * monosymptomatic enuresis * polyuria defined as \> 75 ml/kg/b.w./24 hours * dysfunctional voiding * congenital anomalies affecting lower urinary tract function * current constipation * current urinary tract infection (uti) * catheterization within 2 weeks prior to screening

Keywords: pediatric solifenacin succinate suspension phase 3 pharmacokinetics overactive bladder (oab)
effect of laser acupuncture alone or combined with pranayama exercise on inflammation in allergic rhinitis in geriatrics

Conditions: Allergic Rhinitis

Summary: allergic rhinitis (ar) represents one of the most common global health problems with seriously increasing incidence over the last decades.the goal of the treatment of rhinitis is to prevent or reduce the symptoms through reduction of the inflammation of affected tissues. acupuncture and pranayama yoga exercises had reported a significant improvement in daily symptoms and an increase of symptom-free days in many studies enrolling geriatric patients.

sixty egyptian geriatrics with allergic rhinitis, after randomization, will be divided to 2 groups; the first 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for 8 weeks), the second group will receive 3-session per-week laser stimulation for eight weeks to some bilateral selected acupoints. the stimulated points will be (li 19, li 20, st2, and st4. st6, st7, st17, st36, si18, bl2, gb14, gv24 and exhn5). every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

Eligibility criteria:
inclusion criteria: * geriatrics with allergic rhinitis exclusion criteria: * chest disease or heart disease or local congenital nose deformities participants received within-previous-eight-months self-prescribed or by-therapist prescribed complementary therapies
comparison of pain relief and peripheral perfusion index

Conditions: Erector Spinea Plane Block

Summary: the primary endpoint of this study is to compare the pain relief and peripheral perfusion index using different volume of local anesthetics in erector spinae plane block.

the erector spinae plane block (espb) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. in contrast to common neuraxial techniques such as paravertebral and epidural injections, the espb targets an interfascial plane which is far from the spinal cord, root, and pleura. first applied to thoracic neuropathic pain, currently espb is being applied to postoperative pain control and includes variable clinical situations. in the abdomen and thoracic wall, thoracic espb can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar espb. in addition, espb has also been used for chronic pain conditions in the upper and lower extremities. to investigate the possible mechanism of action of the espb, many previous studies have focused on examining the physical spread of the injected agent. commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (ct), thoracoscopic inspection, or magnetic resonance imaging (mri) with radiocontrast injection. apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. perfusion index is an indirect method which can present the degree of peripheral perfusion. moreover, it is known as a more sensitive measurement tool than the rise of skin temperature. the apply of perfusion index is very simple and noninvasive. the degree of pi increase has been used to determine the success of peripheral nerve block. the volume of local anesthetics has been used 10-30 ml. however, most effective dosage with proper pain relief has never been suggested.

Eligibility criteria:
inclusion criteria: * lumbar disc herniation * lumbar foraminal stenosis * lumbar central stenosis * lumbar spondylolisthesis * numerical rating scale \> 4 * back pain functional scale \< 45 * duration of pain \> 1 mon * patients who can fully understand all items described in back pain functional scale exclusion criteria: * allergy to local anesthetics or contrast medium * pregnancy * spine deformity * prior history of lumbar spine surgery * no previous lumbar mri or ct * patients with coagulation abnormality
norepinephrine versus ephedrine in treatment of hypotension during spinal anesthesia for caesarean section

Conditions: Hypotension; Vasopressors; Cesarean Section Complications; Anesthesia Complication

Summary: prospective, randomized study, including full term parturients scheduled for caesarean section under spinal anesthesia. spinal anesthesia was performed in sitting position with a 25 g spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the spinal block. baseline hemodynamics: heart rate, systolic and diastolic blood pressure were recorded before spinal anesthesia and intraoperatively. postspinal hypotension, defined as decrease of systolic blood pressure\>20% from the baseline value, was managed using ephedrine increments 6 mg/3min in patients of ge group or by 5 mcg norepinephrine/3min for the patients of gn group. intraoperative hemodynamic data of the 2 groups were compared.

prospective, randomized study including full term parturients scheduled for caesarean section under spinal anesthesia. all patients were asa status i/ii and patients with arrhythmia were excluded. spinal anesthesia was performed in sitting position at l3-4 or l4-5. a 25 g spinal needle was used for intrathecal injection of 8 mg of hyperbaric bupivacaine, 2.5 mcg sufentanil and 100 mcg morphine. all patients received 15 ml/kg of crystalloids intravenously during the spinal block. patients were positioned in left lateral tilt position. baseline hemodynamics; hr, systolic (sbp) and diastolic blood pressure (dpb) were recorded before spinal anesthesia and intraoperatively (every 2 min). post anesthesia hypotension was defined as decrease of sbp\>20% from the baseline value. if hypotension occurred, patients were randomized into 2 groups: * ge group in which hypotension were managed using ephedrine increments of 6 mg ephedrine every 3 min until correction of sbp * gn group: patients of this group received 5mcg of norepinephrine/3 min demographic and hemodynamic data of the two groups were compared.

Eligibility criteria:
inclusion criteria: * fully term parturients * caesarean section under spinal anesthesia * asa status i or ii exclusion criteria: * severe cardiac disease * cardiac arrhythmia
processing speed as an objective measure of tinnitus

Conditions: Tinnitus

Summary: the overall purpose of this research is to assess whether both the "60 second brain game" and the "brain speed test" computer-based programs can be used as assessment tools for objectively defining the severity of the functional impact of tinnitus.

this cross-sectional study aims to assess for deficits in brain processing speed and attention (two cognitive domains whose deficits have been implicated in tinnitus) with the use of the "brain speed test".

Eligibility criteria:
inclusion criteria: * participants must be between the ages of 18 and 80. * participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6-months duration or longer. * participants must be able to read, write and speak using the english language. * participants must be able to provide informed consent. exclusion criteria: * participants with tinnitus related to workman's compensation claim or other litigation-related situations. * participants with active diagnoses of any acute or chronic brain-related neurological conditions that alter normal brain anatomy or function including parkinson's disease, multiple sclerosis, alzheimer's disease, cerebral infarcts, traumatic brain injury, history of brain tumor(s), epilepsy, or dementia. * participants with tinnitus related to retrocochlear lesions, cochlear implants, or other known anatomic/structural lesions of the brain, skull-base, temporal bone or ear. * participants unable to hear the highest volume of the computer-based objective assessments. * any medications that may affect or alter cognition including but not limited to sedatives, hypnotics, narcotics, or opiates. * any medical condition the pi determines would compromise the safety of the participant or complicate the interpretation of the study results.

Keywords: tinnitus cognition brain processing speed brain fitness program posit science