Kornimate/medical-research-clean huggingface dataset:
hpv self-sampling in the general population

Conditions: Cervical Cancer

Summary: a randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of hpv self-sampling kit ("outreach" arm), choice between self-sampling or healthcare provider sampling ("choice" arm), and standard care (control arm) in two french departments.

in france, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. the national screening coverage rate of 59% (2018- 2020) remains well below the european union's recommended target of 70% and even further from the french cancer plan 2014-2019 objective of 80%. this study evaluates two innovative strategies to improve participation rates in two french departments (marne and aube). eligible women aged 30-65 years will be randomized into three arms. the "outreach" arm receives hpv self-sampling kit directly at home with sms reminder at 3 months if no participation. the "choice" arm can choose between ordering a self-sampling kit or visiting a healthcare provider with sms reminder at 3 months if no participation. the control arm follows standard procedure with self-sampling offered at 12-month reminder. women with positive hpv self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the "outreach" arm and reminders at 6 months post-positive result in the "choice" arm. the study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. if successful, findings could inform modifications to the national organized screening program.

Eligibility criteria:
inclusion criteria: * women aged 30 to 65 years old * living in the study area (departments of marne and aube, france) * at moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter) exclusion criteria: * outside the target age (less than 30 years old, or 66 years old and more) * already participating in the current screening round * total hysterectomy * history of cervical cancer * current follow-up for abnormal cervical screening result or cervical lesions

Keywords: cervical cancer screening program pilot project randomised control trial france
effect of pneumoperitoneum on remifentanil requirements in the surgical pleth index-guided analgesia

Conditions: Gastric Cancer

Summary: the primary purpose of this study is to investigate the effect of pneumoperitoneum on remifentanil requirements in the surgical pleth index-guided analgesia for laparoscopic gastrectomy.


Eligibility criteria:
inclusion criteria: * laparoscopic gastrectomy under general anesthesia exclusion criteria: * atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
phase ib/ii trial of bez235 with paclitaxel in patients with her2 negative, locally advanced or metastatic breast cancer

Conditions: Inoperable Locally Advanced Breast Cancer; Metastatic Breast Cancer (MBC)

Summary: this is a prospective, multi-center, open-label, phase ib/ ii study (two parts) with patients that have locally advanced or metastatic her2 negative breast cancer. the first part (phase ib) will investigate the mtd / recommended phase 2 dose (rp2d) of the combination therapy of bez235 twice daily (b.i.d.) and weekly paclitaxel using a bayesian model. when mtd/ rp2d is established the second part (phase ii) will start. phase ii will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus bez235 bid.


Eligibility criteria:
inclusion criteria (phase lb): * females with breast cancer that is histologically or cytologically confirmed, her2 negative and locally advanced or metastatic as confirmed by radiology * ecog performance status 0 and 1 * adequate bone marrow and organ function exclusion criteria (phase lb): * previous treatment with pi3k and/or mtor inhibitors * symptomatic central nervous system (cns) metastases * concurrent malignancy or malignancy in the last 5 years prior to start of study treatment * wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug * active cardiac disease (e.g. lvef less than institutional lower limit of normal, qtcf \> 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) * inadequately controlled hypertension * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235 and/or paclitaxel * treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists * sensitivity to paclitaxel treatment * uncontrolled diabetes mellitus * pregnant or nursing (lactating) woman other protocol-defined inclusion/exclusion criteria may apply

Keywords: locally advanced metastatic breast cancer her2 negative pi3k pathway paclitaxel mtor inhibitor
safety and efficacy of p-eswl and ercp

Conditions: Pancreatic Duct Stone

Summary: to determine the types, incidence and risk factors of adverse events after pancreatic extracorporeal shock wave lithotripsy (p-eswl) and endoscopic retrograde cholangiopancreatography (ercp), define the grading criteria of adverse events after p-eswl and ercp, and analyze the efficacy of p-eswl and ercp, which will provide evidence-based medical evidence to guide physicians' clinical practice.

currently, pancreatic extracorporeal shock wave lithotripsy (p-eswl) and endoscopic retrograde cholangiopancreatography (ercp) has become the preferred treatment for pancreatic duct stones. although some studies had confirmed the safety and efficacy of p-eswl and ercp, the sample size were small and the follow-up period were short. therefore, investigators designed this study with a large sample and a long follow-up period to clarify the efficacy and safety of p-eswl and ercp, so as to guide clinical work, standardize the diagnosis and treatment process of adverse events.

Eligibility criteria:
inclusion criteria: * patients hospitalized in changhai hospital from 2011.03.01 to 2018.06.30. * painful patients with chronic pancreatitis. * patients who completed pancreatic extracorporeal shock wave lithotripsy. exclusion criteria: * patients who diagnosed pancreatic cancer within 2 years after diagnosing chronic pancreatitis. * patients who refused to participate in the study.

Keywords: pancreatic duct stone pancreatic extracorporeal shock wave lithotripsy safety efficacy endoscopic retrograde cholangiopancreatography
integrating brain, neurocognitive, and computational tools in oud

Conditions: Opioid Use Disorder

Summary: the 5-year k01 mentored research scientist proposal will employ brain, neurocognitive, and computational tools (e.g., machine learning) to understand the impact of opioid-use disorder (oud) and common co-occurring issues on executive function and clinical outcomes. there have been record numbers of fatal and non-fatal overdoses (ods) associated with opioids (and other drugs) in the past 12-months. improving classification and predictive capabilities to enhance treatment and prevent relapse is of the upmost importance. deficits in neurocognition often are associated with poor treatment outcomes (e.g., more drug use, medication non-adherence), yet co-occurring issues associated with oud (e.g., depression, anxiety, physical/sexual abuse, neglect) make it difficult to parse which contributing factors lead to worse executive function (ef) and poorer treatment outcomes. novel brain, neurocognitive, and computational tools are needed to help determine these differences, in order to lay the foundation for better treatments. this need has shaped both the training plan and the associated research project in a 5-year k01 mentored research scientist proposal, building on dr. regier's prior preclinical and clinical addiction neuroscience experience (focused mostly on cocaine-use disorders, cue-reactivity, subcortical networks, prior adversity, and univariate imaging techniques).


Eligibility criteria:
inclusion criteria: * men and women with moderate to severe opioid use disorder by diagnostic and statistical manual, version 5, (dsm-v) criteria on a stable (at least one week without change) dose of oral buprenorphine-naloxone or methadone. (for oud group) * eligible participants will be between 18-60 years of age; * able to read at an eighth-grade level; * able to speak english. exclusion criteria: * unable to understand or complete the tasks. * certain mental health conditions, including (but not limited to) bipolar i with current manic episode, schizophrenia, and schizoaffective disorder, determined by the principal investigator (pi) to interfere with study participation. * moderate or severe substance-use disorder (for healthy controls)
impact of sleep workshops in college students

Conditions: Sleep; Insomnia; Sleep Deprivation

Summary: the purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood, anxiety and well-being measures in a sample of college students. college students have a high prevalence of sleep problems including poor sleep hygiene, volitional sleep deprivation, and insomnia. sleep disorders in college students negatively affect mood, social functioning, physical safety, and academic performance. rarely recognized by the students themselves, these conditions are therefore often untreated. participants in this study will be randomly assigned to receive the college sleep improvement plan (c-sip) or a control session. participants will be asked to track their sleep as well as complete questionnaires; a subset of participants will be asked to wear an activity monitor.


Eligibility criteria:
inclusion criteria: * currently enrolled in classes at the nyu washington square campus exclusion criteria: * students previously enrolled in the "while you were sleeping" course at nyu
reduction of microembolism after the intervention surgery of intracranial aneurysms by administration of tirofiban

Conditions: Intracranial Aneurysm

Summary: the goal of this clinical trial is to investigate whether intravenous injection of tilofiban can reduce microembolism in patients with unruptured intracranial aneurysms after stent-assisted coil embolization.the main questions it aims to answer are: * is it safe to inject tirofiban intravenously during interventional treatment of intracranial aneurysms？ * what dose of tirofiban is safe and effective?

we aim to reduce microembolism in patients with unruptured intracranial aneurysms after stent-assisted coil embolization.

Eligibility criteria:
inclusion criteria: * age was between 18 and 75 years old; * unruptured aneurysm with surgical indications; * stent assisted coil embolization treatment was received ; * the patient was willing to receive intervention treatment. exclusion criteria: * complicated with hemorrhagic cerebrovascular diseases such as cerebral vascular malformations and moyamoya disease or their medical history; * recent (within 1 year) bleeding symptoms such as gastrointestinal bleeding, clinically significant urinary/reproductive tract bleeding, and skin blueness; * dissecting aneurysm, pseudoaneurysm, and bullous aneurysm; * a known history of coagulation disorders, platelet abnormalities, or thrombocytopenia; 5. platelet count less than 150 × 109/l； * a history of major surgical procedures or severe physical trauma within one month; * severe uncontrolled hypertension (systolic blood pressure\>160mmhg and/or diastolic blood pressure\>100mmhg); * hemorrhagic retinopathy; * chronic hemodialysis; * renal insufficiency.

Keywords: aneurysm tirofiban stent-assisted coil embolization
pharmacotherapy of treatment-resistant mania

Conditions: Mania

Summary: verapamil has been found in some but not all studies to have antimanic activity. therefore, we investigated the use of verapamil, alone or as an adjunctive treatment, in manic patients who did not respond to an initial adequate trial of lithium. each study phase lasted three weeks. subjects were treated openly with lithium in phase 1 (n=45). those who failed to respond were randomly assigned to double-blind treatment in phase 2 with either verapamil (n=10) or continued lithium (n=8). phase 2 responders were continued on the same medication in phase 3. phase 2 nonresponders (n=10) were assigned to combined verapamil/lithium in phase 3.


Eligibility criteria:
inclusion criteria: * to be eligible for the study, patients were required to have a lifetime diagnosis of bipolar 1 or schizoaffective disorder, a current manic episode meeting dsm-iv criteria, and ratings \>/= 7 on the raskin severity of mania scale and \>/= 15 on the bech-rafaelsen mania scale. exclusion criteria: patients were excluded if they had: * a pattern of severe rapid-cycling in which the patient consistently failed to meet the duration criteria for discreet episodes of syndromal mania or depression according to dsm-iv * sustained drug or alcohol abuse within the past three years * schizophrenia * organic affective syndrome * a presenting episode that was secondary to the effect of any pharmacologic agent * the presence of significant medical illness that would preclude or unduly complicate the intended pharmacologic management of the episode * in females, refusal to use appropriate contraception; or * pregnancy.

Keywords: bipolar disorder mania antimanic verapamil lithium
evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure

Conditions: Respiratory Failure

Summary: evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure

assessing the dynamics of changes in physical, instrumental and laboratory parameters in patients with acute respiratory failure taken in the study according to the inclusion criteria and comparing the results with the control group, studying the effectiveness of vibroacoustic lung therapy.

Eligibility criteria:
inclusion criteria: * adults * p/f less 300 torr * ards by berlin convention exclusion criteria: * children * acute stroke * acute coronary syndrome * dvt * implanted pacemaker * rib fracture * infection on chest

Keywords: vibroacoustic therapy, acute respiratory failure, pneumonia
computer-based auditory rehabilitation

Conditions: Presbycusis

Summary: hearing in noisy environments is a perceptual problem that is ubiquitous in modern industrialized societies. this particular listening context offers a particular challenge to individuals living with hearing impairment (30 million in us alone) even after treatment with hearing aids or cochlear implants. the ability of the brain to extract regularities from the environment and suppress distracting information can be improved with intensive cognitive training. the investigators will test whether the hearing in noise abilities of adults living with hearing impairment can be improved with a cognitive training paradigm.

hearing impairment (hi) represents the most common cause of moderate to severe disability in the world, with an estimated prevalence of 636 million individuals (30 million in the us alone). amplification devices (i.e., hearing aids) are commonly used to compensate for hi stemming from acoustic trauma, ototoxic insult, normal aging or other sources of cochlear degeneration. the chief complaint of individuals with hi is hearing in the types of noisy environments that characterize most work, educational, and social situations. unfortunately, hearing aids do not completely address the perceptual impairments in these situations. that is because the difficulties that individuals with hi have hearing in noise result from the reduced salience of cues that are used to sort out auditory scenes. making sounds louder improves audibility, but does not afford adaptation of the brain to the abnormal coding of sensory information by the damaged cochlea. the investigators will test whether the hearing in noise abilities of adults living with hearing impairment can be improved with a cognitive training paradigm.

Eligibility criteria:
inclusion criteria: * binaural sensorineural hearing impairment * use of binaural hearing aids * native english speaker exclusion criteria: * significant cognitive impairment * significant motor impairment * history of neurological disease/head trauma * use of psychotropic and thyroid medications

Keywords: presbycusis hearing in noise hearing impairment hearing loss aging plasticity video games perceptual learning
comparison of different tourniquet release times in bunion surgery

Conditions: Hallux Valgus; Hallux Rigidus

Summary: patients listed for hallux valgus/hallux rigidus correction surgery will be randomised to one of two treatment groups. group 1 (standard care) will have the calf tourniquet released after wound closure. group 2 will have the tourniquet removed five minutes before wound closure. participants will have the volume of their operated foot measured pre-operatively and post-operatively at six weeks and three months.

pneumatic tourniquets provide the benefits of better visualisation and decreased blood loss, but can also cause metabolic changes due to ischemia and compressive damage due to pressure. surveys of foot and ankle surgeons demonstrates prevalent use of tourniquets in their clinical practice, with various patterns of use differing amongst the surgeons. bunion surgery is one of the most common surgical procedures in foot surgery. it involves correcting the hallux valgus deformity through a combination of various osteotomy, fusion, or soft tissue procedures. swelling after any surgery is common, but particularly so after foot surgery as gravity causes fluid to collect in the foot. with regards to recovery after surgery, patients are advised to expect to be off work for between 6-8 weeks for a sedentary occupation, and between 12-14 weeks for heavy work. although patients have low pain levels, the foot remains swollen for an average of 3-6 months after surgery. it is usually the swelling that prevents patients from getting in to normal footwear to be able to return to work sooner. bunion surgery is usually performed under a calf-tourniquet to create a bloodless surgical field and ensure less surgical bleeding, thereby reducing surgical time. however, use of tourniquets can lead to more swelling, increased post-operative pain and challenges in rehabilitation - all of which may affect recovery after bunion surgery. prolonged duration of tourniquet use has been shown to cause post-operative wound healing complications, potentially attributable to local inflammation and tissue hypoxia. it is known from the studies for knee replacement surgery that tourniquet use can lead to decreased range of motion after surgery in early stage. this study will be a randomised controlled trial with two study groups. the control group will have surgery with the tourniquet remaining in situ until the wound is closed. the intervention group will have the tourniquet released after surgery, but closure will be delayed by five minutes.

Eligibility criteria:
inclusion criteria: * patients having hallux valgus or hallux rigidus * able to give informed consent * able to return for follow-up exclusion criteria: * patients with symptomatic peripheral vascular disease * patients with known peripheral oedema from any cause * patients who will also require lesser toe correction as part of the procedure * active smokers

Keywords: randomised controlled trial hallux valgus correction hallux rigidus correction tourniquet foot volume
prospective observational pilot-study for the evaluation of the nephro- an neurotoxicity in the anti-infectious therapy with inhalative colistin therapy for patients with ventilator-associated pneumonia (vap)

Conditions: Infection Resistant to Multiple Drugs

Summary: multi-drug resistant pathogens (mdr) are reported worldwide with increasing incidence, especially in intensive care settings. one of the drugs which are effective against mdrs, is colistin (polymyxin e). this agent has been reintroduced in response to the increase of mdr pathogens and might be used more often in the future. data on safety regarding the most important side effects are not sufficiently available. l this study evaluates the toxicity in patients who receive aerosolized colistin.

there is growing evidence that patients in the icu setting have a special risk profile for consecutive colonization and possible infection due to mdr pathogens. one therapy option is the use of inhalative colistin, as this agent has been demonstrated to be effective against these pathogens. data on pharmacodynamics or - kinetics are transferred from older studies or from other patient populations. for patients with pulmonary colonization or infection due to an mdr pathogen the systemic resorption of the drug is not known, consequently systemic side effects including kidney or neural damage are not predictable. this study focus on patients with inhalative colistin therapy and uses therapeutic drug monitoring to determine the rate of systemic resorption of colistin. for the evaluation of neurotoxicity function of peripheral nerves (neve conduction velocity) and of the eighth cranial nerve is monitored. nephrotoxicity is estimated by creatinine level (-clearance) and the rifle criteria.

Eligibility criteria:
inclusion criteria: * invasive ventilated patients (male and female) with assumed or assured bacteria with an elevated resistance pattern found in a tracheal or bronchial secretion with or without clinical signs of infection * indicated colistin co-therapy or eradication-attempt with inhalative colistin (β-lactam) therapy according to the standard operation procedure (sop) of the hospital exclusion criteria: * consent of the patient or of the patient´s legal representative can´t be obtained soon * age \< 18 years * included within another, prospective clinical antibiotics-study * hypersensitivity to colistin or polymyxin b * patients with cystic fibrosis * present letter of attorney or patient´s provision, which precludes a priori the participation in studies * missing consent for storage of pseudonymised data in context of the study * the patient is in an institution due to a court injunction or administrative order

Keywords: colistin, mdr, inhalative therapy