Kornimate/medical-research-clean huggingface dataset:
an observational study to assess the impact of upadacitinib in adult hungarian participants with moderate to severe rheumatoid arthritis (ra) in real-world practice

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. despite the range of treatment options for ra steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. this study will assess the impact of upadacitinib treatment on achievement of remission and low disease activity in moderate to severe ra hungarian patients in the real-world setting. upadacitinib is an approved drug for the treatment of adults with moderately to severely active ra. adult participants with moderate-to-severe ra will be enrolled. around 90 participants who are prescribed upadacitinib in routine clinical practice will be enrolled in the study in approximately 8 sites in hungary. participants will receive upadacitinib as prescribed by the physician and will be followed for approximately 12 months. there will be no additional burden for participants in this trial compared to their standard of care. participants will attend regular visits during the course of the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe active rheumatoid arthritis (ra) upon judgment of the treating physician. * upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies and upadacitinib treatment was started within 1 week before the enrollment. * physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study. exclusion criteria: * participants who cannot be treated with upadacitinib as per smpc or local prescription criteria. * prior treatment course with upadacitinib or the current upadacitinib treatment was started more than 1 week prior to enrollment. * participant currently participating in any interventional study.

Keywords: rheumatoid arthritis (ra) upadacitinib rinvoq
screening using portable electronic recorders for sleep apnea in hypertensive at-risk populations (super-sharp trial)

Conditions: Obstructive Sleep Apnea; Hypertension

Summary: uncontrolled hypertension is associated with an increased risk of heart disease, stroke, and mortality. obstructive sleep apnea (osa) is common in hypertension and treatment using continuous positive airway pressure (cpap) has been shown to effectively lower blood pressure. despite its clinical significance, osa remains underdiagnosed in patients with hypertension, because the current standard of care to diagnose osa is in-laboratory polysomnography, which is inconvenient and often inaccessible for high-risk populations. an alternative to in-laboratory polysomnography is home sleep apnea testing, which has been validated against in-laboratory polysomnography and may be more convenient, accessible, and potentially cost-effective. the objective of this study is to compare home sleep apnea testing to in-laboratory polysomnography in a randomized controlled trial. the investigators will assess whether the use of home sleep apnea testing, compared to use of in-laboratory polysomnography, leads to higher rates of osa diagnosis and treatment using cpap, a reduction in blood pressure, improved sleep-related outcomes, and greater patient satisfaction among patients with hypertension at 6 months. the investigators will also assess whether home testing is cost-effective.


Eligibility criteria:
inclusion criteria: * (1) hypertension, defined as: * uncontrolled blood pressure on or off medications, or * controlled blood pressure on 2 or more blood-pressure lowering medications * (2) at high risk for osa: * stop-bang sleep apnea screening tool ≥3, or * concomitant renal disease (estimated glomerular filtration rate \[egfr\] 15-59), or * resistant hypertension, defined as a blood pressure above target despite 3 or more bp-lowering drugs at optimal doses (preferably including a diuretic) exclusion criteria: * prior diagnosis of osa, current use of cpap, life expectancy less than 6 months, egfr\<15, gestational hypertension or preeclampsia, current use of dialysis, and physical/cognitive impairment/language barrier restricting the ability to complete the study assessments.

Keywords: home sleep apnea tests
study of the 532 nm ktp laser for the treatment of poikiloderma of civatte

Conditions: Poikiloderma of Civatte; Dyschromia; Pigmentation Disorders; Telangiectasia; Photosensitivity Disorders

Summary: this study will evaluate the safety and efficacy of the excel v 532 nm ktp laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of civatte).


Eligibility criteria:
inclusion criteria: * fitzpatrick skin type i - iii * clinical diagnosis of poikiloderma of civatte affecting the neck and/or chest * willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area * agree not to undergo any other procedure for the treatment of poikiloderma of civatte during the study * willing and able to read, understand and sign the informed consent form * willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions exclusion criteria: * any laser treatment on neck and/or chest within 12 months * any topical treatment on neck and/or chest within 6 months * pregnant and/or breastfeeding * infection, dermatitis or a rash in the treatment area * suffering from significant concurrent illness, such as diabetes mellitus or pertinent neurological disorders * history of seizure disorders due to light, fibromyalgia, connective tissue disease, vitiligo, psoriasis, pigmentary disorders, keloid scarring, hypertrophic scarring or abnormal wound healing * history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications * having a known anticoagulative condition or taking anticoagulation medications * history of diseases stimulated by heat, unless treatment is conducted following a prophylactic regimen * having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely) * history of radiation to the head, neck and/or upper chest * undergoing systemic chemotherapy for the treatment of cancer * systemic use of isotretinoin (accutane®) within 6 months * any use of gold therapy * excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study * current smoker or history of smoking within 12 months of study * participation in a study of another device or drug within 6 months * as per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in study

Keywords: poikiloderma of civatte red dyschromia brown dyschromia sun damage neck chest dyschromia pigmentation disorders erythema photosensitivity disorders sun exposure telangiectasia hyperpigmentation hypopigmentation
assessing tolerability of avonex intramuscular injections

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate patients' views when injecting avonex intramuscularly.


Eligibility criteria:
inclusion criteria: * between 18 - 65 years of age; * confirmed diagnosis of relapsing remitting multiple sclerosis; * currently being treated with avonex® for at least 90 days; * using 25 gauge needles for injection of avonex® for at least 90 days; * willing and able to complete study questionnaires; and * provided informed consent to participate in this study exclusion criteria: * diagnosis of progressive multiple sclerosis; * history of recent illness or infection; * history of allergic reaction to avonex®; * any prior usage of a 30 gauge needle for administration of avonex®; * concurrent treatment with other immunomodulating therapies; * pregnant or planning on becoming pregnant; * nursing mothers; and * unable to complete the requirements of the study

Keywords: multiple sclerosis intramuscular injections relapsing remitting
effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia

Conditions: Cerebral Palsy

Summary: this study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia.

the current study will be directed to investigate effect of virtual reality on gross motor and balance as the weakness of the trunk muscles and lower limb muscles along with spasticity potentially predispose balance and walking issues of children with bilateral spastic cp . the balance deficits in children with cp are multifactorial. according to the system's model proposed by woollacott and shumway-cook, multiple systems contribute to postural dysfunction in children with cp. muscle weakness and stiffness of lower limb muscles account for biomechanical constraints and postural malalignment during standing and functional balancing. virtual reality is one of the novel technology-based approaches to treat balance and motor function in children with cp. it utilizes the interactive simulations created in computer hardware and software, in which the children find opportunities to engage in environments appearing real to them . after reviewing the available previous published studies, it was found that there is no previous study directly compared between the effects of virtual reality and physical therapy in spider cage on gross motor performance and balance with diplegic children cp children. both therapeutic modalities were found to induce good clinical outcomes when studied separately, so this study will be conducted to examine the effectiveness of virtual reality. the greater demand for physical therapy for paediatrics' signifies the need for more effective, safer and evident therapeutic modalities. the findings of this study will help both; the therapists and the children to save time, effort and reach the best results in concise times.

Eligibility criteria:
inclusion criteria: * children will be included in the study if they fulfil the following criteria: 1. a medical diagnosis of spastic diplegic cp made by pediatricians or pediatric neurologists. 2. children with spasticity grades ranged from 1 to 2+ according to modified ashworth scale (mas). 3. their age range from 6 to 12 years. 4. children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques. exclusion criteria: * children with a permanent spastic diplegia, who might have one or more of the following, will be excluded: 1. they had a permanent deformity (bony or soft tissue contractures). 2. children having visual or auditory defects. 3. current hospitalization for urgent medical reasons. 4. severe mental retardation. 5. children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey. 6. children with history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.
sugammadex dosing: anaesthesiologist clinical perception versus quantitative monitoring

Conditions: Neuromuscular Blockade; Anesthesia; TOF; Curarization, Postoperative Residual

Summary: many clinicians continue to rely on subjective evaluation in making decisions about the adequacy of neuromuscular function before tracheal extubation rather than using quantitative monitoring. the aim was to compare the sugammadex dose as suggested by senior anaesthesiologists (ssd) based on clinical experience versus the dose determined by quantitative monitoring (qsd) to determine if the subjective dose was appropriate.

materials and methods: after obtaining approval from the institute ethics committee, a prospective 3-month study in patients aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) nmb and subsequent reversal with sugammadex, was carried out. american society of anesthesiologists (asa ) physical status v, emergency surgery, patients with hypersensitivity history to rocuronium or sugammadex, severe renal impairment/dialysis, neuromuscular diseases, severe hepatic disease, pre-existing coagulopathies and pregnancy were excluded. monitoring included asa standard monitoring, bispectral index and nmb monitoring using tofscan® monitor. the senior anaesthesiologist was blinded to the tofscan®, which was only available to the author. at the time of pharmacologic reversal of nmb, both the sugammadex dose proposed by the anaesthesiologist (ssd) and the dose suggested by tofscan® (qsd) according to the portuguese recommendations for the management of nmb were recorded. afterwards the qsd was administered to overcome ethical issues. when train-of-four (tof) count was 0, the author performed the post tetanic count (ptc) stimulus to determine the recommended dose. the ssd was considered appropriate if it was within 10% of the qsd for the depth of nmb. all patients were extubated with a tof ratio \> 0.9 (tofr) and both the rocuronium and sugammadex dose were calculated based on the real patient weight. data regarding anaesthesia, duration of anaesthesia and dosing pattern of rocuronium were also noted. the results were analysed descriptively.

Eligibility criteria:
inclusion criteria: * patients aged 18-75 years; * above patients who underwent general anesthesia with rocuronium neuromuscular blockade and subsequent reversal with sugammadex. exclusion criteria: * american society of anesthesiologists physical status v; * emergency surgery; * hypersensitivity history to rocuronium or sugammadex; * severe renal impairment/dialysis; * neuromuscular diseases; * severe hepatic disease; * pre-existing coagulopathies; * pregnancy.
a comparison between paclitaxel-coated balloon and paclitaxel-eluting stent in the treatment of in-stent restenosis (compact-isr)

Conditions: Stable Angina; Unstable Angina

Summary: this is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by quantitative coronary analysis.

the purpose of this study is to determine the late luminal loss by quantitative coronary analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.

Eligibility criteria:
inclusion criteria: * informed consent * \>18y * stable angina or unstable angina * single restenotic lesion in a previously stented coronary artery exclusion criteria: * acute myocardial infarction within 72h * serum creatinine\>2.0 mg/dl * contraindications to asa, heparin, clopidogrel, ticlopidine, abciximab, tirofiban, paclitaxel * contraindications to contrast media * life expectancy \< 2y * target lesion length \> 30mm * target lesion diameter \<= 2.5 mm * target stenosis \< 70% * massive calcifications in the target segment * evidence of intra-coronary thrombus

Keywords: restenosis poba stenting paclitaxel
frequency of ventilator associated pneumonia (vap) in mechanically ventilated patients using the anapnoguard system

Conditions: Ventilator Associated Pneumonia

Summary: ventilator associated pneumonia (vap) is a common complication experienced by mechanically ventilated patients and within the framework of respiratory intensive care units. the anapnoguard system, developed by hospitech respiration ltd. is a ventilation guard system that includes a number of unique characteristics. this study was designed to test the frequency vap in mechanically ventilated icu patients using the anapnoguard system.


Eligibility criteria:
inclusion criteria: * icu patients; * patient was connected to anapnoguard system up to six hours from intubation; * age - above 18. exclusion criteria: * pneumonia; * aspiration pneumonia; * chronic or severe pneumonia; * chronic obstructive pulmonary disease (copd) requiring permanent home-based antibiotic treatment; * interstitial lung disease (ild); * post lung transplant state; * immunosuppression. * patients ventilated in prone position * patient who was ventilated 3 months prior to being enrolled in the study * pregnant women

Keywords: vap
social media, smartphone use and self-harm in young people

Conditions: Self-Harm, Deliberate

Summary: self-harm is when somebody hurts their body as a way of coping with difficult feelings. self-harm is becoming increasingly common in young people, particularly in adolescent females. the rise in self-harm has been linked to increasing use of social media and internet technology among young people. however, the evidence is limited to associations with poorer mental health outcomes rather than identifying particular aspects of using these technologies that can negatively impact on mental health. this study aims to investigate how the use of social media and a smartphone may increase the risk of self-harm in young people by exploring changes in usage in the period leading up to an episode of self-harm. the information from this study will allow us to understand whether there are certain behaviours that are more likely to occur before an episode of self-harm. this will inform new strategies to identify and provide support to vulnerable young people. for example, linking young people with crisis support or empowering young people to make changes, manage their own risks and build resilience. this study will recruit young people aged 13-25 years old who have accessed mental health services provided by an nhs trust in south-east london. young people will be invited to provide information on their mental health and social media and smartphone use over a period of six months.


Eligibility criteria:
inclusion criteria * identified via slam's c4c patient research participation register or referral to the study team by their clinician. * aged 13-25 years old at the time of study approach. * accessed mental health services at slam in the last 12 months. * has capacity to consent (and an adult with parental responsibility for young people aged 13-15 years old). mental capacity will be assumed unless evidence from a clinician or during contact with the study team suggests otherwise. exclusion criteria * unable to complete the questionnaires via the study software application or online survey platform. * admitted to an inpatient psychiatric ward, sectioned under the mental health act or in prison at the time of approach. * clinician advises it is not appropriate to approach.

Keywords: young adult adolescent social media smartphone mental health
incisional negative pressure wound therapy for prevention of postoperative infections following caesarean section

Conditions: Surgical Wound Infection; Infection; Cesarean Section; Cesarean Section; Dehiscence; Complications; Cesarean Section; Complications; Cesarean Section, Wound, Dehiscence; Wound; Rupture, Surgery, Cesarean Section

Summary: the purpose of this study is to examine whether obese women (bmi \>= 30) who give birth by caesarean section have a reduced incidence of wound infection and dehiscence when incisional negative pressure wound therapy is applied prophylactically following caesarean section.

this study is a non-blinded randomised controlled trial and a concurrent health economic evaluation. the study examines the effect on wound healing using incisional negative pressure wound therapy (inpwt) compared with standard postoperative dressings in women with a bmi \>= 30, who has a caesarean section (cs). we expect to find a lower frequency of wound complications when using inpwt directly on primary suturing compared to standard postoperative dressings in this high-risk subpopulation. women, who have given informed consent, will be randomised to either intervention or control group via a computer-generated randomisation program. elective and emergency cs will be stratified to ensure roughly equal numbers in each category of cs in each arm of the study and permit valid separate and pooled analysis. the analysis will be carried out on an intention to treat basis. the inpwt or standard postoperative dressings will be applied in theatre immediately following the operation. in the intervention group the therapy will be left in situ for five days corresponding to the date of removal of stitches. in the control group the dressing will be left in situ for at least 24 hours as standard procedure. women, who do not wish to participate, will be asked for permission to use their data in the analysis.

Eligibility criteria:
inclusion criteria: * age ≥ 18 year * women who can read and understand danish * pregestational bmi ≥ 30 kg/m2 exclusion criteria: -

Keywords: randomized controlled trial economical evaluation caesarean section postoperative wound treatment surgical site infections wound infections infectious morbidity negative pressure wound therapy incisional negative pressure wound therapy obesity
metamizol for the treatment of neoplastic chronic pain

Conditions: Pain

Summary: study to evaluate the efficacy of metamizole in reducing morphine requirements in patients with moderate to severe chronic cancer pain in comparison to administration of placebo or diclofenac.


Eligibility criteria:
inclusion criteria: * hospitalized patients with neoplastic chronic pain requiring morphine treatment exclusion criteria: * karnofsky index less than 30%
a study of ibi363 in subjects with advanced melanoma

Conditions: Melanoma

Summary: this is an open-lable, multicenter phase ii study to evaluate the safety, tolerability, and efficacy of ibi363 in advanced melanoma patients


Eligibility criteria:
inclusion criteria: 1. histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the american joint committee on cancer (ajcc) 8th edition staging iii-iv). progression or recurrence after at least first-line systemic standard treatment. 2. at least one measurable lesion (target lesion) per recist v1.1. 3. eastern cooperative oncology group performance status (ecog ps) of 0 or 1. 4. life expectancy of 3 months or more. 5. female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period. exclusion criteria: 1. pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug. 2. active or symptomatic central nervous system metastasis. 3. at baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin\<90 g/l; absolute neutrophil count (anc)\<1.5 × 109/l; platelet count\<100 × 109/l. 4. at baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: total bilirubin\>1.5 × uln; ast or alt\>3 × uln; if it is tumor liver metastasis, ast or alt\>5.0 × uln; serum creatinine\>1.5 × uln or ccr\<45 ml/min, using the cockcroft fault formula to calculate ccr (using actual body weight); albumin\<30 g/l. 5. at baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: inr\>1.5 × uln (\>3 if receiving anticoagulant therapy with stabilizer dosage) × uln); ptt (or activated partial thromboplastin time (aptt))\>1.5 × uln (\>3 if receiving anticoagulant therapy with stabilizer dosage) × uln). 6. history of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational drug, unless sufficient treatment has been given and the investigator believes that the condition is stable. 7. uncontrolled bleeding or known tendency to bleed.