Kornimate/medical-research-clean huggingface dataset:
bioequivalency study of oxcarbazepine 600 mg tablets under fed conditions

Conditions: Epilepsy; Seizures

Summary: the objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation with novartis pharmaceutical's 600 mg oxcarbazepine tablet, trileptal, folloiwng a single 600 mg dose administered with food.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or advers response to oxcarbazepine or any other comparable or similar product.
blood glucose self monitoring and hba1c effects on glucose control

Conditions: Type 2 Diabetes

Summary: the purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve hba1c after one year in typ 2-diabetic patients on conventional insulin treatment.

the design is an open, prospective, randomised, multicentre parallel group study. the total duration will be 5 years with patient recruitment over 4 years and an individual observation period of 1 year. 300 participants from 43 study centres, hospitals and private practices were recruited. the study will run for one year and aims to determine, whether there is an advantage with regard to hba1c levels when (a) a regular three-monthly hba1c or (b) a weekly 4-point glucose profile is taken and reported. after screening, patients will be assigned at random to one of the following study arms: 1. no regular blood-glucose self-monitoring, no regular hba1c 2. regular blood glucose self monitoring, no regular hba1c 3. no regular blood glucose self monitoring, regular hba1c 4. regular blood glucose self monitoring, regular hba1c the control for all participants is that urinary glucose should be monitored at least once a day, preferably in the late morning, as the highest increase in plasma glucose level occurs after breakfast.

Eligibility criteria:
inclusion criteria: * type 2-diabetes (ada/who-criteria) * conventional insulin therapy ( 1-3 daily injections of basal- and/or mixed insulin also in combination with oral agents.) * age:\> 40 years * bmi:\> 20 kg/m² exclusion criteria: * impaired liver function, defined as \> 2 times upper limit of normal * impaired renal function defined liver enzymes as serum-creatinine \> 1.3 mg/dl * gastro-intestinal diseases (disturbances, diagnoses) * inability to perform study-related activities according to the present protocol * pregnancy not certainly excluded * abuse of alcohol and/or other drugs * participation in other clinical trials during the past 3 month * threat to general state of health * intensified insulin therapy (at least 3 times rapid-acting insulin) * frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )

Keywords: diabetes control glycated haemoglobin blood-glucose-self-monitoring type 2-diabetes conventional insulin therapy
stellate ganglion block for hot flushes in men treated with adt

Conditions: Prostate Cancer

Summary: androgen deprivation therapy (adt) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. hot flushes and night sweats are one of the main side-effects of adt. there are no successful and well-tolerable treatment options available. a possible treatment for hot flushes is stellate-ganglion block (sgb), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation. objective of this study: to assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

androgen deprivation therapy (adt) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. hot flushes and night sweats are one of the main side-effects of adt. there are no successful and well-tolerable treatment options available. a possible treatment for hot flushes is stellate-ganglion block (sgb), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation. objective of this study

Eligibility criteria:
inclusion criteria: * male * age: \>18 years * mean daily flush frequency of 10 or more and a hot flush score of 15 or more * treatment with adt because of prostate cancer * absence of any other cause of flushing exclusion criteria: * use of medication that affects flushing: oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteinizing hormone-releasing hormone receptor antagonist * still receiving chemotherapy of radiotherapy * psychiatric disease * any unstable concurrent disease * allergic reactions against bupivacaine or contrast media.

Keywords: stellate ganglion block hot flushes androgen deprivation therapy prostate cancer
oxytocin and cognitive control in adult adhd

Conditions: Attention Deficit/Hyperactivity Disorder

Summary: this is a randomized, double-blind, placebo-controlled crossover study of single-dose intranasal oxytocin (24 iu) in 18-55 year-old men with attention deficit/hyperactivity disorder (adhd). following a screening visit to determine eligibility, participants will return for two main study visits. during the main study visits, study participants will receive either oxytocin (syntocinon® nasal spray, victoria pharmacy, zürich, switzerland) or placebo (inactive ingredients of syntocinon® nasal spray, victoria pharmacy), followed by assessments of cognitive control over attention and behavior. twenty-four participants will be randomized 1:1 to one of two drug orders, i.e., oxytocin - placebo or placebo - oxytocin. in an additional neuroimaging substudy, a subset of participants will undergo task-based and resting-state functional magnetic resonance imaging (fmri) following oxytocin/placebo administration to investigate the effects of oxytocin on fmri activation and functional connectivity within the cognitive control network.


Eligibility criteria:
inclusion criteria: * male * 18-55 years * diagnosis of attention deficit/hyperactivity disorder exclusion criteria: * history of cardiovascular disease (e.g., hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms) * history of diabetes mellitus * untreated thyroid disease * hematocrit below the normal range * tobacco use * any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk * excluded at the investigator's clinical judgement of adhd symptom severity

Keywords: attention attention deficit/hyperactivity disorder cognitive control executive control executive functions impulse control impulsivity oxytocin
study of efficacy and safety of canakinumab in pediatric patients with kawasaki disease

Conditions: Kawasaki Disease

Summary: the purpose of this trial is to evaluate whether, in intravenous immunoglobulin-naïve or refractory patients diagnosed with active kawasaki disease, administration of canakinumab controls fever and acute phase reactants.


Eligibility criteria:
key inclusion criteria: -active kawasaki disease defined as: * fever ≥38.5°c for ≥5 days * four out of five of the following criteria: (i) conjunctival injection, (ii) oral mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii) erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy key exclusion criteria: patients fulfilling any of the following criteria are not eligible for inclusion in this study: * previous kawasaki disease diagnosis, refractory and/or incomplete kawasaki disease (for ivig-naïve patients, cohort 1) * patients who had fever for longer than a week (for intravenous immunoglobulin-naïve patients, cohort 1), or longer than 14 days (for intravenous immunoglobulin-refractory patients, cohort 2) * history of hypersensitivity to any of the study drugs or to drugs or similar chemical classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections) other protocol-defined inclusion/exclusion may apply.

Keywords: kawasaki disease coronary artery aneurysm mucocutaneous lymph node syndrome lymph node syndrome canakinumab intravenous immunoglobulin naïve (ivig-naïve) intravenous immunoglobulin refractory (ivig-refractory) pediatric
staging procedures to diagnose malignant pleural mesothelioma

Conditions: Mesothelioma; Solitary Fibrous Tumor of the Pleura

Summary: the purpose of this study is to evaluate the accuracy of participants imaging versus staging procedures. the investigators will consent subjects that are scheduled to undergo staging procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy, endobronchial ultrasound and laparoscopy) as part of their standard of care.


Eligibility criteria:
inclusion criteria: * subject provides informed consent * subject is \>18 years of age * subject is deemed competent for making medical decisions * subject is scheduled to undergo a staging pleuroscopy * subject is a surgical candidate * a negative pregnancy test is required in women of child-bearing potential, as standard of care. exclusion criteria: * subject is \<18 years old.
holt-ed: holter-monitoring in end-stage renal disease

Conditions: Kidney Failure, Chronic; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency

Summary: the main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.

background: the risk of dying of a cardiovascular disease is 10-20 times increased in patients dependent on dialysis treatment compared to the general population. 1/3 of these deaths is caused by arrhythmia and 'sudden cardiac death'. purpose: investigate the prevalence and type of arrhythmia in patients dependent on dialysis treatment, including the association with patient- and dialysis related factors and cardiovascular outcomes. methods: 7-days holter-monitoring with cortrium c3+ holter-monitor in 540 patients dependent on dialysis treatment in the capital region of denmark. continous blood glucose monitoring in a subgroup. 1-year follow-up via national registers. endpoints: * prevalence of atrial fibrillation * prevalence of other arrhythmia (tachycardia, bradycardia, av-block) * follow-up outcomes: sudden cardiac death, cardiovascular disease and cardiovascular death

Eligibility criteria:
inclusion criteria: * dialysis-treated end-stage renal disease * age ≥ 18 years * competence to understand the study rationale necessary for written informed consent exclusion criteria: * pre-existing pacemaker implantation
gm1 prophylaxis for post-chemotherapy cognitive impairment in patients with early operable breast cancer

Conditions: Chemotherapy-Related Cognitive Impairment; Breast Cancer

Summary: the purpose of this study is to evaluate the prophylactic effects of ganglioside-monosialic acid in post-chemotherapy cognitive impairment in patients with early operable breast cancer.

this is a multicenter, prospective, randomized, single-blind, phase iii clinical trial. the primary endpoint is the changes of cognitive function from baseline to 4 weeks after the completion of adjuvant chemotherapy in the experimental group and the control group, which were evaluated by hvlt-r scale. this study is designed to recruit up to 306 subjects.

Eligibility criteria:
inclusion criteria: 1. have provided written and signed informed consent; 2. histologically confirmed invasive ductal carcinoma; 3. planned to received (neo)/adjuvant chemotherapy; 4. eastern cooperative oncology group (ecog) score of 0 to 1; 5. can cope with hvlt-rdr and adas-cog evaluation; 6. no prior therapy could induce neurological damage,within 4 weeks 7. normal blood routine, liver and kidney functions within 1 week before enrollment in this study; 8. women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; pre-menopause women are contracepted with medically acceptable methods during the study period. 9. compliance with the study protocol. exclusion criteria: 1. eastern cooperative oncology group (ecog) score ≥ 2; 2. hypersensitivity to experiment agents or components; 3. women with pregnancy or breast feeding; 4. a clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 5. abnormal baseline impairment of cognitive impairment; 6. poor compliance, unwillingness or inability to follow protocol to continue the study; 7. any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.

Keywords: ganglioside-monosialic acid, post-chemotherapy cognitive impairment, breast cancer
comparison of two automated mononuclear collection systems in patients undergoing extracorporeal photochemotherapy. a cross-over equivalence study. (mnc_cmnc)

Conditions: GvHD; Lung Graft Dysfunction

Summary: in a study performed in 2012, the investigators demonstrated that in ecp setting , the new automated device (spectra optia-mnc) released by terumo bct for mncs collection based on intermittent flow is safe and ensures high-quality mnc collection and yield.(5, 6) more recently (in 2013), terumo bct released another automated system that allows to collect stem cells and mncs basing on a continuous collection flow.(7, 8) the aim of this cross-over study is to compare yield (i.e. collection efficiency, ce) and quality (i.e. purity and contamination) of mncs collected from patients undergoing ecp with two different automated systems: mnc and cmnc (terumo bct) processing 1.5 blood volumes during every collection procedure.

two-sequences-in-four-periods cross-over, with the same patients randomized to both devices within each ecp cycle in two consecutive cycles, open-label. cycle 1 cycle 1 cycle 2 cycle 2 day 1 day 2 day 1 day 2 sequence a cmnc mnc mnc cmnc sequence b mnc cmnc cmnc mnc there might be some carry over effect between procedure 1 and 2 within each cycle, because during the procedure the patient is administered fluids, and therefore cell counts/ml in the second day might be lower than in the first day; this it is intrinsic to the clinical procedure and can not be modified, but will be taken into account in statistical analyses. carry over effect between first and second cycle is not expected, since they are performed at least 7 days apart; this allow the patient's cell blood count to be restored to baseline values; however, this will also be considered in statistical analyses.

Eligibility criteria:
adult (\>18 years) patients undergoing extracorporeal photochemotherapy for either clad or gvhd inclusion criteria: age \>18 years on extracorporeal photochemotherapy for either clad or gvhd exclusion criteria: age \<18 years,
post-operative sub-tenon kenalog in glaucoma filtering surgery

Conditions: Glaucoma

Summary: determine efficacy of sub tenon kenalog injections for post-operative management of trabeculectomy procedures.

postoperative sub-tenon triamcinolone acetonide in glaucoma filtering surgery objectives: trabeculectomy is a surgical procedure designed to reduce internal eye pressure by draining fluid from within the eye to the sub-conjunctival (superficial eye lining) space. scar formation from conjunctival and tenon's capsule fibroblast proliferation represents the most common cause of failure of trabeculectomies. a number of drugs have been use to prevent failure of trabeculectomies from the scarring process including intraoperative mitomycin c (mmc) and preoperative triamcinalone acetonide (ta). over the past several years, intraoperative mmc has become a preferred method of preventing scar formation. this study looks to determine in a prospective, double-blind, randomized method the long-term efficacy and safety of mmc with postoperative ta compared to the standard practice of intraoperative mmc with postoperative prednisolone acetate drops in preventing scar related failures of trabeculectomies.

Eligibility criteria:
inclusion criteria:trabeculectomy surgery patient, age 18 or older - exclusion criteria:pregnant, nursing, age less than 18, known allergy to medication being studied
efficacy of extended peginterferon alpha 2a treatment in hbeag positive chronic hepatitis b patients

Conditions: Chronic Hepatitis B

Summary: the most important method to slow down and stop the liver disease progression in patients with chronic hepatitis b is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. the aim of the therapy with interferon is make patients obtain immune control to hbv, in clinical practice, it was expressed as hbeag seroconversion, hbsag loss and sustained viral response in hbeag positive patients. however, those targets can't be get in most patients by 48 weeks of interferon treatment, and some patients need extended treatment to enhance the rate of hbeag seroconversion and hbsag loss. in this cohort study, the efficacies of extended therapy of interferon in hbeag positive chronic hepatitis b patients will be evaluated.

in this cohort study, the hbeag positive chronic hepatitis b patients would be treated with peginterferon alpha 2a(peg-ifn a-2a) for 96 week and followed 24 weeks after treatment. serum hbv dna load, hbsag/anti-hbs level, hbeag/anti-hbe will be tested at enrollment and every 3 months during treatment and follow period. parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. the rates of hbeag seroconversion, hbsag loss, and sustained viral response will be evaluated after treatment and follow up.

Eligibility criteria:
inclusion criteria: * hbeag positive chronic hepatitis b patients exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitis b antiviral therapy peginterferon hbeag seroconversion hbsag loss
study aimed at detecting potential abuse of nitrous oxide in children during dental care

Conditions: Periodontal Disease

Summary: the aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care.

the expected prospects are therefore maintaining surveillance around the meopa following his release from hospital reserves, but also to ensure that the meopa not an addictive potential in the context of its use in dentistry. the results of this study will in any case to secure its application for dental care.

Eligibility criteria:
inclusion criteria: * children aged 3 to 15 years * requiring dental care under meopa * not opposing, as well as his parents, his participation in the study * not having difficulties tracking (going on holiday, imminent change, remoteness, lack of motivation) exclusion criteria: excluded patients are those whose dental care can be made to the vigil state, or on the contrary, will present a number of important care, justifying general anesthesia. also excluded will be children whose parents no longer have parental authority or whose parents are divorced or divorcing.

Keywords: dental care emeno abuse
estimated glomerular filtration rate after kidney transplantation - the formula mdrd, ckd-epi or cockroft-gault?

Conditions: Renal Function Disorder

Summary: the study included 300 patients who are post-kidney transplantation (\> 3 months and \<10 years). an analysis of body composition using bioelectrical impedance, calculated bmi and serum creatinine was determined. glomerular filtration rate (gfr) was calculated using the formula ckd-epi, modification of diet in renal disease (mdrd) and cockroft-gault.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * functioning graft longer than 3 months to 10 years * no clinical cardiovascular disease during the 6 months preceding entry * stable graft function- glomerular filtration rate \> 30 ml/min/1.73 m2, creatinine concentration \<2.5 mg/dl exclusion criteria: * not meet the above criteria * episode of illness (for example: infection) * pregnancy
effectiveness of tpd tech vs tsd tech

Conditions: Dental Anxiety

Summary: assessment of the effectiveness of tell play do technique and tell show do technique in management of anxious children .

child dental anxiety has been a matter of concern for many years. it is defined as a nonspecific feeling of apprehension, worry, uneasiness and the source may be not clear or unknown . dental anxiety is considered as a major obstacle for the dental treatment. the dental appointment is a stressful situation specially for children which raises their anxiety level. different studies among 6-12 years old children showed that 20%- 43 % exhibited high dental fear and anxiety . dental fear and anxiety can have negative implications for children's oral health. there is certainty for the negative impact of dental anxiety on the oral health-related quality of life of children, and studies have shown that children with dental fear and anxiety have worse oral health status than their peers (more untreated carious lesions). it is also children with dental fear and anxiety may present with behavioral management problems which can disrupt the provision of dental treatment and negatively impact on the dental treatment the child receives. the anxiety experienced by children is not only distressing for the child, but it can also be a potentially stressful and upsetting experience for their parents . a good patient-dentist relationship is crucial for the management of anxiety. it is the responsibility of pedodontists to make dentistry as child-friendly and pain-free as possible to bring about positive changes in the behavior of children during dental treatment . tell-show-do technique is widely used for managing pediatric dental patients. it is useful for almost all patients who can communicate, especially those patients who are 'monitors. although widely used, the ability of this technique to prepare, and reduce child anxiety remains an area for research, because it's not always appropriate for those patients who are 'blunters' where detailed information can result in increased levels of anxiety . so different modifications of this technique were used one of them is tell play do technique with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one. tell play do technique provides a better explanatory concept of the dental procedure and can lead to more cooperation of the children patients which can influence the dental treatment in a good and positive way.

Eligibility criteria:
inclusion criteria: 1. children with frankl's behavior rating score of 1,2 . 2. patients with no previous dental experience. 3. patients not suffering from cognitive or mental problems. 4. children with primary molars indicated for extraction . 5. age 4- 6 years old . exclusion criteria: 1. medically compromised patients 2. patients suffering from cognitive or mental problems 3. patients with previous dental experience

Keywords: tell show do tell play do dental anxiety child behavior