Kornimate/medical-research-clean huggingface dataset:
comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation.

Conditions: Atrial Fibrillation

Summary: comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation

a side effect of some volatile anesthetics, such as isoflurane and desflurane, is enhanced automaticity, accounting for secondary atrial pacemakers. volatile anesthetics also have varying effects on the av node and his-pukinje system. these agents also prolong the qt interval and, for this reason, volatile anesthetics as a group have at times been avoided for atrial fibrillation ablation due to the fear that they may affect the efficacy of the ablation and increase recurrence. however, sevoflurane does not have the effects shown for other volatile anesthetics cardiac conduction. at this point there has not been a study comparing propofol, a non volatile anesthetic typically used in these cases, to sevoflurane, a volatile anesthetic, to determine if volatile anesthetics should be avoided during these procedures. this study will challenge the existing belief that sevoflurane increases the length of time to ablate atrial fibrillation and also decreases the efficacy of the ablation.

Eligibility criteria:
inclusion criteria: * have paroxysmal atrial fibrillation * undergoing their first ablation. exclusion criteria: * none
radiological and biological tumoural and peri-tumoural factors in neoadjuvant endocrine-treated breast cancers

Conditions: Breast Cancer

Summary: the purpose of this study is to monitor the change in cancer size in women with breast cancer on anti-hormone treatment using different types of assessment including ultrasound scan (us), shearwave elastography (swe) and magnetic resonance imaging (mri), and assess how this corresponds to the changes in the cancer biology.

background endocrine resistance is a significant problem in the management of breast cancer, with increasing evidence that the tumour microenvironment is influential on tumour growth and disease resistance. the neoadjuvant setting provides an excellent opportunity to observe tumour response to treatment in vivo, allowing development of methods for monitoring and predicting response to treatment. aims to assess potential radiological and biological tumoural and peri-tumoural biomarkers in patients before and during neoadjuvant endocrine treatment. our hypothesis is that there will be less response in women with abnormal peri-tumoural stroma, and that tumours with high monocarboxyl transporter (mct4) and loss of caveolin-1 in stroma are resistant to endocrine treatment. techniques and methodology patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, us including swe, and mri. core biopsies will be taken at diagnosis and at surgery from tumour and peri-tumoural stroma, and assessed for biomarkers lysyl oxidase (lox), fibronectin, collagen, proliferation, mct4 and caveolin-1. all data will be correlated to peri-tumoural abnormalities on mri and swe. impact on breast cancer research this study will provide information on the ability of swe and mri to predict and detect endocrine resistance, correlated with biological markers that are associated with endocrine resistance. identifying resistant tumours can prevent unnecessary treatment and reduce risks of recurrence as alternative or additional therapies can be utilised.

Eligibility criteria:
inclusion criteria: * postmenopausal women: defined as \>12 months amenorrhoea in absence of medical therapy known to induce this; or bilateral oophorectomy; or if last menses \ 35 iu/l and lh \>40 iu/l. * er positive (allred score \>3) invasive breast cancer * staging as t1-4, n0-2, m0 * patient agreed to neoadjuvant endocrine therapy as recommended by mdt * fresh tissue stored at time of diagnostic core biopsy * suitable for, and tolerant of mri scan * fit for surgical intervention at time of entry into study exclusion criteria: * premenopausal or unable to determine menopausal status * not fit for surgical intervention due to co-morbidities * contraindication for mri (including severe claustrophobia) * current use of hrt, or hrt use at time of diagnostic core biopsy

Keywords: neoadjuvant endocrine
series studies of bipolar disorder-valproate add-on memantine

Conditions: Bipolar Disorders

Summary: all participants should fulfill the following criteria: aged between 18 and 65 years old, and of domestic han descendants. participants will be randomly assigned to either the (1) pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on memantine) plus cognitive behavior group therapy (cbgt) group; (3) valproate add-on placebo plus cbgt group, or (4) valproate add-on placebo only group. a total of 240-320 individuals (60-80 participants per group) will be recruited for this study. for each cbgt group, 12-weekly sessions are scheduled according to patients' preference. the investigators will attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on neuro-protective drugs, pharmacotherapy with cbgt, mood stabilizer with cbgt, and the use of only traditional mood stabilizers in the treatment of bp ii. comparisons will be made for each type of treatment and possible mechanisms will be examined regarding the pharmacotherapy and cbgt for bipolar disorder patients.


Eligibility criteria:
inclusion criteria: 1. male or female patient aged \>=18 and \<= 65 years. 2. a diagnosis of bipolar ii disorder according to dsm-iv-tr criteria made by a specialist in psychiatry. 3. a total of hdrs score at least 18 or ymrs score at least 14 at screen. 4. signed informed consent by patient or legal representative. exclusion criteria: 1. women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study. 2. females who are pregnant or nursing. 3. patient has received memantine or other selective cyclo-oxygenase 2 (cox-2) inhibitors within 1 week prior to first dose of double-blind medication. 4. axis-i dsm-iv-tr diagnosis other than bipolar ii disorder. 5. current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation. 6. history of intolerance to valproate or memantine or other cox-2 inhibitors. 7. history of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by memantine 8. patient has received electroconvulsive therapy (ect) within 4 weeks prior to first dose of doubleblind medication. 9. inclusion in another bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study. 10. increase in total sgot, sgpt, bun and creatinine by more than 3x uln (upper limit of normal). 11. substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by dsm-iv criteria.
covid-19 infection at samusocial in paris: descriptive and serological survey

Conditions: SARS-COV2 Infection

Summary: study of covid-19 seroprevalence in precarious population living in shelters of samusocial de paris and in staff working in these centers during covid-19 epidemic.

after emergence of a new coronavirus (severe acute respiratory syndrome coronavirus 2, sars-cov2) responsible for a cluster of respiratory infection at wuhan, china, on january, 7th 2020, first cases were diagnosed in france in january 24th 2020. health care components of samusocial de paris (lits haltes soins santé (lhss)) were created in 2006. they provide medical care for homeless people and people in social distress not needing an hospitalization. sometimes there are 3 persons in a bedroom. in december 2018, a special shelter for isolated women or women in precarious situations opened. because of the living conditions in these centers and the difficulty for these populations to respect social distancing and hygiene recommendations. a first case of covid-19 was identified on march 8th 2020 in one of these healthcare centers. other cases were detected in the same center, then in another center on march 16th, then in the dormitory of the women shelter on march 30th. a recent study showed an important prevalence of sars-cov2 in residents of a homeless shelter in boston (36%), most of them were asymptomatic. seroprevalence studies are done in general population or in health care workers, but don't include vulnerable people. it seemed important to us to describe the epidemic in these centers and to study covid-19 seroprevalence in these particular populations.

Eligibility criteria:
inclusion criteria: * to have been hosted or working in one the three centers (lhss ridder-plaisance or saint michel or halte femmes) between march and may 2020 * to be aged 18 y or more * to be able to give an informed consent exclusion criteria: * people who refuse to participate * not being able to give an informed consent * person subject to a legal protection measure (safeguard of justice, curatorship or guardianship) * person who does not understand the information provided on how to carry out the research * obstacle to venous sampling

Keywords: seroprevalence sars-cov2 precarious
european active surveillance study (euras)

Conditions: Contraception

Summary: euras is a multi-national, controlled, prospective, post-marketing, non-intervention cohort study of new users of drospirenone/ethinylestradiol (drsp/ee), levonorgestrel/ethinylestradiol (lng/ee) and other oral contraceptives (ocs) under routine conditions of medical practice in seven european countries. baseline survey and semiannual, active follow-up are based on postal questionnaires, with validation of reported events by the women's treating physicians. a multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates. the objective of the study is the investigation of the incidence of rare serious adverse events associated with the use of new and established ocs, and specifically the incidence of thromboembolic events.

active surveillance using valid epidemiologic study designs is desirable for any new product, because adverse effects may occur that have not yet been identified in pre-marketing studies. the euras study investigates the safety of oral contraceptives with a large cohort of women attending offices of prescribing physicians. its primary objective will be to compare incidence rates of adverse events in users of so-called new ocs and users of other ocs. the study is conducted as a phase iv commitment to the european drug authorities. the combined cohort will include 50,000 to 60,000 women recruited by a selected set of physicians in six european countries. a total of more than 1,500,000 cycles are expected to be observed during the field work which will start early in 2001 and end early in 2006. the participating women will undergo a baseline survey using a self administered questionnaire to describe the baseline risk. every six months they will fill out a questionnaire in which they will record complaints and events during the use of the prescribed oc which will be validated. a multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates. based on experience obtained in previous oc studies complex sources of bias and confounding are expected. thus, multivariate methods such as cox regression will be used to adjust for confounding. regarding the impact of the results on public health, the main emphasis will be on the absolute risk estimates.

Eligibility criteria:
inclusion criteria: * women starting oc use or women switching ocs * women willing to participate in the active surveillance for several years exclusion criteria: * women who have contraindications for oc use

Keywords: venous thromboembolism drospirenone
a study of hypertonic saline for infants hospitalized with bronchiolitis

Conditions: Bronchiolitis

Summary: the purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).

bronchiolitis is a common admitting diagnosis for children less than 1 year of age. although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. there have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the united states and with adjunctive therapy. to date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the united states. the objective of this study is to conduct the first double-blind, randomized controlled trial in the united states of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.

Eligibility criteria:
inclusion criteria: * patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis. exclusion criteria: * status asthmaticus * chronic cardiopulmonary disease * trisomy 21 * immunodeficiency or transplant recipient * neuromuscular disease * admission directly to the intensive care unit * previous use of nebulized hypertonic saline less than 12 hours prior to presentation * previous enrollment in the study in the 72 hours prior to presentation

Keywords: hypertonic saline bronchiolitis infants wheezing nebulized bronchodilator
evaluating an under-mattress sleep monitor compared to a peripheral arterial tonometry device in the diagnosis of obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: a device has been developed which is placed under the mattress, thereby escaping contact with patient, which enables monitoring of sleep activity and has been shown in some studies to provide an estimate of the frequency of sleep disordered breathing. if the estimates of sleep disordered breathing from this new device are medically equivalent to current excepted home sleep apnea test devices within clinically important ranges of sleep disordered breathing, it may have several benefits. this study is designed to help answer several important clinical questions, namely, is the new device clinically equivalent to an established hsat device for patients who have at least moderately severe osa, and what is the effect of multiple nights on classification of severity and presence of osa.

the design will be a prospective test of two diagnostic testing strategies. the tests will take place in the same patient concurrently, so the patient's results from one test will serve as the comparator with the other test device. no randomization or blinding is needed. patients will be recruited from the mayo clinic center for sleep medicine (and another sleep center with enriched racial variety). consecutive patients in whom the clinician has ordered a watchpat™ will be potential candidates for an opportunity to participate in the study. patients will be made aware of the trial by invitation from members of the healthcare team. interested patients will be evaluated according to the inclusion and exclusion criteria.

Eligibility criteria:
inclusion criteria: clinician suspects of having osa due to presence of any: * stop-bang ≥ 3, * overnight oximetry with odi ≥ 5, * stop-bang≥ 2 and one or more of: disrupted sleep, cognitive complaints, paroxysmal or prior atrial-fibrillation (now in nsr), stroke, tia * has a smartphone capable of running both withings and itamar's app * stable sleeping quarters and schedule (i.e., no overnight shifts) for at least 7 days * domicile has capable wireless internet service exclusion criteria: * uses short-acting nitrates within 3 hours of the study * has a permanent pacemaker * atrial fibrillation or sustained supraventricular arrhythmias * known congestive heart failure class ≥ 1, or known lvef\< 45% * sustained hypoxemia or hypoventilation (results of ra daytime abg show sao2\ 45 mmhg, or overnight oximetry shows mean sao2\<90%.) * advanced pulmonary disease (copd gold stage ≥ ii , pulmonary fibrosis with gap ≥ 1 or significant dyspnea on exertion
evaluation of functional rehabilitation in patients undergoing physiotherapy after total hip arthroplasty

Conditions: Osteoarthritis, Hip

Summary: this study aims to objectively evaluate the implications of physiotherapeutic rehabilitation in the assistance protocol of total hip arthroplasty (tha), by assessing the motor performance and testing the quality of life of patients undergoing tha surgery, to improve rehabilitation strategies for this population.

the total hip arthroplasty (tha) is a surgical procedure which has been used for more than half a century in the treatment of hip joint diseases. the physiotherapy is an important component in the care of patients undergoing tha. in order to reduce the length of hospitalization after tha, to promote functional independence and to monitor clinical events during hospitalization and up to the 30th postoperative day, the hip surgery group (hsg) of the department of orthopedics and traumatology department of orthopedics and traumatology of hospital de clinicas de porto alegre (hcpa) has developed a global, multidisciplinary assistance protocol of the hsg with outpatient consultations and scheduled home visits for patients that have undergone tha at hcpa. the team which developed the assistance protocol of the hsg consists of orthopedic doctors and anesthesiologists, nurses and social workers. the insertion of the physiotherapist in the tha assistance protocol is of great importance owing to the professional skills of that professional in the areas of prevention and rehabilitation, working with the multidisciplinary team in functional evaluation and in physical therapy of patients that underwent tha. the monitoring of the physiotherapist is essential to establish a functional diagnosis, aiming pain relief, promoting the early functional rehabilitation, the reintegration of the patients in their daily activities and offering a better quality of life through reintegration into social life.

Eligibility criteria:
inclusion criteria: * patients with indication for tha. exclusion criteria: * patients who refuse to participate in this study. * patients who live outside the city of porto alegre, due to difficulties for visits and the protocol monitoring. * patients with femoral neck fracture, due to the impossibility of evaluation.

Keywords: hip osteoarthritis physiotherapy tha
a study to assess clbr001+abbv-461 in subjects with locally advanced or metastatic breast cancer

Conditions: Breast Cancer Metastatic; Locally Advanced Breast Cancer (LABC); Malignant Neoplasm of Breast; Triple Negative Breast Cancer (TNBC); Hormone Receptor-Positive Breast Cancer; HER2 + Breast Cancer

Summary: the goal of this clinical trial is to evaluate clbr001 and abbv-461 as a treatment for patients with locally advanced or metastatic breast cancer. the goals are to establish the safety and efficacy of the combination therapy while establishing the optimal biologic doses. patients will be administered a single infusion of clbr001 cells followed by cycles of abbv-461 with regular assessments of safety and disease response to treatment.

clbr001 + abbv-461 is novel switchable car-t cell combination therapy comprised of an autologous car-t product (clbr001, the switchable car-t cell \[scar-t\]) and abbv-461 (the "switch" biologic molecule). abbv-461 acts as an adapter molecule that controls the activity of the clbr001 car-t cell product.

Eligibility criteria:
inclusion criteria: * refractory or relapsed locally advanced or metastatic breast cancer * exhaused all standard of care therapy options * measurable disease at time of screening in accordance with recist v1.1 criteria * women or men age ≥18 years of age at time of consent * ecog performance status 0 or 1 * must provide a biopsy sample obtained during the screening period, following the end of the most recent prior line of therapy * adequate hematological, renal, and liver function exclusion criteria: * history of a clinically significant infection within 4 weeks prior to consent * active bacterial, viral, and/or fungal infection * prior allogeneic stem cell transplant * prior lentiviral- or retroviral-based therapy including car-t cell therapy * prior lymphodepleting or t-cell cytotoxic therapy within 3 months of enrollment * subjects receiving attenuated vaccines within 4 weeks of consent or need for live vaccine within 12 months of starting study therapy * history of significant cardiovascular conditions within the past 6 months * subjects with a prior history of or concurrent malignancy whose natural history or treatment has the potential to interfere with either the safety or efficacy assessment of the investigational regimen

Keywords: breast cancer car-t therapy metastatic breast cancer locally advanced breast cancer malignant neoplasm of breast triple negative breast cancer hormone receptor positive breast cancer
honest, open, proud for soldiers with mental illness

Conditions: Mental Illness

Summary: the purpose of the study is to evaluate the feasibility and efficacy of the group-based intervention "honest, open, proud" among soldiers with mental illness.

soldiers with mental illness typically face a two-fold problem. on the one hand, they have to cope with the symptoms of their mental illness; on the other hand, they often have to deal with stigma and discrimination. both due to fear of public stigma and due to self-stigma or shame, soldiers with mental illness may decide to keep their condition a secret or even to withdraw from other people altogether in order to minimize the risk of being labeled. secrecy can help on the short term to protect individuals from public stigma, but usually it has negative long-term consequences such as social isolation, distress and avoidance of help-seeking. disclosure, on the other hand, carries the risk to be discriminated by others, but can reduce the burden of secrecy, lead to support by others and reduce public stigma. in this study investigators aim to test the efficacy (see our outcomes above) of honest, open, proud run by soldiers with lived experience of mental illness.

Eligibility criteria:
inclusion criteria: * at least one self-reported current axis i or axis ii disorder according to dsm-5, which is not restricted to only substance-related disorder(s) * age 18 or above * ability to provide written informed consent * fluent in german (needed for self-report measures) * at least a moderate level of self-reported disclosure-related distress/difficulty (score 4 or higher on the screening item 'in general, how distressed or worried are you in terms of secrecy or disclosure of your mental illness to others?', rated from 1, not at all, to 7, very much) * current inpatient, day-clinic or outpatient treatment at the center for military mental health, berlin, germany * from april 2018 onwards we decided to also include non-military first responders (fire fighters or police officers) who are treated in the center for military mental health, berlin, germany exclusion criteria: * self-reported diagnosis of only a substance- or alcohol-related disorder, without non-substance related current psychiatric comorbidity. we will exclude people who only have a substance-/alcohol-related disorder because the disclosure of these disorders is not the topic of the hop intervention * intellectual disability * organic disorders

Keywords: mental illness disclosure stigma soldiers secrecy