Kornimate/medical-research-clean huggingface dataset:
the anti-ctla-4 monoclonal antibody tremelimumab in malignant mesothelioma

Conditions: Malignant Mesothelioma

Summary: rational: preliminary results fron the study mesot-trem-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (mm) patients. purpose: the proposed study mesot-trem-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 mm patients. subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.

primary endpoint: 1) to assess the rate of objective clinical complete response (cr) or partial response (pr) secondary endpoints: 1. to define toxicity profile according to nci ct-cae v. 3 2. to assess the overall survival (os) 3. to estimate disease control rate (dcr) (proportion of patients with best response of cr+pr+sd) according to the modified recist criteria 4. to assess the progression-free survival in treated patients according to modified recist criteria 5. to evaluate qualitative and quantitative changes in cellular and humoral immune responses

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed mm * have received only one prior systemic chemotherapy platinum-based regimen for advanced mm * measurable disease, defined at least 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral ct scan (modified recist criteria) * disease not amenable to curative surgery * no known brain metastasis * age 18 and over * performance status 0-2 * life expectancy \> 12 weeks * adequate hematologic, hepatic and renal function * platelet count \> 75000/mm3 * absolute granulocyte count \> 1000/mm3 * hemoglobin \> 9 g/dl * bilirubin total \< 1.5 x uln (upper limited normal), except patients with documented gilbert's syndrome, who must have a total bilirubin \< 3.0 mg/dl * ast and alt \< 2.5 x uln ( \< 5 x uln if documented liver metastasis are present) * creatinine level \ 60 ml/min as determined by the cockcroft gault equation. * not pregnant or nursing * fertile patients must use effective contraception * patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution exclusion criteria: * symptomatic chronic inflammatory or autoimmune disease * active hepatitis b or c * prior treatment with tremelimumab or other anti-ctla-4 antibody or anti-pd1, anti-pdl-1 agents * clinically relevant cardiovascular disease * history of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent * uncontrolled active infections * other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents * history of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years

Keywords: tremelimumab anti-ctla-4 monoclonal antibody malignant mesothelioma
cognitive behavior therapy for patients with psychoses.

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders

Summary: patients with psychoses are randomized either to group treatment (act) or individual cbt for 18 sessions.

since patients in the early stage of the illness seem to benefit more from cbt than patients with chronic conditions the present research will focus on patients with psychosis at the early stages of their illness. patients with first episode psychosis from the northern stockholm psychiatry (midhagen) and the south west stockholm psychiatry (tips) will be included. scores on alcohol use disorder identification test (audit) and drug use disorder identification test (dudit) will be used as a covariate in order to control for the patients' s drug and alcohol use habits. the study is single blind randomized controlled trials of manualized cognitive behavior group therapy (cbgt) versus an active treatment condition of individual cbt for patients with first episode psychosis. a total of 16 patients are enrolled and randomly allocated to either cbgt or to individual cbt treatment. then 18 structured cbgt or individual cbt sessions approximately once a week will be offered. three experienced cbt trained therapists will perform the therapies. two therapists will be allocated to each group composed by approximately 5 patients. the group therapies are conducted according to the acceptance and commitment therapy (act) for psychosis manual (an 18 session group therapy protocol by pearson a. \& tingey r.). the individual therapies are conducted according to non-manualized ordinary clinical procedure. the act manual is originally constructed for patients with chronic schizophrenia and has therefore been adapted by the therapists to be appropriate for patients with first episode psychosis. the therapists have taken a course in act and they receive act-supervision during the trial. assessments in both studies will be carried out at baseline, after therapy completion and 6 months later by an independent rater blind to group allocation and not involved in the treatment of the patients. the raters blindness will be measured.

Eligibility criteria:
inclusion criteria: diagnostic and statistical manual 5 (dsm-5): * schizophrenia spectrum disorders: * schizophrenia, * schizophreniform psychosis, * schizoaffective disorder) * delusional disorder, * brief psychotic disorder * psychosis not otherwise classified. exclusion criteria: * patients with drug abuse diagnosis * organic brain injury, * patients with grave somatic illness with secondary psychotic symptoms.

Keywords: acceptance and commitment therapy act cognitive behavior therapy cbt schizophrenia psychoses
safety and immunogenicity of two trivalent subunit influenza vaccines in healthy adult subjects

Conditions: Prophylaxis: Influenza

Summary: the purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (tivc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (tivf). the study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study. the total study participation time per subject is about 3 weeks.


Eligibility criteria:
inclusion criteria: * males or females 18 through 49 years of age. * subjects having provided informed consent. * individuals in good health exclusion criteria: * chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy. * female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
diagnostic assessment of amino acid pet/mri in the evaluation of glioma and brain metastases

Conditions: Brain Neoplasms

Summary: mri is used in clinical routine for diagnosing brain tumors, but has limitations in identifying tumor grade, true tumor extension and differentiate viable tumor tissue from treatment induced changes and recurrences. amino acid pet has demonstrated a great potential for defining true tumor volume, differentiate viable tumor tissue from postoperative changes or radiation necrosis, selection of biopsy site, non-invasive grading of gliomas and for treatment planning and therapy response assessment. by combining pet with mri, the diagnostic accuracy can improve significantly for these patients. more research is however needed to compare the most promising amino acid pet tracers in patients with glioma, but also to assess the diagnostic value of amino acid pet in patients with different brain metastases, where the knowledge concerning the uptake characteristics is limited. three of the most promising amino acid tracers (\[11c\]-methyl-methionine (11c-met), \[18f\] fluoro-ethyl-tyrosin (18f-fet) and anti-1-amino-3-\[18f\]fluorocyclobutane-1-carboxylic acid (18f-facbc)) will be evaluated in 3 substudies in this project; wp1 aminoacid pet/mri in low and high grade glioma; wp2 role of 11c-met in high-grade glioma gamma knife® radiosurgery; and wp3 amino acid pet in brain metastasis. the main aim of the study is to improve diagnostic accuracy, histopathological tissue sampling, delineation of tumor extent and therapy response assessment in gliomas and brain metastases with amino acid pet/mri.


Eligibility criteria:
inclusion criteria: * inclusion criteria glioma (lgg, hgg and recurrent hgg): * planned treatment for who grade ii-iv diffuse glioma * adult patients (\>18 years) * planned tissue sampling for histopathological diagnosis. * kps \>60 (able to care for self) inclusion criteria brain metastasis: * indication of surgery or stereotactic radiosurgery for 1-4 brain metastases * planned surgery: suspicion of brain metastasis or known diagnosis * stereotactic surgery: known primary cancer * adult patients (\>18 years) * estimated survival at least 3 months after inclusion exclusion criteria: * exclusion criteria (glioma and brain metastasis): * pacemakers or defibrillators not compatible with 3t mri * no ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits). * pregnancy (pregnancy test for all women in fertile age when doubt about possible pregnancy exist) * breastfeeding * weight \> 120 kg

Keywords: diagnosis magnetic resonance imaging positron-emission tomography pet-tracer
efficacy and safety of entecavir maleate tablets in chinese patients with hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to evaluate the safety and efficacy of entecavir maleate tablets in chinese patients with hepatitis b


Eligibility criteria:
inclusion criteria: 1. subjects diagnosed of hbeag positive or negative chronic hepatitis b 2. aged 18 to 70 years old，male or female 3. patients with previously hbsag-positive, hbeag-positive for 24 weeks, hbv-dna\> 105copies/ml. hbeag-negative for 24 weeks or more, hbv-dna\> 105 copies/ml. 4. 1.3 times the upper normal limit (1.3 × uln) ≤ alanine aminotransferase (alt) ≤ 10 × uln. 5. total serum bilirubin (tbil) ≤ 2.5 × uln. 6. prothrombin activity (pta) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds). 7. wbc ≥ 3.5 × 109 / l, plt ≥ 70 × 109 / l, serum albumin (alb)≥ 35 g / l. 8. creatinine (cr) ≤ 1.5 × uln. 9. if patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks. 10. patients signed an informed consent form and compliance was good. exclusion criteria: 1. patients were infected with other viruses as hav, hcv, hdv, hev, cmv, ebv, hiv etc. 2. patients with cirrhosis or liver cancer. 3. patients have participated in another therapeutic clinical trial in 3 months. 4. granulocyte count \ 100μg / l, patients' b ultrasonography pointed space-occupying lesions. 5. patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases. 6. patients with metabolic or autoimmune diseases such as systemic lupus erythematosus. 7. pregnant woman, lactating women or those who wre allergic for study drug.
single-port versus multi-port robotic surgery for rectal cancer

Conditions: Rectal Cancer Patients; Robotic Surgical Procedures

Summary: single-port versus multi-port robotic surgery for rectal cancer

this study is a phase 2a clinical trial based on the ideal framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. the primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. secondary endpoints include incision length, visual analog scale (vas) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes.

Eligibility criteria:
inclusion criteria: * rectal cancer with the lower tumor margin less than 15 centimeters from the anal verge (defined by mri); * histological biopsy confirms adenocarcinoma of the rectum; * stage i-iii (assessed by mri and abdominal ct), including downstaging after neoadjuvant therapy; * intends to perform anal sphincter-preserving surgery and plans for primary anastomosis; * informed consent has been obtained from the patient and family; * age greater than 18 years old. exclusion criteria: * previous rectal resection (excluding local excision); * emergency surgery due to complications from rectal tumors; * pregnancy; * signs of acute intestinal obstruction; * multifocal colorectal tumors requiring multisegment bowel resection; * familial adenomatous polyposis (fap), hereditary nonpolyposis colorectal cancer (hnpcc), active crohn's disease, or active ulcerative colitis; * planned synchronous resection of abdominal organs; * history of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; * absolute contraindications to general anesthesia or prolonged abdominal insufflation, such as severe cardiovascular or respiratory diseases (asa classification \>iii); * preoperative mri suggests tumor invasion of the levator ani muscle or external anal sphincter, and preoperative assessment indicates inability to achieve curative resection or the need for abdominoperineal resection; * clinical or radiological evidence of distant metastasis of rectal cancer; * unsuitable for robotic surgery; * local excision of tumor; * anal cancer.
lfb-r603 dose finding in patients with advanced stage b-chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-cd20 monoclonal antibody lfb-r603 in patients with relapsed or refractory b-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen.


Eligibility criteria:
inclusion criteria: * signed informed consent * relapsed or refractory b-cll after at least one prior course of therapy with fludarabine * circulating lymphocytes expressing cd20 * peripheral blood lymphocyte count \> 5,000/µl * ecog performance status ≤ 2 * life expectancy ≥ 3 months * negative blood pregnancy test before inclusion for women of childbearing potential * medically acceptable method of birth control throughout the study for women of childbearing potential * being considered as reliable and capable of adhering to the protocol and compliant with study procedures * covered by healthcare insurance exclusion criteria: * transformation of cll into a high grade lymphoma * allogeneic stem cell transplantation \< 6 months before enrolment * prior treatment with anti-cd20 monoclonal antibodies \< 6 months before enrolment * prior treatment with alemtuzumab \< 2 months before enrolment * treatment with any imp or participation in a clinical study within 30 days prior to enrolment * known severe anaphylactic or other hypersensitivity reactions secondary to a prior exposure to murine antibodies or to any component of lfb-r603 * patient with prior treatment or concomitant medication that may interfere with the interpretation of the study data * patient with a concomitant malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast * patient with serious non-malignant disease, active infection requiring systemic antibiotic, antifungal or antiviral drug or physical examination or laboratory abnormalities, that would compromise protocol objectives * positive serology to hiv, hcv or presence of hbs ag * creatinine clearance, calculated according to cockroft -gault formula \< 60 ml/min * alt and /or ast level \> 1.5 times the upper limit of normal * pregnancy or breastfeeding
intravenous n-acetylcysteine and oseltamivir versus oseltamivir in adults hospitalized with influenza and pneumonia

Conditions: Influenza

Summary: seasonal influenza epidemics are important causes of morbidity and mortality. cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza. early therapy with a neuraminidase inhibitor (nai) is associated with better outcome in patients hospitalized with influenza, but significant mortality occurs despite use of antivirals. n-acetylcysteine (nac) is a modified form of the amino acid cysteine, with anti-oxidant properties. nac was shown to inhibit the production of pro-inflammatory molecules in lung epithelial cells infected with influenza viruses. previous case report showed that high dose nac, administered as continuous intravenous infusion, was effective and safe in improving the clinical outcomes. we aim to perform a randomized controlled trial to evaluate the therapeutic role of adjunctive nac in the clinical management of patients with influenza complicated by lower respiratory tract involvement and abnormal respiratory status. such information when available may reveal the potential of nac for optimization of management of severe influenza, and provide important insights into future adjunctive therapy research.


Eligibility criteria:
inclusion criteria: * influenza a and b virus infections confirmed by polymerase chain reaction (pcr) and/or immunofluorescence assays, * hospitalized for the management of severe manifestations of influenza, * initiation of oseltamivir, * clinical evidence of lower respiratory tract infection (e.g. shortness of breath, tachypnea, oxygen desaturation \<93% on room air, crepitations on auscultation, infiltrations or consolidations on chest radiograph) * written informed consent (by the subjects, or from their next of kin if the subjects are unable to provide written consent at the time of enrollment) exclusion criteria: * use of immunosuppressants (e.g. post-chemotherapy, post-transplant, autoimmune diseases) other than systemic corticosteroids * known immuno-compromised conditions (e.g. active haematological malignancies, hiv/aids patients who are on antiretroviral therapy and cd4 cell count \< 200), * pregnancy * lactation, * end-stage renal failure * hepatic failure * cardiac failure * patients on anticoagulation (except prophylactic dose of low molecular weight heparin), * patients with scheduled major surgery within 2 weeks (nac may affect blood clotting), * patients who have received macrolide antibiotics and nsaid for 1 week prior to enrolment due to their immuno-modulating effects. * use of investigational anti-influenza antivirals and blood products

Keywords: respiratory, mortality, cytokines, chemokines, n-acetylcysteine (nac)
personalized speech therapy for active conversation

Conditions: Parkinson Disease

Summary: background: up to 70% of the patients with parkinson's disease (pd) experience speech problems, which cause a diminished intelligibility. a reduced intelligibility has a profound negative impact on social interaction and quality of life. since pharmacological treatment only has limited effects on speech, non-pharmacological treatment, like speech therapy, is particularly relevant. cochrane reviews (herd et al., 2012a; herd et al., 2012b) showed that evidence for speech therapy in pd is increasing, but is still inconclusive. moreover, only very intensive standardized treatment programs have been studied, which are only feasible for people with mild to moderate pd, but too intensive for people with advanced pd. here, the investigators will perform the first large-scale study to demonstrate the efficacy of speech therapy in pd patients in all disease stages on quality of life and speech quality. objective: the aim is to demonstrate the effectiveness of personalized and home-based speech therapy on quality of life, intelligibility and social participation for people with parkinson's disease who have a reduced intelligibility of speech. methods: the investigators will perform a single blind, randomized and controlled trial. a total of 215 patients (18 years and older) with pd in all disease stages who have difficulty with intelligibility affecting daily communication will participate in this study. the patients will be randomly allocated to either speech therapy or a waiting list control group (1:1 ratio). speech therapy using telerehabilitation will be provided for 8 weeks which consists of 12-16 sessions. the control group will receive deferred treatment after 8 weeks. the measurements will take place before the randomization (to), after 8 weeks (t1), and for the experimental group also after 24 weeks (t2). the primary outcome measure is quality of life, as measured using the total score on the pdq-39. secondary outcome measures include speech and voice, speech intelligibility, non-motor symptoms and caregiver burden. hypothesis: the investigators hypothesize that patients in all disease stages can improve their speech intelligibility by using the explicit feedback from external cues provided by instructed caregivers plus a dedicated smartphone/ tablet app (the voice trainer app).


Eligibility criteria:
inclusion criteria: * a diagnosis of idiopathic pd; * problems in intelligibility affecting daily communication (as indicated by the patient and/or the caregiver); * a desire for improvement; * willing and able to receive online treatment exclusion criteria: * recent (\<1 year) speech therapy; * voice or speech problems due to other causes; * communication difficulties based on language problems without predominantly reduced intelligibility; * inability to receive online treatment

Keywords: speech therapy telerehabilitation quality of life
gw572016 combined with trastuzumab for the treatment of previously trastuzumab-treated breast cancer

Conditions: Neoplasms, Breast

Summary: this is two-part study (phase i/phase ii). part i is designed to find the optimal (best) doses of gw572016 and trastuzumab when given together,part ii is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.


Eligibility criteria:
inclusion criteria: * patients with confirmed breast cancer who have received prior trastuzumab. * patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity. * female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control. exclusion criteria: * patients with certain heart problems.

Keywords: erbb2 stage iv breast cancer erbb1 breast cancer lapatinib herceptin trastuzumab