Kornimate/medical-research-clean huggingface dataset:
feasibility and tolerability of transcranial direct current stimulation with concurrent cognitive training

Conditions: Breast Cancer Survivors

Summary: in this study, the investigators are testing transcranial direct current stimulation (tdcs) in breast cancer survivors. in this pilot study, the investigators want to learn if it is feasible to use this device in memory rehabilitation.


Eligibility criteria:
inclusion criteria: * breast cancer survivors treated with chemotherapy between 40 and 65 years of age with no evidence of disease with treatment completed at least six months prior to study participation with or without current endocrine therapy. * self-reported new onset since initiation of treatment cognitive dysfunction as determined by telephone screen using the brief (3 questions) assessment established by ercoli et al. \[3\] (endorsement on all three questions): 1. do you think or feel that your memory or mental ability has gotten worse since you completed your breast cancer treatment? 2. do you think that your mind isn't as sharp now as it was before your breast cancer treatments? 3. do you feel like these problems have made it harder to function on your job or take care of things around the home? * in the judgment of the investigators and/or consenting professional, able to read and comprehend english * in the judgment of the consenting professional cognitively able to provide informed consent exclusion criteria: * patients with prior history of primary central nervous system (cns) cancer or cns metastases * as per self report and/or medical record history of diagnosed neurological illness including seizure disorder, a dementing condition, or other neurological illness (multiple sclerosis, history of cerebrovascular accident, etc.) * participants with untreated depression or anxiety as assessed by self-report and review of medical history; * participants with a history of treated or untreated schizophrenia or bipolar disorder as assessed by self report and review of medical history; * as per self report participants who are pregnant or who are breastfeeding * as per self report participants with pacemakers, intracranial electrodes, implanted defibrillators or any other prosthesis.

Keywords: transcranial direct current stimulation (tdcs) cognitive training 16-034
home monitoring in idiopathic pulmonary fibrosis; improving use of anti-fibrotic medication and quality of life

Conditions: Idiopathic Pulmonary Fibrosis

Summary: in this study it will be investigate whether a home monitoring program improves disease-specific health-related quality of life (hrqol) for patients with idiopathic pulmonary fibrosis (ipf) through appropriate medication use and subsequently results in better objective and subjective outcomes.

ipf is a chronic disease with progressive scarring of the lung tissue (fibrosis), resulting in a poor prognosis and a devastating impact on the lives of patients and their families. progressive shortness of breath, cough and fatigue are major factors influencing health-related quality of life (hrqol) in patients with ipf. recently two anti-fibrotic drugs became available that slow down disease progression. the availability of effective drugs for this devastating disease has importantly changed daily care and research in ipf. currently, one of the major challenges in daily ipf care is the evaluation of how individual patients objectively and subjectively experience treatment and benefit from treatment. the use of information communication technology in health care, also named e-health, is a promising solution to improve the quality of care. e-health allows remote exchange of data between patients and health care professionals which enables monitoring, research and management of long term conditions. also communication between patients and physicians, and physicians mutually, becomes more accessible. this creates an opportunity for earlier intervention by health care professionals, which may prevent a hospital admission. this might improve quality of life and reduce costs. patients easily get access to up-to-date and tailored information, in an interactive way. by providing these tools, patients may better understand their health conditions and become actively involved in management of their own health care, which may lead to a better health status. an 'internet tool' for patients with ipf have been developed, providing information and enabling them to keep track of their own symptoms, hrqol scores, medication use and lung function results. in this study it will be investigated whether a home monitoring program improves disease-specific hrqol for ipf patients through appropriate medication use and subsequently results in better objective and subjective outcomes.

Eligibility criteria:
inclusion criteria: * all patients with a diagnosis of ipf according to the ats 2011 criteria and about to start on anti-fibrotic treatment (either nintedanib or pirfenidone) exclusion criteria: * not able to speak, read or write in dutch * no access to internet

Keywords: quality of life ehealth patient-reported outcomes home spirometry cost-effectiveness home monitoring
tumor microenvironment in patients with localized osteosarcoma treated with mifamurtide: a translational study

Conditions: Localized Osteosarcoma

Summary: international, multicenter retrospecitve biological study

international, multicenter retrospecitve biological study that will analyze the tumor micro environment in biological archival samples of patients, who were treated with chemotherapy +/- mifamurtide according the protocols for primary localized osteosarcoma (isg-os2 and geis-33)

Eligibility criteria:
inclusion criteria: 1. patients with primary localized osteosarcoma who received chemotherapy +/- mifamurtide according to isg-os2/geis-33 trials, 2. paraffin-embedded tissue tumor (ffpe) blocks from archive available to perform the biological analysis 3. written informed consent prior to any study-specific analysis and/or data collection exclusion criteria: 1) patients with diagnosis different from osteosarcoma -
exercise and health intervention for patients with obsessive compulsive disorder (ocd)

Conditions: Obsessive Compulsive Disorder

Summary: the purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for obsessive compulsive disorder (ocd) patients interested in reducing symptoms. the investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in managing the effects of ocd. if moderate-intensity aerobic exercise is efficacious in helping individuals with ocd manage obsessions and compulsions, this will establish that aerobic exercise may be a valuable adjunct to other ocd treatments such as medication and therapy.


Eligibility criteria:
inclusion criteria: 1. are between 18 and 65 years of age 2. are sedentary, i.e. have not participated in regular aerobic physical exercise for at least 90 minutes per week during the past three months 3. currently engaged in at least 12 weeks of stable dose pharmacotherapy and/or are currently engaged in cognitive-behavioral therapy for the past 13 weeks 4. meet diagnostic and statistical manual of mental disorders-iv (dsm-iv) criteria for ocd as assessed by the structured clinical interview for dsm disorders, patient version (scid-p) 5. have y-bocs score greater than 16 exclusion criteria: 1. dsm-iv diagnosis of substance abuse/dependence except for nicotine dependence 2. dsm-iv diagnosis of anorexia or bulimia nervosa 3. dsm-iv diagnosis of bipolar disorder 4. history of psychotic disorder or current psychotic symptoms 5. current suicidality or homicidality 6. marked organic impairment 7. physical or medical problems that would not allow for safe exercise participation 8. current pregnancy or intent to become pregnant during the next 12 weeks

Keywords: obsessive compulsive disorder ocd exercise aerobic exercise
analgesic effects of ultrasound guided pec blocks on analgesic opioid consumption of cancer surgery patients

Conditions: Malignant Neoplasm of Breast

Summary: examining the analgesic effect of ultrasound guided pectoral blocks on analgesic opioid consumption after surgical removal of breast tissue. this study's uniqueness is in the quantification of the analgesic effect of regional anesthesia on its influence to reduce the use of opioid substances, and the variety of side effects associated with them, which has yet to been described in literature.

this is a prospective, observational,single center study which will be conducted at the rabin medical center (beilinson campus), petach tikva, israel, a tertiary university hospital. sixty women undergoing breast tissue resection under general anesthesia will be enrolled after filling out an informed consent form. as standard protocol in our hospital all participants will include women undergoing the surgery under general anesthesia, and the an addition of regional pec block anesthesia. the use of opioid substances during surgery will be done under the discretion of the anesthesiologist, according to accepted professional criteria. all participants will undergo the the pec block before surgery under general anesthesia under aseptic conditions, which is the standard analgesia protocol in our department. ultrasound guided pecs block will be performed by identifying the thoracic muscles. following the identification, the investigator will inject the anesthetic solution which will contain the conventional 25 cc of bupivacaine 0.25-0.5% . the concentration is determined by the upper dose limit to 2 mg / kg 11. at the end of the operation all participants will be transferred to the post anesthesia recovery supervision unit, as standard protocol. the women will receive analgesic treatment according to accepted recovery unit protocols of beilinson hospital, and according to the professional discretion of the anesthesiologist in charge of the recovery unit. on postoperative day one all participants will be asked to fill out a questionnaire that measures the degree of their pain after surgery, and the extent of the expected side effects from exposure to opioids this questionnaire is based on a questionnaire measuring quality qor recovery from general anesthesia.

Eligibility criteria:
inclusion criteria: women over 18 who undergo breast tissue resection under general anesthesia at beilinson hospital, and are able to comply with the study's protocol exclusion criteria: 1. lack of patient's consent or lack of patient's ability to provide consent. 2. known hypersensitivity to local anesthetic or to opioid, which will affect the nature of the pain management therapy in these patients. 3. existing evidence of infection or gangrene on the thorax which prevents implementation of regional anesthesia - . 4. known coagulation disorder.
implantable microdevice for in vivo drug sensitivity testing in patients with early stage, her2-positive or triple negative breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or patients who plan on receiving standard preoperative chemotherapy prior to their breast surgery. this device may be able to predict what types of treatment work best against an individual's breast cancer. with this device, the investigators hope to be able to personalize treatment choices based on an individual's type of breast cancer.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed invasive breast cancer that is: triple negative (er\<10%, pr\<10%, and her2 0/1+ or 2+/fish not amplified) * tumor size 2cm or greater; n any; m0 * tumor size 1cm or greater; n any; m0 (cohort 1) * tumor size 2cm or greater; n any; m0 (cohort 2) * candidate for curative breast cancer surgery (cohort 1 or 2) * candidate for neoadjuvant chemotherapy with a standard of care, anthracycline-based regimen (cohort 2 preferred over cohort 1) * age \>18 years of age * ecog performance status of ≤2 * serum or urine pregnancy test negative within 2 weeks for women of childbearing potential. * willing and able to provide informed consent exclusion criteria: * prior treatment including surgery, chemotherapy or radiation therapy for the current primary breast cancer. * severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational device administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this

Keywords: implantable microdevice in vivo drug sensitivity testing her2-positive triple negative 15-127
investigation of test (transcranial electric stimulation therapy) for chronic pain

Conditions: Chronic Pain

Summary: the goal in this study is to investigate test (transcranial electric stimulation therapy) for chronic pain. it requires an inpatient stay on our research unit of about a month. the study is designed to address the cognitive and emotional aspects of chronic pain and other conditions that often accompany this disorder, such as major depression or drug use.

this project proposes to investigate the feasibility of test in subjects with chronic pain. this will be an open-label study where subjects (n=12) are administered 8-10 sessions of test over 4 weeks. measurements of pain, mood, and memory will be obtained before and after the sessions. the hypothesis is that test will be feasible and tolerable in this population.

Eligibility criteria:
inclusion criteria: 1. adults (ages 22 to 60) who understand all procedures and have the ability to provide informed consent, with a score on the mini-mental status exam of at least 24; 2. participants experiencing chronic pain, with ongoing pain symptoms, and score on the brief pain inventory of \> 5 on question #3 (which asks about maximal pain in the past 24 hours) or \> 5 on question #5 (which asks about average pain in the past 24 hours); 3. a diagnosis of chronic postoperative pain, low back pain, musculoskeletal pain, fibromyalgia, visceral pain or neuropathic pain, including complex regional pain syndrome or peripheral neuropathy; 4. no significant changes in pain medications for at least one month prior to study entry.
low protein renal formula as meal replacement in predialysis ckd patients

Conditions: Chronic Kidney Disease

Summary: a high energy and low protein renal formula tailored for the specific needs of pre-dialysis ckd patients.

previous studies indicated that low-protein formula nutritional supplements may improve compliance with an lpd and are beneficial in the management of pre-dialysis ckd patients this study will evaluate the suitability of the disease-specific enteral formula fresubin® renal in predialysis chronic kidney disease patients.

Eligibility criteria:
inclusion criteria: * chronic kidney disease stage 4-5 (egfr \<30 ml/min/1.73m2) * age: 20-80 years * patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months * written informed consent exclusion criteria: * dialysis or planned start of dialysis within next 3 months * patients awaiting kidney transplantation * bmi \ 30 kg/m2 * malnourished patients with albumin levels less than 3 g/dl who need additional supplementation of calories and nutrients * severe liver disease, malignant disease, infectious disease * existing gastrointestinal diseases or pathological findings, which do not allow en, e.g. intestinal atony, ileus, acute upper gi bleeding, shock, or malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous surgical gi resection * severely impaired gastrointestinal function, i.e. severe constipation or acute diarrhea (≥ 3 loose or watery stools per day) * dysphagia or high aspiration risk * relevant cns and/or psychiatric disorders * known allergic reaction or intolerance to any of the ingredients of the study product * planned surgery or hospitalization during study period * suspicion of drug abuse * patients unable to follow study instructions or keeping a dietary diary * pregnant or lactating women * participation in another clinical trial with an investigational product within 30 days prior to start of study or during the study

Keywords: chronic kidney disease oral nutrition supplement
pulsed radiofrequency for chronic mastalgia of fibrocystic disease of the breast

Conditions: Chronic Pain

Summary: the investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast


Eligibility criteria:
inclusion criteria: * patients with chronic mastalgia due to fibrocystic disease of the breast * the pain duration maintained for more than 1 year * the pain intensity is more than 5 on vas pain score exclusion criteria: * coagulopathy * infection at the site of the procedure
diagnosing pulmonary aspergillosis in patients with hematological malignancies: a multicentre prospective evaluation of an aspergillus pcr assay and a galactomannan elisa in bronchoalveolar lavage samples

Conditions: Invasive Aspergillosis

Summary: diagnosing invasive pulmonary aspergillosis (ipa) remains a challenge in patients (pts) with hematological malignancies. the clinical significance of testing bronchoalveolar lavage (bal) samples both with polymerase chain reaction (pcr) and aspergillus galactomannan (gm) elisa is unclear, and the bal cutoff for gm has not been clearly defined yet. using a validated nested pcr assay and a gm elisa, we prospectively examine bal samples from hematological patients at high risk of pa.


Eligibility criteria:
inclusion criteria: - hematological patients with lung infiltrates at high risk for invasive aspergillosis exclusion criteria: - patients without informed consent

Keywords: aspergillosis bronchoalveolar lavage galactomannan pcr hematological patients
study to evaluate the efficacy and safety of ph-797804 for 12 weeks in adults with moderate to severe chronic obstructive pulmonary disease (copd) taking salmeterol xinafoate/fluticasone propionate combination

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: ph-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is associated with copd. ph-797804 will be dosed to patients with copd to evaluate its potential safety and efficacy profile in copd.


Eligibility criteria:
inclusion criteria: * male or female subjects between, and including, the ages of 40 and 80 years. * subjects with a diagnosis, for at least 6 months, of moderate to severe copd (gold) and who meet the criteria for stage ii-iii disease. * subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up \> 6 months ago. * subjects must be treated with a laba/ics combination for at least 1 month prior to screening. exclusion criteria: * a copd exacerbation requiring treatment with oral steroids or hospitalization for the treatment of copd within 3 months of screening. * history or presence of significant cardiovascular disease. * ecg abnormalities. * significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study. * evidence of organ or blood disorders.
crowdsourcing a public health campaign

Conditions: HIV

Summary: the purpose of this stepped wedge randomized controlled trial is to evaluate the effectiveness of a crowdsourced intervention on promoting hiv testing among young chinese men who have sex with men (msm). the crowdsourced intervention will include an open contest, judging to determine finalists and prizes, a designathon, and contest-based msm engagement. the hypothesis is that a crowdsourced intervention will be superior to conventional hiv test uptake campaigns in eliciting hiv test uptake.

this study will use an adaptation of the stepped wedge randomized controlled trial design. a total of eight major metropolitan cities will implement the crowdsourced intervention. these cities will be chosen based on the following criteria: 1) previous centers for disease control and prevention (cdc) msm sentinel surveillance site; 2) capacity for campaign implementation; 3) capacity for intervention implementation at the community level. four cities will implement more intensive in-person events to promote engagement (guangzhou, shenzhen in guangdong province, qingdao, and jinan in shandong province) during survey intervention stage. the randomized controlled trial (rct) will be evaluated using two different sources of data: 1) online survey data from msm in the eight cities prior to and after the intervention; 2) cdc routine surveillance data in the eight cities prior to and after the intervention.

Eligibility criteria:
inclusion criteria: * currently living and planning to live in one of the eight cities used in the study in the next 12 months. * not living with hiv * no hiv test in the past three months * born biologically male and identify as either male or transgender female * had anal or oral sex with men at least once during their lifetime * 16 years or older * willing to provide cell phone number * complete the informed consent document exclusion criteria: * women are excluded from this study

Keywords: hiv msm test uptake crowdsourcing
prospective screening and differentiating common cancers using peripheral blood cell-free dna sequencing

Conditions: Cancer Diagnosis; LungCancer; Gastric Cancer; Liver Cancer; Colorectal Cancer; Esophagus Cancer; Breast Cancer; Pancreas Cancer

Summary: the goal of this observational study is to screen and differentiate common cancers in participants with or without suspicious lesions. the main question the investigators aim to answer is: can the developed model, using peripheral blood cell-free dna sequencing, work well in screening and classifying common cancers especially in the early stages? participants will undergo the collection of 15\~20ml of blood and 1\~2 telephone follow-up calls.


Eligibility criteria:
inclusion criteria: 1. \>20 and \< 80 years old. 2. cancer group: newly diagnosed cancer patients with a confirmed pathological diagnosis within 90 days before blood collection or within 30 days after blood collection, including lung cancer, esophageal cancer, breast cancer, stomach cancer, colorectal cancer, liver cancer, and pancreatic cancer. non-cancer group: individuals who have not been diagnosed with cancer during routine physical examinations and one-year follow-up. exclusion criteria: 1. uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, aids, etc. 2. new onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids. 3. new onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection. 4. any cancer treatment performed within the past 3 years. 5. individuals who have undergone organ or bone marrow transplantation. 6. participants during pregnancy or lactation. 7. individuals with malnutrition, severe mental illness, or genetic diseases. 8. other diseases or conditions deemed by the physician as unsuitable for participation in this study. 9. individuals who are unable to sign an informed consent form.

Keywords: multicancer screening liquid biopsy cell-free dna methylation machine learning