Kornimate/medical-research-clean huggingface dataset:
screening for monoclonal gammopathy in individuals undergoing physical examinations using ims-lc assay technology.

Conditions: M Protein; Monoclonal Gammopathy; Monoclonal Gammopathy of Undetermined Significance

Summary: ims-lc assay (intact m-protein screening-light chain assay) is a new technology based on mass spectrometry identification of intact clonal immunoglobulin light chains for the specific detection of m-proteins in peripheral blood. the investigators propose to conduct a prospective, single-center observational study to screen for m-proteins in the peripheral blood of individuals undergoing routine physical examinations using ims-lc assay technology. the goals of this observational study are : (1) to evaluate the diagnostic efficacy of detecting peripheral blood m-proteins using the ims-lc assay method; and (2) to determine the prevalence of mgus in the population undergoing routine physical examinations based on mass spectrometry screening. initially, the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the ims-lc assay, using the clinical methods spep + sife + flc as the gold standard. based on the diagnostic performance of the ims-lc assay, the investigators will then screen for m-proteins in continuous samples from individuals undergoing routine physical examinations, to further determine the prevalence of mgus in this population based on mass spectrometry screening.


Eligibility criteria:
inclusion criteria: 1. clinical patients: * ≥18 years old; * have concurrent spep + sife + flc test results. 2. individuals undergoing routine physical examinations: * ≥30 years old; * have concurrent spep test results. exclusion criteria: * na

Keywords: m protein monoclonal gammopathy of unknown significance
kinesiotaping versus pressure garments on secondary upper extremity lymphedema.

Conditions: Lymphedema of Upper Arm; Burns Chest Right Lateral; Burns Chest Left Lateral

Summary: the goal of this randomised control study is to compare kinesiotaping and pressue garments in secondary upper extremity lymphedema following microsurgical breast reconstruction after severe chest burns. the primary objective of this study was to compare the effects of kinesiotaping and pressure garments on limb circumference, handgrip strength, shoulder pain and disability index (spadi), and limb circumference in patients with lymphedema following breast reconstruction due to chest burns. the participants were randomly assigned to one of two groups: the kinesiotaping group (n = 28) and the pressure garments group (n = 28). to perform taping of the chest in the kinesiotaping group, the patient was asked to stand upright with the affected shoulder rotated externally. five straps of the fan-shaped tape were extended to the chest toward the affected axilla with 15% to 20% tension, and the anchor was positioned without tension in the anterior axilla on the sound side. in the pressure garment group, the participant's skin was washed and dried before applying the pg. the premium lymphedema gradient garment (jobskin, long eaton, england) was used to apply pgs. this garment has a pressure gradient built into it, applying between 20 and 60 mm hg for at least 15 to 18 hours each day for three weeks.

the participants were randomly assigned to one of two groups: the kinesiotaping group (n = 28) and the pressure garments group (n = 28). to perform taping of the chest in the kinesiotaping group, the patient was asked to stand upright with the affected shoulder rotated externally. five straps of the fan-shaped tape were extended to the chest toward the affected axilla with 15% to 20% tension, and the anchor was positioned without tension in the anterior axilla on the sound side. in the pressure garment group, the participant's skin was washed and dried before applying the pg. the premium lymphedema gradient garment (jobskin, long eaton, england) was used to apply pgs. this garment has a pressure gradient built into it, applying between 20 and 60 mm hg for at least 15 to 18 hours each day for three weeks.

Eligibility criteria:
inclusion criteria: * microsurgical breast reconstruction after severe chest burns. * the patient's arm circumference should be at least more than 2cm but not greater than 8 cm when compared to the same site on the opposite arm. exclusion criteria: * conditions that resulted in oedema or swelling, * medication like diuretics, * infections, * allergies, * other systemic diseases, * pregnancy, * bilateral lymphadenitis

Keywords: kinesiotaping pressure garments lymphedema chest burns breast reconstruction
a study of adult participants with braf v600 mutation-positive advanced melanoma treated with cobimetinib (cotellic®) during the french early access program (temporary authorization for use [tau])

Conditions: Melanoma

Summary: this is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in france in adult participants with braf v600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (zelboraf®).

concomitantly to the marketing authorization applications for cobimetinib and vemurafenib to european medicines agency (ema) and united states food and drug administration (usfda) in 2014, a french tau program was initiated in february 2015. this study will enroll participants under this program.

Eligibility criteria:
inclusion criteria: * participants included in the tau from 26 february 2015 * participants with braf v600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib * for alive participants: participants who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control * for participants who died before the inclusion period: participants who did not express their opposition when they were alive exclusion criteria: - alive participants unable to give informed consent
educational follow-up in copd patients after pulmonary rehabilitation.

Conditions: Chronic Obstructive Pulmonary Disease

Summary: after pulmonary rehabilitation, the challenge is to maintain the benefits reached during the program and increase physical activity. as exercise training, education is the corner stone of pulmonary rehabilitation. education allows to support behavioral changes in daily life. recommendations about modalities for maintaining physical activity are still clear, however for educational follow up recommendations need to be clarified. after a pulmonary rehabilitation program, there is no defined plan for educational follow up nor location to perform education session. the aim of this study is to evaluate the proportion of patients who succeed to establish and maintain the objectives they defined during the pulmonary rehabilitation program, one year after this program.


Eligibility criteria:
inclusion criteria: * copd patients copd patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation unit of ch des pays de morlaix or chu brest exclusion criteria: * inability to answer to the questionnaire * refusal to participate. * inability to perform the pulmonary rehabilitation program.
isolation of circulating tumor cells using a novel emt-based capture method

Conditions: Metastatic Progressive Castration-resistant Prostate Cancer; Metastatic Progressive Breast Cancer

Summary: the primary objective of the preliminary lead-in study is to determine whether circulating tumor cells in patients with metastatic progressive castration-resistant prostate cancer or metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based ferrofluid (n-cadherin or o-cadherin based). the primary objective of each comparative cohort (second stage, prostate cancer) is to compare the non-detection rate of circulating tumor cells between the standard and novel methods.


Eligibility criteria:
inclusion criteria: prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply: 1. histologically confirmed diagnosis of adenocarcinoma of the prostate. small cell or neuroendocrine tumors of the prostate are also permitted. 2. clinical or radiographic evidence of metastatic disease. 3. castrate levels of testosterone (\<50 ng/dl) 4. evidence of disease progression on or following most recent therapy as evidenced clinically by the treating physician or by either of the following: * two consecutive psa levels greater than the psa nadir achieved on adt, separated by greater than one week * radiographic evidence of disease progression as defined by new bone scan lesions or growth of soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes). 5. age \> 18 years. 6. ability to understand and the willingness to sign a written informed consent document. breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply: 1. histologically confirmed diagnosis of invasive breast cancer. 2. clinical or radiographic evidence of metastatic disease. 3. evidence of disease progression on the current or following the most recent therapy, determined either clinically by the treating physician or by radiographic evidence as defined by new bone scan lesions or soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes). 4. age \> 18 years. 5. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: a patient will not be eligible for inclusion in this study if any of the following criteria apply: 1. history of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s). 2. treatment with an anthracycline or mitoxantrone within 1 week of ctc collection
mom power with high-adversity mothers and children

Conditions: Self-regulation; Respiratory Sinus Arrhythmia

Summary: this study will evaluate whether the intervention, mom power, improves the self-regulation of mothers with a history of trauma and their children. the central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk.

adverse childhood experiences (aces) are significant risk factors for psychopathology across the lifespan - risks that extend to the next generation, likely transmitted through both biological and behavioral pathways. biobehavioral self-regulation and parenting are key candidates for transmission and potential points of intervention. however, nearly all intervention research takes a one-generation approach, measuring outcomes in the individual adult or child in treatment. additionally, very little research has examined biomarkers of self-regulation in parents or children following treatment, and no known research has examined these processes in parents and young children simultaneously across treatment to explore bidirectional effects. there is a critical need to specify targets of two-generation interventions among high-adversity families to decrease intergenerational transmission of mental illness. the objective of this rct is to determine whether mom power, an evidence-based two generation intervention for mothers with histories of trauma, enhances physiological and behavioral self-regulation in mothers and young children, testing mechanisms and examining bidirectional effects. the central hypothesis is that the intervention will shift behavioral and physiological (respiratory sinus arrhythmia) self-regulation in mothers, children, and dyads to mitigate psychopathology risk. three specific aims are proposed: 1) examine intervention effects on children's biobehavioral self-regulation and psychopathology; 2) examine intervention effects on mothers' biobehavioral self-regulation, psychopathology, and parenting behavior; and 3) examine intergenerational change processes, including shifts in dyadic physiological and behavioral synchrony as well as bidirectional influences between mother and child self-regulation.

Eligibility criteria:
participants in this study must include a mother-child dyad. there is inclusion and exclusion criteria for both mother and child. inclusion criteria: * for moms: mothers must be female, the biological mother, have an ace score of 3 or more, speak english, and be 18 years or older. * for children: children must be between the ages of 2 and 5. exclusion criteria: * for mothers: no pacemaker or self-reported heart condition; no active maternal substance abuse or psychosis on screeners (brown \& rounds, 1995; degenhardt, hall, korten, \& jablensky, 2005). * for children: no parent report of diagnosis of autism or global development delay, no parent report of pacemaker or heart condition

Keywords: biobehavioral self-regulation psychopathology parenting behavior
v3: vancouver-victoria valacyclovir trial for early psychosis

Conditions: Psychosis

Summary: this is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an antiviral drug, valacyclovir (valtrex) is helpful in treating the symptoms of psychosis, a form of a mental disorder.

there is evidence that some of the symptoms of psychosis may be related to past infection with common viruses. researchers are looking to recruit a total of 100 subjects with evidence in the past, of exposure to at least 1 of 3 viruses. the viruses include herpes type 1 (hsv-1, which causes cold sores of the lip and has affected about 6/10 people in vancouver), herpes type 2 (hsv-2 which causes genital sores, and has affected less than 1/10 people in vancouver) and cytomegalovirus (cmv, which causes few symptoms but has affected 8/10 people in vancouver). people who have been infected with these viruses in the past develop antibodies in the blood. the antibodies can be measured in blood, and are a test of whether or not there was infection in the past, and possibly affecting the symptoms of psychosis.

Eligibility criteria:
inclusion criteria: * subjects antipsychotic, mood stabilizing and antidepressant drug treatment must have been stable for at least 3 months, and there is no plan to change the drug treatment during the 4-month phase of the study. * subjects must be seropositive for hsv-1, hsv-2 and/or cmv. * subjects must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing. * subjects must be able to provide written informed consent. exclusion criteria: * females of childbearing age will agree not to become pregnant and will agree to use a medically acceptable method of birth control. * inability to participate in cognitive testing due to severe persistent psychosis or other condition. * mental handicap. * subjects with known hypersensitivity or allergy to valacyclovir or acyclovir. * patient taking nontopical antiviral medications with anti-herpes activity on a regular basis

Keywords: psychosis early psychosis first episode psychosis schizophrenia schizoaffective schizophreniform bipolar disorder valtrex valacyclovir.
hepatitis c screening in the primary care setting

Conditions: Hepatitis C

Summary: the purpose of this study is to determine whether patient education improves hepatitis c screening in the primary care setting.

hepatitis c is a chronic, asymptomatic infection that progresses to liver cirrhosis and cancer in the later stages if left untreated. the centers for disease control (cdc) recommends a one-time screening for high risk birth cohort between the years 1945-1965. prior studies have evaluated methods to improve screening for hepatitis c with focus on increasing awareness in health professionals. targets included nursing staff and electronic medical records. this study targets providing patients with education resources to see if screening rates improve.

Eligibility criteria:
inclusion criteria: * all patients born between the years 1945 and 1965. exclusion criteria: * patients who had already received a prior screening test for hepatitis c before the office visit.

Keywords: public health patient education as topic hepatitis c
ketamine tolerated dose for postpartum depression and pain after cesarean delivery (prepare 1)

Conditions: Pain, Postoperative; Depression, Postpartum

Summary: the purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (mtd) 3+3 design. a loading dose over 1 hour will be the mtd variable to be tested, as our data suggest that ketamine side effects occur with the loading dose. the investigators hypothesize that subanesthetic ketamine dose will be well tolerated and any noted side effects will be rated acceptable by postpartum women following cesarean delivery.

pain management for women having a cesarean delivery is rather limited and risks poor pain control, depressed mood, and poor recovery following the cesarean delivery. current cesarean pain management treatments ignore the multidimensionality of pain, including the influence of mood on pain. recent evidence suggests that ketamine may provide successful post-surgical pain management, opioid reduction, and rapid reduction of depressive symptoms. the current study aims to identify an appropriate dose of ketamine for post-cesarean pain management while minimizing potential dose-dependent side effects in women following childbirth.

Eligibility criteria:
inclusion criteria: * adults 18 years and older * cesarean delivery * american society of anesthesiologists physical status of 2 or 3 * neuraxial anesthesia with neuraxial morphine * term delivery ≥37 weeks gestation * either planning not to breastfeed, or receiving ketamine as part of routine clinical care exclusion criteria: * general anesthesia * allergy to study medications * asa ps 4 or higher * contraindications to neuraxial anesthesia * preterm delivery (\<37 weeks gestation) * anticipated fetal-neonatal complex care plan * participating in another pain intervention trial * hypertensive disorder of pregnancy * pre-eclampsia with severe features * hemodynamic instability * medical history exclusions: ketamine or pcp (phencyclidine) abuse, schizophrenia or psychosis, liver or renal insufficiency, uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled thyroid disease, or other contraindications to ketamine

Keywords: cesarean delivery
study of doxil in the treatment of patients with refractory idiopathic thrombocytopenic purpura

Conditions: Autoimmune Thrombocytopenic Purpura

Summary: this study is designed to evaluate the efficacy and safety of single agent doxil in the treatment of patients with refractory itp (idiopathic thrombocytopenic purpura).

eligible patients will receive doxil 20 mg/m2 iv over 1 hour every 2 weeks. treatment will be continued for 1 course beyond return of the platelet count to normal with a maximum of 18 courses.

Eligibility criteria:
inclusion criteria: * thrombocytopenia with bone marrow findings showing normal or increased numbers of megakaryocytes. * failure to respond to initial treatment with steroids, iv immune globulin, splenectomy and post splenectomy steroids. * platelet count of 30,000 or less. * performance status score of 2 or less. * adequate organ function: \*bilirubin\< 2; \*ast \< 3 times normal; \*creatinine \< 2. * no prior treatment with anthracycline or chemically related drugs. exclusion criteria: * pregnant or lactating women. * presence of a malignancy other than basal cell carcinoma of the skin.

Keywords: immune thrombocytopenic purpura
randomized clinical trial for the uncomplicated diverticulitis in right colon

Conditions: Simple Diverticular Disease

Summary: the aim of the present study was to evaluate whether antibiotics is mandatory for the treatment of acute uncomplicated right-sided diverticulitis. the hypothesis is that patients having acute uncomplicated diverticulitis at right-sided colon will be recovered without antibiotics.

all patients in the study were randomly allocated to one of the following two treatment groups; no-antibiotics group or antibiotics group. patients of no-antibiotics group were admitted to the ward and administered intravenous fluid and bowel rest at least up to 5 days until clinical symptom and sign were stabilized. and then the patient discharge until oral intake was tolerated. in antibiotics group, the treatment was initiated with an intravenous combination of a third generation cephalosporin or quinolone and metronidazole until oral intake was tolerated. oral antibiotics such as cefpodoxime together with metronidazole were initiated subsequently on the ward. the total duration of antibiotic treatment was an expected average 10days. patients in both group were re-visited outpatient clinic after an expected average 7 days for check-up of serology test (including complete blood count and c-reactive protein), and after an expected average 6 weeks for ct. if the patients did not re-visit outpatient clinic, we checked the call.

Eligibility criteria:
inclusion criteria: * right-sided colonic diverticulitis * uncomplicated diverticulitis exclusion criteria: * pregnancy * refuse to investigation * immunosuppressive therapy or immunologic incompetence * colonic diverticulitis except right-sided diverticulitis * complicated diverticulitis * disorder of psychology or cognition * allergic reaction to antibiotics being used in the study (3rd generation cephalosporin, quinolone, metronidazole)

Keywords: uncomplicated diverticulitis, economic cost, hospital stay
correlation between pi max and diaphragm maximum inspiratory excursion detected with ultrasound during weaning

Conditions: Weaning; Diaphragm Ultrasound; Maximum Inspiratory Pressure

Summary: this study evaluates the correlation between maximum inspiratory pressure (pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from invasive mechanical ventilation.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * invasive mechanical ventilation \> 24 hours. * readiness for weaning (following clinician decision made according to recent guidelines). exclusion criteria: * impossibility to perform an echography.
ultrasound-based imaging using the aixplorer system in diagnosing prostate cancer in patients undergoing biopsy

Conditions: Prostate Carcinoma

Summary: this clinical trial studies an ultrasound-based imaging procedure called elastography using the aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. it is not yet known whether elastography imaging using the aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.

primary objectives: i. to evaluate the detection of prostate cancer with elastography using the aixplorer scanner. secondary objectives: i. to obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy. ii. to compare the gleason grade of prostate cancers detected with elastography to the gleason grade of tumors detected by conventional systematic biopsy.

Eligibility criteria:
inclusion criteria: * be scheduled for a clinically indicated biopsy of the prostate * agree to an ultrasound examination using the aixplorer system * sign an institutional review board (irb) approved informed consent prior to any study procedures exclusion criteria: • recent prostate biopsy within 90 days