Kornimate/medical-research-clean huggingface dataset:
a phase ii randomized, double-blind, placebo-controlled study of sorafenib or placebo in combination with transarterial chemoembolization (tace) performed with dc bead and doxorubicin for intermediate stage hepatocellular carcinoma (hcc).

Conditions: Carcinoma, Hepatocellular

Summary: this study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (dc bead) will slow the progression of the disease. the beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

safety issues will be reported in adverse event section. in addition to the secondary outcome measures, biomarkers and patient report outcome will also be analyzed as other variables.

Eligibility criteria:
inclusion criteria: * unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread * confirmed diagnosis of hcc: * cirrhotic subjects: clinical diagnosis by american association for the study of liver diseases (aasld) criteria * hcc can be defined in cirrhotic subjects by one imaging technique (computed tomography \[ct\] scan, magnetic resonance imaging \[mri\], or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. * cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria. * non-cirrhotic subjects: for subjects without cirrhosis, histological or cytological confirmation is mandatory * documentation of original biopsy for diagnosis is acceptable * child pugh class a without ascites * adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization: exclusion criteria: * patients on a liver transplantation list or with advanced liver disease as defined below: * child pugh b and c * active gastrointestinal bleeding * encephalopathy * ascites * lesions having previously been treated with local therapy such as resection of hcc, radiofrequency ablation (rfa), percutaneous ethanol injection (pei) or cryoablation can not be selected as the target lesions.

Keywords: sorafenib tace dc bead combination
bioenergy, depression, anxiety and stress after liver transplantation

Conditions: Mental Health Issue

Summary: in this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation.

simple random sampling method was used to assign liver recipients to experimental and control groups. discharged liver transplant patients will be investigated for anxiety, stress and depression.

Eligibility criteria:
inclusion criteria: (i) liver transplant recipient (ii) must be able to use immunosuppressive agents (iii) 18 years or older liver transplant recipients exclusion criteria: having psychiatric problems having language and communication problems

Keywords: biyoenergy anxiety stress liver transplant recipients
evaluation of the efficacy and safety of lacosamide in pediatric patients with epilepsy

Conditions: Epilepsy

Summary: children with focal refractory epilepsy will be routinely included in the collection of history, blood routine, biochemistry, eeg, mri and 18f-fdg pet to determine the location of the epileptogenic focus and to assess the severity of the disease. this international multicenter clinical trial uses a double-blind, randomized, controlled study to evaluate the safety and efficacy of lcm in clinical applications in children with epilepsy.


Eligibility criteria:
inclusion criteria: * diagnosis of focal epilepsy with or without generalized seizures according to the 2017 international association of anti-epilepsy (ilae) classification criteria. * stable taking 1 or 2 other first-line anti-epileptic drugs for at least 10 weeks before screening visits. * seizure occurred during the 8-week retrospective baseline period with a complete medical record diary. exclusion criteria: * a history of status epilepticus within 3 months prior to screening visits. * poor adherence to previous treatment. * other serious organic diseases, mental illnesses and neurological diseases. * abnormal liver and kidney function and blood routine results.
health2010-14: monitoring biomarkers of chronic diseases in the general population

Conditions: Cardiovascular Disease; Type 2 Diabetes; Asthma; Allergy; Osteoporosis

Summary: the overall aim of the health2010-14 is to monitor the prevalence and trends of common chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and eczema) that are often un-diagnosed in the general population as well as biomarkers of micronutrient status. specific aims include identification of novel lifestyle and genetic risk factors for the above diseases by investigating gene-lifestyle interactions.

over a 5-year period a series of population-based studies are carried out including a total of up to 10,000 persons aged 18-69 years selected from the general population of copenhagen, denmark. the study also include a follow-up of a previous population study (the health2006). participants complete questionnaires on health, lifestyle, and social factors and undergo a health examination including measurements of metabolic biomarkers, allergy tests, anthropometric measures, bioimpedance, biomarkers of micronutrients, spirometry.

Eligibility criteria:
inclusion criteria: * persons living in 10 municipalities of copenhagen exclusion criteria: * pregnancy, non-danish citizenship

Keywords: epidemiology risk factors micronutrients
r(+) pramipexole in early amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the hypothesis of this study is that treatment with r(+) pramipexole at 30 mg/day will alter the slope of decline in als functional rating scale over the course of 6 months. als patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.

this is a futility design phase ii study using als-frsr as the primary variable to monitor progression of disease in patients with early als. the drug to be tested is r(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. r(+)ppx will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. for purposes of this study, futility is defined as failure to decrease the slope of als-frsr decline by less than 40%.

Eligibility criteria:
inclusion criteria: * established diagnosis of als fvc\>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices) exclusion criteria: * als duration \>3 years advanced als with survival predicted \ 30 mmhg history of psychosis or hallucinations abnormal baseline safety lab values

Keywords: amyotrophic lateral sclerosis pramipexole oxidative stress neuroprotection
developing and feasibility testing of a brief contact intervention to reduce self-harm repetition through co-design.

Conditions: Suicide and Self-harm

Summary: suicide is a major public health issue. repeated self-harm may lead to potential future suicide deaths. in addition, it may lead to substantial loss in medical costs. recently, smartphones have been widely used. researchers started to apply mobile health to support individuals with self-harm experiences and to combine brief contact interventions which require lower cost to reduce repeated self-harm. however, the research evidence remains sparse. furthermore, self-harm behaviors might be influenced by different cultural contexts. there is a need to conduct local studies in taiwan. the aim of this study is to establish a co-design team which includes service users and service providers, to collaboratively develop a text- and web-based brief contact intervention (bci) to reduce repeated self-harm, and to evaluate the feasibility of the intervention.

study objectives: 1. to establish a co-design team and develop a brief contact intervention (bci), including the content, frequency, settings, and outcome measures of the intervention. 2. to evaluate the feasibility of bci, including the feasibility of recruitment, required resources, the appropriateness of data collection, and the acceptability of the bci. methods: 1. in study 1, we will recruit 4-6 service users and 4-6 service providers respectively, and we will conduct focus groups to discuss the content of the bci. we will conduct individual interviews with participants to explore their experiences and perspectives regarding their participation in the co-design team. 2. in study 2, we will recruit 30 participants who have self-harm experiences to participate in the bci. the bci will be delivered through texts and web pages and will last around 5 months. the content of bci will include caring messages, reminders of appointments, safety planning, volitional help sheet, and resources information. we will collect user engagement data and compare study outcomes (e.g., suicidal ideation and behaviors, brief symptom rating scale (bsrs), and mental well-being scale) before and after receiving the bci. we will collect the participants' feedback regarding the bci and evaluate the required resources to further revise the bci.

Eligibility criteria:
inclusion criteria: * aged 20 years or over * mentally and physically stable and able to participate in individual interviews and interventions * able to communicate in mandarin and provide written informed consent * willing to be recorded during the interviews * received medical treatments or aftercare due to self-harm experiences, including self-harm ideations, self-harm behaviors, suicidal ideations, and suicidal attempts. * able to use the smartphone to access the internet exclusion criteria: * mental and physical states are unstable (e.g., unconscious, severe psychiatric symptoms, strong suicidal ideations with specific suicide plans) to complete the interviews and interventions according to the health professionals.

Keywords: self-harm psychological intervention
evaluation of the effect of the insupatch device on insulin pharmacokinetics in clamp studies

Conditions: Diabetes Mellitus, Insulin-Dependent

Summary: the study is a prospective, multi-center, open label, randomized; two-arms cross over study. this is the test protocol for the insupatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

fifty five(55) type 1 iddm subjects in three centers who use the minimed paradigm insulin pump, meeting the inclusion/exclusion criteria as outlined below and who provide written informed consent will be enrolled in the study. the study will be done with subjects randomized into one of two procedure sequences. each subject will undergo 3 procedures (two clamps with the insupatch and one clamp without the insupatch) and will thus serve as his/her own control. the same 55 subjects will be randomized into one sequence or the other. the order of the procedures will be selected randomly and will be performed both within one month. there will be six device visits starting with a screening and randomization visit, 3 clamps and a completion visit.

Eligibility criteria:
inclusion criteria: 1. age between 18- 65 years old (including = 18 years and =65 years) 2. gender: men and women 3. bmi: 18-35 kg/m2 4. type 1 insulin dependent diabetes using the minimed paradigm insulin pumps for at least six months and using insulin lispro or insulin aspart. 5. diabetic subjects with hba1c values below 9.5% (including 9.5%). 6. subject understands the study requirements and the treatment procedures and has signed an informed consent before any study-specific tests or procedures are performed 7. subject is willing to comply with all specified follow-up evaluations - exclusion criteria: 1. pregnancy 2. breast feeding women. 3. alcohol addiction 4. had cabg (coronary artery bypass graft), are post mi (myocardial infarction) or had active ischemic heart disease prior to the study date 5. had cva (cardiovascular accident) or tia (transient ischemic accident) prior to the study 6. suffer from uncontrolled hypertension (blood pressure in mm hg \>160 systolic or \> 95 diastolic) 7. low blood hemoglobin concentration \<9 g/dl for female and \<11g/dl for male. 8. abnormal kidney and/ or liver function tests. (if any of the liver or kidney function test parameters are greater than 3 fold normal values. 9. subjects with hyperthyroidism or hypothyroidism with tsh level outside the normal range, tsh\>5.5 miu/l or tsh\<0.4 miu/l 10. psychological incompetence 11. any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant. 12. subjects with diminished skin integrity 13. subjects with heat sensitivity 14. subjects involved in or planed to participate in other studies 15. subjects using other drugs therapies to control blood glucose level other than insulin.

Keywords: minimed paradigm insulin pumps insulin lispro insulin asprt.
establishing the diagnosis standard and analysis the risk factors of poi in chinese women

Conditions: Primary Ovarian Insufficiency

Summary: the study aims to establishing the diagnosis standard of poi and analyzing the risk factors in chinese women.

premature ovarian insufficiency (poi) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. the poi guideline development group of eshre recommends the following diagnostic criteria: oligo/amenorrhea for at least 4 months and an elevated follicle stimulating hormone (fsh) level \>25 miu/ml on two occasion \>4 weeks apart. but there still no diagnosis standard of poi in chinese.the study aims to establishing the diagnosis standard of poi and analyzing the risk factors in chinese women.

Eligibility criteria:
inclusion criteria: * infertility * the length of menstrual cycle longer than 35 days or shorter than/amenorrhea * serum fsh levels ≥10miu/ml/ serum amh levels ≤1.0pg/ml/ afc ≤7, on at least two occasion \>4 weeks apart exclusion criteria: * polycystic ovarian syndrome * other causes of amenorrhea

Keywords: premature ovarian insufficiency diagnosis standard risk factors
electroclinical correlation of anxiety

Conditions: Anxiety Disorder; Generalized Anxiety Disorder; Drug Resistant Epilepsy

Summary: anxiety disorders have the highest prevalence among mental disorders and cause considerable individual and financial costs. current treatments do not relieve mental suffering of many patients. understanding neurobiological mechanisms involved in pathological anxiety is a major scientific challenge.

functional imaging work has made it possible to identify the brain regions involved in anxiety disorders but is insufficient to study the pathophysiological mechanisms that cause anxiety symptoms. brain regions involved in anxiety disorders are located deep in the human brain, and their electrophysiological study requires invasive recording methods. intracerebral electroencephalographic recordings (stereoelectroencephalography - seeg) made for care in hospital before surgery in patients with drug-resistant epilepsy, offer this unique opportunity. indeed, the brain regions involved in anxiety are among the structures registered to delimit the epilepticogenic zone, and 20% of patients with drug-resistant epilepsy suffer from an anxiety disorder. this study propose to compare 10 patients suffering from drug-resistant epilepsy and generalized anxiety disorders (gad), explored by intracranial seeg, and 10 patients suffering from drug-resistant epilepsy without gad ("controls"),explored by seeg. during seeg patient will be proposed to undergo a custom-made behavioral task design to allow clinically-relevant anxiogenic exposure. patients will so be exposed to anxiety scenarios, while intracerebral seeg, physiological stress parameters and the level of anxiety experienced will be monitored. electrophysiological parameters will be compared and correlated with clinical characteristics of the population and outcomes of the task.

Eligibility criteria:
inclusion criteria: * man or woman * aged 18 to 65; * with drug-resistant epilepsy * benefiting from a phase ii pre-surgical assessment with intracerebral electrophysiological exploration by stereo-eeg * meeting the dsm-5 diagnostic criteria for generalized anxiety disorder ("pathological" population) or not meeting the dsm-5 diagnostic criteria for generalized anxiety disorder ("control" population) * wais iv full scale iq \> 75 * affiliate or beneficiary of a social security scheme * giving free, informed consent in writing and signed by the participant and the investigator exclusion criteria: * being unable to give personal consent * be subject to a measure of legal protection (curatorship, guardianship) or placed under judicial protection; * suffer from a chronic delusional disorder (eg: schizophrenia); * have a high risk of suicide assessed using the corresponding section of the structured psychiatric interview called "mini international neuropsychiatric interview" (m.i.n.i. 7.0); * being pregnant or breastfeeding * have severe and / or decompensated somatic illness other than drug-resistant epilepsy

Keywords: focal epilepsy generalized anxiety disorder intracranial recordings stereoenectroencephalography coherence networks
the safety and effectiveness of didanosine plus stavudine plus nevirapine combined with mkc-442 in hiv-infected patients who have not had success with protease inhibitors

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give a new anti-hiv drug combination to hiv-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (nnrtis) and who have failed to respond to protease inhibitors (pis). the drug combination will contain didanosine (ddi) plus stavudine (d4t) plus nevirapine (nvp) plus mkc-442. hydroxyurea (hu) may be added.

patients receive a regimen of didanosine, stavudine, nevirapine, and mkc-442 for 24 weeks. throughout the study, patients are evaluated for changes from baseline in plasma hiv-1 rna levels and lymphocyte subsets and for development of adverse events and toxicities. patients who experience virologic failure have the option of adding hydroxyurea to their treatment regimen or discontinuing from the study. after week 24, patients with documented virologic response may continue treatment with didanosine, stavudine, nevirapine, and mkc-442, and, if applicable, hydroxyurea until a change in virologic status occurs (i.e., the patient experiences virologic failure). follow-up visits are conducted every 4 to 12 weeks until permanent discontinuation from the study.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are at least 18 years old. * are hiv-positive. * have experienced treatment failure on a previous anti-hiv drug combination that contained at least one protease inhibitor. your viral load must be between 5,000 and 50,000 copies/ml after 6 months of continuous treatment with that drug combination. * agree to use a barrier method of birth control (such as condoms) during the study. exclusion criteria you will not be eligible for this study if you: * have a history of certain serious medical conditions, including pancreatitis, neuropathy, untreated seizures, or aids-related cancers, except kaposi's sarcoma (ks). * are enrolled in another anti-hiv drug study while participating in this study. * have ever taken nnrtis (such as nvp or mkc-442). * have ever taken ddi or d4t. * have taken certain medications within 30 days prior to study entry, including medications that affect your immune system (such as corticosteroids, interleukin-2, or interferon). * abuse alcohol or drugs. * have received chemotherapy or radiation therapy within 30 days prior to study entry. (local radiation therapy is allowed.) * are allergic to any of the study drugs. * are pregnant or breast-feeding.

Keywords: drug therapy, combination reverse transcriptase inhibitors anti-hiv agents viral load
trial of azithromycin in campylobacter concisus patients with diarrhea

Conditions: Diarrhea; Fever; Vomiting; Abdominal Pain

Summary: a randomized, double-blind, placebo-controlled clinical trial of azithromycin in campylobacter concisus culture positive patients with diarrhea. the clinical characteristics of emerging campylobacter concisus in adults is vomiting and persistent diarrhea. whether patients may benefit from antibiotic treatment is unknown. the purpose of this trial is to investigate whether antibiotic treatment with azithromycin of campylobacter concisus induced diarrhea can better the symptoms and shorten the duration of illness.


Eligibility criteria:
inclusion criteria: * patients with culture-positive stool sample with campylobacter concisus * diarrheic patients ≥ 18 years * symptoms of diarrhea defined as three or more watery stools per day or * two watery stools per day + at least one of the following symptoms: abdominal pain, nausea, vomiting or fever. * diarrheic symptoms for a minimum of 24 hours before enrollment. * diarrheic symptoms for a maximum of 21 days before enrollment. * informed oral and signed written consent, with documentation that all relevant information about the study is given to the patient. * the patient must be willing and able to participate in the trial. exclusion criteria: * hypersensitivity to azithromycin, erythromycin, macrolide or other ketolide-antibiotics * pregnancy or breastfeeding (if relevant). * culture positive stool sample with a co-pathogen. * treatment with other antibiotics (in any stage 21 days before the first stool sample). * patients with severe liver disease. * patients with severe renal impairment (gfr \<10 ml / min). * patients with congenital or documented acquired qt prolongation. * patients treated with other active drugs that prolong the qt interval such as: antiarrhythmics of classes ia and iii, cisapride and terfenadine. * patients with electrolyte disorders, particularly hypokalemia and hypomagnesemia. * patients with clinically relevant bradycardia, arrhythmia or severe heart failure. * inflammatory bowel diseases * chronic diarrhea of known cause. * dementia. * serious illness less than 21 days from the planned entry into the study. * patients treated with medications that have interactions with azithromycin e.g. alkaloids, ciclosporin or amiodarone. * patients involved in the planning or execution of the study.

Keywords: campylobacter concisus diarrhea fever abdominal pain vomiting