Kornimate/medical-research-clean huggingface dataset:
a study of bms-986166 or branebrutinib for the treatment of participants with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of bms-986166 and of branebrutinib, each versus placebo, for the treatment of participants with moderate to severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * chronic atopic dermatitis (ad) diagnosed according to the eichenfield modification of hanifin's and rajka's (e-hr) criteria at screening * disease duration of at least 24 months since diagnosis by any criteria * documented history of inadequate control of ad by a stable regimen (≥ 4 weeks) of topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of randomization, or inappropriateness of therapy due to side effects or safety risks leading to prior discontinuation * application of fixed doses of an additive-free, basic bland emollient twice-daily for ≥ 7 days before baseline visit and for the duration of the study exclusion criteria: * any major illness/condition or evidence of an unstable clinical condition or local active infection/infectious illness that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study or interfere with the interpretation of study results * clinically relevant cardiovascular conditions or pulmonary conditions * high likelihood - based on participant history, and investigator judgement - of requiring rescue therapy in \< 4 weeks prior to randomization * evidence of acute flare between the screening and baseline/ randomization * skin lesion(s) and/or pruritus due to conditions other than ad that would interfere with the study specified assessments other protocol-defined inclusion/exclusion criteria apply

Keywords: atopic dermatitis bms-986166 bms-986195 branebrutinib
dengvaxia us pregnancy registry

Conditions: Dengue Virus Infection

Summary: the primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with dengvaxia during their pregnancy

exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

Eligibility criteria:
the eligible population will include pregnant women of any age and their offspring(s) residing in the us and its territories whose dengvaxia pregnancy exposure is reported to the pregnancy registry. reports of dengvaxia pregnancy exposure must contain the following information to be included in the registry: * sufficient evidence to confirm the case qualifies as "exposed during pregnancy"; * vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a clinical study of shr8554 injection for the treatment of pain after orthopedic surgery

Conditions: Pain

Summary: the primary objective is to evaluate the analgesic efficacy of iv shr8554 compared with placebo and morphine in patients with acute postoperative pain following orthopedic surgery.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring elective general anesthesia orthopedic surgery 3. conform to the asa physical status classification exclusion criteria: 1. subjects with a history of difficult airway 2. subjects with a history of reflux esophagitis 3. subjects with a history of mental illness 4. subjects with poor blood pressure control 5. transcutaneous oxygen saturation (spo2) \<90% 6. random blood glucose ≥11.1mmol/l 7. subjects with abnormal liver function 8. allergies to opioids and other medications that may be used during the trial 9. pregnant or nursing women
cell-free dna methylation for endometrial cancer

Conditions: Endometrial Cancer; Liquid Biopsy; DNA Methylation; Cervical Cytology; Diagnostic Accuracy; Training Set; Validation Set

Summary: liquid biopsy is challenging for the diagnosis of endometrial cancer. in this study, investigators perform the methylation testing of host dna, namely, bhlhe22, celf4, hand2, and znf177, in the peripheral serum to discover the diagnostic and supervision roles of dna methylation in endometrial cancer. the study compromises two stages. in the training set, dna methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. the cut-off values of methylation are produced in this stage. on the meantime, dna methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues. in the validation set, serum dna methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy. in training and validation sets, serum dna methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of dna methylation.


Eligibility criteria:
inclusion criteria: * with definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set. * with sufficient fresh peripheral serum, cervical cytology, and endometrial samples for dna methylation testing before with or without after major surgeries. * aged 18 years or older. * signed an approved informed consents exclusion criteria: * not meeting all of the inclusion criteria.
real-time internet evaluation of swallowing

Conditions: Head and Neck Cancer; Stroke

Summary: the purpose of this study is to determine whether real-time internet evaluations of swallowing, or x-ray swallow studies viewed over closed internet circuit, are a reliable method of evaluating swallowing function.

the objective of this proposal is to establish the validity of an internet based protocol for real-time, remote, telefluoroscopic evaluation of oropharyngeal swallowing function. the investigators will achieve this goal by testing the hypothesis that oropharyngeal swallowing function evaluated by an experienced speech-language pathologist (slp) using a remote, interactive, real-time, dynamic internet telefluoroscopic procedure, which was developed in the pi's laboratory, has an acceptable level of agreement with the evaluations performed by an experienced slp who is present in the fluoroscopy suite and using the traditional videofluoroscopic methodology. in other words, the primary aim of this investigation is to determine whether the telemedicine approach to evaluation of swallowing function is reliable relative to the traditional method by which a clinician is in direct contact with a patient for a pre-examination interview, clinical examination, and videofluoroscopic evaluation of swallowing function. confirmation of the reliability of the telefluoroscopic evaluation of oropharyngeal dysphagia (hereafter referred to as dysphagia) can result in equity of access for underserved groups for whom slps with expertise in evaluating swallowing function are locally unavailable. ultimately, the success of this project could translate specialty services into routine clinical practice across the united states and globally.

Eligibility criteria:
inclusion criteria: * stroke, head \& neck cancer, referred for swallowing evaluation. exclusion criteria: * no stroke or no head and neck cancer, or not referred for swallowing evaluation.

Keywords: deglutition disorders evaluation real-time internet
lidocaine gel during transrectal sonography

Conditions: Gynecologic Diseases

Summary: the aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal ultrasonography (trs) in gynecologic field.

trs is the common procedure to diagnose or exclude gynecologic disease in virgin women. this procedure can be associated with significant pain, both on insertion of the ultrasound probe as well as on manipulating the probe. the investigators evaluated a new technique for pain relief during trs. in all, 80 consecutive subjects undergoing trs at obstetric and gynecologic department were randomized to receive either lidocaine gel(instillagel) or placebo(aquagel) rectally prior to probe insertion. the pain encountered before, during, and after the procedure was graded by the patient on a 10-point visual analogue score. the gel-associated side effect was also evaluated by phone survey after 2 day of procedure. the aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal gynecologic ultrasonography.

Eligibility criteria:
inclusion criteria: * all virgin women who were scheduled to undergo transrectal sonography invited to participate. exclusion criteria: * allergy to lidocaine or other local anesthetics; * patients with a chronic pain condition for which they were taking daily pain medications of any kind. * a bleeding diathesis and/or anticoagulant treatment; * underlying anal or rectal diseases such as symptomatic hemorrhoid, anal fissure, fistulae or anal stricture; * an inability to rate a visual analogue scale
investigate the relationship between catastrophizing and the perception of itch intensity in healthy individuals

Conditions: Histamine; Cowhage

Summary: this project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting.

chronic itch severely affects the quality of life of patients by interfering with vital functions such as sleep, attention, and sexual activity, with an elevated expression of cognitive and emotional factors such as itch catastrophizing, worrying, as well as personality characteristics such as the predisposition to anxiety, depression, and suicidal thoughts that play an important role in the development, modification, and maintenance of itch. moreover, chronic itch represents a significant socioeconomic burden due to a prevalence of around 10% in combination with largely suboptimal treatment since limited evidence has been found for the effectiveness of pharmaceutical interventions. the hypothesis of this project is that since it is well documented that the relationship between catastrophizing and pain and that itch and pain share many similarities, investigators can assume the existence of a similar connection between catastrophizing and itching.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids, or other addictive drugs * previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results * lack of ability to cooperate * current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids * skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis) * moles, scars, or tattoos in the area to be treated or tested. * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
a study to evaluate rocatinlimab (amg 451) in adolescent participants with moderate-to-severe atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.


Eligibility criteria:
inclusion criteria: * age ≥ 12 to \< 18 years at day 1. * diagnosis of ad (according to american academy of dermatology consensus criteria \[eichenfield et al, 2014\]) that has been present for at least 12 months before signing of informed consent. * body weight ≥ 40 kg at screening. * history of inadequate response to tcs of medium to higher potency (with or without tci). * easi score ≥ 12 at initial screening. * easi score ≥ 16 at day 1. * viga-ad score ≥ 3. * ≥10% body surface area of ad involvement. * worst pruritus nrs ≥ 4. exclusion criteria: * treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1. * treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1: 1. systemic corticosteroids 2. non-biologic, non-targeted systemic immunosuppressants 3. phototherapy 4. oral or topical janus kinase inhibitors * treatment with any of the following medications or therapies within 1 week, prior to day 1: 1. tcs of any potency 2. tci 3. topical phosphodiesterase 4 inhibitors 4. other topical immunosuppressive agents

Keywords: atopic dermatitis amg 451 khk4083 rocatinlimab
an open-label tolerability and exploratory efficacy study of zonisamide for dyskinesias in parkinson's disease

Conditions: Parkinson Disease; Parkinsonism; Dyskinesias

Summary: in this 12-week, open-label pilot study, the investigators will enroll 20 subjects with parkinson's disease to determine if two doses of zonisamide are tolerable and demonstrate clinical benefit for dyskinesias. the primary outcome measure is tolerability, as determined by number of subjects able to complete the study on their originally assigned dosage. secondary outcome measures will use the unified dyskinesia rating scale (udysrs), comprised of an objective section and a historical section, to compare baseline to 6 and 12-week measurements. additional analysis of the effect of zonisamide on quality of life will be measured by the parkinson's disease quality of life questionnaire (pdq-39).


Eligibility criteria:
inclusion criteria: * diagnosis of pd * identified dyskinesias of the limbs or trunk as agreed upon by subject and investigator, with dyskinesias considered moderately to completely disabling (updrs question 33, greater or equal to 2) * able to provide informed consent and swallow capsules * stable doses of dopaminergic therapy for 2 weeks before and expected throughout the study. exclusion criteria: * atypical parkinsonism * concurrent use of amantadine or active dbs where patient has some control over settings * prior surgery for pd * sulfa allergy or intolerance of zonisamide * significant concomitant medical illness in the opinion of the principal investigator (renal disease, liver disease) * pregnant subject or a subject who plans to become pregnant
a study of residual curarization incidence in china

Conditions: Perioperative/Postoperative Complications; PORC (Postoperative Residual Curarization)

Summary: the purpose of this study is to determine the incidence of residual curarization in pacu and relevant risk factors.

in the last twenty years, residual curarization in pacu (post anesthesia care unit) has become a common problem in clinical practice and poses high risk to patients. the residual curarization incidence of neuromuscular blocking agents (nmba) varies very much between different studies. these differences indicates the necessity of further study. in china, there is no common view of the harmfulness of residual curarization and its complications. the consensus on the necessity of neuromuscular transmission monitoring and neuromuscular blockade antagonist has not been reached yet. there is also no similar large-scale survey in china. in this case, the investigators conduct this large scale multicentre study, which is designed to learn the incidence of residual curarization and its complications. further analysis of risk factors will also been made. all these efforts are hoped to fill the data gap and provide reliable evidences for rational use of nmba.

Eligibility criteria:
inclusion criteria: * aged 18 or older * nondepolarized nmba will be given during surgery and tracheal extubation will be performed after surgery * willing to comply with all study procedures and provide signed and dated informed consent exclusion criteria: * allergic reaction to gel electrode * neuromuscular disorders and hepatic or renal dysfunction * scheduled to receive mechanical ventilation therapy * involved in other clinical trials * body position and surgical procedure affecting tof-watch sx normal function

Keywords: tofr (train of four ratio) airway extubation pacu (postanesthesia care unit) porc (postoperative residual curarization)
low-level laser effects on orthodontic tooth movement of periodontally compromised patients.

Conditions: Periodontal Diseases; Cancer Metastatic; Orthodontic Tooth Movement

Summary: to investigate the effect of low level laser therapy on orthodontic tooth movement of periodontally compromised patients by evaluating the rate of orthodontic tooth movement and the level of osteocalcin in the gingival crevicular fluid.

low-level laser therapy has been reported as an effective adjunct to non surgical periodontal treatment for inflammation control and tissue reparation in patients with periodontitis. previous studies have shown that application of low-level laser therapy reduced pocket depth and decreased the inflammatory process through regulatory control of inflammatory cytokines level, therefore this study will investigate the effect of low-level laser on the periodontal tissue .accelerating orthodontic tooth movement is one of the primary demand in orthodontics to prevent side effects as root resorption, caries and decreased patient compliance . numerous researchers have also studied the use of lllt in accelerating orthodontic tooth movement and have considered the laser to be effective while others achieved the opposite . hence, this study is aiming to investigate the effects of lllt in accelerating tooth movement.

Eligibility criteria:
inclusion criteria: * no systemic disease. * no history medication (antibiotics and/or anti inflammatory) in the previous 4 months. * self motivated patients with acceptable oral hygien. exclusion criteria: * previous orthodontic treatment * aggressive periodontitis * smokers * pregnant patients

Keywords: rate of orthodontic tooth movement osteiocalsine
tromsø birch rust allergy study. allergy to birch rust, a possible explanation to seasonal airway allergy during autumn?

Conditions: Hypersensitivity, Immediate; Allergy

Summary: in this project we study if spores from birch rust fungi (melampsoridium betulinum = mb) may be the eliciting allergen in patients with seasonal airway allergy during autumn in north norway. patients with suspected allergy to mb are compared with non-allergic controls using data about allergic disease and daily allergic symptoms during autumn. daily spread of mb spores are compared with daily variations in allergic symptoms. sensitization to mb and mb allergy are tested with skin prick test, specific immunoglobulin e (ige) in serum, nasal provocation test and basophil activation test (bat).

it is unknown why patients experience seasonal airway allergy during autumn in norway, when there is no spread of pollen. some old studies indicate that rust fungi on other plants may act as allergens to humans (1-6). in norway, some patients report typical symptoms of allergic rhino-conjunctivitis and asthma from august to october which stops when temperature falls below zero (celsius). based on several patient experiences we hypothesize that mb may cause seasonal airway allergy during autumn. in this pilot study we will compare 30 patients with suspected allergy to mb with a control group of 15 non-allergic individuals. all 45 participants will answer the medall (mechanisms of the development of allergy) questionnaire (7) about allergic diseases and daily register allergic symptoms (8) in the period from 1st of august to 15th of october 2020. daily variations in symptoms will be compared with daily variations in spread of mb spores registered in pollen traps. sensitization to mb will be tested with skin prick test and specific ige in serum and allergy to mb with nasal provocation test and basophil activation test (bat). identification of allergens and production of mb extracts for testing will be performed by luxembourg institute of health (lih)(9-12) and bat by oslo university hospital (13-14)

Eligibility criteria:
inclusion criteria: * self reported seasonal airway allergic symptoms during autumn exclusion criteria: * perennial airway allergic symptoms without worsening during autumn

Keywords: birch rust fungi melampsoridium betulinum allergy allergic rhino-conjunctivitis allergic asthma
no code artificial intelligence to detect radiographic features associated with unsatisfactory endodontic treatment

Conditions: Endodontically Treated Teeth; Endodontic Underfill; Endodontic Overfill; Apical Periodontitis

Summary: developing neural network-based models for image analysis can be time-consuming, requiring dataset design and model training. no-code ai platforms allow users to annotate object features without coding. corrective annotation, a "human-in-the-loop" approach, refines ai segmentations iteratively. dentistry has seen success with no-code ai for segmenting dental restorations. this study aims to assess radiographic features related to root canal treatment quality using a "human-in-the-loop" approach.

the emergence of artificial intelligence (ai) and specifically deep learning (dl) have shown great potential in finding radiographic features and treatment planning in the field of cariology and endodontics. a growing body of literature suggests that dl models might assist dental practitioners in detecting radiographic features such as carious lesions, and periapical lesions, as well as predicting the risk of pulp exposure when doing caries excavation therapy. although, the current literature lacks sufficient research on the interaction of participants and ai in an ai-based platform for detecting features associated with technical quality of endodontic treatment. this prospective randomized controlled trial aims to assess the performance of students when using an ai-based platform for detecting features associated with technical quality of endodontic treatment and predicting the long term prognosis of the treatment. the hypothesis is that participants' performance in the group with access to ai responses is similar to the control group without access to ai responses.

Eligibility criteria:
inclusion criteria: 1.being a last year dental student at the university of copenhagen exclusion criteria: 1. having any previous ai-related experiences 2. not accepting to sign the informed consent

Keywords: artificial intelligence endodontic treatment