Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety and efficacy of qge031 in atopic dermatitis patients

Conditions: Atopic Dermatitis

Summary: the study will assess the safety and efficacy of qge031 in the treatment of moderate to severe atopic dermatitis patients. in addition, qge031 levels in the blood will be measured and the effect of qge031 on markers in the blood and skin will be evaluated. comparisons of the effect of qge31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.


Eligibility criteria:
key inclusion criteria: * male and female patients 18 to 65 years of age inclusive (at the time of the screening visit), and who passed screening examinations by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests. * presence of atopic dermatitis confirmed by itchy skin condition in the past 12 months (must have), plus three, or more, of the following: 1. history of involvement of the skin creases (fronts of elbows, behind knees, fronts of ankles, around neck or around eyes) 2. personal history of asthma or hay fever 3. history of generally dry skin in the past year 4. onset before age of 2 years 5. visible flexural dermatitis * patients with an easi score of ≥20 at screening and stable ad (not currently experiencing an acute flare of their ad or had a significant change in the extent of their disease or their treatment regimen in the month prior to enrollment) * patients with a total ige in the range of 30 to 5000 iu/ml inclusive key exclusion criteria: * pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hcg) laboratory test * women of child-bearing potential (wocbp), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means unless they were using a highly effective method of birth control: * total abstinence * male/female sterilization * combination of any two of the following (a+b or a+c or b+c): 1. use of oral, injected or implanted hormonal methods of contraception 2. placement of an intrauterine device (iud) or intrauterine system (ius) 3. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository

Keywords: atopic dermatitis atopic eczema skin diseases qge031
act-group for stroke survivors (pilot study)

Conditions: Stroke; Intracerebral Hemorrhage; Depressive Symptoms; Anxiety; Stress

Summary: the goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. the main questions it aims to answer are: * is the group therapy feasible? * is the group therapy accepted by stroke survivors and therapists? * are there first indications on the efficacy of the group therapy to improve mental health? participants will take part in 8 weekly group therapy sessions of 90 minutes each.

this trail aims to investigate the feasibility, acceptance and preliminary efficacy of a group therapy manual based on acceptance and commitment therapy. the manual is an adaptation of "living well with neurological conditions" (hill et al., 2017), which was conducted in groups with acquired brain injury in general. the manual was translated to german and adapted to the needs of stroke survivors who are often older, have more comorbidities and specific neurological impairments. session length was reduced from 165 minutes to 90 minutes. the program includes 8 weekly sessions. in addition, outcome questionnaires were translated to german and all measures are translated into plain language to increase accessibility.

Eligibility criteria:
inclusion criteria: * value above a cut-off on one of the dass-21 subscales (depression \> 10, anxiety \> 6, and stress \> 10) * sufficient cognition and language ability (clinical rating) * sufficient therapy motivation (clinical rating) exclusion criteria: * behavioral disorders (e.g., high irritability or apathy in clinical rating) * other severe mental disorder (dementia, psychosis, personality disorders, intellectual disability) * parallel psychotherapy or neuropsychological therapy

Keywords: acceptance and commitment therapy group therapy pilot study feasibility
long-term follow-up study of risdiplam in participants with spinal muscular atrophy (sma)

Conditions: Spinal Muscular Atrophy

Summary: a multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the evrysdi® u.s. package insert (uspi) in adult and pediatric participants with sma. in this study, participants will be followed for the duration of the study or until withdrawal of consent, loss to follow-up, or death. participants who discontinue risdiplam may still remain in the study, if they agree to continue participating in the follow-up assessments. an optional sub study will assess the feasibility, acceptability, and adherence of remote assessment of motor and bulbar functions in participants with sma using wearable and smartphone-based biosensors. approximately 39 participants from the main study are planned to be enrolled in the sub study.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of sma * prescribed or continued risdiplam based on clinical judgment of prescriber, as per the evrysdi® uspi, after u.s. fda approval (07 august 2020) sub study: participants in the main study (ml43702) are eligible to be included in the sub study only if all of the following criteria apply: * age ≥ 10 years at the time of signing informed consent form * willingness and ability to use smartphone technology * fluency in english (written and spoken as per the judgment of the investigator) * willingness and ability to complete all aspects of the sub study, including respiration and swallowing measurements using respiratory inductance plethysmography (rip) belts and surface electromyography (semgs) * hammersmith functional motor scale-expanded (hfmse) \> 10 * functional oral intake scale (fois) \>1 * willingness to be video recorded during in-clinic sma-dat tasks and adam sensor assessments and training * availability of a caregiver who is willing to participate throughout this sub study exclusion criteria: * hypersensitivity to risdiplam * participated in a registrational trial for risdiplam (i.e., firefish \[nct02913482\], sunfish \[nct02908685\], jewelfish \[nct03032172\], and rainbowfish \[nct03779334\]) sub study: potential participants will be excluded from the sub study if they meet any of the following criteria: * current respiratory infection that, in the opinion of the investigator, would interfere with the conduct of the sub study * history or known presence of any significant psychiatric disorder such as schizophrenia, bipolar disorder, or substance use disorders * current active clinically significant anxiety or depressive disorder, as judged by the investigator, that is likely to impede a participant's ability to participate in the sub study * wearing a pacemaker (due to incompatibility with the adam sensor) * inability to tolerate the performance of sub study procedures
study of atelectasis by electrical impedance tomography

Conditions: Gynecologic Surgical Procedures; Urologic Surgical Procedures

Summary: the goal of this interventional study is to learn about the effects of different positions on the occurrence, regional distribution and reversibility of atelectasis by using a pulmovista 500 monitor (dräger. 23542 lübeck), during general anesthesia with mechanical ventilation. the main questions it aims to answer are: * the increase in atelectasis after induction of general anesthesia in supine and trendelenburg position compared with baseline (spontaneous breathing) * the eventual possibility of reversal of atelectasis caused by general anesthesia and trendelenburg position by reverse trendelenburg position and recruitment manœuvre. participants will be adult, autonomous and able to express their will, undergoing elective gynecological or urological surgery in the extended trendelenburg position.


Eligibility criteria:
inclusion criteria: * adult subjects over eighteen years old; * requiring laparoscopic gynecological, urological or digestive surgery; * surgery requiring trendelenburg position and tracheal intubation. exclusion criteria: * emergency operation; * thoracic surgery; * pulmonary, cardiac pathology; * pregnant woman; * bmi \> 30; * comorbidities defined as an american society of anesthesiologists physical condition greater than 2; * language barrier; * refusal of consent.
kidney function and cardiovascular events: cohort study in general population

Conditions: Chronic Kidney Diseases; Progression; Cardiovascular Morbidity

Summary: prospective multicenter follow-up study of 10 years. cohort established between 2005-2007 with stratified random sample of general population older than 20 years (census 2001), n= 2746 subjects.

the aim of this study is to analyse the evolution of kidney function (kf) in the general spanish population and its impact in terms of quality of life, survival and prognosis for relevant clinical events: mortality, major vascular events and end stage renal disease (esrd), over a period of 10 years. this is in line with the research priorities highlighted by kidney disease: improving global outcomes (kdigo) 2012. the study is a prospective multi-centre 10 year follow-up study. cohort established in phase i of the epirce study conducted in 2005-2007; stratified random sample of the general population over age 20 (2001 census), with 2746 subjects studied with complete baseline characterization: socio-demographic variables, lifestyle factors, vascular risk, morbidity, and rf. cox proportional hazard additive predictors will be used to study the predictive value of renal function models. all models will be adjusted for socio-demographic factors and lifestyle. idi and nri will be used to determine whether the addition of kf improves the predictive ability of the existing scores. decision curve analysis will be used to indicate different kf cut-off points take cost and benefit into account in the decision to treat or not treat. this project addresses the predictive capacity of glomerular filtration and albuminuria on mortality and vascular events after a 10-year follow-up in the general population, with an analysis of potential improvement in predicting vascular mortality and/or major vascular events by incorporating renal function into existing scales. it also establishes associated serum dna samples to a well phenotyped cohort for subsequent studies of gene expression and inflammatory markers on ckd. these results will therefore provide insight into the natural evolution of ckd and associated vascular risk.

Eligibility criteria:
inclusion criteria: * subjects studied in phase i of the epirce study. give their informed consent to participate in this phase of epirce 2 study. exclusion criteria: * exclusion criteria: subjects that cannot be located or who refuse to give their consent to participate in this monitoring phase will be excluded.

Keywords: primary healthcare cohort
effectiveness of pre-emptive analgesia in children with molar-incisor hypomineralization (mih)

Conditions: Pain; Anxiety

Summary: pain is defined by iasp (international association for the study of pain) as "an unpleasant sensory and emotional experience associated with the damage actual or potential tissue or described in terms that suggest such harm". episodes of pain and discomfort experienced by children are one of the main factors for fear and anxiety in dentistry, especially those that present the condition of molar-incisive hipomineralization, where we observed increased levels of anxiety in relation to the treatment. in order to improve the painful sensation that patients with molar-incisor hipomineralization present as well as anxiety demonstrated by these patients in face of dental treatment, the objective of present study will be to evaluate the occurrence and degree of pain after procedures dentists with administration of pre-emptive analgesia or placebo, in children with molar-incisive hipomineralization. fifty patients will be selected in the pediatric dentistry courses of the forp-usp undergraduate course, aged 6 to 12 years, of both sexes, who present at least 2 (two) upper and / or lower molars affected by molar- incisors that need some kind of restorative treatment, extraction or endodontic treatment. also, these patients should present enamel and dentin fractures caused by mih, atypical restoration and / or atypical caries, and that present pain above the moderate degree (6\>), after stimulation with air/water jet for 5 seconds.


Eligibility criteria:
inclusion criteria: * present at least 2 (two) upper molars and/or lower affected by molar-incisor hypomineralization * restorative treatment * extraction * endodontic treatment * pain above the moderate degree (6\>) exclusion criteria: * patients with suspected of analgesics of any type or presence of acute pain in the last 24 hours before the procedure * patient with history of hepatopathy * bleeding hemorrhagic disorders * hypersensitivity to components * patients and family members who do not have a telephone or that the children will not under parental supervision in the first 24 hours after care.
adenovirus encoding rat her-2 in patients with metastatic breast cancer (adher2.1)

Conditions: Metastatic Breast Cancer; Recurrent Breast Cancer

Summary: to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of adenovector expressing rat her-2/neu in patients with metastatic or locally recurrent breast cancer.


Eligibility criteria:
inclusion criteria: 1. metastatic or locally recurrent breast cancer, 2. 18 years of age or older, 3. her-2/neu positive (3+ by immunohistochemistry or fish +), 4. one of the following 1. currently receiving hormonal therapy or are candidates for such or, 2. being considered for trastuzumab or, 3. their cancer has progressed on trastuzumab exclusion criteria: 1. pregnant or lactating women. 2. prior or concurrent malignancies except treated basal cell or squamous carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured more than five years prior to study entry. 3. currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. \[note: concurrent hormonal therapy (tamoxifen,aromatase inhibitors, or megace) is permitted.\]. 4. treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy. 5. hemoglobin \< 80 g/l or granulocytes \< 1.5 x 109 /l or lymphocytes \< 1.0 x 109 /l or platelets \< 100 x 109 /l. 6. baseline liver enzymes (ast or alt) greater than 3 times upper limit of normal or greater than 5 times upper limit of normal if liver metastases present and/or bilirubin greater than 50 mmol. 7. cd4 cells \< 0.5 x 109 /l 8. patients with documented brain metastases. 9. patients with any acute illness that would interfere with vaccination 10. any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids). 11. eastern cooperative oncology group (ecog) performance status of \> 2. 12. patients with a life expectancy of less than 6 months. 13. geographic inaccessibility which would preclude follow-up. patients registered on the trial must be treated and followed at the jewish general hospital. 14. failure to give written informed consent. 15. baseline left ventricular ejection fraction (lvef) \< 55% by echocardiography or muga scan.

Keywords: metastatic breast cancer recurrent breast cancer
self reported oral health, awareness and attitude towards dental care among pregnant women

Conditions: Pregnancy; Oral Health; Attitude; Oxidative Stress

Summary: purpose/objective of the study: the main objective of the study is to investigate oral health awareness and attitudes towards oral health among norwegian pregnant women and assess the impact of information about oral hygiene on the risk of dental caries during pregnancy. the hypothesis of the study are: 1. the state of oral health during pregnancy depends on pregnant woman's preventive oral hygiene behaviour and practice. 2. pregnant women with high level of oral health awareness and positive attitude towards oral health are more likely to visit their dentists regularly and have better oral hygiene compared to those with less awareness. 3. proper information and guidance on oral hygiene care provided during pregnancy can help to improve oral bacteriological milieu and reduce the dental caries risk among pregnant women.


Eligibility criteria:
inclusion criteria: * women with viable pregnancy ≥ 17 weeks gestation exclusion criteria: * those not willing to participate in the study. * women who are unable to communicate well in norwegian. * women who have been diagnosed to have a fetus with a chromosomal or structural fetal anomaly and do not plan to continue their pregnancy

Keywords: pregnancy, oral health, attitude, awareness, streptococcus mutans, lactobacilli, oxidative stress
influence of environmental conditions on in vitro fertilization (ivf) attempts and induced pregnancies

Conditions: In Vitro Fertilisation; Environmental Conditions

Summary: the main purpose of the study is to assess the impact of environmental conditions on live-birth rates after intraconjugal ivf. the second purposes are * to assess the impact on pregnancies (prematurity, preeclampsia); * to assess the impact on newborn's health (stunted growth); * to evaluate the consistency of results observed between assisted pregnancies and spontaneous pregnancies.

this multicenter epidemiological study aims to analyze the individual standardized clinical records, collected prospectively since 2008 in the medically assisted procreation centers (map). these individual data will be mapped to the environmental data (meteorological and air quality), recorded in the area of residence of the mother at the time of conception and pregnancy, as well as to the socio-economic data. choice of centers: * the study will be proposed to the 106 private or public centers in metropolitan france who are authorized for map procedures such as ivf and icsi. * only the centers who perform more than 200 oocyte retrievals per year will be selected to participate in the study. more than 80% of attempts performed by the selected centers should be available (without missing data) on the induced pregnancies and their outcome (minimum data set for each case: age of man and woman, cause of infertility, technique used, sperm collection method (ejaculation, surgical sperm retrieval techniques), total number of embryos obtained, clinical pregnancy or not, term of pregnancy, weight and height of the child at birth).

Eligibility criteria:
inclusion criteria: * intraconjugal ivf and icsi * transfers of frozen embryos after intraconjugal ivf or icsi exclusion criteria: * ivf and icsi with sperm donation * ivf and icsi with egg donation

Keywords: in vitro fertilisation environmental conditions pregnancy live birth rate
remote intelligent interactive virtual reality assessment in patients with degenerative lumbar spine diseases

Conditions: Degenerative Lumbar Spine Diseases

Summary: this study will combine virtual reality (vr) technology with machine learning to focus on functional movement. patients' symptoms will be evaluated, and exercise instruction with real-time feedback will be provided. the goals of this research are to: (1) develop a waist digital sensor for real-time monitoring as an evaluation tool, (2) apply a real-time monitoring system in conjunction with virtual reality for telerehabilitation, and (3) develop the standard model.

the remote assessment and training in this study can assist patients obtaining physical therapy care at home. it is suitable for patients who avoid going to the hospital due to the epidemic, and solve the problem of long-term treatment. the outcomes will provide dlsd patients tele-rehabilitation platform and system, help medical personnel to treat patients more effectively in the future, and reduce the burden of medical costs on close ones.

Eligibility criteria:
inclusion criteria: 1. able to stand and walk for 5 minutes independently 2. aged between 50 and 80 years 3. received a diagnosis of dlsd based on imaging exclusion criteria: 1. neurological disorder such as stroke or spinal cord injury 2. metabolic disease such as diabetes mellitus 3. vestibular disease such as meniere's disease.

Keywords: degenerative lumbar spine disease virtual reality telehealth real-time detection
restorations and furcation involvement on molars

Conditions: Furcation Defects

Summary: the aim of this study will be to analyze the relationship between the presence of second class restorations (interproximal fillings) or prostheses (crowns, bridges) on molar teeth and the presence of bone resorption between the roots of the latter. patients with this type of restorations will be identified and a non-interventional clinical and radiographic analysis will be conducted.

patients who have a molar tooth reconstructed with a second class filling according to black, or a with crown or that is abutment of a prosthetic bridge will be included in the study provided they have at least one other intact molar. the molars included in the study do not have to be wisdom teeth. in these patients, in addition to the presence of furcations (bone resorption in the space between the roots), the probing depth (pd), the loss of clinical attachment (cal), bleeding on probing ( bop), mobility, width of the keratinized tissue, the length of the root trunk (measured radiographically), the presence or absence of endodontic treatments (evaluated on the radiography), the anatomy of the roots (widely separated, fused, separated but fused) and the presence of enamel projections will be recorded. data will be analyzed with utilizing pearson chi-square and the pair-wise t test. the analysis of these data will provide us with evidence on the influence that interproximal restorations and fixed prostheses, in the presence of other co-factors, have on the presence of furcations in molars.

Eligibility criteria:
inclusion criteria: * patients who have molars both with and without restorations * restorations presents for at least 5 years exclusion criteria: * patients who do not want to undergo evaluation * patients who cannot undergo radiation (pregnant women) * patients who do not have at least one other unrestored molar

Keywords: furcation defects dental restoration, permanent dental crowns