Kornimate/medical-research-clean huggingface dataset:
irbesartan and atenolol in hypertensive heart disease

Conditions: Hypertension

Summary: the renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure. this projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.

we included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h holter registrations, 24h ambulatory blood pressure monitoring monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. all patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm hg. all analyses were performed central in a core laboratory.

Eligibility criteria:
inclusion criteria: * at least 18 ys old * male or female with no child bearing potential * seated blood pressure diastolic 90-115 mm hg * left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women * informed consent exclusion criteria: * coronary artery disease, heart failure or other significant cardiac disorder * cerebrovascular accident within the past 6 months * a seated systolic blood pressure above 200 mm hg * significant renal disease, collagen or vascular disease, or gastrointestinal condition * significant allergy or intolerance to study drug * alcohol or drug abuse * uncontrolled diabetes mellitus

Keywords: hypertension cardiac hypertrophy angiotensin human
the effects of inspiratory pressures on diaphragmatic contraction in people after stroke

Conditions: Stroke

Summary: this is a cross-sectional study to determine the optimal inspiratory muscle training (imt) intensity for stroke survivors. participants will breathe through a pressure threshold inspiratory loading device with varying loads in random order. each imt intensity protocol consists of 10 breaths. during the test, accessory inspiratory muscle activity will be measured with surface electromyography (semg) and diaphragm thickness will be used to assessed with ultrasonography. repeated-measures anova will be used for statistical analysis to determine the most effective training intensity for future study.


Eligibility criteria:
recruitment of participants after a stroke: the inclusion criteria are: * clinical diagnosis of ischemic and/or hemorrhagic stroke. * age ≥ 18 years. * duration of stroke ranges from 1 month to 12 months after diagnosis. * had no facial palsy, which could prevent proper labial occlusion. * had not undergone thoracic or abdominal surgery. * could understand and follow the verbal instruction. * stable cardiac conditions. * no previous history of respiratory problems. the exclusion criteria are: * acute myocardial infarction or acute heart failure. * acute pain on chest or abdominal. * with the clinical signs of significant pulmonary disease. * consciousness impaired. * patient with nasal feeding tube, tracheal tube and/or any condition, which prevent the measurement or training. recruitment of healthy participants: the inclusion criteria are: * age ≥ 18 years. * had not undergone thoracic or abdominal surgery. * no previous history of respiratory problems. the exclusion criteria are: * acute myocardial infarction or acute heart failure. * acute pain in the chest or abdominal. * with the clinical signs of significant pulmonary disease. * unstable hypertension, arrhythmias, or unstable cardiovascular conditions, such as fluctuations in blood pressure and heart rate, indicate poor cardiac prognosis or the need for vasopressor medications. * pregnant.

Keywords: stroke diaphragmatic thickening fraction sternocleidomastoid muscles inspiratory pressures
spinal cord compression re-treat study

Conditions: Pain; Radiation Toxicity; Spinal Cord Compression; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine. purpose: this phase ii trial is studying radiation therapy in treating patients with malignant spinal cord compression.

objectives: primary * to determine the efficacy of a biologically effective dose-based re-irradiation strategy, in terms of the response rate (based on the mobility score using the tomita scale where improvement in mobility or stable mobility score will be regarded as a response) in patients with malignant spinal cord compression. secondary * to determine quality of life as assessed by the eortc qlq-c15 pal version 1.0 questionnaire. * to determine the non-spinal radiation-induced toxicity using standard rtog criteria. * to determine the rate of long-term spinal toxicity and radiation-induced myelopathy using the rtog soma morbidity grading system. outline: patients are divided into 2 groups according to the interval since their most recent radiotherapy to the involved area of the spinal cord. * group 1 (\< 6 months since prior radiotherapy): patients undergo radiotherapy for a cumulative biologically effective dose (bed) ≤ 100 gy_2 in addition to receiving other current treatment. * group 2 (≥ 6 months since prior radiotherapy): patients undergo radiotherapy for a cumulative bed ≤ 130 gy_2 in addition to receiving other current treatment. mobility score is assessed and patients complete a quality-of-life assessment at baseline and at each follow-up visit starting at week 5. after completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.

Eligibility criteria:
disease characteristics: * mri-confirmed diagnosis of malignant spinal cord compression * mri of the entire spine performed * histologically proven malignancy * no primary tumors of the spine or vertebral column * undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated) * maximum biologically effective dose received from previous irradiation ≤ 90 gy_2 * deemed not suitable for neurosurgical intervention at the time of initial assessment * patients deemed inoperable are eligible patient characteristics: * karnofsky performance status 40-100% * short life expectancy * no medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study prior concurrent therapy: * see disease characteristics

Keywords: pain radiation toxicity spinal cord compression unspecified adult solid tumor, protocol specific
detection of pseudomonas aeruginosa in the airways of patients with cf

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine if inhaled urea can be used to detect the presence of pseudomonas aeruginosa in the lungs

dose escalation study

Eligibility criteria:
inclusion criteria: * patients with cf aged 18 years and above colonized with p. aeruginosa * normal subjects ages 18 and above without cf or p. aeruginosa exclusion criteria: * for patients and volunteers will include the presence of asthma, allergic rhinitis, pregnancy, a history of gastric or duodenal ulcer, smoking, and a baseline fev1 less than 60% of predicted normal value and a pulmonary exacerbation within the last 2 weeks as defined by use of systemic antibiotic

Keywords: cf
sop's for ckd-mbd-biomarkers

Conditions: Chronic Kidney Diseases

Summary: ckd-mbd (chronic kidney disease - mineral and bone disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency. clinical pictures of peripheral artery occlusive disease (paod), coronary artery disease (cad) and arterial hypertension favours among other main risk factors (smoking, obesity, etc.) additional cardiovascular complications. for this reason it makes sense to monitor these patients regularly. for this purpose the determination of different biomarkers would be appropriate for control of the course of disease. during various studies the biomarkers fgf23, s-klotho, sclerostin, dkk1, bmp2, ykl-40 und mgp were established as indicators for the disease activity, as diagnostic criteria for the existence of ckd-mbd or as risk markers for the incidence of adverse events (incl. death) within the scope of ckd-mbd. for the clinical routine care application of these parameters standard operating procedures (sop) are missing for the determination method relating to optimal pre-analytic and analytic procedures. these analyses are necessary to ensure the reproducibility of study results and to transfer these parameters in the clinical daily routine for risk stratification.


Eligibility criteria:
inclusion criteria: * patients who are regularly (3 times a week) on dialysis in the maria-hilf-clinic or healthy subjects * male or female at the age of at least 18 years * patients who will be admitted to the clinics of the university hospital rwth aachen or of the maria-hilf-clinic mönchengladbach or healthy subjects * written informed consent form * subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel exclusion criteria: * age \< 18 years * subjects who are unwilling or not able to consent * pregnant or lactating women * subject has been committed to an institution by legal or regulatory order * dependency or working relationship with the investigator * participation in a parallel interventional clinical study * hb-value \< 10 g/dl

Keywords: chronic kidney disease - mineral bone disorder (ckd-mbd)
epidemiological study of the covid-19 presto test - the "covidor" study

Conditions: Coronavirus Infection

Summary: the "covidor" epidemiological study. our study would be the first at the community level in orleans métropole, aiming to determine the link between a positive igm level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. it would provide epidemiological surveillance of anti-covid-19 immunity in the community

the metropolitan area of orléans métropole has 6,700 agents divided into 250 different trades and consequently multiple exposures and risks. the global covid-19 pandemic has affected france and the loiret, the sarscov-2 coronavirus, has infected several thousand people. on may 7, 2020, there were 75 deaths at the chro hospital in orleans, excluding ehpad. the contamination rate of the population of the loiret department has been estimated at 5.6% of the population by public health france. this rate is very low and does not allow the use of serological screening tests because of too many false positives or false negatives, there should be a prevalence of the disease greater than 60%. the french health authorities do not recommend the use of a screening test at the present time in view of the uncertainties of the results of this test. the loiret management center, the department and orléans métropole have decided to offer a covid-19 serological screening test, the covid-19 presto test, to voluntary territorial agents regardless of their return to work following the national "deconfinement "on may 11, 2020 this can only be done through an epidemiological surveillance study validated as part of a research protocol.

Eligibility criteria:
inclusion criteria: * all the agents of the 3 local authorities (loire valley region, cctvl and orléans métropole) being voluntary to be tested for the covid-presto® test covid-19 igg / igm rapid test (whole blood / serum / plasma) - cassette * volunteer to get tested exclusion criteria: * opposition to the participation of the study * covid-19 disease

Keywords: covid-19 serology depistage public health voluntary agents
randomised study of concomitant radiochemotherapy in non-small cell lung cancer

Conditions: Non-small Cell Lung Carcinoma

Summary: the purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of non-small cell carcinoma of the lung * initially unresectable non-metastatic stage iii disease * availability for participating in the detailed follow-up of the protocol * presence of an evaluable or measurable lesion * written informed consent * no functional or anatomical contraindication to chest irradiation exclusion criteria: * prior treatment with chemotherapy, radiotherapy or surgery * performance status \< 60 on the karnofsky scale * history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval) * neutrophils \< 2,000/mm³ * platelet cells \< 100,000/mm3 * serum bilirubin \> 1.5 mg/100 ml * hepatic disease contra-indicating the administration of docetaxel and/or got or gpt ≥ 2.5x the normal value and/or alkaline phosphatase ≥ 5x the normal value * serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min * recent myocardial infarction (less than 3 months prior to date of diagnosis) or uncontrolled angina pectoris * congestive cardiac failure or cardiac arrhythmia requiring medical treatment * uncontrolled infectious disease * symptomatic polyneuropathy * auditive impairment contra-indicating cisplatin administration * serious medical or psychological factors which may prevent adherence to the treatment schedule * malignant pleural or pericardial effusion * homolateral supraclavicular lymph node excepting upper lobe lesion * heterolateral supraclavicular lymph node * known hypersensitivity to docetaxel or cisplatin * pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method

Keywords: non-small cell lung carcinoma concomitant radiochemotherapy cisplatin docetaxel radiotherapy chemotherapy unresectable stage iii non-small cell lung carcinoma
cmab vs imab in metastatic prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: to evaluate the efficacy, safety and survival of two treatment regimens: continuous intermittent maximum androgen blockade, using goserelin and bicalutamide in patients with prostate cancer. primary endpoint is time to progression. fifteen patients will be evaluated. qol evaluation is also included.


Eligibility criteria:
inclusion criteria: * histological diagnosis of d2 of adenocarcinoma, * naivety to treatment * valuable bone metastasis exclusion criteria: * hematological, liver or renal toxicity grade iv * severe and active infections
perioperative parameter and treatment outcomes of ecirs in asia

Conditions: Renal Stone

Summary: this is an observational, international, multicenter, cohort study, prospectively collecting clinical data registry on consecutive patients with urinary stone undergoing ecirs.

patients diagnosed with urinary stones and planned for ecirs in different centres will be recruited for the study. this registry collects clinical data on patients with ecirs performed, includes baseline information on demography, symptoms, risk factors, and laboratory variables. treatment information, perioperative outcomes, and follow-up details (up to 3 months after surgery) will also be collected. in summary, it captures patterns of presentation and treatment parameters, as well as perioperative and short-term outcomes of patients managed by ecirs.

Eligibility criteria:
inclusion criteria: * patients with urinary calculi * undergoing endoscopic combined intrarenal surgery (ecirs) * agreed to consent for the study exclusion criteria: * patients who have ecirs for other conditions, such as urothelial cancer etc. * patients who intraoperative record was incomplete. * patients only have either pcnl or ureteroscopy done (not both)
safety and effectiveness of tpa in intra-abdominal abscesses

Conditions: Abscess

Summary: to determine if instillation of tissue plasminogen activator into a percutaneously drained intra-abdominal abscess cavity results in faster resolution of the abscess compared to normal standard of care.

on day 0 subjects will have tissue plasminogen activator injected into a drainage tube and allowed to dwell in the intra-abdominal abscess for one hour before allowing it to drain by gravity. this will be repeated on day 1 and 2.

Eligibility criteria:
inclusion criteria: * intrabdominal abscess exclusion criteria: * hypersensitivity to tpa * recent stroke * uncontrolled htn * recent major hemorrhage * pregnancy

Keywords: tissue plasminogen activator intraabdominal abscess percutaneous drainage
comparision of the effectiveness of physiotherapy methods

Conditions: Cerebral Palsy

Summary: a total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. group 1 received conventional physiotherapy and group 2 received robot-assisted gait training. the treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. the study population was evaluated using range of joint motion evaluation chart, the modified ashworth scale, the gross motor function classification system, the berg balance scale, the functional independence measure for children, and the edinburgh visual gait score

a total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. group 1 received conventional physiotherapy and group 2 received robot-assisted gait training. the treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. the study population was evaluated using range of joint motion evaluation chart, the modified ashworth scale, the gross motor function classification system, the berg balance scale, the functional independence measure for children, and the edinburgh visual gait score.

Eligibility criteria:
inclusion criteria: * aged 4\>, \<16 with cp diagnosis * walking diffculties due to the spasticity of lower extremities, * level i-iv on the gross motor function classification system. exclusion criteria: * mas level iv spasticity, contractures, or rigidity in the lower extremities, * a limb length inequality of \>2 cm, * hypotonic cp, * having drug-related refractory epilepsy, * undergoing intrathecal baclofen pump surgery, * surgical interventions in the lower extremities in the last year, * scoliosis angle of \>30°, * complicated osteoporosis (nontraumatic fracture...), * cardiovascular instability, * gmfcs level v, * metabolic disorder, genetic disease, neurodegenerative and neuromuscular diseases.

Keywords: botulinum-toxin, cerebral-palsy, robot-assisted therapy
psychosocial therapy plus maintenance pharmacotherapy for treating bipolar disorder

Conditions: Bipolar Disorder

Summary: this study will evaluate the effectiveness of interpersonal and social rhythm therapy (ipsrt) versus clinical status and symptom response therapy (cssrt) in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing medication treatment for the disorder.

bipolar disorder is a serious medical illness that causes shifts in a person's mood, energy, and ability to function. these changes are drastic, and can result in damaged relationships, poor job or school performance, and suicide. bipolar disorder is also known as manic-depressive disorder because it is characterized by episodes of mania and depression. some signs and symptoms of a manic episode include the following: increased energy, activity, and restlessness; excessively "high," overly good mood; and extreme irritability. some signs and symptoms of a depressive episode include the following: sad, anxious, or empty mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. bipolar disorder is most effectively treated using a strategy that combines medication and psychosocial treatment. this study will evaluate the effectiveness of ipsrt versus cssrt in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing maintenance medication treatment for the disorder. participants in this open-label study will be randomly assigned to one of two treatment strategies: ipsrt or cssrt. all participants will attend study visits once a week until they have been stable for 4 weeks (acute phase). at this point, they will attend study visits every other week for 12 weeks (continuation phase), and then once a month for 18 months or until another depressive or mixed episode occurs (maintenance phase). participants who experience a recurrence will be treated with medication and the type of therapy they were assigned upon study entry (ipsrt or cssrt). these participants will continue to be followed for a period of time equivalent to their remainder of time in the study had they not experienced a recurrence. outcomes will be measured at week 12 of the continuation phase and week 18 of the maintenance phase.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder * currently in the third episode of mania or major depression * history of one other episode of major depression within 5 years prior to study entry exclusion criteria: * currently in the first episode of mania or schizo-affective disorder (manic type) * rapid cycling drug or alcohol abuse * unstable medical illness * pregnant * index episode caused by medically prescribed drugs

Keywords: manic-depressive psychosis depression, bipolar
phase i study of colchicine therapy in childhood hepatic cirrhosis

Conditions: Cirrhosis; Liver Cirrhosis

Summary: objectives: i. investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.

protocol outline: patients receive colchicine orally twice daily for 24 months. after the first month, the dose of colchicine will increase and remain at that dose for the duration of study. patients are evaluated every 6 months during study.

Eligibility criteria:
* advanced hepatic fibrosis or cirrhosis in children * not pregnant

Keywords: hepatic cirrhosis gastrointestinal disorders rare disease