Kornimate/medical-research-clean huggingface dataset:
effects of clustering care on the physiological stability of preterm infants.

Conditions: Premature Baby 26 to 32 Weeks

Summary: this crossover design experimental study aims to compare the physiological stability of premature newborns during and after a cluster of care compared to a period when they receive standard non clustered care at the neonatal unit.

the cluster care will take place at the time of feeding of the premature infants. the intervention will start with a calm period of 20 minutes before the start of care (no manipulations will be allowed), the baby will then received the cluster care for 20 minutes and a quiet period of 30 minutes will follow after the cluster care.

Eligibility criteria:
inclusion criteria: * between 26 to 31 6/7 weeks of gestation at birth * more than 72 hours of life, * receive a respiratory aid such as endotracheal tube, nippv (non invasive positive pressures ventilation), cpap (continuous positive airway pressure) or nasal prongs with oxygen, * are fed intravenously (iv) or by central venous catheter (cvc), * one of the parents speaks and reads english or french, * one of the parents is at least 18 years old to sign the consent. exclusion criteria: * severely ill (necrotizing enterocolitis, septicemia), * under respiratory assistance or on a high frequency mode, * having a congenital or cardiac abnormality, * requiring surgery, * sedatives or opioids, * diagnosed with grade ii, iii or iv intraventricular hemorrhage and / or hydrocephalus, * have a device for invasive blood pressure, * having an oxygen requirement of more than 30% to maintain oxygen saturation within the limits indicated by the nicu (neonatal intensive care unit). * one of the parents is at least 18 years old to sign the consent.
confocal laser endomicroscopy for the detection of gastric intestinal metaplasia: a randomized controlled trial

Conditions: Intestinal Metaplasia

Summary: the purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. however, present guidelines such as the updated sydney system require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. this study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.

Eligibility criteria:
inclusion criteria: * 40 years old ≤ age \< 80 years old * patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia * able to give informed consent. exclusion criteria: * esophageal, gastric or duodenal cancer or other malignancy * known gim or intraepithelial neoplasia in upper gi tract * scheduled for endoscopic therapy * history of upper gi tract surgery * reflux esophagitis or acute gastritis or peptic ulcers * acute upper gastrointestinal bleeding * coagulopathy or bleeding disorders * allergy to fluorescein sodium * pregnant or breast-feeding (for females) * impaired renal function

Keywords: gastric intestinal metaplasia confocal laser endomicroscopy
tace in combination with pd-1/pd-l1 inhibitors and molecular target therapies for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (tace) in combination with immune checkpoint inhibitors (icis) and molecular target therapies in patients with advanced-stage hepatocellular carcinoma (hcc).

transarterial chemoembolization (tace) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. this provides a theoretical basis for tace combined with immune checkpoint inhibitors (icis) in hepatocellular carcinoma (hcc) patients. the purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (tace) in combination with immune checkpoint inhibitors (icis) and molecular target therapies(including, vegf-tki/ bevacizumab) in patients with advanced-stage hcc. this real-world study also would like to explore the optimal combined treatment and subgroup of hcc patients for providing further information for clinical practice and trials.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of hcc confirmed by radiology, histology, or cytology; 2. barcelona clinic liver cancer (bclc) stage c with the presence of extrahepatic spread and/or macrovascular invasion; 3. has not received any previous systemic therapy for hcc (including chemotherapy, molecularly targeted therapy, immunotherapy); 4. both pd-1/pd-l1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to hcc approval; 5. tace was performed after the first pd-1/pd-l1 inhibitor/anti-angiogenic drug treatment or before treatment; 6. received at least 1 cycle of pd-1/pd-l1 inhibitor/anti-angiogenic drug combination therapy after tace treatment； 7. has repeated measurable intrahepatic lesions; exclusion criteria: 1. cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. unable to meet criteria of combination timeframe described above;

Keywords: hepatocellular carcinoma transarterial chemoembolization immune checkpoint inhibitors molecular target therapies advanced stage
observational study of spatio-temporal patterns of new cases of acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: published data regarding the temporal pattern of aml are scarce and old. the greater knowledge of these neoplasias has made that their classification has been remarkable modified. therefore, we consider relevant to carry out the present study as it would allow us to analyze the potential existence of a spatio-temporal pattern in the incidence of aml in spain.


Eligibility criteria:
inclusion criteria patients with a first diagnostic of aml between 2004 and 2014. .

Keywords: spatio-temporal diagnostic pattern
optimising general practice long covid care - an educational intervention.

Conditions: Long COVID

Summary: this trial will evaluate the feasibility of a pilot educational intervention for gps that aims to enhance care and care outcomes among patients with long covid at six general practices in the ireland east region. our first objective is to conduct focus groups with key stakeholders (gps, other health professionals, patients, families/carers) that will inform the contents of an education intervention. the second objective will be to implement this educational intervention, and the third objective will be to determine whether the intervention is feasible. study outcomes will include: * qualitative findings from co-design focus groups and post-intervention semi-structured interviews with gps. * practice and patient study recruitment and retention data. * gp / practice characteristics: age \& gender, practice location, general and covid-19 patient population figures. * patient characteristics: patient age, gender, covid-19 vaccination status, and medical history details. * patient scores on a self-report measure assessing the symptoms, symptom severity, functional impact, and overall health (covid-19 yorkshire rehabilitation scale (c-19-yrs)).


Eligibility criteria:
inclusion criteria: 1. age: aged 18 years or older at the time of enrolment. 2. registration: are registered as patients at the study's participating practices. 3. covid-19 diagnosis: * previously received a positive covid-19 pcr or antigen test, or * previously been clinically diagnosed with covid-19 by a healthcare provider. 4. persistent symptoms: o have spoken with their general practitioner (gp) about experiencing persistent symptoms lasting four weeks or more since their covid-19 diagnosis. 5. consent: willing and able to provide informed consent to participate in the study. exclusion criteria: 1. vulnerability: deemed by participating gps to be a vulnerable individual whose best interests are served by not participating in the study, such as (but not limited to): * people with language difficulties that prevent meaningful communication. * individuals with a recognised or diagnosed intellectual, physical, or mental impairment. * older adults considered particularly vulnerable. * individuals residing in institutions (e.g., care homes or prisons). * individuals with an unequal relationship with the researcher(s) (e.g., hierarchical dependence). * members of marginalised or disadvantaged groups for whom participation may present undue burden or risk.

Keywords: feasibility studies general practice long covid pilot study medical education
collection of blood from patients with prostate cancer

Conditions: Cancer Of Prostate; Prostate Cancer; Prostatic Neoplasms; Metastatic Prostate Cancer; Prostate

Summary: background: * it is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role. * genes contain the hereditary information that is passed down from parents to children. although everyone has the same set of genes, individuals can have different forms of the same gene. * differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others. objectives: -to obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state. eligibility: -all participants participating in nci prostate cancer protocols. design: * participants with prostate cancer are evaluated in the nci s medical oncology clinic. * blood samples are collected at the initial visit or at follow-up visits. * dna (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines. * gene variations are correlated with prostate cancer prognosis and prognostic indicators.

objectives: -to obtain blood samples from patients with prostate cancer for genotyping analyses. eligibility: - all patients seen in the nci prostate cancer clinic are eligible. design: * patients with a prior diagnosis of prostate cancer will be evaluated in the gmb clinic, nci. * blood samples will be collected after the participant signs the protocol consent form. in general, blood will be collected for genomic dna one time for this study. extra samples may be requested if the original sample was not enough. the additional sample can range from one to two tubes of blood (approximately 2-3 teaspoons total). genomic dna and white blood cells will each be extracted from these samples to be utilized for genotyping and establishment of individual cell lines. * genetic variance will be correlated with prostate cancer prognosis (i.e. time from diagnosis to death) and prognostic indicators (i.e. histological tumor grade). * blood samples for the extraction of cell-free dna (cfdna) and cell-free rna (cfrna) may be collected at multiple timepoints for future investigations * healthy controls will not be compared and no correlations will be made with prostate cancer susceptibility.

Eligibility criteria:
* inclusion criteria: individuals 18 years of age and older are eligible. individuals with a diagnosis of prostate cancer are eligible. exclusion criteria: children are not eligible.

Keywords: genetic prostatic neoplasms genotyping venipuncture polymorphism natural history prostate cancer
sentinel lymph node biopsy to assess axillary lymph nodes in women with stage i or stage ii breast cancer

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease. purpose: phase ii trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage i or stage ii breast cancer.

objectives: * compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in women with resectable stage i or ii breast cancer. outline: patients are stratified according to node status (positive vs negative). patients undergo lymphoscintigraphy, which consists of technetium tc 99m human serum albumin colloid being injected near the tumor. dynamic imaging using a gamma camera is performed for 20 minutes postinjection and static images are obtained for up to 3 hours postinjection. surgery is performed within 24 hours of lymphoscintigraphy. patients are injected with patent blue v dye near the tumor and a gamma detection probe is used to measure radioactive counts in the sentinel node. surgery begins within 5 minutes of the patent blue v dye injection. all lymph nodes that stain blue or have a high radioactive count are removed. the primary breast lump is removed by either wide local excision or mastectomy and the axilla are cleared by standard axillary dissection. some patients may only receive patent blue v dye injected as a pilot study. sentinel lymph node biopsy and axillary dissection proceed as above. projected accrual: a total of 150 patients (75 per stratum) will be accrued for the main study plus another 50 patients for the pilot study.

Eligibility criteria:
disease characteristics: * diagnosis of stage i or ii invasive breast cancer by triple assessment: * clinically * mammogram and/or ultrasound * fine needle cytology * resectable disease by either wide local excision or mastectomy with axillary dissection * no ductal carcinoma in situ * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * not pregnant * no known allergy to vital blue dye * no mental illness or handicap that would preclude study entry * no other severe illness that would preclude study participation prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * see disease characteristics

Keywords: stage i breast cancer stage ii breast cancer
wireless us-guided cvc placement in infants

Conditions: Wireless Ultrasound; Central Venous Catheter; Congenital Heart Disease in Children

Summary: background: neonates and small infants with congenital cardiac disease undergoing cardiac surgery represent major challenges facing pediatric anesthesia and perioperative medicine. aims: we here aimed to investigate the success rates in performing ultrasound guided central venous catheter insertion (cvc) in neonates and small infants undergoing cardiac surgery, and to evaluate the practicability and feasibility of thereby using a novel wireless ultrasound transducer (wust). methods: thirty neonates and small infants with a maximum body weight of 10 kg and need for cvc before cardiac surgery were included in this observational trial and were subdivided into two groups according to their weight: \< 5 kg and ≥5 kg. cannulation success, failure rate, essential procedure related time periods, and complications were recorded and the clinical utility of the wust was assessed by a 5-point likert scale.


Eligibility criteria:
inclusion criteria: neonates and small infants with a maximum body weight of 10 kg and need for insertion of a cvc before cardiac surgery at our institution exclusion criteria: * missing consent for study participation \>10 kg body weight * emergency surgery * central venous catheter in situ
evaluating a drug testing and graduated sanctions program in delaware

Conditions: Probationary Failure; Recidivism; Drug Relapse

Summary: the objective of this three year project funded by the national institute of justice is to conduct a program evaluation of the "decide your time" program at the hares corner office of the delaware department of probation and parole. the program is intended to provide an alternative to incarceration by monitoring chronic drug offenders through increased, regularly scheduled, known urinalysis testing, coupled with increasing sanctions and referral to treatment for positive tests. the program was designed and is being implemented by the delaware department of probation and parole. offenders will become eligible for the program when they test positive for drugs at their initial probation intake at the hare's corner probation office in new castle, delaware or are moved from standard probation to intensive supervision due to failed urine tests. due to budgetary constraints, the office lacks sufficient resources to place all eligible offenders into the program. the department of probation thus intends to randomly assign eligible offenders to either intensive supervision probation (isp)(n=400) or the decide your time program(n=400). those in isp will receive the normal intensive supervision requirements, including weekly visits and random urinalysis. those in the enhanced condition will receive regularly scheduled urinalysis coupled with referral to treatment, if required, and a program of graduated sanctions. the center for drug and alcohol studies is conducting an evaluation of the program that involves examining data on effectiveness, and collecting and examining data on program implementation, and probation officer and client perspectives of how the program worked. it is hypothesized that those randomized to the decide your time program will have fewer arrests, violations and positive urine screens upon program completion than those randomized to the control condition.


Eligibility criteria:
inclusion criteria: * sentenced to intensive supervision and fails a urine drug screen at the hares corner probation office in delaware exclusion criteria: * clinical diagnosis of dsm-iv mental illness * judge ordered zero tolerance program * sex offender * less than sixty days on probation

Keywords: graduated sanctions probationary failure recidivism drug relapse criminal justice
brief and intensive therapy for dysphagia in patients with head and neck cancer

Conditions: Deglutition Disorders; Dysphagia; Head and Neck Cancer; Radiotherapy; Complications

Summary: according to data in the literature, patients with head and neck cancer, who undergo combined treatment of radio-chemotherapy, have, to a greater or lesser extent, swallowing changes. most of the time, these patients undergo traditional speech-language interventions, performed weekly. this project proposes a brief and intensive therapy program for dysphagia, with daily interventions, showing that this therapeutic modality generates benefits in a shorter time interval when compared to traditional therapy. this short service period contributes to the reduction of hospital costs and reduces the total number of interventions, which is beneficial for both the patient and the service that performs the care. the present study was to verify the efficacy of a brief and intensive therapy program for dysphagia in patients with head and neck cancer submitted to radio-chemotherapy treatments, since they present, to a greater or lesser extent, changes of swallowing. this is a randomized clinical trial pilot project that will be developed in an oncology hospital. the population of this study is composed of patients diagnosed with head and neck cancer, over 18 years of age, with indication of combined radiotherapy , referred for speech therapy through the multidisciplinary oncology outpatient clinic of santa rita hospital (amohr).

he sample will consist of 20 patients who will be randomized into two groups: 10 in the intervention group with intensive brief therapy and 10 in the control group with traditional weekly therapy. in both groups, instruments related to swallowing assessment and quality of life will be applied before and after speech therapy. the control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. the sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs.

Eligibility criteria:
inclusion criteria: * adult patients from 18 years of age; * diagnosis of head and neck cancer; * indication of combined treatment of radio-chemotherapy; exclusion criteria: * have performed prior speech and hearing care for at least three months prior to the start of the study; * previous history of other neoplasias and / or neurological diseases, according to the participant's report and information of the medical record; * cognitive deficits and / or changes in the central nervous system that make it difficult to understand commands (illiterate individuals will have scores of at least 20 points, followed by 25 individuals from 1 to 4 years of study, 26.5 to 5 at 8 years, 28 to 9 to 11 years and finally, 29 to 11 years or more of schooling, according to brucki et al., 2003). * cardiac problems, according to the participant's report and information on the medical chart. * do not attend therapy for more than three sessions.
sleep apnea diagnosis using a novel pacemaker algorithm and link with aldosterone plasma level in patients presenting with diastolic dysfunction

Conditions: Sleep Apnea; Arrhythmias, Cardiac; Cardiac Diastolic Function; Hyperaldosteronism

Summary: little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. sleep apnea is often under diagnosed by clinical examination. confirmation tests are expensive and access is limited. a specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea. the purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. the investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.


Eligibility criteria:
inclusion criteria: * indication for permanent cardiac pacing (third degree atrioventricular block, second degree atrioventricular block mobitz 2 type, symptomatic sinus node dysfunction including brady-tachy form of sick sinus syndrome or bradyarrhythmia) * diastolic dysfunction diagnosed at the transthoracic echocardiography exclusion criteria: * younger than 18 years old * lack of informed consent form * impossibility to fit in the scheduled study plan * indication for cardiac resynchronization or left ventricular ejection fraction lower than 45% * indication for epicardial pacemaker, known severe sleep apnea treated by continuous positive airway pressure