Kornimate/medical-research-clean huggingface dataset:
efficacy of a natural ingredient on blood pressure

Conditions: Hypertension

Summary: randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade i without pharmacotherapy. the subjects that meet the selection criteria will make a total of five visits to the research laboratory and perform the tests that were pre-established in the protocol. later, a statistical analysis will be carried out with the variables measured in the study to obtain results.


Eligibility criteria:
inclusion criteria: * subjects of both sexes between 18-65 years old. * systolic blood pressure between 120 and 159 mmhg or diastolic blood pressure between 80 and 100 mm hg. taken in basal conditions. * volunteers able to understand the clinical study and willing to comply with the procedures and requirements of the study exclusion criteria: * in pharmacological treatment of arterial hypertension. * subjects with acute diseases. * volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathological conditions or malignant tumor disease that can modify the blood pressure of subjects. * subjected to major surgery in the last 3 months. * subjects who stopped smoking in the last 6 months or who intend to quit during the study. * subjects with allergies or eating disorders. * participation in another study that includes blood extractions or dietary intervention. * pregnant woman. * subjects whose condition does not make them eligible for the study, according to the researcher.
distribution of bacteria in ome after radiotherapy for npc.

Conditions: Otitis Media Effusion; Nasopharyngeal Carcinoma

Summary: to observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.

this study is a prospective, observational clinical study to observe the difference in prognosis of tympanocentesis in different kinds of otitis media effusion (ome), especially ome after radiotherapy for nasopharyngeal carcinoma (npc). a total of 234 patients diagnosed with ome who are given the treatment of tympanocentesis only, including outpatient and inpatient patients, were included in the study. the middle ear effusion collected during the tympanocentesis is sent for bacterial culture. the positive rate of the effusion and the recurrence rate within 24 weeks will be compared in order to figure out whether bacterial infection is an important influencing factor for some kinds of ome in addition to eustachian tube dysfunction, which is acknowledged.

Eligibility criteria:
inclusion criteria: * patients clinical diagnosis of ome or ome after radiotherapy for npc (diagnostic criteria: fluid visible in the middle ear and a type b tympanogram). * patients volunteered to participate in the study and signed the informed consent exclusion criteria: * npc recurrence or other malignant tumor after radiotherapy. * clear diagnosis of eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc. * pregnant and lactating women. * patients with severe underlying diseases or with severe liver and kidney dysfunction. * patients who could not cooperate (including poor hearing and radiation encephalopathy) * patients with other middle ear diseases, such as middle ear cholesteatoma, osteoradionecrosis of temporal bone after radiotherapy, etc. * severe deglutition disorders * cleft palate

Keywords: otitis media effusion nasopharyngeal carcinoma bacteria
prospective assessment of quality of life in patients treated by radiosurgery for brain metastases (pramece-1302)

Conditions: Neoplasm Metastases

Summary: the aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.

the patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. baseline examinations will be done before receiving the treatment during the hospitalisation for the gamma knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. mri's will also be performed every 3 months. in this way, no additional travel or mri will be carried out as part of the study.

Eligibility criteria:
inclusion criteria: * patient with newly diagnosed brain metastases * patient with cancer regardless of the type of primary cancer, with anatomopathological proof * at least, one measurable lesion ≥ 10 mm on the mri t1 gadolinium sequences * number of brain metastases lower or equal to 5 * indication of radiosurgery treatment * age ≥ 18 years old * ecog-ps 0-2 * expected survival \> 3 months * ability to complete self-administered questionnaires. if the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a cra of the neurosurgery department who will outline the questions without making any comment. * a non-opposition form must have been completed by the patient exclusion criteria: * previous cancer (\< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated * previous brain radiotherapy * neurological pathology with cognitive disorders existing before the study * having a contraindication for mri * associated leptomeningeal disease * patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease) * pregnant or breastfeeding woman. the women must not breastfeed for at least 6 months * impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons

Keywords: brain metastases gamma knife radiosurgery quality of life
evaluation of the french version of the peers social skills training program for adolescents with rare neurodevelopmental disorders

Conditions: Neurodevelopmental Disorders; Rare Diseases

Summary: adolescents and young adults with rare neurodevelopmental disorders are at risk of developing psychiatric pathologies during the transition to adulthood. loneliness and lack of social relationships can lead to anxiety and depression in adolescents and young adults with rare neurodevelopmental disorders. anxiety and depression are major risk factors for the transition to psychiatric symptoms in adulthood. the improvement of social skills and the positive evolution of social relationships in adolescents and young adults with rare neurodevelopmental disorders can lead to a reduction in the risk factors for anxiety and depression. it therefore seems essential to evaluate the evolution of social skills in this population of young adults under the care of the social skills program, peers, in france to assess the overall benefit of the program, particularly in this population of young people with rare neurodevelopmental disorders.


Eligibility criteria:
inclusion criteria: * aged between 12 and 30 years, included at the start of the social skills program. * patients with rare neurodevelopmental diseases * patients benefiting from the social skills program * appropriate level of verbal elaboration * patient with a family member or a friend also participating in the social skills program non-inclusion criteria : * opposition of the patient or, if a minor, of his/her parents to participation in the study * patient not psychiatrically stabilized: acute symptoms of anxiety, depression, psychotic disorders. * severe intellectual disability
breast cancer risk reduction: a patient doctor intervention

Conditions: Breast Cancer

Summary: the proposed research combines the scientific advances in breast cancer research with health information technology (it) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. our goal is to implement a tablet-pc (personal computer) based breast cancer risk education (breastcare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action.


Eligibility criteria:
inclusion criteria: 1. patient component: * women who visit the general internal medicine (gim) practices at sfgh and ucsf during the study period * between the ages of 40 and 74 * self-identify as asian american, spanish- and english-speaking latinas, african american, or white * have no history of breast cancer are eligible to participate. 2. physician component: primary care physicians currently practicing at the gim clinics at sfgh and ucsf exclusion criteria: 1. patient component: women whose physicians object to their participation in the study 2. physician component: no exclusion criteria for physicians

Keywords: breast cancer concern, breast cancer risk perception, breast cancer risk
childhood influenza immunisation in general practice invitation trial

Conditions: Influenza, Human

Summary: this study will investigate whether behaviourally informed changes to the invitation process can improve uptake of childhood influenza vaccine by two and three year olds at primary care.

previous research has shown that small changes to routine invitations/reminders to attend local health services informed by behavioural science can be used to increase a desired behaviour (e.g. uptake of health checks, reducing missed appointments). this trial will determine whether an invitation letter, informed by behavioural insights and sent through a central system (child health information system, chis), can increase uptake of childhood flu vaccine in primary care. the trial will take place within the existing national childhood immunisation programme in the participating area in england. randomisation will be clustered at the primary care practice level. outcome data will be anonymised, routinely collected, individual-level influenza vaccine uptake data extracted from chis. for chis data validation purposes, practice-level vaccine uptake data reported through an alternative, routine system will be collected. data will be collected on additional invitations/communications that primary care practices (in both the intervention and control arms) send to their patients. cost data for the centralised letter will also be obtained. the analysis will investigate the main effect of the intervention on uptake of the flu vaccination for all eligible children included in the trial. the model will include primary care practice and clinical commissioning group effects to account for clustering. secondary analysis will investigate the impact of such individual factors as age, immunisation history and socioeconomic status and practice-level factors (e.g. direct communication from practices) on uptake of the flu vaccination.

Eligibility criteria:
inclusion criteria: * 2 years or 3 year olds at 31st august 2016 * registered with a primary care practice in the participating area

Keywords: immunization behavioural insights children
metformin suspension and insulin sensitivity

Conditions: Polycystic Ovary Syndrome

Summary: metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (pcos). to date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension. the purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in pcos patients.

thirty young normal-weight anovulatory pcos women will be enrolled. the diagnosis of pcos will be based on the presence of clinical \[ferriman-gallwey score ≥ 8\] or biochemical hyperandrogenism (serum testosterone levels (\>2 sd above our reference mean values) and chronic anovulation \[serum luteal progesterone (p) below 2 ng/ml)\]. patients will be randomly allocated into two groups (metformin and placebo group) using a computer-software. fifteen pcos patients will be treated with metformin at a dosage of 1700 mg daily (one tablet of 850 mg twice daily; metformin group), whereas other 15 pcos will be treated with placebo tables (one tablet twice daily; placebo group). the duration of the treatment will be 12 months. patients will be instructed to follow their usual diet and physical activity, and to use barrier contraception throughout the study. the length and the frequency of the menstrual cycles, and the adverse experiences (aes) will be reported on a daily diary. each subject will undergo follow-up visits under (at six and 12 months from treatment starting) and after treatment (at six and 12 months from treatment withdrawal). at each follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic, and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp.

Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome (using nih criteria). exclusion criteria: * age \ 30 years; * bmi higher than 25 and lower than 18; * neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses; * hypothyroidism, hyperprolactinemia, cushing's syndrome, and non-classical congenital adrenal hyperplasia; * current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs; * intention to start a diet or a specific program of physical activity.

Keywords: insulin sensitivity insulin-sensitizing drug metformin pcos treatment
the cardiac insufficiency bisoprolol study in japanese patients with chronic heart failure (cibis-j)

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to investigate the non-inferiority of bisoprolol to carvedilol by evaluating tolerability (the probability that administered maintenance dose reaches the maximum will be determined as an indicator) as a primary endpoint when bisoprolol or carvedilol is administered for 48 weeks to japanese chronic heart failure patients. in addition, the safety and efficacy of bisoprolol will be investigated.


Eligibility criteria:
inclusion criteria: as a result of diagnosis and tests before registration, a patient who is considered by an investigator to meet all requirements and to have ability to consent can be enrolled. 1. primary disease: in principle, ischemic heart disease or dilated cardiomyopathy. 2. heart failure patients with 40% or less of left ventricular ejection fraction (lvef) . 3. patients in nyha functional classification class ii, iii, or iv (including a medical history). 4. basic treatment: in principle, patients undergoing treatment with an ace inhibitor (or angiotensin receptor blocker (arb)), a diuretic, a digitalis preparation, etc. 5. patients who had not undergone treatment with a beta-blocker (except eye drops) within 8 weeks before the registration date. 6. age: patients aged 20 to less than 85 on the day of obtaining written informed consent. 7. hospitalized/outpatient: either hospitalized or outpatient status. 8. gender: male or female exclusion criteria: patients who meet any of the following exclusion criteria at the time of registration will be excluded: 1. patients who are considered not to be candidates for administration of bisoprolol or carvedilol. 2. patients who have developed acute myocardial infarction within 8 weeks before the registration day. 3. patients who have history of stroke or serious cerebrovascular accident within 1 year before the registration day. 4. patients with poor prognosis and life-threatening disease, such as malignant tumor, or such medical history within 5 years before the registration day. 5. patients who are scheduled to undergo coronary revascularization (coronary artery bypass grafting; cabg, percutaneous coronary intervention; pci) during the study period. 6. patients who are pregnant, lactating, may become pregnant, or want to become pregnant during the study. 7. patients from whom written informed consent cannot be obtained. 8. patients who are judged by an investigator to be inappropriate for this study for any other reason.
low glycemic index dietary intervention program in nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease

Summary: nonalcoholic fatty liver disease (nafld) is the most common chronic liver disease in affluent countries. it may progress to cirrhosis and liver cancer. at present, there is no approved drug for nafld. although healthy diet and exercise is often recommended, there is little supportive evidence. therefore, the investigators plan to conduct a randomized controlled trial comparing a low glycemic index dietary intervention program and simple lifestyle advice in nafld patients. the primary endpoint is resolution of nafld. non-invasive tests will be used to assess the study subjects. proton-magnetic resonance spectroscopy is used to quantify hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.


Eligibility criteria:
inclusion criteria: * age 18 to 70 years * fatty liver by proton-magnetic resonance spectroscopy, defined as hepatic triglyceride content 5% or above * serum alanine aminotransferase (alt) above 30 u/l in men and 19 u/l in women * informed written consent obtained exclusion criteria: * positive hepatitis b surface antigen, anti-hepatitis c virus antibody, or anti-nuclear antibody titer above 1/160 * alcohol consumption above 30 g per week in men or 20 g per week in women * alanine aminotransferase (alt) above 10 times the upper limit of normal * liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 10e9/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices * evidence of hepatocellular carcinoma * terminal illness or cancer, unless in complete remission for more than 5 years
human insulin nph and insulin aspart in type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in south america. this aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 12 months * treatment with insulin nph * body mass index (bmi) below 30 kg/m2 exclusion criteria: * total daily insulin dose greater than 1.40 iu/kg * treatment with oral antidiabetic drugs (oads)
respiratory outbreak mitigation in long-term care using point-of-care testing

Conditions: Outbreaks

Summary: outbreaks of seasonal respiratory viruses can spread rapidly in long-term care homes. timely results for diagnostic tests remains a challenge for respiratory viruses due to the logistics of using a reference laboratory with delays leading to missed opportunities to implement virus-specific control measures to interrupt transmission resulting in larger outbreaks. use of a point-of-care testing platform is a potential solution that provides faster results, but it is uncertain whether this translates into benefits for long-term care residents. this trial aims to assess whether rapid test results for respiratory pathogens (influenza, covid-19 and respiratory syncytial virus) can impact the number and size of respiratory virus outbreaks in long-term care homes.


Eligibility criteria:
inclusion criteria: - long-term care facility engaged with an ontario health team overseen by sunnybrook health science centre, michael garron hospital or humber river health exclusion criteria: * no signed statement of agreement for study participation * pre-existing use of a point-of-care testing platform

Keywords: respiratory virus outbreaks outbreak mitigation long-term care home
3d sonohysterography vs hysteroscopy: study for the evaluation of intrauterine abnormalities

Conditions: Uterine Diseases

Summary: uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional problems of the female reproductive system. many articles examine the efficacy of diagnostic hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. most of the articles are from the last decade, but the subject has been laid aside in the recent years. antonio simone lagana and his group have found that there is 100% correlation in uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78% correlation when it comes to intrauterine fibroids and polyps. walid el-sherbiny, md and his group have found that there is a significant advantage to three-dimensional sonohysterography over two-dimensional in the diagnosis of uterine cavity diseases. no significant difference was observed, and 97% correlation was found, comparing three-dimensional sonar and hysteroscopy. work rationale is that there is a reason to reconsider the status of the diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement in resolution and three dimensional technologies.

uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional problems of the female reproductive system. many articles examine the efficacy of diagnostic hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. most of the articles are from the last decade, but the subject has been laid aside in the recent years. antonio simone lagana and his group have found that there is 100% correlation in uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78% correlation when it comes to intrauterine fibroids and polyps. walid el-sherbiny, md and his group have found that there is a significant advantage to three-dimensional sonohysterography over two-dimensional in the diagnosis of uterine cavity diseases. no significant difference was observed, and 97% correlation was found, comparing three-dimensional sonar and hysteroscopy. work rationale is that there is a reason to reconsider the status of the diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement in resolution and three dimensional technologies. purpose of the study: comparison of the sensitivity, specificity, and the amount of information between diagnostic hysteroscopy and sonohysterography (two and three-dimensional, in abdominal and vaginal access). the comparison will be will be made immediately after the completion of diagnostic hysteroscopy test, while using liquid drizzled earlier during the hysteroscopy, in order to simulate sonohysterography which is considered less intrusive and is made as part of standard treatment.

Eligibility criteria:
inclusion criteria: * women aged 20 to 70 who were referred by a physician to perform diagnostic hysteroscopy. exclusion criteria: * refusal to sign a consent form