Kornimate/medical-research-clean huggingface dataset:
a study to assess disease burden, in terms of health-related quality of life and direct healthcare costs, in patients with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant (asct) in spain

Conditions: Multiple Myeloma

Summary: those patients with newly diagnosed multiple myeloma (mm) who are not candidates for autologous stem cell transplant (asct) and who meet the screening criteria described in this protocol can participate. the participating patients must sign an informed consent, which the investigator who will collect the study variables in an electronic case report form (ecrf) will provide to them. the investigators must recruit at least 450 patients in a 24-month period.

following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model: 1. recruitment period: data collection at the baseline visit, every 4 months +/- 15 days in the first year (month 4, 8 and 12) and every 6 months +/- 1 month in the second year (month 18 and 24). 2. follow-up period: (study will end at 4 years following enrolment of the first patient) * from month 24 until up to 4 years from enrolment of the first patient, follow-ups will be performed with semi-annual data collections coinciding with the patient's routine clinical practice visits. * in case of progression, suspension or unexpected termination of treatment (for example due to toxicity), or death, a data collection coinciding with the visit in which any of the cases presented occurs will be performed. * if a new line of treatment is started, the follow-up model will be started with the same frequency of follow-ups described in point 1 above (month 4, 8, 12, 18 and 24 and semi-annually according to routine clinical practice until up to 4 years from enrolment of the first patient in the study). 3. observation period: following this 4-year period, an additional 5-year follow-up will be performed only to evaluate the onset of second primary malignant neoplasms. this follow-up during the 5-year observational period will be performed semi-annually (± 1 month) according to routine clinical practice at each site.

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years of age. * patient with newly diagnosed multiple myeloma (mm) according to imwg criteria who are not candidates for asct and who start treatment for the study disease. * patient who is capable of understanding and filling in the study questionnaires. * patient who has granted his or her informed consent in writing. exclusion criteria: * patient who is participating in the active phase of treatment of any clinical trial during the study period.

Keywords: multiple myeloma autologous stem cell transplant (asct) qolmmbus healthcare costs
effect of tofacitinib in treating anca-associated vasculitis

Conditions: ANCA Associated Vasculitis; Drug Use; JAK-STAT Pathway Deregulation

Summary: the goal of this study is to evaluate the efficacy and safety of tofacitinib 5 mg twice daily in aav patients.

anti-neutrophil cytoplasmic antibody (anca)-associated vasculitis (aav) represents a group of small vessel vasculitides characterized by granulomatous and neutrophilic tissue inflammation, often associated with the production of antibodies that target neutrophil antigens. the predominantly used treatment for induction of remission in aav consisted of cyclophosphamide (cyc) plus corticosteroids (gcs) which leads to remission in about 90% of patients. however, relapses are frequent and remain a challenge. the optimal drug for maintenance treatment is not determined. tofacitinib is a jak inhibitor which has been proved to be effective in multiple inflammatory diseases such as rheumatoid arthritis. considering that t cells and associated cytokine production play an important role in the pathogenesis of aav via activation of the jak/ stat pathway, we hypothesized that tofacitinib-mediated inhibition of jak signaling may represent an effective therapy for active aav. in this prospective, open label, single arm study, tofacitinib 5mg twice a day will be added to the background treatment of gcs and immunosuppressants in aav, the safety and efficacy of tofacitinib will be assessed.

Eligibility criteria:
inclusion criteria: * patients with active aav met the criteria of 1990 acr and 2012 chapel hill criteria * age 18 to 75 years * written informed consent obtained before taking part in the study exclusion criteria: * severe aav defined as potentially organ- or life-threatening disease (i.e. alveolar haemorrhage, heart failure caused by myocarditis or pericarditis, progressive neurological symptoms, deaf, blindness, et al.) * serum creatinine\>120umol/l or proteinuria\>1.0g/d * receipt of a jaki therapy previously * co-existence of another systemic autoimmune disease * secondary vasculitis (following neoplastic disease, an infection or antithyroid drugs) * malignancy or history of malignancy * infection by hiv, hcv, hbv or tuberculosis- * severe uncontrolled cardiovascular, pulmonary, liver, gastrointestinal, endocrine, hematological, neurological, or psychiatric diseases that are not related to systemic vasculitis * allergic to jaki * blood dyscrasias including confirmed: hemoglobin \ 1.5 upper normal limit; estimated glomerular filtration rate\<60ml/min/1.73m2 * incapacity or refusal to understand or sign the informed consent form. * pregnancy, breastfeeding.

Keywords: anca associated vasculitis tofacitinib safety efficacy
an eight-week study to evaluate the efficacy and safety of 2 doses of saredutant in patients with generalized anxiety disorder

Conditions: Generalized Anxiety

Summary: the primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) of saredutant compared to placebo in patients with generalized anxiety disorder. the secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.


Eligibility criteria:
inclusion criteria: * diagnosis of generalized anxiety disorder as defined by diagnostic and statistical manual of mental disorders (dsm-iv-tr) criteria and confirmed by the mini international neuropsychiatric interview (mini) plus generalized anxiety disorder module. exclusion criteria: * total score of less than 22 on the ham-a. * montgomery-asberg depression rating scale (madrs) total score greater than 18. * patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders. * patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. * patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, antidepressants including monoamine oxidase inhibitors (maois) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use. the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: anxiety clinical trials
early recognition and optimal treatment of delirium in patients with advanced cancer

Conditions: Delirium; Advanced Cancer

Summary: the investigators designed a randomised multicenter clinical trial for patients with advanced cancer who are admitted to the medical oncology ward or high-care hospice. on admission all patients with advanced cancer will be asked to participate in this study. consenting patients will be submitted to delirium observation screening according to the dos. subsequently dos screening will be performed twice weekly until discharge. each patient who's score is \> 3 (dos positive) is showing significant symptoms of delirium and will be submitted to the revised delirium rating scale (drs-r-98) to confirm diagnosis. to test validity of the dos scale for this particular population, each dos positive score will be randomly matched with a patient with a dos score \< 3 (dosnegative) and this patient will also be submitted to drs-r-98. when diagnosis of delirium is confirmed by drs-98, patients will be randomised between treatment of delirium with olanzapine or haloperidol (usual care). treatment in both groups will consist of identification and management of underlying aetiologies of delirium if possible and adding neuroleptic medication for symptom control. patients who recover from their delirium episode as well as their caregivers will be asked to complete the delirium experience questionnaire (deq) to assess recall of the delirium experience and the degree of distress related to the delirium episode.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with advanced cancer * age ≥ 18 * patient or his / her significant other speaks dutch fluently exclusion criteria: * delirium is due to alcohol withdrawal * patient has been diagnosed with glaucoma, parkinson's disease or dementia * patient is being treated with other neuroleptic medication or lithium * patient has another psychiatric disorder that is considered (by investigator) to interfere with assessment of delirium * patient had a qtc-interval of \> 480 msec on ecg made on admission to the medical oncology ward (ecg is not required if patient is admitted to a high-care hospice) * patient has a history of neuroleptic malignant syndrome * patient has a history of convulsions.
cohort study of adrenogenic autonomic cortisol secretion

Conditions: Diagnosis; Treatment; Adrenogenic Autonomic Cortisol Secretion

Summary: to investige the etiology, pathogenesis, diagnosis and treatment of adrenogenic autonomic cortisol secretion in chinese adults.

with the development of imaging detection technology and its wide application in clinic, the detection rate of adrenal incidentaloma (ai) has been greatly improved. in our previous study, 18.9% of ai were accompanied by autonomic cortisol secretion (acs) in chinese. the vast majority of acs is mild (macs). due to the lack of typical cushing manifestations and the low rate of progression to overt cushing, macs has received insufficient attention in the past. however, recent studies have found that macs have a higher incidence of diabetes, hypertension, cardiovascular events, metabolic bone disease and mortality risk than those with non-functional adenomas. with appropriate treatment, the complications of macs patients can be effectively improved. however, personalized treatment of macs is a clinical difficulty. it is hard to determine whether the cortisol secretion of patients is caused by ai or whether patients will benifit from operation. there are some retrospective studies have provided some evidence, while prospective studies are lacking. the purpose of this study is to prospectively include patients with autonomic cortisol secretion, evaluate function and diagnosis, develop personalized treatment strategy, and follow up the prognosis. the research results will provide new evidence for standardized diagnosis and treatment of adrenogenic autonomic cortisol secretion in the future.

Eligibility criteria:
inclusion criteria: * ct examination revealed adrenal nodules (maximum diameter ≥10mm); * serum cortisol \> 50nmol/l after 1mg dexamethasone inhibition test (1mg-dst). exclusion criteria: * patients with primary aldosteronism (pa), pheochromocytoma, adrenal metastatic carcinoma, congenital adrenal hyperplasia (cah), ganglionic neuroma/paraganglioma, schwannoma, adrenal hematoma and those with no definite diagnosis were evaluated by clinical and endocrine function. * patients with serious underlying diseases (such as liver and kidney failure, acute severe infection, etc.) that may affect the function of the hypothalamic-pituitary-adrenal axis (hpa axis); pregnancy. * patients with a history of alcoholism, fatigue, trauma, infection, depression, glucocorticoid use, and other drugs affecting the function of the hypothalamic-pituitary-adrenal axis. * patients who are not willing to participate in and complete this study refuse to sign the written informed consent for this study.

Keywords: diagnosis and differential diagnosis treatment and prognosis adrenogenic autonomic cortisol secretion
huc mesenchymal stem cells (19#isclife®-lc) in the treatment of decompensated hepatitis b cirrhosishepatitis b cirrhosis

Conditions: Hepatitis B

Summary: 1. evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis b cirrhosis. 2. observe the curative effect of patients with hepatitis b cirrhosis who use human umbilical mesenchymal stem cells to treat. 3. explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis b cirrhosis.

this experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis b cirrhosis to evaluate its safety and efficacy, this experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (bmi) between 19-25kg/m2 (including boundary value). it was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.

Eligibility criteria:
inclusion criteria: * age 18-60 years old, gender not limited, body mass index (bmi) between 19-25 kg/m2, including boundary value; * the diagnosis of hepatitis b cirrhosis was in line with the 2015 american society of hepatology (aasld) guidelines for the treatment of chronic hepatitis b, and the liver function grade was child-pugh b or child-pugh c, with a score range of 7-12 points, and model for end-stage liver disease score≤21 points. * have not received stem cell therapy in the recent 6 months; * subjects will be able to sign the informed consent in accordance with the study procedures and instructions. exclusion criteria: * insufficiency of vital organs, such as heart, kidney and lung; * end-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,severe bleeding tendency, massive ascites, etc. * concomitant peritonitis, pneumonia, or other types of infection not under control; * have a history of severe allergic reaction or allergy to two or more kinds of food or medicine; * positive serum hiv antibody and syphilis antibody; * alpha fetoprotein\>400ng/ml with primary liver cancer or without imaging evidence; * chronic liver disease and cirrhosis are caused by non-chronic hepatitis b virus infection, or other factors except chronic hepatitis b virus infection ; * patients with severe mental illness and cognitive impairment;

Keywords: hepatitis b cirrhosis, mesenchymal stem cell
prevention of allergic diseases in infants

Conditions: Atopic Diseases

Summary: a multi-center, prospective, randomized, controlled, doubleblind intervention clinical trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.


Eligibility criteria:
inclusion criteria: * healthy term-born male and female infants (gestational age ≥37+0, singleton birth) * birth weight ≥ 2500 g and ≤ 4500 g * age at enrollment: ≤ 56 days of life * at risk of developing atopic diseases * free of atopy symptoms at screening and at any time before randomization * feeding regimen at any time before screening (v1) and baseline (v2, infants who will receive interventional product (ip)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. neocate infant), maltodextrin or glucose solution/gel; breastfeeding allowed * subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. subject's parents/caregivers will decide which feeding regimen will be used (ip or breast milk): * ip regimen (intervention or control group): only ip and breast milk until at least 120 days of life * breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life. * no other infant formulas or solid foods are allowed. * written informed consent. exclusion criteria: * multiple births * premature delivery (gestational age ≤ 36+6) * neonatal illnesses that might have an impact on allergy development (based on investigator's decision) * significant congenital abnormalities * participation in another clinical study with an ip or study method that would influence the outcome of this study * reason to presume that the subject's parents/caregivers are unable to meet study plan requirements.
an observational study of erlotinib (tarceva) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer after failure of pemetrexed in first-line therapy

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) who have progressed after pemetrexed-containing first-line chemotherapy. eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age. * histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable stage iii or iv according to the 7th tnm classification of malignant tumors). * experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen. * eastern cooperative oncology group (ecog) performance status 0-2. * initiated on second-line treatment with tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent). exclusion criteria: * prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (nsclc) setting. * contraindication for tarceva according to the summary of product characteristics.
surgical stabilization for rib fractures

Conditions: Trauma Chest; Rib Fracture Multiple

Summary: the purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.


Eligibility criteria:
inclusion criteria: * blunt trauma mechanism * severe chest wall injury (defined by one of the 3 below): radiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement * at least one true rib (1-7) fractured and accessible for stabilization exclusion criteria: * severe traumatic brain injury (best resuscitated gcs less than 8 as measured at 24 hours) * spinal cord injury * pre-existing congestive heart failure or oxygen-dependent pulmonary disease * any reason for which ssrf could not occur within 72 hours of admission
a multi-center study of low-dose decitabine for the treatment of immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: decitabine has been reported to have a clinically significant, often long lasting effect on the platelet count in myelodysplastic syndromes(mds). it is also reported that decitabine could increase platelet counts by enhancing megakaryocyte maturation and platelet release. immune thrombocytopenia(itp) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. however, refractory itp is lacking of effective treatments and the efficacy of decitabine in itp remains poorly understood. data from this study may provide some idea of decitabine in the treatment of itp.

the investigators are undertaking a multicenter, single-arm study of primary itp adult patients from 9 medical centers in china. all the participants are selected to receive low-dose of decitabine treatment (given intravenously at a dose of 3.5mg/m2 for 3 days per cycle for 3 cycles). platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: * adult patients with the diagnosis of itp according to the international working group (iwg) guidelines * failure to splenectomy or at least four standard itp-specific treatments, but not necessarily undergone splenectomye * baseline peripheral platelet count less than 30,000/ul or the presence of bleeding symptoms * need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. need of on-demand or exclusion criteria: * secondary itp * pregnancy * hypertension * cardiovascular disease * diabetes * liver and kidney function impairment * hcv, hiv, hbsag seropositive status * patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Keywords: decitabine immune thrombocytopenia