Kornimate/medical-research-clean huggingface dataset:
digital diabetes remission trial

Conditions: Diabetes Mellitus, Type 2

Summary: this is a multicentre, open-label randomised controlled trial run in the united kingdom. the main aims are to assess whether the habitual remission programme (digital therapeutics + 12-week 800kcal/day low-energy diet, delivered remotely) is more likely to lead to weight loss and remission in adults with type 2 diabetes, when compared to standard of care.

participants will be randomly allocated to the habitual programme or standard care as delivered by the national health service (nhs). they will take a home blood test for hba1c at baseline, 3 months and 6 months, and complete online fortnightly surveys to record their weight, waist circumference, blood pressure, side-effects and any changes in medication, for 6 months. these measurements will be taken at 6 months and 12 months after finishing the intervention for those allocated to the intervention. participants will be recruited from general practitioner (gp) surgeries in england, managed by lindus health. research nurses at lindus health will complete screening and informed consent procedures.

Eligibility criteria:
inclusion criteria: * able and willing to give consent for the study prior to participation * be aged between 18-75 years, with type 2 diabetes mellitus of duration \<6years. * has access to a smartphone or computer * has a body mass index (bmi) of ≥28 kg/m2 * hba1c between 86 mmol/mol (10%) ≥ 48mmol/mol (6.5%), within the previous 12-months exclusion criteria * is currently using insulin * weight of change \>5% in the past 3-months * has a history of are known to be suffering with alcohol/substance abuse * has cancer or is knowingly under investigation for cancer * has had a myocardial infarction within the previous 6-months * has severe or unstable heart failure e.g., new york heart association (nyha) grade iv * has porphyria * has learning difficulties * is currently on treatment with anti-obesity drugs * has had bariatric surgery * has been diagnosed with an eating disorder or purging * is pregnant or less than 4-months postpartum or considering pregnancy in the next 2-years * is currently breastfeeding * has required hospitalisation for depression or taking antipsychotic drug * has a history of illnesses that could interfere with the interpretation of the study (e.g. hiv, cushing syndrome, chronic kidney disease, chronic liver disease, hyperthyroidism, hereditary fructose intolerance, depression or antipsychotic drug use within the past 2 years) * currently talking glucagon-like peptide-1 receptor agonists (glp-1 ras) * has pancreatitis * currently taking part in a clinical trial of an investigative medicinal product (ctimp) trial for antidiabetic medication * abnormal diabetic foot review (qof codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).
surgical technique, open versus minimally-invasive gastrectomy after chemotherapy

Conditions: Gastric Cancer

Summary: laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. all while maintaining similar results with regard to tumour resection margin and oncological survival. in gastric cancer the role of laparoscopic surgery remains unclear. current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. the extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. therefore, it is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield. preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the west they are often underpowered. a prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy. results of the stomach trial will further aid in determining the optimal surgical technique in patients with gastric cancer.


Eligibility criteria:
inclusion criteria: * age equal to or above 18 years * primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent. * neoadjuvant therapy (epirubicin, cisplatin, capecitabine) * surgical resectable (t1-3, n0-1, m0) * informed consent exclusion criteria: * previous or coexisting cancer * previous surgery of the stomach * asa classification (american society of anaesthesiologists) score 4 or higher

Keywords: gastric cancer minimally-invasive oncological quality of resection
investigation of the pharmacokinetic properties of biphasic insulin aspart 50 in healthy chinese subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in asia. the aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (biasp 50). in addition, the safety and tolerability of biasp 50 will be observed


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ecg), as judged by the investigator (the physician) * body mass index (bmi): 19.0-24.0 kg/m2 (both inclusive) exclusion criteria: * clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the investigator (the physician) * a history of any illness that, in the opinion of the investigator (the physician), might confound the results of the trial or a pose risk in administering the trial product to the subject * subject who has donated any blood or plasma in the past month or more than 400 ml within 3 months prior to screening (trial entry) * not able or willing to refrain from smoking during the inpatient period
pilot trial of deferasirox in the treatment of porphyria cutanea tarda

Conditions: Porphyria Cutanea Tarda

Summary: to determine the efficacy and tolerability of deferasirox in the treatment of porphyria cutanea tarda. primary objective - the elimination of all blistering within 6 months of treatment. secondary objective - decrease in total body iron levels.

phlebotomy is the standard therapy for porphyria cutanea tarda (pct), but it can be inconvenient and cause anemia in some patients. deferasirox is a new class of tridentate iron chelators with high affinity and selectivity for iron. the medication is administered orally, which if effective for pct would make it a more convenient and possibly more tolerable option for patients.

Eligibility criteria:
inclusion criteria: * diagnosis of porphyria cutanea tarda based on clinical exam and 24-hour urine porphyrin levels * have porphyria cutanea tarda for at least 3 months prior to enrollment with active blistering (3 blisters or erosions per month) * women of childbearing potential must use an effective method of contraception during the study, however this cannot include hormonal contraception (oral contraceptives, hormone patches, depo-provera injections, nuva ring, etc.) * treatment naive patients or patients unresponsive or intolerant of phlebotomy * ferritin level is greater than or equal to 25ng/ml exclusion criteria: * patients with serum creatinine above the upper limit of normal * patients receiving phlebotomy who are controlled on this therapy * pregnant or breast feeding females * patients with liver transaminases more than 5 times the upper limit of normal * patients with a history of hypersensitivity to deferasirox * patients with a history of pre-existing renal condition, or receiving medication that depresses renal function * patients on other chelators * history of non-compliance to medical regimens.

Keywords: exjade pct study pct study porphyria cutanea tarda
effectiveness of ginkgo diterpene lactone meglumine in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the primary purpose of this study is to investigate the effectiveness of ginkgo diterpene lactone meglumine (gdlm) for patients with acute ischemic stroke (ais) in real-world settings.

the randomized controlled trial (rct) of gdlm for the treatment of ais was published in jama network open, titled "efficacy and safety of ginkgo diterpene lactone meglumine in acute ischemic stroke: a randomized clinical trial." this study provided valuable insights into the efficacy and safety of gdlm in improving functional recovery for patients with ais. however, the generalizability of these findings to real-world medical settings remains unclear, as the trial was conducted under controlled conditions that may not fully reflect routine clinical practice. to address this gap, we will conduct this study to further explore the effectiveness of gdlm in a real medical environment. using routine clinical care data for real-world evidence, we aim to investigate the treatment's impact on a broader and more diverse patient population. this approach will allow us to better understand the practical application of gdlm in everyday clinical settings, including its potential benefits and challenges when used outside the confines of a rct.

Eligibility criteria:
inclusion criteria: * aged ≥18 years, regardless of gender * within 48 hours of stroke onset of ischemic stroke * patient or their legally authorized representative (lar) has signed informed consent or legally authorized oral consent with documentation exclusion criteria: * mrs score of 2 or more prior to onset * total hospital stay less than 7 days * use of other ginkgo-derived preparations except gdlm * current or planned participation in any other interventional clinical trials * inability to comply with study procedures due to documented psychiatric disorders or severe cognitive impairment

Keywords: ginkgo diterpene lactone meglumine acute ischemic stroke real-world study registry effectiveness
this is the first study using escalating doses of pf-03758309, an oral compound, in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is the first study using pf-03758309, an oral compound, in patients with advanced solid tumors. in this study different doses of pf-03758309 will be administered to different groups of patients. the study will assess the compound's safety, the blood levels of pf-03758309 during the treatment and the effect of the compound on the tumor cells.

the study was prematurely terminated on 26jul2011 due to the undesirable pk characteristics of pf-03758309 and the lack of an observed dose-response relationship. there were no safety concerns that contributed to the study termination.

Eligibility criteria:
inclusion criteria: * advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available. * ecog (eastern cooperative oncology group) performance status (ps) must be 0 or 1. * adequate bone marrow, liver and kidney function. exclusion criteria: * patients with known brain metastases. * previous high dose chemotherapy requiring stem cell rescue. * prior irradiation to \>25% of the bone marrow. * active bacterial, fungal or viral infection including hepatitis b (hbv), hepatitis c (hcv). * current active treatment in another clinical study. * pregnancy or breast feeding. * active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.

Keywords: phase 1 dose escalation dose finding pharmacokinetic and pharmacodynamic study
a mobile personal health record for behavioral health homes

Conditions: Hypertension; Hyperlipidemia; Diabetes

Summary: poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (smi). to address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated clinics in which persons with smi receive coordinated medical and mental health care. however, behavioral health homes have faced logistical and privacy challenges in integrating electronic medical records across organizations. this application proposes to develop and test a mobile personal health record (mphr) to overcome this problem while more fully engaging patients in their health care. the study will develop, test, and disseminate the mphr. the investigators will develop the app building on experience and preliminary data from a pc-based phr project, and link it to the medical and mental health ehr in a behavioral health home. next, the investigators will conduct a randomized trial of the mphr in 300 subjects randomized to the mphr or usual care.


Eligibility criteria:
inclusion criteria: * one or more of the following conditions: hyperlipidemia, hypertension, diabetes * able to give consent * patient in the behavioral health home exclusion criteria: * unable to give consent
safety and efficacy of levofloxacin for acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to determine the efficacy and safety of levofloxacin in treating acute ischemic stroke.

acute ischemic stroke is a leading cause of disability and mortality. the investigators' previous studies suggested levofloxacin to be a newly identified neuro-protective agent, which could reduce infarct volume and improve neurologic function in animal models. to evaluate the efficacy and safety of levofloxacin in treating acute ischemic stroke patients, the prospective, multicenter and randomized controlled trial was designed.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years. 2. the patients were clinically diagnosed with acute ischemic stroke with nihss score ≥5 points and ≤15 points,and nhiss score 1a level of consciousness \< 1 point. 3. mrs≤1 before stroke onset. 4. signed and dated informed consent is obtained. exclusion criteria: 1. patients with transient ischemic attack and those undergoing emergency reperfusion therapy, including intravenous thrombolysis and emergency thrombectomy. 2. patients using glucocorticoids, antiarrhythmic drugs (class i and class iii antiarrhythmic drugs: quinidine, procaine amine, lidocaine, phenytoin sodium, verapamil, etc.), and quinolones within 14 days. 3. patients with other diseases that may aggravate adverse drug reactions, such as ventricular arrhythmias, prolonged qt interval (male: qtc\>430ms, female: qtc\>450ms), severe cardiac insufficiency (nyha functional grade ≥ iii), myasthenia gravis, peripheral neuropathy, seizures, tendon-related diseases, severe immune system-related diseases, hematological diseases, active hepatitis or cirrhosis, serious respiratory diseases. 4. abnormal liver and kidney function: glutamic oxaloacetic transaminase or glutamic pyruvic transaminase exceeds 3 times the upper limit of normal; direct bilirubin or indirect bilirubin more than 3 times the normal upper limit; blood creatinine exceeds 1.1 times the upper limit of normal; creatinine clearance rate≤50ml/min; urea nitrogen≥ 20mg/dl. 5. concurrent infection. 6. blood glucose lower than 3.9 mmol/l. 7. patients allergy to fluoroquinolones or other antibiotics. 8. patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons. 9. not willing to be followed up or poor treatment compliance. 10. patients who are participating in other clinical studies, or have participated in other clinical studies within 3 months before enrollment, or have participated in this study. 11. other conditions not suitable for enrollment.

Keywords: acute ischemic stroke levofloxacin
cladribine tablets as an exit therapy strategy

Conditions: Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Summary: the objective of the study is to evaluate the effectiveness of cladt, in terms of disease stability and safety, as the last treatment option in ageing ms patients vs treatment continuation and discontinuation this observational study will use database from local cohorts (from france, belgium, switzerland). patients included must meet the inclusion criteria: rrms diagnosis for more than 10 years without secondary progression, no evidence of disease activity (no relapse, no new mri lesion, no edss progression) for more than 5 years under a dmt, age≥ 45-year-old. analyses will be using dynamic propensity score to match patients who stopped treatment with patients who had the same probability of continuing / stopping current treatments but took cladt as exit therapy. patients with a minimum of 24 months follow up will be included. the investigators will ensure that cladt provide disease stability compared to treatment continuation / discontinuation in ageing ms patients by measuring: * the percentage of patients free of relapse, and time to first relapse, defined as the appearance, recurrence, or aggravation of neurological symptoms for a period of at least 24 hours without fever. * the percentage of patients free of edss progression confirmed for at least 6 months and until the end of patient follow up. * the percentage of patients free of mri activity, defined as new or enlarged t2 lesions compared with the previous brain mri scan or gadolinium enhancing t1 lesions.


Eligibility criteria:
inclusion criteria: * patient ≥45-year-old with rrms * disease duration ≥10 years * no evidence of disease activity ≥5 years under dmt * edss score between 0 and 6.0 included exclusion criteria: * progressive form of ms * patients without dmt * edss score ≥6.5
the mammography and ultrasonography study for breast cancer screening effectiveness

Conditions: Invasive Cancer; Ductal Carcinoma in Situ

Summary: mammography screening has limited performance in young women or women with dense breasts although it is the only proven method for breast cancer screening that reduces the mortality. the investigators propose a multicenter trial of breast cancer screening to assess the effectiveness of supplemental ultrasonography for korean women aged 40-59 years.

the investigators will screen same consecutive participants using both methods; digital mammography plus supplemental ultrasonography (intervention arm) and digital mammography only (control arm) for 5 years. the investigators will collect follow-up information by assessment of screening records, questionnaire, and official cancer registry. the primary outcome will be sensitivity, specificity, recall rate, cancer detection rate and stage distribution at the end of first round of screening. the secondary outcome will be cost-effectiveness and cost-utility of digital mammography with ultrasonography versus digital mammography only for breast cancer screening. it is hoped that the results of this trial will provide guidance of effective breast cancer screening strategy to women aged 40-59, especially with dense breasts.

Eligibility criteria:
inclusion criteria: * women aged 40-59 years * no history of any cancer * no breast mammography (and ultrasonography, in case of intervention arm) after the introduction of digital mammography exclusion criteria: * interstitial injection * women with history of any cancer

Keywords: screening digital mammography ultrasonography sensitivity specificity
progressive muscle relaxation exercise on care burden, depression, anxiety, and stress levels in dementia caregivers

Conditions: Caregiver Burden; Dementia

Summary: dementia, which leads to deterioration in cognitive and behavioral functions, is a chronic progressive disease. since the diagnosis is made, the care needs of the patients increase. in the later stages of the disease, it becomes completely dependent on the caregiver. they are coming. caregiving is performed by family members in developing countries such as turkey. family members face many difficulties in their social, work, and daily lives after they start to care. these difficulties are the burden of caregiving is called. caregivers who perceive the burden of care also experience anxiety, stress, and depression. jacobson progressive muscle relaxation in coping with these problems exercises can be used. this study was planned to examine the effects of progressive muscle relaxation exercises on anxiety, stress, depression, and caregiver burden in dementia caregivers.

the research is a pre-test, post-test, and cross-sectional research. after explaining the purpose of the study to the caregivers who met the inclusion criteria, the information form, the depression anxiety stress-21 scale (das-21), and the zarit care burden scale will be administered. then, progressive muscle relaxation exercises will be applied to caregivers. during the interview, the audio recording of the exercise will be given to them. also, contact information (caregiver and researcher) will be shared mutually.

Eligibility criteria:
inclusion criteria: * be over 18 years old * being literate * not having difficulties in verbal communication * have been caring for at least 3 months * being able to provide care for free * being the primary caregiver of the patient * not having a psychiatric diagnosis * not using medication for psychiatric illness exclusion criteria: * providing care for less than 3 months * providing paid care
probiotic therapy for children and adults with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this is a study of the effect of a customized probiotic on children and adults with autism, including effects on autism symptoms and gastrointestinal symptoms.

sungenomics provides its customers with a customized probiotic based on an analysis of the microbiota in their stool samples. customers who have autism spectrum disorders are invited to participate in this study by completing several questionnaires about their medical history, diet, autism symptoms, and gastrointestinal symptoms before taking the probiotic, and to repeat those questionnaires approximately 3 months later. this is effectively an open-label study.

Eligibility criteria:
inclusion criteria: 1. new client of sun genomics (has applied for testing and treatment, but not yet begun treatment) 2. diagnosis of asd (initially based on self-report of asd diagnosis by appropriate medical professional, and then verified by an evaluation of the social responsiveness scale (srs-2) by asu staff. 3. children and adults ages 2.5-75 years exclusion criteria: 1. antibiotic use in the last two months (not counting topical antibiotics) 2. any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment.
functional-three-dimensional reconstruction of liver by 99mtc-gsa-spect scan

Conditions: Cirrhosis; Hepatic Carcinoma

Summary: the aims of this study were divided into three parts: 1. to develop a new software to carry out the functional-three- dimensional-reconstruction of the liver by 99mtc-gsa-spect scintigraphy 2. to probe a new dynamic model of the metabolism of the 99mtc-gsa. 3. to evaluate the liver function by 99mtc-gsa-spect scintigraphy before surgical treatment. study design: 1. collectivity type: prospective，randomized, controlled, multi-central clinical study. 2. patients: the subjects were from different hospitals including: peking union medical college hospital (pumch). study arrangement: this study was consisted of three parts:


Eligibility criteria:
inclusion criteria: * patients that with benign tumor、hepatitis and hepatic carcinoma (with or without cirrhosis)diagnosed by examination of ct, ultrasound-b, and/or pathology.

Keywords: cirrhosis hepatic carcinoma