Kornimate/medical-research-clean huggingface dataset:
a clinical trial on hepatitis b vaccine activated-dendritic cells combined with anti-hbv drugs in chb

Conditions: Chronic Hepatitis B

Summary: the anti-virus effects is not satisfying in some of chronic hepatitis b（chb) patients who have been on anti-hepatitis b virus (hbv) drugs therapy. dendritic cell (dc) is critical in hepatitis b virus (hbv) specific immunity in the process of producing hbv promoter specific cytotoxic t cells (ctls) and specific t helper cells (htls), however they are defective in chb patients. therefore, if it were going to remove hbv completely, it mainly depends if the body itself can produce enough hbv specific cytotoxic t cells (ctls) and specific t helper cells (htls). our research is to plus hepatitis b vaccine activated-dcs therapy to chb patients who have been on anti-hbv drugs but with poor effects, supposing to significantly improve anti-hbv efficacy, even to clean hbv from the patients.

patients who have been on anti-hbv therapy complying with the inclusion criteria will be enrolled into our research, nucleoside analogues (nas,entecavir） treatment for more than 1 year or interferon（ifn)-a-2a (ifn-a-2a,pegasys） treatment for more than 24 weeks. the patients will be randomly assigned to experimental group and control group with the ratio of 2:1, one group (control group) will go on receive the anti-hbv drugs treatment solely; another group (experimental group) after enrollment will immediately receive the hepatitis b vaccine activated-dcs (hpdc-t cells) for 24 weeks (every 2 weeks once for 24 weeks, 12 times in total), at the same time co-use anti-hbv drugs treatment, as for pegasys, it will go on to be used for 12 weeks after hpdc-t cells treatment completed. the technical route of hbv-t cells prepared: first, investigators collect fresh blood of chb, mononuclear cells were isolated, and induced to hbsag pulsed dcs in hepatitis b vaccine (shenzhen kangtai, shenzhen, china) and interleukin-4（il-4)/granulocyte-macrophage colony-stimulating factor(gm-csf） (perprotech, new jersey, usa) (7 days), then co-culture of dcs and peripheral blood mononuclear cell(pbmcs ）7days, obtain hbv specific t cells, return to the patient finally.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b patients, aged 18\~65，chinese * have been on entecavir（etv） or telbivudine（ldt） treatment for more than 1 year,and hbv dna\<100 iu/ml（roche cobas）;or have been on * have been on peg-ifn treatment for more than 24 weeks,and 20 \< hbv dna \< 20000 iu/ml（roche cobas）. * hbsag 100\~5000 iu/ml * hbeag 10\~500 coi exclusion criteria: * superinfection or co-infection with hepatitis a, c, d, e, cytomegalovirus and hiv, or epstein-barr virus; * other liver diseases such as alcoholic liver disease, drug-induced hepatitis, wilson disease and autoimmune hepatitis; * ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination; * liver cirrhosis (including compensated and decompensated cirrhosis) and liver failure; * severe bacterial or fungal infections; * a history of diabetes or cardiac disease or hypertension or nephrosis; * pregnant women.

Keywords: hpdc-t cells chb immuno therapy
effectiveness in daily practice of different treatment strategies for early rheumatoid arthritis.

Conditions: Rheumatoid Arthritis

Summary: the combinatietherapie bij reumatoide artritis (cobra) trial was a milestone in the development of the present treatment paradigm for rheumatoid arthritis (ra). this study introduced the principle of fast remission induction by means of a combination of standard disease modifying antirheumatic drugs (dmards) and a step down bridge therapy with high dose glucocorticoids in early rheumatoid arthritis. the purpose of the present study is to compare different combinations of traditional dmards and glucocorticoids, based on the original cobra protocol, for treatment of early rheumatoid arthritis. besides the efficacy and effectiveness of these strategies, patient centered outcomes and potential implementation problems of such treatment strategies are evaluated.


Eligibility criteria:
inclusion criteria: * diagnosis of ra as defined by the 1987 or 2010 revised american college of rheumatology (acr) criteria * early ra (less than 1 year) * use a reliable method of contraception for women of childbearing potential * able and willing to give written informed consent and participate in the study exclusion criteria: * previous treatment with dmards * previous treatment with oral corticosteroids at a dosage of more than 10 milligrams (mg) prednisone within 4 weeks before baseline * previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg prednisone within 2 weeks before baseline * previous treatment with oral corticosteroids for more than 4 weeks * previous treatment with intra articular corticosteroids within 4 weeks before baseline * previous treatment with an investigational drug for the treatment or prevention of ra * contraindications for corticosteroids * contraindications for dmards * psoriatic arthritis * underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study * pregnancy, breastfeeding or no use of a reliable method of contraception * alcohol or drug abuse

Keywords: cobra
pet-ct imaging of neuro-endocrine tumors and preliminary clinical evaluation

Conditions: Neuroendocrine Tumors

Summary: through the investigators involvement in an international consortium, the investigators had the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers. the investigators propose in this project to develop on their site, the radiosynthesis of 68ga-dotatoc and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared with the current imaging octreoscan®. the objectives of this project are: - to validate the radiosynthesis of 68ga-dotatoc on their site with a new synthetizer - and clinically evaluate, through a prospective preliminary study, the diagnostic accuracy of pet-ct with 68ga-dotatoc in comparison with other standard imaging examinations.


Eligibility criteria:
inclusion criteria: * patients over 18 years * patient who is suspected of endocrine tumors according to symptomatology, biology or imaging or pathological context (multiple endocrine neoplasia type 1) * initial staging: this includes research multifocal disease or locoregional or metastatic extension if well-differentiated neuroendocrine tumor (grade 1 et/ou 2) * search of the primary tumor, especially in the case of the inaugural discovery of metastases * staging of a known recurrence * search occult recurrence or suspicion of recurrence (clinical, laboratory, imaging doubtful) * patient who have received in a lower range than 2 months of cervico-thoraco-abdominal-pelvic ct and scintigraphy in octréoscan® * patient who have signed an informed consent * patient affiliated or beneficiary of regime of social security of a member state of the european community exclusion criteria: * patient with another evolutive cancer disease and/or treated for less than 5 years * pregnant or lactating woman * premenopausal woman without effective contraception (estrogen-progestin or intrauterine contraceptive device) * patient unable to give their free and informed consent * persons placed under judicial protection
clinical outcome in patients with syringomyelia（copsm）

Conditions: Syringomyelia/Hydromyelia

Summary: the aim of this study is to determine the clinical spectrum and natural progression of syringomyelia (sm) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.

syringomyelia is a chronic central spinal cord injury, which is characterized by dilation of the central canal of the spinal cord. at present, the treatment of syringomyelia is mainly through surgical decompression to restore the disturbance of cerebrospinal fluid circulation. due to the heterogeneity of the etiology of syringomyelia, almost all published studies on the clinical outcome and prognostic factors of syringomyelia are relatively limited, and most of them are retrospective. it is not clear which is the most reliable predictor of clinical outcome. therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of syringomyelia and determine the main prognostic factors through clinical scales, biomarkers and electrophysiology. at study visits a standardized clinical examination will be performed including application of clinical rating scales. at all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, csf, and/or a muscle biopsy. optionally, additional examinations may be performed including imaging, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.

Eligibility criteria:
inclusion criteria: * patients who was diagnosed as syringomyelia including: chiari malformation， basilar impression， subarachnoid obstruction， patient not received surgical or interventional treatment before， patient willing and able to participate in the registry， * hydrocephalus or other neurodegenerative disease and normal subjects. exclusion criteria: * patient received surgical treatment or interventional treatment before * patient is pregnant * patient unable to complete follow-up * patient with other spinal lesions * other nervous system diseases

Keywords: syringomyelia, biomarker，electrophysiology
behavioral treatment of drug abuse in severe and persistent mental illness (spmi) patients

Conditions: Schizophrenia; Mood Disorders; Substance Dependence

Summary: the main purpose of this study is to determine if the multifaceted treatment for substance abuse in dual disordered patients is more effective in reducing drug use than a supportive control treatment. the researchers will also determine if adding a case management component (critical time intervention; cti) to the intervention will increase treatment engagement and retention.

drug and alcohol abuse by people with severe and persistent mental illness (spmi) is one of the most significant problems facing the public mental health system. we have been conducting a project to develop a multifaceted treatment for substance abuse in dual disordered patients (behavioral treatment for substance abuse in schizophrenia; btsas). results have shown that the treatment is well-accepted by patients and has a significant effect on drug use. while btsas has been effective at retaining subjects and fostering reduced drug use, a major problem that occurred was low rates of engagement. the main purpose of this study is to determine if btsas is more effective in reducing drug use than a supportive control treatment and to determine if adding a case management component (critical time intervention; cti) will increase treatment engagement and retention in btsas.

Eligibility criteria:
inclusion criteria: * a diagnosis of schizophrenia or schizoaffective disorder or a diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder (by definition, the patient has worked 25% or less of the past year; and/or the patient receives payment for mental disability) * a diagnosis of current dependence for opiates, cocaine, or marijuana * ability and willingness to attend treatment sessions for 6 months * ability and willingness to provide consent to participate * enrolled in mental health care exclusion criteria: * documented history of severe neurological disorder or severe head trauma with loss of consciousness * severe or profound mental retardation as indicated by chart review * inability to effectively participate in the baseline assessments due to intoxication or psychiatric symptoms on two successive appointments * had a substantial trial in either intervention of the evaluation of behavioral treatment for substance abuse in schizophrenia protocol (h-20680) * inability to attend group sessions due to transportation or other logistical problems * inability to attend scheduled treatment sessions on a regular basis for any reason, or to appropriately participate in research activities due to behavioral or psychiatric problems

Keywords: treatment dual diagnosis
psychometric validation of a french version of the pisq-r and a new questionnaire about sexuality

Conditions: Sexuality; Pelvic Organ Prolapse; Urinary Incontinence; Fecal Incontinence

Summary: the primary objective of this study is the psychometric validation of two questionnaires (pisq-r and a new questionnaire on sexuality) as compared to a non specific questionnaire on female sexual function (fsfi).


Eligibility criteria:
inclusion criteria: * patient is not pregnant * patient can read and understand french * the patient must have given her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient has genital prolapse and/or urinary incontinence and/or anal incontinence, and have undergone surgery exclusion criteria: * the patient is under judicial protection * the patient does not understand french * patient has vulvodynia * patient has painful bladder syndrome * the patient has had chronic pelvic pain for longer than 6 months

Keywords: pisq-r new sexuality questionnaire
comparison of two d-dimers dosing techniques

Conditions: Blood Coagulation Disorder

Summary: study of the possibility of substitution of the automated stago d-dimers method with the semi-automated vidas method, which is more expensive, longer to implement and requires the use of a dedicated automaton.

to compare d-dimer assay techniques in the exclusion of vte (thromboembolic venous disease):• biomerieux: d-dimers vidas (considered as reference technique)• stago: d-di pluson a population of patients recruited in brest for a period of 1 year: patients for whom a dosage of vidas d-dimers is prescribed (approximately 3700 patients)

Eligibility criteria:
inclusion criteria: * patients for whom a dosage of d-dimers vidas is prescribed in the context of a suspicion of vte at brest chru. * no opposition formulated. exclusion criteria: * curative dose anticoagulant treatment whatever the indication, * pregnancy in progress, * follow-up at 3 months not possible, * patient refusing to participate

Keywords: blood coagulation ddimers
study of clinical outcomes of thyroid cancer

Conditions: Thyroid Neoplasms

Summary: the italian thyroid cancer observatory (itco) repository was established to collect data on thyroid cancer management in a prospective and consecutive series of newly-diagnosed patients, enrolled in centers uniformly distributed across the nation.

little information is available on current practices in the treatment of thyroid cancer: a web-based thyroid cancer database was created to collect real-life data. the participants' network include tertiary referral centers operating at the national level, as well as smaller hospital-based units with local or regional recruitment areas.

Eligibility criteria:
inclusion criteria: * pathologically confirmed thyroid cancer * clinical follow-up including serum thyroglobulin (tg) assays, circulating tg antibodies, and high-resolution gray-scale and color doppler us of the thyroid bed and cervical lymph node compartments. additional imaging studies and/or fine-needle aspiration biopsy for cytology are ordered at the examiner's discretion in accordance with evidence-based guidelines * entire follow-up at a participating clinical center. exclusion criteria: * patients referred to the recruiting centers ≥12 months from the primary treatment

Keywords: papillary thyroid cancer follicular thyroid cancer poorly differentiated thyroid cancer anaplastic thyroid cancer medullary thyroid cancer
a study of shr1210 in combination with paclitaxel-albumin and carboplatin in extensive stage small cell lung cancer

Conditions: Extensive Stage Small Cell Lung Cancer

Summary: this project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer


Eligibility criteria:
inclusion criteria: * 18 to 75 years old * confirmed diagnosis of extensive small cell lung cancer * eastern cooperative oncology group performance status (ps) of 0 to 1 * the function of vital organs meets the following requirements. wbc ≥ 3.0 × 10\^9/l, anc≥1.5×10\^9/l, plt≥100×10\^9/l, hb≥9g/dl, alt and ast ≤2.5 times uln, tbil ≤1.5 x uln, crea ≤1.5 x uln or ccr≥50ml/min. inr≤1.5 x uln, aptt ≤1.5 x uln * have not received first-line systemic therapy or immunosuppressive therapy for es-sclc * the estimated survival period is more than 8 weeks * the subjects voluntarily joined the study, signed informed consent, exclusion criteria: * active or untreated cns metastases were detected by computed tomography (ct) or magnetic resonance imaging (mri); * leptomeningeal diseases * uncontrolled or symptomatic hypercalcemia * active, known or suspected autoimmune diseases * have received any t cell co stimulation or immune checkpoint therapy * corticosteroids (\> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug * subjects had active infections * patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation * known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to paclitaxel-albumin or carboplatin * according to the researcher's judgment, there are other factors that may lead to the termination of the study
biomarkers algorithm for stroke diagnosis and treatment resistance prediction

Conditions: Stroke, Ischemic; Large Vessel Occlusion

Summary: triage of acute ischemic stroke (ais) patients is critical, to decrease time to treatment, and improve functional outcome. the therapeutic standard of care for ais consecutive to large vessel occlusion (lvo) is the association of intravenous (iv) alteplase administration and mechanical thrombectomy (mt). however, there are limited places where mt can be performed. therefore, there is a need for innovative tools to identify, in the ambulance, patients with lvo that require mt. sending the patients at the right, avoiding futile stops (i.e. in places where mt is not available), is definitively a strategy that saves time. there is currently no biomarker nor point of care (poc) lab testing to solve this issue and clinical scoring methods such as the nihss have a low accuracy rate to detect lvo. the relevance of blood biomarkers for lvo diagnosis and therapeutic decisions needs to be confirmed for effective triage in the setting of ais with lvo, which represent 30% of all ais. the main objective of our study is to determine diagnostic performances of a panel of selected blood biomarkers to identify patients with ais consecutive to lvo among those with stroke suspicion, within 24 hours of stroke symptom's onset before brain imaging. this could facilitate the triage of patients with lvo refractory to thrombolysis treatment, who may benefit most from mt.


Eligibility criteria:
inclusion criteria: * symptoms consistent with stroke \<24 hours * adult patients ≥ 18 years old * non opposition of the patient or his/her relatives to the research (emergency inclusion procedure) exclusion criteria: * patient under guardianship or curatorship
smartphone-based aftercare for inpatients with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: inpatient treatment for patients with anorexia nervosa (an) is recommended in extreme or severe cases after failure of outpatient treatment and is highly effective. however, a number of patients show symptom increase and relapse after discharge. the aim of this study is to evaluate the efficacy of a guided smartphone-based aftercare intervention following inpatient treatment of patients with an to support symptom stabilization or continued improvement.

anorexia nervosa (an) is a severe, often chronic and life-threatening disorder. relapse after treatment is common with relapse rates ranging between 9 and 52% and being highest within the first year following treatment particularly as early as 3 months posttreatment. even if weight restoration is achieved, it is quite difficult for patients to sustain improvements after treatment, so aftercare and relapse prevention are essential research topics. there is a recent review on internet- and mobile-based aftercare and relapse prevention in mental disorders that concludes that there is some evidence that such interventions are feasible instruments for maintaining treatment gains for some mental disorders, including eating disorders (eds). however, the authors claim for further high quality, large-scale trials that are needed to expand research fields. so, the aim of this study is to prove the efficacy of a guided smartphone-based aftercare intervention for inpatients with an. our primary hypothesis is that at the end of aftercare intervention (t1), the intervention group shows a significantly lower eating disorder symptomatology than the control group. eligible patients with an who are discharged from inpatient treatment are randomized either to receive a 4-month smartphone-based aftercare intervention with therapist feedback as an add-on element to treatment as usual (tau) or tau alone. assessments include structured interviews as well as online questionnaires and are taken at baseline (discharge, t0), end of the aftercare intervention (t1) as well as 6-month follow-up (t2).

Eligibility criteria:
inclusion criteria: * primary diagnosis of an (dsm-5: 307.1), * sex: female, * age: from 12 years onwards to 60 years, * regular completion of inpatient treatment, * at least a length of inpatient stay of 6 weeks, * bmi at discharge at least 15, at least a 1-point bmi increase during inpatient treatment, * owner of a smartphone, * informed consent of the patient and, in case of minors, also of the parents. exclusion criteria: * major depression (bdi-ii \> 29 at discharge), * suicidal tendency (item 9 of bdi-ii \> 1 at discharge), * very high level of care after inpatient treatment (e.g. therapeutic living community, day clinic), * pregnancy.
flu-bu-mel based conditioning regimen for patients with lymphoid malignancies undergoing allo-hsct

Conditions: Lymphoid Neoplasm

Summary: in this phase ii clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.


Eligibility criteria:
inclusion criteria: * lymphoid malignancies * donor available: hla matched sibling, unrelated donor or haplo-identical related donor. * patients with ecog \<3 exclusion criteria: * inform consent not provided * ecog \>=3 * poor liver function (enzyme \>2n or bilirubin \>2n) * poor renal function (scr \>2n) * poor cardiac function (ef \<45%)