Kornimate/medical-research-clean huggingface dataset:
who and why do patients report lymphedema after breast cancer treatment without an objective measurable swelling

Conditions: Breast Cancer; Lymphedema; Sensory Processing Disorder

Summary: breast cancer related lymphedema (bcrl) at the arm and/or trunk is an extremely dreaded complication after breast cancer treatment due to its chronicity and impact. the incidence of objective arm and trunk/ breast bcrl is declining due to the major shift into the treatment approach of breast cancer. however, many patients report a sensation of swelling without the presence of objective bcrl, referred to as subjective bcrl. therefore, subjective bcrl is defined as the diagnosis of bcrl based on the patient's sensation of a difference in size at the arm and/or trunk without the presence of objective bcrl. at this moment, there is no clear information on the prevalence and the transitions between different bcrl states (no-subjective-objective) over time, as well as about the underlying mechanisms and contributing factors of subjective bcrl. therefore, the investigators hypothesize that four mechanisms might be associated with the presence and severity of subjective arm or trunk/breast bcrl, including the presence and/ or severity of lymphatic (1) and sensory processing problems (nociceptive (2), neuropathic (3), and/or central sensory processing problems (4)). the investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast bcrl at 1, 6, and 12 month(s) post-surgery and the transitions between different bcrl states (no-subjective-objective bcrl) (aim 1). in addition, factors related to four potential underlying mechanisms (lymphatic, nociceptive, neuropathic, and central sensory processing problems) that contribute to the occurrence of subjective bcrl in comparison to no self-reported swelling and objective bcrl will be determined (aim 2). furthermore, the present study will be undertaken to determine factors related to these four underlying mechanisms that contribute to the severity of subjective bcrl at arm or trunk/ breast bcrl within the group of patients with subjective bcrl at different time-points after surgery (at 1, 6, and 12 month(s) post-surgery) (aim 3).


Eligibility criteria:
inclusion criteria: 1. adults (men and women) who are ≥ 18 years of age 2. diagnosed with primary unilateral non-metastatic or oligometastatic breast cancer 3. scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) 4. able to read, understand, and speak dutch 5. have voluntary written informed consent of the patient exclusion criteria: 1. distant metastases 2. planned bilateral lymph node surgery 3. oedema of the arm from another cause 4. an allergy to iodine or indocyanine green (icg), or 5. physically or mentally unable to participate throughout the entire duration of the study

Keywords: lymphedema subclinical edema nociceptive problems neuropathic problems central sensory problems
prepare - how to reach women of reproductive age with obesity to support weight loss before pregnancy?

Conditions: Obesity; Pregnancy Complications

Summary: researchers at harvard pilgrim health care institute and massachusetts general hospital are conducting a study to learn more about how best to reach out to women (age 18-45) who are thinking about a pregnancy in the next couple of years and currently have a bmi greater than 30 kg/m2. interested participants will be asked to complete a 15-minute survey. the survey will ask some more questions about their prior reproductive health history, opinions and experiences regarding lifestyle, weight and health. after completing the survey, researchers would like to arrange a time to complete a 20- to 30-minute semi-structured interview about their perceived health in the process of planning pregnancy.

the purpose of this study is to learn the best ways to support healthful behaviors and weight loss prior to pregnancy. researchers are also interested in what motivates or prevents women of reproductive age from engaging in a structured weight loss program. participants will be asked for no more than an hour of their time to complete a brief survey and participate in an interview. this study is being conducted by harvard pilgrim health care institute. this study is being paid for by the nutrition obesity research center at harvard (norch). at the end of the interview, study staff will also talk to participants about the opportunity to be referred to the mass general weight center if they are interested in participating in a program now being offered there. if participants elect to participate in a program at the weight center, researchers would then like to complete 2 more short interviews with these participants about that process. the first will be about 5 minutes and will take place just after the initial weight center orientation, and the last will be about 10 minutes and take place after 3 months of participation. during this final interview, researchers will ask for participant opinions about the program that they have just participated in.

Eligibility criteria:
inclusion criteria: * women aged 18-45 years old, * bmi\>30 mg/m2, * thinking about planning a pregnancy in the next 2 years exclusion criteria: * previous bariatric surgery, * currently pregnant
model 4195 left ventricular (lv) lead chronic performance study

Conditions: Heart Failure

Summary: evaluate long-term performance of the 4195 lv lead. this evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. the leads will be followed for 5 years after implant. this study is required by fda as a condition of approval of the model 4195 lv lead and is integrated within medtronic's post-market surveillance platform.

model 4195 lv lead complication-free survivability will be summarized.

Eligibility criteria:
patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. inclusion criteria * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive an attain starfix model 4195 lv lead * patient within 30 day post implant enrollment window exclusion criteria * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
glucose variability with dpp-4 inhibition

Conditions: Type 2 Diabetes

Summary: glucose variability with dpp-4 inhibition

patients with type 2 diabetes, age 35-75y., will be included in this double blind randomized placebo controlled study. the sample size of 50 patients completing the 30 day study period is based on statistical input from merck research laboratories, rahway nj.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * receiving a stable dose of metformin ≥ 1500 mg * hba1c 7,5% -10/0 % exclusion criteria: * type 1 diabetes * hba1c \ 10,0%
continuous versus bolus administration of g-csf in children with cancer

Conditions: Pediatric Cancer; Neutropenia; Lenograstim; Filgrastim; G-CSF

Summary: the investigators hypothesized that in terms of granulocyte colony-stimulating factor (g-csf) administration, the route of continuous infusion would lead to a faster neutrophil recovery compared to that of bolus administration

the investigators aimed to enroll 40 hospitalized patients in this phase 4 clinical trial. patients with an anc lower than 500 cells/mm3 will be randomly categorized into experimental and controlled arms. the experimental arm was designed to receive g-csf intravenous infusion for 5 hours at a dose of 5 mcg/kg. the controlled arm was designed to receive a g-csf bolus injection within one minute at a dose of 5 mcg/kg. three days after treatment initiation, serum white blood cell and differential counts will be followed daily to determine the timing of steady neutrophil recovery. in the following time of another neutropenia event, the experimental arm would cross-switch to the controlled arm and receive corresponding g-csf according to the study design

Eligibility criteria:
inclusion criteria: * pediatric patients with an age between 0 to 18 years old will be included * hematologic and oncologic malignancies exclusion criteria: * patients with a diagnosis of myelodysplastic syndrome or severe aplastic anemia will be excluded * patients receiving g-csf treatment 7 days before enrollment will be excluded * patients concurrently receiving cytokine therapy or thrombopoietin receptor agonist therapy will be excluded

Keywords: pediatric cancer neutropenia g-csf
uc-msc infusion for hbv-related acute-on-chronic liver failure

Conditions: Liver Failure

Summary: hepatitis b virus (hbv)-related acute-on-chronic liver failure (aclf) is a severe disease with high mortality. our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (mscs) weekly for 4 times is safe and improves 24 weeks survival rate of aclf patients. in this study, we intend to assess the safety and efficacy of umbilical cord blood derived mscs for hbv-related aclf patients.


Eligibility criteria:
inclusion criteria: 1. patients with aclf-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×uln umol/l) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity \< 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease; 2. positive serum hepatitis b surface antigen (hbsag) for more than 6 months; 3. end-stage liver disease scores ranging from 17-30,; 4.18-65 years of age. exclusion criteria: 1. serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection ); 2. concomitant autoimmune disease; 3. superinfection with other hepatitis viruses; 4. important organ dysfunctions not due to liver disease or malignancies; 5. pregnancy and lactation; 6. liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (ct), or magnetic resonance (mr) imaging; 7. bioartificial liver support therapy; 8. previous liver transplantation.
aerobic training versus cognitive behavioral therapy in management of anxiety

Conditions: Anxiety Depression Disorder

Summary: anxiety and depression disorders (add) have the highest overall prevalence rate among psychiatric disorders in young females. its manifestations are disabling, distressing a substantial negative impact on the quality of life. the purpose of this study was to compare the effect of cognitive-behavioral therapy and physical therapy on female students with mild to moderate anxiety and depression.

female students of taif university will be invited to participate in this study. 40 students will be assigned according to sample size calculation into the study as having mild to moderate anxiety and depression according to depression, anxiety and stress scale (dass 21) most days of the week for at least six months. all study participants will sign an informed consent form. screening for the physical activities in the last 7 days of all participants will be performed one day before starting the study protocol using the international physical activity questionnaires (ipaq) short form. the exclusion will be performed to severe psychological conditions such as schizophrenia and severe depression and any physical condition that limit physical activities. also, participants who are taking any medications for the treatment of anxiety and depression will be excluded. also, participants who had any abnormalities of the cardiovascular status that prevent them to perform the physical activities or reaching the target heart rate without risk as recommended by their primary care physician. the age range will be 18 to 25 years with a mean age of 21±0.75 years. participants will be assigned into two groups: group a (ga) consists of 20 students and they will be instructed to increase their physical activities one hour daily, 5 days per week for 8 weeks of moderate to vigorous activities such as running, jumping, swimming, aerobics or dancing; and group b (gb) consists of 20 students and they will receive cognitive behavioral therapy for 8 sessions (once per week for 8 weeks).

Eligibility criteria:
inclusion criteria: * mild to moderate anxiety and depression according to depression, anxiety and stress scale (dass 21) most days of the week for at least six months * females age 18-25 years exclusion criteria: * severe psychological conditions such as schizophrenia * severe depression * any physical condition that limit physical activities
the number of mesogastria containing metastatic lymph nodes predicts gastric cancer prognosis

Conditions: Gastric Cancer

Summary: to investigate the impact of the number of mesogastria containing metastatic lymph nodes on the prognosis of gastric cancer.

previous studies have established the existence of the mesogastrium, dividing it into six sections. the mesogastrium is identified during surgery and utilized in surgical practice. the aim of the present study was to further investigate its role in gastric cancer prognosis.between january 2014 and january 2018, patients from the tongji hospital were included in this post-hoc analysis, including data from a randomized clinical study (dcgc01; http://www.clinicaltrials.gov, nct01978444). mesogastria containing metastatic lymph nodes (lns) were referred to as metastatic mesogastria. pathology reports were examined to assess metastases in the mesogastrium. survival was assessed using kaplan-meier curves and multivariable cox models.

Eligibility criteria:
inclusion criteria: 1. older than 18, younger than 85 2. primary gastric adenocarcinoma confirmed by preoperative pathology 3. routine blood tests, liver and kidney functions and who health status score are within the range of tolerable surgery 4. it is expected to perform radical gastrectomy through d2+cme exclusion criteria: 1. pregnant or lactating women 2. severe mental disorder or language communication disorder 3. preoperative imaging examination or intraoperative exploration found that the patient had the following conditions: tumor involving surrounding organs requiring combined organ resection, distant organ metastasis or r0 resection could not be achieved 4. those who are not suitable for laparoscopic surgery (such as extensive adhesion caused by anterior abdominal surgery and pneumoperitoneum for various reasons). 5. concurrent malignancies at other sites 6. emergency surgery patients

Keywords: metastasis gastric cancer lymph node mesogastrium
evaluation of the results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without mesh in the surgical treatment of pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: evaluation of the anatomical and functional results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without using mesh in the surgical treatment of pelvic organ prolapse


Eligibility criteria:
inclusion criteria: 1. being 18 years old or older 2. needing an operation for symptomatic pelvic organ prolapse - exclusion criteria: 1. past history of chemotherapy or radiotherapy 2. past history of pelvic organ prolapse surgery 3. if there is a contraindication of laparoscopy -

Keywords: sacrocolpopexy sacrohysteropexy pelvic organ prolapse
efficacy and safety of 14-day concomitant therapy for difficult-to-treat helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the treatment of hard-to-treat helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates

helicobacter pylori infects half of the world's population. h.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. however, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of h. pylori worldwide. an ideal rescue therapeutic regimen to cure refractory h.pylori infection is currently warranted. this study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 with persistent h. pylori infection. * patients failed at least three different standard eradication therapies before.previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to maastricht v report. exclusion criteria: * patients treated with h2-receptor antagonist, ppi, vonoprazan,bismuth and antibiotics in the previous 4 weeks. * patients with gastorectomy, acute gi bleeding and advanced gastric cancer. * history of allergy to any of the drugs used in the study. * severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk. * currently pregnant or lactating. * severe neurologic or psychiatric disorders. * alcohol abuse or drug addiction. * patients with compliance lower than 90% in any previous treatment are not included. * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Keywords: concomitant therapy
ita vs lad; evaluation of inflammatory burden in op-cabg patients

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Atherosclerosis; Inflammation

Summary: introduction. ischemic cardiomyopathy is one of the death leading causes in industrialized countries. up-to-date esc guidelines recommend a surgical approach (coronary by pass graft) in patients with multivessel coronaropathy, with involvement of left main (lm) or proximal left anterior descending (lad) artery. in any case, is recommended the use of the internal thoracic artery (ita) as conduct of choice. in consideration of the very strong evidence supporting the use of ita, the study objective is to analyze and compare some blood markers collected from ita blood vs. lad blood, with the purpose of better understanding the technique benefits from a biological point of view, being the hemodynamic one already evident. methods. forty patients scheduled for coronary bypass graft (cabg) surgery at the cardiac surgery unit of european hospital of rome will be enrolled. patients which intervention includes off-pump ita-lad anastomosis will be included. for each patient blood sample from ita and lad will be collected. on those samples, polymorphonuclear leukocytes and platelets activity, endothelial dysfunction, oxidative stress and inflammatory burden will be analysed. in patients in which a pre-operative coronary ct scan is available, findings will be correlated with atherosclerotic plaque morphology. expected results. diseased lad's blood will have a deranged markers profile compared with ita's, with augmented inflammatory burden, reduce no availability and increased platelet activation. in the patients subgroup with available coronary ct scan will be possible to esteem the effective blood mixing and speculate on a possible pharmacological effect of cabg, in terms of dilution of inflammatory burden in the target vessel.


Eligibility criteria:
inclusion criteria: * scheduled coronary bypass surgery * off-pump procedure * ita-lad anastomosis exclusion criteria: * stemi in the last month * lvef \> 30% * lad chronic occlusion * acute or chronic inflammatory diseases * immunologic or rheumatic diseases * oncologic condition (present or in the last 3 years) * active infections

Keywords: coronary artery bypass graft coronary revascularization
meleis's transition theory on postpartum difficulties and quality of life in primipara mothers

Conditions: Postpartum Care; First Birth; Cesarean Section

Summary: the randomized controlled experimental study sought to determine the impact of the training structured according to meleis's transition theory on postpartum difficulties and quality of life in primipara mothers.

in the study, the intervention group (39 mothers) was given face-to-face training in the hospital, which was structured according to meleis' transition theory, 24 hours after the cesarean section.telephone counseling was provided on the 5th, 15th and 42nd days after discharge. thus, these mothers were followed up 4 times in the postpartum period. no intervention was made in the control group (40 mothers).

Eligibility criteria:
inclusion criteria: mothers with the following criteria were included in the study; * primiparous * cesarean delivery * over 18 years old * at least primary school graduate * communicating verbally * using mobile phone and whatsapp application * married and living with spouse exclusion criteria: mothers with the following criteria were excluded from the study; * having a risky pregnancy history * having a history of chronic disease * diagnosed with a psychiatric illness * having a health problem in herself or her baby that requires separation from each other * having a baby with any congenital anomaly or severe disease detected at birth

Keywords: depression difficulty meleis's transition theory postpartum period primipara mother quality of life