Kornimate/medical-research-clean huggingface dataset:
synergistic treatment for hepatocellular carcinoma (hcc) using tace with antiangiogenesis

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in china)which is also administrated via the hepatic artery. the hypothesis of this protocol is that tace with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of tace.


Eligibility criteria:
inclusion criteria: * patients with cytologically or histologically documented hcc, who are candidates for tace * child-pugh child a or b * age \>= 18 * measurable disease by recist criteria; * performance status ecog 0-2 * previous local therapy completed \> 4 weeks * written informed consent signed * normal organ and marrow function defined as: haematopoietic: * wbc ≥ 3,000/µlplatelet count \> 80,000/mm3 * haemoglobin \> 9g/dl * hepatic: albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; ast or alt \< 5 x uln * renal: creatinine \< 1.5 x uln exclusion criteria: * metastases * prior or concomitant chemotherapy or radiation therapy * vegf/vegfr- inhibitors or other anti-angiogenesis agents * severe and/or uncontrolled medical conditions: * congestive heart failure, serious cardiac arrhythmia, active coronary artery * severe renal impairment * patients who anticipate receiving major surgery during the course of the * pregnant or breastfeeding patients * evidence of bleeding diathesis

Keywords: liver cancer interventional radiology chemoembolization safety effectiveness
optimal dietary treatment of obese adults

Conditions: Obesity; Overweight

Summary: recent decades have shown an alarming increase in obesity. obesity is associated with high costs for both the individual and for society. it is therefore important to prevent and treat obesity. the investigators believe that if you add a self-help weightloss book and teach cooking skills to a standard dietary treatment, then it will result in greater weight loss than with dietary treatment alone. however, this has not yet been studied. since it will require more resources, it is important to investigate whether it also works better before changing the current treatment. hypothesis: conventional dietary treatment supplemented with a self-help weightloss book and cooking classes are more effective than dietary treatment alone in changes in body weight and body composition in obese persons over a period of 12 months. there is no difference if the intervention are based on the national dietary guidelines or a relative low-gi and high-protein diet. secondary to investigate the impact the interventions have; on diet quality and quantity, on markers of metabolic syndrome and on how many subjects complete the study.


Eligibility criteria:
inclusion criteria: * bmi ≥ 25 * waist: female ≥ 88 cm; male ≥ 102 cm) * stable weight for the past three month (+- 5 kilogram) * motivated to make changes in their dietary habits exclusion criteria: * waist \> 150 cm * significant cardiovascular, renal or endocrine disease * psychiatric history * treatment with steroids * alcohol- or drug-addiction * pregnancy or lactation * obesity surgery

Keywords: weight loss dietary intervention self-help book cooking dietitian dietary therapy
therapeutic drug monitoring of guselkumab in psoriasis patients

Conditions: Psoriasis Vulgaris

Summary: biologic such as guselkumab are currently the most effective treatment option for patients with moderate to severe psoriasis. but they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. in this study we aim to investigate the predictive value of early serum trough levels of guselkumab and determine the therapeutic window of guselkumab in psoriasis patients.

patients will be included after signing informed consent. after inclusion, patients will continue on standard dosing schedule of guselkumab (i.e. one loading dose (100 mg) at week 0 and week 4 and followed by subcutaenously injections every 8 weeks). during each study visit blood will be taken in order to quantify ctroughs and/or anti-drug antibodies towards guselkumab. in addition, psoriasis area and severity index (pasi) and investigator's global assessment (iga) score will be evaluated by a physician. patients complete the dermatology life quality index (dlqi) and european quality of life eq-5d instrument at each visit.

Eligibility criteria:
inclusion criteria: 1. participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis 2. participants must sign an icf indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study exclusion criteria: 1. participants who have currently a predominant nonplaque form of psoriasis 2. participants who are pregnant, nursing or planning a pregnancy 3. participants who are unable or unwilling to undergo multiple venapunctures 4. participants who are treated according to a different dosing schedule than standard dosing of guselkumab

Keywords: therapeutic drug monitoring psoriasis guselkumab
drug interaction between ritonavir and sitaxsentan

Conditions: Pulmonary Arterial Hypertension

Summary: the study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.


Eligibility criteria:
inclusion criteria: * healthy male subjects and/or women of non-child bearing potential. * subjects (because of teratogenic risk of sitaxsentan) between the ages of 21 and 55 years, inclusive. * signed informed consent. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * history of significant alcohol and drug use. * has hepatic dysfunction.

Keywords: sitaxentan ritonavir drug interaction pharmacokinetics
12-week efficacy of indacaterol

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this 12-week study evaluated the efficacy and safety of indacaterol versus placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd) (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease \[gold\] guidelines, 2008) and: * smoking history of at least 10 pack-years * post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥ 30% of the predicted normal value * post-bronchodilator fev1/fvc (forced vital capacity) \< 70% exclusion criteria: * patients who have had a copd exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular co-morbid conditions other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: copd indacaterol
characteristics of patients with recessive dystrophic epidermolysis bullosa

Conditions: Epidermolysis Bullosa Dystrophica

Summary: recessive dystrophic epidermolysis bullosa (rdeb) is a disease caused by genetic mutations in the gene for type vii collagen. patients with rdeb develop large, severely painful blisters and open wounds from minor trauma to their skin. we are screening subjects with rdeb to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy and determine whether subjects could be candidates for treatment studies.

we will obtain a detailed medical history and will perform a skin examination and brief physical exam. photographs may be taken. we will ask questions about the size and duration wounds. lab tests we will draw blood to determine overall health status to include hepatitis b, hepatitis c, and human immunodeficiency virus (hiv) testing. genetic testing may also be performed. biopsies biopsies may be collected to check for collagen 7 and for antibodies to collagen 7. based on the results obtained, it may be possible to identify patients who would qualify to participate in current or future clinical trials.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of rdeb by local dermatologist * 7 years of age or older exclusion criteria: -medical instability limiting ability to travel to stanford university medical center
plasma determination of glucagon-like peptide 2 as a predictor of recovery in adults with acute intestinal failure

Conditions: Short Bowel Syndrome

Summary: the purpose of this study is to investigate the theory that the plasma level of glucagon like peptide 2 (glp-2) in patients with intestinal failure can predict their clinical recovery.

when major segments of small bowel have been removed surgically, or damaged by disease, the length of the residual bowel may be inadequate to maintain overall nutrition and the net result is described as "intestinal failure". without medical intervention, patients with intestinal failure become malnourished and dehydrated because their remaining intestine is unable to absorb enough water, vitamins and other nutrients from the ingested food. intravenous feeding offers life saving treatment but causes complications like infections and liver problems. it also poses enormous strain on day to day life. glucagon like peptide 2 (glp-2) is a naturally occurring hormone (or chemical messenger) that is able to increase the surface area of the intestinal lining (or mucosal mass) and the absorptive efficiency of the remaining intestine. intestinal failure patients in whom not only parts of the small bowel but also the large bowel have had to be surgically removed have been shown to have a markedly impaired rise in glp-2 levels following meals, in contrast to patients with a preserved large bowel who have increased levels of glp-2 and are known to have much better functional adaptation. from this we hypothesise that the glp-2 level is directly related to, and could predict, clinical recovery in intestinal failure as measured by amount of parenteral nutrition required length of hospital stay mortality we also aim to compare glp-2 levels of patients with acute intestinal failure with that of patients with chronic intestinal failure as well as healthy controls

Eligibility criteria:
inclusion criteria: * men and woman, aged 18 years of age or older at the time of signing the informed consent form. * referral to or direct admission to st. mark's hospital. * acute intestinal failure resulting in tpn dependency as a result of major intestinal resection performed during admission to st. mark's or at the referring hospital. exclusion criteria: * inability to give consent or comply with the study. * inability to take test meal (unable to be tested) * severe renal impairment (interference with glp-2 excretion) * severe uncorrected anaemia (preventing additional blood-letting) * uncontrolled diabetes mellitus (risk of hyperglycaemia)

Keywords: short bowel syndrome intestinal failure glucagon like peptide 2 parenteral nutrition
aerobic training with and without resistance training in polycystic ovarian syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) characterized by a chronic disorder in ovulation along with hyperandrogenism has become one of the most common endocrine disorders in women of reproductive age with an estimated 5%-15% prevalence. it has the symptoms such as menstrual disorders, infertility, hyperandrogenism, obesity, hirsutism and acne. pcos is linked to psychological morbidities e.g. increased risk of stress, depression, low self-esteem, poor body image, and reduced health-related quality of life. approximately 75% of people with pcos have a fat accumulation in the central area of the body.

a randomized controlled trial will be conducted to determine the effects of aerobic training with and without resistance training on the waist to hip ratio, qol and menstrual dysfunction in polycystic ovarian syndrome. a sample size of 22 pcos women's will be taken, data will be collected from jinnah hospital lahore by using pcosq and sf-36 questionnaire. a written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. one group undergoing aerobic with resistance exercise training i.e., the experimental group and other with aerobic exercise i.e., control group. the interventions will be provided for 30 mints for 3 days per week for 2 months. all participants in both groups will be evaluated before and after the treatment programs.

Eligibility criteria:
inclusion criteria: * age 18-40yrs * waist to hip ratio \>87(20) * women who are diagnosed according to rotterdam criteria e.g. oligo/anovulation, hyperandrogenism, and polycystic ovaries.(21) * female who physically able to performs exercise exclusion criteria: * women who are smoking and using drugs for depression. * married women * women with other pathological conditions like diabetes and thyroid diseases. * females who are not able to perform resistant exercise

Keywords: polycystic ovarian syndrome quality of life waist to hip ratio aerobic exercise resistance training
the china longitudinal aging study of cognitive impairment

Conditions: Mild Cognitive Impairment; Alzheimer Disease; Dementia, Vascular; Dementia With Lewy Bodies; Dementia Frontal; Depression; Anxiety

Summary: alzheimer's disease (ad) and vascular dementia (vad) have become common diseases in the elderly. the burden of dementia is rising in china, with major medical, social and economic impacts. to address this important public health problem, cohort study on elderly cognitive disorders should be carry out. the methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia. at present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention. based on the above understanding, the study carry out the population cohort study based on accurate diagnosis and construct the high standard information and sample bank. the study will establish the standard and quality system of geriatric cognitive disorders cohort study (unified standards and norms). the study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of elderly cognitive disorders, and complete the construction of biological samples bank and clinical diagnosis and treatment information database. the study will apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. the study will evaluate whether peripheral nerve degeneration can predict central nervous system degeneration based on the large cohort of elderly study. in addition, the study will make an effective supplement the sample bank construction of shanghai mental health center.

the neuropsychological test battery are used to access the cognitive function of subjects in the study. the brain mri and biochemical examination will be done in the screening period. the samples such as plasma, serum, urine and faeces et al. of the subjects will be collected in the study.

Eligibility criteria:
inclusion criteria: * registered residents in the community; * ≥ 60 years; * without schizophrenia or mental retardation; * be able to communicate and accept physical and cognitive examinations exclusion criteria: * blind * deaf mute

Keywords: dementia depression cohort study sample bank precision diagnosis brain imaging
metoprolol and formoterol in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: we want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol (a beta-agonist) on long function in patients with chronic obstructive pulmonary disease (copd). there are more and more clues that a beta-blocker, when well chosen and in the right dosage, won't harm the long function in patients with copd. since a beta-blocker can be a valuable addition to treating patients with heart problems we would like to see if this category of medication can be available for copd patients in the future.


Eligibility criteria:
inclusion criteria: * male/female aged between 40-70 inclusive * copd defined by gold criteria * fev1 greater or equal to 60% of predicted without medication * baseline fev1 greater or equal than 1.2l * 10 or more pack years * no hard contraindications for use of beta blockers * being able to perform technically acceptable pulmonary function tests * signed informed consent * systolic blood pressure equal to 130 or greater exclusion criteria: * instable copd during the month before visit 1 * usage of corticosteroids during the month before visit 1 * significant pulmonary diseases other than copd * a history of cancer within the last 5 years (basal cell carcinoma or cutaneous squamous cell carcinoma allowed) * a recent history of myocardial infarction * use of an investigational drug within one month or six half lives (which ever is greater) of visit 1 * contra-indications for the use of ipratropium-bromide
compassionate use ponatinib

Conditions: Philadelphia Chromosome Positive (Ph+) Leukemias; Chronic Myeloid Leukemia

Summary: the main purpose of this protocol is to provide expanded access to the study drug (ponatinib/ap24534) for people with imatinib-, dasatinib-, and nilotinib- resistant/intolerant philadelphia chromosome positive (ph+) leukemias. the other purpose of this protocol is to monitor the safety of the study drug in people with ph+ leukemias that have not responded to prior treatment.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent * cytogenetic or pcr-based diagnosis of any phase of ph+ acute lymphoblastic leukemia (all) and documented resistance or intolerance to imatinib and a second tki (nilotinib, dasatinib, bosutinib) * eastern cooperative oncology group(ecog) performance status of 0-2 * washout from prior anti-proliferative or anti-leukemia treatment: 3 days for hydroxyurea/anagrelide and tyrosine kinase inhibitors * \< grade 2 or baseline recovery from prior therapy related toxicities (except alopecia) * at least 3 months post allogeneic stem cell transplantation * able to take oral capsules reliably * ast/alt less than or equal to 2.5 times uln, or less than 5 times uln if attributable to involvement of leukemia * no active clinical or radiographic pancreatitis * at least 18 years of age * willingness of male and female subjects to use reliable methods of birth control (when applicable) exclusion criteria: * subjects with philadelphia chromosome and bcr-abl-negative chronic myeloid leukemia (cml) * major surgery or radiotherapy within 7 days before the first dose of ponatinib (recovery from any previous surgery should be complete before day 1) * clinically significant active/uncompensated or uncontrolled cardiac disease (active congestive heart failure; uncontrolled angina or hypertension; myocardial infarction in the past 3 months; clinically significant untreated ventricular arrhythmia; diagnosed or suspected congenital or acquired prolonged qt syndrome; unexplained syncope; history of prolonged qtc) * prolonged qtc (\> 0.48 sec) * pregnant or breastfeeding women * evidence of serious active infection, or significant medical or psychiatric illness * known seropositivity to hiv, or current acute or chronic hepatitis b or hepatitis c (antigen positive), cirrhosis, or clinically significant abnormal lab finding that would, in the investigator's judgment, make the subject inappropriate for this study * prior resistance to ponatinib

Keywords: cml
randomized controlled trial of acupuncture versus sham acupuncture in autistic spectrum disorder

Conditions: Autistic Disorder; Autism

Summary: we aim to study the efficacy of acupuncture versus sham acupuncture in children with asd.

in traditional chinese medicine (tcm) philosophy, the approach to autistic spectrum disorder (asd) is a holistic one. the objective is to study the efficacy of a short intensive course of acupuncture versus sham acupuncture in improving the overall functional status of children with autism. a single-blind randomized control trial was conducted in 50 children. these children were randomly assigned to treatment group with tongue acupuncture (40 sessions over 8 weeks) or control group (sham tongue acupuncture to non-acupoints in the tongue).

Eligibility criteria:
inclusion criteria: * subjects with diagnosis of autism made according to the criteria of the 4th edition of the diagnostic and statistical manual of mental disorders (dsm-iv) and autism diagnostic interview-revised and with a score for childhood autism rating scale (cars) greater than 30. exclusion criteria: * children with associated neurological disorders and epilepsy.

Keywords: alternative medicine (am) traditional chinese medicine tongue acupuncture autistic spectrum disorder autism children
rchilduv:study on non-infectious chronic uveitis in pediatric age

Conditions: Uveitis

Summary: uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. it is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. the diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. in italy, there is no national or regional registry for non-infectious chronic uveitis as per the prime ministerial decree (dpcm) of march 3, 2017 (identification of surveillance systems and registries for mortality, tumors, and other diseases). however, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. the universitary hospital meyer institute research hospital (irccs) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases


Eligibility criteria:
inclusion criteria: * diagnosis of non-infectious chronic uveitis before the age of 16; * signed informed consent form. exclusion criteria: * patients with a diagnosis of infectious uveitis * history of malignant pathology, * history of demyelinating pathology, * history of cerebral vasculitis