Kornimate/medical-research-clean huggingface dataset:
sorafenib monotherapy vs. tace-sorafenib sequential therapy for hcc with metastasis

Conditions: Hepatocellular Carcinoma; Metastasis

Summary: sorafenib is the standard therapy for hepatocellular carcinoma (hcc) with extrahepatic metastasis (ehm). however, addition of transarterial chemoembolization (tace) may be beneficial for controlling intrahepatic tumour. the investigators aimed to compare the efficacy between the sorafenib monotherapy and tace-sorafenib sequential therapy in hcc patients with ehm.

sorafenib is the standard therapy for hepatocellular carcinoma (hcc) with extrahepatic metastasis (ehm). however, transarterial chemoembolization (tace) which is a standard therapy for intermediate stage may be beneficial for controlling intrahepatic tumour, thereby providing chance of improving survival in hcc patients with ehm. the investigators aimed to compare the efficacy between the sorafenib monotherapy and tace-sorafenib sequential therapy in hcc patients with ehm. this study is a prospective randomized controlled study being conducted at 6 tertiary hospitals in south korea. hcc patients with ehm are being enrolled and randomized into sorafenib monotherapy or tace-sorafenib sequential therapy group. patients with main portal vein invasion, child-pugh class b or c, and history of tace or previous systemic therapy are being excluded. the sorafenib monotherapy group receives sorafenib immediately after randomization while the tace-sorafenib group receives 2\~4 times of tace before starting sorafenib. response evaluation are performed every 2 months, and time to progression (ttp), progression free survival (pfs), median survival time (mst), and overall survival (os) which is the primary outcome measure will be compared.

Eligibility criteria:
inclusion criteria: * patients with hepatocellular carcinoma by the european association for the study of the liver (easl) criteria or pathology * one or more extrahepatic metastatic lesion by proven radiologically or histologically * no serious coagulation abnormalities * performance status 0 or 1 by eastern cooperative oncology group(ecog) criteria * child-pugh score 5 or 6 * serum creatinine \<1.5mg/dl * age between 18 \~ 75 years old * no other life-threatening medical illness exclusion criteria: * patients with main portal vein invasion * child-pugh class b or c * history of tace or previous systemic chemotherapy including sorafenib * age \>75 years old * cardiovascular diseases * history of gastrointestinal bleeding within 2 weeks
motivating value of vegetables study

Conditions: Overweight; Obesity

Summary: the purpose of this study is to see if perceived barriers to vegetable consumption can be overcome by making it easier for people eat more vegetables and to see if the effects last over time.

high vegetable consumption is associated with maintenance of a healthy body weight. americans do not eat vegetables in the amounts recommended by the dietary guidelines and interventions to increase intake have had limited results. reported barriers to consumption include not knowing how to prepare them and being unused to eating them.to get people to eat vegetables, they have to be motivated to do so. repeated consumption of snack foods increases overweight and obese individuals' motivation to eat snack foods. the investigators hypothesize that by increasing people's consumption of vegetables by making them easy to eat will increase the motivation value of vegetables. for this study the investigators propose to provide minimally-processed (cleaned, packaged) vegetables to overweight and obese individuals. the motivating value of vegetables will be measured using a computer task where people play a game to earn points towards portions of a vegetable or a neutral food (crackers). the investigators will determine potential moderators of the increase in the motivating value of vegetables such as genetics (single nucleotide polymorphisms) that are associated with the motivating value of food and whether people substitute eating vegetables for other foods. the investigators will also determine changes in adiposity as a result of vegetable consumption. lastly, the investigators will determine if repeated consumption increases psychosocial predictors of vegetable intake, such as self-efficacy of eating vegetables.

Eligibility criteria:
inclusion criteria: * bmi ≥ 25 kg/m2 * currently eating ≤ 1 cup of vegetables (apart from fried potatoes) per day * willing to consent to study conditions exclusion criteria: * bmi \< 25 kg/m2 * age \ 65 years * currently dieting or following specific diet * allergies or unwillingness to consume study foods * gastrointestinal disorder or disease * pregnant, lactating, or planning pregnancy * current smoker or tobacco user * high dietary restraint or certain eating patterns * inability to give consent * medications that would influence appetite, weight gain, or weight loss * exclusionary medications: didrex, tenuate, belviq, contrave, phendimetrazine, adipex-p, suprenza, xenical, qsymia, saxenda

Keywords: vegetables
antenatal detection by array cgh genomic rearrangements unbalanced front uninsulated thick neck or a combination of two signs of ultrasound calling normal karyotype

Conditions: Abnormality of the Neck; Fetus; Abnormal, Affecting Management of Pregnancy

Summary: this is the first study with a real diagnostic and prognostic focus in prenatal. in addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies. this research aims to: 1. to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis, 2. demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above, 3. assist in the diagnosis of these fetuses and genetic information for their families, 4. identify new regions of the genome potentially involved in the occurrence of congenital malformations.


Eligibility criteria:
inclusion criteria: * a karyotype performed from a trophoblast biopsy or an amniotic fluid puncture is normal or apparently balanced. * the fetuses included in the study should have one of the following two criteria: * 1) thick bone (greater than 99th percentile, between week 11 and week 13 of amenorrhoea plus 6 days, correlated to a cranio-caudal length measured between 45 and 84 mm) detected in the first trimester of pregnancy associated with one or more echographic sign (s). * 2) at least two ultrasound call signs involving the following organs (heart, kidney, brain, limbs, digestive tract, face) or intrauterine growth retardation (less than 3rd percentile) associated with one of these signs of appeal. exclusion criteria: * the parturientes in emergency situation, * benefiting from a legal protection (guardianship / curatorship)
the early integrated intervention for child brain-developmental disorders in china

Conditions: Brain Developmental Diseases; Autism Spectrum Disorder; Global Developmental Delay; Attention Deficit-Hyperactivity Disorder

Summary: this study is focused on developing the early integrated intervention for child brain-developmental disorders, including globe developmental delay (gdd), autism spectrum disorder (asd), and attention deficit-hyperactivity disorder (adhd), in china.

the early integrated intervention of gdd and asd is developed by children's hospital of fudan university. the early integrated intervention of adhd is developed by nanjing brain hospital.

Eligibility criteria:
inclusion criteria: * gdd: iq\<70, in more than 2 areas of development; * asd: diagnose must meet the criteria of dsm-v; * adhd: diagnose must meet the criteria of dsm-v, and iq\>70 tested by wechsler intelligence scale； * at least one of the parents could take part in the whole courses, and do the training at home. exclusion criteria: * physical disability, visual or hearing loss; * combined other sever chronic diseases: liver or kidney function failure, rheumatic diseases, or tumor, and so on;
effect of shock wave therapy on truncal obesity and lipid profile in obese post menopausal women

Conditions: Obesity

Summary: this study aimed to evaluate the effect of six weeks extracorporeal shockwave therapy (swt) on truncal obesity and serum lipids in obese postmenopausal women

truncal obesity occurs when the excess abdominal fat around the stomach and abdomen has accumulated to the point where it is likely to have a negative influence on health , increased visceral abdominal fat (vaf) is directly related to abdominal obesity (ao), which is also linked to endothelial dysfunction, inflammation, insulin resistance, diabetes mellitus, hypercholesterolemia, hepatic steatosis metabolic syndrome \[mets\] and cancer. high density lipoprotein (hdl) cholesterol, often known as cardio protective cholesterol, increases in a hypoestrogenic state such postmenopausal status, whereas triglyceride (tg), total cholesterol, and ldl cholesterol levels fall the prevention of cvd and dyslipidemia depends on the management of truncal obesity, and the reduction of serum lipid levels. extracorporeal shock wave therapy (eswt) has lately been popular for treating fat-related disorders by altering the permeability of lipocyte membranes, improving blood flow and hastening macrophages' clearance of debris so cellulite, body contouring and localized fat can all be treated with the safe and non-invasive eswt technology because to its mode of action in biological tissue in order to identify the best methods for treating abdominal obesity and prevent the risk of developing cardiovascular disease (cvd) in post-menopausal women. the current randomized controlled trial aimed to determine the effect of extracorporeal shockwave therapy (swt) on truncal obesity and serum lipids in obese postmenopausal women.

Eligibility criteria:
inclusion criteria: * obese post menopausal women body mass index more than or equal 30kg/m2 waist circumference more than or equal 88 cm waist hip ratio more than or equal 0.88cm women not engaged in any procedure to treat obesity or received medication from 6 months exclusion criteria: * women diagnosed with malignancies or received chemical or radiotherapy or hormone replacement therapy or corticosteroids or diagnosed with liver disease or active infection or trauma

Keywords: obesity-menopause-shock wave-lipid profile
family help program: nighttime enuresis treatment program

Conditions: Enuresis

Summary: the purpose of the strongest families (formerly family help program)is to evaluate the effectiveness of the strongest families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate enuresis diagnoses. this is a single-centre trial based at the iwk health centre. the primary outcome is change in diagnosis.

the purpose of the family help program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. approximately 46 children (5-12 years of age)suffering from pediatric enuresis (at least 2 times a week) will be randomized. the intervention is delivered from a distance, using the urine alarm system accompanied by educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. the telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team. fifty percent of the eligible participants will receive family help program telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. those receiving standard care will be evaluated for outcome results and then compared to the family help treated participants. it is anticipated that family help treatment will be proven to be as or more effective than standard care.

Eligibility criteria:
inclusion criteria: * is your child 3 to 12 years of age * child wets the bed more than twice per week * child dry during the day exclusion criteria: * child received any treatment for bedwetting in the past 6 months * child at any time been dry for 6 months or longer * child currently on imipramine or desmopressin
utract jelmyto registry: a registry of patients with upper tract urothelial cancer (utuc) treated with jelmyto

Conditions: Urothelial Carcinoma; Urothelial Carcinoma Recurrent; Urothelial Carcinoma Ureter; Urothelial Carcinoma Ureter Recurrent; Urothelial Cancer of Renal Pelvis; Urothelial Carcinoma of the Renal Pelvis and Ureter; Carcinoma, Transitional Cell; Transitional Cell Carcinoma of Renal Pelvis

Summary: the purpose of this registry is to evaluate real world experience and outcomes of patients with upper tract urothelial cancer (utuc) treated with jelmyto in the united states.

patients may be enrolled prospectively, at the time of receiving jelmyto, or after receiving jelmyto for retrospective data capture and prospective follow up. patients will be followed until 3 years after the first dose of jelmyto or death. data will be captured to address specific clinical questions and data gaps related to real world use of jelmyto. example clinical questions: 1. how is jelmyto used in the real world setting? 2. what adverse events (aes) and at what rates and time points are they observed in the real world setting? 3. what is the disease volume before and after resection/ablation prior to treating with jelmyto? 4. did the use of jelmyto impact clinical decision making and management? 5. what is the complete response (cr) rate, duration of response, and rate of progression, including subgroups of interest? 6. what are the rates of, time to, and pathology at radical nephroureterectomy (rnu) by response to treatment and number of jelmyto doses received? 7. what are outcomes for non-responders or partial responders? what are the rates of surgical and therapeutic treatment options received following response assessment, including additional jelmyto? 8. what was the outcome of patients with solitary kidney and/or chronic kidney disease (ckd)? did jelmyto prevent dialysis by avoiding nephrectomy in solitary kidney or in patients with baseline ckd? 9. what is the rate and timing of bladder cancer occurrence and/or recurrences?

Eligibility criteria:
inclusion criteria: * adults \>18 years old and capable of giving informed consent. * diagnosis of utuc. * receipt of at least 1 dose of jelmyto after fda approval (15 apr 2020). exclusion criteria: * incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia). * receipt of 1 or more doses of jelmyto (also referred to as ugn-101 or mitogel in clinical development) before fda approval (on or before 15 apr 2020). * pregnancy or lactation. * unable to comply with protocol requirements (for prospective data capture). * any medical or mental condition(s) that makes participation in the registry inadvisable in the opinion of the investigator (for prospective data capture).

Keywords: upper tract urothelial cancer utuc ugn-101 mitomycin c tcc ureteral upper tract carcinoma kidney renal gel local prolonged release slow release kidney sparing recurrence neoplasms by histologic type neoplasms urologic neoplasms urogenital neoplasms neoplasms by site antibiotics, antineoplastic antineoplastic agents alkylating agents nucleic acid synthesis inhibitors enzyme inhibitors
surgery plus target-reduction chemoradiotherapy vs regular chemoradiotherapy for newly diagnosed resectable nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: through a prospective clinical trial, we intend to combine surgery, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined surgery could bring patients better local-regional control and lower adverse reactions.


Eligibility criteria:
inclusion criteria: * performance status score 0-1 points. * non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., who type ii or iii) confirmed histologically and/or cytologically. * patients with primary nasopharyngeal lesions evaluated as surgically resectable before chemotherapy, including t1 (tumor limited to nasopharynx), t2 (tumor limited to the surface of parapharyngeal space) and t3 (tumor limited to the bottom wall of sphenoid sinus or pterygoid process). clinical stage: t1-3n1-3m0, t2-3n0m0 (stage ii-iva) according to ajcc v8. * patients with cervical lymph nodes evaluated as surgically resectable before chemotherapy, including cervical lymph nodes with no invasion (encasement) of the common or ica, the epidermis, mediastinal structures, prevertebral fascia, or cervical vertebrae. * patients with retropharyngeal lymph nodes evaluated as surgically resectable before chemotherapy, including simple rplns with intact capsule or rplns ≤ 1.5cm with mouth opening range \> 4cm. * adequate organ function: wbc ≥ 4×10\^9 /l, neut ≥ 2×10\^6 /l, hgb ≥ 9 g/dl, plt count ≥ 100×10\^9/l, tbil ≤1.5 uln (tbil ≤3 uln for patients with gilbert disease), alt ≤3 uln, ast ≤3 uln, alp ≤3 uln, alb ≥ 3 g/dl, inr or aptt≤1.5 uln, scr ≤1.5 uln or ccr ≥ 60 ml/min. * informed concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol. exclusion criteria: * diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy. * suffering severe cardiopathy or pulmonary dysfunction with cardiac or pulmonary function no more than grade 3. * extensive recurrent primary tumour beyond the resectable area such as extensive invasion of the skull base or a distance from the tumour margins to the internal carotid artery of less than 0·5 cm. * retropharyngeal lymph node involved or adjacent to primary nasopharyngeal lesions (less than 0·5 cm). * unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons. * during pregnancy or lactation. * other patients that the chief physician considered as illegal for this trial.

Keywords: surgery target-reduction chemoradiotherapy locally resectable nasopharyngeal carcinoma
a phase 1/ phase 2 study of tthx1114(nm141)

Conditions: Corneal Endothelial Dystrophy; Fuchs Endothelial Corneal Dystrophy; Pseudophakic Bullous Keratopathy; Endothelial Dysfunction

Summary: prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study

this is a prospective, multi-center, randomized, masked, vehicle-controlled, dose-escalation study that will include an observational (no intervention) sub-study. eligible subjects with moderate to severe corneal endothelial dystrophy (defined as endothelial cell density \< 2000 mm\^2) in at least one eye will be enrolled and randomized.

Eligibility criteria:
key inclusion criteria: * fuchs endothelial corneal dystrophy, pseudophakic bullous keratopathy, or endothelial dysfunction/ insufficiency due to surgical intervention diagnosed more than 6 months prior to study day 0 * central endothelial cell count of \< 2000 mm\^2 in at least one eye as determined by the central reading facility key exclusion criteria: * conditions that would impair examination of the anterior chamber structure * documented repeated elevated intra ocular pressure (in either eye) * corneal transplant (in either eye) * posterior polymorphous corneal dystrophy (ppcd) * history of uveitis or herpetic keratitis * cataract surgery within the past 3 months * refractive surgery (in the study eye) * anterior chamber iol placement (in the study eye) * active extra-ocular inflammation from any non-infectious or infectious cause within the past 6 months * expected or planned ocular surgery within the next 3 months * use of cytotoxic chemotherapy within the last 1 month * treatment with a rho kinase inhibitor within the last 3 months * use of cyclosporine ophthalmic emulsion or lifitegrast ophthalmic solution in the last 30 days * systemic or ophthalmic corticosteroid use in the 30 days prior to study day 0 unless approved by the medical monitor * history of significant allergy, hypersensitivity, or intolerance to any drug compound, food, or other substance * unwilling to use birth control
effect of hco1100 on cardiovascular function

Conditions: Cardiovascular Disease; Chronic Kidney Failure

Summary: the purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.

cardiovascular events are the leading cause of the increased mortality rate of chronic dialysis patients. it is believed that increased micro-inflammation plays an important role in the pathophysiological process of cardiovascular disease. high porous dialysis membranes can better eliminate inflammatory mediators as compared to standard dialysis membranes. in this study, the high porous dialysis membrane hco1100 is investigated for its potential capability to improve the cardiovascular status of chronic dialysis patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * dialysis dependent chronic renal failure (ckd 5) in a stable condition * serum albumin at randomisation equal to or above the median of the normal range (pre- dialysis value) exclusion criteria: * diabetes mellitus as the disease underlined end stage renal failure * haemodynamic instability that precludes unsupported dialysis * planned surgical interventions \<= 4 months at time of inclusion * known allergy against dialysis membranes * significant cardiac disease (atrial fibrillation, myocardial infarction within 6 months; unstable angina pectoris; lv-ef \< 30%, clinically significant pericardial disease; cardiac amyloidosis) * pulmonary disease with chronic hypoxia * advanced disease or significant co-morbidity with poor short term prognosis, necessitating palliation and not subject to active or disease specific treatment * clinically significant liver dysfunction (bilirubin \> 1.8mg/dl (30µmol/l)) * prior fistula surgery on both arms or other operations or paralysis on both arms * known hiv, hcv infection * alcoholism * active uncontrolled infection * pregnancy or lactation * inability to give informed consent to participate in the study

Keywords: ckd5 dialysis high porous membranes micro-inflammation
super-bolus: effects on postprandial glycemia after high glycemic index meal

Conditions: Diabetes Mellitus, Type 1

Summary: the aim of this study is to determine whether super-bolus is more effective in postprandial glycemic control than normal-bolus after the high glycemic index (h-gi) meal in children with type 1 diabetes (t1dm) treated with insulin pump (continuous subcutaneous insulin infusion, csii).


Eligibility criteria:
inclusion criteria: * duration of type 1 diabetes longer than 12months, * insulin pump therapy longer than 3 months, * written informed consent to participate in the study signed by parents (and patient older than 16 years). exclusion criteria: * celiac disease, * diabetes related complications (e.g. nephropathy), * bmi at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex, * withdrawal of consent to participate in the study, * comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.

Keywords: super bolus diabetes type 1 insulin bolus high glycemic index meal prandial insulin requirement postprandial glycemia insulin pump therapy