Kornimate/medical-research-clean huggingface dataset:
feasibility of hobscotch telehealth intervention in refractory epilepsy

Conditions: Refractory Epilepsy

Summary: the purpose of this study is to see whether a phone-intervention called hobscotch will improve health, daily functioning and quality of life among patients with refractory epilepsy. hobscotch stands for "home-based self-management and cognitive training changes lives." this study will also help to find the best ways of integrating this telehealth intervention to routine clinic use.

the proposed project will assess the efficacy of an 8-week phone-delivered, experimental treatment called "home-based self-management and cognitive training changes lives" (hobscotch) on sixty patients with refractory epilepsy (pwre). the investigators will employ a prospective, single blind randomized clinical trial design with wait-list controls to examine both objective and subjective measures of daily life, daily functioning, cognition, and emotional well-being. investigators will also assess the impact of hobscotch on employment and work productivity using the lam employment absence and disability scale (leaps) and the sheehan disability scale (sds). lastly, the investigators will examine whether changes in these domains are maintained three months after completion of the intervention. the study will expand the efficacy literature for hobscotch and further refine its use in a busy clinical environment, and therefore has potential to benefit the patient population (pwre), who currently lacks treatment options besides the pharmacological and surgical care currently available.

Eligibility criteria:
inclusion criteria: * patient is able to read and speak english. * patient has a reliable telephone connection and a private place they can use during the course of this study * they do not have any treatment or intervention plan in place for the next 6 months. they may be on an anti-epileptic drug regimen that has not been changed in the past 3 months.

Keywords: refractory epilepsy, self-management quality of life
lift study: a safety, tolerability, efficacy, and pharmacokinetics study of tern-101 in subjects with non-cirrhotic non-alcoholic steatohepatitis (nash)

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (pk) of tern-101 in non-cirrhotic nash patients.


Eligibility criteria:
inclusion criteria: * male or female, 18 to 75 years of age * overweight or obese with a body mass index (bmi) ≥ 25 kg/m2 * presumed nash based on clinical characteristics or prior liver biopsy * alt ≥ 43 iu/l for men and ≥ 28 iu/l for women * mri pdff liver fat content ≥ 10 % * written informed consent exclusion criteria: * history or clinical evidence of chronic liver diseases other than nafld * history or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment * history of liver transplant, or current placement on a liver transplant list * total bilirubin \> 1.2 mg/dl * albumin \< 3.5 g/dl * inr \> 1.1 * ast or alt \> 5 x uln * alp \> 156 iu/l * platelet count \< 150,000 /mm3 * egfr \< 60 ml/min/1.73m2 * weight loss \> 5% within past 3 months prior to screening * uncontrolled diabetes * uncontrolled hyperlipidemia * active covid-19 infection * other protocol-defined inclusion/exclusion criteria could apply

Keywords: farnesoid x receptor nash nonalcoholic steatohepatitis nafld nonalcoholic fatty liver disease fxr
labor analgesia with ropivacaine and clonidine

Conditions: Labor Pain

Summary: the aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. the effect of the drugs on mother and newborn was also determined.


Eligibility criteria:
inclusion criteria: * singleton healthy * full-term pregnancy * american society of anesthesiologists physical status i or ii exclusion criteria: * patients who had received opioids * history of hypersensitivity to local anesthetic or to clonidine * fetus showed signs of possible intrauterine suffering * fetus showed signs of possible neurological deficit

Keywords: analgesia obstetrical anesthesia epidural newborn anesthetics, local clonidine pregnant women infant, newborn
a study of mabthera (rituximab) in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to anti-tnf agents.

Conditions: Rheumatoid Arthritis

Summary: this single arm study will assess the safety and efficacy of mabthera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-tnf agents. patients will receive mabthera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of mabthera. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * active rheumatoid arthritis; * receiving outpatient treatment; * an inadequate response, or intolerance, to \>=1 anti-tnf agent. exclusion criteria: * other rheumatic autoimmune disease or inflammatory joint disease; * concurrent treatment with any anti-tnf-alpha therapy; * joint or osseous surgery during 8 weeks prior to recruitment.
a study to determine the role of physician gestalt in predicting covid-19 in patients

Conditions: All Patients Undergoing COVID 19 Specific Testing

Summary: this is a prospective observational study to determine the role of physician gestalt in clinical prediction of covid 19.

among patients attending the emergency department, prompt identification of possible cases of covid 19 is important to avoid the spread. an immediate clinical diagnosis is important for point of care decision making on choice of treatment facility as well as for triaging, testing and to quarantine patients admitted to the hospital from emergency room. hence this study attempts to find out the role of physician gestalt in early diagnosis and differentiation of covid 19.

Eligibility criteria:
inclusion criteria: * all patients presenting to ed, who undergo covid 19 specific testing. exclusion criteria: * patients with active covid 19 disease diagnosed outside all brought dead cases. all patients not consenting to take part in the study.
role of msct of chest in differentiation between copd patients according to their smoking status

Conditions: Patient Participation

Summary: chronic obstructive pulmonary disease (copd) is a major cause of morbidity and mortality all over the world. smoking is considered as an important risk factor, but other risk factors are present. around 30 % of patients with copd are non-smokers. cessation of smoking in patients with copd causes decreases the presence of micronodules and other criteria of ct chest. in last few years, some researchers reported that cessation of smoking raise the apparent extent of emphysema. the cause is not obvious, but this paradoxical fall in lung density is thaught to be resulting from decrease in inflammation after smoking cessation. ct chest criteria of copd in active smokers, non-smokers and ex-smokers seem to be different. so, comparison between ct chest criteria of copd in smokers, ex-smokers and non-smokers will be searched in this study to detect the role of multislice computed tomography (msct) chest in differentiation between copd patients according to their smoking status.

basic ethical principles of medical research; beneficence (do well), non-maleficence (do no harm), respect and distributive justice were implemented. the study will be carried out in accordance with the declaration of helsinki and the principles of good clinical practice.

Eligibility criteria:
inclusion criteria: 1. all patients with chronic obstructive pulmonary disease. 2. patients above 18 years. exclusion criteria: 1. patients with unclear smoking history. 2. patients with active pneumonia. 3. patients with acute copd exacerbation.
safety and efficacy of mupirocin gel in children with impetigo

Conditions: Impetigo

Summary: the purpose of the study is to show non inferiority in terms of safety and efficacy of topical administration bid (twice daily) of mupirocin gel 20 mg/g compared to topical administration of mupirocin ointment 20 mg/g tid (three times daily) (bactroban) in the treatment of impetigo in paediatric population.


Eligibility criteria:
inclusion criteria: * age between 18 months and 15 years at the signature of informed consent * impetigo susceptible to be treated with topical mupirocin and non requiring systemic antibiotic treatment (maximum of 4 different affected areas and no fever). * global score of skin infection rating scale (sirs) ≥ 4, with positive value (≥ 1) in at least 3 of the 5 categories evaluated. * signature of informed consent by parent or legal tutor and, in case of mature minor (12 years or more), signature of informed assent. * patient or parent's ability to understand and fulfill with protocol requirements. * in potentially pregnant patients, negative pregnancy urine test at baseline and use of reliable contraception double barrier methods during the trial. exclusion criteria: * allergy to any compound of the trial treatments * have received systemic treatment with antibiotics or steroids, during the week prior to the baseline visit. * have received topical treatment with corticosteroids, antibiotics or antifungals, during the 48 hours prior to the baseline visit. * primary or secondary immunodeficiency. * have received cytostatic or immunosuppressive treatment three months prior to baseline. * any skin disorder that could interfere with the evaluation of the results of impetigo, such as presence of staphylococcal or streptococcal ecthyma, cellulitis, furunculosis, acute dermatitis, contact dermatitis or impetiginized eczema. * diabetes mellitus. * infection that, in the investigator's opinion, should be treated with systemic antibiotic. * any medical condition which, in the investigator's opinion, contraindicates the subject's participation in the trial. * forecast of little cooperation, non-compliance with medical treatment or low credibility. * have participated in any clinical investigation with medicine within 30 days prior to basal visit.

Keywords: impetigo mupirocin mupirocin gel mupirocin ointment impetigo in children
assessment of sedation depth using processed eeg in icu patients with ards receiving neuromuscular blockade: a prospective observational study"

Conditions: Sedation Complication; Acute Respiratory Distress Syndrome Due to COVID-19; Anesthesia Awareness

Summary: "in intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. both inadequate and excessive sedation levels can be highly detrimental to the patient. clinical assessment may not always provide accurate information regarding sedation depth. recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to covid-19 pneumonia. therefore, the investigators believe that inadequate sedation may be common in these patients. processed electroencephalogram parameters such as bispectral index or patient state index (psi), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. in this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used."


Eligibility criteria:
inclusion criteria: * "patients aged 18 years and older who have received continuous neuromuscular blocking agents for at least 24 hours." exclusion criteria: 1. patients under 18 years of age, 2. pregnant individuals 3. trauma patients, 4. intracerebral pathology 5. major bleeding 6. central nervous system diseases, 7. pre-existing poor neurological condition before admission to the intensive care unit, 8. inability to document continuous neuromuscular blocking agent infusion for at least 24 hours."
comparison of topical skin adhesive to subcuticular suture closure of implantable port incisions

Conditions: Port-A-Cath Placement; Octylcyanoacrylate

Summary: hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in port a cath patients, who, as a population, are at increased risk for complications. all adult patients who present for initial port a cath placement during the recruitment period will be eligible to participate in the study. subjects will be randomized to either skin incision closure with standard stitches or closure with skin glue. time to complete skin closure and costs of closure will be compared. patients will be evaluated approximately one month and three months from the procedure to assess for complications of wound breakdown or infection, as well as for the appearance of the port a cath incision.


Eligibility criteria:
inclusion criteria: * all adult patients (≥18 years) who present for initial implantable port placement during the recruitment period will be eligible to participate in the study exclusion criteria: * patients who cannot provide informed consent for the procedure will be excluded from the study.

Keywords: port catheter octyl 2-cyanoacrylate 2-octylcyanoacrylate
effect of lia on postoperative pain following acl reconstruction

Conditions: Anterior Cruciate Ligament Rupture; Pain, Postoperative

Summary: an anterior cruciate ligament (acl) rupture is one of the most common sport injuries, which typically develops after a sudden knee torsion. arthroscopic repair of the acl is often required as a complete acl tear can cause instability of the knee joint. during arthroscopic reconstruction the lower leg is reattached to the upper leg using part of the hamstring tendon (mm. gracilis and mm. semitendinosus). optimal postoperative analgesia is necessary to allow a quick recovery. intravenous analgesia during surgery is often associated with a number of side effects such as nausea, vomiting and muscle weakness and does not anesthetize the donor site of the hamstring tendon graft. local infiltration of ropivacaine and lidocaine in the knee joint and at the donor site can be a valuable asset to control the postoperative pain. this study evaluates the effect of local infiltration analgesia (lia) on the postoperative pain in the first month after an acl reconstruction. half of participants will only receive intravenous analgesia during surgery, the other half will receive intravenous analgesia and a lia.

2 x 20 patients which are planned for arthroscopic acl reconstruction are randomised: standard-group and lia-group. all patients receive standardised multimodal intravenous analgesia. after standardised induction of anesthesia, patient positioning and administration of basic analgetics (paracetamol, diclofenac, clonidine and morfine), patients in the lia-group receive a local infiltration in the knee of 10 ml ropivacaine and 10 ml lidocaine. visual analogue scores are assessed 15 minutes after awakening from surgery and on day 1, 2, 3, 7, 14, 21 and 28 after surgery. postoperative analgesic consumption are registered in the first month after the surgery. the quality of recovery after anesthesia is assessed on day 1 by the postoperative quality of recovery score (qor-15).

Eligibility criteria:
inclusion criteria: * elective arthroscopic anterior cruciate ligament reconstruction * adult exclusion criteria: * unwilling or unable to grant written informed consent * revisions * contra-indication for ropivacaine

Keywords: local infiltration analgesia postoperative analgesia
pain relief by applying tens on acupuncture points during the first stage of labour

Conditions: Pain Relief at First Stage

Summary: we aimed to establish the reduction of labor pain by applying tens at acupuncture points during the first stage of labour, to assess their efficacy, and to ascertain their acceptability.

we conducted a double-blind, placebo-controlled randomised trial involving healthy parturient at term pregnancy using tens on 4 acupuncture points (li 4 and sp 6) (n=50) and the placebo group (n=50). visual analogue scale (vas) was used to assess the effect on pain before the application, 30 minutes and 60 minutes after tens. the objective parameter of outcome was the score of vas decreased in each groups. a post-partum questionnaire was given 24 hours later to evaluate the satisfaction and the use of this pain relieving method for the next delivery.

Eligibility criteria:
inclusion criteria: the inclusion criteria were: * voluntary informed participation to the study * an initial wish to deliver without epidural analgesia * planned vaginal childbirth (non-obstetrical complicated pregnancy) * fetal vertex presentation * term pregnancy (\>37 weeks of gestation) * apply at 1st stage of labour and excluded if cervical dilatation \> 5 cm * age between 20 and 40 years * chinese speaking, capable to understand the study * no experience of pain relief by systemic or epidural anesthesia in previous delivery * no experience in acupuncture or tens in other field * had no heart disease nor using pace-maker. exclusion criteria: * cervical dilatation \> 5 cm * experience of pain relief by systemic or epidural anesthesia in previous delivery * experience in acupuncture or tens in other field * had heart disease or using pace-maker

Keywords: pain relief, tens, acupuncture points
determine the effect of administering periostat(r) twice daily on patients with acne rosacea

Conditions: Acne Rosacea

Summary: the purpose of this study is to determine whether periostat(r), doxycycline hyclate 20 mg tablets, taken twice daily is effective in reducing the red and white heads and overall redness associated with rosacea.


Eligibility criteria:
inclusion criteria * healthy, post-pubescent male and females \> age 18, with rosacea, 10 to 30, \[papules and pustules\] and \< 2 nodules. * presence of moderate to severe erythema. * presence of telangiectasia. * female patients must utilize one of the following methods of birth control throughout the study: iud, diaphragm, a condom plus the use of a spermicidal gel or foam, oral contraceptives (provided patient has been utilizing this method for at least 4 months prior to baseline and has not changed the brand within this period). patients may also participate if they are surgically sterilized, in a monogamous relationship with a sterile partner, or sign an agreement that they will abstain from sexual intercourse during the course of a study. * patients must sign an informed consent form. * negative pregnancy test and non-lactating. exclusion criteria * the initiation of a hormonal method of contraception within 4 months of baseline; or discontinuation during the course of study; or change in the actual product within 4 months of baseline or during the study. * the use of topical acne treatments within 2 weeks of baseline. * the use of systemic antibiotics within 4 weeks of baseline. * the use of an investigational drug with 90 days of baseline. * pregnant women or women of child-bearing potential who are not using an adequate form of birth control as described in item 4 of the inclusion criteria. * nursing women. * patients with a known hypersensitivity to tetracyclines. * patients on clinically significant, concomitant drug therapy (see section below). * the use of any acne treatment during the course of the study. * the use of topical steroids 6 weeks prior to baseline and during the study. * the use of systemic corticosteroids 6 weeks prior to baseline and during the study. * the use of vasodilators 6 weeks prior to baseline or during the study. * the use of α-adrenergic receptor-blocking agents 6 weeks prior to baseline and during the study. prohibited medications: * chronic use (\> 14 days) of sulfa drugs, erythromycin, cephalosporins, and quinolones. * the use of tetracycline antibiotics is prohibited. * use of any acne treatment during the course of the study, including spironolactone. * chronic use (\> 14 days) of nsaids. chronic use of aspirin at sub-analgesic doses (\< 325 mg q.d.) may be used by those patient requiring platelet aggregation inhibitor. * penicillin antibiotics should not be used during the course of this trial since the bacteriostatic action of doxycycline may interfere with the bactericidal action of penicillins. * antacids and vitamins containing aluminum, calcium, or magnesium may impair drug absorption and should be taken at least 1.5 hours before or 3.0 hours after taking study medication.

Keywords: rosacea
active surveillance for low risk prostate cancer

Conditions: Prostate Cancer; Prostate Adenocarcinoma

Summary: an active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. we plan to use psa (prostate-specific antigen) testing, dre (digital rectal examination), trus (transrectal ultrasound), mri (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.


Eligibility criteria:
inclusion criteria: * prostate adenocarcinoma verified by at least 12 core biopsy * patient must understand the sense of research, agree to participate and sign a form of agreement * low oncological risk according to eau (european association of urology) guidelines: stage t1-t2a, psa\<10 ng/ml, isup (international society of urological pathologists score)=1 (gleason score 3+3=6) * not more than 33% cores with adenocarcinoma exclusion criteria: * previous treatment of prostate cancer * other prostatic malignant neoplasms * other oncological diseases * treatment with 5-alfa-reductase inhibitors * patient's refuse to continue study * patient's desire to begin treatment

Keywords: prostate cancer active surveillance low oncological risk
the effect of using desensitizers containing s-prg in treatment of dentin hypersensitivity over 6 months: a randomized clinical trial

Conditions: Dentin Hypersensitivity

Summary: the goal of this clinical trial is to compare the effect of desensitizer containing s-prg have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (vas) along the follow up periods on both groups.


Eligibility criteria:
inclusion criteria: * good oral hygiene. * cooperative patients who show interest to participate in the study and welling to sign the informed consent. * healthy patients with no history of previous systematic diseases that can affect their oral health. * normal and healthy gingival tissue. * teeth that have no cavitation or restorations. * patients with at least 20 natural permanent teeth and at least two teeth with a vas score from 4 to 10. * anterior teeth. exclusion criteria: * allergic to the ingredients used in the study. * gastrointestinal disorders (they have repeated vomiting attacks). * medically compromised (they cannot tolerate the procedures). * taking desensitizing treatment in the last 6 months (it affects the outcome). * taking anti-inflammatory drugs (it affects the hypersensitivity perception). * pregnant females (they complain from nausea and repeated vomiting attacks) * smokers (smoking will affect the oral hygiene and periodontal health).

Keywords: s-prg