Kornimate/medical-research-clean huggingface dataset:
non-interventional study to evaluate the ease of reaching individual goals in serum phosphorus (steering)

Conditions: Hyperphosphataemia; ESRD

Summary: the objective of this non-interventional study is to confirm that with standard osvaren® treatment it is possible to achieve in at least 60% of the patients the levels of phosphorus, total calcium, and ipth seen in the calmag study also in the normal clinical practice.

only a small fraction of haemodialysis patients meet the published nkf-kdoqi standards for calcium, phosphorus, calcium x phosphorus product and intact parathyroid hormone. one of the reasons is the still difficult and insufficient therapy with phosphate binders. even though calcium containing phosphate binders have been proven to be effective, they are reported to lead in certain patients to hypercalcaemia. this observational study therefore not only evaluates the efficacy of the phosphate binder osvaren® (containing calcium acetate and magnesium carbonate) but also the frequency of untoward events in daily practice as well as to the state of hyper-/ hypoparathyroidism as represented by serum ipth values and the practice patterns used to adjust to and to fully exploit the qualities of the different available phosphate binders. in addition, the compensatory actions of the physicians, such as adaptation of the dialysate calcium or the combination with non-calcium containing phosphate binders, are going to be monitored. in order to receive additional safety data in the context of daily practice, the frequency of untoward events related to the treatment will be documented and analysed.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed informed consent * patient on maintenance haemodialysis, online haemodiafiltration, or peritoneal dialysis at the time of osvaren® prescription * patients being treated with osvaren® for up to 6 months at the day of inclusion exclusion criteria: * prior participation in this observational study * use of osvaren® for purposes other than those indicated in the summary of product characteristics (smpc) / package leaflet
evaluation of efficacy and safety of the dosage adjustment of aprovel® (irbesartan) in hypertensive outpatients in current clinical practice

Conditions: Hypertension

Summary: primary: * to evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema n°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks) secondary: * to evaluate the percentage of patients with dbp \< 90 mmhg at 6 and 12 weeks * to evaluate the percentage of patients with sbp \< 140 mmhg at 6 and 12 weeks * to evaluate rate of adverse events during the study


Eligibility criteria:
inclusion criteria: * mild to moderate hypertension (90mmhg\<dbp\<110mmhg and 140mmhg\<sbp\<180mmhg) * or new diagnosed hypertension (after 2 visits within 1 month), never treated before and responding to required conditions for a treatment with irbesartan, after an adapted but insufficient diet * or a patient having already been treated with a non-satisfying antihypertensive treatment stopped since at least 2 weeks before the inclusion * a minimum exam labs as required by who-ish within the month before the inclusion exclusion criteria: * severe arterial hypertension (pas \> than or = to 180 mm hg or pad \> than or = to 110 mmhg) * isolated systolic hypertension * secondary hypertension * bilateral renal arterial stenosis or renal arterial stenosis * non surgically sterilised woman or non post-menopausal woman * confirmed sodium depletion * irbesartan hypersensitivity the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
peak study (physical exercise and activity in kids)

Conditions: Juvenile Idiopathic Arthritis

Summary: the objectives of this study are to study the effect of formal exercise training on motor function and overall physical fitness in children with arthritis. a 12-week comprehensive exercise program will be used. formal exercise training will be compared to qi gong.

childhood arthritis is a common and often debilitating disease. children with arthritis are less active than their peers, and consequently they often have poor physical fitness. this study follows up our pilot study, in which we showed that exercise training can be safely carried out in children who have arthritis. we plan to randomly assign 80 children with arthritis to one of two groups. the experimental group undergoes a vigorous exercise training program consisting of twelve weekly supervised sessions as well as twice weekly at home sessions using an exercise video. the control group also has twelve supervised sessions and two home sessions. however, their exercises are non-strenuous, based on qi gong. all children have comprehensive fitness testing before and after the training at the exercise lab at the hospital for sick children. if we show that fitness exercise leads to improved motor function and improved ability to carry out activities of daily living, then we will change the way in which we provide therapy for childhood arthritis. we hope that this study will lead to an improved quality of life for children with arthritis.

Eligibility criteria:
inclusion criteria: 1. age 8 - 16 years. 2. diagnosis of juvenile idiopathic arthritis - based on the revised durban criteria. 3. polyarticular or pauciarticular course. 4. stable disease - on a stable dose of nsaid, and if applicable methotrexate or other second line agents - in the preceding month, and judged by the attending rheumatologist to be clinically stable and unlikely to need a change in medication over the course of the trial. 5. medications. there are no restrictions on medication use for this study; however, every effort is made to keep medication dosage stable over the course of study. exclusion criteria: 1. co-morbidity with cardiac, pulmonary or metabolic disease. 2. moderate or severe hip pain while walking (as judged by the patient and scored on a 4 point scale) or active systemic symptoms (fever, rash). 3. children who engage in more than 3 hours of structured extracurricular physical activity weekly may not show additional gains from fitness training and, therefore, are not studied. children are not otherwise excluded from the study if currently attending a physiotherapy pool program with emphasis on joint range of motion and stretching. 4. children who are unable to cooperate with testing procedures.

Keywords: juvenile rheumatoid arthritis, randomized control trial, attention placebo, exercise testing, aerobics, qi gong, exercise video, activities of daily living, quality of life, economy of walking, fitness pediatrics
improving lactation success in black mothers of critically ill infants

Conditions: Insufficient Lactation

Summary: racial disparities result in black infants in the neonatal intensive care unit (nicu) receiving less breast milk (bm) than white and hispanic infants.1 bm improves infant health yet mothers of critically ill infants produce insufficient amounts to provide these benefits which is likely due to inadequate daily breast pumping frequency. black mothers face unique challenges to frequent breast pumping including returning to work earlier, working in facilities with inadequate lactation support, and limited privacy for breast pumping at home. therefore, the objective of this pilot study is to determine the feasibility and potential benefits of using a discreet, hands-free, wearable breast pump with an associated app that tracks pumping frequency and bm production to increase lactation success in black mothers of infants admitted to the nicu. specific aims include (1) evaluate the feasibility of a discreet, hands-free, wearable pump in black mothers of critically ill infants to increase pumping frequency and bm production and (2) assess whether results indicate a signal of effectiveness supporting a subsequent adequately powered randomized clinical trial (rct). following delivery, 40 black mothers of critically ill infants will be randomized to one of two groups. group 1 will be provided a discreet, hands-free, wearable breast pump with an associated app and group 2 will be provided a standard mechanical breast pump with no associated app. results will be used to revise the intervention and study processes and to estimate outcome measurement variability and effect sizes needed for sample size calculations for an adequately powered rct.


Eligibility criteria:
inclusion criteria: * mothers self-identified as black * \> 18 years of age * english speaking * stated intent to provide breast milk to her infant * rate their level of commitment to pumping breast milk for their infant for at least 3 weeks as 3 or greater or a 1-5 point likert scale * state they are available for an approximately 30 minute education session prior to hospital discharge * infant not expected to be stable enough to bottle/breastfeed for \> 21 days * access to a mobile phone and able to download app. exclusion criteria: * known illicit drug use * breast reduction or augmentation * positive hiv status * infant not expected to live \> 7 days following delivery * has pacemaker
the effect of vocal rest versus vocalization following xeomin® injections in spasmodic dysphonia

Conditions: Adductor Spasmodic Dysphonia

Summary: this study will compare the effects of vocal rest versus continuous vocalization for one hour immediately following botulinum toxin injections for adductor spasmodic dysphonia.


Eligibility criteria:
inclusion criteria: * diagnosed with adductor spasmodic dysphonia (adsd) by an experienced neurologist and otolaryngologist. adsd patients who have been stabilized on their treatment dose for at least 2 treatment cycles. exclusion criteria: * diagnosed with another neurological disorder that is combined with adsd (i.e. parkinson's disease and adsd). previous history of an additional vocal pathology (i.e. vocal polps, vocal nodules, unilateral vocal fold paralysis, etc.)
best practice advisory to initiate high-intensity statin therapy in patients with peripheral artery disease

Conditions: Peripheral Artery Disease

Summary: the purpose of this study is to understand how a best practice advisory (bpa) for high-intensity statin therapy in patients with peripheral artery disease impacts prescription rates.

the central hypothesis is that an automated best practice advisory embedded within the electronic medical record (emr) will improve prescription of high-intensity statins among hospitalized patients with peripheral artery disease (pad). aim 1: to assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on high-intensity statin prescription among hospitalized patients with pad. aim 2: to assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on short-term cardiovascular outcomes among hospitalized patients with pad.

Eligibility criteria:
inclusion criteria: * primary hospital diagnosis of pad defined by icd/cpt codes * inpatient status at the adult hospital at vanderbilt university medical center * not currently prescribed a high-intensity statin (atorvastatin 40-80mg daily or rosuvastatin 20-40mg daily) exclusion criteria: * on comfort measures * history of statin allergy or intolerance recorded in the emr * history of rhabdomyolysis defined by international classification of diseases/current procedural terminology (icd/cpt) codes * history of hepatitis a, b, or c defined by icd/cpt codes * pregnant * aspartate aminotransferase \>120 units/l within 30 days of alert * alanine aminotransferase \>165 units/l within 30 days of alert * primary hospital diagnosis of acute myocardial infarction defined by icd/cpt codes * primary hospital diagnosis of acute stroke defined by icd/cpt codes

Keywords: peripheral artery disease statin electronic alert best practice advisory
nodal radiation therapy for sentinel lymph node positive melanoma

Conditions: Melanoma

Summary: this phase ii trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (slnb) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.

primary objective: i. to determine if regional nodal radiation therapy prolongs the time to regional recurrence. outline: patients are randomized to 1 of 2 groups. group i: patients receive adjuvant immunotherapy and nodal radiation therapy (30 gy in 5 treatments over 2-2.5 weeks). group ii: patients receive adjuvant immunotherapy alone. after completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Eligibility criteria:
inclusion criteria: * must be planned for post-operative immunotherapy * no evidence of distant metastasis as determined by clinical examination and any form of imaging * no evidence of clinically involved lymph nodes prior to slnb * pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension \[ece\] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor) * has provided written informed consent for participation in this trial * eastern cooperative oncology group (ecog) performance status of 3 or less * life expectancy greater than 6 months * patients capable of childbearing are using adequate contraception * available for follow-up exclusion criteria: * complete lymph node dissection (clnd) of the nodal basin containing the positive sln * distant metastasis * previous radiation therapy (rt) to the nodal area planned for rt such that the prior rt field would be included in the current treatment field. in other words, treatment on this trial would require re-irradiation of tissues * women who are pregnant * adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study
intervention effects on health promoting behaviors and factors influencing long-term behavior change

Conditions: Overweight (BMI &gt; 25); Obese Patients

Summary: this study aims to compare the 8-week virtual healthy you program with a standard care intervention that sends weekly nutrition and healthy living tips via email. it will evaluate short- and long-term changes in health behaviors, such as diet, physical activity, biomarkers, and body composition. the study also seeks to identify factors that help participants make lasting health changes and explore how lifestyle interventions can improve overall health. findings may guide future programs and support non-weight-focused approaches to chronic disease management and healthcare policy.


Eligibility criteria:
inclusion criteria: * adults aged 18-65 * bmi between 25.00 and 40.00 exclusion criteria: * pregnancy or lactation * existing or previous eating disorders * use of a medically prescribed diet * weight loss or gain of 3 kg or more in the past 3 months * use of medications or supplements for weight or chronic disease management (withing the last 3 months)

Keywords: sustainable health behaviors virtual healthy eating program eating behavior intervention
study to determine mutations in the gaucher gene in patients with idiopathic parkinson's disease for phenotype-genotype correlation

Conditions: Parkinson Disease; Idiopathic Parkinson Disease

Summary: the genotype-phenotype correlation in patients with parkinson's disease with specific mutations in the glucocerebrosidase gene (gaucher gene) is known from own clinical experiences as well as from case reports in the literature. the epidemiological study will determine the frequency of heterozygous mutations in the glucocerebrosidase gene and correlate to the clinical onset and development by measuring and documenting severity of symptoms (e.g. cognitive deficits, l-dopa responsiveness, depression) in clinically well-characterized parkinson's patients.

parkinson's disease (also known as parkinson's, parkinson disease, or pd) is a degenerative disorder of the central nervous system that impairs motor skills, cognitive processes, and other functions. the most obvious symptoms are motor-related, including tremor, rigidity, slowness of movement, and postural instability. among non-motor symptoms are autonomic dysfunction and sensory and sleep difficulties. cognitive and neurobehavioral problems, including dementia, are common in the advanced stages of the disease. pd usually appears around the age of 60, although there are young-onset cases. gaucher's disease is a genetic disease in which a fatty substance (lipid) accumulates in cells and certain organs. gaucher's disease is the most common of the lysosomal storage diseases. it is caused by a hereditary deficiency of the enzyme glucocerebrosidase (also known as acid β-glucosidase). the enzyme acts on a fatty substance glucocerebroside (also known as glucosylceramide). when the enzyme is defective, glucocerebroside accumulates, particularly in white blood cells (mononuclear leukocytes). glucocerebroside can collect in the spleen, liver, kidneys, lungs, brain and bone marrow. symptoms of parkinson's syndrome in classical type 1 gaucher patients were first systematically described in 1996. in gd patients, a marked heterogeneity is detected in terms of disease-causing mutations. in 17 gaucher patients with symptoms of parkinson's disease, 12 different genotypes were sequenced and compared to other parkinson's patients, a lower l-dopa responsiveness, a higher frequency of cortical dysfunction and a relatively early onset of the symptoms was described. many of these gaucher patients with clinical parkinson's symptoms had a positive family history of parkinson's disease among relatives with heterozygous mutations in the gaucher gene that could be confirmed in systematic studies.

Eligibility criteria:
inclusion criteria: * male or female patients at 18 years old * patients with confirmed diagnosis of parkinson's disease * signed informed consent exclusion criteria: * male or female patients being younger than 18 years old * patients without confirmed diagnosis of parkinson's disease * missing signed informed consent

Keywords: parkinson disease parkinsonian disorders brain diseases central nervous system diseases nervous system diseases neurodegenerative diseases
influence of an oral nutritional supplement rich in omega-3 fatty acids on functional state and quality of life in malnourished patients with gastroenterological tumors

Conditions: Colorectal Neoplasms; Hepatocellular Carcinoma; Cholangiocarcinoma

Summary: malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. eicosapentanoic acid (epa) has been introduced as specific and anticatabolic acting substrate in cancer patients. only few randomized trials are available which investigated the effect of epa in form of an epa-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma. therefore, the effect of an epa-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.


Eligibility criteria:
inclusion criteria: * malignant disease: colorectal neoplasm, hepatocellular carcinoma, cholangiocarcinoma * palliative treatment of malignant disease: uicc stage \>1 * impaired nutritional state: weight loss \> 5% body weight in the preceding 6 months or subjective global assessment grade b (moderately malnourished) or grade c (severely malnourished) * informed written consent exclusion criteria: * age \< 18 years * pregnancy * exclusive enteral or parenteral nutrition * taking of eicosapentanoic acid in form of fish oil capsules * contraindications for oral nutrition (i.e. ileus, uncontrollable vomiting) * terminal stage of disease with a life expectancy \< 3 months * missing or withdrawn consent * simultaneous participation in another trial

Keywords: oral nutritional supplement eicosapentanoic acid gastroenterological tumors muscle function quality of life body composition
the effect of ganglion sphenopalatine block (gsp-block) follow-up

Conditions: Post-Dural Puncture Headache; Ganglion Sphenopalatine Block

Summary: the purpose of this study is to evaluate the long term effects of the ganglion sphenopalatine block (gsp block) on postdural puncture headache.

adult patients with postdural puncture headache was enrolled in main study (nct03652714). in the main study the patients was randomised to receive a ganglion sphenopalatine block (gsp-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone nacl). following inclusion in the main study all participants are sent a follow-up questionnaire. primary outcome is disability due to headache defined as moderate to severe disability measured with migraine disability assessment test (midas) in the 3 months following initial block and average pain score in the 3 months following the initial block on a 0-10 pain intensity scale. secondary outcome is disability due to headache defined as moderate to severe disability measured with migraine disability assessment test (midas) in the 3 previous months as well as average pain scores in the previous 3 months, days with headache and long and short term side effects of the block.

Eligibility criteria:
patients who where included in main study and had the following eligibility criteria: inclusion criteria: * age \> 18 years * patients with postdural puncture headache defined as moderate to severe postural headache (vas \>= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture. * lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol * patients who have given their written informed consent for participation in the study after fully understanding the protocol content and limitations. exclusion criteria: * patients who cannot cooperate to the study * patients who does not understand or speak danish * allergy to the drugs used in the study * has taken opioids within 12 hours prior to intervention