Kornimate/medical-research-clean huggingface dataset:
validation of the norwegian visa-g questionnaire

Conditions: Hip Pain Chronic; Hip Bursitis

Summary: the aim of this study is to translate, cross-cultural adapt and validate the norwegian visa-g (visa-n-g) questionnaire. the study will test the psychometric properties for the visa-n-g in terms of test-retest reliability, internal consistency, construct validity and responsiveness.

the victorian institute of sport assessment-gluteal questionnaire (visa-g) questionnaire have already been developed and used as a measurement tool in research on english speaking greater trochanteric pain syndrome (gtps) populations. the aim of this study is to translate, cross-cultural adapt and validate the norwegian visa-g (visa-n-g) questionnaire. the translation of the original visa-g into norwegian has been done following the official guidelines. the patients will be recruited from the outpatient clinic at the department of physical medicine and rehabilitation, oslo university hospital and will follow the ordinary patient care. after given written consent, patients will be asked to fill out the following norwegian questionnaires: visa-n-g, harris hip score (hhs), oswestry disability index (odi) and a numeric rating scale (nrs) for assessment of pain intensity. the aforementioned questionnaires will be used to test the construct validity with various hypothesis at baseline. within one week the investigators will ask the patients to fill out the visa-n-g once more to test the test-retest reliability. to investigate responsiveness the patient will be asked to fill out the visa-n-g together with hhs, odi, nrs and a 11-point global rating of change scale (groc) after seven weeks. responsiveness will be tested with various hypothesis and measured by the area under the receiver operating characteristics curve (roc).

Eligibility criteria:
inclusion criteria: * hip pain * ability to read and write norwegian * \> 18 years old exclusion criteria: * not able to read and write norwegian * \< 18 years old
evaluate the effectiveness of an experimental urethane dimethacrylate resin based dental composite material

Conditions: Dental Caries; Restorative Material

Summary: this double blind randomized controlled prospective clinical trial will compare the clinical success of two tooth colored resin composite dental filling materials - tph3 (dentsply caulk) and an experimental urethane dimethacrylate resin based composite resin (dentsply caulk) for wear resistance, staining and marginal seal using modified ryge criteria to evaluate the posterior restorations for 24 months in duration

the purposes of this clinical trial is to evaluate two composite resins used to restore class i and class ii cavities in teeth of adults. the clinical study will evaluate the resin composite restorations placed in class i and class ii cavity preparations for anatomic form, color match, marginal integrity, marginal discoloration, proximal contact, polishability, caries, sensitivity, gingival index, staining,wear, and thermal response for 24 months..

Eligibility criteria:
inclusion criteria:• must have given written consent to participate in the trial * must be in need of at least two restorations in natural tooth * replacement restorations with or without caries are acceptable * must be available for the required post-operative follow-up visits * restorations to be in bicuspids, 1st or 2nd molars * restorations to be in contact with opposing natural or crowned teeth * class ii restorations must have at least one proximal contact * restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips * 75% of the restorations must be class ii * all restorations must have at least one occlusal contact in habitual closure exclusion criteria: * have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) or disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene * have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or sjogren's syndrome patients * have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored * have a history of chronic bruxism and those unavailable for long term recall * can not tolerate the rubber dam required for tooth isolation during preparation and restoration. * do not meet all inclusion criteria * present with any systemic or local disorders that contra-indicate the dental procedures included in this study * have an unstable occlusion * have severe bruxing or clenching or need of tmj related therapy * have teeth with periapical pathology or expected pulp exposures * have teeth that are non-vital or that exhibit signs of pulpal pathology * pregnancy * known sensitivity to methacrylates and/or acrylates

Keywords: restorative material
adr-002k for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery

Conditions: D017202

Summary: ischemic cardiomyopathy undergoing coronary artery bypass surgery


Eligibility criteria:
inclusion criteria: 1. patients who are clinically diagnosed with ischemic cardiomyopathy and receive cabg 2. patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent 3. others exclusion criteria: 1. patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure 2. patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator 3. others

Keywords: coronary artery bypass ischemic cardiomyopathy adipose-derived mesenchymal stem cells regenerative medicine spray method
oculusgen-glaucoma historical control study in taiwan

Conditions: Glaucoma

Summary: the purpose of this study is to determine whether the oculusgen collagen matrix are effective and safe to implant as an aid of glaucoma surgery.

oculusgen® collagen matrix is a porous, scaffold matrix. it is to be implanted on the top of the scleral flap and beneath the conjunctiva and tenon's capsule at the end of trabeculectomy. the pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. the space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the iop in the right side. the collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (iop).

Eligibility criteria:
subject inclusion criteria: 1. age 18 years or over. 2. at least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy. 3. subject able and willing to cooperate with investigation plan. 4. subject able and willing to complete postoperative follow-up requirements. 5. subject willing to sign informed consent form. subject exclusion criteria: 1. have allergic reactions to collagen 2. subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication 3. normal tension glaucoma patient 4. subject has one eye received oculusgen™ implantation 5. subject who been diagnosed infection with the operation eye 6. subject with anterior chamber abnormality 7. subject with steroid glaucoma

Keywords: glaucoma collagen matrix oculusgen trabeculectomy tissue engineering
implementation of the hybrid treatment in clinical care. a sced.

Conditions: Emotional Problem; Chronic Pain

Summary: in society today, mental health problems, specifically stress-, anxiety- and depressive disorders, are a primary cause of long-term sick leave, leading to significant societal costs and suffering. one important issue hindering implementation of successful treatments is that there is a marked co-occurrence between these problems and somatic health problems, such as different types of pain. an important key to solving this problem is to develop a more integrated conceptualization of, and treatment model for, these patients' health problems. specifically, one way to understand the co-occurrence between mental and somatic health problems is offered by the 'transdiagnostic' perspective. the aim of this project is to implement and evaluate the effectiveness of a transdiagnostic emotion-focused treatment protocol in clinical context. the treatment addresses comorbid mental (stress, anxiety- and depressive) and somatic health (pain) problems and targets core emotion regulation processes that are hypothesized to maintain and exacerbate these problems.


Eligibility criteria:
inclusion criteria: * \> 11 points on the anxiety or depression subscale, hospital anxiety and depression scale * somatic health problems (pain \> 3 months) with functional impairment (\>3 on question 2 of the multidimensional pain inventory, mpi, or \> 20 points on question 21-24 of the örebro musculoskeletal pain questionnaire, ömpq) exclusion criteria: * severe psychiatric problems requiring immediate other treatment * current psychological treatment * recently started psychopharmacological treatment for anxiety or depression (\<3 months prior to planned treatment) * insufficient mastery of the swedish language
prenatal screening for congenital heart diseases in the antwerp region

Conditions: Congenital Heart Disease in Pregnancy

Summary: no systematic research has been done in the last 15 years on the accuracy of prenatal ultrasound of congenital heart diseases in belgium. nor are there any population-based studies available on this subject for belgium. based on the data of eurocat (european surveillance of congenital anomalies) the investigators analyse prenatal diagnostic sensitivity of congenital heart diseases in the eurocat regions antwerp (flanders, belgium)

congenital heart defects are a leading cause of infant mortality with an incidence of 0,4-1,3% at birth. although prenatal detection rates vary widely, morphological (structural) cardiac malformations are among the most frequently missed abnormalities by prenatal ultrasonography. however, identifying fetal cardiac abnormalities early in pregnancy is essential. early diagnosis allows extensive cardiac ultrasound, genetic testing and planning delivery in a paediatric-cardiac centre offering optimal neonatal care. it also may allow the future parents to consider and decide for a termination of pregnancy in case of a severe fetal heart malformation with poor prognosis. the investigator conducts a retrospective study on 2500 cases of congenital heart diseases over 20 years. detailed data for this were made available by the eurocat antwerp registry, a population-based database with controlled, reliable and robust data. the study wants to reveal the prevalence and prenatal diagnostic sensitivity of congenital heart defects in the eurocat regions antwerp (flanders) and especially the evolution of the prenatal diagnostic rate over time. in the second phase, a similar study in two adjacent regions, hainaut (wallonia, belgium) and groningen (the netherlands) will follow. on condition of correct statistic processing, these data will be suitable to compare the prevalence and to benchmark diagnostic rates of congenital heart defects in these three regions.

Eligibility criteria:
inclusion criteria * all fetal congenital heart diseases registered in the antwerp-eurocat database, * in the period 1/1/1997-31/12/2017 period exclusion criteria * all cases of congenital heart diseases where the mother was under \<18 years old. * all cases of congenital heart diseases were the parents did not allow inclusion in the eurocat registered. * all cases of congenital heart diseases where the mother delivered outside the ec countries.
pharmacokinetics and pharmacodynamics of mk-8245 in participants with type 2 diabetes (mk-8245-012)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of mk-8245 in participants with type 2 diabetes. the primary hypothesis of the study is that after 4 weeks of treatment, mk-8245 produces a greater reduction in 24 hour weighted mean glucose (wmg) from baseline than placebo.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents * subject is willing to follow a weight-maintaining diet and exercise program during the study * subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit exclusion criteria: * subject has a history of stroke, chronic seizures, or major neurological disorder * subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening * subject has a history of type 1 diabetes * subject has used contact lenses within the last 6 months * subject has used any lipid-lowering therapy in the last 3 months, except statins, zetia, or vytorin * subject has more than 3 alcoholic beverages per day * subject has more than 6 servings of caffeine a day * subject has participated in a previous mk8245 study
randomized, prospective controlled trial of paraesophageal hernia repair with small intestinal submucosa (sis)

Conditions: Hernia; Paraesophageal Hernia

Summary: the purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (sis) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.


Eligibility criteria:
inclusion criteria: * age \> 18 years * documented symptomatic paraesophageal hernia * ability to participate in follow-up evaluation * has a telephone * free of cognitive or speech impairment exclusion criteria: * patients requiring intra-operative conversion to an open procedure * unable to close the crura primarily * short esophagus that requires the surgeon to perform a lengthening procedure * previous operation of the esphagus or stomach * associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment * intraoperative full-thickness perforation of the esophagus * emergent operation for acute volvulus * ineffective peristalsis defined as average amplitude of peristalsis less than 30 mmhg or \< 70% propagation of peristaltic waves in the distal esophagus

Keywords: biomaterials paraesophageal hernia laparoscopy
innovation in pulmonary rehabilitation

Conditions: Pulmonary Disease; Pulmonary Emphysema

Summary: the purpose of this study was to compare the effect of exercise treatment combined with breathing retraining (a computerized feedback program), with exercise treatment combined with heliox (a helium and oxygen combination), with exercise only in patients with moderate to severe chronic obstructive pulmonary disease. this was an 8-week intervention study.

dynamic hyperinflation limits exercise tolerance in patients with chronic obstructive pulmonary disease (copd). recently, several innovative approaches have been developed to reduce the burden of dynamic hyperinflation. two such innovations, ventilation-feedback training and heliox supplementation during exercise show great promise and posit a reduction in dynamic hyperinflation as a key to their effectiveness. in our recently completed trial, when age, fev1 and rv/tlc were controlled, exercise plus vf (e+vf) was superior to e training alone (e only) or vf training alone in improving exercise tolerance. the mechanism responsible for this difference was, in part, a reduction in exercise-induced dynamic hyperinflation secondary to a change in breathing pattern. in additional preliminary studies, we determined that exercise tolerance can be increased when patients exercise while inhaling heliox. similar to vf, the mechanism for exercise improvement with heliox was a reduction in exercise-induced dynamic hyperinflation. although both interventions are promising, there are no definitive data to support use of either intervention as a standard of care for pulmonary rehabilitation. hypothesis/research questions overview: the two primary hypotheses are that patients with moderate-severe copd who successfully complete eight weeks of (a) e+vf training will achieve longer exercise duration than patients randomly assigned to e only and (b) e+heliox training will achieve longer exercise duration than patients randomly assigned to e only. methods: this study was a randomized controlled clinical trial. after baseline testing is completed, 103 subjects with moderate-severe copd were randomized into one of three groups: e+vf, e+heliox and e training only. follow-up testing was completed at 8 weeks. testing, activity monitoring, and dyspnea measurements. after baseline testing was completed, randomized subjects trained in the physical performance laboratory three times weekly. exercise prescriptions were standardized and based on data from the exercise stress test.

Eligibility criteria:
inclusion criteria: * 40 years of age * fev1 70% * fev1/fvc \<70% * rv/tlc \> 120% exclusion criteria: * respiratory infection/exacerbation within last 4 weeks * exercise limiting heart disease * primary asthma * congestive heart failure new york heart association (nyha) class iii-iv * exercise limiting peripheral arterial disease or arthritis * inability to walk on a treadmill

Keywords: breathing exercise exercise therapy helium oxygen inhalation therapy pulmonary emphysema pulmonary ventilation rehabilitation
the effects of add-on anti-diabetic drugs in type 2 diabetic patients

Conditions: Hyperglycemia

Summary: recently, there are some new classes of anti-diabetic drugs availible in taiwan. in this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

recently, there are some new classes of anti-diabetic drugs availible in taiwan. however, the effects of these anti-diabetic drugs should be further evaluated. specially, the effects on inflammation and energy homeostasis are still not well assessed. in this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Eligibility criteria:
inclusion criteria: * type 2 diabetic outpatient exclusion criteria: * refusal of anti-diabetic drugs * preganacy
hormonal effect of different menstrual phases on dynamic balance in postpubertal females

Conditions: Menstrual Cycle

Summary: high rate of injuries detected during certain periods of menstrual cycle, raised the suggestion of the effecacy of the female sex hormones on soft tissue and neuromuscular control with subsequent deterioration of postural stability and high injury prevalence in post pubertal females so the aim of the present study is to investigate the effect of female sex hormones on postural stability in post pubertal females.

thirty-six post pubertal females will participate in this study. they will be selected from students and graduates of faculty of physical therapy, deraya university and they will be assigned into one group. postural stability assessment will be carried out throughout three menstrual cycle phases, early follicular, ovulation and mid luteal phases by biodex balance system. the timing of menstrual cycle phases will be determined by measuring serum estradiol and progesterone level. the exact time of ovulation will be determined by urine lutenizing hormone ovulatory strip test.

Eligibility criteria:
inclusion criteria: 1. all females will be virginal. 2. their ages will range from 15-25 years. 3. their body mass index (bmi) will range from 18-27 kg/m2. 4. all females will have regular menstrual cycle within average of 28 days. exclusion criteria: 1. females having menstrual irregularity. 2. use of oral contraceptives or any hormonal treatment in the previous six months before participate in this study. 3. history of lower extremity injury, surgery or pain during adl. 4. females having any vestibular problems , otitis media, labyrinthitis or any inner ear problems that affect balance.

Keywords: sex hormones, postural stability, menstrual cycle.
heart rate variability in early prediction of a noxic brain injury after cardiac arrest

Conditions: Cardiac Arrest

Summary: despite advances in post-resuscitation care of patients with cardiac arrest (ca), the majority of survivors who are treated after restoration of spontaneous circulation (rosc) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state. early prognostication in comatose patients after rosc remains challenging. recent recommendations suggest carrying out clinical and paraclinical tests during the first 72 h after rosc, to predict a poor neurological outcome with a specificity greater than 95% (no pupillary and corneal reflexes, bilaterally absent n20 somatosensory evoked potential wave, status myoclonus, highly malignant electroencephalography including suppressed background ± periodic discharges or burst-suppression, neuron-specific enolase (nse) \> 60 µg/l, a diffuse and extensive anoxic injury on brain ct/mri), but with a low sensitivity due to frequent confounding factors. the heart rate variability (hrv) is a simple and non-invasive technique for assessing the autonomic nervous system function. in patients with a recent myocardial infarction, reduced hrv is associated with an increased risk for malignant arrhythmias or death. in neurology, reduced hrv is associated with a poor outcome in severe brain injury patients and allows to predict early neurological deterioration and recurrent ischemic stroke after acute ischemic stroke. a reduced hrv could be a sensitive, specific and early indicator of diffuse anoxic brain injury after ca. this multicenter prospective cohort study assesses the added value of early hrv (within 24h of icu admission) for neuroprognostication after cardiac arrest.


Eligibility criteria:
inclusion criteria: * admitted in intensive care unit (icu) after resuscitation from cardiac arrest (in-hospital or out-of-hospital) * coma (glasgow score \< 8) after rosc, requiring sedation and targeted temperature management for at least 24h exclusion criteria: * dying patient (limitation of life support techniques at admission to the icu) * non-sinus rhythm * pregnant or breastfeeding women * patient under protection of the adults (guardianship, curators or safeguard of justice) * opposition by the trusted person or by the patient once he/she wakes up

Keywords: heart rate variability neurologic prognosis