Kornimate/medical-research-clean huggingface dataset:
impact of rosuvastatin doses on ldl levels, cpk levels and aspartate aminotransferase levels

Conditions: LDL - Low Density Lipoprotein Receptor Disorder; Rosuvastatin

Summary: particpants were divided into groups based on doses of rosuvastatin and were assessed and for cpk, ldl and ast levels


Eligibility criteria:
inclusion criteria: patients who were already on statins exclusion criteria: hereditary diseases including familial hypercholesterolemia and kidney diseases
effect of arterio-venous ecmo on severe sepsis and ards

Conditions: Patients With Respiratory Failure and Shocked

Summary: to evaluate and compare the effect of immunoadsorption effect of a-v ecmo on course of sepsis weaning from inotropes, weaning from the ventilator, duration of icu stays and effect on mortality rate in patients with septic shock and respiratory failure due to ards followed severe lung contusion.

100 patients with respiratory failure without improvement after 10 days ventilation due to development of vap with ards, had \>2 sofa score and \>6 cpis score included in two groups 50 patients in each. only patients of group b put on a-v ecmo while patients of group a continue on traditional way of management. improvement of ards \&vap, weaning from ventilation, duration of icu stays, improvement of one/all parameters of both sofa and cpis scores, morbidity and mortality recorded and compared within 14 days.

Eligibility criteria:
inclusion criteria: * those who had an age between 18-65 years old * patients ventilated for more than 10 days * with conscious level more than 8/15 on glasgow coma scale exclusion criteria: pediatric patients below 18 years of age
clifutinib food effect study in healthy subjects

Conditions: Acute Myeloid Leukemia in Children

Summary: the purpose of this study is to evaluate to determine the effect of food on the pk of a single dose of 40 mg clifutinib in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy subjects (male or female), age greater than or equal to 18 years and less than or equal to 45 years; * weight ≥50 kg (≥45 kg for female), and have a body mass index (bmi) between 18 and 28 (including 18 and 28) at screening; * physical examination, clinical laboratory examination and other related examinations are normal or acceptable deviations that are judged to be not clinically significant by the investigator; * male or female subjects with child-bearing potential must agree to use effective contraception during the study and within 6 months after the administration of the last dose, and sperm donation is not allowed for male subjects during the study; female subjects must be non-pregnant and non-lactating； * volunteer to participate in this study, understand the study procedures and sign the informed consent prior to any study specific procedures, good compliance and willing to follow study procedures. exclusion criteria: * have a history of or current cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, endocrine, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; * unable to tolerate standard meals; * prolonged qt interval corrected for heart rate using fridericia's formula (qtcf) \>470 ms (female \>480 ms), or history of long qt syndrome； * have received live vaccine(s) within 3 months prior to screening; * have used over-the-counter or prescription medication , including herbal medications, within 14 days prior to dosing and during the study; * have known allergy to any drug or food; * smoking more than 5 cigarettes per day (or equivalent in tobacco or nicotine products) within 3 months prior to screening, or unwilling to abide by smoking restrictions during the study; * any positive result on screening for serum hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibody ,human immunodeficiency virus (hiv) antibody or treponema pallidum antibody; * known history of drug abuse
influence of light exposure on cerebral mao-a in seasonal affective disorder and healthy controls measured by pet

Conditions: Seasonal Affective Disorder

Summary: this study aims to assess differences in monoamine oxidase a (mao-a) distribution in the brain between seasonal affective disorder patients and healthy controls using positron emission tomography. in addition the investigators aim to demonstrate the impact of light therapy on mao-a distribution in addition, a pilot study and a sub-study in healthy controls were performed

this study aims to assess differences in monoamine oxidase a (mao-a) distribution in the brain between seasonal affective disorder patients and healthy controls using positron emission tomography. in addition, the investigators aim to demonstrate the impact of light therapy on mao-a distribution by investigating patients and controls in the winter before bright light therapy, in the winter after bright-light therapy, and in the summer. bright light therapy will be placebo controlled, randomized, and double blinded.

Eligibility criteria:
inclusion criteria for patients: * dsm-iv diagnosis of sad established by diagnostic interview according to the scid. * global seasonality score of 10 or higher on the seasonal pattern assessment questionnaire (spaq) * somatic health based on history, physical examination, ecg, and laboratory screening * aged 18 to 55 years * no therapeutic treatment of sad in the last 6 months (drugs and light therapy) * willingness and competence to complete the informed consent process inclusion criteria for healthy controls: * aged 18 to 55 years * somatic and psychiatric health based on history, physical examination, ecg, laboratory screening, scid * willingness and competence to complete the informed consent process exclusion criteria for patients and healthy controls: * concomitant major medical or neurological illness * concomitant psychiatric disorders * current smoking * ingestion of antidepressants or other psychotropic agents targeting the serotonergic system, within the last 6 months. * bright light therapy within the last 6 months. * current substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to the dsm-iv. * failure to comply with the study protocol or follow the instructions of the investigators. * positive urine pregnancy test. * for participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 20 msv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (allg. strahlenschutzverordnung 2010; www.ris.bka.gv.at).
a trial on efficacy and safety of full dose tenecteplase combined with unfractionated heparin (ufh) or enoxaparin in acute myocardial infarction (ami) in the prehospital setting

Conditions: Myocardial Infarction

Summary: the primary objective of assent 3 plus (the same as for assent 3) was to evaluate the safety and efficacy of full dose tenecteplase combined with unfractionated heparin (ufh, group a) and full dose tenecteplase combined with enoxaparin (enox, group b). an additional objective in assent 3 plus was to describe the different time intervals in the prehospital phase.


Eligibility criteria:
inclusion criteria: * onset of symptoms of ami within six hours prior to randomisation * a 12-lead ecg with one of the following: st-segment elevation ≥ 0.1 millivolt (mv) in two or more limb leads, or ≥ 0.2 mv in two or more contiguous precordial leads indicative of ami, or left bundle-branch block * age ≥ 18 * informed consent received exclusion criteria: * hypertension defined as blood pressure (bp) \> 180/110 mmhg (systolic blood pressure (sbp) 180 mmhg and/or diastolic blood pressure (dbp) \> 110 mmhg) on repeated measurements during current admission prior to randomisation * use of abciximab (reopro ®) or other glycoprotein-iib/iiia antagonists within the preceding seven days * major surgery, biopsy of a parenchymal organ, or significant trauma within two months * any minor head trauma and any other trauma occurring after onset of the current myocardial infarction (mi) * any known history of stroke or transient ischaemic attack or dementia * any known structural damage of the central nervous system * prolonged cardiopulmonary resuscitation (\> 10 min) in the previous two weeks * current oral anticoagulation * standard ufh (heparin sodium) \> 5000 international units (iu), or a subcutaneous (sc) therapeutic dose of any low molecular weight heparin (lmwh) within six hours of randomisation * known thrombocytopenia (prior platelet count below 100 000 cells/μl (100 x 10\*\*9/l)) * known renal insufficiency (prior s-creatinine \> 2.5 mg % (\> 220 μmol/l) for men and 2.0 mg % (\> 175 μmol/l)) for women * pregnancy or lactation, parturition within the previous 30 days. women of childbearing potential had to have a negative pregnancy test, or use a medically accepted method of birth control * treatment with an investigational drug under another study protocol in the past seven days * previous enrolment in this study * known sensitivity to tenecteplase, tissue plasminogen activator (tpa), abciximab, heparin or lmwh * any other condition that the investigator felt would place the patient at increased risk if the investigational therapy was initiated (e.g. known haemorrhagic diathesis, acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, severe hepatic dysfunction, diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions, active peptic ulceration, arterial aneurysm and known arterial/venous malformation, neoplasm with increased bleeding risk) * inability to follow protocol and comply with follow-up requirements
piracetam for treatment of cocaine addiction - 3

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the effects of iv cocaine administration in cocaine dependent subjects maintained on piracetam while they are residing in an inpatient addictions treatment research unit and to subsequently follow these patients in an eight week open label assessment of piracetam in an outpatient treatment program.


Eligibility criteria:
please contact site for information.

Keywords: cocaine
sutent® in the first line treatment of renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with sutent and who did not receive any other systemic therapy before. the aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of sutent. the individual observation period of each patient will be 1 year.

the statistical analysis plan provides detailed specification of the analysis

Eligibility criteria:
inclusion criteria: * first-line treatment in patients with metastatic renal cell carcinoma exclusion criteria: * any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

Keywords: sunitinib kidney diseases urogenital neoplasms kidney cancer
remediation of cognitive dysfunction in euthymic bipolar disorder patients using transcranial direct current stimulation (tdcs)

Conditions: Bipolar Disorder

Summary: this study aims to investigate the potential for transcranial direct current stimulation (tdcs) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tdcs (placebo control) during the performance of two cognitive tasks. the investigators hypothesize that task performance will be improved with active relative to sham tdcs.


Eligibility criteria:
inclusion criteria: * participants will be right-handed subjects aged 18-65 meeting dsm-iv diagnostic criteria for bipolar disorder, with no acute episodes of depression or mania within the previous 12 weeks * a score of ≤ 20 on the madrs, and a score of ≤ 6 on the ymrs, who have been on a stable dose of mood stabiliser medications for at least 1 month. exclusion criteria: * patients with high suicide risk * co-morbid dsm-iv diagnosis of any psychotic disorder (current or within the last year), schizophrenia and schizoaffective disorder * mental retardation * a history of drug or alcohol abuse or dependence within the last 3 months * co-morbid attention deficit hyperactivity disorder (adhd), or any neurological disorder * recent stroke * head injury * history of seizure, or who have had electroconvulsive therapy (ect) within the 6 months preceding enrolment. * participants will also be excluded if currently taking medications known to be associated with frank cognitive impairment (e.g., benzodiazepines).
refining and testing the diagnostic accuracy of pat-pops

Conditions: Pediatric ALL

Summary: increasing attendances by children (aged 0-16 years) at uk emergency departments (eds) is putting pressure on the national health service (nhs). health professionals make complex judgements on whether children attending eds can be sent home safely or require admission. the pennine acute hospitals (pat) paediatric observation priority score (pat-pops) was developed as an ed-specific screening tool for this purpose. a preliminary study showed it to be a potentially effective tool for deciding admission of children from the ed. therefore, the focus of this study is to refine the original screening tool.


Eligibility criteria:
inclusion criteria: * children and young people aged 0-16 years of age who attend the emergency department exclusion criteria: * patients who are confirmed dead on arrival at the emergency department * patients who attend the emergency department in cardio-respiratory arrest
analgesic effect of accelerated repetitive transcranial magnetic stimulation in neuropathic pain

Conditions: Peripheral Neuropathy

Summary: peripheral neuropathy is a frequent condition, commonly associated with pain. repetitive transcranial magnetic stimulation (rtms) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. rtms is usually performed once a day and the whole therapy of neuropathic pain lasts one week. in a number of recent clinical trials including patients with depression and some other disorders, rtms was delivered several times a day, which reduced the time of the whole therapy. this approach was termed an accelerated rtms. the purpose of this study is to investigate feasibility of accelerated rtms in treatment of neuropathic pain.

peripheral neuropathy is a frequent condition, commonly associated with pain, which is often drug resistant. repetitive transcranial magnetic stimulation (rtms) is a noninvasive method of modulation of brain plasticity. in this method, series of magnetic stimuli are delivered to the cerebral cortex, where they turn to electric current and depolarize repetitively the targeted neurons. if the stimulation is repeated during subsequent days it is capable to modify the activity of targeted cortical area for weeks or even months and by this way to achieve therapeutic effect. rtms is most commonly used to treat drug-resistant depression but a number of other psychiatric and neurologic conditions is increasingly being regarded as therapeutic indication for rtms. in patients suffering from neuropathic pain rtms is delivered with high frequency, over primary motor areas (pma). stimulation of pma should result in modulation of thalamic activity, achieved by antidromic excitation of thalamocortical connections. rtms is usually performed once a day and the whole therapy of neuropathic pain lasts one week. in a number of recent clinical trials including patients with depression and some other disorders, rtms was delivered several times a day, which reduced the time of the whole therapy. this approach was termed an accelerated rtms. the purpose of this study is to investigate feasibility of accelerated rtms in treatment of neuropathic pain.

Eligibility criteria:
inclusion criteria: * diagnosis of peripheral neuropathy * neuropathic pain of constant severity since not less than a month and requiring use of analgesics more than once a week * score of 30 millimeter or more on the 100 millimeter visual analog scale of pain intensity at inclusion exclusion criteria: * severe depression * personality disorders and other psychiatric conditions, which could disturb the participation in the study * cognitive deficits, which could disturb the participation in the study * epilepsy * presence of magnetic material in the reach of magnetic field * pregnancy * likelihood to get pregnant * intracranial electrodes

Keywords: peripheral neuropathy neuropathic pain rtms analgesic effect
fast-a study to evaluate the efficacy and safety of quetiapin ir in patients with acute psychosis

Conditions: Psychotic Disorders; Schizophrenia; Bipolar Disorder

Summary: the purpose of this study is to compare the efficacy of quetiapine ir, following rapid titration versus conventional titration in patients with acute psychosis


Eligibility criteria:
inclusion criteria: * provision of written informed consent * male or female, aged 18-65 years * requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode * able to swallow tablets from day 1 exclusion criteria: * in-patients who are anticipated to be discharged before evaluation of the primary outcome variable at day 5 * patients with known relevant clinical disease * history of syncope, or orthostatic hypotension * patients with known neutropenia

Keywords: acute schizophrenia schizoaffective disorder psychosis not otherwise specified (nos) bipolar mania with psychotic symptoms
drug-drug interaction of clomipramine hcl and sildenafil citrate in healthy males

Conditions: Healthy

Summary: the purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of co-administration of clomipramine hcl 15mg and sildenafil citrate 100mg compared to the effects after single oral administration in korean healthy male volunteers.

clomipramine is a dibenzazepine-derivative tricyclic antidepressant (tca) and is a potent inhibitor of serotonin and norepinephrine reuptake. clomipramine may be used in a variety of indications. condencia tab contains low dose of 15mg of clomipramine hcl as an active ingredient, which is newly approved to market for the treatment of premature ejaculation. this study is a prospective, randomised, open-labeled, 6-sequence, 3-period, 3-treatment, crossover, and single-center clinical trial. a total of 30 healthy male volunteers will be enrolled and randomised into one among 6 groups (5 subjects per a group). the safety and pk/pd characteristics of co-administration of clomipramine hcl and sildenafil citrate will be investigated closely compared to the effects after single dose administrations.

Eligibility criteria:
inclusion criteria: * korean healthy males aged between 19 and 65 * body weight between 60kg and 90kg, bmi between 19 and 27 * given informed consent exclusion criteria: * clinically significant medical history and/or concurrent disease * sbp \>=140 mmhg or \ =95 mmhg or \<=50 mmhg * orthostatic hypotension * hypersensitivity to any ingredient of investigational drugs * severe bleeding or blood donation within 8 weeks prior to study participation * alcoholism or drug abuser * smoking more than 0.5 pack-year * persistent alcohol consumption more than 21 units(210g)/week * participation in other investigational clinical trial

Keywords: clomipramine premature ejaculation
robotic surgery in the treatment of deep endometriosis: da vinci vs hugo ras comparison

Conditions: Deep Endometriosis

Summary: the aim is to clarify whether both surgical approaches represent, equivalently, a good treatment for the management of patients with deep endometriosis who are candidates for surgery, or whether there are any differences between the two methods, and, if so, how they differ

numerous studies have shown how surgical excision of deep endometriosis nodules improves pain and quality of life. robotic-assisted laparoscopic surgery has been employed for the treatment of deep endometriosis. while the da vinci system is widely used for the surgical treatment of endometriosis, with good results, the available data regarding the benefits of the hugo ras system, however, are limited, given the recent introduction of this method in gynecology, and particularly in the treatment of endometriosis. the aim of the study is to investigate whether the robotic surgical approach using hugo ras is noninferior to that performed using da vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis

Eligibility criteria:
inclusion criteria: * age between 18 and 55 years; * pelvic ultrasound and/or radiologic (mri/ct scan with rectal insufflation) diagnosis of endometriosis * indication for surgery (symptomatic despite or refractory to medical therapy, and/or with critical bowel stenosis or urinary stenosis, and/or infertile awaiting medically assisted procreation (pma) treatment or with previous failed assisted fertilization attempts); * asa (american society of anesthesiologists physical status classification) class between 1 and 3; * acquisition of consent to undergo surgical treatment; * acquisition of consent for study participation and data processing exclusion criteria: - past or current diagnosis of gynecologic oncologic pathology.

Keywords: endometriosis gynaecology surgery da vinci hugo ras
multistimulation group therapy for alzheimer's disease

Conditions: Alzheimer's Disease

Summary: our previous findings support the notion that group activity program, based on cognitive stimulation, recreational-occupational activities and physical-psychomotor exercises, can lead to an improvement in behavioral aspects for people with alzheimer's disease (ad). the purpose of this study is to clarify the efficacy of a rehabilitation program in outpatients affected by ad in mild to moderate stages.


Eligibility criteria:
inclusion criteria: * diagnosis of possible/probable ad * mild to moderate stage of ad (mmse score of 15 - 24)and cdr score of 1-2 * range years in age (65-85) and in school attendance (5-17) * right handed exclusion criteria: * severe aphasia (token test score \< 20) * severe auditory and/or visual loss * overt severe behavioral disturbances (delusions, hallucinations, agitation) * recent (three month before the mst) introduction or dose modification of the following pharmacological treatments: cholinesterase inhibitor, memantine, antidepressant or antipsychotic drugs.