Kornimate/medical-research-clean huggingface dataset:
vsmart (video-conference stress management and relaxation training for older women with breast cancer)

Conditions: Stress

Summary: the proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (r-cbsm) intervention on improving health and quality of life in older women undergoing breast cancer (bca) treatment. this study tests if delivered home-based group cbsm (r-cbsm) improves response to influenza vaccine (iv) in parallel with improved psychological adaptation, inflammation and other immune functioning indicators in older women treated for bca.


Eligibility criteria:
inclusion criteria: 1. must meet the criterion of a score of \>14 on the impact of event scale-intrusion scale (ies-i48) for cancer-specific distress or self-report at least moderate distress (score of 4 or greater) on a screening question, "how would you rate your distress level, over the past week, on a scale of 0 to 10, with 0 meaning no distress and 10 being extreme distress" 2. no prior history of cancer (with the exception of non-melanoma skin cancer) 3. life expectancy of \> 12 months. 4. no diagnosis of major psychiatric condition or mental disorder (i.e. schizophrenia, psychosis, and/or bipolar disorder) or active (in the past 12 months) major depressive disorder (mdd), panic disorder, post traumatic stress disorder (ptsd) diagnosis or history of suicide thoughts, attempts or plans. 5. no substance dependency in the past 12 months. 6. no acute or chronic co-morbid medical condition with known effects on the immune system (e.g., hiv infection, autoimmune diseases) 7. no prior neo-adjuvant therapy 8. no current medications that act as direct immunomodulators (e.g., granulocyte macrophage colony stimulating factor (gm-csf), interferons) 9. no significant cognitive impairment, must score \<31 on the telephone interview for cognitive status (tics)49. 10. at least a 6th grade reading level in english and be available for follow-up 11. women age 50 and older diagnosed with stage 0-iii breast cancer. exclusion criteria: * does not meet all inclusion criteria.

Keywords: breast cancer flu vaccine
treatment of non-hodgkin lymphoma with cd19-tricar-t/silk cell therapy

Conditions: Non-Hodgkin Lymphoma

Summary: this is a single arm, open-label, early phase ⅰ study, to determine the safety and efficacy of cd19-tricar-t and cd19-tricar-silk cell therapy in non-hodgkin lymphoma treatment.

cd19-tricar contains an anti-cd19 scfv, a pd-l1 blocker, and a cytokine complex, enabling the cd19-tricar-t/silk to simultaneously targeting the cd19 positive non-hodgkin lymphoma，blocking the inhibitory pd-l1 signal and stimulating innate t/nk cell activation and expansion, thus make it a tri-functional car (tri-car). cd19-tricar-t is an autologous tri-functional car-t cell therapy, cd19-tricar-silk is an allogeneic tri-functional car-nk cell therapy, patients ineligible for leukapheresis or car-t therapy will be recommended for cd19-tricar-silk therapy.

Eligibility criteria:
inclusion criteria: 1. all subjects must personally sign and date the consent form before initiating any study specific procedures or activities; 2. all subjects must be able to comply with all the scheduled procedures in the study; 3. refractory or relapsed malignant non-hodgkin lymphoma, defined as one or more of the following: relapsed in 6 months after most recent therapy; progressive disease in standard chemotherapy; disease progression or relapsed in ≤12 months of asct; 4. at least one measurable lesion per revised iwg response criteria; 5. aged \<70 years; 6. expected survival ≥12 weeks; eastern cooperative oncology group (ecog) performance status of≤2; 7. systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks; 8. all other treatment induced adverse events must have been resolved to ≤grade 1; 9. laboratory tests must fulfill the following criteria: anc ≥ 1000/ul, hgb\>70g/l, platelet count ≥ 50,000/ul, creatinine clearance ≤1.5 uln, serum alt/ast ≤2.5 uln, total bilirubin ≤1.5 uln (except in subjects with gilbert's syndrome); exclusion criteria: 1. presence of fungal, bacterial, viral, or other infection that is hardly to control（defined by investigator）; 2. patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. the specific selection is ultimately determined by the investigator; 3. lactating women or women of childbearing age who plan to conceive during the time period; 4. active infection with hepatitis b (hbsag positive) or hepatitis c virus (anti-hcv positive); 5. known history of infection with hiv; 6. subjects need systematic usage of corticosteroid; 7. subjects need systematic usage of immunosuppressive drug; 8. planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study; 9. other reasons the investigator consider the patient may not be suitable for the study.

Keywords: car-t tricar-t cd19-tricar-t cd19-tricar-silk non-hodgkin lymphoma
endothelial leakage and the association to endothelial biomarkers after surgery

Conditions: Pancreas Disease

Summary: the primary aim of this study is to investigate fluid loss from the blood stream (''endothelial leakage'') and the damage on the vessel wall (''endothelial function'') during surgery. cardiovascular complications during surgery are said to have different causes, e.g. lack of fluid in the blood stream (''hypovolemia'') and decreased vascular tone. hypovolemia can have different causes, one being damage to the endothelial function. during trauma and infection, it has been previously shown, that damage to the endothelial function causes fluid loss from the blood stream. nevertheless, this has never been demonstrated during surgery. secondary this study will measure the blood flow using a thermo-camera during surgery. this will together with selected blood tests provide information on various possible causes to hypovolemia. the purpose of this study is to describe and quantify endothelial damage (assessed by selected endothelial biomarkers) and albumin escape rate as a proxy for endothelial leakage (assessed by measuring radioactive 125-i labeled hsa injected postoperatively), combined with assessment of mts (assessed by laser speckle contrast imaging (lsci) and digital thermography). this will allow a detailed description of the surgery's impact on the endothelial integrity and contribute to a better understanding of the physiological changes that occur postoperatively. the study will investigate patients undergoing pancreaticoduodenectomy (whipple) and total pancreatectomy. these patients have a vast clinical need, being one of the most extensive abdominal surgical procedures with great stress response. the study is a prospective exploratory cohort study and methods include blood sampling pre- and post-operatively, 125-i labeled humane serum albumin postoperatively (and preoperatively if logistically possible) and thermography. the hypothesis of this study is that the extent of endothelial damage measured by selected biomarkers is associated with the level of albumin escape rate after major abdominal surgery. secondly, inflammation increases albumin escape rate after major abdominal surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients are scheduled for whipple or total pancreatectomy exclusion criteria: * patient having received immunomodulating treatments less than four weeks prior to surgery * patient having other major surgery performed less than four weeks prior to surgery. thus, minor surgery allowed, for instance minor skin incisions * patient having endoscopic retrograde cholangiopancreatography (ercp) or percutaneous transhepatic cholangiography (ptc) performed less than two weeks prior to surgery * patients scheduled for major vascular surgery during whipple or total pancreatectomy * patient is diagnosed with chronic kidney failure or is in diuretics treatment
post-marketing surveillance for the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer (study hal01s)

Conditions: Inoperable or Recurrent Breast Cancer

Summary: to investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer


Eligibility criteria:
inclusion criteria : * inoperable breast cancer * recurrent breast cancer exclusion criteria : * corresponding to contraindication of eribulin mesylate * not applicable to indications of eribulin mesylate * not applicable to aggravation or recurrence of breast cancer in patients who have previously been treated with anthracycline and/or taxane antitumor drugs

Keywords: eribulin mesylate inoperable or recurrent breast cancer
a multicenter, open label, single dose study to evaluate the effect of renal insufficiency on the pharmacokinetics of sk 0403

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase 1, multicenter, open label, single dose study. a total of 30 subjects are planned (5 groups of 6 subjects each.)

this is a phase 1, multicenter, open label, single dose study. a total of 30 subjects are planned (5 groups of 6 subjects each) as follows: group a: subjects with esrd who are receiving hemodialysis treatment group b: subjects with severe renal impairment group c: subjects with moderate renal impairment group d: subjects with mild renal impairment group e: healthy subjects

Eligibility criteria:
inclusion criteria: * subject is an adult male or female aged 18 to 79 years, inclusive. * all female subjects (that are not 2 years postmenopausal with a documented serum follicle stimulating hormone level \>35 miu/ml) must have a negative serum pregnancy test at screening and upon check in to the study clinic. * subject provides written informed consent before any study-specific evaluation is performed. * subject is able and willing to comply with the protocol and study procedures. exclusion criteria: * subject has a bmi \>37 kg/m2. * subject has taken any prescribed systemic or topical medication * subject has donated more than 450 ml of blood within 30 days before the start of dosing. * subject has received an investigational drug within 30 days before dosing. * subject has had any surgery of the gastrointestinal tract likely to affect drug absorption. * subject has had a clinically significant illness
correlation of children and parental anxiety and effectiveness of breathing exercises on anxiety reduction

Conditions: Dental Anxiety

Summary: the purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction.

this study evaluated the correlation of children and parental anxiety and effectiveness of breathing exercises on anxiety reduction

Eligibility criteria:
inclusion criteria: * children aged 5_8 years old. * moderate or severe dental anxiety based on the (cdas). * good general health, free from any systemic diseases or psychological disorders. * teeth indicated for restoration treatment under local anesthesia. * no allergy to anesthetic drugs exclusion criteria: * use of analgesics before treatment. * presenting with acute pain and requiring emergency dental treatment.

Keywords: dental anxiety parental anxiety breathing exercises bubble blower breathing diaphragmatic breathing relaxation distruction
the utility of breath biopsy as a screening tool for hcc

Conditions: HCC; Cirrhosis, Liver

Summary: the aim of this pilot study is to examine whether there is a discriminating ability of the breath sample analysis to capture biomarkers specific to the hcc in the breath of affected individuals. if positive, our research could open up a new horizon for cost-effective and feasible screening tools.

20 participants will be included in the study. ten cirrhotic patients with hcc and 10 cirrhotic patients without hcc. the first group is patients with hcc secondary to cirrhosis. the second group will be patients with cirrhosis who are currently on the standard surveillance program with no hcc. confirmation of the absence of hcc would have been ensured via a recent advanced imaging modality (dynamic ct scan or mri) in the ongoing surveillance programme. participants will breathe into either a mouthpiece or collection tube then breath samples will be analyzed via an analyzer to detect the volatile organic compounds (voc) and quantitatively compare them

Eligibility criteria:
inclusion criteria: * cirrhotic patients with hc. * cirrhotic patients without hcc exclusion criteria: * patients with more than one primary cancer (hcc in addition to other cancer) * patients who are not aware of the diagnosis * patients in whom the diagnosis of hcc is not clear and only suspected * patients with severe chronic obstructive pulmonary disease (copd) or severe asthma.
brief digitally-enhanced intervention for reducing alcohol use during moud

Conditions: Opioid Use Disorder

Summary: the goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (moud) outcomes in individuals receiving moud. the main questions it aims to answer are: * does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called managing physical reactions to overwhelming emotions (improve), impact daily alcohol use and moud adherence? * does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity? researchers will compare improve to a control intervention (health education treatment) to see if improve impacts daily alcohol use and moud adherence. participants will: * complete a baseline electroencephalography (eeg) and self-report questionnaires. * complete three one-hour intervention sessions (improve or control) each one week a part. * complete a post-intervention eeg and self-report questionnaires. * complete five ecological momentary assessment (ema) surveys a day for 21 days. * complete self-report questionnaires one-month after their last intervention session.


Eligibility criteria:
inclusion criteria: * enrolled in outpatient medication for opioid use disorder (moud) program (within the past month) * heavy alcohol user defined using the national institute on alcohol abuse and alcoholism (niaaa) criteria (i.e., consume 8+/15+ drinks per week \[women/men\] with at least two binge episodes \[4/5+ drinks for women/men in a 2 hour period\] in the past month) * elevated psychological distress defined as a total score of \> 12 on the kessler psychological distress scale (k10; 0 to 40 range) * 18 years of age or older * can read and comprehend english exclusion criteria: * do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent * presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication) * current comorbid moderate to severe substance use disorder other than alcohol and opioids * limited or no access to a smart phone that is compatible with the mobile application * participation in phase one * possibility of being pregnant (by self-report) * current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer

Keywords: medications for opioid use disorder heavy alcohol use ecological momentary assessments electroencephalography
retrospective study on the use, efficiency, and safety of the at-home mosie kit

Conditions: Infertility; Infertility, Female; Infertility, Male

Summary: this study examines the experience of people who have selected to use the at-home insemination mosie kit to understand the user's experience, the perceived safety and the efficiency. people who have recently purchased and voluntarily selected to use the mosie kit will be invited to complete a one-time online anonymous survey. the results of the survey will be analyzed to understand their experiences.

at-home intracervical insemination (ici), folklorickly known as the "turkey-baster" method, has been used for decades to increase likelihood of pregnancy. this method works by depositing semen close to or at the cervix. while there are several devices such as over the counter syringes and silicone caps, the creator of the mosie baby syringe believes it is designed to be more ergonomic and compatible with a woman's body, easy and safe to use, and results in depositing the semen at or near the cervix opening. the mosie kit provides people with an at-home intracervical insemination option which could be used before resorting to more invasive and expensive options such as intrauterine insemination (iui) or in vitro fertilization. there is vast evidence of mosie's success in the form of happy users who have conceived. there is a desire to learn more about the safety, useability and experience of using the mosie kit. this retrospective study will examine the experience of people who have voluntarily chosen to purchase and use the mosie kit. the mosie kit consists of 2 syringes and a semen collection cup understanding the safety, useability and experience of using the mosie kit will provide additional information about the nature of using intracervical insemination as a viable method for getting pregnant. the information gained will increase understanding of how viable the mosie kit is as a first step in trying to conceive and how it is perceived by the people who have chosen to use it.

Eligibility criteria:
inclusion criteria: * provide implicit consent by filling out and submitting the survey. * used a mosie kit to conceive during at least one cycle. * at least 18 years old. * has an active email on file (presumed or they would not have received an invitation to participate. this information will not be verified as there is a desire to keep the survey completely anonymous.) exclusion criteria: * never used a mosie kit

Keywords: insemination infertility pregnancy
radiation eliminates storming cytokines and unchecked edema as a 1-day treatment for covid-19

Conditions: Pneumonia; Coronavirus Infection in 2019 (COVID-19); Severe Acute Respiratory Syndrome (SARS) Pneumonia

Summary: this phase i/ii trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or sars associated with covid-19 infection.

primary objective: i. to compare treatment of covid-19 between best supportive care plus provider's treatment choice versus best supportive care plus low-dose, whole-lung radiation therapy outline: patients undergo 1 fraction of low-dose radiation therapy. after completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.

Eligibility criteria:
inclusion criteria: * have had a positive test confirming the diagnosis of covid-19 * have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment) * have visible consolidations/ground glass opacities on chest x-ray or computed tomography * have received pre-intubation respiratory support or undergone endotracheal intubation and have been on ventilator support for no longer than 5 (five) calendar days prior to the schedule date of delivery of low-dose radiation therapy. * willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions * evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation exclusion criteria: * no use of disallowed medications 1 day prior to delivery of ldrt: azithromycin, chloroquine, hydrochloroquine, covid-targeted antiviral medications * pregnant and/or planned to be pregnant within in next 6 months
center for stroke disparities solution - community transitions intervention

Conditions: Hypertension; Stroke; Transient Ischemic Attack

Summary: the stroke cti study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (np) only and a np and health coach (hc) community transitions intervention (cti) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.

targeted study participants are black and hispanic patients with a history of stroke and a current systolic blood pressure (bp) above jnc7 recommended range (\>=140 mmhg) who recently entered home care service. the np only program will provide a 30 day intervention while the np/hc team will provide 3 months of support via in-home and telephone encounters for patients randomized to one of these groups. in the first 30 days post-enrollment the np will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on bp reduction and preparing the patient for ongoing bp maintenance. as applicable, the hc will pick up the case after 30 days and follow up with the plan of care jointly established by the patient, np and hc. the focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed.

Eligibility criteria:
inclusion criteria: * newly admitted to the vnsny post acute care program * 21 years of age or older * black and/or hispanic * speaks english or spanish * history of stroke or transient ischemic attack (tia) * hypertension diagnosis * average screening systolic bp \>= 140 mmhg * is available to participate in intervention activities during the study timeframe if randomized to treatment group exclusion criteria: * dialysis * end stage renal disease * kidney transplant * severe heart failure * significant cognitive impairment. unable to provide informed consent, accurate self-report, and/or unable to participate effectively in intervention * significant verbal speech impairment. unable to participate in intervention telephone sessions * patients with upper arm circumference outside of valid use parameters for the automated device used for eligibility screening

Keywords: stroke transient ischemic attack high blood pressure hypertension
chest compression technique in infants

Conditions: Atelectasis

Summary: evaluate the effect of chest manual compression technique (cct) in the variables of oxygenation, hemodynamic and respiratory work in infants with respiratory diseases that are associated with atelectasis.


Eligibility criteria:
inclusion criteria: group a * infants (29 days to 24 months of age). * after the legal representatives of the patients have read agreed and signed an informed consent * infants diagnosed with atelectasis by medical staff, with chest x-ray with opacification directors * respiratory disease group b (control group) * infants whose inpatient diagnosis has not been respiratory ailments that did not show any pain at the time of the evaluation. for the control group followed the same evaluation criteria of group a. exclusion criteria: * infants with respiratory disorders that don't have with atelectasis * infants who showed signs of irritability or intense crying at the time of evaluation