Kornimate/medical-research-clean huggingface dataset:
buprenorphine induction and naloxone distribution program-combined with warm hand-off referral to continued treatment

Conditions: Opioid Abuse

Summary: this study is a collaboration between the university of utah and castleview hospital in price, utah. buprenorphine is a medication approved by the fda to treat opioid use disorder (oud). castleview hospital currently does not prescribe buprenorphine in the emergency department (ed) instead it refers patients to outside addiction treatment facilities. this is a service focused project which the university of utah will provide mentoring and education to castleview in implementing an in ed buprenorphine/naloxone distribution program along with referral to continued services. after the program has been implemented, the investigators will evaluate it using quantitative surveys of program participants and qualitative interviews of hospital staff and stakeholders.

among health care environments, ed often are the front lines of care for those with oud or who experience opioid overdose. the university of utah hospital ed has the bridge program which provides buprenorphine and naloxone with warm-hand off referral for continued treatment to people presenting with oud. in order to extend the services offered by the bridge program to rural hospitals, the investigators will be providing mentoring and education to castleview hospital in establishing a similar program. castleview hospital is the only acute care hospital that serves carbon and emery counties, which outside of the salt lake city metro area have the highest opioid overdose rates in the state of utah. this project will utilize both quantitative and qualitative measures to evaluate the impact of this program on patients, hospital staff, and community members.

Eligibility criteria:
inclusion criteria: for qualitative interviews with providers, administrators, stakeholders: * must be affiliated with castleview hospital as a provider, administrator or stakeholder. for the quantitative surveys: * must be a castleview hospital patient who receives the binder-tx model. exclusion criteria: for qualitative interviews with providers, administrators, stakeholders: * not familiar with the binder-tx model * no interaction with the binder-tx model for the quantitative surveys: * unable to speak and read english * subject is unable to provide contact information
effects of dexmedetomidine during radiofrequency ablation of abdominal tumours

Conditions: Cancer of Kidney and Renal Pelvis; Cancer of Liver

Summary: the purpose of he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours.

although radiofrequency ablation (rf) is accepted as the best therapeutic choice for patients with early stage hepatocellular carcinoma when liver transplantation or surgical resection are not suitable options, it is still performed only in a few hospitals and experience is so far limited (goldberg \& ahmed, 2002; shiina et al., 2005). in addition, rf ablation is emerging as a viable alternative to surgery for inoperable patients with limited hepatic metastatic disease, especially from colorectal cancer. although radiofrequency ablation has been accepted as a safe and effective treatment for liver and kidney tumours, there are few studies addressing periprocedural pain. thus, the optimal anaesthetic procedure is still to be determined. currently at our institution rf is performed as monitored sedation procedure using remifentanil infusion supplemented with midazolam boluses, when considered necessary. however, when using remifentanil and midazolam combination it is quite difficult to avoid too deep respiratory depression. dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. dexmedetomidine has a great deal of potential in this arena given its analgesic and anxiolytic properties while preserving respiratory drive (bergese sd et al., 2010). all patients will receive dexmedetomidine 0.4 µg/kg/hr infusion from the start of procedure. the infusion will be continued during the whole rf procedure. at the same time all patients will receive remifentanil infusion according to tci (target controlled infusion) protocol. plasma concentration target will be set from 0.5 ng/ml and, if necessary, will be increased to achieve a comfortable state of patient (ramsey sedation scale: 2-3).

Eligibility criteria:
inclusion criteria: * liver or/and kidney cancer for which radiofrequency ablation procedure is planned * signed informed consent form exclusion criteria: * patient refusal * pregnancy * known allergy to dexmedetomidine or remifentanil * atrioventricular block grade ii or iii or other significant cardiac conduction disturbance * stroke * low blood pressure not responding to treatment
neuromed- integrated health life platform and biobank

Conditions: Cardiovascular Diseases; Neuro-Degenerative Disease; Cancer; Pregnancy

Summary: this project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the neuromed group clinics, associated with a biobanks of biological fluids and human tissues and a biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.

there is a need for a change of vision in health care that could become a key innovation point for digital medicine in the future, a sort of copernican revolution: the starting point is no longer the disease, but the patient around whom pathologies and risk factors rotate, not as distinct and uniquely defined entities, but as communicating and interconnected possibilities that define their form only in relation to the individual, his genome, his personality, his habits of life and the environment in which he lives. from these interactions, a personalized, dynamic, integrated, and continuous diagnostic and therapeutic pathway is created that accompanies the person not only in the stage of the disease but also in the previous and subsequent phases, becoming a way of life oriented towards the health of the person rather than a way to cure a disease. an integrated health life platform enables you to develop an interactive healthcare health model among all actors who manage the health of the person, healthcare professionals in the area, and hospitals, caregivers, and community through the integration of remote monitoring of data with a virtual community. the platform is thought not as a pure aggregation of data, but as a digital hub centered on the patient, with his (clinical and personal) data, but also the environment in which he lives, his behaviors, accessibility to services and the relationships that come to them and from them. the platform aims to effectively integrate self management, personalization of the path, and co-production of health, demonstrating that these three key dimensions of care are mutually reinforcing.

Eligibility criteria:
inclusion criteria: * men and women * older than 18 years * cardiovascular disease * neurodegenerative disease * cancer * pregnancy exclusion criteria: * inability to understand and to want * refusal to sign the informed consent

Keywords: biobank chronic disease omics big data 4 p medicine
good rate of clinical response to cholinesterase inhibitors in alzheimer's disease after three months of treatment

Conditions: Late Onset Alzheimer

Summary: life expectancy in brazil has increased markedly over the last 30 years. hence, age-related disorders, such as alzheimer's disease (ad), warrant special attention due to their high prevalence in the elderly. pharmacologic treatment of ad is based on cholinesterase inhibitors (chei) and memantine, leading to modest clinical benefits both in the short and long-term. however, clinical response is heterogeneous and needs further investigation. objective: to investigate the rate of response to chei in ad after three months of treatment. methods: patients with mild or moderate dementia due to probable ad or to ad associated with cerebrovascular disease were included in the study.

the subjects were assessed at baseline and again after three months of chei treatment. subjects were submitted to the mini-mental state examination (mmse), mattis dementia rating scale, katz basic activities of daily living, pfeffer functional activities questionnaire, neuropsychiatric inventory and cornell scale for depression in dementia. good response was defined by a gain of ≥2 points on the mmse after three months of treatment in relation to baseline.

Eligibility criteria:
inclusion criteria: * patients fulfilling the national institute on aging and the alzheimer's association diagnostic criteria of probable ad dementia or the ninds-airen (national institute of neurological disorders and stroke and association internationale pour la recherché et l'enseignement en neurosciences) diagnostic criteria of ad with cerebrovascular disease (ad + cvd) * patients presenting mild or moderate dementia according to the clinical dementia rating (cdr), i.e., cdr 1 or 2, respectively exclusion criteria: * patients treated with chei or memantine before study entry * patients diagnosed with frontotemporal dementia, dementia with lewy bodies or vascular dementia, * patients with cdr 3 * illiterate patients * patients with different comorbidities, with signs of clinical decompensation

Keywords: alzheimer, mmse, response, colinesterase inhibitors (chei)
misoprostol for non-viable pregnancies

Conditions: Abortifacient Agents, Nonsteroidal; Abortion, Incomplete; Misoprostol; Pregnancy

Summary: the purpose of this study is to examine the effectiveness of misoprostol (cytotec; gd searle and co., chicago, il) for the management of non-viable first trimester pregnancies. specifically, misoprostol (15-s-15-methyl pge1) will be compared to a placebo with expectant management in who have documented non-viable gestations. we will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.

patients presenting to the ob/gyn clinic with a nonviable gestation, diagnosis documented by endovaginal ultrasound will be enrolled. ultrasonic findings will be verified by two of the resident staff from the obstetrics and gynecology department of madigan army medical center. patients consenting will be directed to the ob/gyn clinic for evaluation, exam, and counseling and to watch the video giving explanation of purpose of the study and the planned procedure, but also expected side effects and possible complications. patients will be randomized into two groups: study group receiving misoprostol per vagina and the control group receiving a placebo per vagina. subjects will be issued an envelope and go to the pharmacy to pick up their study medication, blinded to them and the provider. they will also be given motrin and phenergan to help alleviate undesired side effects. four 200 ug tablets of misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider. patients will return in 24 hours for re-examination. if no evidence of an intrauterine pregnancy remains, patients will be informed that their miscarriage was complete, given precautions and asked to make an appointment for follow-up in 4 weeks in addition to weekly visits to the lab for quantitative bhcg. all patients will be followed until the quantitative bhcg has fallen zero to ensure resolution of the pregnancy event. patients with evidence of a gestational sac will be given a second dose of misoprostol or a d\&c if they choose to withdraw from the study or a surgical intervention if it is deemed clinically indicated by the attending staff. again, subjects will be given appropriate counseling and precautions and asked to follow up in an additional 24 hours for re-evaluation. surveys will be given at each visit and follow up to evaluate patient satisfaction and also to query for unintended side effects and complications.

Eligibility criteria:
inclusion criteria: * pregnant patients with nonviable pregnancy document by ultrasound * gestation at or less than 13 weeks by ultrasound measurements * clinically stable as determined by provider * afebrile * hematocrit \> 30 * over 18 years of age exclusion criteria: * history of allergy to, or intolerance of, misoprostol * refusal to abstain from intercourse for 72 hours * significant vaginal bleeding (\> 2 pad/hr) * history of inflammatory bowel disease
keyhole limpet hemocyanin in chronic hepatitis c

Conditions: Chronic Hepatitis C; Liver Cirrhosis

Summary: in this study the investigators examine the safety and efficacy of keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. the investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.


Eligibility criteria:
inclusion criteria: * chronic hepatitis c infection * no previous therapy * at least one contraindication to interferon therapy * liver cirrhosis * age between 18-80 y * women of not childbearing age exclusion criteria: * hypersensitivity against keyhole-limpet hemocyanin * previous treatment against hepatitis c * autoimmune disorders * immunosuppression * hepatocellular carcinoma or other malignancies * coinfection with hepatitis b or hiv * pregnancy * cardiovascular event during the last 6 months (stroke or mci) * uncontrolled diabetes * renal insufficiency (gfr \< 50 ml/min) or chronic hemodialysis
doxorubicin and cyclophosphamide followed by paclitaxel, trastuzumab, and lapatinib in treating patients with her2/neu-overexpressed breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to study a new treatment for her-2/neu (+) breast cancer.


Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the breast * bilateral synchronous breast tumors allowed * any nodal status or tumor size allowed * no stage iv disease * her2/neu-positive disease * 3+ by ihc or fish-amplified * hormone receptor status not specified patient characteristics: * male or female * menopausal status not specified * ecog performance status 0-1 * absolute neutrophil count ≥ 1,000/mm³ * platelet count ≥ 100,000/mm³ * bilirubin ≤ 1.1 mg/dl * sgot or sgpt ≤ 2.5 times upper limit of normal (uln) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception during and after completion of study therapy * lvef ≥ 50% by muga scan * no peripheral neuropathy \> grade 1 * no active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix * no known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in cremophor el * no psychiatric illness or concurrent medical conditions that would preclude study treatment * no other conditions, including any of the following: * unstable angina * congestive heart failure * myocardial infarction within the past 12 months * high-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade av block, or supraventricular arrhythmias that are not adequately controlled) * no qt prolongation (\> 500 ms) * no active unresolved infections * no sensitivity to e. coli derived proteins prior concurrent therapy: * prior hormonal therapy for chemoprevention allowed * no prior trastuzumab (herceptin®) * no prior anthracyclines * no concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy) * no other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer * no concurrent drugs that may prolong the qt

Keywords: recurrent breast cancer stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer male breast cancer
a gene transfer therapy study to evaluate the safety of srp-9004 (patidistrogene bexoparvovec) in participants with limb-girdle muscular dystrophy, type 2d (lgmd2d)

Conditions: Limb-Girdle Muscular Dystrophy, Type 2D

Summary: this is an open-label, dose escalation gene transfer therapy study evaluating the safety of srp-9004 (patidistrogene bexoparvovec) via isolated limb infusion (ili) administration in approximately 6 participants with lgmd2d.


Eligibility criteria:
key inclusion criteria: * cohort 1a must be adult and wheelchair-dependent; cohorts 1b and 2 will be participants of age 7 or older. * confirmed alpha-sarcoglycan deficiency or identified sarcoglycan alpha (sgca) deoxyribonucleic acid (dna) mutation. * participants enrolled in cohorts 1b or 2 must be able to walk independently, but must exhibit signs of lower extremity weakness (that is, a gowers' sign, use a handrail for climbing stairs) and walk ≤80% of predicted distance on the 6 minute walk test (6mwt) based on normative data. key exclusion criteria: * active viral infection based on clinical observations. * the presence of sgca mutations without weakness or loss of function. * symptoms or signs of cardiomyopathy. * serological evidence of human immunodeficiency virus (hiv), hepatitis b, or c infection. * diagnosis of (or ongoing treatment for) an autoimmune disease. * participants with aavrh74 or aav8 binding antibody titers ≥ 1:50 as determined by enzyme-linked immunosorbent assay (elisa) immunoassay. other inclusion/exclusion criteria apply.

Keywords: limb girdle muscular dystrophy lgmd2d alpha-sarcoglycan gene transfer adeno-associated virus
the effect of a probiotic on upper respiratory tract infections

Conditions: Infections, Upper Respiratory Tract

Summary: this study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. the study will investigate the effect of daily intake of a probiotic on upper respiratory tract infections (urti) during a 16-week intervention.


Eligibility criteria:
inclusion criteria: 1. children aged 2-6 years, both inclusive, at the time of informed consent 2. no urti at the time of inclusion as assessed by a gp 3. attending day-care with at least 10 children or primary school with at least 10 children in the class for at least 20 hours a week 4. generally healthy as determined by a gp 5. guardian consents to participate in the study and to comply with all its procedures exclusion criteria: 1. any known concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis, congenital cardiac defects. 2. suspected or challenge-proved food allergy 3. use of any prescribed immune suppressive medications at enrolment 4. use of oral or iv antibiotics in the 1 month before randomisation 5. not willing to exclude pre/pro/synbiotics during the study 6. intake of echinacea, high dose vitamins or zinc four weeks before and during the study period. 7. language limitations regarding interviews or questionnaires 8. participation in other clinical studies in the last 2 months 9. planning extensive travel (for \>1 month) during the duration of the study
cryoballoon pulmonary vein isolation for atrial fibrillation with heart failure

Conditions: Atrial Fibrillation; Heart Failure; Cryoballon Ablation

Summary: the combination of atrial fibrillation (af) and heart failure (hf) is common and implies a poor prognosis. pulmonary vein isolation is an established method for the treatment of symptomatic af in patients with normal heart function and has been shown to be more effective than drug therapy. recently, radiofrequency ablation has shown a positive effect in patients with af and hf. polar-hf has been designed to investigate efficacy and safety of cryoballoon pulmonary vein isolation in patients with paroxysmal or persistent af and severe hf (lvef ≤ 40%).


Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal or persistent atrial fibrillation * patients with severe heart failure (lvef ≤40%, assigned to heart failure group) * patients with normal cardiac function (assigned to control group) * age \> 18 years * consent capacity exclusion criteria: * age under 18 years * pregnancy * lack of consent capacity
integrating addiction treatment and hiv services into primary care clinics in ukraine

Conditions: Hiv; Opioid-use Disorder

Summary: a randomized controlled trial to: 1. to compare both primary (composite quality health indicator (qhi) scores) and secondary (individual hiv/methadone maintenance treatment (mmt)/tb/primary care qhi scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (pwid) receiving mmt from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. after stratifying pwids based on their current receipt of mmt, they will be randomized to receive mmt in specialty addiction clinics (n=450) or in an echo-ic/qi-enhanced primary care clinic with (n=450) or without (n=450) pay for performance (p4p) incentives. 2. using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) qhi scores.

original outcomes were edited and implementation outcomes were added november 2023.

Eligibility criteria:
inclusion criteria: * pwid * interested in mmt * meets dsm-v criteria for opioid dependence exclusion criteria: * not willing to consent