Kornimate/medical-research-clean huggingface dataset:
keto drinks as a meal primer in patients with type 2 diabetes

Conditions: Type 2 Diabetes; Ketoses, Metabolic

Summary: the main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-ohb), just before a meal in patients with type 2 diabetes. moreover the investigators will compare the effects of two different ketone drinks. the hypothesis is: 3-ohb as a pre-meal may: * lower postprandial blood glucose and lipids. * mediate release of intestinal hormones and affect gastric emptying. * affect appetite and other subjective measures related to food intake. the effects of 3-ohb as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosis, metformin treated or dietary treated * hba1c \< 80 mmol/mol * 25 \< bmi \< 35 * written consent exclusion criteria: * severe comorbidity * treatment with insulin, glp-1 analogues, sglt-2-inhibitors or sulfonylureas * specific diets, e.g. ketogenic diet * pi finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)
phase i mitomycin combined with bacillus calmette-guérin (bcg) for bladder cancer

Conditions: Urinary Bladder Neoplasm

Summary: the study aims to establish the safety and toxicity of a combined intravesical mitomycin c with bcg for patients with bladder cancer.

urine sample collection and handling: voided urine will be collected pre and post bcg procedure. urinalysis will be performed if participant presents with urinary symptoms. analysis of urinary cytokines as predictors of response to therapy will be conducted by elisa kits. tissue sample collection and handling: tissue biopsy specimens will be collected pre bcg procedure. analysis of gene expression will be conducted. test procedures subjects will be given one of three concentrations of mitomycin c (mmc) (10 mg in 20 ml, 20 mg in 20 ml or 40 mg in 20 ml) for 30 minutes followed by a 10 minute washout period. followed by three concentrations of bcg including ¼ strength, ½ strength, and full strength for 2 hours. dose escalation will take place among subsequent patients and not within each patient. approximately 30 subjects will be enrolled to reach the target completion enrollment of 10 subjects. long-term follow-up a chart review will be conducted every three months for 2 years after initial 6 month study data collection. patient charts will be reviewed to assess disease progression and any data supporting findings. long-term follow-up is necessary to determine recurrence rates and long-term safety and efficacy of mitomycin/bcg treatment therapy as well as bcg therapy in the control group.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed or recurrent multi-focal ta, large ta, high-grade ta, cis, or t1 bladder cancer 2. in urologist's opinion a good candidate for bcg induction therapy 3. be able to give informed consent 4. be age 18 or older. exclusion criteria: 1. inadequate marrow function (defined as granulocytes less than 1,500 cells/mm3 and platelets less than 150,000 cells/mm3) 2. immunosuppressed state (e.g. hiv, use of chronic steroids)

Keywords: bladder cancer mitomycin bcg intravesical non-muscle invasive
erythropoietin treatment in extremely low birth weight infants

Conditions: Infant, Low Birth Weight; Anemia

Summary: objective: to investigate whether recombinant epo reduces the need for transfusion in extremely low birth weight (elbw) infants and to determine the optimal time for treatment. the concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. study population: 219 patient randomized into 3 groups

methods: blinded , multicenter trial, elbw infants were randomized on day 3 to one of 3 groups: early epo group (rhepo from the first week for 9 weeks , n= 74), late rhepo group (rhwepo from the fourth week for 6 weeks, n=74), or control group (no rhepo, n= 71). all infants received enteral iron (3-9 mg/kg/day) from the first week. the rhepo ß dose was 750 iu/kg/week. success was defined as no transfusion and hematocrit levels never below 30%. the concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. clinical and nutritional data were recorded prospectively.

Eligibility criteria:
inclusion criteria: * extremely low birth weight infants exclusion criteria: * cyanotic heart disease * major congenital malformation requiring surgery * gestational age \> 30 weeks * administration of an investigational drug during pregnancy * lack of parental consent

Keywords: extremely low birth weight infants transfusion need erythropoietin trace elements antioxidant enzymes reduction of the transfusion need by epo treatment trace elements and antioxidant enzymes in blood
efficacy of icg-based nir imaging in intralesional curettage of giant cell tumors of bone in limbs: a prospective, single-center, single-arm, open study

Conditions: Giant Cell Tumor of Bone

Summary: icg fluorescence imaging will be applied during the intralesional curettage of giant cell tumor of bone in the limbs. this study aims to preliminarily explore whether icg fluorescent-guided curettage could find small residual tumors and reduce the recurrence rate of tumor.

recurrence is a problem in the treatment of giant cell tumor of bone(gctb). with the application of high-speed burr and other adjuvant therapy (phenol, liquid nitrogen freezing, cauterization, etc.), the recurrence rate is greatly reduced, but it is still as high as 20%. the main cause of local recurrence is the difficulty in distinguishing small residual tumor lesions by the naked eye. the application of frozen section is limited due to the long-term decalcification of bone specimens. intraoperative near-infrared (nir) imaging is a promising technology expected to solve the above problems. it allows for real-time scanning of a wide area with tumor showing fluorescence. such intraoperative fluorescent signals provide objective evidence for the surgeon and are more reliable than subjective visual and tactile information. this study aims to explore whether icg-based nir imaging guided curettage could find small residual tumors and reduce the recurrence rate of gct.

Eligibility criteria:
inclusion criteria: 1. . aged 18-65. 2. biopsy confirmed giant cell tumor of bone. 3. the lesions located in the limbs. 4. this operation is the initial treatment. 5. denosumab and diphosphonates are not used before surgery. 6. planned operation is intralesional curettage and filling bone defects with bone cement. 7. preoperative bone scan and thin layer (layer thickness ≤3.5mm) chest ct plain scan confirmed that the lesion is a single occurrence without metastasis. 8. subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent. exclusion criteria: 1. . known allergy to iodine contrast, indocyanine green or bone cement. 2. . severe hepatic and renal insufficiency. 3. . during pregnancy or lactation. 4. . have other malignant tumors and are receiving related medical treatment.

Keywords: icg giant cell tumor of bone curettage
clinical efficacy of glucosamine plus diacerein versus mono-therapy of glucosamine

Conditions: Osteoarthritis; Glucosamine; Diacerein

Summary: the purpose of this study is to compare pain scores, womac total and subscores, actual and change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine in oa patients


Eligibility criteria:
adult patients age 50 years or older who have been diagnosed as primary or secondary osteoarthritis of the knee base on clinical criteria of american college of rheumatology inclusion criteria: * clinical diagnosis of primary osteoarthritis * mild deformity clinical (having no varus or valgus deformity, no crepitus) ? physical examination grade 0 assessed by stress test radiographic assessment (kellgrane-lawrance type ii-iii), a minimum baseline medial tibiofemoral jsw of _2 mm. * willing to participate and provide written informed consent exclusion criteria: * non-secondary osteoarthritis rheumatoid arthritis, inflammatory arthritis (e.g. sle, gout), post traumatic osteoarthritis, those who received intra-articular treatment of the signal joint with any product (corticosteroids in the previous 2 months, or glycosaminoglycans/hyaluronic acid in the previous 6 months) or had undergone joint lavage andarthroscopic procedures in the previous 6 months. * no contraindication of using diacerein and glucosamine * non-current or ex-users of oral sysadoa (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics known hypersensitivity to diacerein, to similar compounds, to the excipients or to paracetamol

Keywords: osteoarthritis glucosamine sulfate diacerein randomized controlled trial
robotic-assisted upper extremity training in spinal cord injury patients

Conditions: Spinal Cord Injury Cervical

Summary: study design: controlled trial objective: to evaluate the effectiveness of robotic-assisted training of forearm and hand functions in spinal cord injury patients setting: ankara physical medicine and rehabilitation training and research hospital, turkey methods: forty patients were allocated into robotic and control groups. both groups received conventional rehabilitation program for four weeks. moreover, robotic group received robotic rehabilitation program tailored to the patient five times a week (each session of 30 min). baseline data and post-intervention data was compared.


Eligibility criteria:
inclusion criteria: * ages between 18-50 * cervical level of spinal cord injury exclusion criteria: * severe upper extremity contractures in the joints * intensive spasticity (ashworth 3-4) * shoulder pain that causes exercise intolerance
preoperative prediction of flexible ureteroscopy outcome in the treatment of renal calculi

Conditions: Flexible Ureteroscopy

Summary: to predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free status postoperatively.

although flexible ureteroscopy has been in use for decades, neither the european association of urology (eau) nor the american urological association (aua), in their clinical guidelines, recommends flexible ureteroscopy (furs) as a first-line procedural treatment for renal stones . several reports showed that furs is a suitable alternative to shockwave lithotripsy (swl) and percutaneous nephrolithotripsy (pcnl) for the treatment of renal stones, with potentially higher stone-free rates than swl and lower morbidity than pcnl. safe and effective removal by furs of multiple and large intrarenal stones, including lower pole calculi, has been documented suggesting that furs is effective for complex intrarenal stone removal . with the multitude of available procedures, selection of the optimal one for management of renal stone is becoming more challenging. established models for predicting the outcomes of swl and pcnl exist . however, a predictive model for predicting the outcome of urs is still in development , particularly for furs treatment of renal stones. four scores have been developed for furs. two of these have been compared and validated in different cohorts: the resolu unsal stone score (russ) and modified seoul national university renal stone complexity (s-resc) score , the other two scores, the s.t.o.n.e score described by molina et al. and ito's nomogram. many studies have demonstrated that stone volume is the most significant factor predictive of stone-free status (sf) after furs. the investigators speculate that stone volume combined with other variables might improve prediction of sf after furs. the aim of the present study is to evaluate various preoperative parameters as predictors of furs outcome based on the ito's nomogram

Eligibility criteria:
inclusion criteria: 1. renal stones (≤ 2 cm) 2. radiolucent stone resistant to swl and oral chemical dissolution treatment (≤2cm) exclusion criteria: 1. large stones (\> 2 cm). 2. staghorn stone (stone involving the renal pelvis and more than two calyces). 3. patient preference of other treatment modality
impact of soymilk on liver disease severity of children with non-alcoholic fatty liver disease (nafld)

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: a randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with non-alcoholic fatty liver disease (nafld). the investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing nafld and other obesity-related comorbidities. the investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.


Eligibility criteria:
inclusion criteria: * children with overweight/obesity * non-alcoholic fatty liver disease (nafld) and an mri pdff \>10% * known nafld or elevated alt for sex (\>22 for females and \>26 for males) exclusion criteria: * mri-pdff \<10% * baseline habitual (\>3 days per week) consumption of soy foods * allergy to soy or cow's milk protein * inability to undergo mri * recent (past 8 weeks) antibiotic exposure * treatment for existing endocrine disorders

Keywords: nafld
misoprostol effect on second trimester abortion blood loss

Conditions: Blood Loss, Surgical; Second Trimester Abortion

Summary: although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. misoprostol is a prostaglandin e1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage, however the effect of preprocedural misoprostol on procedural blood loss is not well described. we will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at stanford health care. participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure. a quantified blood loss (qbl) will be measured during the procedure and participants will complete a survey to assess symptoms. our primary outcome is quantified blood loss. secondary outcomes include clinical interventions to manage excess bleeding, total procedure time, provider reported experience, patient reported experience.


Eligibility criteria:
inclusion criteria: * pregnant people, 18 years of age or older; intrauterine pregnancy between 18/0-23/6 weeks of gestational age (by ultrasound dating performed prior to same day of enrollment visit) consented for an induced abortion; english or spanish speaking, able to consent for a research study, literate in english or spanish. exclusion criteria: * known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.
melatonin secretion and sleep quality in spinal cord injury patients

Conditions: Spinal Cord Injuries

Summary: to evaluate the relationship between secretion of melatonin and sleep quality in spinal cord injury patients versus a database of healthy volunteers.

melatonin is a neurohormone secreted by the pineal gland and excreted by the urinary tract. it has a key role in the synchronisation of circadian rhythms including the sleep wake cycle, with a peak secretion around 03:00. the neural pathway controlling melatonin secretion is long and transits via the thoracic spine. the exact level is not known, but interruption of the connection in patients with lesions of the spinal cord is known to occur. tetraplegic patients often complain of insomnia, daytime sleepiness and poor sleep quality but the contribution of melatonin levels to sleep quality has not been explored in large studies, although case reports have shown reduced or abolished melatonin secretion and altered melatonin secretion profiles with delayed peak secretion. paraplegic patients report fewer sleep difficulties and little is known about melatonin secretion in this group. the investigators hypothesize that sleep abnormalities are related to abnormalities in melatonin secretion and that this is in turn related to the level of the spinal cord injury the study aims to explore the profiles of melatonin secretion in patients with spinal cord injuries and comparing melatonin profiles with a database of healthy volunteers. the investigators will further analyse the results looking at the severity of spinal cord injury using the abbreviated injury scale (ais) and the level of the injury. outcome measures are melatonin secretion profile, sleep complaints measured using the pittsburgh scale and daytime sleepiness measured using the epworth sleep scale.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years * spinal cord injury patient * all score ais * with a chronic lesion (more than 6 months from initial injury) * signed informed consent exclusion criteria: * pregnant women * breast feeding women * refusal to participate at study * not covered by national health insurance scheme * patient unable to give informed consent * transmeridian flight crossing more than 3 time zones in the month preceding the study * recent treatment with melatonin (\< 1 month) or beta blocker

Keywords: tetraplegia spinal cord injury melatonin sleep quality sleepiness
tranexamic acid for upper gastrointestinal bleeding

Conditions: Acute Upper Gastrointestinal Hemorrhage

Summary: this study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.

previous studies reported that iv/oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. however, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and ppi administration are considered norm. although a recent meta-analysis done by cochrane review group concluded that it improves patient survival, other review articles including "gut" suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. we hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.

Eligibility criteria:
inclusion criteria: 1. chief complaint of hematemesis, melena or hematochezia 2. and objective signs of upper gastrointestinal bleeding exclusion criteria: 1. pregnant woman, age less than 18 2. patients whose use of the study drug is contraindicated * increased thromboembolic risk * history of thromboembolic disease * alleged inherited thrombophilic disorders * malignancy (except those cured and has not recurred more than two years) * nephrotic syndrome * estrogen use * pregnancy * hit, apa * high-risk for cardioembolism * underlying structural heart disease where anticoagulation is indicated * underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter) * possibilities of ongoing dic * signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature \> 38 degree) * any malignancy except those cured and has not recurred more than two years * patients with history or presence of subarachnoid hemorrhage * acquired color vision impairment, visual loss and retinal venous and arterial occlusions * past history of seizure or organic brain lesion that predispose to seizure disorder 3. previous history of variceal bleeding 4. cases where informed consent is unobtainable

Keywords: gastrointestinal hemorrhage peptic ulcer hemorrhage hematemesis melena tranexamic acid
evaluation of treatment response using multiparametric mri after prostate radiotherapy

Conditions: Prostate Cancer

Summary: the purpose of this study is to better understand prostate cancer changes after radiation treatment, through magnetic resonance imaging (mri). mri is an imaging test that allows doctors to see prostate gland without any operation procedures. it can help identifying the tumors in the prostate. for patients with newly diagnosed prostate cancer, mri may help doctors manage treatment better and sooner.


Eligibility criteria:
inclusion criteria: * patients with biopsy proven (completed and/or reviewed at msk) adenocarcinoma of the prostate, who will undergo external beam radiotherapy using conventional fractionation igrt including moderate hypofractionated radiation, low rate brachytherapy alone, brachytherapy (either high dose or low dose) combined with supplemental image guided radiation (including igrt, ebrt, and sbrt), sbrt, or proton radiotherapy. * age ≥ 18 years old * baseline mp-mri, which is obtained at mskcc main campus on the 3-tesla philips mri unit as part of the standard (clinical) staging assessment demonstrates at least one dominant or visible lesion which measures \> 0.5 cm in maximum axial diameter as assessed on t2-weighted images. * no prior history of androgen deprivation therapy within the last month. however patients who will receive neoadjuvant and concurrent and adjuvant hormonal therapy will be eligible. * willing to come to msk main campus for baseline and follow-up mp-mris. exclusion criteria: * history of radical prostatectomy * patients who are unwilling or unable to undergo mri including patients with contraindications to mri such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc. * patients with a metallic hip implant, metallic implant or device in the pelvis or ferromagnetic fiducial beacons (calypso) that might distort local magnetic field and compromise quality of mp-mri * patients in which gadolinium contrast is contra-indicated. * metastatic disease

Keywords: mri 14-172
prevention of contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions

Conditions: Kidney Disease, Chronic; Ischemic Heart Disease

Summary: there is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. the current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions


Eligibility criteria:
inclusion criteria: patients with estimated glomerular filtration rate\<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines: 1. elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle. 2. non st-elevation acute coronary syndrome with a grace score\>110 exclusion criteria: * patients on dialysis or those planned for dialysis in the next 3 months. * patients with st-elevation myocardial infarction * no symptoms or signs of heart failure * treatment with iv diuretics during the 48 hours prior to enrolment * patients with acute renal failure (creatinine raise of at least 0.3mg/dl from )baseline * patients post coronary artery bypass surgery