Kornimate/medical-research-clean huggingface dataset:
cognitive and health benefits of expressive writing for family caregivers under stress

Conditions: Stress, Psychological; Anxiety

Summary: the purpose of this study is to determine if expressive writing is an effective intervention for reducing stress, enhancing cognition, and improving quality of life for caregivers of older adults with dementia

a significant and growing need exists to support caregivers of older adults with dementia, including methods of support that are easily implemented and targeted at caregivers who can not access multicomponent interventions. the current intervention examines the efficacy of one such approach: expressive writing (ew). we are examining the efficacy of ew, in terms of its ability to reduce stress, enhance cognition, and improve well-being, by comparing it to two control conditions: objective writing about how caregivers spend their time (time management; tm) and objective writing about non-personal historical events (history writing; hw).

Eligibility criteria:
inclusion criteria: * primary family caregiver for an older adult with dementia * self-reported caregiver stress or burden * fluency in written/spoken english exclusion criteria: * non-family or non-primary caregiver * existing use of expressive writing / diary

Keywords: expressive writing written emotional expression caregiver stress cognition
cardiovascular outcomes sglt-2 inhibitors versus glp-1 receptor agonists

Conditions: Type 2 Diabetes

Summary: patients with type 2 diabetes (t2d) suffer from an excess risk of adverse cardiovascular events. recently, two classes of glucose lowering agents, namely sglt-2 inhibitors (sglt2i) and glp-1 receptor agonists (glp-1ra), have proved superior to placebo in protecting t2d patients from cardiovascular events in dedicated trials. patient populations in such trials were mainly composed of t2d individuals with established cardiovascular disease (cvd) or at very high risk for cvd. in addition, no clinical trial has so far compared cardiovascular outcomes of t2d associated with sglt2i versus glp-1ra. in addition, whether different results would incur in patients at lower cvd risk is unclear. on this basis, we designed this retrospective real-world study to compare cardiovascular outcomes of patients newly treated with sglt2i versus glp-1ra in routine clinical practice


Eligibility criteria:
inclusion criteria: * italian citizens, residing in the region * registered as beneficiaries for at least one year between january 1st, 2012 and september 30th, 2018 * diagnosis of type 2 diabetes * newly initiating sglt-2 inhibitors or glp-1 receptor agonists * being treated with glucose lowering medications before (at least one prescription of an antidiabetic agent in atc class a10b prior to the index date) * time between the index date and the last sglt2 inhibitors or glp-1 receptor agonists prescription shorter than 8 months, * follow-up time or time-to-endpoint of at least three months exclusion criteria: * patients who started sglt2i or glp-1ra before 2014 * patients with an insufficient exposure time * patients with an incident event within three months after the index date.
avn of weight-bearing joints in patients with hematologic malignancies treated with dexamethasone or prednisone

Conditions: Avascular Necrosis; Acute Lymphoblastic Leukemia

Summary: the primary purpose of this study is to compare the incidence of avn in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation.

patients with acute lymphoblastic leukemia enrolled on the st. jude children's research hospital front-line acuter lymphoblastic leukemia protocol, total xiiib or the front-line non hodgkin's lymphoma protocol nhl13 from 11/94 to 6/98, in continuous complete remission or who have an mri-confirmed diagnosis of avn of the hip or knee prior to relapse are eligible for this study. patients will receive an mri examination of the hips and knees based on the following: 1. patients who have no previous diagnosis of avn and no previous mri of the hips and knees will have a mri of the hips and knees after the patient completes therapy. 2. patients who have no previous diagnosis of avn and have had a previous mri of the hips and knees after completion of therapy will need no further imaging. if the patient had not completed therapy at the time of the mri, she/he will undergo mri of hips and knees. 3. for patients with a previous avn diagnosis and previous mri of the hips and knees\*, the first mri which showed avn will be used and plain radiographs of affected joints, if not already done, will be done. \*if a previous mri showed avn, but plain radiographs were not performed, the patient will have mri and plain radiographs after enrollment in avn2. if mri of both hips and both knees with plain radiographs of affected joints have been done previously, the patient requires no further imaging but still will be enrolled on the study for the purpose of analysis. 4. patients who have a previous diagnosis of avn and no previous mri of the hips and knees will have a mri evaluation of the hips and knees and plain radiographs of affected joints. patients will be referred to a bone doctor as needed. patients will be asked to fill out a questionnaire (which will take approximately 10 minutes) about any pain or problems that have with their hips and knees. if patients have already agreed to take part in the pgen4 or pgen5 research study; studies researching how genes affect the way the body uses certain chemotherapy drugs, genetic information from the blood tests done as part of those studies will be used to see if it can be predicted who has the greatest risk of avn. all study tests will be done on one day.

Eligibility criteria:
inclusion criteria: * patients with acute lymphoblastic leukemia enrolled on the sjcrh front-line all protocol, total xiiib or the front-line nhl protocol nhl13 from 11/94 to 6/98. * patients must be in continuous complete remission or have an mri-confirmed diagnosis of avn of the hip or knee prior to relapse. exclusion criteria: -
pilot studies testing levels of p63 in psoriasis skin lesions

Conditions: Psoriasis

Summary: the purpose of this study is to understand the role of a specific protein, tumor protein p63 in the skin disease psoriasis. this study is to further understand how psoriasis lesions happens. an understanding of key mediators that lead to psoriasis might aid in the discovery of more effective treatments for this skin disorder. this is not an intervention study. the study is looking to obtain currently untreated plaque psoriasis biopsies and also biopsies from non psoriasis patients. psoriasis and medical history will be collected then skin biopsies will be obtained from the subjects.


Eligibility criteria:
inclusion criteria: * female and male adult subjects age 18 to 50 with plaque psoriasis that is currently untreated (no topical agents for 2 weeks, no systemic agents for 1 month) or controls w/o psoriasis and no family history of psoriasis. * must be able to give informed consent * all skin types on fitzpatrick scale (type i-vi) * able to provide medical history and list of medications for psoriasis and control subjects exclusion criteria: * underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus) * tanning bed use within last 2 months * photodynamic therapy or uvb treatments in past 2 months * female subjects: pregnant or nursing * history of abnormal scarring (i.e., keloids) * family history of psoriasis in first-degree relatives for control subjects
study of aro-hbv in normal adult volunteers and patients with hepatitis b virus (hbv)

Conditions: Hepatitis B

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of aro-hbv in healthy adult volunteers and participants with hepatitis b virus (hbv).


Eligibility criteria:
inclusion criteria for parts a \& b: * women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception. * willing to provide written informed consent and comply with study requirements additional inclusion criteria for part b: * diagnosis of chronic hbv infection * hepatitis b surface antigen (hbsag) at screening \> or = 50 iu/ml * liver elastography score \< or = 10.5 exclusion criteria: * clinically significant health concerns (with the exception of hbv for patients in part b) * abnormal for any clinical safety laboratory result considered clinically significant * regular use of alcohol within 1 month prior to screening * recent use of illicit drugs * use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study note: additional inclusion/exclusion criteria may apply, per protocol
a phase iii study of dasatinib vs imatinib in patients with newly diagnosed chronic phase chronic myeloid leukemia

Conditions: Myeloid Leukemia, Chronic

Summary: the purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase philadelphia positive chronic myeloid leukemia. the safety of this treatment will also be studied.


Eligibility criteria:
key inclusion criteria: * male or female, aged 18 years and older * chronic phase, philadelphia chromosome-positive chronic myeloid leukemia (cml) * eastern cooperative oncology group performance status score of 0-2 key exclusion criteria: * pleural effusion * uncontrolled cardiovascular disease * significant bleeding disorder unrelated to cml * prior treatment with interferon/imatinib/dasatinib/anti-cml systemic treatments except anagrelide/hydroxyurea

Keywords: chronic phase philadelphia chromosome positive chronic myeloid leukemia
the effect of cold application on patient's pain, comfort and satisfaction after cesarean section

Conditions: Pain

Summary: a healthy postpartum period is important for the health of the mother and baby. one of the main problems that occur after cesarean section, which is a major surgical procedure, is pain. however, since the mother is in the postpartum period, she may have problems in her own care, healing process and baby care due to pain. non-pharmacological treatment is methods such as massage, acupressure, hot and cold application that can be applied at birth to support scientific medicine. the cold application examined in our research, is among these applications. participants will be determined by the block randomization method. cold application will be applied to the cesarean section site of the patient for 10 minutes in the experimental group, followed by a break of 20 minutes, followed by a 10-minute application, and immediately after the application, the patient will stand up. only the routine practice of the clinic will be applied to the control group. data; will be collected using the introductory information form, visual analog scale (vas) and cold application satisfaction evaluation form. when the studies were examined, no other study was found in the same application as our study. therefore, in this study, it was aimed to evaluate the effect of cold application on the patient's pain during the first leg, the need for painkillers and satisfaction, due to the higher first take-off pain after cesarean section.


Eligibility criteria:
inclusion criteria: * postpartum women who had cesarean section surgery * having had a previous cesarean section, exclusion criteria: * those who have problems in postpartum vital signs and bleeding control * those who have systemic diseases that may affect cold application * those who are distressed and not suitable for practice by the service midwives and doctors, * those who do not want to participate in the research
exploration of the efficacy and mechanisms of lymphaticovenous anastomosis in the treatment of alzheimer's disease

Conditions: Alzheimer&amp;#39;s Disease (AD)

Summary: the aim of this clinical trial is to determine whether lymphaticovenous anastomosis can treat alzheimer's disease，in ad patients aged 18-80.he main questions it aims to answer are: 1. can lymphaticovenous anastomosis improve cognitive function, daily living ability, mood, or sleep status in patients with alzheimer's dementia, demonstrating good therapeutic efficacy? 2. does deep lymphaticovenous anastomosis lead to changes in peripheral blood biomarker levels, neuroinflammatory responses, and neuroimaging in patients with alzheimer's dementia?


Eligibility criteria:
inclusion criteria: 1. at least two deputy chief physicians or above, diagnosed with alzheimer's dementia according to the dsm-5 diagnostic criteria; 2. age between 18-80 years old; 3. the course of the disease is at least 1 year; 4. mmse score ≤ 24 points; moca score \< 26 5. brain mri shows hippocampal atrophy; 6. patients and their families agree to participate in this project for surgical treatment and sign an informed consent form. exclusion criteria: 1. individuals with contraindications for lymphaticovenous anastomosis; those allergic to anesthetics and contrast agents (indocyanine green); 2. those unable to cooperate with cranial magnetic resonance imaging and scale testing; 3. patients simultaneously suffering from schizophrenia, depression, bipolar disorder; 4. patients with severe somatic diseases (such as cardiovascular, liver, kidney, gastrointestinal, etc.), infectious diseases, and immune system disorders; 5. individuals with serious neurological diseases (such as epilepsy, cerebrovascular diseases, etc.), other types of dementia, mental retardation; 6. pregnant or lactating women.

Keywords: lymphaticovenous anastomosis cognitive function therapeutic efficacy mechanism alzheimer&#39;s disease
pemetrexed and gemcitabine in patients with advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to look at how well the combination of two chemotherapy drugs, pemetrexed (alimta) and gemcitabine (gemzar) work to treat your cancer.

this research study is being done because we have not yet been able to find the best treatment for recurrent or advanced head and neck cancer (scchn). pemetrexed and gemcitabine have helped fight against scchn when each was given by itself. this study is different from others because it tests these two drugs together, which has not been tried before in patients with scchn. we will see how well these drugs can work to help to control or shrink your cancer. we also want to find out what effects (good and bad) gemcitabine and pemetrexed have on you and your head and neck cancer. we do not know if these drugs will help you. your cancer might get better or it might get worse. it might not have any effect on your condition. we can use what we learn from this research study to help other people with the same cancer.

Eligibility criteria:
inclusion criteria: * diagnosis of squamous cell cancer of the head and neck - unresectable or metastatic. must have measurable disease by recist. * karnofsky performance status greater than or equal to 60% * up to one prior systemic chemotherapy, immunotherapy allowed in the advanced or metastatic setting. this does not include prior chemotherapy, immunotherapy used with radiotherapy (ie concurrent with radiation therapy or as and induction regimen pror to definitive radiation therapy). * at least 4 weeks from prior radiation or chemotherapy, must have recovered from all acute effects of treatment. * adequate organ and marrow function * negative pregnancy test. agree to use birth control during and for 3 months after last dose of study drug. * at least 18 years of age. * sign an informed consent and hipaa consent. * must be able to take and absorb enteral medication. exclusion criteria: * serious concomitant systemic disorder that would compromise safety or ability to complete study. * prior treatment with gemcitabine or pemetrexed within the previous year, unless used concurrently with radiation therapy. * pregnancy or breastfeeding. * symptomatic or uncontrolled brain mets. if treated, must be off steroids for at least 2 weeks. * inability or unwilling to take folic acid, vitamin b12, or dexamethasone. * treatment within last 30 days with a drug that has not received regulatory approval for any indication. * inability to interrupt and nsaid or salicylate with a long half-life (piroxicam or nabumetone) for a 5 day period. * presence of clinically relevant third space fluid that cannot be controlled by drainage or other procedure prior to study entry. * active, concurrent, invasive malignancy requiring ongoing treatment. * corticosteroids impermissible unless for adrenal failure, septic shock or as temporizing measure for symptomatic pain, breathing, or rash.

Keywords: advanced head neck cancer
triple therapy for postoperative nausea and vomiting in laparoscopic gastrointestinal surgery

Conditions: C.Surgical Procedure; Gastrointestinal

Summary: postoperative nausea and vomiting (ponv) are common in patients, especially in patients at high risk. ponv may result in prolonged hospital stay and threaten patients' life. because the etiology of ponv is very complex, there is an increasing focus on combining antiemetics from different classes for ponv prophylaxis. fosaprepitant is a neurokinin-1 (nk-1) receptor antagonist to prevent ponv. palonosetron is a 5-ht3 receptor antagonist with high efficacy and sustained action for ponv prophylaxis. dexamethasone belongs to corticosteroid and also has the ability to reduce the incident of ponv. this study aims to use the combination of these three drugs in high-risk patients to test whether triple therapy is better than combination of palonosetron and dexamethasone to prevent ponv.

this trial is a prospective, randomized controlled study with blinded participant, care provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing laparoscopic gastrointestinal surgery will be enrolled.triple therapy of palonosetron and dexamethasone plus fosaprepitant will be administered in the intervention group, and double therapy of palonosetron and dexamethasone will be used in the control group. the anxiety of patients will be evaluated. the primary outcome is proportion of participants with ponv during the first 24 postoperative hours. secondary outcomes are as follow: proportion of participants with ponv,emetic episodes, nausea, with rescue antiemetic medication; the scores of qor-15; pain scores;time to first flatus after surgery; time to first defecation after surgery; recovery time; health related quality of life; proportion of participants with adverse events.

Eligibility criteria:
inclusion criteria: * age ≥18 years and age ≤75 years; * scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ; * the score evaluated by apfel simplified ponv risk assessment systems is ≥3. exclusion criteria: * the american society of anesthesiologists (asa) rating is \>3; * severe hepatic dysfunction(the score of child-pugh is \>9); * with contraindications for using fosaprepitant, 5-ht3 receptor antagonist or dexamethasone ; * take medications with known antiemetic properties preoperatively ; * with mental disorder, or not be able to communicate ; * pregnant women or nursing mothers.

Keywords: postoperative nausea and vomiting, fosaprepitant,
gastrointestinal and health-related quality of life in kidney transplant patients treated with mycophenolate mofetil

Conditions: Maintenance Kidney Transplant

Summary: this study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (mmf) because of gastrointestinal (gi) side effects and will also access the relationship between mycophenolic acid (mpa) dose in those patients receiving enteric-coated mycophenolate sodium formulation(ec-mps). patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.


Eligibility criteria:
inclusion criteria 1. patients who are recipients of a renal transplant. 2. patients treated with an immunosuppressive regiment including mmf before recruitment. 3. patients suffering from gi side effects related to mmf standard doses or patients treated with a reduced mmf dose to control the aforementioned gi side effects. 4. patients 18 years or older. 5. patients who have given written informed consent to participate in the study 6. patients complying with all study requirements including completing questionnaires and attending to the three study visits. exclusion criteria 1. patients with gi symptoms assumed or known not to be caused by mpa therapy (eg. oral bisphosphonate induced, infectious diarrhea) 2. acute rejection less than 1 week before recruitment. 3. females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control. 4. presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements. 5. patients undergoing surgery due to acute illness or hospitalized. 6. existence of any medical condition which, in the investigator's opinion based on anamnesis or medical records, could affect study completion, including but not limiting visual problems or cognitive deterioration. 7. patients currently treated or who have been treated with any other study drug or treatment within 30 days prior to baseline visit. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: kidney transplant enteric-coated mycophenolate sodium quality of life gastrointestinal symptoms