Kornimate/medical-research-clean huggingface dataset:
evaluating symptom management educational materials for patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: collecting feedback from patients with prostate cancer may help doctors develop better symptom management educational materials for patients. purpose: this clinical trial is evaluating symptom management educational materials for patients with prostate cancer.

objectives: * to collect formative evaluation data about a new educational intervention using focus groups of patients with prostate cancer. * to use the focus group data in the master's research paper of a baylor college of medicine physician-assistant student who is documenting the process of organizing and conducting the focus groups, enumerating areas where the new materials are deemed problematic, and identifying themes in the comments made by the focus group participants. outline: study participants are assigned to 1 of 3 focus groups according to educational level and ethnicity (i.e., lower educational-level african-american men primarily from the michael e. debakey veterans affairs medical center (medvamc); lower educational-level caucasian men from medvamc, baylor college of medicine (bcm), or the community; or higher educational-level caucasian men primarily from bcm or the community). participants review written patient educational-intervention materials on prostate cancer and provide feedback to the investigator on the content and acceptability of these materials during a 1½-2-hour focus group discussion. feedback data are used to revise the intervention materials so that they are appropriate to the target population.

Eligibility criteria:
disease characteristics: * biopsy-proven prostate cancer * localized disease that has been previously treated * selected for participation from 1 of the following: * convenience sample of men from the baylor college of medicine (bcm) urology clinics at scurlock tower (including the urology clinic at medvamc) and local prostate cancer-support groups * prostate cancer survivors who participated in the us too father's day walk/run or the gay pride celebration patient characteristics: * able to speak and read in english * willing to review the written patient educational materials and discuss them in a group setting prior concurrent therapy: * see disease characteristics

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer
alk21-014: efficacy and safety of medisorb® naltrexone (vivitrol®) after enforced abstinence

Conditions: Alcohol Dependence

Summary: vivitrol is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with vivitrol. this phase 3b trial was designed to evaluate the efficacy and safety of vivitrol versus placebo. injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

the study consisted of 2 parts, part a and part b. part a was a double-blind, placebo-controlled assessment of safety and efficacy of vivitrol versus placebo for 3 months. part b was an open-label extension to assess longer-term safety, durability of effect, and health economics of vivitrol when administered for up to 9 additional months.

Eligibility criteria:
primary inclusion criteria: * current diagnosis of alcohol dependence, meeting at least 5 of dsm-iv criteria * expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization * must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to first dose * negative urine toxicological screen for opioids on the day of randomization * women of childbearing potential must agree to use an approved method of contraception for the study duration primary exclusion criteria: * pregnancy or lactation * evidence of hepatic failure including: ascites, bilirubin \>10% above upper limit of normal and/or esophageal variceal disease * current dependence (within the past year) to benzodiazepines, opioids or cocaine by dsm-iv criteria * use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period * use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening * known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or plg * parole, probation, or pending legal proceedings having the potential for incarceration during the study period

Keywords: addiction alcoholism inpatient detoxification
continuous signs monitoring in covid-19 patients

Conditions: COVID-19

Summary: this is a pilot study to assess whether artificial intelligence (ai) combined with continuous vital signs monitoring from wearable sensors can predict clinically relevant outcomes in patients with suspected or confirmed covid-19 infection on general medical wards.

adult patients on general medical wards with covid-19 infection considered to be at high risk of deterioration will be asked to wear vital signs sensors for the duration of their hospital stay. these sensors are an established method of recording patient vital signs and are ce marked. patients enrolled in the study will continue to receive routine medical care as directed by their treating team. all data recorded from the wearable sensors in this study will be analysed in conjunction with routine data collected during the patient's treatment. several models will be created using deep learning ai techniques with the aim of reliably predicting several important clinical outcomes. the study will identify whether continuous monitoring alone can improve identification of deteriorating patients compared to traditional vital signs and if the addition of ai technology / algorithms can provide even earlier identification.

Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: 1. adult (aged 16 years or older), hospital inpatients 2. suspected or confirmed covid-19 infection (nasopharyngeal swab sent or planned): 1. positive nasopharyngeal swab during this admission or 2. nasopharyngeal swab pending during this admission and the treating team suspect covid-19 or 3. negative nasopharyngeal swab during this admission but the treating team continue to suspect covid-19 or 4. positive nasopharyngeal swab in the last 7 days 3. emergency admission to hospital within the last 72 hours and/or a positive nasopharyngeal test within the last 72 hours taken from a patient who was already an inpatient at the time the swab was taken. 4. symptoms consistent with covid-19 infection at the time of admission or when swab taken: cough, shortness of breath, alteration to sense of taste or smell, fevers or other symptoms in keeping with covid-19 in the opinion of the study team. 5. for full active treatment (including escalation to critical care) 6. the patient is at risk of deterioration (as evidenced by a requirement for supplementary oxygen) exclusion criteria: participants are excluded from the study if any of the following criteria apply: 1. patients unable to give informed consent. 2. patients with a life expectancy of \<24hours. 3. known allergy or history of contact dermatitis to medical adhesives. 4. patients with pacemakers, implantable defibrillators or neurostimulators. 5. patients with an arterio-venous fistula in either arm.
evaluation of efficacy and safety of levocetirizine to subjects with perennial allergic rhinitis to house dust mites

Conditions: Rhinitis; Allergic; Perennial

Summary: evaluation of efficacy and safety of levocetirizine to subjects with perennial allergic rhinitis to house dust mites


Eligibility criteria:
inclusion criteria: * male or female ≥ 12 years * suffering from a perennial allergic rhinitis to house dust mites for at least 2 years * positive skin test or positive radio-allergo-sorbent-test for house dust mites * the mean of the t4ss evaluated in the evening over the last 24 hours of the selection period was ≥ 5 exclusion criteria: * seasonal allergic rhinitis likely to change significantly the symptoms of the subject * an ear, nose or throat (ent) infection during the two weeks preceding initial visit * asthma requiring corticosteroid treatment * atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids * associated ent disease

Keywords: levocetirizine dihydrochloride xyzal tablets
respiratory infection monitoring

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential respiratory infections.

the advanced, bio-integrated wireless sensor (adam) that provides a comprehensive assessment of cardiopulmonary health. the technology employs advanced low-power operation, in-sensor analytics, and cloud integration. the sensor's novel soft mechanics allows for comfortable placement on the suprasternal notch, a location of unique anatomical importance, to collect both core vitals (heart rate, respiratory rate, temperature, and physical activity including sleep quality) and novel respiratory digital biomarkers (cough count, swallowing, throat clearing and respiratory effort). the investigators will deploy this system in a cohort of high-risk patients for respiratory infection in a home setting to predict for respiratory infections prior to clinical deterioration. the investigators aim to capture data on 122 study subjects over the course of 52 weeks of continuous wear or the investigator's device to thoroughly characterize physiological data and diagnosis of respiratory infections. data from standard of care appointments, diagnostic testing or imaging, or treatment will be collected from the patient medical record to validate device data.

Eligibility criteria:
inclusion criteria: * ≥18 years old * outpatient at start of the study * established clinical history of copd * previous hospital or icu admission for pneumonia or copd * active corticosteroid prescription * willingness to participate in the study (long term continuous wear of the device) * ability to apply and remove devices and use a mobile application exclusion criteria: * mental or neurodegenerative disease * including a current diagnosis of asthma, respiratory disorders (e.g. active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases); pneumonia or other rtis not resolved ≤14 days or ≤7 days, respectively, prior to screening * skin condition or wound on suprasternal notch.
efficacy of compassion focused therapy in group for posttraumatic stress disorder

Conditions: PTSD

Summary: the purpose of this study is to determine the efficacy of a 8-week program of compassion focused therapy in group comparing to supportive cognitive behavioral therapy in group for patients with posttraumatic stress disorder.

this study will be a randomized clinical trial with two parallel groups, with two models of treatment: group 1 - control group - will receive cbt supportive group (cbt-sg) and group 2 - experimental group - will receive compassion focused therapy (cft-g). will be attended in total, the maximum of 80 patients, with 40 patients in each arm (cbt-sg versus cft-g). both groups will be formed by at least eight patients and a maximum of twelve patients who receive eight weekly sessions with an hour and a half each session, and the total duration of treatment will be eight weeks. the groups will be closed, that is, after the start will not be permitted to input any more participants. the experimental group (cft-g) will be structured and the control group (cbt-sg) will be unstructured, and free format. all patients will be assessed through self-report scales, within three distinct phases: assessment i - initial (before therapy); assessment ii - final (after therapy); assessment iii - follow-up (after 3 months of therapy ending). all groups will be led by a principal therapist and co-therapist. all sessions will be recorded for later evaluation of the researcher responsible for the research.

Eligibility criteria:
inclusion criteria: * clinical administered ptsd scale 5 monthly version criteria a and \>30 points exclusion criteria: * suicidal patients and/or severe automutilation behavior and/or psychotic symptoms and/or lack of event memory.

Keywords: ptsd cbt cft compassion shame guilty self-criticism
evidence based mental wellness programming online for adults across chronic physical conditions

Conditions: Primary Biliary Cholangitis; Heart Failure; Digestive Diseases; Women Who Have Experienced a Cardiac Event; Cirrhosis, Liver; Post-Transplant; Cancer; Chronic Kidney Diseases; Other Chronic Physical Condition

Summary: chronic physical conditions are deﬁned as conditions that require ongoing management and treatment over extended periods of time. chronic physical conditions are not only leading causes of death and disability in north america but they are commonly associated with mental distress and reduced quality of life. online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. building upon a previously developed online wellness program for inﬂammatory bowel disease (ibd) and primary biliary cholangitis (pbc), the research team has developed a mind-body wellness program for adults ≥18 years of age living with different chronic conditions (e.g., cirrhosis, pbc, heart failure). the 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. in a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (hads). at the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage. after the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. the researchers will also send surveys to the participants eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.


Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * identified diagnosis of one of nine chronic conditions (heart failure, pbc, digestive disease, cirrhosis, cancer survivor, post-transplant, women who have experienced a cardiac event, chronic kidney disease), or another general category for physical chronic conditions not captured by these nine * english language proficiency to complete questionnaires and read the educational material * access to the internet and a computer or smart device at home exclusion criteria: * receiving compassionate care * inability to provide informed written consent * severe psychiatric disorders (presence of uncontrolled schizophrenia, post-traumatic stress disorder (ptsd), and/or bipolar disorder unless approved to participate by their physician/psychologist; suicidality nearly every day) * no access to the internet

Keywords: mind body wellness depression anxiety quality of life wellbeing yoga meditation psychology
acupuncture technique for restoring consciousness on post-stroke dysphagia

Conditions: Dysphagia

Summary: this is a randomized controlled study, including post-stroke dysphagic patients. the participants were divided randomly into the experimental group and the control group. both two groups were given routine treatment and swallowing rehabilitation training. moreover, the experimental group was given acupuncture technique for restoring consciousness. swallowing function will be compared before and after treatment.

this is a randomized controlled study, including post-stroke dysphagic patients. the participants were divided randomly into the experimental group and the control group. both two groups were given routine treatment and swallowing rehabilitation training. moreover, the experimental group was given acupuncture technique for restoring consciousness. swallowing function will be compared before and after treatment. specifically, our main focus is on neiguan, renzhong and sanyinjiao.

Eligibility criteria:
inclusion criteria: * age \>18 years. * meeting the diagnostic criteria for stroke. * diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. * water swallow test\> level 3. * stable vital signs, conscious, able to cooperate with assessment and treatment. exclusion criteria: * dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. * history of mental diseases or use of antipsychotics. * complicated with cognitive impairment or consciousness dysfunction. * simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
outpatient treatment of covid-19 in patients with risk factor for poor outcome

Conditions: COVID

Summary: covid-19 is a respiratory disease due to a novel coronavirus (sars-cov-2) that causes substantial morbidity and mortality. to date, no treatment has been proved to be effective in covid-19. elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, icu admission and death. the efficacy of an early outpatient treatment could be suggested but need to be confirmed. this confirmation is mandatory to improve prognosis of covid-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.

the investigators make the hypothesis that an early outpatient treatment of covid among patient with respiratory symptoms and risk factors for poor outcome can improve the prognosis of these patient and decrease the need for hospital admission. our study is an open label randomized clinical trial comparing 4 arms of treatment: standards of care (soc) alone versus soc + azithromycine versus soc + hydroxychloroquine vs soc + lopinavir/ritonavir. our involved population is patients more than 50 years of age with comorbidity or patients more than 70 years of age. our primary objective is to evaluate the efficacy of early outpatient treatment compared to standard of care in patients covid-19 with risk factors for poor outcome. the criteria is hospital admission at day 20 and the hospital admission rate will be compared between groups by a chi² test or a fisher's exact test.

Eligibility criteria:
inclusion criteria: 1. either patients over 50 years of age with at least one comorbidity (hypertension, diabetes, obesity, cancer, chronic renal disease, immunodeficiency) or patients over 70 years of age with or without comorbidity 2. laboratory (pcr-) proved infection by covid-19 or radiological sign highly suggestive of covid-19 3. respiratory symptoms (cough, chest discomfort, dyspnea) 4. affiliation to the social security network 5. able to understand and sign a written informed consent form exclusion criteria: 1. need for hospitalization according to updated french guidelines (ministère de la santé_04/04/2020) 2. patient in long-term care facility 3. patient without concern confirmation of covid-19 by laboratory (pcr swab) test or chest ct 4. known hypersensitivity or contra-indication to the 3 experimental treatments (azithromycin, hydroxychloroquine, lopinavir/ritonavir). 5. any reason making follow up of the patient impossible during the study period.

Keywords: covid outpatient ambulatory prognosis
regional anesthesia in total hip and knee arthroplasty

Conditions: Knee Osteoarthritis; Hip Osteoarthritis

Summary: the purpose of this study is to test whether the use of ropivacaine and mepivacaine are better in terms of effectiveness, cost, and safety than bupivacaine as regional anesthetics in elective hip or knee replacement surgery.

advances in pain management, regional anesthesia, and focused rehabilitation have increased the popularity of outpatient total hip and knee arthroplasty in a select group of eligible patients. however, one of the main impediments to same-day discharge is the prolonged motor block post-spinal anesthesia, as patients are routinely kept in the post-anesthesia care unit (pacu) until they demonstrate that the spinal anesthesia has worn off. at the ottawa hospital, the standard treatment for people receiving anesthesia during a total arthroplasty is the use of the anaesthetic, bupivacaine. mepivacaine and ropivacaine are alternative anaesthetics that are also in use at the ottawa hospital. they are growing in popularity as anaesthetics because they and allow quicker recovery time when compared to bupivacaine. bupivacaine results in a long-lasting sensory-motor block, meaning that in the area that the local anesthesia was used, there is no sensation and limited movement for long periods of time. during hip or knee replacement surgery, you may want to have no sensation and the inability to move your lower limbs. however, it is not ideal for after surgery where weakness in the legs puts a person at increased risk for falls. therefore, hospitalization after surgery typically lasts for a longer duration. mepivacaine and ropivacaine have a shorter motor block duration, allowing for a potentially earlier hospital discharge.

Eligibility criteria:
inclusion criteria: * patients undergoing total hip or knee replacement exclusion criteria: * study refusal * inability to provide consent * contra-indications to spinal anesthesia (refusal, infection, anti-coagulation, bleeding diathesis) * bilateral surgery * revision surgery * pre-exiting chronic pain or opioid consumption ≥ 30mg oxycodone or equivalent * pregnancy * not receiving preoperative adductor canal block for any reason * contra-indication to multimodal analgesia (acetaminophen or nsaids) * obstructive sleep apnea requiring extended pacu stay * history of severe postoperative nausea and vomiting
partial breast irradiation for low-risk ductal carcinoma in situ after breast-conserving surgery

Conditions: Breast Cancer

Summary: this study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk dcis after breast-conserving surgery.

randomized clinical trials have demonstrated that the recurrence of dcis is low and most of the recurrence occurs around the tumor bed. besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. however, whether or not partial breast irradiation is safety in dcis is still unknown. the purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk dcis after breast-conserving surgery.

Eligibility criteria:
inclusion criteria: * female * 18\~65 years old * pathologically confirmed dcis, low- or intermediate- grade dcis: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade dcis: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3) * treated with breast conserving surgery * tumor bed is labeled with titanium clips * no malignancy history * ecog score 0\~1 * written informed consent exclusion criteria: * dcis of both breast * invasive breast cancer * multicentric disease * patients underwent mastectomy * previous radiation therapy of breast * medical contraindication for radiotherapy * pregnant or nursing * suspicious calcification after surgery

Keywords: breast cancer partial breast irradiation dcis