Kornimate/medical-research-clean huggingface dataset:
a phase i study of bendamustine and melphalan conditioning and autologous stem cell transplantation for treatment of multiple myeloma and relapsed/refractory b-cell lymphoma in elderly patients

Conditions: Lymphoma

Summary: this study is testing a combination of chemo-immuno therapy called rbm. rbm consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem cells which is called autologous stem cell transplant (asct). compared to the standard beam regimen, this rbm regimen may or may not be less effective in lymphoma, but will likely have fewer side effects.


Eligibility criteria:
inclusion criteria: phase i eligibility: * any patient with multiple myeloma b-cell non-hodgkin lymphoma would be eligible for phase i portion of the study. dose expansion eligibility: * histologically confirmed diagnosis of multiple myeloma or rel/ref dlbcl, or diffuse large b cell lymphoma transformed from an indolent lymphoma since the endpoint of the phase i portion is safety, any patient with myeloma or b-cell nhl can be enrolled. for dose expansion study patients with myeloma and b-nhl will be analyzed separately. the pfs endpoint varies greatly amongst different types of lymphoma. in order to accurately interpret the survival data as secondary endpoint, a homogeneous cohort of patients with dlbcl will be evaluated. dlbcl is the most aggressive b-nhl with limited options. other b-nhl's are generally more indolent and have more options available to them. additional eligibility for both the phase i and dose expansion cohort: * patients between the ages of 65 to 69 years old with a hematopoietic stem cell transplant comorbidity index (hct-ci) score of 3 or higher. * any patient age 70 years old or older, irrespective of their hematopoietic stem cell transplant comorbidity index (hct-ci) score. * kps ≥ 70 * males must agree to use an acceptable form of contraception per institutional practices. * complete or partial response to salvage chemotherapy by iwg working group criteria * cardiac ejection fraction of ≥ 45% * hemoglobin-adjusted diffusing capacity of carbon monoxide (dlco) of ≥45% * creatinine clearance of ≥50 ml/min * completion of most recent salvage therapy within 8 weeks of enrollment * direct bilirubin ≤2.0 mg/dl in the absence of suspected gilbert's disease (if gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dl), and ast ≤ 2.5 uln. exclusion criteria: * in lymphoma: disease progression by iwg working group criteria since last therapy * patients with history of cns involvement * prior autologous (only in lymphoma) or allogeneic stem cell transplantation * patients who have failed bendamustine-based regimen previously * patients within 6 months of mi and stroke will be excluded

Keywords: rituximab bendamustine melphalan autologous stem cell transplantation (asct) 17-373
incobotulinumtoxina for treatment of focal cancer pain after surgery and/or radiation

Conditions: Pain

Summary: the purpose of this research study is to investigate the safety and effectiveness of botulinum toxin a (xeomin) ® injections in patients who suffer from focal pain in areas of radiation and/or surgery as a result of cancer treatment. our hypothesis is that injection of incobotulinum toxin a into an area of local pain, at or around the area of a post-surgical/post radiation scar, relieves the focal cancer pain.

please contact the pi for more detailed information.

Eligibility criteria:
inclusion criteria: * subjects 18- 80 years, both sexes, all races and ethnic groups. * diagnosis of post- surgical/post - radiation cancer pain. * focal pain duration longer than 3 months * pain of moderate to severe intensity ( mean vas over the previous week \>4 ) * subjects who are able to read, speak, and understand english. exclusion criteria: * existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders). * pregnancy or planned pregnancy (determined by urine pregnancy test). women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc). * active breast feeding. * enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol. * any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication. * subjects who are younger than 18 years of age. * neuromuscular-junction disorders. * axis i diagnosis determined by a neurologist or psychiatrist. * use of anesthetic medications within two weeks or corticosteroid injections within 4 weeks of enrollment. * received botulinum toxin injections in the past 4 months. * patients taking high doses of aminoglycosides or other drugs affecting the function of neuromuscular junction ( anticholinergic, muscle relaxants) * patients who have unstable pain in/at sites other than areas of planned injection

Keywords: cancer pain, radiation therapy, surgery, incobotulinum toxin
increasing caregiver and patient engagement through phr use

Conditions: Cardiovascular Diseases

Summary: informal caregivers play an integral role in managing complex, chronic disease patients providing services equivalent to an estimated economic value of $470 billion. the inclusion of informal caregivers in the healthcare team can improve care coordination and make health care safer by reducing potential medical errors caused by miscommunication. the investigators reason that a properly designed phr with a simplified user interface and easy access to relevant content can improve the management of chronic diseases and better integrate caregivers and patients into the healthcare team.

informal caregivers (caregivers, often family or friends) play an integral role in managing patients with complex, chronic diseases. it is estimated that caregivers provide $470 billion of uncompensated care. despite their impact, healthcare systems largely neglect caregivers. long distance caregivers of older adults (who make up 15% of caregivers in america) are at a particular disadvantage. in the current healthcare system, health information technology (hit) has not been optimized to support the needs of caregivers and patients. providing hit that supports enhanced communication between patients, caregivers, and clinicians can improve patient safety by increasing the accuracy of patient data and by reducing miscommunication(1). there is limited knowledge concerning best practices to promote caregivers' and patients' activation and engagement, especially with hit. access to personal health information through the personal health record (phr) has the potential to improve chronic health care management, and encourage patient engagement. although caregivers and patients express a willingness to adopt phrs, in practice, multiple barriers hinder phr adoption. a properly designed phr can help caregivers and patients manage their health and become partners in the healthcare team. this study's overall objective is to identify caregivers and cardiovascular patients' communication and technology needs and to build and test an optimized phr design that promotes active participation of patients and their caregivers in their health. the overall hypothesis is that an optimized phr will expand the role of caregivers to improve the patient's health and improve the satisfaction of both patients and caregivers with their care. the investigators will employ an agile, user-centered design process involving caregivers and older cardiovascular patients.

Eligibility criteria:
inclusion criteria: * eligible patients will be patients with heart disease, able read, write, and speak english, and at least 65 years of age. * eligible caregivers will be a primary caregiver of an eligible patient, able to read, write, and speak english, and at least 18 years of age. exclusion criteria: * individuals under the age of 19 will not be considered for participation.
28-day repeat dose study of gsk573719

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study will evaluate the efficacy, safety, and pharmacokinetics of gsk573719 compared with placebo in subjects with copd

this is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of gsk573719 administered once-daily over 28 days in subjects with copd.

Eligibility criteria:
inclusion criteria: * a signed and dated written informed consent prior to study participation * males or females of non-childbearing potential * 40 to 80 years of age * copd diagnosis * 10 pack-years history or greater of cigarette smoking * post-bronchodilator fev1/fvc ratio of 0.70 or less * post-bronchodilator fev1 of 25 to 70% of predicted normal exclusion criteria: * asthma * other significant respiratory disorders besides copd, including alpha-1 deficiency * previous lung resection surgery * chest x-ray or cp scan showing clinically significant abnormalities not due to copd * use of oral steroids or antibiotics for a copd exacerbation within 6 weeks of screening * hospitalization for copd or pneumonia within 3 months of screening * any significant disease that would put subject at risk through study participation * bmi greater than 35 * pacemaker * significantly abnormal ecg or clinical lab finding (including hepatitis b or c) * cancer * allergy or hypersensitivity to anticholinergics or inhaler excipients * diseases that would contraindicate the use of anticholinergics * use of oral corticosteroids within 6 weeks of screening * use of long-acting beta-agonists within 48 hours of screening * use of tiotropium within 14 days of screening * use of theophyllines or anti-leukotrienes within 48 hours of screening * use of short-acting bronchodilators within 4 to 6 hours of screening * use of investigational medicines within 30 days of screening * use of high dose inhaled corticosteroids * use of long-term oxygen therapy, cpap or nippv * participation in acute phase of pulmonary rehabilitation program * history of alcohol or drug abuse within 2 years prior to screening * history of psychiatric disease limiting validity of consent * affiliation with the investigative site * previous use of gsk573719

Keywords: chronic bronchitis anticholinergic emphysema long-acting muscarinic antagonist copd
efficacy and safety of mtx-loaded nanoparticles to treat severe covid-19 patients

Conditions: COVID-19

Summary: the aim of this study is to evaluate the efficacy and safety of mtx-loaded nanoparticles in three different doses to treat severe covid-19 patients.

patients with acute lung injury caused by covid-19 disease are experiencing an inflammatory reaction that can be harmful and worsen the severity of the clinical condition. thus, the use of mtx-loaded nanoparticules in patients with acute lung injury secondary to covid-19 aims to decrease the exacerbated inflammatory reaction leading to a decrease in cell damage caused by this inflammatory process in patients. the study will be divided in 3 phases: phase a (n=4): iv administration of 20 mg of mtx-loaded nanoparticles. four doses of investigational product (ip) will be administered, once per week. if patients show clinical improvement after 2nd or 3rd administration, the next phase will start. phase b (n=12): iv administration of 30 mg of mtx-loaded nanoparticles. four doses of investigational product (ip) will be administered, once per week. if patients show clinical improvement after 2nd or 3rd administration, the next phase will start. fase c (n=26): iv administration of 40 mg of mtx-loaded nanoparticules. four doses of investigational product (ip) will be administered, once per week.

Eligibility criteria:
inclusion criteria: 1. informed consent from patient or legal representative. 2. male or female, aged ≥ 18 years; 3. acute respiratory distress syndrome; with imminent risk of death, and with chest ct scan with pulmonary impairment greater than 50%; 4. confirmed or pending diagnosis of covid-19. exclusion criteria: 1. pleural effusion \> 150ml or ascites \> 200ml; 2. chronic liver disease; 3. alt and ast serum levels \>= three times the upper limit of normality; 4. renal failure (dialysis) 5. multiple organ failure 7. concomitant use or use in the last 7 days of cell therapy with stem cells; 8. any clinical or laboratory condition or comorbidity that, at medical discretion, 9. known hypersensitivity to the investigational product; 10. subject who is pregnant or lactating
treatment uptake chatbot for eating disorders

Conditions: Eating Disorders

Summary: eating disorders (eds) are serious mental illnesses associated with high morbidity and mortality, clinical impairment, and comorbid psychopathology. although evidence-based treatments for eds have been established, the treatment gap is wide. indeed, \<20% of individuals with eds receive treatment. there is need for a novel solution not only to identify individuals with eds but also to encourage mental health services use and to address treatment barriers. this study aims to implement a conversational agent or "chatbot" that is optimized to increase mental health services use among individuals with eds through such features as: 1) education on the seriousness and consequences of eds; 2) engaging the user in motivational interviewing to overcome barriers to care; 3) providing a personalized recommendation for seeking intervention; 4) repeated check-ins with the user to encourage follow-up with care. this study will utilize a randomized optimization trial with adults who have completed screening on the national eating disorders association (neda) website and screen positive for an ed but are not in treatment to determine chatbot feasibility and to generate data on the effect of the chatbot on motivation for treatment and mental health services use. this trial will employ the multiphase optimization strategy framework, using a 2\^4 full factorial design, to randomly assign participants to a combination of the four proposed intervention components (n=16 conditions) to isolate the active ingredients.


Eligibility criteria:
inclusion criteria: * u.s. resident * english-speaking * age 18 years or older * owns a personal smartphone * screens positive for a diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) clinical or subclinical eating disorder * not currently receiving treatment for an eating disorder exclusion criteria: * non-u.s. resident * younger than 18 years old * does not own a personal smartphone * does not screen positive for a dsm-5 clinical or subclinical eating disorder * screens positive for avoidant restrictive food intake disorder * currently receiving treatment for an eating disorder
nab-ptx, ifosfamide and cisplatin in the treatment of pediatric extracranial germ cell tumor.

Conditions: Extracranial Germ Cell Tumor, Pediatric

Summary: the purpose is to evaluate the effectiveness and safety of albumin-bound paclitaxel (nab-ptx), ifosfamide and cisplatin in the treatment of children patients with advanced, recurrent or refractory extracranial germ cell tumor.

children patients with advanced, recurrent or refractory extracranial germ cell tumor were treated with albumin-bound paclitaxel (nab-ptx), ifosfamide and cisplatin . this is a multi-center and single arm phase ii clinical study.

Eligibility criteria:
inclusion criteria: 1. age: 1-18 years old; 2. ecog ps score: 0-1; 3. patients was confirmed pathologically with malignant germ cell tumor. 4. patients with tumor progressed, relapsed or refractory after first-line chemotherapy, and complete or partial remission was not achieved after recent treatment. 5. have at least one measurable lesion defined by recist standard; 6. the estimated survival time was more than 6 months; 7. patients must fully recover from the acute toxicity of previous anticancer chemotherapy: 8. bone marrow function met the following criteria: 1. absolute neutrophil count (anc) ≥ 1.0 × 109 / l; 2. platelet count ≥ 100.0 × 109 / l (not after platelet transfusion); 9. liver and kidney function should meet the following criteria: 1. bilirubin (the sum of bound and unconjugated) ≤ 1.5 × upper limit of normal value (uln) (corresponding to age). patients with confirmed gilbert's syndrome can be classified according to the researcher; 2. aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 × uln; 3. estimated glomerular filtration rate ≥ 70 ml / min / 1.73 m2 or normal serum creatinine (cr); 10. adequate pulmonary function: no dyspnea at rest, no exercise intolerance, pulse oxygen saturation \> 94% (if there are clinical symptoms); 11. cardiac function: 1. lvef ≥ 50% was detected by echocardiography; 2. there was no history of arrhythmia requiring drug intervention before enrollment; 12. seizures that can be fully controlled without enzyme-induced anticonvulsants; 13. during the study period, they were able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits; 14. parents / guardians of child or adolescent subjects have the ability to understand, agree and sign the study informed consent form (icf) and the applicable child consent form before starting any program related procedures; subject has the ability to express consent (when applicable) with the consent of parents / guardians. exclusion criteria: patients with any of the following items will not be enrolled in this study: 1. patients with recurrent germ cell tumor were treated by surgery alone previously; 2. patients with immature teratoma (any grade); 3. patients with sex cord stroma; 4. hbsag positive patients; 5. patients with hiv or syphilis infection; 6. patients who had received organ transplantation before; 7. uncontrolled active systemic bacterial, viral or fungal infections;
prevalence of major depression among immigrants in santiago, chile

Conditions: Major Depressive Disorder

Summary: the general aim of this study is to explore the prevalence of major depressive disorder and the use of mental health services in the immigrant populations in the metropolitan region of santiago, chile. the hypotheses are: 1. a healthy immigrant effect will be observed in the studied population by which their prevalence of major depressive disorder will be lower than the prevalence in the general chilean population. 2. a significant association will be observed between the loss of socio-economic position after migration and a greater probability of major depressive disorder. 3. a significant association will be observed between the report of victimization experience(s) in the previous year and a greater probability of major depressive disorder. 4. a significant association will be observed between financial difficulties and a greater probability of major depressive disorder. the sampling framework of the chilean national institute of statistics (ine) from the 2016 census will be used for the purpose of this research. the sampling units are as follows: 1. primary sampling units (psus): conglomerates or groups of adjoining houses, organized in spatial blocks (200 households on average) 2. secondary sampling units (ssus): individual households within each of the conglomerates selected in the first stage 3. final sampling units: persons meeting the study's inclusion criteria multi-stage random probability sampling involving a 3-stage sampling design will be used - first, the sampling of the primary sampling units (psus); second, the sampling of households within the selected psus and finally, the random sampling of a household member. participants (n=1,100) will then take part in a 45-minute interview. this interview will be a household survey using the modular version of the composite international diagnostic interview (who-cidi) looking at exploring a broad spectrum of factors traditionally associated with increased risk of affective disorders: 1. sociodemographics 2. finance 3. variation in socioeconomic position 4. experience of victimization 5. discrimination 6. experience of childhood adversity


Eligibility criteria:
inclusion criteria: * country of birth other than chile * time since arrival to chile: 3 months exclusion criteria: * unable to understand spanish

Keywords: prevalence mood disorders affective disorders major depressive disorder service use migration health global mental health
the catholic university bima grafting study

Conditions: Multivessel Coronary Artery Disease

Summary: the present study hypothesizes that the systematic use of bilateral internal mammary artery (bima) grafting is feasible in the practice of a university cardiac surgery institution for the treatment of multivessel coronary artery disease (primary hypothesis). the secondary study hypothesis is that the bima grafting meets the safety endpoint compared with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets. the tertiary study hypothesis is that the bima grafting yields better follow-up results in terms of recurrence of symptoms related to coronary disease, of repeat revascularization and of cardiac mortality compared with patients treated with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.


Eligibility criteria:
inclusion criteria: * patiens undergoing primary or elective-urgent isolated multivessel coronary artery bypass grafting (cabg) surgery exclusion criteria: * emergency status * previous cardiac operation * any associated cardiac procedure other than cabg surgery * left ventricular ejection fraction \<20%

Keywords: coronary artery bypass grafting mammary artery grafts bilateral mammary artery grafting clinical outcomes
early palliative care in metastatic lung cancer in northern france

Conditions: Lung Cancer Metastatic

Summary: single-center, prospective, controlled, open-label, randomized, two parallel arms comparing early palliative care versus standard care in patients with non-small-cell metastatic lung cancer

144 patients will be included; 72 per arm. * "standard" control arm: patient supported by the onco-respiratory service. * intervention arm: patients benefit from early palliative care in addition to standard onco-pneumologic care. the main criterion of judgment is the toi score measured at 12 weeks. factl questionnaires, hads and phq-9 will be filled out before randomization , at 12 weeks and 21 weeks

Eligibility criteria:
inclusion criteria: * being diagnosed with non-small cell lung cancer * proven histologically * metastatic proven imaging (mri, ct scanner, pet scan) * stage iv (any t, any n, m1) * prior to secondary chemotherapy treatment. * age\> 18 years * ps ≤2 * patient able to understand the nature, purpose and methodology of the study * signed informed consent exclusion criteria: * age \<18 years * patient already supported by palliative care * patient with an activating egfr mutation or eml4-alk rearrangement or ros1 gene translocation * patient under trusteeship / guardianship

Keywords: early palliative care lung cancer quality of life