Kornimate/medical-research-clean huggingface dataset:
intralymphatic immunotherapy in increasing doses, substudy

Conditions: Rhinitis, Allergic, Seasonal

Summary: the study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 sq-u, 3000 sq-u and 10 000 sq-u, or placebo. \*\*\*important information!\*\*\* the up-dosing protocol is changed due to adverse events at 5000 sq-u. one patient had general utricaria 15 minutes after injection (moderate reaction). one patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 sq-u and 3000 sq-u have been given with no serious adverse events.) new regimen: 1000 sq-u, 3000 sq-u, 3000 sq-u.

40 patients with seasonal allergic rhinitis will be recruited. study subjects are randomized to intralymphatic injections with placebo or alk alutard 5-grasses or birch. injections are given with 4-5 (-7) weeks interval.

Eligibility criteria:
inclusion criteria: * seasonal allergic symptoms for birch and/or grass verified by skin prick test, * accepted informed consent exclusion criteria: * pregnancy or nursing * autoimmune or collagen disease (known) * cardiovascular disease * perennial pulmonary disease * hepatic disease * renal disease * cancer * any medication with a possible side-effect of interfering with the immune response * previous immuno- or chemotherapy * chronic diseases * other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease) * disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers) * major metabolic disease * known or suspected allergy to the study product * alcohol or drug abuse * mental incapability of coping with the study * withdrawal of informed consent

Keywords: hay fever pollen allergy allergic rhinitis
evaluating the effectiveness of a chronic disease management program for gout

Conditions: Recurrent or Tophaceous Gout

Summary: the aim of this study is to test the effectiveness of a pharmacist-staffed, protocol-based chronic disease management program compared to patients receiving usual care in achieving a target serum uric acid level in patients with recurrent gout.

gout is a chronic condition with intermittent symptoms and should be managed through an outcome-based disease management approach. unlike other common chronic conditions, strategies for population management in gout patients have not been tested. the study will identify adult members of kaiser permanente (kp) northern california with a diagnosis of gout and 3 or more outpatient or emergency department visits for gout over a 1-year period preceding study enrollment. these patients will be randomized to either an active management group, or to usual care. the participants will be enrolled and followed over a period of 26 weeks. the primary outcome to be measured will be the attainment and maintenance of a uric acid lowering regimen targeted to achieve serum uric acid level of 6.0 mg/dl or less. the treatment protocol will use standard treatment guidelines to lower and maintain uric acid levels to less than or equal to 6.0 mg/dl (or maximum doses of uric acid lowering medications) and provide patient education and dietary counseling. monitoring and medication management will be carried out by a licensed clinical pharmacist under the supervision of an experienced rheumatologist. control subjects will have regular monitoring of serum uric acid levels and will be provided with educational material and dietary counseling, but otherwise receive usual care. the demonstration that a chronic disease management approach to gout care can improve the health and reduce morbidity in patients with gout may illuminate a simple path towards improved quality of life and reduced morbidity in this growing population of patients.

Eligibility criteria:
inclusion criteria: three or more outpatient/ed visits in a 24-month period prior to selection for study with one of these primary visit diagnoses: * gouty arthropathy * gout, unspecified * gout with other specified manifestations * tophaceous gout of ear (274.81) or other sites * gouty nephropathy at least 2 years of continuous kaiser foundation hospital plan membership baseline uric acid level above 7.0mg/dl exclusion criteria: * current cancer diagnosis with active treatment * end stage renal disease * pregnant or lactating * patients with a diagnosis of dementia * terminally ill patients

Keywords: recurrent gout tophaceous gout gout flares arthritis joint diseases rheumatic diseases
norepinephrine vs norepinephrine and dobutamine in cardiogenic shock

Conditions: Cardiogenic Shock

Summary: cardiogenic shock is a frequent cause of admission and death in the intensive care unit. mortality is about 50%. once the etiologic treatment has been done, for instance coronary revascularization, management of the shock state is the cornerstone of the treatment. norepinephrine is the first-line vasopressor therapy because of its minor effect on heart rhythm. morever norepinephrine is a inotrope. in a previous study, we demonstrated that increasing the norepinephrine dose increases cardiac index, cardiac power index, svo2 and tissue perfusion without acceleration of heart rate. nevertheless, dobutamine remains the first-line inotropic treatment. dobutamine has a positive chronotropic effect that might cause higher myocardial oxygen consumption. as a result, combination of vasopressor / inotrope is still controversial. the aim of this study was to compare hemodynamics and metabolics effects of 2 treatments strategies (norepinephrine dose increasing or addition of dobutamine) in patients with cardiogenic shock and optimised blood pressure level (map≥65 mmhg) under norepinephrine treatment. the secondary objectives were : * to evaluate the efficacy of the treatments on micro- and macrocirculation parameters * to evaluate the tolerance of the treatments * to evaluate the dose and the admistration's kinetics of the treatments


Eligibility criteria:
inclusion criteria: * patients with cardiogenic shock (ischemic, rythmic, valvular) defined : by cardiac index (ci) \ 2 mmol/l) * mean arterial pressure \> 65 mmhg under norepinephrine treatment * patients with social coverage exclusion criteria: * \< 18 years old * pregnancy * inclusion in other drug study * poisonings with cardiotoxicants * patient with intra-aortic ballon pump, extracorporeal life support * patient under guardianship

Keywords: norepinephrine dobutamine shock
effect of omega-3 supplementation on child behavior problems

Conditions: Antisocial; Aggressive; Externalizing Behavior Problems; Internalizing Behavior Problems

Summary: the primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.

this study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on behavior problems in children. all behavior problem outcomes were assessed, although the primary focus was on antisocial and aggressive behavior.

Eligibility criteria:
inclusion criteria: * child * age between 8 and 16 years * residing in the community exclusion criteria: * fish allergy * diagnosed mental disorder * mental retardation * on medication that may modify lipid metabolism * extensive use of nutritional supplements within the previous 3 months

Keywords: randomized controlled trial omega-3 nutrition behavior problems externalizing internalizing antisocial aggressive
measuring uterine electrical activity throughout pregnancy and labor measuring uterine electrical activity throughout pregnancy and labor

Conditions: Pregnancy

Summary: the eum100pro (electrical uterine monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.the study will compare the eum100pro measurements to the already existing uterine contractions monitors (tocodynamometer and intra uterine pressure catheter) in pregnant women with complaints of uterine contractions.

the main objective of the study is to demonstrate that the eum100pro is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, iupc) in measuring uterine contractions. this will be performed by measuring the expectancy of time differences between the tocodynamometer/iupc and the eum in the beginning, end, peak and duration of each contraction. a good correlation will be 0.9 and significance of 95%. 100 women will be recruited to the study. the measurement with the eum100pro will not interfere with the usual clinical care, meaning- the eum100pro will be used in addition to the standard care and monitoring.

Eligibility criteria:
inclusion criteria: * women at term with complaint of uterine contractions at meir medical center * women at preterm with complaint of uterine contractions at meir medical center. * women at gestational age \>24 weeks * subjects who understood, agreed and signed the informed consent form exclusion criteria: * subjects who refused to sign the informed consent form * abnormal fetal heart rate recording at admittance * subjects with indications for immediate delivery * subjects younger than 18 years of age * subjects at gestational age \<24 weeks

Keywords: pregnancy term preterm uterine contractions
atrial fibrillation recurrence following cardioversion: the role of clinical factors and alpha defensin levels

Conditions: Atrial Fibrillation

Summary: atrial fibrillation and inflammation are strongly correlated. the aim of this study is to evaluate whether inflammation markers (alpha defensin) predict maintenance of sinus rhythm following cardioversion. a secondary aim is to evaluate the role of colchicine, an anti-inflammatory medication, in reducing the recurrence rate of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * atrial fibrillation * candidate for cardioversion exclusion criteria: * colchicine allergy * hepatic or renal failure
the effect of white sweet potato meal replacement on weight control of the obesity

Conditions: Overweight

Summary: the purpose of this project is to use white-skinned sweet potato as the main material for weight control for overweight and obesity, the non-communicable diseases (cardiovascular diseases, cancers, chronic respiratory diseases and diabetes) are also included. all high quality sweet potato are provided by caes in taiwan to produce special nutrient food and health food that to do functional study in shih chien university and taipei medical university. in this study, the investigators will recruit overweight and obesity subjects that divide into white sweet potato group (experimental group) and no intervention group (control group) by using randomized, parallel and open clinical study in sixty days.

all subjects will be evaluated the body weight and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.

Eligibility criteria:
inclusion criteria: * 24≦ bmi≦30 exclusion criteria: * pregnant and lactating women * patients within six months after surgery * mental illness or depression * suffering from cancer, ulcers, acute respiratory infections, dialysis, acute hepatitis and other diseases * those who have taken "additional nutritional supplements" habit
primary versus deferred ureteroscopy for calculus anuria in children

Conditions: Ureter Obstruction

Summary: to evaluate the role of both primary and deferred urs in the management of calculus anuria concerning the feasibility, clinical outcome, and cost-effectiveness in children in a comparative study

thirty group b (30) patients will be admitted to do urinary drainage through the insertion of a jj stent or percutaneous nephrostomy (pcn) at first , then a deferred urs will be done children will undergo primary urs( group a ) and in. ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. ureteroscopic lithotripsy will be done using a 6.5:7.5 fr semi-rigid ureteroscope and holmium laser. the ureteric stent will last for one week after lithotripsy. postoperatively, the patients in both groups will monitored for post obstructive diuresis, fever, hematuria, and extent of renal function improvement.

Eligibility criteria:
inclusion criteria: * children ˂12 years with calculus anuria. * clinically stable (serum creatinine \ 7.1) * all the patients free of sepsis. exclusion criteria: * unstable children (serum creatinine ≥ 3.5 mg/dl, blood urea ≥ 100 mg/dl, serum potassium ≥ 7 milliequivalent/l, and/or blood ph ≤ 7.1, signs of acidosis, sepsis, or fluid retention). * children with underlying urological structural abnormalities
graves' disease remission study: mycometh combo

Conditions: Graves' Disease

Summary: a randomized study to evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed graves' disease.

the remission rate of methimazole standard therapy in patients with newly diagnosed graves' disease is only around 50%. main reason for the low remission rate is methimazole therapy is not a drug targeting etiology of graves' disease. the investigators hypothesize that adding mycophenolate mofetil, an immunosuppressor, to methimazole standard therapy will improve remission rate. the study will evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed graves' disease. 205 eligible patients will be randomized to mycophenolate mofetil combined with methimazole therapy or methimazole standard therapy. the primary outcome is the remission rate at 12 months.

Eligibility criteria:
inclusion criteria: - 1. aged 18 to 60 years. 2. patients newly diagnosed with graves' disease. exclusion criteria: * 1. patients with graves' disease who have undergone treatment or experienced relapse. 2. hyperthyroidism due to other etiologies (toxic multinodular goiter, toxic thyroid adenoma, hashimoto's thyroiditis, subacute thyroiditis, iodine-induced hyperthyroidism, etc.). 3. individuals requiring intervention for moderate to severe thyroid eye disease at the time of enrollment. 4. patients with hyperthyroidism requiring surgery due to concurrent thyroid cancer. 5. those with severe liver or kidney dysfunction (alt or ast \> 3 times the upper limit of normal reference values, blood creatinine \> 135 mol/l for males, and 110 mol/l for females). 6. individuals with leukopenia (wbc \< 3.0×109/l). 7. patients with severe heart failure (nyha class iii or iv). 8. individuals with chronic or severe infections such as pulmonary tuberculosis, hepatitis b, etc. 9. pregnant women, breastfeeding women, those planning pregnancy in the near future, or individuals who cannot comply with contraception during trial. 10. participants in or previously involved in other clinical studies. 11. individuals unwilling or unable to comply with follow-up or unwilling to participate.

Keywords: newly diagnosed graves' disease mycophenolate mofetil methimazole remission
phase iii study to assess the long term efficacy, carry-over effect and safety of 300 ir sublingual immunotherapy tablets

Conditions: Allergy

Summary: a phase iii study to evaluate long term efficacy , carry-over effect and safety of 300 ir sublingual immunotherapy (slit) tablets in adults patients suffering from grass pollen rhinoconjunctivitis


Eligibility criteria:
inclusion criteria: * male or female outpatients aged 18 to 50 years * grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons * positive spt and specific ige values of at least class 2 for grass pollen allergens * a score of greater than or equal to 12 out of a possible 18 on the retrospective rhinoconjunctivitis total symptom score (rrtss) exclusion criteria: * patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. patients must be asymptomatic to all other allergens during the grass pollen season. patients who have allergic rhinitis due to perennial allergen may not be included. * asthma requiring treatment other than beta-2 inhaled agonists. * patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.

Keywords: sublingual immunotherapy grass pollen tablet allergic rhinoconjunctivitis
safety and efficacy of talactoferrin alfa in patients with severe sepsis

Conditions: Severe Sepsis

Summary: study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * onset of severe sepsis within the previous 24 hours * must be receiving antibiotic therapy * informed consent form signed by patient or authorized representatives according to local rules or regulations * able to take liquid medication by mouth or feeding tube exclusion criteria: * receipt of investigational medication within 4 weeks prior to participation in the study * pregnant or breast-feeding * severe congestive heart failure * known severe hiv infection * presence of severe burns * patients on high dose immunosuppressants * patients whose death is considered imminent * patients whose life expectancy for concurrent illness is less than 6 months * severe hypoxic encephalopathy or persistent vegetative state * severe liver disease * chronically bed bound * patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Keywords: sepsis talactoferrin lactoferrin recombinant human lactoferrin
myocardial damage in patients with cerebral infarction

Conditions: Ischemic Stroke

Summary: introduction for several years "ischemic" electrocardiographic (ecg) changes in the acute phase of ischemic stroke have been reported. whether these ecg changes reflect true myocardial ischemia remains controversial. so far no study has assessed different markers of myocardial ischemia or necrosis in consecutive patients admitted to hospital with an acute ischemic stroke. purpose the main purpose of this study is to determine the potential burden of reversible and irreversible myocardial ischemia in patients with an acute ischemic stroke. patients and methods serial blood samples for measuring troponin t, ck-mb and nt-probnp are collected in 250 patients with evidence of an acute ischemic stroke admitted to the department of neurology at odense university hospital. in addition resting 12-lead ecg recordings will be obtained on a daily basis, and a 24-hour st-segment ambulatory monitoring will be performed once within the first week of hospitalisation. finally, myocardial perfusion patterns during rest will be evaluated by means of a myocardial perfusion scintigraphy in patients with an elevated troponin t level. six months later control measurements of troponin t, ck-mb and nt-probnp and a 12-lead ecg will be obtained. expectations the study will contribute with original observations in patients with acute ischemic stroke considering the following issues: 1. the prevalence and characteristics of ecg changes suggestive of myocardial ischemia. 2. the prevalence of transient st-segment changes on ambulatory monitoring. 3. the prevalence and degree of myocardial necrosis as judged from biochemical markers. 4. the prevalence of reversible and irreversible perfusion defects on myocardial scintigraphy. 5. the prevalence, size and patterns of nt-probnp. 6. whether there is a change in ecg and biochemical markers over a 6-month follow-up period. the results may have clinical implications regarding early and late treatment as well as clinical follow-up of patients recovering from an episode of acute ischemic stroke.


Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke. 2. age ≥ 18 years old. 3. written, informed consent. exclusion criteria: 1. onset of stroke symptoms 8 to 21 days before admission. 2. transient ischemic attack. 3. intracerebral or subarachnoid haemorrhage. 4. previous myocardial infarction. 5. any pathological q waves on the baseline ecg. 6. current atrial fibrillation. 7. unstable angina pectoris ≤ 3 weeks before admission. 8. systolic blood pressure ≤ 90 mmhg and symptoms. 9. resuscitation after cardiac arrest. 10. unwillingness to participate.

Keywords: ischemic stroke myocardial ischemia myocardial necrosis
optimizing management of low back pain through the pain and disability drivers management model

Conditions: Mechanical Low Back Pain

Summary: this study aims to determine the feasibility of conducting a future randomized controlled trial to collect preliminary data on the effectiveness of a previously validated approach that takes into account all the pain and disability vectors associated with low back pain - the pain and disability drivers management model (pddm). the overall objective is to provide data to assess the feasibility of implementing a future randomized clinical trial to evaluate the impact of the pddm on the management of non-specific lbp in a clinical setting and to explore the short-term effect of using the model on patient's clinical outcomes.

background: non-specific mechanical low back pain (lbp) is highly prevalent, recurrent and is a leading cause of disability worldwide. despite increased efforts in improving care, the self-reported levels of disability in individuals with lbp have not improved in the last decade. in order to more effectively manage lbp through non-pharmacological approaches, evidence endorses the use of classification systems to support diagnosis and guide treatments. however, this approach to care is not without limitations and a more comprehensive and broader perspective is needed. hence, we recently proposed and validated the low back pain and disability drivers management (pddm) model, which aims to identify the domains influencing pain and disability to create a profile or phenotype to guide clinical decisions. the objective of this study is to assess the feasibility of conducting a trial and to gather preliminary effect outcomes of the intervention in clinical setting. methods: the design is a prospective single arm experimental design. physiotherapists (pts) working with a population suffering from musculoskeletal disorders and patients presenting with non-specific mechanical lbp from two different clinical settings will be recruited. the intervention consists of a one-day training workshop for pts on using the pddm to guide management decisions. pts will then perform a 6-weeks follow-up with their participating patients. this feasibility study will assess recruitment and retention rates as well as pts' acceptability and patients' satisfaction outcomes related to the intervention. preliminary effect outcomes will also be gathered. discussion: this study will inform the feasibility and acceptability of the intervention and gather preliminary outcomes to conduct a future randomized controlled trial to measure the effectiveness of the intervention in managing non-specific mechanical lbp.

Eligibility criteria:
inclusion criteria: clinicians: * be working with a population suffering from musculoskeletal disorders such as lbp and have a valid license to practice physiotherapy in the province of quebec * agree to participate to the one-day training workshop (intervention) * assess and initiate treatment of their patients presenting with non-specific lbp guided by our newly developed model

Keywords: low back pain pain management rehabilitation feasibility outcomes