Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of esn364 in healthy japanese male and pre- and post-menopausal female subjects

Conditions: Healthy Subjects

Summary: the purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of esn364 in healthy japanese male and pre- and post-menopausal female subjects. this study will also evaluate the pharmacokinetics (pk) of esn364 and its metabolite, and the pharmacodynamics (pd) of esn364 after single and multiple oral doses administration in healthy japanese male and pre- and post-menopausal female subjects.

this study consists of two parts. part 1; single dose (sd) and part 2; single and multiple dose (sd and md).

Eligibility criteria:
inclusion criteria: * male subject between 20 to \< 45 years of age, or female subject between 20 to \< 65 years of age. * body weight at screening: ≥ 50.0 kg and \< 80.0 kg for male, ≥ 40.0 kg and \< 70.0 kg for female. * body mass index (bmi) at screening: range of ≥ 17.6 kg/m2 and \< 26.4 kg/m2 \[bmi = body weight (kg) ÷ {body height (m)2}\]. exclusion criteria: * subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 84 days prior to screening. * subject has had previous exposure with esn364. * subject has any clinically significant history of allergic conditions prior to study drug administration. * subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy. * subject has contracted pyretic or symptomatic viral, bacterial, or fungal infection within 7 days prior to hospital admission. * any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ecg at screening or on the day of hospital admission. * subjects who has any significantly abnormal results of laboratory tests at screening or on the day of hospital admission. * subjects who are positive for any of urinary drug abuse test or serology test at screening. * subject took a drug or underwent therapy within 2 weeks prior to hospital admission. * subjects used a drug or underwent therapy that affects sex hormones within 3 months prior to hospital admission. * subjects who had bilateral orchiectomy. * subject has used any inducer of metabolism in the 3 months prior to hospital admission. * subject has a history of smoking more than 10 cigarettes per day within 3 months prior to screening test. * subject consumes, on average, more than approximately 500 mg/day of caffeine * subject has a history of consuming more than 30 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening. * subjects who conducted or is scheduled to conduct any blood donation or blood drawing.

Keywords: asp2693 pharmacodynamics pharmacokinetics esn364 safety
metacognitive therapy for obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder (OCD)

Summary: cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder. however, the majority of treated patients remain symptomatic. the metacognitive therapy by wells (1997) could achieve substantial gains in first pilot studies. the purpose of this study is to investigate this approach with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.

the purpose of this study is to investigate metacognitive therapy by wells (1997) with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.

Eligibility criteria:
inclusion criteria: * primary diagnosis: obsessive-compulsive disorder * german-speaking * agreeing to participate, verified by completion of informed consent * stable medication (at least 4 weeks) exclusion criteria: * current or past diagnosis of substance dependence, psychosis, neurological conditions * mental retardation
multi-catheter high dose rate (hdr) breast brachytherapy

Conditions: Breast Cancer

Summary: breast conservation therapy (bct) is now widely accepted as a treatment option for most women with stage i and ii invasive breast cancer and most patients with ductal carcinoma in situ (dcis). despite superior cosmetic outcome, bct is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. the purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. if this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.


Eligibility criteria:
inclusion criteria: * invasive breast cancer or dcis, tumor stage of tis, t1, t2 if lesion is \< 3 cm, n0 or n1 if 1-3 + nodes with no extracapsular extension
two narrative medicine interventions in type 1 diabetes

Conditions: Type1diabetes

Summary: a randomized prospective study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (problem areas in diabetes questionnaire paid) and illness perception ( illness perception questionnaire ipqr) during a 5 day education course

this randomized prospective pilot study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (problem areas in diabetes questionnaire paid) and illness perception ( illness perception questionnaire ipqr) during a 5 day education course on functional insulin therapy (fit). questionaries at t0 (course day 1 ) and t1 (3 months later). qualitative interviews in a sub group of patients random g1 and g2 subgroup at t1, with a general inductive approach to capture all representations

Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * no french language
osimertinib or docetaxel-bevacizumab as third-line treatment in egfr t790m mutated non-small cell lung cancer

Conditions: Progression Free Survival

Summary: acquired epidermal growth factor receptor (egfr) t790m mutation is the most common genetic change after resistant to first generation egfr tyrosine kinase inhibitor (egfr tki) in non-small cell lung cancer. after a 10 to 14 months median progression-free survival with the treatment of first generation egfr tki, half of patients will get disease progression.for patients progression after treated with first line egfr tki and second line double bullets chemotherapy or chemotherapy then egfr tki, optimal third line therapy is quite critical important for benefit patients' survival. we conducted this study was aimed to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy in patients with local advanced or metastatic non-squamous cell lung cancer.


Eligibility criteria:
inclusion criteria: * local advanced or metastatic non-small cell lung cancer * large cell lung carcinoma or adenocinoma * previously treated by tki-chemotherapy or chemotherapy-tki * egfr t790m positive * no uncontrolled hypertension * no active bleeding or thrombosis in recent 6 months * no previously treated with vegf antibody exclusion criteria: * newly diagnosed thrombosis * anti-coagulation therapy * uncontrolled hypertension * uncontrolled nephropathy

Keywords: osimertinib egfr t790m resistant mutation docetaxel bevacizumab non small cell lung
human centric lighting to improve patient sleep parameters

Conditions: Sleep Disturbance

Summary: human centric lighting (hcl) is a technology that supports the body's circadian rhythm, as it can stimulate the sleep triggering hormone, melatonin, to improve sleep hygiene over standard lighting (sl), and promote recuperative sleep for a timely return-to-duty. in intensive care units, exposure to hcl has improved sleep measures. however, the effect in the medical surgical (ms) environment is unknown. the purpose of this study is to assess the feasibility of study procedures in ms setting and conduct a preliminary evaluation of the effect of light on inpatient sleep. recruitment started november 2020 through april 2021. data analysis is pending.


Eligibility criteria:
inclusion criteria: * patient who is an active duty service member, gs civilian, dependent or retiree affiliated with the army, air force or navy. * patient who is informed by provider or anticipates being admitted for at least two nights. * patient who can read and speak english fluently (since surveys are not translated in any other language). exclusion criteria: * patient with visual impairment which cannot be corrected with glasses or contact lenses such as complete blindness, (defined as inability to see light), or partial blindness (defined as very limited vision) such as patients with history of cataracts. * patient taking an oral medication for sleep. * patient receiving radioactive ionization treatment. * patient who requires isolation or palliative care. * patient recovering from head/neck or oral maxillofacial surgery that would impede saliva sample collection (i.e. jaw wiring, extensive gauze packing in oral cavity) * patient who reports status as a department of defense contractor at screening.
assessing continuous non- invasive blood glucose sensor- physical logic ag

Conditions: Type 1 Diabetes

Summary: the present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.

the non invasive continuous glucose sensing system of physical logic is based on a vector network analyzer (vna), which monitor blood glucose through propriety sensors.dielectric spectroscopy is an analytical technique whereby the electromagnetic radiation is affected by the electric dipole moment of the sample it interacts with. this method utilizes the change in the impedance of the antenna to measure the change in the relaxation processes of the interrogated medium. the vna (vector network analyzer) , which emits non irradiating electromagnetic waves in very low power emission, is connected via standard coaxial cables to propriety sensors that are attached to the patient skin without direct contact. study objective: to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.the glucose values generated by the investigational non invasive devise will be compared to glucose reading of a reference devise, which measure blood glucose levels at the subcutaneous tissue. during the study we will evaluate the reliability of the study device under the conditions of alter blood glucose values in the range of 50-400 mg/dl:

Eligibility criteria:
inclusion criteria: 1. signing an inform consent form 2. type 1 diabetes diagnosed at least 12 months prior to study inclusion 3. age \> 18 years old 4. willing to perform all study related procedures exclusion criteria: 1. known or suspected allergy to the sensor or one of its components 2. psychiatric disorder 3. patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease 4. patients who are not willing or are not capable of performing the protocol requirements 5. participating in another study that includes investigational drug or investigational equipment 6. pregnancy

Keywords: continuous glucose monitoring system non invasive type 1 diabetes dielectric spectroscopy
reducing sedentary behaviour with technology

Conditions: Fatigue; Prostate Cancer; Breast Cancer; Sedentary Behaviour; Physical Activity

Summary: cancer-related fatigue (crf) can be experienced by individuals with prostate cancer (pc), which can have profound effects on their well-being. although physical activity has been shown to improve crf, the recommended levels are generally not met. step count and distance traveled information can help individuals to increase their physical activity. wearable technology (wear) provides the user with feedback of their physical activity which can motivate behaviour change. similarly, education workshops (edu) on the effects of sedentary behaviour and physical activity may also reduce sedentary behaviour. the objectives of this study are to evaluate the effects of wear and edu on sedentary behaviour and crf, and to explore the feasibility of wear in this population. participants in this study will be randomly assigned into wear, edu, wear+edu, or control over a three-month intervention. assessments at baseline, post-intervention and a 3-month follow up will evaluate crf, quality of life and level of sedentary behaviour, and use of wear devices. the results from this study will provide evidence-based knowledge on the impact of wear and edu on sedentary behaviour and crf, and an understanding on the use of technology within the pc population. these results can shape the development of programming for crf and the use of scale-able technology-based interventions/approaches in this population.


Eligibility criteria:
inclusion criteria: * pc survivors aged 18 years or older * currently sedentary, defined as \<90 minutes per week of activity * fluent in english * access to a computer with internet connectivity exclusion criteria: • men who are or have received chemotherapy
colchicine for acute coronary syndromes

Conditions: Acute Coronary Syndrome

Summary: multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. the study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.

multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.

Eligibility criteria:
inclusion criteria: * \>18years * acute coronary syndrome (unstable angina or acute myocardial infarction) * life expectancy\> 2 years * absence of contraindications to colchicine exclusion criteria: * colchicine treatment for any cause * severe liver disease * renal insufficiency with creatinine\>150mmol/l or creatinine clearance\<30ml/min/1.73m2 * known cancer * chronic inflammatory bowel disease * treatment with cyclosporine * allergy or hypersensitivity to colchicine * pregnancy or lactating woman or woman with childbearing potential without valid contraception

Keywords: acute coronary syndrome colchicine
the effect of nebulization of alkaline solution on treating xdrab pneumonia with c/s plus minocycline

Conditions: Pneumonia

Summary: the mortality of pneumonia with extensively drug resistant acinetobacter baumannii (xdrab) is still high, even if these patients received certain strong anti-infection treatment such us the combination of cefoperazone-sulbactam (c/s) and minocycline. health airway lining fluid is mildly alkaline but airway acidification usually appears for the infection of xdrab. the hypothesis is offered that the biologic activity of xdrab might be inhibited if the circumstance including ph is changed. in the vitro study we observed that the inhibit effect of antibiotics on xdrab growth was improved significantly by alkaline solution within the scope of physiology. so the aim of this clinical study is to explore the effects of nebulization of alkaline solution on c/s plus minocycline on the pneumonia with xdrab.

pneumonia patients with xdrab are eligible for this multicenter study, do not meet the exclusion criteria and will sign the informed consent. they will received the anti-infection protocol with cefoperazone/ sulbactam 3.0g（intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h). all enrolled patients were randomly divided into three groups according to the difference in ph value of aerosol inhalation with sodium bicarbonate solution. group one is blank-control and patients will received usual antibiotic treatment without inhalation. the ph value in group two is 7.4 and that in group is 7.8. each time the volume of aerosol solution is 5ml, q8h. the average course of treatment will be two weeks. clinical indexes will be collected including vital signs, pulmonary rales, cough level, expectoration level, sputum color,blood count, arterial blood gas, biochemical parameters, chest x-ray score, apache ii score, clinical pulmonary infection score, ecg, sputum culture, et al.the primary endpoints are pathogenic clearance rate and recovery rate. the secondary end point is adverse reaction rate.

Eligibility criteria:
inclusion criteria: * age: 18 to 75 years old, male or female * the pneumonia patients met the diagnostic criteria, and clinical pulmonary infection score (cpis) ≥ 5; * the sputum bacteriology detection only prompted acinetobacter baumannii culture for pathogens concentration meets the diagnostic criteria of the chinese hospital-acquired pneumonia diagnosis and treatment guidelines, 2002 edition of "acinetobacter baumannii and susceptibility results show only 1 to 2 sensitive to antimicrobial drugs (polymyxin, minocycline or tegafur doxycycline); * cephalosporins or tetracyclines drug treatment without a history of allergies and contraindications; * be able to accept inhalation therapy. * informed consent gained exclusion criteria: * refused to accept inhalation therapy * renal insufficiency, creatinine clearance (cockcroft-gault formula) (clcr) 15 ml / min or less; * liver dysfunction, defined as child-pugh score b or c * within one week before the start of cefoperazone sulbactam, minocycline treatment.

Keywords: extensively drug resistant a. baumannii
phase iv study of the safety and efficacy of everolimus in adult patients with progressive pnet in china

Conditions: Pancreatic Neuroendocrine Tumors

Summary: to evaluate safety and efficacy of everolimus (afinitor®) in chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.

this was an open-label, multicenter, single-arm clinical study to evaluate the safety and efficacy of everolimus in chinese adult patients with locally advanced, unresectable or metastatic, well differentiated progressive pancreatic neuroendocrine tumors. the inclusion and exclusion criteria, as well as the dosing and dose modification criteria are designed according to the approved chinese package insert. the planned sample size of the study was approximately 60 subjects. subjects who were eligible received the treatment with everolimus provided by sponsor to treat pnet and followed the visit schedule in the protocol to collect safety and efficacy data until progression of disease, unacceptable toxicity, death, protocol deviation or other reason that may lead to discontinuation before the end of study. all subjects were followed-up for survival status every 6 months by the investigator until death, lost to follow-up, withdrawal of consent for survival or end of study. the "end of study" is defined as either at least 75% of subjects have completed survival follow up or all subjects discontinued study treatment or the last subject finished 5-year survival follow up, whichever comes first. final analysis was conducted at the end of the study.

Eligibility criteria:
inclusion criteria: * patients must have histological confirmed g1 or g2 pancreatic neuroendocrine tumors(pnets) (who 2010) * patients must have radiological documentation of progression of disease per recist 1.1 within 12 months prior to enrollment. * measurable disease per recist 1.1 criteria using triphasic computed tomography (ct) scan or multiphase mri for radiologic assessment. * everolimus treatment which is recommended by the treating physician exclusion criteria: * hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients. * patient who is unwilling to receive afinitor treatment due to any reason. * pregnant or nursing (lactating) women, * prior therapy with mtor inhibitors (e.g. sirolimus, temsirolimus, everolimus). * use of an investigational drug within the 30 days prior to enrollment
the role of the gp in the management of ambulatory heart failure

Conditions: Heart Failure

Summary: to describe the causes mentioned by general practitioners, explaining the under-treatment of the three main treatments for heart failure with impaired ejection fraction (ars blockers of the type aceinhibitor/ara2/arni, ß- and/or anti-aldosterone).


Eligibility criteria:
inclusion criteria: * patients with a previous diagnosis of heart failure with impaired ejection fraction (lvef \< 40%) * under 85 years of age * admitted to an emergency department for cardiac decompensation * hospitalized following this decompensation * not deceased within one month of hospitalisation * whose sum of the doses of acei or arb2 + bb + aldosterone antagonist is less than 50% of the dose required for this patient\* (definition in annex) * who did not object within one month of being informed exclusion criteria:- patient objecting to the use of their data * patient who is a minor * patient who does not have a general practitioner
e-lombactifs: evaluation of the impact a smartphone application on adherence an exercise program in chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients. adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months. a control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain. the hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.


Eligibility criteria:
inclusion criteria: * adult people * with nonspecific chronic low back pain (according to the definition of the has) * covered under the national health insurance * giving informed written consent to participate in the study exclusion criteria: * patient who do not meet the diagnostic criteria according to the definition of has * behavioral disorders or comprehension difficulties making assessment impossible * patient with a contraindication to physical exercise for medical reasons * patient under guardianship, curatorship or safeguard of justice

Keywords: chronic low back pain physical activity adherence