Kornimate/medical-research-clean huggingface dataset:
guiding icu physicians' communication and behavior towards bereaved relatives

Conditions: Patients Died in Intensive Care Unit (ICU)

Summary: as icu mortality is high, end-of-life is a subject of major concern for intensivists. with a mortality rate of 20%, end-of-life care has become a daily responsibility. among those deaths, 60 to 80% follow a decision to withhold or withdraw treatment, situations where physicians, nurses and relatives must work together towards the most consensual decision. in this context, patients' relatives feel vulnerable and, in the months that follow the death, they are most likely to present symptoms that negatively affect their quality of life (anxiety, depression, ptsd, prolonged grief). many studies have shown that communication with caregivers is one of the most highly valued aspects of care that impacts on family members' experience during the patient's stay and after the patient's death. improving communication during the end-of-life process in the icu context is a necessity that has been put forward in palliative care and family-centered care guidelines. this study aims to improve both communication skills and behaviour by giving precise recommendations to physicians (3 step strategy) in their direct contact with patients' relatives. a 3-step physician-driven support strategy is used, that consists in 3 meetings with the relative - one before, one during and one after the patient's death. the underlying hypothesis is that this strategy will improve communication in the end-of-life setting and thus should reduce post-icu burden for family members, specifically the development of prolonged grief 6 months after the death.


Eligibility criteria:
inclusion criteria: * relatives of patients who died in the intensive care unit after a decision to withhold or withdraw treatment (adult icus only, icu length of stay \> 2 days). * consent to participate in the study * relative who was seen at least once by the physician before the patient's death exclusion criteria: * relative that does not understand, read or speak french * relative who refuses to participate
community based promotion of physical activity in nepal (cobin-pa)

Conditions: Exercise

Summary: globally, one in four adults does not meet the who-recommended level of physical activity. insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. pa is effective in weight management, cardiorespiratory fitness, and increasing quality of life. however, there is lack of evidence on effectiveness on promoting physical activity in community level. the aim of the study is to test the effectiveness of female community health volunteers (fchvs)-led community-based educational program on physical activity promotion in community level. this is an open label cluster-randomized controlled trial with 1:1 allocation where fchvs will deliver a family-based education for the promotion of physical activity at community level in nepal. the intervention package will be guided by theory of planned behavior and will contain home-based interactive health education sessions focused on increasing pa in a household setting. fchvs will use resource materials for health education. the mixed-effect linear regression model will determine the adjusted interaction between time and intervention. the results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. the evidence generated from this study will help to provide new knowledge on the community-based promotion of physical activity and its effectiveness for policymakers and researchers. it will hopefully support the attainment of the national and global target of reducing insufficient physical activity.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 69 years * without the intention of migrating out of the area for the next 6 months exclusion criteria: * those severely ill * history of mental illness * decline to provide consent

Keywords: physical activity non-communicable disease nepal
carboplatin and paclitaxel in patients with metastatic, castrate-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel and correlate response to study treatment with biologic parameters (i.e. lab studies of blood, urine, or tissue). it is hoped that this will allow researchers to gain insight into the underlying biology of prostate tumor progression and perhaps predict which patients may benefit from this chemotherapy regimen.

docetaxel/prednisone is the standard of care in patients with metastatic, castrate-resistant prostate cancer (crpc) but duration of response is limited, with median time to prostate-specific antigen (psa) progression of 6-8 months. there is currently no standard second-line therapy for patients who have progressed after receiving docetaxel. carboplatin and paclitaxel have demonstrated activity, but prospective clinical trials evaluating this regimen are limited. in addition, correlative studies investigating why some patients respond are lacking.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of prostate carcinoma. * subject must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy. furthermore, if applicable, medical castration must be maintained for the duration of the protocol. * serum testosterone \< 50 ng/ml. * subjects who have received anti-androgen therapy with a resulting psa decline must demonstrate progression following discontinuation of anti-androgen therapy. * subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial. * must have previously received docetaxel for prostate cancer * ecog performance status 0-2 * willing and able to give informed consent exclusion criteria: * platelet count \<100,000/mm3 * absolute neutrophil count (anc) \<1,500/mm3 * hemoglobin \< 8 g/dl * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>2.5 x upper limit of normal * bilirubin (total) \>2 x upper limit of normal. subjects with known gilbert's syndrome are eligible if direct bilirubin is within normal limits * for subjects with serum creatinine \> 1.5 x uln, calculated creatinine clearance \ 30 ml/min * other serious illness(es) involving the cardiac, respiratory, cns, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study * prior investigational therapy within 4 weeks of treatment. furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase. * grade \> 1 peripheral neuropathy

Keywords: metastatic castrate resistant prostate cancer crpc
the efficacy and safety of cdk4/6 inhibitors in combination with endocrine therapy in the neoadjuvant treatment

Conditions: Breast Cancer Stage III; Breast Cancer Stage II

Summary: to explore the efficacy and safety of cdk4/6 inhibitors combined with endocrine neoadjuvant therapy for stage ii-iii hr-positive/her2-negative breast cancer. this study adopts a single-arm, open-label design, and plans to include 40 patients with stage ii-iii hr+/her2- breast cancer.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old. 2. premenopausal and postmenopausal stage ii-iii females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of er and/or pr\>10% and her2- (her2 expression 0 or 1+ or 2+ and negative fish test). 3. patients must have histologically confirmed er and/or pr \>10%, her2-, early invasive breast cancer. 4. intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation pd/sd, advanced age, and inability to tolerate chemotherapy with underlying diseases. 5. ecog ps score 0-2. 6. patients must be able and willing to swallow and retain oral medications. 7. premenopausal women within 14 days of enrollment, or women with amenorrhea for less than 12 months at the time of enrollment, must have a negative serum or urine pregnancy test. 8. patients who have received neoadjuvant endocrine therapy are eligible for enrollment as long as they are enrolled within 6 months of initial histologic diagnosis and have completed no more than 2 months of neoadjuvant endocrine therapy. 9. absolute neutrophil count ≥ 1500/µl, platelet ≥ 100000/mm3, hemoglobin ≥ 10g/dl exclusion criteria: 1. prior treatment with any cdk inhibitor. 2. inflammatory breast cancer or stage iv breast cancer or bilateral breast cancer. 3. history of anaphylaxis caused by chemical or biologic components similar to dalsily. 4. patients who have received any drugs or substances with effective cyp3a isoenzyme inhibitors or inducers within 7 days of enrollment. 5. uncontrolled intercurrent illness that would limit compliance with study requirements. 6. pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission. 7. patients with any history of malignancy are not eligible. 8. patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.

Keywords: hormone receptor (hr) positive her2 negative neoadjuvant treatment cdk4/6 inhibitors
rad001 in previously treated patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this research study is to investigate if rad001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. experiments have shown that rad001 can prevent cells from multiplying. rad002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.

* participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. each cycle lasts four weeks during which you will be taking the study drug, rad001, orally every day. * participants will come into the clinic every other week during the time of enrollment. at each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. ct scans will be repeated every 2 months to assess the tumor. * participants will remain on the study as long as they continue to benefit from the study medication.

Eligibility criteria:
inclusion criteria: * pathologic confirmation of pancreatic adenocarcinoma * 18 years of age or older * at least one measurable site of disease according to recist criteria that has not been previously irradiated. if patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. * treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine. * prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease. * minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy. * ecog performance status 0-1. * life expectancy of greater than 12 weeks. * adequate bone marrow and liver function. * must be able to swallow tablets. exclusion criteria: * prior treatment with an investigational drug within the preceding 4 weeks. * prior treatment with an inhibitor of mtor * chronic treatment with systemic steroids or another immunosuppressive agent * more than one prior chemotherapy treatment for metastatic disease * uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases. * other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin * patients with chronic renal insufficiency * other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study. * known history of hiv seropositivity * impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of rad001. * active, bleeding diathesis or an oral vitamin k antagonist medication * women who are pregnant or breast feeding

Keywords: rad001 metastatic pancreatic cancer
online asthma self-management for children aged 5-10 and their parents

Conditions: Asthma

Summary: the potential benefits of this research to public health include improved understanding of cultural factors in pediatric asthma self-management, improved self-management skills for children, and better asthma management skills for their parents. this could result in eased suffering and improved quality of life for millions of children and their families, and also reduce the economic burden borne by society in the forms of medical expenditures and lost productivity.

this proposal will create an interactive multimedia (imm) program designed to support the self-management efforts of asthmatic children aged 5-10 years and their families. this behavior change program will be designed to promote self-management by (a) increasing child and caregiver knowledge about asthma, (b) encouraging compliance with medication protocols and environmental controls, and (c) increasing self-efficacy to create and implement an asthma action plan.

Eligibility criteria:
inclusion criteria: * children aged 5-10 with physican-diagnosed asthma and who had been prescribed any type of asthma medication, and one of their parents or primary caregivers. parents and children needed to have access to an internet- and video-capable computer, and the parent needed to have a valid e-mail address in order to receive study-related correspondence. exclusion criteria: * only english-speaking participants were accepted because the program was developed only for english speakers. children less than 5 years of age and older than 10 were excluded because the program is developed targeted to the developmental abilities and interests of children aged 5-10. there were no exclusions based on race/ethnicity.

Keywords: self management education children caregivers health care providers
phase ii research study of arsenic trioxide (trisenox) in patients with myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndrome (MDS)

Summary: in this phase ii study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. the secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule. arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of myelodysplastic syndrome by fab. can be made with cytogenetic analysis of bone marrow or hematologist evaluation * patient must have had bone marrow biopsy and aspiration to confirm diagnosis within 60 days prior to treatment * ecog performance status of 0-2 * an ekg must be performed within 7 days prior to treatment to confirm qt interval \<460msec. * serum creatinine less than or equal to 2.5 times the upper limit of normal. * serum bilirubin less than or equal to 2.5 times the upper limit of normal. * serum potassium greater than or equal to 4.0 meq/dl and serum magnesium greater than or equal to 1.8 mg/dl. if these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide. * patients must be 18 years of age to participate in this study exclusion criteria: * pregnant or nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception. * corrected qt interval of greater than or equal to 460msec in the presence of serum potassium and magnesium values within normal range. * significant chf, coronary is ischemia or serious arrhythmias including conduction delays. * peripheral neuropathy greater than or equal to 2. * evidence of active infection * concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents. * inability or unwillingness to comply with the treatment protocol, follow up, or research tests.
glycemic impact of myo-inositol in pregnancy

Conditions: Gestational Diabetes Mellitus as Antepartum Condition

Summary: myo-inositol has been shown to decrease the rate of diabetes in pregnancy in european studies. it is not known exactly how this occurs or what it does to the sugar when the supplement is taken. this study purpose is to look at the patient's sugar levels while taking the supplement to see if the overall levels of sugar go down. we hypothesize that in addition to sugar levels, other hormones influencing diabetes will be altered.

myo-inositol is important for glucose homeostasis and has been shown to improve insulin sensitivity. this is a prospective cohort pilot study to determine daily glycemic pharmacokinetics and metabolic influences of myo-inositol supplementation using continuous glucose monitoring system (cgms) and pre- and post-supplement blood work in high risk pregnancies and women diagnosed with gestational diabetes mellitis (gdm). risk factors include: obesity, previous pregnancy with gdm, family history of diabetes, glucose intolerance, and polycystic ovarian syndrome (pcos). women will have a cgms device placed on day one and begin with 3 days of placebo plus folic acid (400mcg) to determine baseline glycemia and metabolic levels. for the final 4 days, women with take myo-inositol supplementation (4g) plus folic acid (400mcg). the cgms device will be removed on day 7 when final blood work will be obtained. self-capillary glucose testing 4 times per day is recorded to calibrate cgms glucose values. these observations will help determine the effects of myo-inositol on overall mean glucose and other metabolic factors in high risk and gdm patients, identify pharmacokinetic discipline in pregnancy, and develop the groundwork for future prospective clinical trials for the prevention and/or augmentation in treatment gdm.

Eligibility criteria:
inclusion criteria: * english-speaking * singleton * pregnant females between 20-28 weeks of gestation at time of enrollment plus (either of the following) * high risk including women must have passed routine glucose screening and have greater than or equal to 1 of the following high risk criteria: first degree family member with diabetes mellitus, previous pregnancy with gestational diabetes, pcos, or body mass index great than or equal to 30. * gestational diabetes diagnosed in current pregnancy based on iadpsg or nih consensus diagnostic recommendation exclusion criteria: * pre-pregnancy diagnosis of diabetes mellitus * renal disease * immunocompromised * currently taking immunosuppressive medications * age \<13 years old * non-english speaking * multifetal gestation.

Keywords: gestational diabetes myoinositol
metacognitive training in the older adults with depressive symptoms (mct-silver)

Conditions: Depressive Symptoms

Summary: depression is one of the most common mental disorders in older adults and a major cause of years lived with disability. depression does not always respond to antidepressants, and non-pharmacological interventions are recommended by international guidelines. the metacognitive training for depression in later life (mct-silver) is a creative and innovative group intervention that aims to reduce depressive symptoms by challenging the cognitive and metacognitive beliefs characteristic of this disorder, that intends to enable participants to recognize and correct their automatic and dysfunctional thinking patterns and behavior. it was developed by the partner institution's team, and has already demonstrated positive results. this project aims to extend the research study to portugal, through cultural adaptation, pilot study, and a randomized controlled trial (rct). to this end, we defined the following aims: to plan and conduct a pilot study to assess the efficacy of the mct-silver in the portuguese population; to conduct a multicenter randomized controlled trial (rct).


Eligibility criteria:
inclusion criteria: * ability to give informed consent * age: 60 years or older * sufficient command of the portuguese language * willingness to participate in the intervention for a period of 4 to 8 weeks (participants who do not participate in the intervention will also be included in the analysis) * adequate visual and hearing acuity for neuropsychological testing and participation in the group sessions * values above 10 on the hamilton depression scale exclusion criteria: * active psychotic symptoms (i.e., hallucinations, delusions, or manias) * acute suicidal ideation * cognitive impairment * dementia or other neurological disease
rehabilitation for head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: patients treated for head and neck cancer (hnc) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss. more than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly decreased quality of life. rehabilitation that includes physical exercise, nutritional counselling and oral nutritional supplements (ons) can potentially reduce or prevent muscle wasting. the primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (rt). newly diagnosed hnc patients referred for curative rt with or without chemotherapy, will be randomised to a) rehabilitation during rt or b) rehabilitation after rt. rehabilitation during rt will be carried out at an outpatient facility during the treatment period (6-7 weeks) and rehabilitation after rt will be carried at a rehabilitation centre and last for 3 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of squamous cell cancer (scc) originated in the head/neck (naso, oro, hypo pharynx, larynx and oral cavity) * due to commence curative radiotherapy (rt) or chemoradiotherapy (crt) * all baseline assessments can be completed within 4 weeks prior to first cycle of rt or crt * written informed consent is present * willing to comply with study procedures exclusion criteria: * stage t1n0m0 laryngeal cancer

Keywords: radiotherapy exercise diet therapy rehabilitation patient compliance feasibility studies sample size patient satisfaction