Kornimate/medical-research-clean huggingface dataset:
evaluate the effect of omalizumab on markers of asthma impairment in patients with persistent allergic asthma

Conditions: Persistent Allergic Asthma

Summary: this study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on step 4 or above therapy as defined in the 2007 national heart, lung, and blood institute (nhbli) guidelines


Eligibility criteria:
inclusion criteria: * total asthma control test (act) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average: * symptoms \> 2 days/week * night-time awakenings ≥1 time/week * short-acting beta2-agonist (saba) use for symptom control \>2 days/week forced expiratory volume in 1 second (fev1) ≤ 80% predicted exclusion criteria: * history of intubation for asthma. * an asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (visit 1). * less than 3 months of stable maintenance oral corticosteroid therapy for asthma other protocol-defined inclusion/exclusion criteria applied

Keywords: asthma; asthma management; asthma impairment ; xolair ; omalizumab
serur: covid-19 serological survey of staff from the university reims-champagne ardennes

Conditions: Covid19

Summary: this study was designed to determine, in a screening situation within the framework of university preventive medicine, the prevalence of positive anti-sars-cov 2 serology among the staff of the university of reims champagne-ardenne. the serological tests chosen will allow systematic detection of anti-sars-cov-2 igm and anti-sars-cov-2 igg to assess the moment of potential contamination prior to resumption of occupational activity.

objective: this study was designed to determine, in a screening situation within the framework of university preventive medicine, the prevalence of positive anti-sars-cov 2 serology among the staff of the university of reims champagne-ardenne. the serological tests chosen will allow systematic detection of anti-sars-cov-2 igm and anti-sars-cov-2 igg to assess the moment of potential contamination prior to resumption of occupational activity. type of study: this is a prevalence study, a single-center cross-sectional study published on the human person. population: inclusion criteria: on a voluntary basis, the staff of the university of reims champagne ardenne will be offered a serological blood test (1 dry tube of 7ml). the use of the collected data for research purposes will be explained to each requester, with signature of an informed consent. only people over 18 will be included. non-inclusion criteria: staff of the university of reims champagne ardenne who have not requested to be tested. duration of participation of subjects: 1/2 day time judgment criterion (s): main endpoint (in connection with the main objective): prevalence of positive sars-cov-2 serology at the university of reims champagne-ardenne. clinical investigation plan: * phase 1: communication strategy an email will be sent to all the staff of the university of reims champagne ardenne to offer them anti-sars-cov-2 serological tests, as part of a health research protocol. before sampling, a questionnaire will be completed by the applicant. * phase 2: analysis of the samples * phase 3: transmission of results to pr frédéric deschamps, head of summps at the university of reims champagne ardenne

Eligibility criteria:
inclusion criteria: * major volunteers from the staff of the university of reims champagne-ardenne (\>18 years old) exclusion criteria (non inclusion): * persons who do not desire to participate

Keywords: covid-19 sars-cov2 antibodies
effects of pioglitazone, a ppargamma receptor agonist, on the abuse liability of oxycodone

Conditions: Opioid Abuse

Summary: the ability of pioglitazone (pio) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. accordingly, the proposed investigation seeks to examine the effects of pio on oxycodone, one of the most commonly used and abused opioid drugs in the u.s. (davis et al., 2003). more specifically, the primary aim of this investigation is to characterize the subjective effects of oxycodone under maintenance on various doses of pio (0, 15, and 45 mg) in non-dependent, prescription opioid abusers. secondary aims of the study are to examine the influence of pio on the analgesic, cognitive, and physiological effects of oxycodone.

this 9-week investigation will use an inpatient/outpatient design in which participants will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on pio 15 mg followed by 3 weeks on pio 45 mg). at the end of each maintenance period the effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session using a cumulative dosing procedure.

Eligibility criteria:
inclusion criteria: 1. recreational use of prescription opioids at least once per month within the past year 2. no current major mood, psychotic, or anxiety disorder 3. physically healthy 4. aspartate aminotransferase (ast) or alanine aminotransferase (alt) within normal limits 5. able to perform study procedures 6.21-45 years of age 7.blood glucose concentration between 70-145 mg/dl for men and 70-125 mg/dl for women (fasting) 8.hb \> 13 for men and hb \> 11 for women with no other evidence of medical disorder resulting in blood loss or anemia/hematological disease exclusion criteria: 1. physical dependence on any drugs, excluding nicotine and caffeine 2. participants requesting treatment 3. participants on parole or probation 4. pregnancy or lactation: female participants must agree to the use of a barrier control method of contraception (e.g. male and female condoms, diaphragms, cervical caps and contraceptive sponges used in combination with spermicide) 5. current or recent history of significant violent behavior (within the past 6 months) 6. current major axis i psychopathology that might interfere with ability to participate in the study 7. significant suicide risk 8. current chronic pain 9. current or history of congestive heart failure, edema, or diabetes mellitus 10. sensitivity, allergy, or contraindication to opioids or pioglitazone 11. unstable physical disorders that might make participation hazardous, such as end-stage aids, hypertension (blood pressure \> 140/90), or heart disease (please note that participants will be asked about previous visits to a cardiologist, chest pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded unless cleared for participation by a cardiologist)

Keywords: oxycodone opioid abuse
evaluation of total blood volume measurement during dialysis on the incidence of intradialytic hypotension

Conditions: Hemodialysis Complication; Hypotension During Dialysis; Diagnostic Tests

Summary: establishing the euvolemic state in hemodialysis patients -the so called "dry weight"- is an important clinical conundrum in every nephrologist's daily practice. underestimation of dry weight (with excessive ultrafiltration) results in dialysis-induced hypotension. currently used methods to establish dry weight, including clinical assessment, bio-impedance spectroscopy and online relative blood volume (rbv) measurements, all have their limitations. rbv measurement reflects changes in blood volume during dialysis without providing any information about the initial hydration status, or the initial absolute blood volume (abv). recently, researchers proposed a new method to calculate abv, by using the principle of dilution-indicator with rbv measurement. in a small cohort study they identified a total blood volume threshold of 65 millilitres per kilogram dry weight predicting for intra-dialytic hypotension associated symptoms. the goal of current clinical trial is to re-investigate the accuracy of the above-described method and to confirm the hypothesis of a critical threshold of 65 ml blood volume per kg dry weight in haemodialysis patients. researchers will compare adjustment of dry weight based on the abv measurement with standard care to see if dialysis-induced hypotension will be reduced.


Eligibility criteria:
inclusion criteria: * hemodialysis patients of three dialysis locations of the haga hospital (zoetermeer, the hague leyweg and the hague sportlaan). * maintenance hemodialysis, with initiation of treatment predates inclusion in the study by at least 3 months. * hemodialysis scheme three times weekly for four hours * age above 18 years. exclusion criteria: * clinically relevant fistula dysfunction resulting in single poold kt/v \<1,2 * severe volume overload with a contraindication to bolus fluid infusion during dialysis according to the treating physician. * severe cardiac dysfunction responsible for \>1x intradialytic hypotension associated adverse event /week according to treating physician * severe liver failure with or without presence of ascites * more than three hemodialysis sessions per week * single needle treatment * central venous access * residual diuresis \> 500 ml/ 24h * inability to provide informed consent

Keywords: hemodialysis intradialytic hypotension intradialytic morbid events
speeded anomia treatment in chronic post-stroke aphasia

Conditions: Aphasia

Summary: the main aim of the study is to investigate the effect of a novel, speeded anomia therapy (conroy et al., 2018) in a large population of patients with chronic post-stroke aphasia. the treatment will be delivered via a web application (quickword).

the main aim is to test the clinical efficacy of a novel, web based, rehabilitation approach to aphasic word-finding difficulties (quickword). in an initial development and case-series evaluation, conroy et al (2018, brain) found that training for both speed as well as accuracy of naming generated much better outcomes to picture naming accuracy and also augmented the carry-over to connected speech production. this is a randomised, crossover, clinical trial of quickword in a group of aphasic patients in the chronic post-stroke period. the comparison will be standard care. the main outcome measures are clinically relevant improvement in naming to confrontation, and spontaneous use of the target vocabulary in a connected speech sample (detailed picture description). secondary outcome includes measured use of the vocabulary in a story-telling, connected speech assessment (retelling of the cinderella story).

Eligibility criteria:
inclusion criteria: * native english speakers * age 18 years or above * stroke (any type) greater than 12 months post onset * no history of neurological disorders / psychiatric disorders * normal or corrected-to-normal hearing \& vision * able to give informed consent * currently not receiving speech \& language therapy * minimal repetition skills (\>40% on an immediate word repetition test) * evidence of naming difficulties (\<90% in boston naming test - goodglass et al., 1983) exclusion criteria: * non-native english speakers * less than 18 years old * stroke less than 12 months post onset * history of neurological disorders / psychiatric disorders * uncorrected hearing \& vision * unable to give informed consent * currently receiving speech \& language therapy * insufficient repetition skills (\<40% on an immediate word repetition test) * good naming performance (\>90% in boston naming test - goodglass et al., 1983)

Keywords: anomia speech disorders language disorders communication disorders
short-term effect of podiatric callus debridement on plantar pressure in diabetic neuropathic patients

Conditions: Diabetic Neuropathies; Plantar Callus

Summary: diabetes peripheral neuropathy (dpn) affects up to 50% of the diabetes population. in the diabetic neuropathic foot, it commonly manifests as loss of protective sensation, foot deformity and skin dryness. alongside with day-to-day weightbearing activities, this can lead to formation of callus over plantar pressure points. studies have proven that callus formation leads to high plantar pressure and increased risk of diabetic foot ulcers. for podiatrists, diabetic foot screening and treatment is our daily practice. plantar callus are commonly treated by sharp debridement to relief pressure from the hard skin build up and thus reducing the risk of ulceration. however, the effectiveness of callus sharp debridement is not commonly studied in researches. only a few studies in the past evaluated the effectiveness of callus treatment by different outcome measurements. among those studies only 2 were specifically done in diabetic patients, in which one reported results of diabetic neuropathic patients. all the available studies used peak plantar pressure only as their pedobarographic outcome measure. in this study, the treatment effect of podiatric sharp debridement of callus in diabetic neuropathic patients will be evaluated using a range of pedobarographic parameters and foot and ankle outcome score (faos) questionnaire. the immediate and short-term (3-4 weeks) effect of sharp debridement in dpn patients with callus could be quantified. change in loading pattern could also be analysed based on different areas of the foot.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. active out-patient status in podiatry department of princess margaret hospital 3. men and women 4. ambulatory 5. diagnosis of type i or ii diabetes 6. failed peripheral neurological assessment (vibration perception threshold \>25 volts or unable to detect one or more sites of 4-point 10g semmes-weinstein monofilament test) 7. presence of plantar callus 8. compliance with instructions (in chinese or english) 9. ability to read and write (in chinese or english) exclusion criteria: 1. peripheral vascular disease 2. painful neuropathy 3. charcot deformity 4. undergone any form of callus debridement in the past 6 weeks 5. active foot ulcer 6. any dermatological condition other than callus that causes hyperkeratosis (e.g. verruca pedis, eczema, tinea pedis) 7. any musculoskeletal condition that affects balance and gait 8. allergic to chlorhexidine gluconate or alcohol
effect of early postoperative drinking water on postoperative recovery quality of patients with thyroid surgery

Conditions: Thyroid Tumor

Summary: this study is a single-center, prospective and randomized controlled study to investigate the effects of early recovery of oral intake (e) and late recovery of oral intake (l) on postoperative recovery quality and satisfaction of patients undergoing thyroid surgery. the study's primary outcome is quality of recovery-15 scale (qor-15).

the subjects of this study are patients who will receive thyroid surgery in peking union medical college hospital. after the patient is included in the experiment, when the patient meets the exit criteria of the pacu, the patient will be randomly assigned to early resumption of oral intake group and late resumption of oral intake group to receive different treatments. finally, researchers will collecte and evaluate the different outcome indicators of the two groups of patients.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. asa physical status i-ii 3. body mass index 18.5-29.9kg/m2 4. first operation on operation day 5. thyroid surgery exclusion criteria: 1. patients or family members cannot understand the conditions and objectives of this study 2. preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high risk of aspiration 3. the surgeons or anesthesiologists point out that the patient is not suitable for early postoperative drinking (such as considering the injury of recurrent laryngeal nerve or lymphatic vessels during the operation) 4. exclusion criteria of qor-15\* (\*qor-15 exclusion criteria: 1. unable to understand words and language; 2. difficult to cooperate due to mental disorders; 3. history of alcohol or drug abuse; 4. any serious pre-existing medical condition that can limit the objective evaluation after surgery; 5. any life-threatening complications; 6. emergency surgery)

Keywords: thyroidectomy enhanced recovery after surgery quality of recovery-15
genotropin study assessing use of injection pen

Conditions: Growth Hormone Deficiency; Idiopathic Short Stature

Summary: assessment of genotropin patient and caregiver (dyad) perception of convenience and preference of genotropin injection pen. patients already on genotropin will be asked to use a genotropin pen for 2 months. patient and caregiver will be asked to complete a questionnaire at baseline and 2 months.


Eligibility criteria:
inclusion criteria: * age 8-18 years * using genotropin pen for at least 3 months prior to study enrollment * compliance with genotropin treatment exclusion criteria: * medical conditions that can affect participation in study * insufficient command of english language to understand questionnaire * using other growth hormone device and not genotropin pen

Keywords: genotropin medical device patient reported outcome
the comparison of effectiveness between epidural combined bilateral us tap block versus epidural alone for gynaecology operation.

Conditions: Gynecologic Disease

Summary: the goal of this clinical trial is to compare effectiveness between epidural combined with tap block versus epidural alone in gynaecology operation participant .the main question\[s\] it aims to answer are: * what is the pain score for both groups * what is the requirement of epidural infusion between the 2 groups participants will be given general anesthesia for the operation with the epidural insertion prior to induction. patient will be randomized into epidural plus tap block or epidural alone for the study. the us tap block will be given at the end of operation prior to extubation. researchers will compare pain score, epidural infusion requirment between the two groups.

the research is a prospective randomized control study. it is blinded study as accessor is blinded whereby the acute pain service (aps) team will be reviewing patient postoperatively. study size of 46 subjects based on repeated measure anova between factor , alpha value 0.05% with 80% power study, a dropout 10%. divided into 2 groups ; group e - epidural alone, group t - epidural plus bilateral us tap block. perioperatively, epidural catheter will be inserted then induction for general anesthesia given. intraoperatively anesthesia maintain with inhalation agent. prior to extubation, bilateral tap block is provided using portable us guidance. at this location, the 3 layers of anterior abdominal wall is visualized for the truncal block. post operatively, participant will be given epidural cocktail bupivacaine 0.1% + fentanyl 2mcg/ml infusion for next 24hrs. the aps team will review patient post operatively in ward and all data will be recorded. participation of patient's during study is approximately 2 days duration.

Eligibility criteria:
inclusion criteria: * elective major laparotomy gynaecology procedure. * age 18 years and above * asa i, ii, iii exclusion criteria: * prolonged inr * allergic to la * history of chronic pain * psychological disorder/addict to opioid or benzodiazepine * any contraindication for epidural or tap block procedure * pregnancy
nicotine skin patch in treating patients with kaposi's sarcoma

Conditions: Sarcoma

Summary: rationale: nicotine may stimulate the immune system to kill kaposi's sarcoma cells. purpose: this phase ii trial is studying the side effects and how well the nicotine skin patch works in treating patients with kaposi's sarcoma.

objectives: * evaluate the toxicity and efficacy of transdermal nicotine applied to lesions in patients with classic kaposi's sarcoma. outline: this is a double-blind, placebo-controlled study. patients apply a nicotine dermal patch to a selected lesion and a placebo patch to the other lesion, replacing the same type of fresh patch every other day, during the first 2 weeks, increasing the nicotine dose in week 3 and again in week 5 for a total of 15 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 24 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven classic kaposi's sarcoma (ks) * at least 2 ks lesions that can be measured (minimum diameter 0.5 cm to maximum diameter 3 cm) and located on body sites (leg, arm, torso, dorsum of foot or hand) to which a patch can be applied * a third measurable lesion (if available) of the same size can be located on any body site * ks lesions must be separated by at least 8.0 cm at their centers and 6.0 cm at closest edges * patient must be a nonsmoker * no smoking, chewing, or other use of tobacco within the past year patient characteristics: * hiv antibody negative * willing to shower or bathe no more than every other day * no life-threatening conditions * not pregnant * fertile patients must use effective contraception * chronic conditions (e.g., hypertension or diabetes) must be stable and well controlled * no history of hiv/aids, unstable angina pectoris, or claudication * ecog performance status 0-1 prior concurrent therapy: * no prior biopsy of the selected ks lesion(s) within the past 90 days * no prior systemic therapy for ks within the past 90 days * no concurrent systemic or local conventional treatment for ks * no prior use of a nicotine product within the past year * no prior surgery, chemotherapy, biologic therapy, or radiotherapy within the past 90 days * no prior organ allograft

Keywords: classic kaposi sarcoma recurrent kaposi sarcoma
a full face study to evaluate the efficacy of dermapen 4™ microneedling device in addition with mg-clr serum for acne treatment over 12 weeks.

Conditions: Acne

Summary: this study is conducted to check how well the dermapen 4™ microneedling device works with mg-clr serum for treating acne over 12 weeks.


Eligibility criteria:
inclusion criteria: 1. female subjects aged between 18-45 years (both ages inclusive) 2. fitzpatrick skin phototype i to vi. 3. subjects having iga score of 2 and 3. 4. subjects who have not received any kind of treatment for acne 1 month before the start of the study. 5. subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face. 6. subjects who agree not to use any other product/treatment/home remedy/ except the provided products on their face during the study period exclusion criteria: 1. subjects with known skin condition that may impact the assessment. 2. subjects with active herpes labialis infection. 3. subjects known to have bleeding and clotting disorders (self-declared). 4. subjects known to have connective tissue disorders. 5. subjects with any other signs of significant local irritation or skin disease. 6. subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.

Keywords: dermapen, microneedling, acne