Kornimate/medical-research-clean huggingface dataset:
radiofrequency ablation versus hemithyroidectomy of small thyroid cancers

Conditions: Thyroid Cancer

Summary: this is a multicenter randomized controlled trial including patients with small (\<2 cm) suspected or confirmed thyroid cancers. patients are included after informed consent and randomized to one of two treatments. one treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (rfa) of the specific tumor. the investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment. the overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. in patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. for participants undergoing surgical treatment with ht, the investigators will measure final histology and both beneficial and adverse outcome from the operation. for participants undergoing rfa, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase qol without a reduction in oncologic safety and outcome.


Eligibility criteria:
inclusion criteria: * single tumor in the thyroid gland with a fnab suspecious of cancer or diagnostic of cancer (category v or vi in the bethesda system) * tumor size of less than 2 cm in all dimensions. exclusion criteria: * suspicion of disseminated disease because of pet-positive lymph nodes ; suspect lymph-nodes by ultrasonography (us); or signs of capsular invasion of the tumor or * tumor not eligible for rfa treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium \> 1.32 mmol/l and pth \> 6 pmol//l ) or * if the patient is pregnant or * if the patient is unable to give informed consent.

Keywords: radiofrequency ablation hemithyroidectomy thyroid cancer differentiated thyroid carcinoma
an observational safety study in zelboraf (vemurafenib)-treated patients with braf-v600 mutation-positive unresectable or metastatic melanoma (zess)

Conditions: Malignant Melanoma

Summary: this multi-center, prospective, observational safety study will evaluate the safety and effectiveness of zelboraf (vemurafenib) in a real world setting. data from zelboraf-treated patients with braf-v600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.


Eligibility criteria:
inclusion criteria: * adult patients of the age of 18 years or older * diagnosis of braf-v600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib * vemurafenib treatment must have been initiated at the time of enrollment or no more than one month prior to enrollment * patient (or legally acceptable representative) has personally signed and dated the informed consent document indicating that he or she has been informed of all pertinent aspects of the study, if applicable * patient is willing to provide information on at least one alternate contact person for study staff to contact regarding the patient's whereabouts, should the patient become lost to follow-up during the course of the study exclusion criteria: * patient was treated with vemurafenib as part of a clinical trial or expanded access program * patient has participated in any studies involving any investigational study drug within one month prior to initiating vemurafenib treatment * patient has any significant history of disease of medical condition (except metastatic melanoma) which in the judgment of the investigator has the potential to impact participation on the study
recurindex predicts risk of recurrence in early-stage luminal breast cancer

Conditions: Breast Cancer; Recurrence

Summary: this study will conduct a multicenter, open, prospective clinical trial to observe the recurindex to assist in predicting the risk of recurrence in patients with early-stage luminal-type breast cancer. the aim of this study is to validate the predictive effect of the recurindex on the risk of recurrence in women with early-stage luminal-type breast cancer in china.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, ≤ 70 years old. * eastern cooperative oncology group (ecog) ≤ 2. * postoperative pathology is clearly diagnosed as invasive breast cancer. * estrogen receptor (er) or progesterone receptor (pr) positive, her2 negative. * available with formalin-fixed and parrffin-embedded (ffpe) tumor tissue. * stage i-ii patients who have received surgery (breast-conserving or mastectomy) and the pathological staging is pt1-2n0-1m0 or pt3n0m0. * the patient had not received systemic systemic treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy) before enrollment. * signed an informed consent form. exclusion criteria: * breast cancer patients whose clinical or pathological stage is t4, n2-3 or m1. * known human immunodeficiency virus infection (hiv) or acquired immunodeficiency syndrome (aids) related diseases. * other psychiatric disorders that may interfere with the judgment of the study results, or abnormal laboratory tests; and who, in the judgment of the investigator, are considered unfit to participate in the study. * patients with double breast cancer. * severe/uncontrolled intercurrent diseases/infections. * subjects with allogeneic organ transplants requiring immunosuppressive therapy. * hormone receptors er and pr are negative (any detectable estrogen and progesterone receptors do not express or express \<1%) and/or her2 overexpression/amplified by fish detection. * not suitable for hormone receptor modulators (e.g. tamoxifen) and adjuvant endocrine other drug therapy.
brazilian prospective hodgkin lymphoma registry

Conditions: Hodgkin Lymphoma; Hodgkin Disease

Summary: the study is a prospective registry of hodgkin lymphoma (hl) patients in brazil. the purpose of the study is to gather clinical, epidemiologic and outcomes data on the treatment of hl, on the basis of records collected by key brazilian institutions, through a centralized web-based registry of clinical data verified by central board of hematopathologists.

hodgkin lymphoma is considered one of the malignancies with highest cure rates. its prognosis improved substantially along the last three decades, as a result of relevant cooperative studies carried out in american and european institutions. around 70-80% of the patients are cured with the available chemotherapy regimens. however, data about hl in developing countries are scarce. it is well established that patients in underprivileged societies present with malignancies in more advanced stages. in studies of hl patients treated in brazil during the 80's, most patients presented with advanced disease. the creation of registry of patients with hl will provide a more reliable picture of the disease in the country, its prevalence in different areas and socioeconomic groups, and treatment outcomes. it will also foster the establishment of a network among hospitals in all regions of the country, which may serve as a platform for further development of cooperative studies engaging the main brazilian institutions. the data collection allows comparison of data entered into the registry against predefined rules for range or consistency with other data fields in the registry. also, quality assurance addresses data validation and data analysis. standard descriptive analyses will be carried out. for a crude association analysis, categorical data will be analysed using the chi-square or fisher's exact test (two-sided). survival curves will be estimated using the kaplan-meier method and compare using the log-rank test. univariate and multivariate cox regression analyses will be conducted to verify the prognostic factors regarding progression free survival and overall survival, adjusted for relevant prognostic clinical variables and treatment.

Eligibility criteria:
inclusion criteria: * previously untreated hl patients * clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 5 years are requested * written informed consent exclusion criteria: -

Keywords: hodgkin lymphoma hodgkin disease
the mindfulness intervention as myocardial infarction rehabilitation additive (mimira) study

Conditions: Coronary Artery Disease; Depressive Symptoms

Summary: the mindfulness intervention as myocardial infarction rehabilitation additive (mimira) study aimed at studying the feasibility and acceptability of mindfulness based stress reduction - an 8 week course in meditation and yoga - in patients with a recent coronary artery event and elevated depressive symptoms. to address these questions patients with elevated scores on a depression scale were invited to participate in mbsr, and there evaluation of the course as well as a panel of psychological risk factors and resources was measured.

depressive symptomatology in patients with coronary artery disease (cad) has prognostic importance. yet, psychological interventions in clinical practice are scarce. here, we explored the feasibility and acceptability of mindfulness-based stress reduction (mbsr) in patients with depressive symptoms after a recent coronary event. a second aim was to investigate psychological risk factors and resources among participants. to address the research questions, depressive symptoms were first measured in a reference population, at 1 and 12 months after a coronary event (myocardial infarction or unstable angina pectoris), and a cut-off for elevated depressive symptoms were obtained from the median in this group. thereafter, similar cad patients with elevated depressive symptoms (above median in the reference group), from the same outpatient clinic, were consecutively invited to an 8-week mbsr program. serious physical or psychiatric illness that would be an obstacle to participation were exclusion criteria. patients who completed the mbsr-course were asked to evaluate its various facets, and completion rate and attendance were feasibility outcomes. psychological variables were measured before, after the course as well as 12 months later.

Eligibility criteria:
inclusion criteria: 1. recent (within 12 month) first time coronary artery event; defined as a diagnosis of myocardial infarction or unstable angina pectoris addressed with either percutaneous coronary intervention (pci) or coronary artery by-pass graft surgery (cabg). 2. depressive symptoms above a score of 8 on the questionnaire centre for epidemiological studies depression scale (ces-d). 3. interest for participation in mbsr. exclusion criteria: 1. major depression or other serious psychiatric illness (such as psychosis or ongoing life crisis). 2. severe comorbidities, such as cancer, severe cognitive impairment and alcohol or drug abuse. 3. practical hindrances for participation in mbsr.

Keywords: mindfulness based stress reduction depressive symptoms coronary artery disease mastery
korea post marketing surveillance (pms) study of talzenna®

Conditions: Breast Neoplasms

Summary: talzenna will be approved for the treatment of gbrca advanced breast cancer in korea. in accordance with the standards for re-examination of new drug, it is required to conduct a pms. post marketing surveillance is required to determine any problems or questions associated with talzenna after marketing in korea, with regard to the following clauses under conditions of general clinical practice. therefore, through this study, effectiveness and safety of talzenna will be observed.


Eligibility criteria:
inclusion criteria: 1. patient scheduled to start treatment with talzenna® based on the clinical judgment of their treating physician as specified in the korean-prescribing information (local label) 2. evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: 1. patients with known hypersensitivity to talzenna®, or to any of the excipients. 2. breastfeeding 3. any patients (or a legally acceptable representative) who does not agree that pfizer and companies working with pfizer use his/her information.

Keywords: gbrca
evaluation of osteopathic protocol on rachialgia

Conditions: Spine Injuries and Disorders

Summary: rachialgia are among the most common reasons for consultation with the general practitioner in europe. most of the guidelines recommend spinal manipulation. this study attempts to propose a solution with 2 parts: tests of induced pain that have a greater sensitivity than palpatory tests of movements and a comprehensive musculoskeletal treatment protocol. the aim of this study is to evaluate the osteopathic protocol in 2 sessions (po2).

rachialgia, whether it is cervicalgia, chest pain or low back pain, are among the most common reasons for consultation with the general practitioner in europe. in 2018, the therapeutic strategies for non-specific acute and subacute spine are diverse based on country clinical practice guidelines. recommendations are rest or maintenance of normal activity, medications, surgery, psychological support, physiotherapy, acupuncture and manipulations. most of the guidelines, notably from germany, belgium, france, england and the united states, recommend spinal manipulation. in general, it can be recommended alone, or accompanied by usual care, or integrated into a multimodal treatment program. may be recommended in acute, chronic or not recommended. the strength of osteopathy is that it tries to understand the musculoskeletal balance as a whole. however, the differences in recommendations can be explained by the weaknesses of osteopathy, which are related to a technical and methodological problem. the first technical problem is at the level of osteopathic clinical examination. while much of this clinical examination is based on palpatory tests, there is evidence that these range of motion palpatory tests have low sensitivity regardless of the examiner's experience. the second methodological problem is the use of protocols. this study attempts to propose a solution to these two problems: by proposing for the clinical examination tests of induced pain that have a greater sensitivity than palpatory tests of movements, and a comprehensive musculoskeletal treatment protocol that should allow the study to be both reliable and valid in order to be true to osteopathic values and to accept the evidence based medicine methodological evaluation model. the aim of this study is to evaluate the osteopathic protocol in 2 sessions (po2).

Eligibility criteria:
inclusion criteria: * patients with acute or subacute cervico-dorsalgia or lumbo-dorsalgia (less than 3 months) * patients who gave their informed consent to participate in this study. exclusion criteria: * patients whose specific spine is caused by inflammatory, tumor, infectious disease or back trauma in the past 3 months * patients with a history of back surgery and/or vertebral fracture in the past 6 months * patients with a motor disability related to the reason for consultation * pregnant women over six months. * patients not communicating or unable to understand the course of the study.

Keywords: osteopathic pain spine
c-reactive protein (crp) in obese diabetic women

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether treatment with rosuvastatin for 6 months in obese type 2 diabetic women will improve their lipid profiles and thus prevent the progression to cardiovascular disease.


Eligibility criteria:
inclusion criteria: * menopausal * diagnosed diabetes mellitus type 2 * obese (body mass index \[bmi\] \> 25 ≤ 30) exclusion criteria: * fasting blood glucose ≥ 200 mg/dl * crp \ 10 mg/l

Keywords: obesity menopause
pprime: parents views on diagnosis and information-giving in neonatal care (pilot study)

Conditions: Parents of Preterm Infants Born Before 33 Weeks Gestation

Summary: the aim of the pilot study is to explore and identify the issues of concern to parents whose babies have been cared for in a neonatal unit and exposed to imaging, its influence on diagnosis and information-giving process

the aim is to explore the recent experience and views of parents in a qualitative way to assist the development of a questionnaire which can be used with a much larger group of parents. the interview guide with the topics to be covered will include: expectations, concerns and issues relating to the equipment used with their baby, any investigations, including cranial ultrasound and mr imaging and the information provided. the data collected will then inform the development of a standard instrument or questionnaire which will be used with parents participating in a trial using a randomised design to compare the influence of mr and ultrasound-based information on parental perceptions, stress and coping in association with healthcare usage and costs.

Eligibility criteria:
inclusion criteria: * parents of babies born before 33 weeks gestation parents who are 16 years of age or older parents who are able to give informed consent parents who are able to take part in interviews which are conducted in english exclusion criteria: * parents who are under 16 years of age parents who are unable to give informed consent parents who are unable to take part in interviews which are conducted in english parents where there are possible or know child protection issues

Keywords: preterm perinatal ultrasound cerebral palsy anxiety parents
metabonomic of patients with hepatitis b cirrhosis complicated with sarcopenia.

Conditions: Sarcopenia

Summary: sarcopenia is a common complication in liver cirrhosis patients and has been confirmed that associated with poor prognosis. china has the world's largest burden of hepatitis b virus-related liver cirrhosis (hbv-related liver cirrhosis). however, the relationship between hbv-related liver cirrhosis patients with muscle mass loss and normal muscle mass is remain largely unknown. our study aimed to reveal the metabolic profile and identify potential biomarkers of muscle mass loss in hbv-related liver cirrhosis.


Eligibility criteria:
inclusion criteria: 1. the diagnostic criteria for decompensation of liver cirrhosis of chronic viral hepatitis b formulated according to the guidelines for diagnosis and treatment of liver cirrhosis issued by the chinese society of hepatology in 2019 2. the diagnosis of muscle mass loss conforms to smi less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females 3. patients aged between 18 and 60 years old 4. patients with no history of drinking or abstinence for more than 1 year 5. voluntary participants with informed consent exclusion criteria: 1) the etiology of cirrhosis without hepatitis b virus (hbv), such as cirrhosis, alcoholic cirrhosis, autoimmune cirrhosis, and so on; 2) the age of patients over 60 years old; 3) patients with acute, chronic and acute liver failure; 4) other diseases which can lead to the secondary muscle depletion, such as chronic disease in heart, lung, kidney, brain, and malignant tumor; 5) neurodegenerative diseases or muscle degenerative diseases; 6) perioperative patients; 7) patients without ct scan within 3 months; 8) patients who have exercise habits with the physical activity rating scale-3 (pars-3) \> 19 points

Keywords: hepatitis b virus-related liver cirrhosis muscle mass loss metabolites
anti-exercise-fatigue effects of rice protein rp-80ny in men

Conditions: Healthy

Summary: the aim of this study is to investigate the anti-exercise-fatigue effects of rice protein rp-80ny in men

each subject must undergo a maximum oxygen consumption test 1 week before the intervention (day 1), eat the test food for 28 days (day 1 to day 28), following 14 days of wash-out (day 29 to day 42), and undergo second maximum oxygen consumption test (day 43) and another test food intervention (day 43 to day 70). the assays of anthropometric measurement, diet questionnaire survey, grip strength test and fecal collection were carried out before and after the intervention (the 1st ,28th ,43th and 35th day). each subject has to join the wingate anaerobic test (day 21 and day 63), and the endurance exercise test (day 28 and day 70) during the intervention. all of the trial period was 70 days, and the blood samples of the subject will be collected at the times of exercise beginning, 15 min after exercise, the end of exercise, 1 hour after rest, 2 hour after rest ,and 3 hour after rest. during the whole period of participating in the program, blood will be collected 14 times, the blood volume of each times is 10 ml. gas is collected before the period and within 1 hour, 2 hour and 3 hour after exercise (5 minute at a time). after intervention, the exercise time, oxygen intake, blood biochemical value and gut microbiota will be analyzed.

Eligibility criteria:
inclusion criteria: * the subject is a male and aged 20-40. * the subject has a usual exercise habit (exercising 2 times or more per week) and did not participate in professional sports competitions or professional sports training during the study period. * no smoking or drinking habits. * no food allergies and the liver function is normal. * no cardiovascular diseases or other chronic diseases, and no serious illnesses requiring hospitalization during the study period. * the subject can understand the test process described in the consent form and the possible potential risks and benefits, and can sign the consent form. * the subject can accept dietary control during the trial period. exclusion criteria: * those who have taken nutritional supplements containing branched-chain amino acids. * those who cannot complete the wingate anaerobic test and the endurance exercise test. * those who are diagnosed with kidney disease, heart disease, or cancer and are still under active treatment. * have used other drugs, whose pharmacological effects may affect fatigue. * subjects who have systemic infections and require systemic antibiotics.