Kornimate/medical-research-clean huggingface dataset:
a study of ibi362 in chinese patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the efficacy and safety of ibi362 in chinese patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. have type 2 diabetes (t2dm) for ≥6 months according to the criteria for diagnosing type 2 diabetes mellitus (who 1999) 2. t2d patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening. 3. have hba1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening). 4. have a body mass index (bmi) between 20(inclusive) and 40 kilograms per square meter exclusion criteria: 1. type 1 diabetes, special types of diabetes, or gestational diabetes. 2. have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening. 3. history of severe hypoglycemic episodes within 6 months prior to screening. 4. have had any of the following within the last 6 months prior to screening: myocardial infarction (mi), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (tia), cerebrovascular accident or decompensated congestive heart failure, or currently have new york health association class iii or iv heart failure.
rehabilitation for post-covid-19 syndrome through a supervised exercise intervention

Conditions: Covid19; Post-COVID-19 Syndrome

Summary: this is a randomized controlled trial of the efficacy of a tailored exercise program, based on multicomponent exercise training and/or inspiratory muscle training, compared to the who self-management leaflet commonly used in outpatient scenarios, on the recovery of persistent symptoms and functional limitations after covid-19. . the primary objective of the study is to evaluate the clinical efficacy and safety of a tailored exercise-based treatment relative to the control arm in improving the subject clinical status in ambulatory patients.

a fraction \~10% of the covid-19 patients who undergo a variable acute symptomatic phase of the disease are coming forward with continuing effects of the disease over a month, with chronic complaints like mental fog, delayed latent periods in recalling events of recent past, tachycardia, extreme fatigue, inability to perform daily physical tasks and likely to develop stress, depression, irritability, insomnia, fear, confusion, anger and frustration. this condition is defined as post-covid-19 syndrome and increasingly affecting a high number of people as the pandemic evolves. the post-covid-19 syndrome has become a usual situation in the evolutionary course of the disease with its own entity. the national health service (nhs) of uk has recently published a clinical guide for long-term management of the effects of covid-19 with a comprehensive plan for the assessment and care of patients who present or develop symptoms from the fourth week after diagnosis. the effective long-term management of the effects of covid-19 is a challenge that requires awareness. the recove project aims at determining the role of exercise in the treatment of post-covid-19 syndrome ambulatory patients.

Eligibility criteria:
inclusion criteria: * sars-cov-2 diagnosed using real-time reverse transcriptase polymerase chain reaction (pcr) tests or positive for sars-cov-2 virus antigen \>90 days before randomization. * still present a chronic symptomatic phase lasting \>90 days since debut of symptoms * have not been hospitalized * there is no evidence on clinical records of pneumonia or any other organ failure related to sars-cov-2 * non-coincident participation in any intervention trial * capable and willing to provide an informed consent exclusion criteria: * refusal to participate expressed by patient or legally authorized representative if they are present * pregnancy or breast-feeding. * acute heart attack (recent 3-6 months) or unstable angina * uncontrolled atrial or ventricular arrhythmias * aortic dissecting aneurysm * severe aortic stenosis * acute endocarditis / pericarditis * uncontrolled high blood pressure (\>180/100 mmhg) * acute thromboembolism * acute or severe heart failure * acute or severe respiratory failure * uncontrolled acute decompensated diabetes mellitus or low blood sugar * a recent fracture in the last month. * conditions preventing cooperation
a study of adjuvant melanoma stakeholder treatment preferences

Conditions: Melanoma

Summary: the purpose of this study is to understand the trade-offs that participants with surgically treated melanoma would be willing to make among key features and outcomes of adjuvant anti-cancer treatments or no adjuvant treatment / observation.


Eligibility criteria:
inclusion criteria: * self-reported medical diagnosis of stage ii or stage iii melanoma * have been resected (had surgery) for their melanoma within 12 months prior to study participation exclusion criteria: * self-reported stage iia * self-reported recurrence of melanoma after surgery other protocol-defined inclusion/exclusion criteria apply

Keywords: melanoma discrete choice experiment resected melanoma adjuvant treatment patient preference
the debated role of sleep studies in patients under established home mechanical ventilation

Conditions: Hypoventilation Syndrome; Chronic Obstructive Pulmonary Disease; Obesity Hypoventilation Syndrome; Restrictive Lung Disease; Neuromuscular Diseases

Summary: patients suffering chronic hypercapnic respiratory insufficiency (e.g. in chronic obstructive pulmonary disease, obesity hypoventilation syndrome) benefit from home mechanical ventilation. these patients are complex; and the ventilator´s parameters should be set-up according to the underlying disease and particular patient's characteristics. the non-invasive ventilation therapy is mostly titrated while the patient is awake, hence problems, such as patient-ventilator asynchrony, arising while sleeping on the ventilator therapy would remain undetected. sleep studies, such as polysomnography or polygraphy and transcutaneous carbon dioxide monitoring could be valuable tools to fine-tune the ventilator's settings. this could foster the ventilator´s effectivity and patient satisfaction, thus therapy's adherence. nevertheless the sleep studies are expensive, time-consuming and not widely available. the aim of this study is to learn the findings of sleep studies when they are performed on stable patients on home mechanical ventilation as part of their routine check-ups. in this context, it will be assessed whether the sleep studies' findings lead to a change (adjustment) of the ventilator´s therapy. moreover, this study aims to investigate whether the absence of sleep studies would result in missing important events that require an adjustment of therapy. the results of this study could provide information that lead to a more standardized protocol of follow-up checks of patients on home mechanical ventilation in a cost-effective manner.


Eligibility criteria:
inclusion criteria: * patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases) * home mechanical ventilation for ≥ 6 months * stable condition for ≥ 1 month exclusion criteria: * previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months * current respiratory exacerbation * any current comorbidity decompensation * any medical or psychological condition impairing the patient's ability to provide informed consent * missing signed informed consent * total sleep time during polysomnography \<180 min

Keywords: chronic hypoventilation syndrome polysomnography transcutaneous capnometry noninvasive ventilation home mechanical ventilation ventilator´s set-up
this is a non-interventional, study to assess demographic characteristics and patient reported outcomes in china patients with sea treated with benralizumab

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. the study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in china. this study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.


Eligibility criteria:
inclusion criteria -patients are eligible to be included in the study only if all of the following criteria apply: * patients must to be 12 years old (inclusive) at the time of signing the informed consent. * patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician. * blood eos≥150/ul in the 3 months prior to or eos≥300/ul in the 1 year prior to the time of signing the informed consent. * participating patients and/or their legally authorized representative must provide signed and dated written informed consent form prior to any study specific procedures. exclusion criteria -patients should not enter the study if any of the following exclusion criteria are fulfilled: * patients currently participating in any other clinical trial. * known history of allergy or reaction to any component of the study treatment formulation. * malignancy of any kind. * patients with prior or ongoing treatment with benralizumab.

Keywords: copd
to evaluate the safety and efficacy of microwave ablation therapy in patients with primary liver cancer

Conditions: Hepatocellular Carcinoma

Summary: through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer.

the safety and effectiveness of the microwave ablation treatment system produced by suzhou hengrui hongyuan medical technology co., ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. according to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.

Eligibility criteria:
inclusion criteria: * pathological and/or clinical diagnosis confirmed as primary liver cancer (hepatocellular carcinoma). * single tumor with maximum diameter ≤ 5cm ; or tumors number ≤ 3 with maximum diameter ≤ 3cm. * no invasion of blood vessels, gallbladder, adjacent organs and distant metastasis. * child-pugh class a or b classification, or meet the standard after treatment. * able to understand the content of clinical trials, voluntarily participate in the trial and sign informed consent. exclusion criteria: * pregnant or breastfeeding, or preparing to become pregnant during the trial. * participating in clinical trials of other devices or drugs. * uncorrectable coagulation dysfunction (after corrective treatment, the pt exceeds the normal control value by more than 3s). * plt \<50x109/l. * intractable massive ascites. * cachexia. * mri examination is contraindicated or the investigator judges it is not suitable for mri examination. * patients with bleeding from esophageal (fundus of stomach) varicose veins 1 month before surgery. * patients with impaired consciousness or unable to cooperate with treatment. * the investigator judged that it is not suitable to participate in clinical trials.
multicultural healthy diet to reduce cognitive decline

Conditions: Diet Modification; Cognitive Decline; Cognitive Change

Summary: this is a pilot randomized controlled clinical trial is designed to investigate whether the multicultural healthy diet (mhd), an anti-inflammatory diet tailored to a multi-cultural population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in bronx, new york compared to a usual diet.

the multicultural healthy diet (mhd) is a pilot randomized controlled clinical trial designed to test the effects of an 18 month intervention on cognitive function among 290 middle-aged individuals (40-65 yr). mhd is an anti-inflammatory diet tailored to a multicultural population. the emphasis of the intervention is on plant-based foods and limited animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participants. the trial will employ a parallel group design comparing the effects of the dietary intervention (mhd) on cognitive status to those of the control diet or usual diet plus modules on self-care matters such as dealing with aches and pains of aging, obtaining a health care proxy ,etc. to show that mhd can be adapted to this population serum biomarkers indicative of the mhd diet pattern such as fatty acid profile as well as other key nutrition biomarkers will be evaluated. other aims include testing whether the mhd intervention can benefit cognitive function using real-time ambulatory assessments. the investigators will also assess plasma and serum markers of inflammation. components of the mhd diet that are associated with stable or improved measures of cognition will also be evaluated. the clinical site for the proposed study is at the albert einstein college of medicine; the ambulatory cognitive assessment reading center is at pennsylvania state university, state college; the statistical core is at the kaiser permanente washington health research institute and the laboratory for biospecimen analysis is at the university of minnesota.

Eligibility criteria:
inclusion criteria: * living, working, attending school or visiting co-op city, bronx (e.g. for shopping, doctors' visits, etc.) or communities neighboring co-op city and between 40-65 yr of age * willingness to accept assignment to intervention or comparison diet group * willingness to participate in a study where weight loss is not a primary goal exclusion criteria: * cognitively impaired * history of traumatic brain injury * psychiatric illness * history of diabetes and experiencing hypoglycemia * liver disease * uncontrolled hypertension as defined as blood pressure \> 140/90 mm hg * history of cardiovascular disease that affects physical functioning * severe chronic illness * low literacy * history of alcohol or drug dependence * hematologic disease or malignancy not in remission for more than 5 years * visual, auditory, or motor impairment that precludes cognitive testing. * chronic kidney disease on dialysis or special diet
cost effectiveness analysis of an ancillary study of the remotev study

Conditions: Venous Thromboembolic Disease

Summary: the implications of the medico-economic impact are essential in the choice of first-line therapists. the economic impact is an important criterion to recommend the privileged use of direct oral anticoagulants (aod) in first intention.


Eligibility criteria:
inclusion criteria * major patient whose age is ≥18 years * patient with a diagnosis of mtev: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations * major patient included in the remotev registry * patient having accepted that his data recorded in the remotev register be re-used for research and publication purposes criteria of non-inclusion * refusal to participate in the remotev register * patient who refused to have his data reused for research and publication purposes * pregnant woman * subjects under safeguard of justice subject under guardianship or curatorship

Keywords: venous thromboembolic direct oral anticoagulants aod cost analysis remotev avk pulmonary embolism
retrospective study in the use of the alfapump and the treatment of malignant ascites

Conditions: Malignant Ascites

Summary: treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. so far, there is no systematic analysis of patients with this indication available in the literature. this retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. based on this analysis, a prospective analysis can be designed.


Eligibility criteria:
inclusion criteria: * patients with malignant ascites * patients with alfapump implanted for malignant ascites * patients 18 years or older at the time of death exclusion criteria: * patient is alive at the time of inclusion assessment
effective iodide therapy for untreated patients with graves' hyperthyroidism avoiding thionamide drugs with many side effects

Conditions: Graves Disease

Summary: as the drug treatment of graves' hyperthyroidism, plummer reported the effectiveness of excess iodide in 1923 and iodide was used as the therapy for graves' hyperthyroidism starting from the 1930s. after the introduction of more potent antithyroid drug, thionamide, most thyroidologists preferred to use thionamide expecting potent antithyroid effect, but some careful thyroidologists continued to prescribe iodide in mild type graves' hyperthyroidism. recently, american and europe thyroid association recommended methylmercaptoimidazole (mmi), one of the potent thionamide drugs, as the first-choice drug for graves' hyperthyroidism. however, it became apparent that thionamide has serious side effects such as not only agranulocytosis, but also severe liver injury, mpo-anca related vasculitis and embryopathy in the pregnant women. in japan, one patient died of thionamide-induced agranulocytosis every year. the incidence of side effects including minor side effect of drug eruption is more than 10%. we used to treat the patients with graves' hyperthyroidism with mmi, as we reported in j clin endocrinol metab 65:719, 1987. however, many side effects of thionamide prompted us to revive the treatment with classical ki in our outpatient clinic and found that ki was effective in the patients who showed side effects to thionamide, resulting in remission (reported in j clin endocrinol metab 99:3995, 2014). therefore, we began to treat the patients without serious complications such as heart failure or arrhythmia, with 100mg ki since 1996 and followed for 180 days. we were surprised to find that serum thyroid hormone level decreased in all the patients. thionamide drugs were added only when euthyroidism could not be achieved by ki alone. compared with thionamide, side effect of ki was almost none. between 1996 and 2004, about 504 patients were treated with ki and a third of the patients were successfully treated with ki alone and other patients were also successfully treated with the combination of ki and thionamide, suggesting additive effect, or by radioactive iodine therapy. the long term prognosis of the patients initially treated with ki was almost the same as the patients initially treated with mmi. our clinical experience suggested that patients with graves' hyperthyroidism are also susceptible to excess iodide, as in the cases with hashimoto thyroiditis, and this suppressive effect of excess iodide on the thyroid gland is a useful information for many patients suffering from graves' hyperthyroidism and thionamide side effects.


Eligibility criteria:
inclusion criteria: untreated graves' hyperthyroidism. (elevated serum free t4 and/or free t3 level, suppressed serum tsh level, positive anti-tsh receoptor antibody and high thyroidal radioactive iodine uptake - exclusion criteria: dropped out patients within 180 days -
cardiopulmonary resuscitation (cpr) video to enhance advance care planning in advanced upper gastrointestinal cancer patients

Conditions: Pancreas and Hepatobiliary Cancer Patients

Summary: advance care planning involves thinking about choices if the patient becomes sick, and is important for everyone. it does not matter if the patients are ill or healthy. it is especially important for people who have diseases that cannot be cured. it allows people to make sure their wishes are respected if they become very sick or are dying. thinking about these issues can be upsetting. but, for many people, it is helpful. this type of discussion can help the family learn what the patient may want but cannot tell them when these decisions need to be made


Eligibility criteria:
inclusion criteria: * primary pancreatic or hepatobiliary cancer (including ampullary carcinoma)as well as gastric and/or esophageal cancers, excluding neuroendocrine histology * progressive disease: locally advanced or metastatic disease with progression on at least one course of treatment (surgery, radiation, or chemotherapy), or untreated patients unfit for therapy because of comorbidities or ecog performance status \>2, and finally, patients with ecog performance status 2 -- patients must have discussed on at least one occasion with the treating investigator oncologist that their cancer cannot be cured * in the estimation of the treating physician investigator, life expectancy ≤ 1 year * known to a gi medical oncology mskcc clinic: patients who have already established a relationship with a gi medical oncologist (who is an investigator on this protocol) after at least one new visit in the clinic (or as an in-patient), have mskcc pathologist confirmed cancer of an above histology, and express an initial intent to be followed primarily at mskcc * english speaking\* * able to provide informed consent * age greater than or equal to 18 years * do not have an advance directive or living will \* english is the validated language in one of the study tools, and the language in which information is communicated in the narrative and video. exclusion criteria: * short portable mental status questionnaire (spmsq) score of less than "intact mental functioning" (3 or more errors). spmsq in appendix. * any patient psychological state deemed by the treating physician to pose any risk of psychological harm by issues raised in a discussion of the trial, or in its testing procedures. any subject who may become upset during any aspect or discussion of the study will be offered counseling services.

Keywords: advance directive cpr intervention video narrative 10-043