Kornimate/medical-research-clean huggingface dataset:
extension study for patients entered into study infacort 003

Conditions: Adrenal Insufficiency

Summary: a phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of infacort® in neonates, infants and children with adrenal insufficiency and congenital adrenal hyperplasia who had completed study infacort 003. all subjects who had satisfactorily completed study infacort 003 were offered the opportunity to take part in infacort 004.

a phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of infacort® in neonates, infants and children with ai who had completed study infacort 003 (eudract number 2014-002265-30). all subjects who had satisfactorily completed study infacort 003 wiere offered the opportunity to participate in study infacort 004 at or after their final visit of study infacort 003. subjects received the usual clinically-appropriate dose (since bioequivalence has been demonstrated with conventional hydrocortisone), as determined by the investigator, which was administered according to usual clinical practice - generally 3 or 4 times a day. subjects could continue to be treated in this study until they met the study withdrawal criteria, until infacort® was commercially available locally (which has now been achieved), or until the sponsor decided to discontinue the study.

Eligibility criteria:
inclusion criteria: subjects successfully completing study infacort 003, whose inclusion criteria were: 1. male and female children less than 6 years of age. 2. a diagnosis of adrenal insufficiency (ai) as confirmed by an inappropriately low cortisol usually with other supporting tests. 3. receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without fludrocortisone). 4. adequately hydrated and nourished. in addition, the parents/carers must be able to understand and give written informed consent for this extension study. exclusion criteria: 1. clinically evident acute ai (adrenal crisis) (note: the subject can be re-evaluated for eligibility once the episode is over) 2. inability of the child to take oral therapy 3. subjects with clinical signs of acute infection or fever on inclusion (note: the subject can be re-evaluated for eligibility once the episode is over) 4. any surgical or medical condition that in the opinion of the investigator may place the subject at higher risk from his/her participation in the study 5. parents/carers of subjects unwilling to consent to saving and propagation of pseudonymised medical data for study reasons 6. subjects who are in a dependent relationship with the investigator or the sponsor
clinical trial of donepezil between the patients with alzheimer's disease and mixed dementia

Conditions: Alzheimer's Disease; Dementia

Summary: to compare the clinical efficacy of donepezil between patients with alzheimer's disease and mixed dementia.

the purposes of this study are: 1. to compare the clinical efficacy of donepezil between patients with alzheimer's disease and mixed dementia 2. to help to clinicians in choosing the best treatment for patients with mixed dementia

Eligibility criteria:
inclusion criteria: 1. a diagnosis of probable ad and mixed dementia according to the criteria of the nincds-adrda 2. korean version mini-mental state examination scores between 10 and 26 3. history of cognitive decline that had been gradual in onset and progressive over at least 6 months 4. a caregiver who could assist the patient with medication, attend the assessment and provide information about the patient. exclusion criteria: 1. they had evidence of any neurodegenerative diseases other than ad (i.e. parkinson's disease, huntington's disease) 2. psychiatric disorder or severe behavioral disturbances that required psychotropic medications 3. cerebral injuries induced by trauma, hypoxia, and/or ischemia 4. clinically active cerebrovascular disease; history of seizure disorder 5. other physical conditions that required acute treatment.

Keywords: alzheimer's disease mixed dementia donepezil efficacy adverse event
combination of fimasartan/amlodipine/hydrochlorothiazide in healthy male subjects

Conditions: Pharmacokinetics

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety/tolerability between fimasartan/amlodipine/hydrochlorothiazide and co administration of fimasartan/amlodipine and hydrochlorothiazide in healthy volunteers.


Eligibility criteria:
inclusion criteria: * a healthy adults aged 19-50 years exclusion criteria: * history or presence of clinically significant medical or psychiatric condition or disease * hypersensitivity to ingredient of ip and other medication, food * participation in any other study within 3months * history of whole blood donation within 2months and apheresis 1month

Keywords: hypertension
pharmacokinetics of anacetrapib (mk0859) in subjects with impaired renal function (mk-0859-038)

Conditions: Dyslipidemia

Summary: this study will evaluate the area under the curve (auc(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.


Eligibility criteria:
inclusion criteria: * female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study * subject is in good health * if subject is a smoker, smoking is limited to no more than 10 cigarettes per day exclusion criteria: * subject has a history of stroke, chronic seizures or major neurological disorder * subject has a history of cancer * subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study * subject consumes excessive amounts of alcohol or caffeine * subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks * subject is a nursing mother * subject has had a kidney removed or has a functioning renal transplant

Keywords: renal insufficiency
appendicectomy versus antibiotics in the treatment of acute uncomplicated appendicitis

Conditions: Acute Appendicitis

Summary: appendicectomy has been the treatment of acute appendicitis for over a hundred years. appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. at the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. there have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis. the aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, invanz). before randomization acute uncomplicated appendicitis is diagnosed with a ct scan.the hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.


Eligibility criteria:
inclusion criteria: * age range from 18 to 60 years * ct scan diagnosed uncomplicated acute appendicitis exclusion criteria: * age under 18 years or age over 60 years * pregnancy or breast-feeding * allergy to contrast media or iodine * renal insufficiency * metformin medication (dm) * peritonitis (a perforated appendix) * lack of co-operation (unable to give consent) * a severe other medical condition * ct-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour
all-active: a family-based lifestyle program for pediatric acute leukemia patients

Conditions: Childhood Acute Lymphoblastic Leukemia in Remission

Summary: this randomized pilot phase ii trial studies how well nutritional intervention and exercise intervention works in preventing metabolic syndrome in younger patients with acute lymphoblastic leukemia. nutritional intervention may help weight loss and improve quality of life in patients with acute lymphoblastic leukemia. exercise may help decrease feelings of being tired caused by cancer, may help improve strength, and may help build up lost muscle tissue. nutritional intervention plus exercise intervention may be effective at preventing metabolic syndrome.

primary objectives: i. to evaluate feasibility, adherence, completion rates and participant satisfaction associated with a family based lifestyle intervention for overweight pediatric acute lymphoblastic leukemia (all) patients or those at high risk to become so (body mass index \[bmi\] \>= 50th percentile). ii. assess changes in bmi z-score, waist circumference, body composition, blood pressure exercise tolerance and physical activity at baseline, immediately post intervention and three months later. iii. assess changes in serum glucose, insulin, leptin and adiponectin in patients over the intervention course and at 3 months post intervention. iv. assess changes in self-reported quality of life, physical activity, caloric intake, and fatigue associated with the nutrition and exercise program in the participant and their primary caregiver. outline: patients are randomized to 1 of 2 arms. arm i: patients receive standard of care individualized diet and exercise plan and monthly booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone counseling with a trained health coach to address barriers to improve plan adherence. arm ii: patients receive standard of care individualized diet and exercise plan. after completion of study treatment, patients are followed up at 3 and 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of pre-b cell or t cell all and in continuous first remission; at least 3 months into maintenance therapy with at least 7 months remaining before therapy completion * english speaking patient and primary caregiver * bmi \>= 75th percentile at time of study enrollment; (patients \>= 75th percentile were selected as they were the group in our preliminary data that had a high risk of becoming overweight during maintenance therapy) * provision of informed consent by primary caregiver exclusion criteria: * any physical or mental limitation that would prevent participation in study activities (including but not limited to grade 4 neuropathy or inability to ambulate) * as this is intended to be a family-based intervention, all family members will be invited to participate, including those living in more than one household, however endpoints will only be assessed formally in the patient and identified primary caregiver; siblings are not required for participation.

Keywords: adiponectin, glucose, insulin, leptin
body mass index and age correlate with antioxidant supplementation effects on sperm quality

Conditions: Male Infertility

Summary: spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. therefore, it is essential that appropriate nutrients are available during maturation. this randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. semen analyses were done at the beginning and end of the treatment. in addition to main analyses, post-hoc analyses for age and body mass index (bmi) were carried out. results were interpreted by dividing the population into two age and bmi classes.


Eligibility criteria:
inclusion criteria: * men with oligo- and/or astheno- and/or terato-zoospermia * with or without varicocele * men aged between 18 and 50 years * men from couples with history of difficulty conceiving for more than 12 months exclusion criteria: * subjects with known hypersensitivity to any of the treatment compound * history of undescended testes or cancer * endocrine disorders * history of post-pubertal mumps * genitourinary surgery * obstructive azoospermia or obstructive pathology of the urogenital system * autoimmune disease * cystic fibrosis * history of taking any therapy affecting fertility within last 3 months * excessive consumption of alcohol or regular use of illicit or "recreational" drugs * positive serology for hiv * subjects following any special diet * any condition which in the opinion of the investigator might put the subject at risk by participation in this study and subjects involved in any other clinical trials
fabry aim children early (ace) project

Conditions: Fabry Disease

Summary: the purpose of this study is to assess the frequency of fabry disease in children with early symptoms.

fabry disease is a complex, multisystemic and clinically heterogeneous disease that commonly presents in childhood and is caused by deficient activity of the lysosomal enzyme alpha-galactosidasea (α-gal a). symptoms of fabry disease in the pediatric population are well described. symptoms can occur in early childhood, before age 5 years. incidence estimations of fabry disease vary widely. the true incidence is likely to be higher than originally thought, owing to the existence of milder variants of the disease. the purpose of this study is to assess the frequency of fabry disease in children with early symptoms. patients would benefit from early diagnosis, appropriate treatment, follow-up and surveillance. early detection of fabry patients would also benefit affected relatives, many of whom do not have a clear diagnosis of their clinical condition.

Eligibility criteria:
inclusion criteria: * patients with fabry disease-associated phenotypes in infancy, childhood and adolescence: pain in the hands and feet, angiokeratomas, hypohidrosis, corneal whorls, unexplained renal failure, unexplained hypertrophic myocardiopathy and unexplained early onset stroke. exclusion criteria: * patient's parent(s) or legal guardian(s) are unable to understand the nature, scope, and possible consequences of the screening.
safety and efficacy study of bms-823778 to treat uncontrolled high blood pressure in overweight and obese patients

Conditions: Hypertension

Summary: the purpose of this study is to determine whether bms-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.


Eligibility criteria:
inclusion criteria: * qualifying seated blood pressure between ≥90 and ≤105 mmhg diastolic and ≤155 mmhg systolic * mean 24-hour diastolic blood pressure ≥85 mmhg * body mass index (bmi) ≥27 kg/m2 * if receiving an oral anti-hyperglycemic medication or a cholesterol lowering medication, receiving a stable dose for at least 6 weeks exclusion criteria: * history of cushing's disease or syndrome, or addison's disease * glycosylated hemoglobin (hba1c) ≥10% * cerebrovascular insult, unstable angina, or myocardial infarction (mi) within 6 months * history of impaired renal or hepatic function * bmi ≥50 kg/m2 * any injectable antihyperglycemic agent (such as insulin) within 16 weeks * currently receiving more than one class of antihypertensive agents within 4 weeks * daily use of nonsteroidal anti-inflammatory agents within 1 week * use of androgen medications, including topical preparations, within 6 weeks * diagnosis or history of breast cancer
cardiorespiratory parameters and glycated hemoglobin of patients with type 2 diabetes after a rehabilitation program

Conditions: Diabetes Mellitus, Type 2; Rehabilitation; Respiratory Therapy

Summary: cardiovascular autonomic dysfunction reflects the pathophysiology of diabetes mellitus in this patient group favors an increase in morbidity and mortality related to cardiovascular events, and for this reason has been one of the most studied clinical entities. therefore this work aims to analyze the cardiorespiratory parameters and glycated hemoglobin after the commission of a rehabilitation program in patients with diabetes mellitus type 2. the collection protocol is to check the heart rate, blood pressure, double product, borg scale, variability heart rate and glycated hemoglobin of patients with type 2 diabetes this project this is an experimental study, the type randomized clinical trial on the hemodynamic response and glucose levels in patients with dm2 institutionalized in acre hospital foundation submitted to one rehabilitation program consisting of aerobic and anaerobic exercises performed for 12 weeks in three weekly meetings, of 60 minutes each.

background: built with evidence that makes it possible to work in cardiac rehabilitation programs in patients with type 2 diabetes with more security, guaranteeing them an improvement in cardiorespiratory fitness, the hemodynamic and glycemic variables, allowing them a better quality of life method/design: the research instrument is applied before and after the practice of the proposed exercise program (consisting of aerobic and anaerobic exercises performed for 12 weeks in three weekly meetings, of 60 minutes each). the instrument is based on the following collection protocol: assessment of bp, hr, borg scale, respiratory rate (rr), oxygen saturation (sat), the dp calculation and will be carried out the examination to check hba1c will be performed for 12 weeks in three weekly meetings, of 60minutes each, in total of 36 sessions with antecipated 60 pacients splited in 2 groups "control" and "intervention" discussion: correlate the variability of heart rate behavior and glycated hemoglobin after the exercise program; to demonstrate the possible association between the change of the cardiorespiratory parameters according to the variation of glycated hemoglobin; demonstrate the possibility of association between the variation of the cardiorespiratory parameters and glycated hemoglobin according to sex;

Eligibility criteria:
inclusion criteria: * type 2 diabetes * sedentary * non-smoker * with medical prescription for rehabilitation program. exclusion criteria: * neurological disease * acute heart failure * morbid obesity * atrial fibrillation * sick sinus syndrome * atrioventricular block grade ii or iii * who used beta-blockers * who used antiarrhythmic medication.

Keywords: type 2 diabetes mellitus heart rate variability rehabilitation hemoglobin glycated
renal tracer elimination in thyroid cancer patients treated with 131-iodine

Conditions: Thyroid Carcinoma

Summary: correlation analysis between estimated renal function and biological half life of 131-i during radioiodine treatment of patients with differentiated thyroid cancer.

131-i during radioiodine treatment of patients with differentiated thyroid cancer is mainly renally excreted. it is advised in the clinical guidelines that serum creatinine should be determined before applying 131-i and if necessary the administered dose should be reduced. nevertheless no guideline gives advice in what extent the dose should be decreased. the adjustment is at the discretion of the attending physician. aim of this prospective study is to correlate the biological half life of 131-i with the renal function to give objective recommendations concerning the reduction of the applied dose in patients with limited renal function.

Eligibility criteria:
inclusion criteria: * patients with differentiated thyroid carcinoma * stationary for treatment or diagnostic with radioiodine * state after thyroidectomy * written consent of the patient * minimum age 18 years exclusion criteria: * no written consent of the patient * patients with large residual thyroid tissue (iodine uptake \> 10%) * children under 18 years of age * inclusion in concurrent interventional studies * patients without tsh-stimulation by rhtsh
cytochrome p450 2d6 (cyp 450 2d6) genotype and flecainide efficacy

Conditions: Atrial Fibrillation

Summary: the determination of the 2d6 genotype will enable us to determine the way flecainide is metabolized by the liver. some individuals are poor metabolizers and some individuals are extensive metabolizers of the drug. this will also determine which patients will benefit from the drug.

pharmacogenetics is the study of genetic variations on drug metabolizing enzymes and transporters. pharmacogenetics is one of the first clinical applications of the human genome project. pharmacogenomics is the study of the role of interindividual genomics variability on drug response, efficacy, and metabolism. it correlates the effects of the entire expressed genome to the clinical usefulness and toxicity of a drug. pharmacogenomics has the potential to change the way patients' therapy is optimized, allowing an era of "personalized medicine" in which patients will be divided into groups based on genetic markers that treatment outcomes.

Eligibility criteria:
inclusion criteria: * patients with recurrent af * patients with a structurally normal heart * patients \> 18 yo * patients who signed an informed consent exclusion criteria: * renal failure with creatinine clearance less than 40 * elevated liver enzymes 3 times the normal range, or causing coagulation test abnormality * pregnant patients * patients treated with psychiatric agents

Keywords: flecainide pharmacogenetics
web-based cbt for insomnia patients with fibromyalgia

Conditions: Insomnia; Fibromyalgia

Summary: researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.

the investigators are studying the effect of an internet-based cognitive behavioral therapy for insomnia, compared with usual care in fibromyalgia patients. fibromyalgia patients will consent to study, and a determination made if the patients meet criteria. if eligible, qualifying patients will be randomized, and begin participation in randomized intervention. during participation on the study subjects will complete surveys at set intervals.

Eligibility criteria:
inclusion criteria: * meets diagnostic criteria for fibromyalgia * has insomnia * have internet access and a device that can access the web-based program. exclusion criteria: * active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome) * active psychiatric disorder (bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed. * chronic fatigue syndrome * morbid obesity

Keywords: insomnia fibromyalgia