Kornimate/medical-research-clean huggingface dataset:
medical data collection of patients with head and neck cancer treated with proton therapy

Conditions: Head and Neck Carcinoma

Summary: this trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy. collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer and help doctors improve therapy for future patients with head and neck cancer.

primary objective: i. to evaluate the outcomes in patients who have received treatment for their head and neck malignancy with proton radiation therapy. outline: patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. patients also have their medical records reviewed.

Eligibility criteria:
inclusion criteria: * patients documented to have head and neck cancer treated with proton therapy at mdacc from january 1, 2008 through april 30, 2012 and patients who receive treatment from may 1, 2012 through december 31, 2018
biomechanical and viscoelastic properties of plantar fascia in pregnant women

Conditions: Pelvic Girdle Pain; Biomechanical and Viscoelastic Properties of Plantar Fascia; Pregnant Woman

Summary: pelvic girdle pain is frequently experienced in pregnant women and the mechanism of pelvic girdle pain is not known exactly. the aim of this study is to investigate the effect of biomechanical and viscoelastic properties of plantar fascia on pelvic girdle pain in pregnant women.


Eligibility criteria:
inclusion criteria: * pregnant women in the 2nd or 3rd trimester of pregnancy with pelvic girdle pain * pregnant women in the 2nd or 3rd trimester of pregnancy without pelvic girdle pain * first pregnancy * 20-40 years old * healthy woman without pregnancy exclusion criteria: * participant having any kind of connective tissue disease * presence of orthopedic or neurological problems in the lower extremities that may cause musculoskeletal disorder and biomechanical alignment deviations * presence of foot pain that started before pregnancy and lasts for more than 3 months * presence of lumbar-pelvic pain that started before pregnancy and lasts for more than 3 months * have had 2 or more births * presence of multiple pregnancy (twins, triplets etc) * presence of ankle-ankle fracture and operation history in the last 6 months

Keywords: pelvic girdle pain, pregnant women, plantar fascia
impact of changes in muscle secretome in the remission of type 2 diabetes mellitus induced by bariatric surgery

Conditions: Diabete Type 2

Summary: bariatric surgery is recognized as a therapeutic modality of type 2 diabetes. the mechanisms of this remission of diabetes remain poorly understood. the aim of our research is to characterize the changes in muscle secretome induced by bariatric surgery and to determine their role in improving the insulin sensitivity of skeletal muscle and insulin secretion by the b cell responsible for the remission of diabetes.

bariatric surgery is recognized as a therapeutic modality of type 2 diabetes. the mechanisms of this remission of diabetes remain poorly understood. the aim of our research is to characterize the changes in muscle secretome induced by bariatric surgery and to determine their role in improving the insulin sensitivity of skeletal muscle and insulin secretion by the b cell responsible for the remission of diabetes. this prospective study will be carried out in insulin-resistant diabetic patients or not in whom blood and muscle samples will be carried out before and after bariatric surgery

Eligibility criteria:
inclusion criteria: * age from 19 to 69 year-old candidate for bariatric surgery bmi ≥ 35kg / m² with at least one subsequent comorbidity (sas or type 2 diabetes mellitus or refractory hta) or bmi ≥ 40kg / m² non-diabetic or diabetic with hba1c \<7.5% without treatment except metformin caucasian no pregnancy or breastfeeding no history of neoplasia in the last 5 years no history of uncontrolled endocrinopathy other than diabetes informed consent signed by patient exclusion criteria: * non-caucasian major depression hemorrhagic risk (biopsy) associated with taking anticoagulants/antiaggregants known myopathy systemic administration of steroids (\> 1mg/kg in hydrocortisone) hyperthyroidism type 1 diabetes psychological, familial, sociological or geographical condition potentially limiting compliance with the protocol participation in other clinical drug studies modification of anti-diabetic treatment during the month preceding surgery
thrombospondin-1 and pigmented epithelium derived factor levels in patients with diabetes mellitus.

Conditions: Diabetes; Diabetes Mellitus

Summary: you are being asked to be in a research study to determine blood levels and vitreous levels of compounds called thrombospondin 1 (tsp1) and pigment epithelium derived factor (pedf). these compounds exists naturally in your body.

the hypothesis tested here is that diabetic patients that express the higher molecular weight pigment epithelium-derived factor (pedf) isoform have lower thrombospondin-1 (tsp1) level and, as a result, are at a greater risk for the development of more severe diabetic retinopathy.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * diabetes mellitus * undergoing pars plana vitrectomy for any reason exclusion criteria: * use of any anti-vegf (vascular endothelial growth factor ) medications

Keywords: pedf tsp1 thrombospondin pigment epithelium derived factor wills eye institute pars plana vitrectomy vitreous levels mid atlantic retina blood draw blood test
multicenter study of safety and efficacy of pet-adapted treatment with nivolumab, bendamustine, gemcitabine, vinorelbine (nivo-begev) in patients with relapsed/refractory hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: nivolumab is an anti-pd-1 antibody highly effective in patients with relapsed/refractory classical hodgkin lymphoma. a pet-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\r chl patients. this study evaluates the safety and efficacy of pet-adapted treatment of nivolumab at the 3 mg/kg in combination with bendamustine, gemcitabine, vinorelbine (nivo-begev) in patients with relapsed/refractory hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * diagnosis: histologically confirmed hodgkins lymphoma * relapsed or refractory disease after the first line of treatment * age 18-70 years old * ejection fraction greater than 50% * ecog 0-2 status * signed informed consent * no severe concurrent illness exclusion criteria: * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * severe organ failure: creatinine more than 2 norms; alt, ast more than 5 norms; bilirubin more than 1.5 norms * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign an informed consent * active or prior documented autoimmune disease requiring systemic treatment.

Keywords: pet-adapted treatment relapsed/refractory hodgkin lymphoma nivolumab begev
pore excision, curettage, and injection of cymetra for pilonidal disease

Conditions: Pilonidal Sinus

Summary: chronic pilonidal disease is a common problem with no ideal treatment. this is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, cymetra, on patients with chronic pilonidal disease.

in addition, the study will evaluate the credibility and reproducibility of results within other surgeons trained to perform the procedure. data collection will focus on post-operative wound failure, infection ratwes, analgesic requirements, time lost from work or school, wound care requirements, and 6 month recurrence rates. these outcomes will be compared to outcomes using conventional pilonidal surgical intervention using published data.

Eligibility criteria:
inclusion criteria: * any patient with pilonidal diseas

Keywords: cymetra
a phase 2 trial of alimta (pemetrexed) plus gemcitabine in locally advanced or metastatic transitional cell carcinoma of the urothelium

Conditions: Urologic Neoplasms

Summary: definition: patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment or have moved to a new site in the body.


Eligibility criteria:
inclusion criteria: * you must have been diagnosed with bladder cancer that has recurred or moved to a new part of the body. * you must have at least one tumor that can be physically measured or scanned by x-ray. * you may not have had previous chemotherapy (drug) treatment or you have had surgery followed by one chemotherapy treatment at least 4 months ago. exclusion criteria: * you may not have used an experimental medicine or device within the past month. * cancer that has spread to your brain. * if you are unwilling or unable to take folic acid or vitamin b12 supplements.

Keywords: bladder cancer metastatic transitional cell carcinoma of the urothelium
genetic study of children with soft tissue sarcoma or rhabdomyosarcoma

Conditions: Leukemia; Myelodysplastic Syndromes; Sarcoma

Summary: rationale: determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia. purpose: clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.

objectives: * identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-mds/aml) prior to initiation of high-dose chemotherapy for sarcoma. * identify patients who are at increased risk of t-mds/aml during or after therapy. outline: blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy. blood specimens are examined by clonality analysis (humara), variant cell frequency (glycophorin a assay), gst nat2/cyp1a1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles). patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. projected accrual: a total of 321 patients will be accrued for this study within 4 years.

Eligibility criteria:
disease characteristics: * diagnosis of sarcoma including: * rhabdomyosarcoma * ewing's sarcoma * primitive neuroectodermal tumor * fibrosarcoma * malignant peripheral nerve sheath tumor * synovial cell sarcoma * osteosarcoma * other soft tissue sarcoma * must be currently receiving intensive or high-dose chemotherapy for sarcoma patient characteristics: age: * children performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: secondary acute myeloid leukemia secondary myelodysplastic syndromes localized osteosarcoma metastatic osteosarcoma childhood soft tissue sarcoma nonmetastatic childhood soft tissue sarcoma metastatic childhood soft tissue sarcoma childhood fibrosarcoma childhood synovial sarcoma childhood neurofibrosarcoma previously untreated childhood rhabdomyosarcoma localized ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic ewing sarcoma/peripheral primitive neuroectodermal tumor
inflammation and cellular immunity in vaginal tissue in patients with pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: the aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (imc) in the vaginal tissue in women with advanced pelvic organ prolapse (pop) (stage iii-iv) and in normal non-pop controls. we hypothesize that the processes contributing to pop may be related to immune response and changes in myeloid cell populations and the cytokine environment.


Eligibility criteria:
inclusion criteria: * women with pop undergoing colporrhaphy * women undergoing hysterectomy exclusion criteria: * autoimmune and connective tissue disorders * cancer in genital tract
efficacy study of the lara wheelchair system for subacute stroke patients

Conditions: Cerebrovascular Accident

Summary: this study will test the effectiveness of a new lever drive wheelchair, lara - lever actuated resonance assistance. lara facilitates patients in performing a high amount of practice using their moderate to severely impaired upper extremity after stroke. investigators will recruit 44 subjects with subacute strokes to participate in the study through the acute rehabilitation unit of the uc irvine douglas hospital. study participants will be randomized into 2 groups: lara therapy group or standard therapy group. the lara therapy group will use lara to propel themselves to therapy appointments in the unit and to play video games with the affected upper extremity for 30 mins / day. the standard therapy group will use a standard wheelchair to propel themselves using their unaffected upper and lower extremities. they will be asked to perform a matched duration of standard arm exercises for 30 mins/ day. this program of standard arm exercises was developed by an ot at the rehabilitation institute of chicago which consists of graded-difficulty table-supported exercises. this study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge from the acute rehabilitation unit if sooner, and a 3-month follow up.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at the time of enrollment 2. stroke onset 1-4 weeks prior to study enrollment 3. arm motor fm score of \< 30 (out of 66) at baseline visit 4. absence of moderate to severe shoulder pain ( score \<3 on the 10 point visual analog pain scale) 5. any deficit in vision, alertness, language, attention, or other cognitive functions that interfere with playing the lara games exclusion criteria: 1. age \>80 years at the time of enrollment 2. severe tone in the affected upper extremities (score ≥ 4 on the modified ashworth spasticity scale) 3. severe language problem that would prevent participants from properly understanding instructions 4. severe reduced level of consciousness 5. severe aphasia (score of 3 on the nih stroke scale (question 9)) 6. severe loss of sensation in stroke-affected upper extremities (score \< 1 on the nottingham sensory assessment) 7. currently pregnant 8. difficulty in understanding or complying with the instructions given by the experimenter 9. inability to perform the experimental task that will be studied
an open-label study to evaluate the long-term safety of medi-546, for the treatment of sle, in adults

Conditions: Lupus Erythematosus, Systemic

Summary: the purpose of this study is to evaluate the long-term safety of anifrolumab (medi-546) in adults with moderate to severe active systemic lupus erythematosus (sle).

this is an open-label extension study to evaluate long-term safety and tolerability of intravenous (iv) anifrolumab in adult participants with moderately-to-severely active sle. participants must have completed the qualifying phase 2 study and meet this study criteria in order to be eligible.

Eligibility criteria:
inclusion criteria: * must be willing to use 2 methods of effective contraception * must have venous access * must be willing to forego participation in other clinical trials for sle. exclusion criteria: * any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product * major surgery within 8 weeks before signing informed consent form (icf) * elective major surgery planned during the study period * concomitant medications within the last 12 weeks: azathioprine \> 200 mg/day, mycophenolate mofetil/mycophenolic acid \> 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate \> 25 mg/week * a live or attenuated vaccine within 4 weeks of signing the icf * bacillus of calmette and guérin (bcg) vaccine within 1 year of icf

Keywords: systemic lupus erythematosus
set-recovery/healthy home

Conditions: Substance-Related Disorders; Mental Health

Summary: the study conducts a community-based randomized trial comparing an adaptation of structural ecosystems therapy (set), "healthy home", as an enhancement of substance abuse or mental health outpatient treatment, to outpatient treatment as usual (tau) among approximately 172 black, hispanic and white nonhispanic mothers enrolled in outpatient substance abuse or mental health services. the study is conducted with a community partner, banyan health systems, that delivers substance abuse/mental health treatment and primary care. data is collected at baseline and 4, 8, and 12 months postrandomization. the specific aims of the proposed study are to: 1) test the effectiveness of healthy home for improving physical and mental health and reducing relapse of mothers in substance abuse/mental health recovery; 2) test the effectiveness of healthy home for improving health and mental health outcomes of children of mothers in recovery; 3) test mechanisms of action of healthy home (self care, environmental risk, family functioning and stigma); 4) assess implementation and sustainability factors and the relationship between fidelity and outcomes; and 5) examine the interactions of ethnicity and ethnicity related factors on outcomes. healthy home is a manualized, strength-based, directive and process oriented family ecosystemic home health intervention developed to address the needs of mothers and their children affected by substance abuse and other mental health disorders.


Eligibility criteria:
inclusion criteria: 1. enrolled in outpatient substance abuse or mental health treatment (or treatment for substance abuse as a co-occurring disorder) or case management for mental health or substance abuse problems, 2. have at least one child age 0-17 with whom she has at least monthly contact 3. be age 18 or above, 4. capable of giving informed consent and comprehending either english or spanish, 5. willing and able to participate fully in the protocol exclusion criteria: persons who do not meet the inclusion criteria listed above will be excluded.
a randomized two-arm proof of concept study testing a novel approach to exercise promotion based on affect-regulation

Conditions: Breast Cancer

Summary: the goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. the main questions it aims to answer are: 1. do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up? 2. what level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription. 3. what proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription. all participants will: * be assigned to either the affect-based exercise prescription or the effort-based exercise prescription. * participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. these meetings are the same for all participants. * be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: baseline, 2weeks, 6weeks, and 12weeks.


Eligibility criteria:
inclusion criteria: * ≥18 years old * within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for stage 0-iii breast cancer * \<60 mins/week moderate-vigorous physical activity (mvpa) with no major changes for the past 6- months * own an android or iphone smartphone (or tablet) and willing to use it to complete app-based surveys during assessment periods * willing to wear the actigraph monitor during assessment periods * access to internet to complete redcap survey assessments exclusion criteria: * non-english speaking/not able to read english * evidence of major contraindications for exercise (informed by the 2020 physical activity readiness-questionnaire (par-q)+) * currently pregnant * history of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium) * evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the patient health questionnaire-8) * evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener) * evidence of clinically significant substance use as indicated by a score of ≥ 2 on the cage- aid screener.
daily sedative interruption in critically ill patients being managed with a sedation protocol

Conditions: Critical Illness; Mechanical Ventilation

Summary: all critically ill, mechanically ventilated patients in the intensive care unit receive medications to relieve pain and anxiety. however, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the icu. two strategies have been shown to dramatically improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation. however, these strategies have not been widely adopted, because of physicians' concerns, and because it is unclear which strategy is better. given that patient outcome is improved with either of these strategies, the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation (protocolized sedation and daily interruption) have an even better outcome than patients managed with only one of them (protocolized sedation). we propose a multicenter study in which 700 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies. both groups of patients will have the following recorded: icu and hospital lengths of stay, mortality, total sedative drug use, icu human resources used, side effects and recall of their icu stay. the results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in canada and elsewhere. in addition, reducing icu stay could be economically attractive, as the cost of an icu day in canada is approximately $3000.


Eligibility criteria:
inclusion criteria: 1. age\>18 years 2. mechanically ventilated, with anticipated need for mv ≥ 48 hours 3. icu team has decided to initiate continuous sedative/analgesic infusion(s) 4. informed consent. exclusion criteria: 1. admission after resuscitation from cardiac arrest 2. traumatic brain injury 3. currently receiving neuromuscular blocking agents 4. allergy to any of the study medications 5. history of alcohol, sedative or analgesic abuse 6. history of psychiatric illness 7. acute or chronic neurologic dysfunction 8. administration of sedatives for \>24 hr, 9. lack of commitment to aggressive treatment 10. current enrollment in a related trial 11. previous enrollment in this trial.

Keywords: icu sedation strategies daily sedative interruption sedation protocols