Kornimate/medical-research-clean huggingface dataset:
pegfilgrastim vs. filgrastim - comparison of mobilized blood stem cells in patients with non hodgkin-lymphoma

Conditions: Non-Hodgkin Lymphoma

Summary: the purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to mobilize peripheral blood stem cells in patients with non hodgkin-lymphoma in an intraindividual study

patients with non hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). the number of circulating cluster of differentiation 34+ cells, colony-forming units and primitive progenitors will be analyzed at corresponding time points. peripheral blood stem cells will be collected after the second cycle of chemotherapy by leukapheresis. after the second cycle, high-dose therapy with peripheral blood stem cell support will be administered (the protocol will be chosen according to the diagnosis, including total body irradiation-containing regimens).

Eligibility criteria:
inclusion criteria: * histological diagnosis of non-hodgkin lymphoma * planned high-dose therapy with autologous stem cell transplantation * who performance status 0-2 * written consent exclusion criteria: * allergy against (peg)filgrastim * life expectancy \<3 months * other malignant diseases within the last 5 years * cardial insufficiency (\>= new york heart association ii°) * uncontrolled infection * pregnancy, lactation * central nervous system lymphoma * karnofsky score \<70%

Keywords: stem cell transplantation stem cell mobilization high-dose therapy
safety and efficacy of stem cell therapy in patients with autism

Conditions: Autism

Summary: autism is one of those disorders in autism spectrum disorders (asd), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress .neural hypoperfusion and immune deregulation are the two key pathologies associated with autism. human umbilical cord mesenchymal stem cells (huc-mscs) and human cord blood mononuclear cells (hcb-mncs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. in this study, the safety and efficacy of huc-mscs and hcb-mncs transplantation will be evaluated in patients with autism.

to investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of autism.

Eligibility criteria:
inclusion criteria: * children between the ages of 3 and 12 years. * dsm-iv diagnosis of autistic disorder. * total score of cars ≥ 30. * parents or legal guardian willing to sign the icf. exclusion criteria: * any history of hypersensitivity to serum products, or other known drug and food allergy. * history of prior or current dsm-iv psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), pervasive developmental disorder not otherwise specified (pdd nos), asperger's, or rett's. * history of epileptic seizure activity in the past 6 months. * autism caused by seizure disorders (active), cerebrovascular disease or brain trauma. * the global autism ratings are assessed as being absent, minimal or mild. * existing moderate or severe extrapyramidal symptoms (eps) or history of tardive dyskinesia. * subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves). * hiv+ * acute and chronic hepatitis. * autoimmune disease, e.g. lupus erythematosus, multiple sclerosis. * severe pulmonary and hematological disease, malignancy or hypo-immunity. * currently undertaking other treatment that may affect the safety/efficacy of stem cells. * enrollment in other trials in the last 3 months. * other criteria the investigator consider improper for inclusion.

Keywords: autism human cord blood mononuclear cells human umbilical cord mesenchymal stem cells
open label treatment of severe tactile defensiveness with intrathecal baclofen

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder.

the purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder. some people with autism spectrum disorder do not like to be touched. this is referred to as tactile defensiveness. baclofen is a drug approved for treatment of spasticity in patients with conditions such as cerebral palsy, spinal cord injury and traumatic brain injury. intrathecal means that baclofen is administered by injection into the spinal canal. in this study, each patient will undergo a trial administration of intrathecal baclofen and the effect of intrathecal baclofen on symptoms of tactile defensiveness and autism spectrum disorder will be evaluated. each patient will have three visits in connection with the study. first, there will be a screening visit in which the investigators determine if the patient is eligible to participate in the study. to participate, each patient must have autism spectrum disorder, severe tactile defensiveness, and meet other listed criteria. at the second visit, each patient will undergo the intrathecal baclofen trial procedure. the procedure used is the standard procedure to determine if intrathecal baclofen is effective for treatment of spasticity. in this study however, instead of evaluating the effect of intrathecal baclofen on spasticity, the investigators will evaluate the effect of intrathecal baclofen on symptoms of tactile defensiveness and autism spectrum disorder. the trial procedure and evaluation will require about one day. at the third visit, the follow up visit, the investigators will evaluate and discuss the patient's response to the treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosis of autism prior to study entry 2. exhibits these specific symptoms of autism: * tactile defensiveness * increased sensitivity to sensory stimulation 3. patients must be scored as "always" for "reacts emotionally or aggressively to touch" on a modified short sensory profile questionnaire. additionally, patients must score "always" or "frequently" in the other categories of a modified short sensory profile questionnaire exclusion criteria: 1. allergy to baclofen or compounds with similar structure 2. unable to be evaluated by the chosen efficacy measures 3. any condition that in the opinion of the principal investigator will place the patient at increased risk of adverse events or preclude completion of the study 4. concomitant use of any medication that in the opinion of the principal investigator is contraindicated with intrathecal baclofen administration 5. females of child-bearing potential who have a positive urine pregnancy test at visit 2

Keywords: tactile defensiveness autistic disorder
a pilot study for toxicity evaluation of hiv rectal microbicides

Conditions: HIV Infections

Summary: the purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of hiv microbicide gels or medical procedures, such as flexible sigmoidoscopy.

it is not currently known if procedures used to observe the lining of the distal colon, such as endoscopy with or without pinch biopsy, may cause mucosal trauma and thus alter colonic permeability. additionally, the application of topical hiv microbicides (to prevent hiv transmission) and shearing forces associated with rectal intercourse might also adversely affect the epithelial layer, and thus alter colonic permeability. in order to appropriately interpret testing of the effects of topical hiv microbicides on the mucosal lining of the distal colon, it is essential to understand whether these procedures themselves, adversely affect the epithelial layer. if changes in permeability can be detected, this method may be developed to help determine microbicide distribution/toxicity in early phase studies, thus improving the selection of candidate microbicides for study in larger scale clinical trials.

Eligibility criteria:
inclusion criteria: * greater than or equal to 21 years of age * prior history of receptive anal intercourse (rai) * subjects must have a history of using commercially-available personal lubricants for rai. * ability to provide signed informed consent. * willingness to abstain from lubricant use and anal receptive intercourse for 48 hours prior to and 48 hours after phases a and b. * willingness to use a single dose of rectally-applied n-9. exclusion criteria: * mental handicap or impaired cognitive performance status as judged by the investigator. * coagulation abnormality which would put the subject at risk for bleeding as judged by the principal investigator. * history of anorectal surgery within the last month or the presence of any anorectal disease or condition that in the judgment of the investigator could affect permeability of the rectal mucosa. * presence of any painful anorectal conditions or anorectal lesions that would be tender to manipulation. * history of occupational radiation exposure. * history of acute or chronic diarrhea defined as three or more loose stools per day. * history of any allergic response to rectal lubricants. * history of sleep apnea, or airway problems with previous sedation procedures. * history of significant adverse reaction to sedation medications.

Keywords: microbicide safety hiv prevention hiv seronegativity
early palliative care in patient with acute leukaemia

Conditions: Acute Leukaemia in Relapse

Summary: several studies have shown that patients with acute leukemia have many symptoms during disease these symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression several studies point to the involvement of supportive care and palliative care is delayed in these patients the aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .


Eligibility criteria:
inclusion criteria: * \> 18 years old * acute lymphoblastic or myeloblastic leukemia at first relapse and diagnosed within 8 weeks before inclusion. * patients in whom a curative strategy (transplant) is not considered. * patients older that 75 years at the diagnosis * informed signed consent exclusion criteria: * unable to answer the questionnaire * psychiatric disorders other than depression * persons under guardianship

Keywords: acute leukaemia supportive / palliative care
a study of acp-196 (acalabrutinib) in subjects with relapsed/refractory cll and intolerant of ibrutinib therapy

Conditions: Chronic Lymphocytic Leukemia

Summary: a phase 2 study to evaluate the efficacy and safety of acp-196 (acalabrutinib) in subjects with relapsed/refractory cll and intolerant of ibrutinib therapy

a multicenter, open-label, phase 2 study evaluating the efficacy and safety of acalabrutinib in subjects with relapsed/refractory cll (n=60) who are intolerant of ibrutinib therapy.

Eligibility criteria:
inclusion criteria: 1. men and women ≥ 18 years of age. 2. prior diagnosis of cll 3. must have received ≥ 1 prior therapy for cll 4. intolerant of ibrutinib 5. documented disease progression after stopping ibrutinib therapy as defined by the iwcll 2008 criteria 6. willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty. 7. ecog performance status of ≤ 2. exclusion criteria: 1. ongoing ae attributed to ibrutinib therapy 2. treatment with systemic anticancer therapy for cll is prohibited between discontinuation of ibrutinib and enrollment on this trial. 3. prior exposure to a bcl-2 inhibitor (eg, venetoclax/abt- 199) 4. prior malignancy (other than cll), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years. 5. significant cardiovascular disease such as uncontrolled or symptomatic untreated arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification, or qtc \> 480 msec at screening. exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 6. malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. 7. evidence of active richter's transformation or any evidence of disease progression on ibrutinib therapy or any btk inhibitor. 8. cns involvement by cll or related richter's transformation. 9. known history of human immunodeficiency virus (hiv), serologic status reflecting active hepatitis b or c infection, or any uncontrolled active systemic infection. 10. uncontrolled autoimmune hemolytic anemia (aiha) or idiopathic thrombocytopenic purpura (itp) 11. history of stroke or intracranial hemorrhage within 2 months before the first dose of study drug. 12. history of bleeding diathesis. 13. presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening. 14. major surgical procedure within 28 days of first dose of study drug. 15. requires treatment with a strong cyp3a inhibitor

Keywords: chronic lymphocytic leukemia ibrutinib intolerant
prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities

Conditions: Venous Thromboembolism

Summary: the study objective is to evaluate the efficacy and safety of oral ym150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.


Eligibility criteria:
inclusion criteria: * subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery * written informed consent obtained before screening exclusion criteria: * subject has history of deep vein thrombosis and/or pulmonary embolism * subject has a hemorrhagic disorder and/or coagulation disorder * subject has had clinically important bleeding occurred within 90 days prior to the screening visit * subject has an acute bacterial endocarditis * subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke * subject is receiving anticoagulants/antiplatelet agents * subject has a body weight less than 40 kg

Keywords: ym150 bleeding anticoagulant venous thromboembolism fxa inhibitor
observation of the effect of chemotherapy combined with tyrosinase inhibitor on the reactivation of cmv and ebv in patients with acute lymphoblastic leukemia

Conditions: Leukemia, Lymphoblastic, Acute

Summary: philadelphia-chromosome-positive or partial ph-like acute lymphoblastic leukemia (all) preferred chemotherapy combined with tyrosine kinase inhibitors (tkis) therapy. recently we found that there were cytomegalovirus reactivation and even cytomegalovirus infection in three all patients treated with chemotherapy combined with tkis. however, the cytomegalovirus risk after dasatinib use in patients with philadelphia-chromosome-positive all is still unknown. it is reported that dasatinib can be observed in the treatment of philadelphia-chromosome-positive leukemia patients with significant increase in large granular lymphocytes, the cytomegalovirus is often positive, and this part of the patient's prognosis is relatively good. dasatinib can inhibit src and tec kinase, and induce immune function inhibition,and in vitro experiments have confirmed that it inhibits the immune function of t cells and nk cells. in this study, we examined the potential association between cytomegalovirus and ebv reactivation the treatment of chemotherapy combined with tkis, and the numbers of large granular cells and nk cell activity.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with acute lymphoblastic leukemia who had not previously received chemotherapy (except for hormone preconditioning) or started with chemotherapy but not more than 3 days, and cmv and ebv quantitative negative; 2. age limits:\>or= 14 years old. exclusion criteria: 1. patients who had previously received chemotherapy and hematopoietic stem cell transplantation; 2. patients with cmv and ebv infection before treatment and not to turn yin; 3. the researchers considered unsuitable patients.

Keywords: leukemia, lymphoblastic, acute
safety and efficacy of indacaterol once daily versus salmeterol twice daily in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * adults aged ≥ 40 years * diagnosis of chronic obstructive pulmonary disease (copd) (moderate to severe as classified by the gold guidelines, 2007) and: * smoking history of at least 10 pack years * post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥ 30% of the predicted normal value at screening * post-bronchodilator fev1/fvc (forced vital capacity) \< 70% at screening exclusion criteria: * patients who have received systemic corticosteroids for a copd exacerbation in the 6 weeks prior to screening or during the run-in period * patients requiring long-term oxygen therapy (\> 15 h a day) for chronic hypoxemia * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * any patient with active cancer or a history of cancer with less than 5 years disease-free survival time * patients with a history of long qt syndrome or whose qtc interval (fridericia's) measured at screening is prolonged * patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period * patients unable to successfully use a dry powder inhaler device or perform spirometry measurements other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: respiratory dyspnea breathlessness copd indacaterol long-acting β2-agonist
investigator-sponsored protocol - continued use of ibalizumab

Conditions: HIV Infections

Summary: this protocol serves to extend the successful treatment for hiv positive patients beyond the endpoints provided by the phase 2b taimed biologics-sponsored protocol tmb202 (entitled "a phase 2b randomized, double-blinded, 48-week, multicenter, dose-response study of ibalizumab plus an optimized background regimen in treatment-experienced patients infected with hiv-1 (amended to 24 week study)"), for 24 weeks. ibalizumab may be administered beyond 24 weeks under this protocol as supply permits and patients continue to demonstrate virologic response.

ibalizumab is to be administered to hiv-infected patients that have responded (defined as a minimum 0.7 log10 decline in hiv-1 viral load from tmb-202 baseline) on the tmb-202 protocol. in addition to the investigator-selected optimized background regimen, patient(s) will continue to receive the tmb-202 randomized dose of ibalizumab in open-labeled fashion (800mg iv every two weeks or 2000mg iv every four weeks) as per their original drug assignment for the tmb-202 protocol.

Eligibility criteria:
inclusion criteria: * capable of understanding and have voluntarily signed the icf * have documented hiv-1 infection * have successfully completed protocol tmb202 (amendment 2)(week 16) * have had at least a 0.7 log10 decline in hiv-1 rna from baseline at week 16 and beyond while in tmb202 and are no longer eligible to participate in tmb-202 due to tmb-202 protocol-defined virologic failure * have not withdrawn or been discontinued from tmb202 9amendment 2) for any reason * are able and willing to comply with all protocol requirements and procedures * are 18 years of age or older * if sexually active, are willing to use an effective method of contraception during the study and for 30days after the last administration of the study drug. exclusion criteria: * any active aids-defining illness per category c except for cutaneous kaposi's sarcoma and wasting due to hiv * any significant disease (other than hiv-1 infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study * any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations * any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation

Keywords: hiv
procedural outcomes of percutaneous pda closure: comparative study between different devices.

Conditions: Congenital Heart Disease

Summary: to compare safety, efficacy and procedural outcome of percutaneous pda closure using different approaches for better characterization of device selection criteria.


Eligibility criteria:
inclusion criteria: * all patients who are candidate for transcatheter pda closure exclusion criteria: 1. patients with pda dependent pulmonary circulation. 2. patients with small sized pda which is silent by auscultation 3. patients with large sized pda which is unsuitable for trans-catheter closure 4. patients with pda and severe irreversible pulmonary hypertension (eisenmenger's syndrome) (7). 5. patients with active infection or active infective endarteritis. 6. patients refusing the study.