Kornimate/medical-research-clean huggingface dataset:
the effect of bracing on sagittal balance in scoliosis

Conditions: Idiopathic Scoliosis

Summary: the goal of the study is to analyze the influence of bracing on sagittal balance in scoliosis. in special we want to observe if there is a difference between two types of tlso-brace, namely boston and cheneau. retrospective analyses of full spine x-rays of patients who underwent bracing-therapy in the context of scoliosis. different spinopelvic parameters will be analyzed: pelvic incidence, pelvic tilt, sacral slope, lumbar lordosis, spinopelvic angle, spinosacral angle, thoracal kyphosis. four different x-rays will be reviewed for these parameters: 1. profile before bracing therapy 2. profile after initiation of bracing therapy 3. profile immediately after termination of bracing therapy 4. profile more than 3 months after termination of brace it concerns patients with idiopathic scoliosis (exclusion of congenital scoliosis, neuromuscular scoliosis and associated spondylolisthesis). goal of the study is to check if treatment with tlso-brace has a delordosing effect on sagittal balance (decrease of lumbar lordosis). the zero-hypothesis: tlso causes no decrease in lumbar lordosis. secondary goal is to compare the effect of the boston tslo-brace and otherwise the cheneau tlso-brace on spinopelvic parameters and lumbar lordosis in special.


Eligibility criteria:
inclusion criteria: * late onset idiopathic scoliosis * non-operative indication exclusion criteria: * early onset idiopathic scoliosis * neuromuscular scoliosis * congenital scoliosis * associated spondylolisthesis * operative indication

Keywords: bracing sagittal balance
predictors of steroid response in childhood nephrotic syndrome

Conditions: Nephrotic Syndrome in Children

Summary: retrospective study of predictors of steroid response in childhood nephrotic syndrom

nephrotic syndrome is the most common glomerular disease affecting children worldwide ,nephrotic syndrome is the combination of nephrotic-range proteinuria with a low serum albumin level and edema. nephrotic-range proteinuria is the loss of 3 grams or more per day of protein into the urine or, on a single spot urine collection, the presence of 2 g of protein per gram of urine creatinine. minimal change disease (mcd) or minimal change glomerulonephritis and focal segmental glomerulosclerosis (fsgs) are the two major causes of nephrotic syndrome in children and young adults, idiopathic, hereditary, and secondary forms are due to underlying increased protein leakiness across the glomerular capillary wall, as a result of immune and non-immune insults affecting the podocyte. the incidence worldwide varies widely between 1.2 and 16.9 cases per 100,000 children with the highest incidence observed on the indian subcontinent compared to 2-3 cases per 100,000 children in most other regions . males appear to be more affected than females at a ratio of 2:1 at a younger age, but this predominance fails to persist in adolescence. treatment of nephrotic syndrome:- corticosteroids have been used to treat childhood nephrotic syndrome since 1950 when large doses of adrenocorticotrophic hormone (acth) and cortisone given for two to three weeks were found to induce diuresis with loss of oedema and proteinuria. the response to treatment with steroids has been shown to vary by ethnicity, likely due to environmental and genetic factors. corticosteroid usage has reduced the mortality rate in childhood nephrotic syndrome to around 3%, with infection remaining the most important cause of death. of children who present with their first episode of nephrotic syndrome, approximately 80% will achieve remission with corticosteroid prednisolone is the mainstay treatment, whose response is often presumed to determine the long-term risk of disease progression and is a better prognostic indicator . although patients with steroid-sensitive nephrotic syndrome generally have good outcomes, more than half will have a frequently relapsing course and steroid dependence. up to 95% of patients with minimal change nephrotic syndrome (mcns) attain complete remission after an 8-week course of high dose steroids there are some factors affecting response to treatment with the steroids such as age of onset (the older the age of onset the better the response) ,gender (the females respond more to treatment) and type of nephrotic syndrome( minimal change glomerulonephritis responds more than focal segmental glomerulosclerosis to steroids ).

Eligibility criteria:
inclusion criteria: * all children from 1 year to 18 years treated with steroid for nephrotic syndrom exclusion criteria: * children with other kideny disease children less than 1 year old children with secondary nephrotic syndrom
a study of pc786 to evaluate the antiviral activity, safety and pharmacokinetics of multiple doses in an rsv challenge study

Conditions: Respiratory Syncytial Virus Infections

Summary: pc786 is a new medicine being developed for treatment of respiratory syncytial virus. the main purpose of this study is to evaluate the antiviral activity of pc786 in healthy adults infected with rsv virus in a viral challenge study.


Eligibility criteria:
inclusion criteria: * subject is in good health as determined by the investigator based on medical history, physical examination, and routine laboratory tests at a screening evaluation. * male or female, aged between 18 and 55 years inclusive * body weight ≥ 50 kg and body mass index (bmi) ≥ 18 kg/m2 and ≤ 30kg/m2 * subject must provide written informed consent * serosuitable to the challenge virus. exclusion criteria: * history or evidence of any clinically significant or currently active major clinical illness. * any significant abnormality altering the anatomy of the nose or nasopharynx * any nasal or sinus surgery within six months of the study * abnormal lung function * positive human immunodeficiency virus (hiv), active hepatitis a (hav), b (hbv), or c (hcv) test. * presence of cold like symptoms and/or fever on admission for the study * history or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks of the study * history of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug
efficacy of acceptance and commitment therapy (act) in group in fibromyalgia

Conditions: Fibromyalgia

Summary: the main objective is to assess the efficacy of acceptance \& commitment therapy (act) in group for the treatment of fibromyalgia. the secondary aims are: 1.- to assess the cost-effectiveness of act and 2.- to assess the efficacy of act in other variables such as anxiety, depression, pain or global function. 3.- to evaluate the usefulness or electroencephalographic cordance as a prognostic variable of the treatment. hypothesis: act in group is effective for improvement of pain acceptance and other outcome variables (pain, anxiety, depression, global function) in fibromyalgia, and it is cost-effective. cordance is an useful predictor of treatment efficacy in these patients. design: multicentre, randomized, controlled study, with parallel groups, and a 6-month follow-up period. participants will be randomly allocated to one of two conditions: 1.- group acceptation \& commitment therapy or 2.- treatment as usual by his general practitioner. patients diagnosed of fibromyalgia, according to the american college of rheumatology, will be recruited in primary care. assuming an alpha=0.05 and p=80%, using two tails, and calculating 5% of refusals, it will be necessary a sample size of 55 patients for each group of patients.

the main outcome will be pain acceptance. other outcome measures will be global function (assessed with the fibromyalgia impact questionnaire, fiq), cost-effectiveness (evaluated by the client service receipt inventory, csri) and electroencephalographic cordance. the mediating variables included are anxiety and depression (assessed with the hospital anxiety and depression scale, hads) and pain (measured with an analog visual scale). a psychiatric interview will be administered to the participants to diagnose posttraumatic stress disorder. statistical analysis will be carried out for intention to treat, and using the method last observation carried forward. a repeated measures mixed model will be used to study the main outcome. all calculations will be made with two tails and a significance of 0.05.

Eligibility criteria:
inclusion criteria: 1. age: 18-65 year old 2. discontinuation drug treatment 7 days before the start of the trial 3. not having received psychological treatment previously or at least in the last 2 years 4. ability to understand spanish 5. given consent to participate in the study exclusion criteria: 1. age: \ 65 year old 2. clinical or psychological disease that, at investigator's opinion, can interfere the psychological examination or the adherence to psychotherapy (dementia, alcohol or drug abuse, psychosis, severe personality disorder)

Keywords: fibromyalgia acceptation & commitment therapy randomized controlled trial
a research study, looking at how tresiba® works in people with type 2 diabetes in local clinical practice in china

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how tresiba® works in patients with type 2 diabetes in china. the study will be based on data already recorded in participants' medical records and no new tests or procedures are required as part of the study. this study does not affect participants' current diabetes treatment. the study will look at data recorded in participants' medical records for approximately the last year. after signing the informed consent form, no further activities will be required from the participants.


Eligibility criteria:
inclusion criteria: * signed informed consent form (icf) obtained before any study-related activities. study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * male or female, aged at least 18 years at the time of signing the icf. * diagnosed with t2d. * treated with any oad(s) or basal insulin ± oad(s), with or without prandial insulin for at least 20 weeks prior to treatment initiation with tresiba®. * the decision to initiate treatment with commercially available tresiba® has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study. * treated with tresiba® (with or without oads, with or without prandial insulin) for at least 20 weeks and have at least one documented medical visit with hba1c measurement in the first 20 weeks (plus/minus 8 weeks) after tresiba® initiation. the patient may or may not be treated with tresiba® at the time of patient selection to this study. * minimum available data: age, weight, and sex at the time of tresiba® initiation, hba1c (most recent value within 12 weeks prior to tresiba® initiation and a value in the first 20 weeks \[plus/minus 8 weeks\] after tresiba® treatment), and duration and type of insulin treatment (for insulin treated patients). exclusion criteria: * previous participation in this study. participation is defined as having signed the icf. * participation (defined as randomisation) in a diabetes clinical trial of an approved or non-approved investigational medicinal product within 20 weeks prior to the treatment initiation with tresiba® or during the first 28 weeks of treatment with tresiba®. * tresiba® not used in accordance with the local label. * patients treated with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving tresiba® (short-term \[equal to or less than 14 days\] treatment with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving tresiba® is allowed). * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
respiratory muscle training in cf patients

Conditions: Cystic Fibrosis; Respiratory Muscles

Summary: the present study aims at evaluating the effect of respiratory muscle training in adult patients with cystic fibrosis on lung function, exercise performance and quality of life.


Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of cystic fibrosis * patients in steady state exclusion criteria: * patients during exacerbation * patients treated by oral corticotherapy (\>0.5 mg/kg/j during \>7 days) during the past 2 months * pregnant patients

Keywords: training exercise quality of life
phase 2 study mpc-6827 for recurrent glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: the purpose of this study is to determine the safety and effectiveness of azixa in patients with recurrent glioblastoma multiforme


Eligibility criteria:
inclusion criteria: * have histologically proven malignant glioblastoma multiforme in first or second relapse * have failed prior fractionated external beam cranial irradiation or imrt * be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior avastin therapy * have a karnofsky performance status of ≥ 60 * have adequate bone marrow function, liver function, and renal function before starting therapy exclusion criteria: * have had more than two relapses * have had radiosurgery * have a cardiac ejection fraction \< 50% by muga or echo * have troponin-i elevated above the normal range * have an increasing steroid requirement * have mri evidence at baseline of enlarging or clinically significant intratumor hemorrhage * have active stroke and/or transient ischemic attack not optimally managed * have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension) * be pregnant or breast feeding * have had prior hypersensitivity reaction to cremophor el * be hiv positive

Keywords: glioblastoma brain neoplasms recurrence
extension study of long-term safety and tolerability of octreotide acetate in patients with moderately severe or severe non-proliferative diabetic retinopathy or low risk proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: this multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study csms995 0802. during this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe npdr and low risk pdr.


Eligibility criteria:
inclusion criteria: * written informed consent provided prior to participation in the extension study * successful completion of study csms995 0802 * willingness to comply with all study requirements exclusion criteria: * more than 8 weeks interval since the completion of study csms995 0802 * premature discontinuation from study csms995 0802 other protocol-defined inclusion/exclusion criteria may apply.

Keywords: diabetic retinopathy, octreotide acetate in microspheres
effect of high-dose vitamin d on bone density in osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: * overall objective: to test the hypothesis that oral vitamin d supplementation at higher than currently prescribed doses has a beneficial effect on the skeleton of young patients with osteogenesis imperfecta (oi). * specific aims: 1. to determine whether 12 months of high-dose vitamin d supplementation, compared to standard-dose vitamin d supplementation, increases areal bone mineral density z-scores at the lumbar spine. 2. to examine the effectiveness of high-dose vitamin d supplementation to increase trabecular and cortical bone mineral density at the radius. 3. to examine whether high-dose vitamin d supplementation has an effect on physiological determinants of bone mass (parathyroid hormone, activity of bone metabolism, muscle function). * background: in a preliminary cross-sectional study of 282 oi patients we observed an inverse relationship between serum 25-hydroxyvitamin d and parathyroid hormone levels and a positive relationship between circulating levels of 25-hydroxyvitamin d and lumbar spine areal bone mineral density z-scores. this suggested that high-dose vitamin d supplementation would have a beneficial effect on bone density. most oi patients currently receive oral vitamin d supplementation of 400 international units per day, but doses of 2000 international units per day are safe and have been shown to be beneficial in studies on healthy adolescents. * study design: this is a parallel-group double-blind randomized controlled trial of 12 months duration on 60 children and adolescents aged 6 to 19 years with a clinical diagnosis of oi. one group of 30 participants will be randomized to receive vitamin d3 at a dose of 2000 international units per day ('high-dose group'). the other group of 30 participants will be randomized to receive vitamin d3 at a dose of 400 international units per day ('standard-dose group'). randomization will be stratified according to pubertal status and bisphosphonate treatment status. * clinical relevance: the proposed study aims at direct improvements in the care of oi patients. if a simple and low-cost 'intervention' such as high-dose vitamin d supplementation can be shown to be effective in relieving some of the disease burden associated with oi, the benefit to oi patients worldwide would be substantial.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of oi of any type. exclusion criteria: * any condition that renders bone density measurements at the lumbar spine impossible. an example for this is prior spinal fusion surgery. * bisphosphonate therapy for less than two years duration. * use of medication, other than bisphosphonates, known to affect bone metabolism or 25ohd serum concentrations. examples are anti-epileptics, active vitamin d metabolites, corticosteroids and thyroid hormones. * liver and renal disease known to interfere with vitamin d metabolism. * any other disorder of calcium and phosphate metabolism (apart from vitamin d deficiency) that might interfere with pth.

Keywords: osteogenesis imperfecta high-dose vitamin d bone density muscle function
a randomized intervention for cardiovascular and lifestyle risk factors in prostate cancer patients

Conditions: Prostate Cancer; Cardiovascular Disease

Summary: radical pc1 is a prospective cohort study of men with a new diagnosis of prostate cancer. radical pc2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.

radical pc describes two prospective studies, one of which is embedded in the other. radical pc1 is a prospective cohort study of men within one year of their first diagnosis of prostate cancer, or treated with androgen deprivation therapy for the first time within 6 months prior to enrollment visit, or to be treated with androgen deprivation therapy for the first time within one month after the enrollment visit. its goal will be to identify factors associated with the development of cardiovascular disease among men with prostate cancer, with a particular focus on androgen deprivation therapy. radical pc2 is a randomized, controlled trial embedded in radical pc1. radical pc2 will test a systematic approach to modifying cardiovascular and lifestyle risk factors in men within one year of their first diagnosis of prostate cancer, or treated with androgen deprivation therapy for the first time within 6 months prior to enrollment visit, or to be treated with androgen deprivation therapy for the first time within one month after the enrollment visit.

Eligibility criteria:
inclusion criteria: 1. a man with a diagnosis of prostate cancer that is either: * new (i.e. the diagnosis was made within 1 year of the enrolment visit) or * treated with androgen deprivation therapy for the first time within 6 months prior to the enrolment visit, or * to be treated with androgen deprivation therapy for the first time within 1 month after the enrolment visit exclusion criteria: 1. patients will be excluded if they fulfill any of the following: 1. are unwilling to provide consent or 2. are \<45 years of age, or 3. prostate cancer was found incidentally following cystectomy for bladder cancer 2. patients will be eligible for radical pc1, but will not be eligible for radical pc2 if they: 1. see a cardiologist every year, or 2. both take a statin and have systolic blood pressure ≤130mmhg

Keywords: androgen deprivation therapy
renal denervation in patients with uncontrolled hypertension in chinese

Conditions: Hypertension

Summary: the purpose of this study is to determine whether renal denervation is safe and effective in the treatment of chinese patients with uncontrolled hypertension.

prevalence of hypertension is increasing in china.while actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in chinese patients. we hypothesis that renal denervation is effective and safe in treatment of chinese patients with uncontrolled hypertension. this trial plan to recruit 100 patients(ablation group vs control group = 1:1) with a follow up duration of 3 years.patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. we aim to explore the long term safety and validity of renal denervation in chinese patients with uncontrolled hypertension.

Eligibility criteria:
inclusion criteria: * \>= 18 years of age * a systolic blood pressure of 160mmhg or more and/or a diastolic blood pressure of 90mmhg or more * receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen * estimated glomerular filtration rate (egfr) of ≥45ml/min * agrees to have the study procedure(s) performed and additional procedures and evaluations * is competent and willing to provide written, informed consent to participate in this clinical study exclusion criteria: * secondary hypertension * renal arterial abnormalities * has experienced mi, unstable angina pectoris, or cva within 6 months * has an implantable cardioverter defibrillator (icd) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (mri) * requires respiratory support * patients with sick sinus syndrome * pregnant woman * others
study of sitagliptin treatment in patients with type 2 diabetes during ramadan (0431-263)

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: this study will examine whether the incidence of hypoglycemia in patients fasting for ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

this study and nct01340768 (mk-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Eligibility criteria:
inclusion criteria: * muslim men and women with type 2 diabetes * participants who intend to fast during the month of ramadan * participants who have been on a stable dose of sulfonylurea for at least three months exclusion criteria: * participants with type 1 diabetes mellitus * pregnant or breast feeding women * participants with hypersensitivity or contraindication to dipeptidyl peptidase (dpp-4) treatment * participants on insulin * participants on any class of oral diabetic therapy other than sulfonylurea or metformin