Kornimate/medical-research-clean huggingface dataset:
bendamustine, wkly bortezomib, lenalidomide and dexamethasone for multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of the study is to determine the safety and efficacy of the use of bendamustine in combination with a commonly used combination chemotherapy to treat relapsed and refractory multiple myeloma. the study will be conducted in two phases. participants in phase i will receive 1 of 4 escalating doses of bendamustine. once the maximum tolerated dose of bendamustine is determined, phase ii of this trial will begin. participants in phase ii will receive the maximum tolerated dose of bendamustine in combination with standard of care chemotherapy.

multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of plasma cells. it has an incidence of about 4.5/100,000 per year in the u.s., making it the second most common hematologic malignancy. for many years, alkylating agents have been the backbone of treatment. the combination of melphalan and prednisone was, for many years, the standard of care for patients who were not candidates for autologous transplantation. melphalan continues to be the primary conditioning agent for autologous transplant,and cyclophosphamide has also gained a foothold in the treatment of this disease. the introduction of novel agents has fundamentally changed the landscape of treating this disease, although the true effects on survival are not yet known. immunomodulatory agents and proteosome inhibitors, including thalidomide, lenalidomide and bortezomib have been used in both newly diagnosed and relapsed patients. currently, there is intense clinical research on the optimal way to combine these novel agents with the traditional backbones of treatment - including alkylators, with one another and, eventually, with the subsequent iterations of these classes of drugs. however, despite the therapeutic excitement surrounding this disease, most patients will relapse and a cure remains an elusive goal.

Eligibility criteria:
inclusion criteria: * adults with relapsed and/or refractory myeloma who have received between 1-4 prior lines of therapy * must have adequate liver and renal function * zubrod performance status (zps) of 2 or better * must have measurable disease exclusion criteria: * peripheral neuropathy of grade ii or higher * thrombocytopenia (platelets less than 50,000/ul) * neutropenia (anc\<1000/ul) * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>2.4 x uln * total bilirubin \>1.5 x upper limit of normal (uln) * creatinine clearance of less than 45 milliliters per minute (ml/min) * patients with hiv * patients with active hepatitis * pregnant or lactating women * individuals of child-bearing potential not using adequate contraception * individuals unable to provide informed consent

Keywords: relapsed multiple myeloma refractory multiple myeloma bendamustine bortezomib lenalidomide dexamethasone treanda velcade revlimid
impact of antenatal exposure to pesticides on neurophysiological functions (sleep, respiration) of preterm neonates

Conditions: Premature Infants

Summary: during pregnancy, the foetus is therefore chronically exposed to a large number of substances. a number of studies have started to emphasize the effects of this antenatal exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.). however, in addition to these morphological effects, pesticides may also induce various effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters involved in many nervous system regulation pathways in man. this is particularly the case for organophosphates, which act as acetylcholinesterase inhibitors. a previous study conducted by the coordinator of the project presented here demonstrated the presence of high levels of this type of pesticide in meconium (1st stool) in neonates born in picardy. this inhibition of the enzyme metabolizing ach could have an impact on neurophysiological functions mediated by this neurotransmitter. sleep or respiratory control, vital functions of the neonate particularly in preterm neonates, could therefore be affected. the physioméco project is therefore designed to study the possible links between antenatal exposure to pesticides and modifications of respiratory control allowed by peripheral chemoreceptor in preterm neonates. antenatal exposure will be determined by pesticide assays in the meconium of neonates in combination with an exposure questionnaire to determine the sources of these pesticides. sleep and respiratory control will be studied in these neonates nursed in incubators. hypoxic test will be used in order to assess respiratory control involving the peripheral chemoreceptors.


Eligibility criteria:
inclusion criteria: * premature neonates born at after 26 week of gestational age studied after 32 weeks, mothers living in picardy and more than 18 years exclusion criteria: * neonates with neurological, respiratory and cardiac disorders or receiving treatments known to affect cardiorespiratory variables or sleep structure

Keywords: pesticide exposure respiratory control sleep
cooperation for primary care patients on sick leave for cmd: care manager and workplace intervention - co-work-care

Conditions: Depressive Disorder; Anxiety Disorders

Summary: this study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the primary care centre rehab coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with a care manager during the period of sick leave. the study will be performed as a randomised controlled trial with randomisation at the pcc level where intervention pccs offers a convergence dialogue meeting with the work place representative during sick leave in addition to care manager contact.

in sweden sick leave time and frequency are increasing. this is primarily in the area of common mental disorders (cmd), and cmd is now the most common single cause of sickness absence. primary care is the area in which most individuals with mental illness seek care and also receive care. a care manager function at the primary care centre (pcc) where the care manager is responsible for the support and close contact with patients with cmd and act as the "spider in the web" and combine patient support with other measures, have been shown to have beneficial effects for depression course. in region västra götaland an implementation of the care manager function at the pcc has been set out, and the function is now available in nearly 100 pccs in the region. the present study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the pccs rehab coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with the care manager during the period of sick leave. the study will be performed as pragmatic randomised controlled trial with randomisation at the pcc level. around 20 pccs with a care manager function for patients on sick-leave with cmd diagnosis will be recruited and randomized to intervention where patients in addition to a care manager contact (12 weeks) will have one convergence dialogue meeting with the work place representative during sick leave. control pccs will give care manager contact 12 weeks only.

Eligibility criteria:
inclusion criteria: patients attending primary care centers with care manager function * aged \>=18 to 67 years * diagnosed with a new (\< 1 month) depression diagnose (f32, f33), anxiety syndrome (f41, f48) or stress related adjustment disorder (f43) * on sick-leave \> 14 days exclusion criteria: * bipolar disorder * psychosis * addiction * other serious mental disorder * suicidal ideation or earlier suicide attempt * cognitive impairment or not speaking/understanding swedish

Keywords: primary care convergence dialogue sick leave care manager
micro-doppler radar: a gold standard comparison

Conditions: Musculoskeletal Injury; Anterior Cruciate Ligament Injuries

Summary: the purpose of this study is to see if the study team can use micro-doppler signal (mds) technology to determine if someone has had an anterior cruciate ligament (acl) reconstruction. the investigators will do this by comparing the movement data from a group of people who have had the surgery with a group who has not had the surgery to see if the micro-doppler radar technology can accurately and predictably tell the difference.

the objective of this research is to validate that radar mds can accurately and predictably differentiate individuals at high-risk for mski from those who are low risk. the investigators hypothesize that mds will identify individuals at a high-risk for mski more accurately than the gold-standard mc technologies. to test this hypothesis, the investigators propose a case control study that will compare adults who have undergone acl reconstruction to a control group of healthy adults that has not. patients who have undergone acl reconstruction have a 6-24% chance of either re-tearing their acl or having a subsequent knee surgery on either side within two years of successful completion of surgery and post-surgical rehabilitation. despite being released for full activities, little is known about what makes this group at high-risk for re-tear. as such, the investigators will use this patient population as a model for identifying an at-risk population for musculoskeletal injury (mski). the researchers will simultaneously collect radar micro-doppler signals and biomechanical motion capture (mc) data in a state-of-the-art human movement lab. participants will be asked to perform a series of functional activities that will be captured by both the mds radar and mc systems. the data sets will then be analyzed independently.

Eligibility criteria:
inclusion criteria: high risk cohort * age 18-40 * history of acl reconstruction * no current musculoskeletal injuries * acl repair between 9 and 24 months prior to recruitment control cohort * age 18-40 * never had lower extremity surgery exclusion criteria: high risk cohort * age \ 40 * pregnancy * institutionalization * history of cerebral vascular accident * unable to provide informed consent * inability to perform study activities * history of hip or knee replacement * inability to walk or jump without a limp * current neuromuscular disease * any surgery in the last 6 months control cohort * age \ 40 * pregnancy * institutionalization * history of cerebral vascular accident * unable to provide informed consent * inability to perform study activities * history of knee or hip replacement * inability to walk or jump without a limp * current neuromuscular disease * history of lower extremity surgery * any surgery in the last 6 months

Keywords: musculoskeletal injury anterior cruciate ligament injury anterior cruciate ligament repair micro-doppler radar motion capture
9mw2821 in combination with toripalimab vs standard chemotherapy in locally advanced or metastatic urothelial cancer

Conditions: Urothelial Carcinoma

Summary: this is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9mw2821 combined with toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.

the study is planning to enroll approximately 460 participants with unresectable locally advanced or metastatic urothelial cancer who have not previously received systematic treatment.

Eligibility criteria:
inclusion criteria: * sign the informed consent form approved by iec. * male or female subjects aged 18 to 80 years. * ecog status: 0 or 1. * histologically confirmed local advanced or metastatic urothelial cancer * previously untreated with local advanced or metastatic urothelial cancer * at least one measurable lesion, according to recist v1.1. * adequate tumor tissues submitted for test * suitable for cisplatin/carboplatin-based chemotherapy assessed by investigator * life expectancy for more than 12 weeks. * adequate organ functions. * proper contraception methods. * willingness to follow the study procedures. exclusion criteria: * history of another malignancy within 3 years. * history of autoimmune disease requiring systemic treatment within 2 years. * history of clinically significant cardiac/cerebrovascular diseases or thrombosis within 6 months. * major surgery treated within 28 days; any live vaccines got within 28 days; radiotherapy or intravesical therapy treated within 21 days; traditional chinese medicine or any potent cyp3a4 inducers/inhibitors taken within 14 days. * lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; systemic treatment with active infection within 7 days. * previously treated with pd-1, pd-l1, pd-l2, ctla-4 inhibitors; previously treated with adcs which target nectin-4 or are conjugated with payload mmae; organ transplantation or allogeneic hematopoietic stem cell transplantation in the past. * clinical significantly toxicity grade ≥ 2 (except alopecia and pigmentation) related to previous treatment. * any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc. * peripheral neuropathy grade ≥ 2. * any other serious chronic or uncontrolled disease. * uncontrolled central nervous system metastases or carcinomatous meningitis. * active hbv/hcv/hiv infection, etc. * known allergic sensitivity to any of the ingredients of the study drug. * history of drug abuse or mental illness. * other conditions unsuitable into the study.
prevention of chemotherapy-induced cardiotoxicity in high-risk patients

Conditions: Cardiotoxicity; Chemotherapeutic Toxicity

Summary: in cancer patients, the increase of troponin i soon after chemotherapy is a strong predictor of left ventricular dysfunction and poor cardiologic outcome. this information provides a rationale for the development of prophylactic strategies directed against chemotherapy-induced cardiotoxicity (ctic). activation of the renin-angiotensin system has been proved to be involved in the development and progression of cardiac dysfunction in several clinical settings, and has been suggested to have a role in the occurrence of ctic. we investigated the role of treatment with ace-inhibitors in the prevention of ctic in high-risk cancer patients.


Eligibility criteria:
inclusion criteria: * consecutive patients undergoing high-dose chemotherapy showing early release of troponin i exclusion criteria: * contraindication to ace-inhibitors * on-going therapy with beta-blockers, ace-inhibitors, angiotensin-receptors blockers

Keywords: chemotherapy induced cardiotoxicity troponin heart failure
chronic kidney disease - real life study in alsace

Conditions: Chronic Kidney Diseases

Summary: chronic kidney disease (ckd) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. the approach to ckd in france is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the rein registry). real-life data are essential to specify the characteristics of patients with chronic kidney disease and the factors associated with the evolution of ckd and the occurrence of complications in order to improve the management of ckd before the suppletion stage. since october 2019, ckd at the severe stage (stage 4) and at the non-dialysis end stage (stage 5) is subject to an annual flat fee (article l. 162-22-6-2 of the social security code). the reimbursement of these lump sums by the health insurance is subject to the collection and transmission of certain medical data by the establishments.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years) * subject included in the mrc package (gfr \<30 ml/min/1.73 m2) * subject who has not expressed opposition, after information, to the reuse of his or her data for the purpose of this research exclusion criteria: - subject having expressed his opposition to participate in the study

Keywords: kidney chronic disease chronic kidney disease
pre-pectoral breast reconstruction part 2

Conditions: Breast Cancer

Summary: the rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.

this phase iii randomized clinical trial will be investigating the two-stage, using tissue expander (te) pre-pectoral reconstructions. the trial will comprise two arms: pre-pectoral technique with a biological acellular dermal matrix (adm) prosthesis coverage and support + fat grafting vs pre-pectoral technique with a synthetic titanium coated polypropylene mesh (tcpm) prosthesis coverage and support + fat grafting

Eligibility criteria:
inclusion criteria: * inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy ssm, nipple-sparing mastectomy nsm and skin-reducing mastectomy srm), both prophylactic and therapeutic. included patients baseline characteristics will be: * age 18-80 years old * bmi between 18.5 and 35. * former smokers (up until 3 weeks before surgery) * hypertension at oral medications * diabetes * previous breast surgery * previous breast and chest wall radiation therapy will be allowed. exclusion criteria: * t4 and metastatic breast cancers * obese patients (bmi over 35) * currently smoking patients (within 3 weeks before surgery) * refusal to sign the consent * severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).
breast choice decision tool r21

Conditions: Breast Cancer

Summary: breast reconstruction is a critical component of breast cancer treatment because it restores quality of life and body image after mastectomy. however, spanish-speaking latina women are significantly less likely to undergo reconstruction (13.5% vs. 41% for non-latina white or highly acculturated latina), meet with a reconstructive surgeon (18.1% vs. 72.6% for non-latina white), or receive adequate information. spanish-speaking latina breast cancer survivors who do not have reconstruction experience the highest rates of decisional dissatisfaction and regret, compared to any other group of breast cancer survivors. persons diagnosed with cancer who primarily speak spanish and identify as latin american (hereafter we use the term "spanish-speaking latinx/a cancer survivor") are less likely to receive guideline-concordant treatment and more likely to have poor cancer outcomes. one way to improve guideline-concordant treatment is through shared decision-making and decision support. when a decision is preference-sensitive (the right choice depends on the person's preferences), such as decisions about breast reconstruction after mastectomy, decision aids are effective. unfortunately, most decision aids in the united states are written in english and developed or tested with few latinx people. the breastchoice decision aid, proven effective in two randomized controlled trials, addresses knowledge gaps in breast cancer survivors. this study focuses on developing a spanish-language version of breastchoice, which was previously unavailable. for that reason, the cultural and linguistic adaptation framework (claf) incorporates qualitative and experiential data to adapt breastchoice. the adaptation process takes place in five steps: appraise, review, assess, solicit, and integrate.


Eligibility criteria:
inclusion criteria for survivors: (must meet all criteria) * female sex * adult at least 18 years of age * latina, latino, or latinx ethnicity - defined as born in or descending from south america, mexico, central america, other spanish-speaking caribbean islands * prefer to speak spanish at home * have a history of breast malignancy (e.g., ductal carcinoma, dcis) or high risk for breast cancer (e.g., brca mutation) * had breast surgery within the last 8 years * able to understand an irb-approved consent information sheet inclusion criteria for health care providers:(must meet all criteria) * provides breast cancer care (physicians, nurses, and advanced practice providers in breast surgery, reconstructive surgery, radiation oncology, medical oncology) * provides treatment to spanish-speaking latina breast cancer survivors * able to understand an irb-approved consent information sheet exclusion criteria: -

Keywords: surgery breast reconstruction mastectomy spanish-speaking latina the breastchoice cultural and linguistic adaptation framework
an efficacy and safety study of sevelamer carbonate in hyperphosphatemic pediatric participants with chronic kidney disease

Conditions: Hyperphosphatemia; Chronic Kidney Disease

Summary: objective: in hyperphosphatemic pediatric participants with chronic kidney disease (ckd) to * evaluate the safety and tolerability of sevelamer carbonate * evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

the study was divided into 3 periods: a phosphate binder washout period; a randomized, double-blind, placebo-controlled, fixed dose period; and an open-label, sevelamer carbonate dose titration period.

Eligibility criteria:
inclusion criteria: * the participant had ckd requiring dialysis or ckd not on dialysis with an estimated glomerular filtration rate (gfr) \<60 ml/min/1.73 m\^2 based on central laboratory results. * the participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results. exclusion criteria: * the participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery. * the participant had a non-renal case of hyperphosphatemia.

Keywords: chronic kidney disease pediatric sevelamer carbonate hyperphosphatemia
a clinical investigation to evaluate the healing of tooth extraction sites filled with biorestore™

Conditions: Alveolar Bone Loss

Summary: the aim of this study was to evaluate by histology and msct scans during a 7-month period, the efficacy of a bioactive glass (inion biorestore™) placed in human extraction sockets in the maintenance of alveolar ridge.

14 subjects in need of implant therapy were enrolled in the study. a total of 32 teeth were extracted and the fresh sockets underwent to ridge preservation procedures using inion biorestore™. two different time points (1 week and 3 months after rpp) msct scans for each patient were used as a basis for bone change analysis occurred in the localized grafted alveolar sites. twenty-two biopsied, representative of intermediate (3-4 months, n=10) and late phase (6-7 months, n=12) of healing, were harvested and histologically analysed.

Eligibility criteria:
inclusion criteria: * systemically healthy females or males subjects. * they did not smoke * did not take any medications. exclusion criteria: * subjects with less than 18 years of age, * with current alcohol or drug abuse, * with systemic/local conditions that would interfere with wound healing or osseointegration * with a history of chemotherapy and radiotherapy in the head and neck region.

Keywords: alveolar ridge preservation, bioactive glass, tooth extraction, graft material