Kornimate/medical-research-clean huggingface dataset:
low gi diet effects on non-alcoholic fatty liver disease

Conditions: Fatty Liver; Nutritional and Metabolic Disease

Summary: a 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low glycemic index (lgi) versus high glycemic index (hgi) diet on hepatic fat accumulation and gut microbiota composition in participants with nafld. participants will be allocated randomly to a 2-week either high gi (hgi) or low gi (lgi) diet followed by a 4-week wash-out period and then the lgi or hgi diet, opposite to the first 2-weeks (n= 16).


Eligibility criteria:
inclusion criteria: * • adult males and females aged from 18 to 65 years (balanced number). * detected nafld by cap-fibroscan™ \>288db/m or by mri-pdff) \> 5% fat of liver weight. * body mass index ≥ 25 kg/m2 * have current moderate to high gi diet intake of ≥ 60 (assessed from a completed 7-day food diary). * abdominal obesity (waist circumference \> 102 cm for males and \> 88 cm for females) * able to give informed consent. * able to undergo mri/s and cap-fibroscan™. exclusion criteria: * • current smokers and excessive alcohol drinkers (\> 14 units/week). * perimenopausal (irregular periods) women. * participants with other liver abnormalities. * participants with history of gastrointestinal surgeries, depression, eating disorders or difficulties. * participants using pharmacologic agents for obesity or nafld. * participants with type 1 diabetes. * participants with type 2 diabetes on second line medications (eg glp-1 analogues, sulfonylureas). * participation in any other trial in the last 3 months. * participants on any special diets (e.g. vegetarians). * intolerance to foods included in the diet plan.
sgi-110 in combination with carboplatin in ovarian cancer

Conditions: Ovarian Cancer

Summary: a 2-part, phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. in part 1, participants received sgi-110 and carboplatin. the optimum dose of sgi-110 (guadecitabine) was identified in part 1 based on safety and efficacy. in part 2, participants were randomized to receive the dose identified in part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. the treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.


Eligibility criteria:
inclusion criteria: 1. participants who are women 18 years of age or older. 2. participants who have histologically or cytologically confirmed recurrent high-grade serous epithelial ovarian cancer (grade 2 or 3), primary peritoneal carcinomatosis or fallopian tube cancer. 3. participants who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen). there is no limit on the number of prior treatment regimens in part 1. in part 2, participants may have had no more than 3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy. 4. participants must have had prior paclitaxel treatment. 5. participants who have measurable disease according to recist v1.1 or detectable disease. 6. participants with ecog performance status of 0 or 1. 7. participants with acceptable organ function. 8. participants must be at least 3 weeks from last chemotherapy. exclusion criteria: 1. participants who have hypersensitivity to sgi-110 and/or carboplatin or other components of these drug products. 2. participants who have received prior therapy with any hypomethylating agents. 3. participants who are refractory to platinum treatment i.e., progressed while on platinum treatment. 4. participants with abnormal left ventricular ejection fraction. 5. participants with grade 2 or greater neuropathy. 6. participants with known brain metastases. 7. participants with known history of hiv, hcv or hbv.

Keywords: ovarian cancer
factors associated with future fractures in middle-aged men and women

Conditions: Fractures, Bone; Fragility; Life Style

Summary: from prospectively collected health and life-style data and anthropometric data in the malmo diet and cancer (mdc) cohort identify factors that predicts or are associated with forthcoming fracture in middle-aged men and women.

in adults, the incidence of fractures increases with age. in predisposed individuals, even a minor trauma can result in a fracture. such an injury is known as low-energy fracture or fragility fracture, and the risk increases with age. fragility fractures may be preventable, either by changes in lifestyle or by medication of underlying diseases. fragility fractures also put a burden both on the affected individual and on society. as the population age, more individuals are at risk, and the absolute numbers of fragility fractures increase. therefore, identification of individuals at risk before fracture occurs would be ideal.in the prospectively collected malmo diet and cancer (mdc) cohort a large number of health and life style variables have been gathered from randomly invited men and women in a city of 350,000 inhabitants in the 1990s'. the mdc database the investigators use for this study comprises 30,351 participants. outcome is updated via crosslinking with the national patient register in sweden. mdc physfract - investigation of the following factors socioeconomical factors: level of education, employment status in middle age, physical activity / work load, living alone, stress, number of friends, feeling of loneliness. life style factors: tobacco use, alcohol use. summary of physical and psychological well-being. mdc cardfract - investigation of the following factors comorbidities: hypertension, syncope/orthostatism, diabetes, coronary artery disease, atrial fibrillation, heart failure, ischemic stroke and others. pharmaceutical drugs associated with fracture risk. cardiovascular blood tests. mdc hormfract - investigation of the following factors body composition: weight at 20 yrs, weight change pattern, weight difference middle age minus 20 yrs. hormonal/gynecological status - women: date for menarche and menopause, number of children, intake of oral contraceptives / hormonal replacement therapy, surgical menopause.

Eligibility criteria:
inclusion criteria: * invited population based cohort from 1990's exclusion criteria: * none
failed retrograde cholangiopancreatography (ercp) stone extraction: surgical interference

Conditions: Common Bile Duct Calculi

Summary: assessment of the differences in stone size and the largest cbd diameter before and after stenting in one or two sessions. stone clearance and complications were also determined with the ercp, and factors associated with complete clearance were evaluated in patients with difficult cbd stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] cbd stones). and also compared the outcomes with conventional procedure of open surgery.

gallstones are a very common problem in developed countries. most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. the development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (cbd). common bile duct stones (cbdss) may be treated by endoscopic retrograde cholangiopancreatography (ercp) or surgically during cholecystectomy. removal of common bile duct (cbd) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable cbd stones. however, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. an indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.

Eligibility criteria:
inclusion criteria: 1. all cases of difficult common bile duct stones leading to variable occlusion. 2. patients fit for intervention. 3. patients informed consent for study. exclusion criteria: 1. surgically unfit cases according to asa 2. locally advanced irresectable cases. 3. patients refuse consent to participate in the study.
gammaga: prevalence of acid sphingomyelinase deficiency disease (asmd) and gaucher disease in patients with monoclonal gammopathies and/or multiple myeloma

Conditions: Gaucher Disease; Acid SphingoMyelinase Deficiency

Summary: the study of splenomegaly, and the follow-up of splenectomized patients, is one of the causes of referral of these patients to pediatric gastroenterology and oncohematology clinics, and adult internal medicine and hematology. the study and management of splenomegaly is well described among the different medical specialties to which these patients arrive. after the application of the different algorithms and the different studies that are carried out, these splenomegaly are identified as being of hepatic, infectious, inflammatory, congestive, hematological origin and primary causes. despite these studies of splenomegaly, approximately 10-15% of these patients still remain undiagnosed. several studies have suggested that there is an increased frequency of mgus (monoclonal gammopathy of undetermined significance) and/or multiple myeloma (mm) among gaucher patients. regarding asmd (acid sphingomyelinase deficiency), few studies have been published but it seems the 21% of patient with asmd has mgus and 15% asmd patients have mgus. moreover, patients with mgus and gaucher disease (gd) are at increased risk of developing mm. the objective of the present study is to increase the diagnostic sensitivity of these unknown splenomegalys, or unknown splenomegaly patients with mgus or multiple myeoloma who remain in consultations, using the usual diagnostic clinical procedures of unknown splenomegaly and unknown splenectomy patients, where we include the extraction of a blood sample for dry drop test (dbs), where the determination of the enzymatic/genetic activity will be carried out for gaucher disease (gd) and acid sphingomyelinase deficiency (asmd) , analysis of lisogl1 and lisosm.


Eligibility criteria:
inclusion criteria: * adult patients of both sexes. * patients with splenomegaly (spleen palpable at ≥ 1cm from the costal margin) or splenectomy not related to any specific condition, or patients with thrombocytopenia (with or without splenomegaly). in cases where the patient is undergoing treatment for their underlying condition, the thrombocytopenia must have been present prior to the start of the treatment. * patient who gives their consent to participate in the study. exclusion criteria: * splenomegaly due to portal hypertension (documented by abdominal ultrasound or other instrumental test) due to liver disease * hematologic malignancy \[documented by positive physical exam + blood smear or fine needle aspiration (fna) or bone marrow biopsy\] * hemolytic anemia and/or thalassemia * patients who cannot meet the requirements of the protocol due to mental and/or cognitive alterations, uncooperative patients, educational limitations and understanding of written language * refusal of the patient to participate in the study

Keywords: gaucher disease acid sphingomyelinase deficiency gd asmd dbs splenomegaly monoclonal gammopathies multiple myeloma
deep cervical lymphatlc-venous anastomosis surgery for the treatment of alzheimer's disease: a pilot study (diva study)

Conditions: Alzheimer's Disease

Summary: the goal of this clinical trial is to to demonstrate the safety and efficacy of dclva surgery for the treatment of alzheimer's disease. patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dclva surgery plus standard medication) or the control group (receiving standard medication alone) participants will: undergo cognitive assessment and brain mri assessment; undergo a lumbar puncture; undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/l (1ml gadodiamide: 20ml 0.9% saline). primary outcome measures: the change in the sum of clinical dementia rating scale (cdr) scores at 12-month in relative to baseline

this study aims to enroll patients diagnosed with ad. patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dclva surgery plus standard medication) or the control group (receiving standard medication alone). following randomization, patients will undergo cognitive and brain mri assessments, a lumbar puncture, and an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/l (1ml gadodiamide: 20ml 0.9% saline). mri imaging scans will be conducted at 4 hours, 24 hours, and 48 hours post-injection to measure the dural signal unit ratio, which will be used to assess glymphatic clearance function. the study will track changes in cognitive function and glymphatic clearance function at baseline and during follow-up periods (7 days post-surgery, 6 months, and 12 months) and will evaluate the safety of the two treatment approaches.

Eligibility criteria:
inclusion criteria: * diagnosed as an ad patient according to biological markers and clinical symptoms; * over 35 years old and with an mmse or moca score ≤ 26; * the patient or family member has signed an informed consent form. exclusion criteria: * inability to cooperate with lumbar puncture; * cognitive impairment due to neurological infections (e.g., hiv, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction); * significant organ dysfunction (heart, lung, liver, kidney); * coagulation disorders or contraindications to surgery; * inability to fully cooperate with follow-up visits.
intensity modulated radiotherapy (imrt) vs. 3d-conformal accelerated partial breast irradiation (apbi) for early stage breast cancer after lumpectomy

Conditions: Breast Cancer

Summary: in the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3d-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.


Eligibility criteria:
inclusion criteria: * histologically confirmed disease (ajc classification): tis, t1, t2 (≤ 3.0 cm), n0, m0. * microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less. * negative surgical margins ( ≥ 0.2 cm) after final surgery. * subjects with infiltrating lobular histologies or high nuclear grade dcis will be required to have breast mri scanning as part of the initial staging to verify localized disease. * subjects with dcis will be included in the study only if they had an mri prior to lumpectomy. * findings on mri scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease. * subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications. * willing to complete additional screening requirements and meet eligibility criteria as defined in protocol sec. 4.4. * successful placement of fiducial markers for igrt requiring nonmigrating fiducials. * ptv to ipsilateral breast ratio (ibr) ≤ 25 %. * radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins. exclusion criteria: * pregnancy or breast-feeding. * have collagen-vascular disease. * inadequate surgical margins ( \< 0.2 cm) after final surgery. * subjects with persistent malignant/suspicious micro-calcifications. * gross multifocal disease and microscopic disease greater than 3.0 cm.

Keywords: breast-conservation adjuvant radiotherapy breast cancer early-stage breast cancer dcis lumpectomy accelerated partial breast irradiation apbi three dimensional conformal external radiotherapy intensity modulated radiotherapy 3d crt imrt
peer-led psycho-education for schizophrenia

Conditions: Schizophrenia

Summary: profession-led psycho-education programs for people with schizophrenia are evidenced to improve patients' knowledge about the illness, mental state and relapse rate. nevertheless, other benefits to patients, for example, their functioning and insight into illness or to be substantive in a longer term (\>12 months) are inconsistent and uncertain, especially in asian populations. this single-blind multi-site randomized clinical trial was to test the effects of a peer-expert-led psycho-education group intervention (in addition to usual care) for adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison to a profession-led psycho-education group or treatment-as-usual only.

objectives: this study is to test the effectiveness of a peer-expert-led psycho-education group programme for chinese outpatients with schizophrenia spectrum disorders over an 24-month follow-up. the program is an integrated,psycho-education program that addresses patients' knowledge and self-management of schizophrenia and problem-solving skills. methods: a single-blind, multi-site randomized controlled trial will be conducted with 342 chinese patients with schizophrenia in hong kong, china and taiwan. in each of three study sites, the participants will be randomly selected from the eligible patient list (i.e., 114 subjects from each study site) and after baseline measurement, be assigned to either the peer-led psycho-education program, profession-led psycho-education group, or usual psychiatric care. the patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24 months after completing the interventions. hypothesis: the patients in the peer-led psycho-education program will report significantly greater improvements in their symptoms and re-hospitalisation rates (primary outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the 24-month follow-up, when compared with those in profession-led psycho-education group and/or usual care. conclusions: the findings will provide evidence whether the peer-led psycho-education group program can better improve chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.

Eligibility criteria:
inclusion criteria: * patients, aged 18+, attending one psychiatric outpatient clinic under study; * diagnosed as schizophrenia and its subtypes according to the diagnostic and statistical manual, 4th text-revised edition, as ascertained by the structured clinical interview (scid-i); * having onset of the illness for not \>5 years; and * able to communicate in cantonese language. exclusion criteria: * mentally unstable and unfit for study participation at recruitment; * with co-morbidity of other severe mental health problems such as depression and substance misuse; and * have recently received or are receiving any structured psychosocial intervention.

Keywords: peer expert or specialist psycho-education schizophrenia outpatients
effectiveness of knee sync partner and strengthening exercises versus strengthening exercises in knee osteoarthritis.rct

Conditions: Knee Osteoarthritis

Summary: this study explores the effectiveness of a novel treatment approach for knee osteoarthritis (oa) by comparing the combined use of a new device, "knee sync partner," which provides electrical knee traction with stimulation and strengthening exercises, to traditional strengthening exercises alone. knee osteoarthritis is a leading cause of chronic pain and disability worldwide, significantly impacting the quality of life for many individuals, especially with the growing elderly population.

while strengthening exercises are a well-established treatment for improving joint stability and mobility in knee oa patients, the potential benefits of integrating electrical stimulation and traction therapy remain underexplored. this research addresses the gap by conducting a randomized controlled trial to assess whether this combined approach leads to superior outcomes in terms of pain relief, functional improvement, and joint health. the findings could provide valuable insights into more effective, non-invasive management strategies for knee oa, expanding therapeutic options in physical therapy.

Eligibility criteria:
inclusion criteria: * having pain in knee for more than 3 months in most days of week * age between 40 and 70 years * patient who filled kellgren-lawrence radiographic criteria exclusion criteria: * joint injection in the previous three months. * the exclusion criteria were patients who had inflammatory arthritis * osteoarthritis of the hips.
clinical evaluation of stenfilcon a contact lenses

Conditions: Myopia

Summary: this study is to evaluate the fitting performance of stenfilcon a contact lens (test) compared to narafilcon a contact lens (control).

this study is to evaluate the fitting performance of stenfilcon a contact lens (test) compared to narafilcon a contact lens (control) over 3 hour of wear time in a japanese population.

Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: * is japanese * has had a self-reported oculo-visual examination in the last two years. * is at least 18 years of age and has full legal capacity to volunteer. * has read and understood the informed consent letter. * is willing and able to follow instructions and maintain the appointment schedule. * is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * currently wears soft contact lenses. * has clear corneas and no active ocular disease. exclusion criteria: a person will be excluded from the study if he/she: * has never worn contact lenses before. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.