Kornimate/medical-research-clean huggingface dataset:
long-term follow-up on immunogenicity & safety of measles-mumps-rubella-varicella (mmrv) combined vaccine

Conditions: Rubella; Varicella; Mumps; Measles

Summary: follow-up to evaluate the immunogenicity and safety of three production lots of gsk biologicals' mmrv vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of gsk biologicals' measles-mumps-rubella (mmr) vaccine (priorix®) and varicella vaccine (varilrix®) in germany \& austria. blood samples were collected at three time points during the follow-up period (year 1, 2 \& 3). no new subjects will be enrolled in these follow-up phases of the study.


Eligibility criteria:
inclusion criteria: * written informed consent from the parents/guardians of the child before participating in the long-term follow-up. * subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of mmrv combined vaccine, or two doses of priorix vaccine and one dose of varilrix vaccine as separate injections in the primary vaccination study. * subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study. exclusion criteria: * subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.

Keywords: rubella varicella measles mumps germany austria
study of ozurdex® in the treatment of diabetic macular oedema (dme) in australia - the aussiedex study

Conditions: Diabetic Macular Oedema

Summary: this prospective study will assess ozurdex in the treatment of diabetic macular oedema in clinical practice.


Eligibility criteria:
inclusion criteria: * pseudophakic or phakic and scheduled for a cataract operation * macular oedema due to dme exclusion criteria: * previous ozurdex® treatment
serum levels of angiotensin converting enzyme in systemic lupus erythematous patients

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a heterogeneous autoimmune disease that involve many different organs and display a variable clinical course.the prevalence of sle varies across gender, race/ethnicity, and geographic regions. sle demonstrates a striking female predominance with a peak incidence of disease during the reproductive years. in adults, the female to male ratio is 10- renal involvement is common in sle and is a significant cause of morbidity and mortality. it is estimated that as many as 90% of patients with sle will have pathologic evidence of renal involvement on biopsy, but clinically significant nephritis will develop in only 50%. aii is a potent pro-inflammatory modulator with the ability to augment the immune responses in renal and non-renal tissues. specifically in the kidney, aii stimulates mononuclear cells, favoring hyperplasia and hypertrophy of mesangial, tubular cells and interstitial fibroblasts, and increases expression and synthesis of the extracellular protein matrix leading to fibrosis. angiotensin ii and strong candidate for a mediator of the development and progression of renal disease in sle has been found to promote glomerular cell proliferation, alter growth factor expression, and activate proinflammatory cytokines, all of which promote glomerulosclerosis


Eligibility criteria:
inclusion criteria: * 1-patients who fulfill the 2019 american college of rheumatology/european league against rheumatism classification criteria of systemic lupus erythematosus 2-patients diagnosed as lupus nephritis , actually did renal biobsy 3-patients who is able to give informed consent to join the study exclusion criteria: * - any patient with any collagen disease other than systemic lupus erythematosus.
precision approach to ppi therapy in gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux; Laryngopharyngeal Reflux

Summary: this study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.

reflux associated laryngeal symptoms, coined "laryngopharyngeal reflux", occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. over the past 25 years, reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.

Eligibility criteria:
inclusion criteria: * age 18-89 years male and female, * \>8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness, * naïve to ppi or able to stop for 8 weeks exclusion criteria: * laryngeal mass lesion on laryngoscopy; * pregnant; * unable to consent in english; * imprisoned; * ppi intolerance; * contraindication to uesad use per manufacturer guidelines which include: * patients with implants or implant parts that reside in the area where uesad is applied. * patients with an implanted pacemaker, implanted cardioverter defibrillator (icd), vagus nerve stimulator, or other such similar devices implanted in the neck. * patients diagnosed with glaucoma. * patients who had a malignancy of the neck, including neck surgery. * patients that may have an altered mental status including due to the use of sedative drugs or narcotics. * patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., marfan's syndrome or ehlers-danlos syndrome). * patients who use nocturnal niv machines such as cpap or bipap.

Keywords: esophageal disorders
study of motexafin gadolinium (mgd) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: the primary purpose of this study is to determine if motexafin gadolinium may be an effective treatment for patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). secondly, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening will be evaluated. additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * cll as defined by the nci 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t\[11;14\] translocation or cyclin d1) or sll as defined by who classification criteria and is refractory or relapsed as defined by one of the following: 1) refractory disease- progressive disease while on therapy, or 2) relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization * ecog performance status score of 0, 1, or 2 * willing and able to provide written informed consent exclusion criteria: laboratory values of: * platelet count \< 30,000/µl * ast or alt \> 2 x uln (upper limit of normal) * total bilirubin \> 2 x uln * creatinine \> 2.0 mg/dl and * chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (\> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment * greater than three prior regimens (where a regimen is defined as a treatment for cll/sll given initially or after disease progression) * uncontrolled hypertension * known history of porphyria (testing not required at screening) * known history of glucose-6-phosphate dehydrogenase (g6pd) deficiency (testing not required at screening) * known history of hiv infection (testing not required at screening) * pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) * woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection * physical or mental condition that makes patient unable to complete specified follow-up assessments

Keywords: chronic lymphocytic leukemia small lymphocytic lymphoma leukemia lymphoma motexafin gadolinium relapsed chronic lymphocytic leukemia relapsed chronic lymphocycic lymphoma refractory chronic lymphocytic leukemia refractory small lymphocytic lymphoma
tsui test as a predictor of bupivacaine consumption in labour epidurals

Conditions: Pain

Summary: low current electrical stimulation test, also called the tsui test, has been used successfully to confirm the catheter location in the epidural space in various patient populations. the results of this study will show whether or not doing a tsui test can predict inadequate epidural analgesia early in the course of placing the epidural, so that the appropriate measures could be applied immediately upon gathering unfavorable results.

despite its very high success rate, the epidural technique remains a rather blind technique, and failures continue to occur. the incidence and reasons for failure are not well understood. the tsui test is not routinely performed with each epidural catheter insertion, but rather it is used when there is suspicion about the catheter location. in this study, the tsui test will be performed twice during the epidural procedure, and bupivacaine consumption will be recorded for the first 2 hours. information gained from this study could have great impact in clinical practice, since the incidence of inadequate labor analgesia is still relatively high (10-20%), leading to maternal distress and disappointing labor experience.

Eligibility criteria:
inclusion criteria: * women over 18 years of age requesting an epidural for labor and delivery * cervix dilated 0-5 cm and pain vas\>6 * able to communicate in english * informed consent exclusion criteria: * refusal to provide written informed consent * patients unable to communicate in english * contraindication to regional anesthesia * allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl * sedatives or opioids received prior to insertion of epidural catheter * abnormal vertebral anatomy, such as previous spine surgery and scoliosis * coexisting neurological disorders * patients with implanted electronic devices

Keywords: tsui test epidural analgesia
observational study of drug naive diabetes receiving insulin therapy

Conditions: Type 2 Diabetes

Summary: a multi-centre, open-label trial to investigate the efficacy and possible mechanism of continuous subcutaneous insulin infusion treatment in patients with drug naive type 2 diabetes.


Eligibility criteria:
inclusion criteria: for type 2 diabetes: 1. male or female age ≧ 25 years and ≦75 years old 2. hba1c ≧8.0% 3. durg naive for normal controls： 1. male or female age ≧ 25 years and ≦75 years old 2. normal glucose tolerance confirmed by oral glucose tolerance test exclusion criteria: 1. islet antibody positive 2. athletes, has a history of skeletal muscle injury ( trauma or surgery ), skeletal muscle wasting diseases ( such as mitochondrial myopathy, muscular atrophy, etc ) 3. acute infection(such as cute upper respiratory infection, acute pneumonia) 4. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs 5. consists with other endocrine diseases 6. pregnancy 7. cancer 8. use of antibiotics in 3 months 9. chronic digestive inflammations 10. magnetic resonance imaging contraindications

Keywords: insulin drug naive
comparing music-supported and traditional aerobic training in geriatric health outcomes

Conditions: Geriatric; Aerobic Exercise; Music Therapy; Physiotherapy and Rehabilitation

Summary: the aim of this study is to comparatively evaluate the effects of a music therapy-based aerobic exercise program and traditional aerobic exercise training on cardiopulmonary functions, functional capacity, balance, peripheral muscle strength, cognitive functions, depression level and quality of life in geriatric individuals.


Eligibility criteria:
inclusion criteria: * being 65 years of age or older * willingness to participate in the study exclusion criteria: * presence of uncontrolled hypertension (≥180/110 mmhg) or severe complications of diabetes (e.g., diabetic neuropathy, proliferative retinopathy, uncontrolled hypoglycemic episodes) * presence of respiratory diseases such as chronic obstructive pulmonary disease (copd), asthma, etc. * presence of chronic neurological disorders such as multiple sclerosis (ms), parkinson's disease, amyotrophic lateral sclerosis (als), etc. * diagnosis of any oncological disease * presence of acute musculoskeletal conditions that would prevent participation in exercise (e.g., fracture, advanced osteoarthritis, severe musculoskeletal injuries) * having undergone any surgical operation within the past 6 months * presence of visual or auditory impairments that could interfere with the assessment procedures * a score of ≤24 on the mini-mental state examination (mmse), indicating cognitive impairment * participation in a regular exercise program within the last six months
validation of hc250 and hc240 series.

Conditions: Obstructive Sleep Apnea (OSA)

Summary: this study is designed to determine the effectiveness of two different cpap devices. one a standard cpap which has the ability to store comprehensive compliance and efficacy data and the second a auto adjusting cpap which uses the energy spectrum analysis of flow signals to automatically adjust cpap pressure and improve sleep variables.

all patients with suspected obstructive sleep apnea presenting at the auckland hospital sleep laboratory and referred for either a split-night or full night diagnostic study, will be offered participation in the study and will be recruited. from these patients, a total of 20 patients that are diagnosed with clinical obstructive sleep apnea syndrome, based on diagnostic polysomnography, will undergo titration with the hc254 auto cpap. an additional 20 patients will undergo titration with the hc244 cpap. the sleep physiologist evaluating the patient clinically will approach patients for participation in this study during their sleep laboratory visit. consenting patients will undergo either an initial full night diagnostic polysomnography or a split night study as determined by the physician based on clinical requirements. patients diagnosed with obstructive sleep apnea (ahi \> 15/hr) during this diagnostic component will then undergo one of the following: * treatment with the hc254 auto cpap during the second half of the study. * treatment with the hc244 cpap during the second half of the study. the sleep physiologist will then determine final cpap prescriptions for all patients based on the patient's response to cpap therapy. 5 subjects who have completed the hc254 arm of the study will be brought back to the sleep lab for an additional psg or partial psg while on cpap pressure set to 90th percentile pressure determined on the diagnostic night.

Eligibility criteria:
inclusions criteria: * ahi \> 15 on the diagnostic night or portion of the split night study. * ≥18yrs of age exclusion criteria: * significant central apnea * chf * co-existing obesity related hypoventilation * inability to give informed consent * patient intolerance to cpap * anatomical or physiological conditions making cpap therapy inappropriate. * less than 3 hours in the titration period * under land transport new zealand (ltnz) investigation
effects of fascia therapy versus facial manipulation on neck pain

Conditions: Neck Pain

Summary: this study a randomized clinical trial to determine the effects of fasiatherapy versus facial manipulation on pain, range of motion and function in patients with chronic neck pain. a sample of 52 patients will be taken and divided into two groups each with 26 patients. group a will receive dbm fasciatherapy along with conventional physical therapy while group b will receive fascial manipulation along with the conventional physical therapy protocol. the conventional physical therapy protocol will include hot pack, neck isometrics and stretches. the session will be around 45 to 60 min on each patient with three session per week on alternate days. a total of three-week treatment regime will be given to the patients and assessment of patient's pain, range of motion and function with nprs (numeric pain rating scale), goniometry and ndi (neck disability index) will be done at the baseline, after the completion of treatment at three weeks and after 6 weeks to observe the long-term effects. the data will be analyzed using spss.

chronic neck pain is one of the most common musculoskeletal disorder among general population. like muscular spasm of neck that can cause neck pain, fascial adhesions are also the common cause of neck pain. fascia is a form of connective tissue that is made up of collagen, surrounds the body parts and also resist tissue tensile load. fascial injury and adhesions are common and can lead to pain, restricted motion and swelling. the treatment of the fascial injury is necessary to relieve those symptoms. there are many treatments for the chronic neck pain and this study focuses on two new treatment techniques for the fascial pain. the first is the dannis bois method fasciatherpy which is a manual approach that focuses on the structural segmentation of fascia and involves the application of gentle pressure while stretching the body's connective tissues. the other treatment technique is the fascial manipulation method that involves the treatment which is directed to specific fascial adhesions. the current study is novel in a way that there is limited literature about dbm fasciatherapy versus fascial manipulation on chronic neck pain. both methods were employed to see if they improve ranges along with accompanying pain and disability.

Eligibility criteria:
inclusion criteria: * both genders * age 18-40 years * chronicity of pain - 6 months minimum exclusion criteria: * post-op patient * any bony, soft tissue or systemic disease * pregnant females * radiculopathy

Keywords: neck pain fascia therapy facial manipulation
incontinence and mri results in children with cerebral palsy

Conditions: Cerebral Palsy; Lower Urinary Tract Symptoms

Summary: more than 50 % of children and adults with cerebral palsy experience lower urinary tract symptoms (luts). this can negatively influence quality of life of the child and the total social environment. previous research demonstrated that the brain lesion, characteristic for cerebral palsy (cp), is a prognostic factor for the functional abilities of a child with cp. previous research within our department demonstrated functional impairment as a risk factor for incontinence. this demonstrates an indirect connection between the brain lesion and incontinence of a child with cp. however, this connection isn't alway correct as some children with high functionality also demonstrate incontinence. as bladder control is also regulated by higher brain centers, the present study wants to investigate a direct connection between the brain lesion of the child, visible by means of mri, and the incontinence status of the child. .

the current study is a cross-sectional observational study in which a correlation is investigated between known anatomical mri results and the continence status of a child with cp. although neuroimaging isn't seen as a requirement for the definition and diagnosis of cp2, mri imaging is often part of diagnostic evaluation. the surveillance of cerebral palsy in europe (scpe) working group composed the mri classification system or mrics classifying neuroimaging results in maldevelopments, predominant white matter injury, predominant grey matter injury, miscellaneous and normal. these results will be correlated with results of the validated vancouver symptoms score for dysfunctional elimination syndrome.

Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy * mri investigation in history * dutch or french speaking child and parent exclusion criteria: * no mri investigation in history * child or parent not speaking dutch or french

Keywords: cerebral palsy lower urinary tract symptoms magnetic resonance imaging brain lesion incontinence
a study to evaluate the long-term efficacy and safety of bmn 110 in patients with mucopolysaccharidosis iva (morquio a syndrome)

Conditions: MPS IV A; Mucopolysaccharidosis IVA; Morquio A Syndrome

Summary: this multicenter, open-label extension study is designed to assess long-term efficacy and safety of 2.0 milligrams (mg)/kilogram(kg)/week of bmn 110 in patients diagnosed with mucopolysaccharidosis iva (mps iva). patients with mps iva, who enrolled in a prior biomarin sponsored clinical study of bmn 110 (nct00884949; study identification number mor-002), were eligible to enroll in this study (except patients who enrolled in nct01275066; study identification number mor-004).


Eligibility criteria:
inclusion criteria: * willing and able to provide written, signed informed consent, or in the case of patients under the age of 18 (or 16 years, depending on the region), provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures. * sexually active patients must be willing to use an acceptable method of contraception while participating in the study. * females of childbearing potential must have a negative pregnancy test at baseline and be willing to have additional pregnancy tests during the study. * must have enrolled in a prior biomarin sponsored clinical study of bmn 110. exclusion criteria: * pregnant or breastfeeding at baseline or planning to become pregnant (self or partner) at any time during the study. * use of any investigational product (other than bmn 110 in a prior clinical study) or investigational medical device within 30 days prior to baseline, or requirement for any investigational agent prior to completion of all scheduled study assessments. * concurrent disease or condition, including but not limited to symptomatic cervical spine instability, clinically significant spinal cord compression, or severe cardiac disease that would interfere with study participation or safety as determined by the investigator. * any condition that, in the view of the investigator, places the patient at high risk of poor treatment compliance or of not completing the study. * were enrolled in mor-004 (patients from mor-004 may be eligible to participate in a separate, appropriately designed, extension study).

Keywords: mucopolysaccharidosis iv type a mps iv type a mucopolysaccharidosis iva mps iva morquio a syndrome lysosomal storage disorder lsd n-acetylgalactosamine-6-sulfatase n-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase galns enzyme replacement therapy ert