Kornimate/medical-research-clean huggingface dataset:
nonmyeloablative stem cell transplantation with cd8-depleted or unmanipulated peripheral blood stem cells (pbsc)

Conditions: Hematologic Malignancies

Summary: prospective randomized study of allogeneic minitransplantation from hla-identical family or unrelated donors comparing unmanipulated or cd8-depleted pbsc. the conditioning regimen will be 2 gy tbi alone (related donor with low-risk of transplant rejection) or 2 gy tbi and 3 x 30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). patients will receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. the rationale for using pbsc instead of marrow transplant is to avoid general anesthesia of the donor and to minimize the risk of rejection. the rationale for cd8+ depletion is to diminish the risk of gvhd after pbsc transplantation or dli.


Eligibility criteria:
1. patients 1.1. diseases malignant diseases confirmed histologically and not rapidly progressing: * hematologic malignancies * aml; * all; * cml and other myeloproliferative disorders; * mds; * multiple myeloma; * cll; * non-hodgkin's lymphoma; * hodgkin's disease. * non-hematologic malignancies * renal cell carcinoma (metastatic). 1.2. inclusion criteria * male or female; female patients must use a reliable contraception method; * age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor); * hiv negative; * no terminal organ failure; * no uncontrolled infection, arrhythmia or hypertension; * family donor (hla-identical) or unrelated donor (matched for a-b by low resolution typing and for drb1-dqb1 by high resolution typing); * no previous radiation therapy precluding the use of 2 gy tbi * informed consent given by patient or his/her guardian if of minor age. 1.3. clinical situations * theoretical disease indication for a standard allo-transplant, but not feasible because: * age \> 55 yrs; * unacceptable end organ performance; * patient's refusal. * indication for a standard auto-transplant: * perform mini-allotransplantation 2-6 months after standard autotransplant. * not an indication for intensification but a potential candidate for cellular immunotherapy. 2. donors 2.1. inclusion criteria * related to the recipient (sibling, parent or child) or unrelated; * male or female; * weight \> 15 kg (because of leukapheresis); * hiv negative; * no major contraindication for allogeneic pbsc donation by generally accepted criteria; * informed consent given by donor or his/her guardian if of minor age. 2.2. exclusion criteria * any condition not fulfilling inclusion criteria; * unable to undergo leukapheresis because of poor vein access or other reasons.

Keywords: hematopoietic cell transplantation allogeneic nonmyeloablative cd8-depletion pbsc gvhd hematological malignancies and renal cell carcinoma
an evaluation of the adrenal suppression potential and pk of cb-03-01 cream in pediatric patients with acne vulgaris

Conditions: Acne Vulgaris

Summary: this study is designed to determine the hypothalamic-pituitary-adrenal (hpa) axis suppression potential and pharmacokinetic (pk) properties of cb-03-01 cream, 1%, applied every twelve hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris. adrenal suppression effects and systemic safety are an important safety concern. the current study is designed to investigate these potential concerns under maximal use conditions.


Eligibility criteria:
inclusion criteria: * patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. the parent or legal guardian must provide written informed consent for the patient. * patient has moderate to severe facial acne vulgaris as determined by the investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back). * females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (upt) at study start. * patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start. * patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits. exclusion criteria: * patient is pregnant, lactating, or is planning to become pregnant during the study. * patient has a body mass index (bmi) for age percentile \> 95%. * patient has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy. * patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start. * patient is currently enrolled in an investigational drug or device study. * patient has any condition which, in the investigator's opinion, would make it unsafe for the patient to participate in this research study. * patient has known allergy or sensitivity to cb-03-01 or any of its ingredients * patient has participated in a previous cb-03-01 study.

Keywords: acne cortexolone anti-androgen
impact of mental health and cognitive disorders on quality of life in severe covid-19 survivors

Conditions: COVID-19 Post-Intensive Care Syndrome

Summary: the objective of this single-center retrospective observational study is to describe cognitive and psychological outcomes and their impact on quality of life after at least 3 months of intensive care unit (icu) discharge in severe covid-19 survivors.

background: the covid-19 pandemic has already affected more than 600 million people worldwide and resulted in at least 6 million deaths (https:coronavirus.jhu.edu/map.html). the pandemic has also resulted in a growing population of individuals recovering from acute sars-cov-2 infection. accumulating observational data suggest that these patients often experience a wide range of symptoms after recovery from acute illness. the dysfunctions ranging from motor, cognitive disability, anxiety, depression and post-traumatic stress disorder. however, there is still unknown data about the occurrence of mental health manifestations after a critical illness and their consequences in mid term quality of life. purpose: many patients with coronavirus disease 2019 (covid-19) required critical care. mid-term outcomes of the survivors need to be assessed. the objective of this single-center retrospective observational study is to describe their cognitive and psychological outcomes and their impact on quality of life afer at least 3 months following intensive care unit (icu)-discharge. objectives: our objective will be to evaluate the incidence of non-physical post-intensive care syndrome, such as symptoms of anxiety, depression, cognitive and post-traumatic stress disorder (ptsd) after hospital discharge in our severe covid-19 population, as well as determining their long-term consequences in quality of life (qol). methods: an observational retrospective study will be conducted, including all patients with severe covid-19 admitted to the intensive care unit of a private tertiary hospital from april 2020 to october 2021. patients were routinely assessed after 3 months of icu discharge in our multidisciplinary follow-up clinic. a trained research team routinely applied the montreal cognitive assessment scale (moca), hospital anxiety and depression scale (hads), pcl-c (post-traumatic stress disorder checklist: civilian version) and short form health survey 36 (sf-36), during the follow-up evaluation.

Eligibility criteria:
inclusion criteria: * all 18 years and older patients with severe covid-19, confirmed by real-time reverse transcriptase-polymerase chain reaction., admitted to a 15- bed intensive care unit of a tertiary hospital from april 2020 to october 2021. exclusion criteria: * still hospitalized or inpatient in rehabilitation facility * previous cognitive impairmant

Keywords: covid-19 critically ill patients cognitive disorders post-traumatic stress disorder anxiety depression post-intensive care syndrome
pulmonary veins circular ablation catheter evaluation for atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (pvi) in subjects with atrial fibrillation. currently, two technologies of irrigated ablation catheters are available for pvi. one of the two, the "conventional" catheter is widely used for atrial fibrillation (af) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming. the second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way. these two types of catheters have never been compared for atrial fibrillation. if one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct af ablation.


Eligibility criteria:
inclusion criteria: * subject with atrial fibrillation refractory to anti-arrhythmic drugs, with episodes lasting less than 7 days and eligible for atrial fibrillation ablation. * age superior or equal to 18 years old, both genders. * patient's oral agreement for study participation after reading information note. * patient affiliated or recipient of a social welfare regimen. exclusion criteria: * age inferior to 18 years old * pregnancy * unbalanced psychiatric disorders * contraindication to atrial fibrillation ablation by endocardial way. * redo-ablation * no patient's oral agreement for study participation
salpingectomy at cesarean delivery for ovarian cancer reduction (score)

Conditions: Ovarian Cancer

Summary: to compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.

all pregnant women receiving prenatal care within the uab health system, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat) will be approached about the study. patients will be randomized to receive either the standard tubal ligation practice at our institution (modified pomeroy procedure or parkland) or a complete salpingectomy. the objective of this trial is to evaluate if a complete salpingectomy can be performed safely and comparable to a standard postpartum tubal ligation.

Eligibility criteria:
inclusion criteria: * all pregnant women \> 25 years receiving prenatal care within the uab health system, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat) * informed consent obtained exclusion criteria: * inability to obtain informed consent * fetal death or anomalies * preterm delivery \< 36 weeks gestation * immune-compromising disease * chronic steroid use * chronic prophylactic or therapeutic anti-coagulation * patients no followed in our regional health system * known brca mutation carrier status * age \< 25 years

Keywords: complete salpingectomy standard tubal ligation cesarean delivery feasibility safety partial salpingectomy
music for the mind study

Conditions: Mild Cognitive Impairment (MCI); Memory Disorders, Age Related; Memory Decline

Summary: the goal of this pilot clinical trial is to learn if older adults with mild cognitive impairment (mci) find two music programs equally acceptable. this pilot study will help researchers prepare for a future, large-scale clinical trial to learn if music training can slow cognitive decline and promote emotional well-being in those at risk for alzheimer's disease and related dementias. the main questions this pilot study aims to answer are: * do participants like the music programs? * do participants stay enrolled in the study? * do participants report perceived benefits of the programs for their emotional well-being or everyday memory? participants will: * participate in 12-weekly sessions of piano lessons or music lessons, with group and individual lessons alternating each week. * have home practice in between lessons, with a keyboard or other instruments provided. * keep a diary of their home practice and their mood before and after practice. * participate in interviews before and after the 12-week programs.


Eligibility criteria:
inclusion criteria: * aged ≥ 60 years * english-speaking * community-dwelling * medical diagnosis of mci by a physician or research diagnostic criteria for mci, defined by having montreal cognitive assessment (moca), with a cutoff of 20- 25 (further adjusted for racial/ethnic differences) * capable to consent as identified by the university of california, san diego brief assessment of capacity to consent (ubacc) * no severe psychiatric condition (e.g., bipolar disorder) exclusion criteria: * demonstrate musicality knowledge, as assessed by the musicality assessment developed by the study team * currently participating in a formal music activity (performance, classes, lessons, etc.) * major impairment in eyesight or hearing that precludes music reading, hearing, or engagement in the class * any difficulty using a keyboard (portable electric piano) due to pain, neuropathy, tremor, or upper finger/hand/limb injury

Keywords: music memory mood emotion well-being
effect of ibuprofen on postoperative opiate medication use and shoulder functional outcomes

Conditions: Rotator Cuff Tear Arthropathy

Summary: this will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, visual analog scale (vas) pain scores, shoulder range of motion (rom), and repair integrity.

patients will be randomized into two cohorts: 1. ibuprofen 400mg by mouth three times daily. patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the ucsf orthopaedic clinic for postoperative pain control. 2. placebo tablet by mouth three times daily. patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the ucsf orthopaedic clinic for postoperative pain control. patients will be screened for the study at the preoperative clinic vist and randomized on the day of surgery if they meet our inclusion criteria. postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years. pill counting will be done at the 1 week postoperative visit. vas pain scores will be assessed at every visit. functional shoulder outcomes including shoulder range of motion and the american shoulder and elbow society (ases) survey will be completed at these visits as well. the sf-12 health and disabilities of arm, shoulder, and hand (dash) survey will be completed at the preoperative visit and final follow-up visit only. we will assess rotator cuff repair integrity with ultrasound study at 1 year after surgery

Eligibility criteria:
inclusion criteria: * patients 18 years or older * patients that undergo arthroscopic rotator cuff repair only exclusion criteria: * patients less than 18 years of age, pregnant, are incarcerated. women who are not post-menopause are screened for pregnancy preoperatively with a urine test per our ucsf orthopaedic institute preoperative guidelines. * patients who are unable to and not willing to comply with the study protocol and follow-up visits * patients with a history of prior rotator cuff repair * patients with rotator cuff tears that require open repair * patients with an allergy to ibuprofen or anti-inflammatory medications * patients with a medical chart record or those who report a history of upper gastroenterology bleed or gastric ulcers * patients who are currently on warfarin, enoxaparin, heparin, or a factor xa inhibiting anti-coagulation medication * patients with a known past medical history of chronic kidney disease, history of kidney transplant, or egfr \< 60 ml/min per 1.73m2.
atogepant for prophylaxis of migraine in participants who failed previous oral prophylactic treatments.

Conditions: Episodic Migraine

Summary: this study will assess the safety, tolerability, and efficacy of atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.


Eligibility criteria:
inclusion criteria: * at least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ichd-3, 2018. * age of the participant at the time of migraine onset \< 50 years -history of 4 to 14 migraine days per month on average in the 3 months prior to visit 1 in the investigator's judgment * female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. * 4 to 14 migraine days in the 28-day baseline period per ediary * failed oral migraine prophylaxis medications from 2 to 4 medication classes exclusion criteria: * any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease * participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder * in the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine * has ≥ 15 headache days per month on average across the 3 months prior to visit 1 in the investigator's judgment * has ≥ 15 headache days in the 28-day baseline period per ediary * clinically significant cardiovascular or cerebrovascular disease * has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ichd-3, 2018 * has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ichd-3, 2018

Keywords: episodic migraine
esomeprazole for relief of upper gastrointestinal symptoms associated with continuous use of nsaids

Conditions: NSAIDs; Upper GI Symptoms

Summary: this study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of nsaids, including cox-2 selective nsaids, for a treatment period of 4 weeks for relief of upper gi symptoms.


Eligibility criteria:
inclusion criteria: * signed informed consent. * 18 years of age, or older. * capable of completing the diary card. * ability to complete the hrql questionnaires. * a clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily nsaid treatment for at least 7 months. daily nsaid treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include cox-2 selective nsaids, multiple nsaids, and high-dose aspirin (\>325 mg/day). * daily nsaid treatment dose and type: (must have been stable for at least 4 weeks prior to baseline endoscopy and; are expected to remain stable for the duration of the study. and; must be administered orally for the duration of the study. if more than one type of nsaid treatment is used, at least one type must be given orally.) * hp negative by ubt, serology or biopsy based test, at visit 1. exclusion criteria: * current, or history of, gastric or duodenal ulcer * current, or history of, esophageal, gastric or duodenal surgery. * history of gerd, not associated with nsaid use. * pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation. * pain, discomfort or burning in the upper abdomen not associated with the use of nsaids, including cox-2 selective nsaids, as judged by the investigator. * endoscopic barrett's esophagus(\>3 cm) or significant dysplastic changes in the esophagus.
pole walking intervention in retirement communities

Conditions: Fall Injury; Osteoporotic Fractures

Summary: this patient-oriented study aims to co-design and pilot a pole walking intervention with residents and staff of the participating independent living/retirement communities. the proposed pilot will answer the following principal question: is pole walking intervention feasible in the independent living/retirement communities? we will also assess if pole walking intervention will be associated with improved physical activity, function, mobility and quality of life. the final format of the intervention will be designed with resident- and staff-advisors. we anticipate that the pole walking sessions will be held outdoors, 2-3 times a week, for 20-60 min/session, over 12 weeks.

pole walking provides an attractive form of exercise therapy for older adults. it is a simple, well-tolerated and effective means to improve overall functional fitness in older adults. pole walking has improved upper and lower body muscle strength, cardiovascular endurance, and flexibility in community dwelling older adults. it has been positively associated with balance, functional mobility, muscle strength, and aerobic exercise capacity in older adults. pole walking is considered to offer a safe format for walking as poles provide support and help with balance and thus, contribute to confidence in being active. however, there has not yet been a study assessing the feasibility of pole walking intervention in older adults living in independent living/retirement communities. this study is a patient-oriented pilot intervention. our target is to include 50 independent living/retirement community's residents. pole walking exercises are based on ongoing, patient-oriented nordic walking intervention, tailored for participants and progressive in nature. training sessions will be led by trained peer/staff/student-instructors. training sessions will be held outdoors, 2-3 times a week, for 20-60 min/session, over 12 weeks.

Eligibility criteria:
inclusion criteria: * being an ambulatory resident in the independent living/retirement * pass the get active questionnaire. if the participant has heart conditions, angina during daily living, balance, and bone or joint problems, then a physician clearance form is required to be filled out and signed by the participant's family physician. exclusion criteria: * using assistive devices for mobility * being active (moderate-to-vigorous physical activity\>1h/week) * diagnosed with parkinson's disease

Keywords: patient oriented exercise intervention feasibility