Kornimate/medical-research-clean huggingface dataset:
anesthetic blockades and migraine

Conditions: Chronic Migraine; Pain

Summary: greater occipital nerve (gon) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. the aim of this study is to evaluate the short-term clinical efficacy of gon anaesthetic blockades in chronic migraine and to analyze their effect on pressure pain thresholds (ppts) in different areas. we hypothesize that those patients receiving real gon anesthetic blockade will receive greater improvements in pain nociception. we will conduct a double-blind, randomized, parallel and placebo-controlled clinical trial where one group will be treated with bilateral gon blockade with bupivacaine 0,5% and the other group will be treated with placebo.


Eligibility criteria:
inclusion criteria: * chronic migraine exclusion criteria: * other primary headaches * other secondary headaches * co-morbid medical diseases

Keywords: migraine, pressure pain, anesthetic blocks patients
validating the ain shams cognitive assessment tool

Conditions: Mild Cognitive Impairment (MCI); Dementia

Summary: the diagnosis of cognitive impairment, including dementia and mild cognitive impairment (mci), is crucial for timely intervention and management. various screening tools are available for assessing cognitive function, among which the mini-mental state examination (mmse), the addenbrooke's cognitive examination (ace), and the montreal cognitive assessment (moca) are widely used. however, the recently developed ain shams university cognitive assessment (asca) has shown promise in detecting early cognitive decline. this study aims to assess the performance of asca in diagnosing cognitive impairment against dsm5 criteria.


Eligibility criteria:
inclusion criteria: older adult participants 60 years old and above who are native arabic speakers - exclusion criteria: * severe dementia, delirium, major mental disorders, aphasia, and those with severe visual or hearing impairment that interfere with the assessment.

Keywords: mild cognitive impairment dementia cognitive assessment arabic cognitive assessment tools
an open-label, phase 2 study to assess the efficacy and safety of nemolizumab in subjects with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: to evaluate the efficacy of nemolizumab in systemic sclerosis patients. to evaluate also the safety and pharmacokinetics.


Eligibility criteria:
inclusion criteria: * diagnosis of systemic sclerosis according to american college of rheumatology (acr) and european league against rheumatism (eular) 2013 criteria * systemic sclerosis patients with moderate to sever skin sclerosis exclusion criteria: * patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease * patients with a diseases that could interfere with assessment of systemic scleorosis * patients with body weight less than 30.0kg * pregnant or lactating women.
effects of cb1 antagonist/reverse agonist rimonabant on walking abilities in incomplete spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this is a placebo controlled study comparing rimonabant 5 mg per day for 90 days with placebo for the same period. objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population.

this is a placebo controlled study comparing rimonabant 5 mg per day for 90 days with placebo for the same period. main goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) of rimonabant in a specific population (incomplete spinal cord injury).

Eligibility criteria:
inclusion criteria: * age \>18 yo and \<75yo * non progressive spinal cord injury * incomplete lesion (ais c or d) * neurological level between c4 and l1 * chronic stage (\>1 year since injury) * preserved walking ability for at least 5 m (aid allowed) * capability to provide informed consent * for fertile women, possibility to use anti conceptive methods exclusion criteria: * age \ 75 * ais a, b or e * neurological level above c4 or below l1 * subacute stage (\<1 year since injury) * preserved walking ability for less than 5 m (aid allowed) * pregnancy or breast feeding * for fertile women, impossibility to use anti conceptive methods * anticoagulant treatment * hypothyroidism * severe bone, kidney or liver disfunction * impossibility to reach the hospital * impossibility to rovide informed consent

Keywords: walking abilities rimonabant endurance incomplete sci
efficacy and safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women (replicate study)

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

Summary: this study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.


Eligibility criteria:
inclusion criteria: * subject is a premenopausal female at the time of screening. * subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound). * subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \> 80 ml during each of two screening menses as measured by the alkaline hematin method. * subject has negative urine and/or serum pregnancy test in screening and just prior to first dose. * subject has an adequate endometrial biopsy performed during screening, the results of which show no clinically significant endometrial pathology. exclusion criteria: * subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder. * subject has history of osteoporosis or other metabolic bone disease. * subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. * subject has a history of major depression or post-traumatic stress disorder (ptsd) within 2 years of screening, or a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). * subject is using any systemic corticosteroids for over 14 days within 3 months prior to screening 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: elagolix elagolix sodium heavy uterine bleeding heavy menstrual bleeding (hmb) leiomyomata menorrhagia abt-620 elagolix + e2/neta (elagolix + norethindrone acetate)
quality of sleep in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: as one of the characteristic clinical features of the patients with rheumatoid arthritis, the unique character of the patients, somewhat difficult to be persuaded but theoretical, has long been pointed out. the investigators hypothesized that this unique character might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. the investigators test (1) the sleep quality of the patients and draw some characteristic features, and (2) investigated the connection between unique biochemical changes such as the increase of c-fos or wee-1.

under the hypothesis the unique character of patients might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. we do following studies; the study of sleep quality of the patients; the number of patients expected to be included in the study is 1,000. inclusion criteria is the acr criteria, and exclusion criteria is any defined disease conditions of sleep disorders in icsd. the method includes questionnaire using the pittsburgh sleep quality index (psqi) scoring and epworth scoring, and actigraphy measurement for more than 3 days. in a portion of the patients, we measure clinical arthritis activities in conjunction with western blot for c-fos and wee-1 as well as routine clinical laboratory tests. also in a portion of the patients, we do the polysomnography study; expected number of participants would be 100. we also plan to test the effect of good sloop on arthritis in a portion of the patients.

Eligibility criteria:
inclusion criteria: * fulfilling the american college of rheumatology criteria of rheumatoid arthritis exclusion criteria: * any defined sleep disorders of international classification of sleep disorders (icsd)

Keywords: rheumatoid arthritis sleep disturbance
mycophenolate mofetil in pediatric steroid dependent nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. the long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity. mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. to determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.


Eligibility criteria:
inclusion criteria: * steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year * in complete remission exclusion criteria: * hereditary or secondary nephrotic syndrome * estimated glomerular filtration rate (gfr) \< 60 mg/min/1.73 m\^2 * body weight \<16 kg * leukocytopenia (absolute neutrophil count \< 2000/mm\^3) or anemia(hct \< 25%) * severe gastrointestinal disease * chronic or acute active infection (e.g. hepatitis b,c, herpes, varicella zoster) * prior live vaccine inoculation within 6 weeks (from the study enrollment) * got/gpt elevation or hyperbilirubinemia * malignant disease * pregnant or breast feeding * previous history of mycophenolate mofetil use * participation to other therapeutic trial within recent 3 months * deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase

Keywords: mycophenolate mofetil immunosuppressive agents nephrosis
a study of sertraline and early alprazolam xr administration versus sertraline only in panic disorder patients

Conditions: Panic Disorder

Summary: the primary objective for the study is to test the hypothesis that sertraline plus alprazolam xr will result in superior early stabilization of primary care pd patients versus sertraline/placebo over a 12-week treatment period. the secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam xr taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam xr will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.


Eligibility criteria:
inclusion criteria: * subjects will include men and women over the age of eighteen; * the ability to give written informed consent; * current principal or co-principal psychiatric diagnosis of panic disorder with or without agoraphobia based on dsm-iv criteria (american psychiatric association, 1994); * willing to use an effective means of contraception; * free of psychoactive medications for at least 2 weeks prior to study enrollment; * not actively be suicidal. exclusion criteria: * actively suicidal; * medical conditions for which either sertraline or alprazolam xr would be contraindicated; * recent six month history of substance or alcohol abuse; * history or presence of psychotic or bipolar disorder; * women who are pregnant or breastfeeding; * history or presence of a seizure disorder or a known history of more than one childhood febrile seizure; * presence of a personality disorder severe enough to compromise the investigator's ability to evaluate the efficacy and safety of the study medication; * concomitant therapy with other psychotropic medication(s); * clinically significant abnormality during physical examination, vital signs, ekg, urine drug screen, or laboratory tests at the screen visit.
dexamethasone and ketamine on change of postoperative mood

Conditions: Depressive Symptoms

Summary: ketamine and dexamethasone have been known to be effective postoperative pain. many studies also have reported these two drugs might change mood such as depression. this study aimed to investigate the effect of each drug individually with their combination on perioperative change of mood in patients undergoing gynecologic surgery

after receiving by irb approval and obtaining informed consent from patients, 93 patients who are aged between 18 and 70 years old and classified as american society of anesthesiologists (asa) classes i and ii. afterward, the patients will be randomly (sealed envelopes) allocated into one of three treatment; group k (n = 31) will receive a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, group d (n = 31) receive dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and group kd (n = 31) receive ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v. at 5 minutes after the induction of anesthesia in a double-blinded method.

Eligibility criteria:
a total of 93 patients inclusion criteria: * patients who were scheduled for laparoscopic gynecologic surgery exclusion criteria: * patients with hepatic and renal insufficiency, history of allergy to the study drugs, previous gastric ulcer, diabetes mellitus, and receiving analgesic, antiemetic, antihistamine, steroids or psychiatric drugs within 24 hours before surgery steroids

Keywords: ketamine, dexamethasone, mood
a study of roactemra/actemra and, if initially inadequately responded to roactemra/actemra, followed by mabthera/rituxan in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis. patients will receive 8 mg/kg roactemra/actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. patients, who show an inadequate clinical response after the first 12 weeks to roactemra/actemra, will receive 1 g mabthera/rituxan (rituximab) intravenously at week 16 and 18. the anticipated time of study treatment is 32 weeks.


Eligibility criteria:
inclusion criteria: * adult patients \>/=18 years of age * body weight \< /=130kg * active rheumatoid arthritis of at least 6 months duration, diagnosed according to the american college of rheumatology (acr) criteria of 1987 * disease activity score (das28) of \>3.2 * inadequate clinical response to a stable dose of traditional disease-modifying anti-rheumatic drugs (dmard) * have received permitted dmards, one or more; current dmard therapy must have been at stable dose for at least 4 weeks prior to baseline exclusion criteria: * prior treatment with tnf-inhibitors or other biologic dmard * major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration * functional class iv (american college of rheumatology classification) * rheumatic autoimmune disease other than rheumatoid arthritis * history of or current inflammatory joint disease other than rheumatoid arthritis
remote hypertension management for black patients

Conditions: Uncontrolled Hypertension

Summary: this study will compare two approaches for managing hypertension in black patients with uncontrolled blood pressure (bp). one approach will include home bp telemonitoring supported by a pharmacist and a community health worker. the other approach will include usual clinic-based care along with a home bp monitor and routine care.

this study is a pragmatic effectiveness-implementation hybrid type 2 trial with two study arms. one arm will include home bp telemonitoring supported by a pharmacist and a community health worker providing centralized self-management support. the other arm will include enhanced usual clinic-based care with a home bp monitor and routine care from providers trained on evidence-based guidelines.

Eligibility criteria:
inclusion criteria: * black or african american race * hypertension diagnosis * aged 21 to 85 years * uncontrolled blood pressure as defined by \[a\] most recent sbp ≥140 mmhg and an additional sbp≥140 mmhg within the past 12 months in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or \[b\] most recent sbp\>160mmhg in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or \[c\] referral by pcp for uncontrolled hypertension with at least one documented sbp≥140 mmhg (in clinic or at home) in the past 12 months; and (v) primary care provided at a participating clinic. * able to speak english * primary care provided at a participating clinic exclusion criteria: * currently pregnant or planning to get pregnant during the study period * residence in a long-term care facility, hospice or with a terminal illness with less than 1 year life expectancy as determined by the primary care physician or study team. stable chronic illness such as compensated cirrhosis, chronic obstructive pulmonary disease, congestive heart failure etc. will not be excluded. * estimated glomerular filtration rate (egfr) \<30 ml/min or on dialysis. patients with a functioning kidney transplant will not be excluded. * inability to provide informed consent or participate in study procedures. for example, conditions that limit ability to participate in phone visits or check bps in at least one arm. * currently participating in another bp management program. * plan to move out of the area within the next 12 months. * hispanic ethnicity.

Keywords: high blood pressure african-american population remote blood pressure monitoring
an observational study of epoetin beta [neorecormon] to evaluate the quality of life in patients on dialysis with chronic renal anemia

Conditions: Anemia

Summary: this multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta \[neorecormon\] in patients with renal chronic anemia, who are on dialysis. for each eligible patient data will be collected for 6 months. target sample size is 5000-7000 patients.


Eligibility criteria:
inclusion criteria: * adult patients \>/=18 years of age * dialysis patients with chronic renal anemia * written informed consent exclusion criteria: * red blood cell transfusion in the previous 2 months * severe neuropsychological disorder * diabetic patients with serious complications this trial is being conducted in morocco.
patient outcomes in unattended and in- lab polysomnography

Conditions: Sleep Apnea; Hypersomnia

Summary: this randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and sleep-related movement disorders, provides similar patient outcomes when compared to level 1 sleep studies.

individuals referred to the sleep disorder centre with a major complaint of snoring or, apneas or hypersomnia, with at least one additional minor concern of snoring, apneas, restless leg syndrome or insomnia, will be considered for entry into the study. using a randomized controlled trial design, study participants will be randomly assigned to either the intervention group who will undergo a full unattended polysomnography (level 2 home sleep study) using the prodigy portable wireless sleep monitor or in-lab polysomnography (level 1 sleep study). other aspects of care including the clinical assessment will be equivalent between groups. a randomly assigned sleep specialist physician will make treatment recommendations to the patient based on the sleep study results and determine the need for a subsequent testing (including repeat sleep studies) as part of each patient encounter. physicians participating in the study will receive an introduction to the odds ratio product (orp) and training on its diagnostic potential. diagnostic confidence using a 5 point likert scale from 10% (very unsure) to 90% (very confident) will be assessed after each sleep study review.

Eligibility criteria:
inclusion criteria: * referral for major concern of "snoring" or "apnea" or "hypersomnia" with additional minor concerns of "snoring", "apneas" "restless leg syndrome" or "insomnia" * willing to undergo a sleep study exclusion criteria: * referrals where parasomnias, respiratory failure, narcolepsy listed as concerns * comorbid congestive heart failure, ischemic heart disease, arrhythmia, stroke, chronic obstructive pulmonary disease/respiratory failure, patients with a bmi 50 kg/m2 * undergone a previous sleep study
tourniquet complications in orthopaedic surgery

Conditions: Tourniquet Complications; Paresis; Palsy; Nerve Compression

Summary: the purpose of the study is to establish the number and nature of complications that we, the researchers, have with the use of a tourniquet in orthopaedic surgery in norway.

this is a multicenter, prospective study where contact persons in 10 different hospitals throughout norway monitor problems and complications that occur in relation with tourniquet use in orthopaedic surgery. if a complication occurs, it is documented in detail by the contact person.

Eligibility criteria:
inclusion criteria: * all patients in 10 orthopaedic hospitals in norway undergoing surgery which requires a tourniquet, from 1 january to 31 of december 2005

Keywords: tourniquet paresis