Kornimate/medical-research-clean huggingface dataset:
comparison in japan t80/a5 (telmisartan 80 mg and amlodipine 5 mg) and t40/a5 (telmisartan 40 mg and amlodipine 5 mg)

Conditions: Hypertension

Summary: blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. therefore in japanese society of hypertension (jsh) 2009 combination therapy is recommended. in jsh 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. in the japanese long-term safety study, 259 patients received the t40/a5 mg fixed-dose combination (fdc), and after 6 weeks treatment 48 patients of them could not control their blood pressure (dbp =90) (u09-2494-01). for those patients who cannot control their blood pressure with t40/a5 mg fdc, a switch to a higher dose such as t80/a5 mg is recommended. in the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between t80/a5 mg free combination and t40/a5 mg free combination was shown (u07-3503-02). but the sponsor has no data that verifies this difference in japanese patients. thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose t80/a5 mg fdc compared with low dose t40/a5 mg fdc in japanese patients with essential hypertension. in this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.


Eligibility criteria:
inclusion criteria: 1. essential hypertensive patients * if already taking antihypertensive drugs, mean seated diastolic blood pressure (dbp) must be \>=90 and \>=114 mmhg * if not taking any antihypertensive drugs, mean seated dbp must be \>=95 and \>=114 mmhg 2. able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion. exclusion criteria: 1. patients taking 3 or more antihypertensive drugs at signing the informed consent form 2. patients with known or suspected secondary hypertension 3. patients with clinically relevant cardiac arrhythmia 4. congestive heart failure with new york heart association (nyha) functional class iii-iv 5. patients with recent cardiovascular events 6. patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form 7. patients with a history of sudden deterioration of renal function with angiotensin ii receptor blockers (arbs) or angiotensin converting enzyme (ace) inhibitors; or patients with post-renal transplant or post-nephrectomy 8. patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with arbs or ace inhibitors 9. patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs 10. patients with hepatic and/or renal dysfunction 11. pre-menopausal women who are nursing or pregnant
impact of ursodeoxycholic acid, silymarin, antioxidants and colchicine on fibrosis regression in hcv after svr

Conditions: Fibrosis, Liver

Summary: with the introduction of direct-acting antiviral agents in the management of hcv, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving svr. the debate about the impact of svr on halting fibrosis progression had risen; some studies postulated that patients benefit from an svr through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving svr and the risk for hcc remains even after virologic eradication.


Eligibility criteria:
inclusion criteria: * chronic hcv * compensated liver disease (child class a-b) * sustained virological response * liver stiffness by fibroscan \>12.5 kpa denotes cirrhosis exclusion criteria: * decompensated liver disease * chronic active hcv * hepatocellular carcinoma * other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease * pregnancy

Keywords: fibrosis hcv reversal sustained virological response
development of diagnostics and treatment of urological cancers

Conditions: Prostate Carcinoma; Kidney Cancer; Urothelial Carcinoma; Testicular Cancer; Penile Cancer

Summary: the purpose of the study is to evaluate whether state-of-the-art technologies such and next generation sequencing and drug sensitivity and resistance testing of patient derived tumour tissue can facilitate research translation and improve outcome of urologic cancers.

access to high-quality clinical patient material (e.g. tissue of primary tumor and metastasis, plasma and urine) linked to comprehensive registry and clinical data and molecular characterization of the patient material using state-of-the-art technologies (e.g. ngs, transcriptomics, imaging, dsrt) will facilitate a more rapid translation of basic research innovations into clinical care (diagnostics, imaging, therapeutics) and result in improved outcome of patients suffering from urologic cancers ("personalized medicine"). the principal aim of the project is to establish a framework and infrastructure for the systematic collection and interpretation of biological patient samples. similarly, the investigators aim to establish the format how the related clinical and research data can be made readily accessible for both clinicians and researchers without compromising patient privacy. the key objectives of the project are to facilitate research translation and to improve outcome of urologic cancers.

Eligibility criteria:
inclusion criteria: 1. the patient is able to provide written informed consent and is at least 18 years of age 2. the patient must have a verified diagnosis of an urologic cancer by a board-certified clinician exclusion criteria: 1. the patient is not willing to provide a written informed consent 2. the patient has a severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent

Keywords: prostate bladder renal ngs dsrt drug screening sequencing personalised medicine
anti-vegf intravitreous injections for diabetic macular edema in patients undergoing cataract surgery

Conditions: Diabetic Macular Edema; Cataract

Summary: the investigators aim to evaluate how different timing of anti-vegf intravitreous injections affect visual acuity (bcva) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-vegf intravitreous affect oct csf thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. diabetic patients, particularly those with diabetic macular edema (dme), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. an increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline dme is reported and this poses a significant challenge in managing concomitant dme and visually-significant cataracts. goals of the study are to evaluate how different timing of anti-vegf intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (bcva) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-vegf intravitreous injections affect oct csf thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Eligibility criteria:
inclusion criteria: adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery exclusion criteria: patients who have undergone panretinal photocoagulation (prp) in prior 4 months or an ocular condition (other than cataract and dme) that might affect visual acuity during course of study. patients with history of vitrectomy. patients with neovascular glaucoma
cytogenetic studies in acute leukemia and multiple myeloma

Conditions: Acute Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Multiple Myeloma

Summary: chromosomal analysis or the study of genetic differences in patients previously untreated with aml, all, mds or mm may be helpful in the diagnosis and classification of disease. it may also improve the ability to predict the course of disease and the selection of therapy. institutions must have either an alliance-approved cytogeneticist or an agreement from an alliance-approved main member cytogenetics laboratory to enroll a patient on calgb 8461. the alliance approved institutional cytogeneticists list is posted on the alliance for clinical trials in oncology website.


Eligibility criteria:
1. patients from adjuncts are eligible if the main member cytogenetics laboratory has agreed to process samples from that adjunct. 2. within one month of registration on calgb 8461, register onto a calgb treatment study for previously untreated aml, all, mds, or mm patients. 3. simultaneously with registration on calgb 8461, register patients within the continental united states onto calgb 9665 (ltb).
deep learning-based artificial intelligence for the diagnosis of small bowel obstruction

Conditions: Bowel Obstruction; Artificial Intelligence

Summary: the study will compare the diagnostic accuracy and time to diagnosis of computed tomography images of patients with suspected intestinal obstruction seen in the emergency room by residents and surgeons, with and without artificial intelligence.

design: this is an diagnostic study. setting: we developed a deep learning-based ai technology to automatically extract the intestinal tract from ct images using 5 200 ct images of 158 patients. the ct images of patients who visited the emergency department and were suspected of small bowel obstruction between june 6 and july 26, 2018, were obtained from two tertiary referral centers, which were used as the test samples. data analysis was completed in december 2023. participants: residents and surgeons participated in the study. interventions: residents and surgeons were divided into two groups: one group read using the ai technology, and the other group read without the ai technology. main outcomes and measures: participants indicated whether or not small bowel obstruction and obstruction location. the time for diagnosis was also collected. we applied a hierarchical bayesian model.

Eligibility criteria:
inclusion criteria: * persons with documented consent exclusion criteria: * persons without documented consent
efficacy of ciclesonide vs fixed combination of fluticasone propionate/salmeterol vs placebo in patients with mild persistent asthma (12 to 75 y) (by9010/m1-132)

Conditions: Asthma

Summary: the aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. the study duration consists of a baseline period (2 weeks) and a treatment period (12 months). the study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * clinical diagnosis of mild persistent asthma * pre-treatment with sabas only * fev1 ≥80% predicted * good health with the exception of asthma main exclusion criteria: * concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * copd (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function * pregnancy * intention to become pregnant during the course of the study * breast feeding * lack of safe contraception * current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years

Keywords: asthma ciclesonide fluticasone propionate salmeterol
cft-focused mental health intervention with exposure training for youngsters

Conditions: Conduct Disorder; Psychopathic Personality Trait

Summary: the aim of this study is to explore if individual cft-based intervention with exposure training in virtual reality decreases conduct disorder symptoms and callous-unemoitonal traits , as well as increases subjective emotional welbeing among 15-to-20 year-old male prisoners and boys placed to state's residential schools. we will also study factors that may predict adherence to the intervention. these factors include mental well-being, motivation, and working alliance. in addition, we will evaluate the costs of the program.


Eligibility criteria:
inclusion criteria: * express conduct disorder psychopathology and psychopathic personality traits * are placed to a prison or a state residential school for at least 9 months exclusion criteria: * females * non-finninsh-speaking * remaining in the institution facility less than 9 months * intellectual dissability * presence of psychotic symptoms * autism * history of epilepsy * currently participating another psychotherapeutic intervention

Keywords: psychotherapy, virtual reality, boys
albumin bound paclitaxel plus s-1 as the first line chemotherapy in advanced or recurrent gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the effectiveness and safety of s-1 plus albumin bound paclitaxel as first-line therapy in the treatment of patients with advanced gastric cancer.

as the first phase ii clinical trial of fluoropyrimidines plus nab-ptx in agc patientsphase ii trial, this study aimed to evaluate the efficacy and safety of s-1 plus nab-ptx as a first-line treatment for patients with metastatic gastric cancer. all patients were orally treated with s-1 in doses of 40 mg (bsa\<1.25 m2), 50 mg (1.25≤bsa\<1.50 m2) and 60 mg (bsa≥1.50 m2) b.i.d. on days 1-14 in combination with nab-ptx (240 mg/m2, divided on days 1 and 8, intravenously for 30 minutes) of each 21-day cycle. treatment was planned for 6 cycles or until progression, unacceptable toxicity, or patient refusal.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease. * male or female. * age ≥ 18. * no previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study). * measurable disease, according to the response evaluation criteria in solid tumours(recist) * ecog performance status 0, 1 or 2 * haematological, biochemical and organ function: neutrophil count \>2.0 × 10 9/l, platelet count \> 100 ×10 9/l. serum bilirubin\ 5 × uln in patients with liver metastases,creatinine clearance \> 60 ml/min. * signed informed consent. exclusion criteria: * prior palliative chemotherapy. * received any investigational drug treatment within 30 days of start of study treatment. * patients with active gastrointestinal bleeding. * other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. * history or clinical evidence of brain metastases. * serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. * pregnancy women. * subjects with reproductive potential not willing to use an effective method of contraception. * patients with known active infection with hiv. * known hypersensitivity to any of the study drugs. * neurological toxicity ≥ grade 2 nci-ctcae.

Keywords: gastric cancer albumin bound paclitaxel s-1 first line
physical activity in men newly diagnosed with prostate cancer: a feasibility study

Conditions: Prostate Cancer

Summary: recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. however, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment. the purpose of this study is to 1. measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and 2. explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe: 1. examine intervention safety and tolerance by self-report 2. examine changes in functional capacity by 6-minute walk test 3. examine changes in symptom experience by self-report


Eligibility criteria:
inclusion criteria: * newly diagnosed with prostate cancer * will not start treatment for at least 2 weeks * able to read and understand english * capable of giving informed consent * at least 18 years old exclusion criteria: * patients who are incompetent for interview (documented diagnosis of active psychosis or dementia) * unable to provide informed consent as assessed by the interviewer * too sick to participate, as judged by a member of the research team or the exercise physiologist * have been treated for another cancer

Keywords: physical activity
french single centre experience of critically ill patients with covid 19

Conditions: Epidemiology; Sars-CoV2; COVID 19; Critical Care; Prognostic; Survival

Summary: since the outbreak of a syndrome of acute respiratory distress associated to a novel coronavirus 2 (sars-cov2) that began in china, europe and france have to face a sanitary emergency with critically care support when the patient evolves to an acute respiratory distress (ards). in the context of supply shortages (ventilators, bed capacities) that countries have to deal with, data were lacking of characteristics and outcomes of patients admitted to intensive care unit (icu). the purpose of this project is to report the epidemiology and the outcomes of a french cohort of critically ill patients with sars-cov2


Eligibility criteria:
inclusion criteria: * 18 years old * patient with positive rrt pcr of sars cov2 on a sample of nasopharyngeal swab * admission in intensive care unit exclusion criteria: * patient under 18 years old

Keywords: epidemiology sars-cov2 covid 19 critical care prognostic survival
aquatic exercise and efficacy enhancement to decrease fall risk in older adults with hip osteoarthritis

Conditions: Arthritis

Summary: the objective of this project is to determine the effect of aquatic exercise and aquatic exercise combined with an education program on decreasing fall risk in older adults with hip osteoarthritis. the hypothesis is that aquatic exercise will improve function, strength and balance and the addition of the education session will enhance confidence in movement.

older adults with hip osteoarthritis (oa) often experience pain and loss of mobility that significantly impairs their ability to walk, climb stairs, shop or participate in exercise programs. this can result in social isolation, depression and loss of confidence in their ability to manage independently in the community. a decline in physical and psycho-social function leads to increased risk of falling. it is crucial to identify high-risk fallers as well as the best interventions to decrease that risk; hip fractures from falls are devastating, resulting in death or admission to long-term care for the majority who sustain them. exercise programs designed to improve balance, strength and mobility can help to improve function and decrease risk of falling. however, individuals with hip oa may have difficulty participating in these programs due to pain. aquatic exercise offers an activity alternative to improve mobility, strength and decrease fall risk. as well, the addition of a group program designed to enhance confidence in movement may further reduce the risk of falls by improving independence to be more active at home and in the community. this project will evaluate the effect of aquatic exercise and aquatic exercise combined with a group educational program on decreasing fall risk in older adults with hip oa. determining optimal fall prevention programs may avert death and loss of quality of life for older adults, clearly an important contribution to preventative health care.

Eligibility criteria:
inclusion criteria: * over age 65 * clinical diagnosis of hip osteoarthritis exclusion criteria: * medical condition tha significantly decreases functional ability such that not safe to exercise in a community program * already exercising in a moderate exercise program 2/week or more

Keywords: older adults, falls, arthritis, aquatic, exercise
randomized evaluation of the 24-hour coverage: efficacy of rotigotine

Conditions: Parkinson's Disease

Summary: the objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic parkinsons´s disease. in addition, effects of rotigotine on specific nocturnal and non-motor symptoms of parkinson´s disease will be evaluated.

the objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic parkinsons´s disease. in addition, effects of rotigotine on specific nocturnal and non-motor symptoms of parkinson´s disease will be evaluated. after a screening period of up to 28 days subjects will be hospitalized for two nights. after the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. afterwards patients will be titrated to their optimal dose. after subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. at the end of maintenance the subjects will be hospitalized for two nights. afterwards the doses will be continuously decreased. efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of parkinsons. safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

Eligibility criteria:
inclusion criteria: * early and advanced idiopathic parkinson disease with early morning motor impairment exclusion criteria: * atypical parkinsonian syndromes

Keywords: rotigotine neupro® parkinson's disease