Kornimate/medical-research-clean huggingface dataset:
personalizing docetaxel dosing in advanced prostate cancer

Conditions: Prostate Cancer

Summary: patients with advanced prostate cancer are often treated with the chemotherapy drug docetaxel. the manufacturers of this drug suggest using the same dose of drug per m² body surface area for all patients. however we know that individuals end up with more or less of the drug circulating in their blood even after they have been given the same dose. a software program (a "dosing tool") has been developed to provide information to doctors on how docetaxel will affect individual patients. the program may help doctors to make informed decisions about exactly how much drug to give to different people. the purpose of the partner study is to gather information from blood tests on patients being treated with docetaxel to help in the further development of the dosing tool. some of these blood tests would have been taken anyway as part of patients' routine treatment. others are extra for this study. apart from the additional blood tests, everyone who enters the study is treated just as they would normally be if they were not taking part in the study.


Eligibility criteria:
inclusion criteria: * diagnosed with metastatic prostate cancer (hormone sensitive or castrate resistant) and histologically confirmed * metastatic at disease onset or relapsed disease * a treatment decision has been made to start a course of docetaxel as part of their standard of care treatment in accordance with the drug's label and the treating clinician's judgement * patient has not received a previous cycle of docetaxel within 8 weeks of the date of enrolment * life expectancy \> 12 weeks * participant is willing and able to give informed consent for participation in the study exclusion criteria: - patients with autoimmune disease receiving active treatments participant is unable to give informed consent
duloxetine vs pregabalin for thoracotomy pain

Conditions: Postoperative Pain

Summary: this study investigates the effects of preoperative use of oral combination of duloxetine and pregabalin in comparison with preoperative oral pregabalin only in treatment of acute postoperative and prevention of chronic pain following thoracotomy surgeries.

75 patients, undergoing thoracotomy surgery will be randomly allocated into three equal groups, each (n=25 ), using computerized generated random tables: group p: will receive oral pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day. group d:will receive oral duloxetine 30mg two hour preoperatively ...will be continued for one week once per day after breakfast . group c: will receive single dose of pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week. the total amount of morphine consumption in the first 24 hours postoperatively, total amount of intraoperative fentanyl will be recorded, change in hemodynamics ((heart rate and mean arterial blood pressure), respiratory rate and oxygen saturation will be monitored and recorded at 0,2, 4, 8, 12 ,16 \&24 hours and visual analogue scale at 0, 2,4, 8, 12, 16 \&24 hours postoperatively then at 3rd, 5th days, 4th week and12th week will be measured.

Eligibility criteria:
inclusion criteria: * ● physical status asa ii, iii. * age ≥ 18 and ≤ 65 years. * body mass index (bmi): \> 20 kg/m2 and \< 40 kg/m2. * cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or metastatectomy from the lung. * patient is able to provide a written informed consent. exclusion criteria: * ● patients with known sensitivity or contraindication to drug used in the study * history of psychological disorders and/or chronic pain. * previous administration of antidepressants, anticonvulsants, or opioids before surgery. * patient refusal. * severe respiratory or cardiac disorders. * advanced liver or kidney disease.
use of a novel synbiotic to change human gut bacteria and improve health in obese adults

Conditions: Intestinal Microbiota and Barrier Function

Summary: this study evaluates the effect of a dietary supplement to improve gut health. the participants will take one of six dietary treatments for three weeks, and the gut bacteria and the gut intestinal barrier will be assessed to determine if these dietary treatments beneficially change these markers of gut health.

in this study, we intend to test the ecological and therapeutic functionality of a synbiotic combination of a bifidobacterium adolescentis strain and the prebiotic galactooligosaccharide (gos) in a human clinical trial. the synbiotic combination was selected based on a novel in vivo selection; specifically, the strain (bd1) is an human autochthonous gut organism that was enriched in an individual by gos. our experiments will test the efficacy of this synbiotic compared to a conventional synbiotic. we hypothesize this rationally selected synbiotic will improve intestinal barrier function in obese adult subjects, thereby preventing endotoxemia and metabolic inflammation, physiologically relevant functions that are increased in obese individuals. our objectives are to: (1) compare the ability of the test and control synbiotic preparations to alter the gut microbiota in obese individuals; (2) test if gos supports colonization and metabolic activity of test and control strains in the human gut; (3) compare the ability of the two synbiotic preparations to improve intestinal permeability and endotoxemia in obese subjects; and (4) assess associations between the gut microbiota and the test strain with biomarkers for translocation and endotoxemia.

Eligibility criteria:
inclusion criteria: * 18-65 yrs, obese (30 kg/m2 and greater) exclusion criteria: * (1) prior intestinal resection, (2) patient history of gi diseases except for hiatal hernia, gerd, hemorrhoids, (3) severe renal disease defined by creatinine more than twice normal, (4) markedly abnormal liver function defined by alt/ast over 4 times normal levels or elevated bilirubin (5) antibiotic use within the last 12 weeks prior to enrollment, (6) lean or overweight (bmi \ 2 drinks for men, 1 drink for women daily), (10) presence of uncontrolled chronic metabolic disease (cardiovascular disease, insulin requiring diabetes or uncontrolled diabetes, cancer, etc, (11) a plan to have a major change in dietary habit during the following 6 months, (12) consumption of probiotics, prebiotics or synbiotics without an appropriate 4 week washout period, (13) lactose intolerance or malabsorption; (14) subjects younger than 18 or older than 65, (15) unwillingness to consent to the study.
pragmatic randomized control trial of telehealth vs standard care in follow-up of patients with chronic conditions

Conditions: Chronic Disease; Diabetes; Vascular Diseases; Chronic Lung Disease; Cancer; Psychiatric Disorder

Summary: the norwegian health authorities has initiated a three-year trial of telehealth solutions as part of the treatment of patients with chronic illness in the period 2018-2021. within the trial, telehealth indicates that patients are followed-up outside health-care facilities using information and communication technologies (icts). patients who are followed up using telehealth solutions can answer questions about their own health and/or perform measurements related to their health (e.g. blood pressure, blood glucose, oxygen measurement, weight) via a tablet according to a personalized schedule. the measurement values are transferred from the measuring devices to a tablet so that the users can easily see them and track their results over time. the results are also transmitted digitally to a follow-up service, a healthcare center with nurses, who contacts the patient when needed. the follow-up service provides medical support and guidance based on the patient's needs and planned follow-up, and will, in consultation with the user, evaluate whether the user should contact the general practitioner (gp) or emergency room. the study population of the trial includes users with comprehensive medical needs, with medium to high risk of worsening of their condition, hospitalization or increased need for health and care services. the evaluation includes three main parts: 1) an effect evaluation which is designed as a randomized control trial, 2) a cost-benefit analysis, and 3) a process evaluation which aims to provide recommendations for how to organize and implement telemedicine in clinical practice. the primary outcomes include physical and mental health state, patient experience and use of health services. the effect evaluation is designed as a pragmatic open label multi-center randomized control trial, with two parallel arms with 300 patients in each arm. patients are recruited between february 2019 and june 2020.


Eligibility criteria:
inclusion criteria: * the patient has a considerable disease burden and comprehensive medical needs * the patient has a chronic disease * the patient has medium to high risk of worsening of their condition, hospitalization or increased need for health and care services * the patient has a high consumption of healthcare services * the patient has a reduced level of function * the patient is motivated to use telehealth solutions * the patient is likely to benefit from the use of telehealth solutions exclusion criteria: * the patient is not competent to consent * the patient is unable to handle the tablet and the measuring equipment to be used * the patient has a substance abuse

Keywords: telemedicine telehealth randomized control trial chronic disease health services research primary health care primary care nursing
prevalence of cardiac amyloidosis among patients with a history of lumbar spinal stenosis.

Conditions: Cardiac Amyloidosis; Spinal Stenosis

Summary: the study investigates the prevalence of cardiac amyloidosis among patients with a history of lumbar spinal stenosis within the last ten years in the region of central denmark.


Eligibility criteria:
inclusion criteria: * history of lumbar spinal stenosis. * age \> 60 years at the time of spinal stenosis surgery. * written informed consent. exclusion criteria: * known amyloidosis * myelomatosis * monoclonal gammopathy of unknown origin, mgus * morbus waldenstrøm
radiological findings in primary intestinal ischaemia

Conditions: Acute Intestinal Ischemia

Summary: to investigate which findings on a non-specific ct scan that predict acute primary intestinal ischaemia.

48 patients with primary intestinal ischemia admitted in 4 consecutive years (2006-2009) in department of gastrointestinal surgery, aalborg university hospital. control group consists of 82 patients operated in the same department and in the same time range. abdominal ct scans are described with respect to intestinal diameter, changes in intestinal wall, extra intestinal changes and vessel pathology.

Eligibility criteria:
inclusion criteria: * primary acute intestinal ischaemia in an abdominal operation. * ct-scan within 48 hours preoperative. exclusion criteria: * secondary intestinal ischaemia * intestinal ischaemia isolated intestinal mucosa. * no ct-scan within 48 hours preoperative

Keywords: diagnoses disease
safety of viracept® 625mg administered to hiv-infected women during pregnancy

Conditions: HIV Infection

Summary: this study is an evaluation of the safety of 625 mg formulation when administered to hiv-infected pregnant women from their second trimester through six weeks postpartum. the study will also evaluate the pharmacokinetics of viracept


Eligibility criteria:
inclusion criteria: * hiv infection * second trimester of pregnancy exclusion criteria: * major current or prior history of obstetrical complications * serious current medical diseases * evidence of hiv virus resistance to antiretroviral agents

Keywords: non-randomized open-label single-arm study of nelfinavir plus combivir in pregnant females infected with hiv-1 virus.
primary connections for youth and families

Conditions: Substance Use

Summary: the goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment to a in primary care settings. primary outcomes (aod use, co-occurring behavior problems, parent-youth communication about aod use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up.

this randomized effectiveness trial compares a standard adolescent-only approach (sbirt-a-standard) versus a family-based approach (sbirt-a-family) in which caregivers are systematically included in screening, intervention, and referral activities. the study includes n = 2,300 adolescents (age 12 - 17) and their caregivers attending one of three hospital-affiliated pediatric settings serving diverse patients in major urban areas. study recruitment, initial screening, randomization, and all sbirt-a activities occur during a single pediatric visit. sbirt-a procedures are delivered primarily in digital format on hand-held tablets using both patient-facing and provider-facing programming. primary outcomes (aod use, co-occurring behavior problems, parent-youth communication about aod use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up. the study is well powered to conduct all planned main and moderator (age, sex, race/ethnicity, youth aod risk status) analyses.

Eligibility criteria:
inclusion criteria: * youth aged 12-17 years with a primary caregiver (i.e., parental figure) also in attendance to primary care appointment * youth and caregiver are fluent in english or spanish * youth and caregiver are capable of using audio-assisted informed consent procedures and independently operating a hand-held tablet device * youth and caregiver are complete routine site aod risk screening questions prompted during pc visit intake

Keywords: adolescent substance use pediatric primary care screening brief intervention referral to treatment family-based
human papillomavirus and oropharynx carcinoma

Conditions: Oropharyngeal Neoplasms

Summary: high risk papillomavirus (hr-hpv) have an oncogenic role in oropharyngeal squamous cell carcinomas (op-scc) in at least 25% of the cases and the prevalence is increasing. hpv+ might be more chemo and radio sensible with a better prognosis (disease-free survival (dfs) and overall survival (os) as compared to hpv negative op-scc ; hypothesis : 2y dfs \> 20% improvement). the principal objective is to determine the impact of the status of hr-hpv in the prognosis of the op-scc. the principal criteria is the 2-years dfs. secondary objective : virologic characteristics of hpv+ tumors.

the study has no impact on the treatment of the observed population. the clinical study include tnm status, previous story of hpv infection, smoking and alcoholic habits, treatment and outcome during 5 years. the virologic study include : hpv type, e6-e7 viral charge of hpv16, viral dna integration in the tumoral genome, hpv16 variants, expression of hpv 16, 18, 31, 45 coding oncoproteins e6-e7 mrna. moreover a serologic study will be done.

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of oropharynx proven histologically * all stages tnm * informed consent * no previous or simultaneous head neck cancer * age \>18 exclusion criteria: * squamous cell carcinoma other than oropharynx * 2nd synchronous scc localization * no consent * age \< 18

Keywords: squamous cell carcinoma of oropharynx human papillomavirus. biological prognostic markers.
value of additional corpus biopsy for diagnosis of h pylori in atrophic gastritis. prospective non-randomized study

Conditions: Helicobacter Pylori; Gastric Antrum; CORPUS BIOPSIES

Summary: there are controversies about the best sites -biopsy based -tests for h pylori associated gastritis. the study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

. the study is designed to evaluate the optimal site of gastric mucosal biopsy for identification of helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia. 400 patients with dyspepsia are planned to be enrolled in this study. in addition to the routine antral biospy, corpus biospies are taken to evaluate the optimal site of gastric mucosal biopsy for identification of helicobacter pylori, especially in case of gastric atrophy and/or intestinal metaplasia.

Eligibility criteria:
inclusion criteria: * patients included in this study are those with peptic ulcer disease, previous upper gastrointestinal surgery, a known or a suspected past history of h.pylori eradication therapy, a personal or first-degree family history of gastric cancer exclusion criteria: * those having received antibiotic or proton pump inhibitor treatment one month beforehand
study of statin for reduction of postoperative paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the study will select all recruited patients with paroxysmal atrial fibrillation will be randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before ablation and last for 3 months. to observe the early relapse of atrial fibrillation and the changes of white blood cell count, hs-c reactive protein (crp), interleukin (il)-6 and tumor necrosis factor (tnf)-α, and the changes of safety indicators . this study assumes that the early atrial fibrillation (af) recurrence will be decreased in patients with paroxysmal af if rosuvastatin 20mg/d is received from 7 days before surgery in these patients who plan to undergo radiofrequency catheter ablation for consecutive 3 months.

this study is a randomized, open-label, multi-centers, parallel-control study to explore whether rosuvastatin 20mg/d could decrease early af recurrence in patients with paroxysmal af after radiofrequency catheter ablation. 346 patients with paroxysmal af are planned to be enrolled. the patients are randomized to receive oral rosuvastatin 20mg/d or control therapy from 7 days before operation and last for 3 months. the early af recurrence within 90 days after ablation and the changes of 4 inflammatory markers including white blood cell count, hs-crp, il-6 and tnf-α and safety indicators will be observed. the study is aim to evaluate the efficacy and safety of rosuvastatin on decreasing early recurrence in patients with paroxysmal af and discuss its mechanisms of action.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures; 2. age from 18 to 75 years old, male or female; 3. the course of paroxysmal af is more than 3 months and confirmed by ecg; 4. plan to undergo radiofrequency catheter ablation exclusion criteria: 1. concomitant with serious organic heart disease such as valvular heart diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardial infarction and unstable angina pectoris; 2. concomitant with sinoatrial node functional disorder and (or) atrioventricular block; 3. acute cerebral apoplexy or contraindication of anticoagulant; 4. thyroid function abnormality; 5. accepted radiofrequency catheter ablation (rfca) previously; 6. being receiving other statins; 7. be allergic to statins; 8. pregnancy or women during lactation period; 9. be not aligning to treatment or follow-up due to mental disorders or other reasons; 10. be with myopathy or active hepatopathy including agnogenic persistent elevation of serum transaminase and any serum transaminase being over 3 times of upper limit of normal; 11. be with serious renal dysfunction (creatinine≥3 mg/dl); 12. need steroid or non-steroid anti-inflammatory drugs to treat inflammation.

Keywords: atrial fibrillation statin radiofrequency ablation
efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin

Conditions: Cardiovascular Diseases

Summary: this study is a multicenter, randomized, open-label, parallel, phase iv trial. the purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.

the study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy. after enrollment, subjects are randomized into two groups in a 1:1 manner. the combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily. the subjects in the intensive statin group will receive rosuvastatin 20 mg once daily. subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects. the primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.

Eligibility criteria:
inclusion criteria: 1. aged between 19 and 75 years 2. presence of atherosclerotic cardiovascular disease coronary artery disease * history of acute coronary syndrome * stable or unstable angina * history of coronary revascularization stroke or tia peripheral arterial disease, history of peripheral arterial revascularization 3. patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization 4. patients who gave informed consent exclusion criteria: 1. patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months 2. a serum triglyceride on fasting \>400 mg/dl 3. a history of muscular symptoms or rhabdomyolysis due to the use of statin 4. hypersensitivity to rosuvastatin or ezetimibe 5. labeled contraindications to rosuvastatin or rosuvastatin severe renal impairment (crcl \<30 ml/min by cockcroft-gault formula or estimated gfr \<30 ml/min / 1.73 m2 by mdrd equation) alt, ast ≥3 × uln or active liver disease cpk ≥3 × uln 6. enrollment of other clinical trials within 30 days 7. any other issues that the treating physician assumes ineligible for participation in the trial