Kornimate/medical-research-clean huggingface dataset:
palliative care messaging for american indians

Conditions: Knowledge, Attitudes, Practice

Summary: the investigators will be conducting a randomized trial in 3 reservation communities to test the efficacy of the narrative as culture-centric health promotion model for increasing american indian tribal members' palliative care knowledge and intentions to discuss palliative care.

palliative care is specialized patient-/family-centered care designed to reduce suffering and enhance quality of life for persons with serious illness. culturally responsive palliative care can ease serious illness burden experienced by american indians (ais) and improve seriously ill ais end-of-life decision-making. however, for seriously ill northern plains ais, specifically those in south dakota (sd), access to and use of culturally responsive palliative care is severely limited. to address this need, the investigators have formed a multidisciplinary, tribally-driven collaborative team consisting of great plains tribal leaders health board, active ai community advisory boards at the following reservations: cheyenne river, rosebud, and pine ridge, and south dakota state university. the research team will conduct a campaign messaging efficacy test using the narrative as culture-centric health promotion model (nchp) to create and test culture-centric narrative messaging that improves knowledge of palliative care and encourages participants to engage in formal and informal communication about palliative care. the nchp model is an evidence-based innovative approach to enhance ai's knowledge and intentions to talk formally and informally about palliative care, because it provides guidelines for how to construct culture-centric narratives which identify the features of effective narratives and the mechanisms by which the narratives work to transform cognitive and behavioral outcomes. the investigators have developed a culture-centric narrative health video message and will be conducting a randomized trial to test the efficacy of the nchp model for increasing ai tribal members' palliative care knowledge and intentions to discuss palliative care.

Eligibility criteria:
inclusion criteria: * 18 years old or older * self-identify as american indian * must be able to read and comprehend english * live on or around the pine ridge indian reservation, rosebud indian reservation, or cheyenne river indian reservation exclusion criteria: * under the age of 18 years * not american indian * do not live near or on the pine ridge indian reservation, rosebud indian reservation, or cheyenne river indian reservation

Keywords: palliative care american indian hospice end of life
evaluation of different smoking cessation protocols: nicotine replacement, motivational interviewing (mi), cognitive behavioural therapy (cbt) or hypnotherapy in cancer patients scheduled for surgery

Conditions: Breast Cancer; Gynecologic Cancer; Digestive Cancer; Melanoma

Summary: this trial offers support and assistance to patients wishing to quit smoking in order to increase the success rate of smoking cessation and all the benefits associated with it. patients will be monitored by a tobacco specialist and will be able to benefit from one or more therapies complementary to nicotine replacement therapy (nrt): motivational interviewing (mi), cognitive behavioural therapy (cbt) or hypnotherapy.

the study respire is aiming to identify some interventions to be proposed as part of a smoking cessation programme for smokers with cancer requiring surgical treatment and wishing to stop smoking. we aim to compare different smoking cessation methods in addition to the currently recommended treatments: nicotine replacement therapy (nrt). these procedures are: cognitive behavioural therapy (cbt), motivational interviewing (mi) or hypnotherapy in order to improve the success rate of smoking cessation in this specific population. all patients wishing to be supported to stop smoking will be randomized and will be followed by a tobacco specialist before and after surgery. they will receive nrt for 12 months. smoking assessment, exhaled co measurement, questionnaires will be completed regularly to assess depression, anxiety and quality of life during the 12 months. patients randomized in group 2 will receive 1 to 3 mi. patients randomized in group 3 will receive 1 to 3 mi and 6 cbt sessions by a psychotherapist. patients randomized in group 4 will receive 1 to 3 mi and at least 3 sessions oh hypnotherapy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * smoking patient: daily tobacco consumption. * patient with cancer requiring surgical treatment (breast cancer, digestive cancer, gynecological). * patient wishing to quit smoking. * fagerström \> 3. * patient has valid health insurance * information and agreement of the patient to participate in the longitudinal cohort. * signing of specific informed consent for patients in groups 1 to 4 before any study-related intervention. * person able to speak, read and understand french. exclusion criteria: * patient not receiving surgical treatment. * refusal to participate in the longitudinal cohort study. * pregnant or likely to be pregnant or nursing patient. * persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian * disability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.

Keywords: smoking cessation motivational interviewing (mi) cognitive behavioural therapy (cbt) hypnotherapy nicotine replacement therapy (nrt) surgery surgery complications longitudinal cohort
study to evaluate efficacy and safety of bronpass tab. in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of bronpass tab. in 96 patients with chronic obstructive pulmonary disease.

this study is to prove that bronpass tab. is superior in clinical efficacy and safety in improving copd symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.

Eligibility criteria:
inclusion criteria: 1. 40 years ≤ age 2. patients who are diagnosed as copd (based on the definition in the korean society of tuberculosis and respiratory diseases copd guidelines) 3. patients who meet all of the following criteria at the screening test * fev1/fvc \< 0.70 after bronchodilator administration * 30% ≤ fev1 \< 80% predicted after bronchodilator administration * cough or sputum-related score on the cat ≥ 3 4. current or former smokers with a smoking history of 10 pack-years or more at screening. 5. patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate. exclusion criteria: 1. patients with a current medical history of asthma (however, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of copd are eligible for participation.) 2. patients with a medical history of respiratory diseases other than copd 3. patients who have undergone lung volume reduction surgery. 4. patients with a history of lung transplantation. 5. patients with a history of respiratory infections within 4 weeks prior to screening 6. patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening. 7. pregnant or lactating women. 8. patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.
expanded access protocol of zulresso™ (brexanolone) injection for adult patients with postpartum depression

Conditions: Postpartum Depression

Summary: this is an expanded access program intended to provide access to zulresso™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial availability. requests for access must be made by a healthcare provider for a specific patient based on a determination with patient that the benefits of treatment outweigh the risks and an assessment of eligibility based on program criteria. sites with eligible patients must apply and meet requirements for participation in the expanded access program.


Eligibility criteria:
inclusion criteria: 1. subject has signed an informed consent form prior to any study-specific procedures being performed 2. subject is an ambulatory female at least 18 years of age 3. subject agrees to adhere to the study requirements 4. subject agrees not to be the primary caregiver of any dependents during the infusion 5. subject must have a negative pregnancy test on day 1 prior to the start of the zulresso infusion 6. subject has a current diagnosis of ppd, as assessed by the investigator exclusion criteria: 1. subject has end stage renal disease 2. subject has a known allergy to progesterone or allopregnanolone

Keywords: expanded access
a study of tasisulam in treating participants with malignant melanoma

Conditions: Metastatic Melanoma

Summary: the primary purpose of this study is to determine the objective response rate (complete and partial response) for participants who receive tasisulam after one prior systemic treatment for unresectable or metastatic melanoma.

participants will receive a 2-hour intravenous infusion of study drug (tasisulam) once every 28 days. radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. participants will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Eligibility criteria:
inclusion criteria: * diagnosis of malignant melanoma that is unresectable or metastatic (stage iii or iv) * have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. an immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counted as a prior treatment regimen for determining study eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer drug. * have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days exclusion criteria: * serious pre-existing medical conditions * have received two or more previous treatment regimens for unresectable or metastatic melanoma * have a second primary cancer (unless disease-free to more than 2 years) * active treatment with warfarin (coumadin) * primary ocular or mucosal melanoma
radiosurgery before surgery for the treatment of brain metastases

Conditions: Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm

Summary: this early phase i trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). radiation may stimulate an anti-tumor immune response. giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.

primary objective: i. to determine the safety of pre-operative stereotactic radiosurgery (srs) followed by surgery for brain metastasis. secondary objectives: i. to evaluate the immune niche in brain metastasis following srs in the presence of low or high dose dexamethasone. ii. to evaluate the impact of pre-operative srs on survival outcomes. outline: patients are assigned to 1 of 2 arms. arm a: patients undergo srs to the brain metastasis for 1-3 fractions over 1-5 days. patients also receive low dose dexamethasone orally (po) or intravenously (iv) for 2-21 days until the day of surgical resection. patients then undergo surgical resection. arm b: patients undergo srs to the brain metastasis for 1-3 fractions over 1-5 days. patients also receive high dose dexamethasone po or iv for 2-21 days until the day of surgical resection. patients then undergo surgical resection. after completion of study intervention, patients are followed up for 120 days, and then every 12 weeks thereafter.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * prior or suspected diagnosis of malignancy * brain metastases visible on contrasted magnetic resonance imaging (mri) brain * eastern cooperative oncology group (ecog) performance status =\ = 60%) * life expectancy \> 12 weeks as determined by the investigator * patients must have adequate organ function as determined by neurosurgery to undergo surgery * willingness and ability of the subject to comply with scheduled visits, study procedures, and study restrictions * evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation * patient must have a negative pregnancy test, be actively taking oral contraceptives or have undergone a hysterectomy exclusion criteria: * patients on any immunosuppressive medication other than dexamethasone * patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * human immunodeficiency virus (hiv)-positive * pregnant or nursing women are excluded * prior whole brain radiotherapy or srs to the same site planned for surgery
aural rehabilitation for cochlear implant users via telerehab technology

Conditions: Hearing Loss; Deafness

Summary: this study evaluates the benefits of short-term training via telehealth for post-lingually deafened adult cochlear implant users. half the participants will receive aural rehabilitation and the other half cognitive training. the hypothesis is that short-term aural rehabilitation via telerehab technology will improve outcomes for post-lingually deafened cochlear implant users

aural rehabilitation training (ar) has been demonstrated to improve outcomes for adult cochlear implant users. there are both financial and non-financial barriers to ar service delivery including accessibility (mobility, distance and transportation problems), accommodation (time off work impossible, caring for family) and availability (limited providers in rural areas, financial constraints, and lack of transportation. in this study the investigators will measure the impact of telerehab delivery on optimizing speech recognition, communication function, goals, social participation and hearing handicap. twenty-four participants will be randomly assigned to one of two treatment groups: aural rehabilitation (ar) and cognitive training (ct). participants will complete six 90-minute treatment sessions in their home or office via a telerehab platform. participants will come to a center for three 90-minute assessment sessions: pre-treatment, 1 week, and 2 months post-treatment.

Eligibility criteria:
inclusion criteria: * speech tracking rate of at least 20 words per minute * sentence recognition scores (caspersent) between 10% and 85% * passing score on cognitive screener (callahan et al., 2002) exclusion criteria: * less than 18 years of age * pre-lingually deafened * prior aural rehabilitation with cochlear implant * greater than three years post-activation of ci

Keywords: adult post-lingual auditory training communication strategies speech tracking speech recognition quality of life
nutritional study in spanish pediatric population

Conditions: Child, Only; Metabolic Diseases; Child Development; Diet Habit; Healthy Diet; Feeding Behavior; Health Behavior; Sedentary Lifestyle; Food Habits; Nutritional Status; Diet, Food and Nutrition

Summary: this study investigates the aspects related to the intake of food and nutrients, physical activity and sedentary behavior of spanish children from 1 to 9 years. furthermore, the investigators will know if the consumption of dairy products is associated with a better dietary pattern. hypothesis: the habitual consumption of dairy products as part of a regular diet is associated with a better dietary pattern and a higher global diet quality.

a prospective cross-sectional observational study in 1500 spanish children (1 to 9 years) in urban areas \>50,0000 inhabitants, distributed in eight regions (according to nielsen spanish areas) aiming to evaluate the food habits, dietary patterns, and nutrient intake, as well as physical activity behaviors.

Eligibility criteria:
inclusion criteria: * healthy participants between 1 and 9 years old without diseases carrying changes in the dietary patterns. * those following dietary advice such as for prevention of non-communicable chronic diseases exclusion criteria: * children with any disease that cause changes in the dietary pattern and with any dietary restriction. * children suffering a metabolic disease such as hyperthyroidism or hypothyroidism. * children diagnosed with allergy and/or food intolerance like dairy allergy, milk allergy, lactose intolerance or cows milk protein allergy. * children with any chronic disease that causes changes in the dietary pattern * children who live in an institution (colleges, nursing homes, hospitals, host institutions, etc ) * children with a transitory pathology (flu, gastroenteritis, chicken pox, etc) at the time of the fieldwork. * children following a therapeutic diet due to recent surgery or any other medical prescription. * children related to lactalis or madison mk employees. * children whose parents or caregivers did not provide a signed consent form for their participation or not completed any study phase.

Keywords: nutrition pediatric age physical activity dairy products dairy consumption sedentary habits diet quality children
multi-modal image fusion for precision prostate biopsy navigation

Conditions: Prostate Cancer

Summary: this study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and ai-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.

this study is a prospective randomized controlled clinical trial designed to investigate the efficacy of ai-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. the target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.

Eligibility criteria:
inclusion criteria: 1. age \> 18 2. psa \> 4 ng/ml and/or abnormal dre 3. sign the informed consent exclusion criteria: 1. have acute or chronic prostatitis 2. contraindications to prostate biopsy 3. contraindications to mri 4. other reasons that not suitable for this trial

Keywords: prostate cancer targeted biopsy
inhaled dornase alpha to reduce respiratory failure after severe trauma

Conditions: Multiple Trauma; Respiratory Distress Syndrome, Adult

Summary: severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. severe trauma and associated musculoskeletal injuries result in the acute release of damage-associated molecular patterns (damps) in plasma, many of which are made of nucleic acids. damps then bind leukocytes and trigger netosis (neutrophil extracellular traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ards). considering that many damps and all nets are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (dnase) could reduce damps and nets-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (icu). the primary objective is to demonstrate a reduction in the incidence of moderate to severe ards in severe trauma patients during the first seven icu days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive icu days and compared to equivalent provision of placebo (nacl 0,9%). the secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo: * an improvement in static lung compliance * a reduction in mechanical ventilation duration / an increase in ventilation-free icu days * a reduction in the length of icu stay * a reduction in the hospital length of stay * a reduction in multi-organ failure * a reduction in ventilator-associated pneumonia (vap) * a reduction in mortality at day 28


Eligibility criteria:
inclusion criteria: * adult (\>18) patient of either sex affiliated to the national health service * severe trauma patient (either blunt or penetrating), injury severity score \> 15 * under mechanical ventilation for an expected duration \> 48h * admitted in the icu * signed informed consent from the patient's relative * patient equipped with an indwelling arterial catheter exclusion criteria: * pregnancy or breast feeding * opposition from the patient or his/her relatives * protected major (guardianship) * contraindication to the use of dornase alfa * known intolerance to dornase alfa

Keywords: severe trauma acute respiratory distress syndrome damage-associated molecular patterns neutrophil extracellular traps dornase alfa