Kornimate/medical-research-clean huggingface dataset:
investigating patient characteristics of intermediate stage hepatocellular carcinoma patients treated with nexavar and their distribution to different treatment groups as well as determining effectiveness and safety

Conditions: Carcinoma, Hepatocellular

Summary: the study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma (bclc-b) for whom the decision has been taken by the investigator to prescribe nexavar (the bclc intermediate stage (bclc-b) consists of child-pugh a and b patients with large/multifocal hcc who do not have cancer related symptoms, macrovascular invasion or extrahepatic spread). exclusion criteria: - prior targeted therapy for hepatocellular carcinoma.

Keywords: hepatocellular carcinoma intermediate stage observational study
evaluation of cardiovascular risk markers in psoriasis patients treated with secukinumab

Conditions: Psoriasis

Summary: the purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in subjects with chronic plaque-type psoriasis. furthermore soluble biomarkers were assessed to evaluate the influence of secukinumab on cardiovascular risk. magnetic resonance imaging (mri) was performed in a sub-population to assess the treatment effect on arterial vessel wall morphometry in atherosclerosis prone vascular beds.


Eligibility criteria:
key inclusion criteria: * chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization with a psoriasis area and severity index (pasi) score ≥ 10 at randomization. * inadequate response, intolerance or contraindication to cyclosporine, methotrexate and psoralen plus ultraviolet a light treatment (puva) as documented in the patient's medical history or reported by the patient or determined by the investigator at screening. relative contraindications such as interference of patient's lifestyle with the treatment are accepted. key exclusion criteria: * forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttata psoriasis) at screening or randomization. * ongoing use of prohibited psoriasis and non-psoriasis treatments.
effect of aerobic training in moderate or severe asthmatic patients

Conditions: Asthma.

Summary: exercise training has been proposed as adjunctive therapy in asthma to improve many clinical outcomes; however its effects on bronchial hyperresponsiveness (bhr) and inflammation, characteristic features in asthma, remains poorly understood. we aim to investigate the effects of aerobic training on bhr (primary aim) and systemic inflammation (secondary aim). in addition, clinical control and health related quality of life (hrqol) will be also assessed.

this is a randomized, controlled and single-blind trial whose intervention will be an aerobic training. fifty -eight patients with moderate or severe persistent asthma will be recruited at a university hospital and randomly assigned in two groups: control (cg) or training (tg) .the study will be performed between two medical visits with intervals of six months and during this period the same medication dosage will be maintained. patients in cg will perform (an educational program + breathing exercise; n=28) and tg patients will perform (an educational program+breathing exercises+aerobic training; n=30).the sessions will be conducted twice a week, for 3 months. before and after the intervention, all patients will be evaluated by bronchial hyperresponsiveness, serum cytokines levels, total immunoglobulin e, induced sputum, fractional exhaled nitric oxide (feno), asthma clinical control (daily symptoms dairy, exacerbations and asthma control questionnaire - acq), health related quality of life (hrqol); asthma quality of life questionnaire-(aqlq), pulmonary function and cardiopulmonary exercise testing. all the patients will be evaluated by specific immunoglobulin e (atopy) through (skin prick test or phadiatop).

Eligibility criteria:
inclusion criteria: * patients with moderate and severe persistent asthma * asthma will diagnosed according to global initiative for asthma (gina) * body mass index \<35 kg/ m2 * patients will submitted the medical treatment, followed by pulmonary specialists for at least 6 months. patients will considered clinically stable (i.e., no exacerbation or changes in medication for at least 30 days). exclusion criteria: * patients will diagnosed with cardiovascular, musculoskeletal or other chronic lung diseases; * patients with current participation in exercise programs * current smokers or ex-smokers will excluded from the study.

Keywords: exercise, bronchial hyperresponsiveness, inflammation
clinical re-evaluation of removing blood stasis therapy in treating acute cerebral hemorrhage safety and efficacy

Conditions: Intracerebral Hemorrhage

Summary: in order to investigate the time window of acute intracerebral hemorrhage(aich) by "blood activating and stasis dispersing" therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. patients are classified to （0-6h）and (6-72h) teams. herbs is separated too. the period of the therapy lasts two weeks, and the follow up should last three months. the main indexes are mortality rate, disability rate and the brain hematoma situation. the review is made by the reference to (nihss),(gcs) and so on. so, the window time is determined through this test.

objective: to investigate the safety and effect of acute cerebral hemorrhage treated with "blood activating and stasis dispersing" therapy and to verify the traditional methods can influence the brain hematoma enlargement or not. methods: from 2013.8 to 2015.12, 360 cases of aich will be included in 13 research centers. patients are randomly into 3 groups within 6hrs from onset,such as, group a, blood activating herbal medicine (8 herbals), group b, herbal medicine without blood activating herbal(6 herbals), group c, placebo for 10days. all the patients will be treated according aha guideline of aich. all patients will be set to the ct at the onset, 24h later and 10-14days after treatment. so the rate of enlargement of brain hematoma in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.

Eligibility criteria:
inclusion criteria: * no younger than 18 yrs * acute cerebral hemorrhage confirmed by brain ct scan * within 6 hours from onset * gcs≥6 * sign the informed consent form exclusion criteria: * tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc; * patients with severe heart, liver and renal insufficiency. * intolerance to traditional chinese medicine (tcm), allergic constitution. * patients with severe cerebral hernia in the early onset * compliance is poor.

Keywords: activating blood stagnation and expelling blood stasis hematoma enlargement herbal medicine traditional chinese medicine random clinical trial
comparing single needle and double needle arthrocentesis for temporomandibular joint disorders

Conditions: TMJ Disc Disorder

Summary: the purpose of this study was to compare the clinical success and efficacy of single-needle, double-cannula arthrocentesis with conventional arthrocentesis techniques in patients with temporomandibular joint disorders. patients with nonreducible disc displacement complained of limited mouth opening and/or pain. all treated patients had baseline and follow-up (with mouth opening and vas). comparisons were made within and between groups.

the patients included in the study were evaluated in the preoperative, 1week, 1-3, and 6 months after the procedure. double-needle group: two needles were inserted into the joint and washed. in the single-needle group, two needles were bent (from their lower parts) before the procedure and their pointed ends were joined by placing acrylic on the plastic parts from a single point. the resulting combined needle was directed to the upper joint space and washed. 13 underwent single-needle double cannula arthrocentesis and 15 underwent double needle arthrocentesis.

Eligibility criteria:
inclusion criteria: * with complaints of pain and restricted mouth opening and who had not received any previous treatment. * patients with a diagnosis of disc displacement without reduction characterized by persistent or frequent tmj pain, history of joint clicking, limited mouth opening with deviation to the affected side, limited lateral movement to the opposite side, limited protrusive movements with deviation to the affected side were included. exclusion criteria: * patients with systemic inflammatory joint disease, facial growth disorder, and direct trauma to the tmj were excluded.

Keywords: arthrocentesis disc displacement without reduction temporomandibular joint disorders
myocet® in children with relapsed or refractory non-brainstem malignant glioma

Conditions: Malignant Glioma

Summary: the purpose of this study is to determine the toxicity and tolerance of myocet® in children and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20% of the dose recommended for adults and a dose recommended for adults, administered in single dose in 1-hour perfusion each 21 days. other purposes are to determine the recommended dose of myocet and to assess the response to drug. pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite doxorubicinol during 72 hours after myocet administration will also be studied.


Eligibility criteria:
inclusion criteria: * patients having received at least one cycle of chemotherapy after radiotherapy * patients having grade iii or iv (who) glioma, not localized in brainstem * tumor measurable with magnetic resonance imaging * absence of other concomitant anti-cancer treatments * absence of chemotherapy for 4 weeks; 6 weeks if nitrosourea * good general health and nutritional status according to nci-ctc scale (version 3) (appendix 6) * lansky score \> 50% or karnofsky \> 50 in children older than 12 years * absence of organ toxicity (grade \> 2 according to nci-ctc criteria (version 3) * hematology: polynuclear neutrophil count \> 1.0 x 109/l * hematology: platelet count \> 100 x 109/l * liver function: bilirubinemia \< 1.5 normal value * liver function: asat and alat levels \< 2.5 normal values * liver function: prothrombin level \> 70% * liver function: fibrinogen \> 1.5 g/l * renal function: creatinemia \< 1.5 normal value/age * cardiac function: ef \> 60% and/or sf \> 30% * signature of informed consent by patient if adolescent, by 2 parents or legal guardian if minor patient * for patients with childbearing potential, a contraceptive method is compulsory. this contraception must be continued 6 months after myocet treatment end * for patients with childbearing potential, negative pregnancy test (betahcg test) exclusion criteria: * non compliance with eligibility criteria * severe or life-threatening infection * non controlled evolutive or symptomatic intracranial hypertension * history of myocet treatment, but patients could be treated with anthracyclines if cardiac function is normal * hypersensibility to the active substance, to premixtures or one of excipients * pregnancy and breastfeeding
circulating cell-free dna in metastatic melanoma patient: mutational analyses in consecutive measurement before and after chemotherapy

Conditions: Metastatic (Stage IV) Melanoma

Summary: therapies that target specific molecules markedly inhibit cancer growth in several malignancies, and provide valuable strategies for the treatment of advanced melanoma. in recent years, braf and kit have become established therapeutic targets in melanoma patients showing activating mutations in these oncogenes. however, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. the tumour genotypes that determine the selection of molecular-targeted therapies are usually identified in primary tumours; however, primary tumours are not always representative of metastases. circulating free dna may be a source of valuable information because it can be obtained via routine blood sampling, it provides real-time information about a patient's current disease state, and it allows monitoring and molecular characterization before and after chemotherapy. the aim of the study is to determine the mutational status in circulating dna in melanoma metastatic patients, with the sequenom mass array, a next generation sequencing technology. results obtained before and after treatment will be compared with the primary tumor genotype.


Eligibility criteria:
inclusion criteria: * age\>18 years * surgical biopsy for histologic diagnostic * all melanoma subtypes * known genotype braf v600 * affiliation social security * consent form signed exclusion criteria: * patient with histories of cancer or the other synchronous cancer * pregnant women * breast-feeding women * vulnerable patients: major under guardianship; patient deprived of its rights
plantar compartment block in hallux valgus ambulatory surgery

Conditions: Hallux Valgus Ambulatory Surgery

Summary: hallux valgus surgery is known as a painful surgery. qualitative pain management is the key to successful early recovery and rehabilitation. popliteal sciatic nerve block is widely used despite the risk of falling due to prolonged motor blockade. plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation. the purpose of this study is to describe the analgesic effect of the plantar compartment block following hallux valgus surgery.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years old * patient covered by social health insurance * have signed written informed consent * scheduled for hallux valgus ambulatory surgery exclusion criteria: * protected patients or patients incapable of giving written informed consent * pregnant or breastfeeding woman * vulnerable adult * inability to participate in pain scoring scales * severe coagulopathy * allergy or contraindications to study drugs * preopérative gait disorders * chronic kidney disease with glomerular filtration rate (gfr) ≤ 50 ml/min (estimated by the cockroft and gault formula) * severe chronic liver disease * chronic pain (treated by non steroidal anti inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants) * peripheral neuropathy * intervention under general anesthesia

Keywords: early ambulation plantar block
immune recovery in advanced , arv-naïve, hiv-1-infected individuals taking dolutegravir or ritonavir-boosted darunavir

Conditions: Acquired Immune Deficiency Syndrome Virus

Summary: there are few randomized clinical trials in advanced hiv patients. this is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (qd): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve hiv-1 infected patients with less than 100 cd4+ t-cells/mm3. primary endpoint is the median increase in cd4+ t-cell count at 48 weeks after starting haart.


Eligibility criteria:
inclusion criteria: 1. hiv patients \> 18 years old who provide signed and dated informed consent. 2. male and female. 3. chronic hiv infection. 4. antiretroviral naïve. 5. confirmed cd4+ t cell count below 100 cells/mm3 6. hla b5701 negative patients. exclusion criteria: 1. active opportunistic infections requiring parenteral treatment 2. patients with cryptococcal meningitis treated with voriconazole 3. aids-defining cancers needing chemotherapy. 4. female patients pregnant or breastfeeding. 5. patients with documented history of allergy to sulfonamides. 6. any contraindications to study drugs.

Keywords: acquired immune deficiency syndrome virus hiv hiv-1 antiretroviral treatment hiv advanced disease aids dolutegravir darunavir
sleep signal analysis for current major depressive episode (samde)

Conditions: Depressive Episode; Depression; Depressive Disorder; Depressive Disorder, Major; Depression Mild

Summary: the objective of this study is to collect data to finalize the development of meb-001 software as a medical device. the data collected in this study will be used to develop meb-001 machine learning algorithms by training the algorithms to match the patient's demographic and clinical information, and the objective physiological signals (i.e., electroencephalogram (eeg) and electrocardiogram (ecg)) recorded during psg with the diagnosis of cmde performed through the mini neuropsychiatric evaluation.

this is a two (2)-phase, single-arm, prospective, non-significant risk, multi-center trial where each enrolled subject's data will be used for the development of meb-001. study population: subjects who are at least 22 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbances and sign an informed consent form (icf) will be evaluated for participation in this study. the selection of the population involved in the study will consider the geographic diversity needed to obtain a representative sample of the intended use population. centers will be selected to secure geographic and clinical diversity across the usa to obtain a representative distribution of the intended patient population. all patients undergoing psg due to primary or secondary sleep disorders, which include, but are not limited to, sleep-related movement disorders, sleep-related breathing disorders, intrinsic and extrinsic circadian rhythm sleep-wake disorders, hypersomnia, parasomnia, and insomnia, will be consecutively recruited, according to the inclusion/exclusion criteria.

Eligibility criteria:
inclusion criteria: subjects must meet all the following conditions to be eligible to participate in the study: 1. subject is age ≥ 22 years and ≤ 75 years. 2. subject is undergoing polysomnography due to suspected primary or secondary sleep disorders. 3. subject is willing and able to provide informed consent. 4. subject has the ability to read and understand the instructions for the study. 5. subject is willing to adhere to study procedures. 6. subject is willing to undergo full night diagnostic psg study, as prescribed. exclusion criteria: subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present: 1. subject has a pacemaker. 2. subject has undergone a heart transplant. 3. subject is undergoing a full night c-pap titration study.

Keywords: major depressive episodes depression sleep study
quality of life in patients with multiple myeloma-validation study

Conditions: Multiple Myeloma

Summary: in this study, the myeloma patient outcome scale (mypos) will be translated from english to german. this translated version will be quantitatively and qualitatively validated with patients with multiple myeloma.

patients with multiple myeloma (n=10) will be interviewed in the qualitative phase about their comprehension of the translated mypos. the questionnaire will be revised according to the results of the interviews. this culturally adapted swiss-german mypos will be assessed in the quantitative phase for its' psychometric properties with 200 patients with multiple myeloma.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * confirmed histological diagnosis of multiple myeloma, * age ≥ 18 years, * mental capacity to give written informed consent exclusion criteria: * inability to communicate in german * participation in another clinical study * more than one cancer diagnosis * mental illness (i.e. psychiatric diagnosis)

Keywords: quality of life psychometrics
empower weight management

Conditions: Obesity; Overweight; Weight Loss; Diet Habit

Summary: this research is to develop a virtual weight loss and weight maintenance program through dietary modifications for adults with obesity. although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.

empower is a remote weight management program utilizing an online textbook platform, e-text, and mobile web application. empower is a two-year program: 1-year intervention, 1-year follow up. data is collected via ffq (nih dhqiii), daily weighing using a wifi-enabled scale, and 24-hour dietary records via the web application. empower consists of 19 online sessions (45 minutes/each) and 3 individual advising sessions with an rd. empower aims to improve health parameters related to obesity, such as hyperlipidemia and hypertension. health parameters will be monitored primarily by the subject's personal physician. any test results will be sent to the empower research team for analysis via redcap. empower team consists of social workers in addition to nutrition experts. the social work team aims to monitor and improve lifestyle, stress management, and behavior.

Eligibility criteria:
inclusion criteria: * body mass index in the overweight or obese range (bmi) \>28 kg/m2 (if asian, bmi \>25kg/m2); * not currently pregnant or lactating; * have wi-fi at home, a working email, and an iphone or android smartphone; * self-reported obesity co-morbidities (such as diabetes type 2 or hyperlipidemia); * be a carle foundation hospital patient and have regular contact with a primary care physician; * not using insulin injection; * able to attend the 22 (1 hour) diet improvement sessions; * willing and safe to lose 20 lb. or more for 6 months and maintain a healthy weight for one year; * keep weighing their weight for two years; * fluent in reading and writing english. exclusion criteria: * age \ 75 years; * body mass index of \<28 kg/m2 (if asian, bmi \<25kg/m2); * currently pregnant; * currently lactating; * use insulin injection; * not able to attend the 22 (1 hour) diet improvement sessions for 1 year; * failed to set up a wi-fi scale; * failed to submit a ffq.