Kornimate/medical-research-clean huggingface dataset:
positive affect regulation skills at northwestern university

Conditions: Anxiety; Depression; Social Isolation

Summary: the positive affect regulation skills (park) course is an online program containing a series of positive emotion skills for individuals experiencing stress and distress as a result of covid-19 and the return to "normal." the study specifically targets positive emotion, and offers an array of skills in a self-guided online delivery platform, making the program accessible and convenient in confusing and stressful times. our main aims are: aim 1: to explore the effects of park on anxiety, depression, feelings of social isolation, positive affect, and a sense of meaning and purpose. aim 2: to test whether age or gender moderate the effects of the program.

the goal of the proposed program, park, is to reduce feelings of anxiety, depression, and social isolation, as well as increase well-being and a sense of meaning and purpose through the practice of positive emotion skills via a self-guided online platform. we will compare baseline scores on promis measures of anxiety, depression, social isolation, meaning and purpose, and positive emotion to scores after completing the online course (approximately 8 weeks later), and again at 6 months post-baseline. research will be based in northwestern's feinberg school of medicine through the department of medical social sciences (mss), with all study procedures conducted online. eligibility screening, consent, and assessments will be conducted on redcap. for the positive skills course (including weekly lessons and daily skills practice) and daily emotion check-ins, consenting participants will receive access to the online park platform, hosted by brightoutcome. the skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * speaks and reads english * able to access the online platform through their phone, a public device (i.e., at the library) or at home. * lives in us exclusion criteria: * inability to communicate in english * lives outside the us * under 18 years of age
efficacy and safety of odevixibat in children with biliary atresia who have undergone a kasai hpe (bold)

Conditions: Biliary Atresia

Summary: double-blind, randomized, placebo-controlled, phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a kasai hepatoportoenterostomy.

up to 70 sites will be initiated for this study in north america, europe, middle east, and asia pacific.

Eligibility criteria:
inclusion criteria: * a male or female patient with a clinical diagnosis of ba * age at kasai hpe ≤90 days * eligible to start study treatment within 3 weeks post-kasai hpe key exclusion criteria: * patients with intractable ascites * ileal resection surgery * alt ≥10× upper limit of normal (uln) at screening * patients reliant only on total parenteral nutrition, or not able to take study medication orally, at randomization * acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis) * choledochal cystic disease * inr \>1.6 (the patient may be treated with vitamin k intravenously; sample may be redrawn and if inr is ≤1.6 at resampling the patient may be randomized) * any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or gi disease which, in the opinion of the investigator or medical monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements * weight \<3.5kg at randomization

Keywords: kasai
collection, evaluation and assessment of adverse drug reactions on the oncology ward

Conditions: Adverse Drug Reactions

Summary: the proposed cohort study collected within a 5-month observation period adverse drug reaction (adverse drug events - ade) in patients at the department of oncology at the university of zurich. ade have been recorded using prospective monitoring and assessed using standardized algorithms regarding causality and severity. data sources included information from the medical records, laboratory values and internal rounds. additional information has been collected using a standardized patient questionnaire. the primary endpoints of this study are to determine the frequency of ade, the comparison of the quality of data sources and collection methods for the detection of ade in regard to patient characteristics, size, number of medications, the category of ade, severity, causation, diagnosis, hospitalization, cause of hospitalization and medication cause. secondary endpoint is the assessment of the ade causality, severity and predictability.


Eligibility criteria:
inclusion criteria: * german-speaking patients, * at least 18 years old. exclusion criteria: * patients who could not give her consent, or have given, and any minor patient.

Keywords: adverse drug reactions in patients on the oncology ward
effects of antibodies to white blood cells on platelet transfusion patients

Conditions: Healthy; Transfusion Reactions

Summary: this study will determine if transfusion of platelets containing hla antibodies (certain antibodies to white blood cells) are more likely to cause transfusion reactions than transfusion of platelets that do not contain hla antibodies. people 18 years of age or older who donate platelets at the nih clinical center may be eligible for this study. an extra tube of blood (about one teaspoon) is obtained from participating donors at the time of their donation at the nih platelet center. the blood plasma in the extra tube is tested for hla antibodies and antibodies to certain white blood cells called granulocytes. the research sample is assigned a code number for identification and sent to the hla laboratory in the department of transfusion medicine.

leukocyte antibodies can cause febrile transfusion reactions, pulmonary reactions to granulocyte transfusions, and transfusion related acute lung injury (trali). despite the fact that the role of leukocyte antibodies in these reactions was first described almost 50 years ago, and that trali is now the leading cause of transfusion related fatalities, much remains uncertain concerning the role of hla antibodies in these reactions. the primary purpose of this study is to retrospectively and prospectively determine if the incidence and nature of transfusion reactions differs in clinical center (cc) patients that were transfused with platelet components from donors with hla antibodies and those without hla antibodies. in addition, this study will prospectively determine the incidence of hla antibodies in the nih department of transfusion medicine (dtm) platelet donor population. in this natural history study a 10-ml blood sample will be drawn from 600 platelet donors at the time that they are in the dtm donating platelets and it will be tested for hla antibodies in the dtm. the blood sample for hla antibody testing will be collected with other samples collected as part of the regular platelet donation process. reactions in platelet transfusion recipients will be assessed by reviewing cc and dtm patient records.

Eligibility criteria:
* inclusion criteria: 1. both male and female donors 2. any ethnic group 3. 18 years of age or older 4. must meet the criteria for donating platelets in the dtm exclusion criteria: 1. donors are not eligible to donate platelets in the dtm

Keywords: human leukocyte antigens (hla) transfusion reactions platelet donors
aromatherapy for blood and marrow transplant patients (ambient)

Conditions: Anxiety; Nausea; Vomiting

Summary: the study is comparing the difference between the use of elequil aromatabs versus standard of care practice treatments on blood marrow transplantation patients.

the primary objective is to examine whether there are differences in the level of anxiety and nausea between patients in the treatment and control groups. the secondary objective is to compare the number of as needed (prn) antiemetics and anxiolytics, as well as the duration of prolonged standardized antiemetic and anxiolytic regimen for the treatment and control cohorts. the sample size of 200 patients is anticipated to be enrolled over a period of 1 year. a total of 50 patients will be enrolled in each of the four groups the enrollment procedure will begin with a screening of patients who are admitted within 24 hours of admission for blood and marrow transplantation conditioning to evaluate if they meet the inclusion criteria. patients who meet inclusion criteria will be offered an opportunity to participate in the study. the patient will complete an informed consent form, then assessed to identify their predominant symptom:anxiety or nausea. based on the patients' primary symptom, they will be randomized into either control or treatment group for a total of four groups (nausea treatment, nausea control, anxiety treatment, and anxiety control). the study will be using a wei's urn algorithm for the randomization sequence. the randomization sequence and patient information will be stored in a protected sharepoint folder between the 8pe and 8pw nurses enrolled with the institutional review board as study staff. patients enrolled in the nausea control/treatment group will be required to complete a generalized anxiety disorder 7-item scale (gad-7) form to determine the baseline of anxiety.

Eligibility criteria:
inclusion criteria: * adult blood and marrow transplant patients admitted to 8 pavilion east blood and marrow transplant and 8 pavilion west blood and marrow transplant for autologous and allogeneic blood and marrow transplant conditioning (chemotherapy and/or radiation therapy) and transplant cell infusion * ages 22 and above. adults ages 18-21 are admitted under the pediatric service and are not admitted to 8pe and 8pw * patients with blood and marrow transplant conditioning induced nausea and vomiting- * patients expressing feeling of anxiety * english and spanish speaking only * patients enrolled in other research studies that allow them to participate exclusion criteria: * patients with known allergy to lavender * patient with known allergy to orange/peppermint * patients less than 22 years * patients with olfactory/sinus impairment * patients unable to give written informed consent * patients admitted for inpatient conditioning but receiving transplant cell infusion in the outpatient setting
long term follow up of the ltog cohort

Conditions: Lung Transplant Failure and Rejection

Summary: the purpose of the study is to follow participants who enrolled in the lung transplant outcomes group. clinical data, functional assessments, and surveys will be collected to determine long term graft function and functional status of lung transplant recipients.

this project will involve both retrospective and prospective data collection from participants enrolled in the ltog cohort studies. we will perform long-term chronic lung allograft dysfunction (clad) phenotyping of lung transplant recipients who participated in the ltog cohort studies utilizing data collected for routine clinical visits. surviving lung transplant recipients who participated in the ltog cohort studies will be recruited to enroll in the longitudinal portion of the project. the longitudinal component will include follow-up data collection at 6 month intervals while alive until study termination, study withdrawal, or no longer being seen for follow-up at the participating center. follow-up data collection will include clinical data collected by study coordinators by reviewing medical records, functional assessment through administration of the short physical performance battery (sppb), blood collection and surveys. data from this project will be linked to data and samples collected during the ltog cohort or ancillary studies.

Eligibility criteria:
inclusion criteria long-term phenotyping of clad * lung transplant recipients who have previously enrolled in the ltog cohort studies at one of the participating centers long-term functional status and well-being * lung transplant recipients who have previously enrolled in the ltog cohort studies at one of the participating centers * alive exclusion criteria long-term phenotyping of clad * lung transplant recipient not enrolled in ltog cohort research studies long-term functional status and well-being * lung transplant recipient not enrolled in the ltog cohort research studies * lung transplant recipient not receiving post-transplant follow-up care at a participating ltog center

Keywords: chronic lung allograft dysfunction functional status lung transplantation
lumaent and patient satisfaction

Conditions: Thyroid

Summary: patient satisfaction is an important metric currently used to rate quality of healthcare in hospitals. maximizing patient satisfaction scores is therefore significantly beneficial to any hospital establishment. recent studies have shown patient satisfaction depends on multiple factors, including patient involvement in treatment decision-making processes and patients' knowledge of treatment options. internal review of departmental patient satisfaction survey scores revealed deficits in the aforementioned areas of patient satisfaction, with the domains of "how well concerns were addressed", "explanation of tests and procedures" and "effort to include patients in decisions" having the lowest scores on patient satisfaction surveys. this highlights the gap in patient satisfaction that the otolaryngology department seeks to improve on, so as to maximize patient satisfaction, and in turn, the quality of healthcare provided. the aim of this study is to assess the improvement in patient satisfaction scores that can be obtained by incorporating luma ent™, a disease-specific multimedia patient education software, into the treatment decisions for thyroid disorders. luma ent™ is a leading patient education software that provides visual anatomic animations of disease processes, disease progression and treatment options to improve patients' knowledge. thyroid disorders have been chosen for study due to their high frequency of occurrence in the patient population and generalizability to a wide medical audience. the investigators will perform a single-blinded randomized-controlled study of patients visiting the physician practices of the department of otolaryngology for management of thyroid disorders. participants will be randomized into control and intervention groups. upon completion of the routine physician-patient clinical encounter, the intervention group will view a 5- minute luma ent™ video discussing their specific thyroid condition, its natural progression history, and treatment options. they will have an opportunity to ask the physician any further questions that arise from viewing the video. the control group will not view the luma ent video. patient satisfaction surveys will then be provided to both groups at the end of the visit as is routinely done and scores subsequently compared.


Eligibility criteria:
inclusion criteria: * participants will be patients scheduled to visit the bjh/wu department of otolaryngology clinic for management of thyroid disorders (ranging from benign to cancerous nodules or masses) that will involve surgical interventions of complete or partial thyroidectomies. * must be between the ages of 18 and 80 * may be male or female * must understand spoken or written english language * must be able to provide informed consent exclusion criteria: -patients who have already undergone any thyroid surgery will be excluded
noninvasive positive pressure ventilation in moderate acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: in order to identify the effect of noninvasive positive pressure ventilation (nppv) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ards) patients, the investigators conduct this clinical trial comparing nppv with invasive mechanical ventilation in more than twenty icus in china.


Eligibility criteria:
inclusion criteria: 1. acute onset 2. a clinical presentation of respiratory distress 3. arterial oxygen tension/inspired oxygen fraction (pao2/fio2) between 200 mmhg to 300 mmhg. the arterial oxygen tension will be measured in fifteen minutes after nppv (cpap 5 cmh2o) was used to the patients stably 4. presence of bilateral pulmonary infiltrate on chest radiograph 5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( pawp) \< 18 mmhg exclusion criteria: 1. age \> 70 years or \< 18 years 2. paco2 \> 50mmhg 3. glasgow coma scale (gcs)\< 11 4. upper airway/facial deformity or injury 5. pneumothorax or pneumomediastinum 6. unable to spontaneously clear secretions from their airway 7. respiratory arrest 8. severe ventricular arrhythmia or active myocardial ischemia 9. severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, sofa score \> 1) 10. severe chronic lung diseases(copd, asthma or ild, et al) 11. end-stage patients who are expected to survive less than six months 12. severe abdominal distension 13. refuse to receive nppv 14. unable to cooperate with nppv

Keywords: noninvasive positive pressure ventilation
a phase 2 study of the safety and efficacy of a tofimilast in adult patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with chronic obstructive pulmonary disease


Eligibility criteria:
inclusion criteria: * moderate-severe copd (gold 2003 definition) * smoking history of at least 10 pack-years exclusion criteria: * any significant co-morbid disease, particularly cardiovascular * use of any maintenance therapy except short acting bronchodilators
implantation of vaginal construct for patients with vaginal aplasia

Conditions: Congenital Mullerian Duct Anomaly

Summary: in this phase 1, single site, clinical trial, vulvar/vaginal smooth muscle cells (smc) and epithelial cells (epc) are isolated from autologous patient's biopsy

the cells are expanded in vitro and seeded on scaffold and matured - the final tissue engineered vagina (tev) is implanted into the native vaginal site

Eligibility criteria:
inclusion criteria: * diagnosed with congenital mullerian duct anomaly that includes absence or obliteration of all or part of the vagina, as confirmed on pelvic mri * females between the ages of 15 and 45 years * patients with stable medical comorbidities * patients that are willing to comply with all study instructions and are willing to return for study follow-up visits exclusion criteria: * patients with a history of surgery in the target area more recent than the last 6 months * patients with an active vaginal area infection or urinary infection as evidenced by clinical exam or culture result * patients with a history of keloid scarring * patients who are currently taking anti-platelet medications or blood thinners * patients with a history of clotting disorder * patients with autoimmune disease or immune disorder * patients requiring concomitant use of or treatment with immunosuppressive agents * patients with a history of systemic conditions, including but not limited to hiv, thrombocytopenia, uncontrolled diabetes and chronic liver disease (including hepatitis b or c), that the investigator believes may jeopardize the safety of the patient to participate in the study * patients with evidence or diagnosis of any primary coagulation disorder (including concomitant anticoagulation therapy at enrollment) * patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study * patients with neurological disorders (e.g., multiple sclerosis, parkinson's disease) * patients who are current tobacco users * patients with alcohol/drug abuse problems * patients with any systemic disease * patients with any psychiatric disorders * inability to participate in all necessary study activities due to physical or mental limitations. * any circumstance in which the investigator deems participation in the study is not in the subject's best interest * the following vital sign cut-off values, laboratory cut-off values and ecg reading will be monitored as the exclusion criteria in the biopsy visit and again before the implantation surgery bp systolic \>160 or \ 100 or\ 105bpm respiratory rate \ 20 temp \> 100.4 degrees fahrenheit liver enzymes \>2 times the upper limit of normal (uln) abnormal bilirubin unless subject has gilbert's glomerular filtration rate (egfr) \ 8% hb \<10 mg/dl platelet count \<100,000 o2 saturation \<95% * if a vital sign or lab value results in exclusion, the subject could be rescreened later

Keywords: vaginal abnormality
continuous data collection and analysis for stroke prevention using a wearable sensor

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ecg).

the purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ecg). these wristbands detect your pulse based on a technique called "photoplethysmography," (ppg). ppg is a common method in which an individual's pulse is detected based on a light signature interpreted by the wristband. most commercially available heart rate monitors use ppg to determine your heart rate, but the accuracy is variable.

Eligibility criteria:
inclusion criteria: 1. male or female 18 years of age or older with a primary diagnosis of atrial fibrillation 2. willing and able to provide informed consent and follow the study protocol 3. clinically indicated planned restoration of normal rhythm exclusion criteria: 1. unable to provide informed consent 2. unable to follow the study protocol 3. women who are pregnant 4. subjects with implantable devices (only if participating in phase 2-bodyguardian processes/testing)

Keywords: cardioversion bodyguardian amiigo wristband
profiling spike protein antibody response post covid-19 booster

Conditions: COVID-19 Booster; Spike Protein IgG Antibody

Summary: a descriptive study that will quantify the mean igg antibodies remaining in vaccinated healthy participants after their covid booster.

this is primarily a descriptive study that will quantify with 95% confidence intervals the mean igg antibodies remaining in vaccinated healthy participants three to nine months after their covid booster. at specified intervals during this period, a titer will be performed on blood drawn from participants to quantify the igg antibodies to the sars-cov-2 spike protein. this evaluation will not be performed in a lab with clia certification and this study will not be used to seek an eua from the fda. the fda and clia regulate diagnostic laboratory testing but do not regulate surveillance testing.

Eligibility criteria:
inclusion criteria: * adults at travis air force base who are active duty, dod beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mrna spike protein covid vaccine (moderna, pfizer, or johnson \& johnson) and booster. exclusion criteria: * unvaccinated, partially vaccinated, or unable to provide proof of covid vaccination * unwilling or medically unable to have an initial or follow up blood sample drawn * positive covid test after receiving covid booster * current history of a bleeding disorder, cancer, or are immunocompromised * received a covid vaccine booster seven or more months ago