Kornimate/medical-research-clean huggingface dataset:
predictive value of the pbs-score in children with clubfoot

Conditions: Clubfoot

Summary: evaluate the predictive value of the pbs-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.

using a consecutive inclusion, we aim to include 60 children and register data proposed by the cos for peva. all items of the pbs-score are video-documented, and dynamic foot pressure during walking is recorded during a clinical visit at the motion analysis lab at karolinska university hospital. children and caregivers will complete roye's score, a disease-specific prom and oxford foot and ankle questionaire-child (oxfaqc). for children aged 6 years or older, standing radiographic imaging of both feet will be performed. inclusion criteria include: age 4-8 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in swedish or english. included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.

Eligibility criteria:
inclusion criteria: * age 4-10 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in swedish or english. exclusion criteria: * syndromic clubfoot

Keywords: pbs-score oxford foot and ankle questionaire-child roye's score pedobarography
study of istradefylline (kw-6002) for the treatment of restless legs syndrome

Conditions: Sleep Disorder; Restless Legs Syndrome

Summary: the primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (kw6002) in patients with restless legs syndrome.

restless legs syndrome (rls) is a very common neurological disorder with a prevalence of approximately 10% in the adult population. it is characterized by an almost irresistible urge to move the legs, usually accompanied by feelings of intense discomfort. the feelings are usually present while at rest and are temporarily relieved by activity. symptoms are worse in the evening and at night and lead to profound sleep disturbance and daytime fatigue. although a number of therapeutic approaches have been used to treat the symptoms of rls, none have been universally adopted. while it has been shown that some dopaminergic anti-parkinsonian medications are effective in treating rls, their use may be somewhat limited by side effects associated with long-term dopaminergic activation. istradefylline may provide a nondopaminergic approach to the treatment of rls. this study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of rls with placebo.

Eligibility criteria:
inclusion criteria: rls that is mild to moderate in severity, non-nursing and non-pregnant if female, with an otherwise normal examination. exclusion criteria: unable to stop other rls medication, treatment with excluded medications, abnormal medical status.

Keywords: sleep -sleep disorder sleep- restless legs syndrome clinical trial
connect study - clinical evaluation of remote notification to reduce time to clinical decision

Conditions: Arrhythmia; Tachycardia; Atrial Fibrillation; Ventricular Fibrillation

Summary: the purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.


Eligibility criteria:
inclusion criteria: * patient will be implanted with a medtronic conexus-enabled cardiac resynchronization therapy defibrillator (crt-d) or implantable cardioverter-defibrillator (dr-icd) device. exclusion criteria: * patient has permanent rapid beats in the upper chamber of the heart (atrial fibrillation) - (constant atrial fibrillation in which pharmacological therapy or cardioversion failed or not attempted). * patient plans to be on chronic warfarin therapy post-implant and is no longer receiving therapies to attempt to control the rhythm of the beats in their atrium. * patient has a previous icd, crt-d, implantable pulse generator (ipg) or cardiac resynchronization therapy pacemaker (crt-p).

Keywords: randomized controlled trials defibrillators remote consultation
utility of dynamic variables measured by calibrated pulse contour analysis of oesophageal doppler monitor for predicting fluid responsiveness during robot-assisted laparoscopic prostatectomy

Conditions: Prostate Cancer

Summary: robot-assisted laparoscopic prostatectomy (ralp) is widely performed due to its many advantages, including a reduced need for blood transfusion and fewer surgical complications compared with conventional open prostatectomy. as this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important. dynamic variables such as pulse pressure variation (ppv) and stroke volume variation (svv) are used to predict and guide fluid therapy during controlled ventilation. these variables arise from heart-lung interactions during positive pressure ventilation, which influence left ventricular stroke volume (sv). ralp requires carbon dioxide insufflation and the steep trendelenburg position to optimise surgical conditions, and can reduce cardiac output and respiratory compliance. accordingly, the usefulness of ppv and svv, which are affected by changes in intrathoracic pressure, in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned. a recent study established that ppv and svv derived by uncalibrated pulse contour analysis had a relatively poor capacity to predict fluid responsiveness during laparoscopy on dynamic preload indices. in contrast, another study svv measured by oesophageal doppler monitor (odm) could predict fluid responsiveness during laparoscopic surgery. the cardioq-odm+ combines the proven odm doppler measurement of blood flow with pulse contour analysis, which is quickly and easily calibrated from the doppler signal. we hypothesized that ppv and svv measured by calibrated pulse contour analysis would be a good indicator of fluid responsiveness during laparoscopy with pneumoperitoneum. the primary objective of this study was to demonstrate that ppv and svv measured by calibrated pulse contour analysis of cardioq-odm+ can accurately predict fluid responsiveness during ralp, which involves both pneumoperitoneum and the trendelenburg position. investigators also assessed the capacity of other dynamic variables (spv \[systolic pressure variation\], and svv determined by odm doppler flow, dynamic elastance \[ppv/svv\] and corrected flow time \[ftc\]) to predict fluid responsiveness during ralp.


Eligibility criteria:
inclusion criteria: * patients undergoing elective robot-assisted laparoscopic prostatectomy exclusion criteria: * patients with a bmi \> 30 or , \< 15 kg/m2 valvular heart disease left ventricular ejection fraction \< 50% a history of lung disease preoperative arrhythmia contraindications to oed monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, and severe coagulopathy)
the effects of an addition of water enema to peg for colon preparation

Conditions: Adenoma, Bile Duct

Summary: the purpose of this study is to compare the preparation quality by using ottawa bowel preparation scale between the standard peg preparation and the addition of water enema in participants scheduled for crc screening

background : good bowel preparation improves the rate of polyp detection and the time of caecal intubation during colorectal cancer (crc) screening. suboptimal bowel preparation can results in adenoma miss rate up to 42% (95% ci, 35-49) and advanced adenoma miss rate up to 27% (95% ci, 17-41) the european society of gastrointestinal endoscopy (esge) guideline recommends a split regimen of 4l of polyethylene glycol (peg) solution (or a same-day regimen in the case of afternoon colonoscopy) for a routine bowel preparation and the delay between the last dose of bowel preparation and colonoscopy should be minimized and no longer than 4 hours. the investigators hypothesize that the addition of water enema to the standard peg bowel preparation could provide the better quality of bowel preparation and then result in improvement in the rate of adenoma detection among participants scheduled for crc screening with preparation to procedure interval \> 8 hr. the purpose of this study is to compare the preparation quality using ottawa bowel preparation scale between the standard peg preparation and the addition of water enema in participants scheduled for crc screening. the secondary aim is to compare the effect of the standard peg bowel preparation and the addition of water enema in terms of adenoma detection rate, the completeness of the examination, total and withdrawal time, safety and adverse events among those scheduled for crc screening.

Eligibility criteria:
inclusion criteria: * patients scheduled for crc screening * bowel preparation using 3 liters of peg solution * colonoscopy performed at 8-16 hours after bowel preparation exclusion criteria: * history of a failed bowel preparation * previous colonic surgery * uncontrolled underlying disease * pregnancy

Keywords: bowel preparation crc screening
tolerability and toxicity of topically applied nepafenac 0.3% vs ketorolac 0.5%

Conditions: Cataract

Summary: this study will examine the tolerability and toxicity of topically applied nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.

this will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). the study will involve one eye of each subject. the study will follow good clinical practices (gcp). the primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.

Eligibility criteria:
inclusion criteria: 1. patients 18 years and older currently undergoing femtosecond or manual cataract surgery with or without astigmatic keratotomy. 2. patients willing to take an electronic survey about their tolerability of either study medication. exclusion criteria 1. active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings. 2. any of the following ocular (eye or eyelid) conditions in either eye within 1 months prior to the enrollment visit: 1. ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure. 2. clinically significant ocular trauma. 3. active ocular herpes simplex or herpes zoster (eye or eyelid) infection. 4. ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) 5. ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye) 3. moderate to severe (grade 2-4) allergic, vernal or giant papillary conjunctivitis 4. severe (grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis) 5. eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) 6. ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy) 7. participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey 8. participation in this trial in the same patient's fellow eye. 9. patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.

Keywords: cataract
physical performance of women at different stages of the menstrual cycle, and photobiomodulation therapy

Conditions: Menstrual Cycle Disorder

Summary: hormonal fluctuations present during the ovarian cycle may have a strong influence on physiological and psychological aspects on physical performance in women. the aspects surrounding performance and ovarian cycles in women during different phases of the cycle, are still current and should be debated in the literature, as the available evidence has conflicting results. in addition to the above, new ergogenic methods have been studied to improve the sports scenario in different populations. research on the use of ergogenic electrophysical resources so that hormonal effects may possibly be mitigated, allowing women to use this resource and improving their physical performance is still scarce in the current literature.

objective: to evaluate the physical performance of women during different phases of the ovarian cycle and the influence of photobiomodulation therapy in this setting. methods: the research will be conducted in two subprojects - subproject i is a cross-sectional study. initially the participants will be evaluated in two phases separately, being the first and second day within the ovarian cycle in the follicular phase (ff) and the third and fourth day in the luteal phase (fl). the aspects of body composition, body water volume and skin temperature by infrared thermography will be evaluated, and the physical performance evaluation will be constituted by the evaluation of the muscular performance by isokinetic dynamometer, and by a treadmill supramaximal effort test. , together with analysis of vo2max and blood lactate levels. subproject ii is a double-blind placebo-controlled randomized clinical trial. after completion of subproject i, during the next ovarian cycle within the participants will return to conduct the second part of the study, which will analyze the influence of photobiomodulation therapy on the physical performance of women within their menstrual cycle, related to low hormone rate ( ff). 200 j of energy will be applied before each evaluation, which is muscle performance and endurance. the tests will be performed in the same order, following the same protocol in both phases of the study. for data analysis, a normality test will be used to verify the distribution and statistical tests consistent with the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time and group. a significance level of 5% will be adopted. the effect size will be calculated by cohens'd.

Eligibility criteria:
inclusion criteria: * women * 18 to 35 years * healthy * physically active (150 min / week) exclusion criteria: * eating disorders; * hormonal disorders; * amenorrhea; * pregnancy; * polycystic ovary; * endometriosis; * tumors; * musculoskeletal injury in the last 6 months; * cardiorespiratory disease; * use of alcohol and illegal drugs during the study.

Keywords: menstrual cycle photobiomodulation therapy fatigue clinical trial
immunity against severe acute respiratory syndrome coronavirus 2 disease (covid-19) in the oncology outpatient setting

Conditions: Cancer; Covid19; Immunity

Summary: the covidout study will prospectively investigate the serological immunity of outpatient cancer patients to evaluate the prevalence of previous severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infections and dependency of serological immunity on systemic (chemo)therapy after covid19 disease as well as after vaccination.

in this prospective observational study all cancer patients who are regularly treated in the oncology outpatient clinic of the university medical center hamburg-eppendorf (uke) will be included in the study upon consent. data will be collected as follows: (i) serological antibody screening at study inclusion and every 3 months (ia) in case of vaccination monthly screening for 3 months (ii) routine clinical data: demographic and biometric data, medical history, common laboratory parameters (iii) patient questionnaire: assessment of past covid-19 infection, past covid-19 specific symptoms, social environment, vaccination recruitment is limited to a one-year period (december 2020 - december 2021)

Eligibility criteria:
inclusion criteria: * known diagnosis of cancer * active disease or (in case of cure) last systemic therapy \<12 months * signed informed consent exclusion criteria: * refusal of participation
post marketing surveillance to monitor the safety and efficacy of metalyse® in korean patients with acute myocardial infarction

Conditions: Myocardial Infarction

Summary: to monitor the safety of metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by korean authorities, with the following observations: 1. unexpected adverse drug reactions 2. frequency and nature of adverse events (aes) 3. factors on the safety and efficacy profile of the metalyse® injection. efficacy of metalyse® was also assessed.


Eligibility criteria:
inclusion criteria: * none exclusion criteria: * none
investigation of the effects of sleep fragmentation on itch and pain sensitivity

Conditions: Histamine; Cowhage; Sleep Fragmentation

Summary: in this experiment, the investigators would like to test following hypotheses regarding the influence of sleep fragmentation on itch: * to investigate similarity and differences between itch and pain by comparing the effect of sleep deprivation in them. * to evaluate the inflammatory state induced by sleep fragmentation via the analysis of c-reactive protein (crp) levels from blood samples. * to correlate the anxiety and depression scores (evaluated through questionnaires) with itch and pain sensitivity and evaluate how they are affected by sleep fragmentation.

chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. furthermore, there is a lack of efficient treatment options for chronic itch. poor sleep is a common companion of itch and is often reported by patients with chronic itch. poor sleep is often characterized by nightly awakenings and troubles falling asleep. this is a significant problem as poor sleep in general is associated with lowered quality of life. while previous research has already established the negative impact of itch on sleep, it is yet to be studied whether the opposite tendency might be true as well. knowledge about patients with chronic pain has shown that poor sleep can increase the sensitivity to pain and inflammation, and this tendency can also be observed in healthy participants after experimental sleep provocations. therefore, the investigators wish to investigate how sleep provocations affect markers of itch in healthy participants.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english * access to a smartphone during the experimental nights exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids, or other drugs * previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses (psychiatric diagnosis) that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia etc.) * moles, wounds, scars, or tattoos in the area to be treated or tested * current use of medications that may affect the trial such as antihistamines and pain killers. * skin diseases * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain and itch * participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies) * lack of ability to cooperate
multiregional rtfmri neurofeedback for the prevention of alzheimer's disease (npad)

Conditions: Alzheimer Disease

Summary: this study aims to predict cognitive decline using a performance endophenotype of neuro-feedback based on functional magnetic resonance imaging in real time in a population at risk for alzheimer's disease (ad).

in this research project, a longitudinal study in a healthy population that is under increased risk of developing ad will be performed. it is anticipated that some of the participating subjects will develop episodic memory decline within this longitudinal follow-up. the memory binding test (mbt) and/or the free and cued selective reminding test (fcsrt), the most accurate and reliable available episodic memory tests, are going to be performed by the subjects at multiple longitudinal data collection points. the project proposes to develop a real-time functional magnetic resonance imaging (rtfmri) task, and to test whether the subjects' performance on the task can predict the apparition of cognitive decline. the impact of other relevant biomarkers by adding them to the model: age, gender, number of apoe-e4 alleles, cognitive scores, cerebrospinal fluid (csf) biomarkers, amyloid positron emission tomography (pet), lifestyle habits and clinical background will be studied.

Eligibility criteria:
inclusion criteria: * adult men and women (aged 45-75) that have participated in the study 45-65/fpm2012. * persons that accept the study's test and procedures that are as follows: magnetic resonance imaging and neuropsychological tests. * signature of the study's informed consent form, accepting to not receive information with regards to any research results that are not clinically relevant. exclusion criteria: * any contraindication to mri (e.g. pacemaker, claustrophobia, etc.) * any condition that according to the investigator's judgement could interfere with the proper execution of the study's procedures and/or its follow-up.

Keywords: neurofeedback episodic memory real-time functional mri