Kornimate/medical-research-clean huggingface dataset:
portuguese research on telemonitoring with carelink® (portlink)

Conditions: Arrhythmia

Summary: compare use of carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (icd)

the objective of the portlink (portuguese research on telemonitoring with carelink), a multicenter randomized study, is to assess the safety, functioning and costs of remote icd monitoring when compared to traditional in-clinic follow-up. it will evaluate aspects such as the clinician and patient acceptance and satisfaction with the reviewing device data via the website, the complexity for troubleshooting calls to the support center, the utilization of emergency resources by symptomatic patients, the percentage of the unscheduled appointments after a remote interrogation, the levels of anxiety, depression and quality of life, and the main consumed resources with carelink system.

Eligibility criteria:
inclusion criteria: * subject has implanted medtronic implantable cardioverter defibrillator: crt-d (cardiac resynchronization therapy - defibrillator), icd * subject or the subject's caregiver is willing and able to use the medtronic carelink monitor and perform the required duties at home or have a family member or assistant to perform those studies * subject has signed a patient informed consent form from this study exclusion criteria: * subject has medical condition(s) that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available) * subject is less than 18 years of age * subject is enrolled or intends to participate in another clinical trial
prevalence of persistent covid-19 in punta arenas, magallanes and chilean antarctic region

Conditions: COVID-19

Summary: this cross-sectional observational study aims to determine the prevalence of persistent covid-19 in 282 individuals in punta arenas, magallanes and chilean antarctic region. persistent covid-19 is a complex array of symptoms that persist or emerge for more than 4 weeks beyond sars-cov-2 infection. recent studies suggest that up to 80% of survivors may develop chronic multi-organ dysfunction due to persistent inflammation and immune dysregulation, making it an ongoing public health concern worldwide. the study aims to (1) describe and establish the frequency of physical and psychological signs and symptoms in adult patients who have tested positive for covid-19, (2) identify individuals who meet the who case definition of persistent covid-19 in chile, (3) explore risk factors associated with persistent covid-19 to guide intervention strategies, and (4) explore inflammatory and molecular biomarkers associated with persistent covid-19. the research project utilizes a stratified random sampling with a mixed-methods embedded design. in the first phase, individuals diagnosed with covid-19 will be recruited and followed up to complete the study's sample universe. a sociodemographic survey, blood sampling (including complete blood count, biochemical profile, immunoglobulin mutational status analysis, and analysis of inflammatory biomarkers), and a battery of psychological tests will be administered. in the second phase, kinesiology studies and medical consultation and evaluation will be conducted to determine if individuals have persistent covid-19 and to derive them to the healthcare network. in the final follow-up phase, participants diagnosed with persistent covid-19 will be invited to undergo musculoskeletal and respiratory assessments to complete the diagnosis of symptoms associated with the pathology.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * individuals must be included in the covid-19 monitoring database by the seremi of health in punta arenas between july 2022 and july 2023. * patients able to give informed consent. exclusion criteria: * age \< 18 years * any physical, mental, immunosuppressive, or social condition that, in the investigator's judgment, might interfere with the completion of the baseline assessments and evaluations. * individuals who are digitally illiterate and do not have access to nearby networks to support them during the process.
outcome after conservative and surgical treatment of splenic injuries after blunt abdominal trauma.

Conditions: Splenic Rupture; Abdominal Injuries

Summary: retrospective study in order to investigate the outcome after conservative (with or without transcatheter arterial embolization) and surgical treatment of splenic injuries.

background splenic injuries after blunt abdominal trauma are treated with increasing frequency without operation. patients undergo observation and bed rest. in certain circumstances an additional transcatheter arterial embolization is performed. it is uncertain which splenic ruptures (injury grades according to moore) are best treated non-operatively and which are best treated with an emergency operation. furthermore the value of organ-preserving surgery (splenorrhaphy) is uncertain. in addition, the importance of transcatheter arterial embolisation is unknown. objective evaluation of outcome (splenic salvage rate, complications, survival) after conservative and surgical treatment. evaluation of the importance of organ-preserving surgery and of transcatheter arterial embolization. methods all adult patients with splenic injuries after blunt abdominal trauma are included (2002-2008). the patients charts are studied and the following main information retrieved: age, gender, mechanism of accident, grade of splenic injury, concomitant injuries, patient management in the emergency department (fluid administration etc.), diagnostic methods (ultrasound, computed tomography), treatment modalities (bed rest, surgery, embolization), complications of treatment, re-operations, long-term outcome.

Eligibility criteria:
inclusion criteria: * traumatic splenic rupture * 16 years and older

Keywords: splenic rupture abdominal injuries surgery angiography embolisation computed tomography classification
soluble ve-cadherin in prediction and diagnosis of early postoperative hypoxemia after cardiopulmonary bypass

Conditions: Hypoxemia; ARDS; Lung Injury, Acute; Cardiopulmonary Bypass

Summary: more than 2 million patients worldwide receive heart surgery every year, majority of these surgical patients will undergo cardiopulmonary bypass. however, the incidence of postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%. according to clinical experience, the earlier lung damage is detected, the more successful the treatment will be. on the basis of traditional detection, the investigators found a new indicator, serum soluble vascular endothelial-cadherin, which are easy to obtain and have certain specificity. importantly, they can predict postoperative acute lung injury within 1 hour after cardiac surgery. it is meaningful that this indicator can provide clinicians with early decision-making advice and immediate treatment for patients who may be at risk.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * underwent cardiac surgery using cpb technology. exclusion criteria: * patient's lack of consent to participate; * presence of abnormal liver, kidney or other organ function; * pulmonary inflammation, chronic obstructive pulmonary disease or tumors; * underwent cardiac surgery without cpb technology; * postoperative need for extracorporeal membrane oxygenation support.

Keywords: hypoxemia acute lung injury cardiopulmonary bypass fio2/pao2
treatment of bv with donaxyl and a molecular test of cure

Conditions: Bacterial Vaginoses

Summary: . treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

this is the first study to utilize a molecular diagnostic test as a test of cure for bacterial vaginosis. the nugent score is a reliable method for diagnosing bacterial vaginosis, but similar to traditional clinical diagnostic methods, it is not equally reliable when utilized as a test of cure. this study demonstrated that molecular diagnostic testing can be used as a test of cure and this is the first molecular test that can do that. treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

Eligibility criteria:
inclusion criteria: bv exclusion criteria: no other infection (gc, clhlamydia, trihomonas)

Keywords: bacterial vaginosis, polymerase chain reaction, molecular diagnostic
savi scout clinical evaluation study

Conditions: Breast Neoplasm

Summary: the purpose of this study is to evaluate the performance of the savi scout® surgical guidance system (savi scout). the savi scout is a medical device, used to provide real-time guidance during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate and remove the desired tissue (i.e., the lesion and surrounding normal tissue). the savi scout has been 510k cleared. the savi scout is intended to assist surgeons in the location and retrieval of a non-palpable abnormality as localized by radiographic or ultrasound methods. in this study, the ability of the savi scout to guide surgeons to find a lesion will be evaluated instead of the standard technique of wire localization.

using radiography or ultrasound guidance, the savi scout reflector will be placed percutaneously up to 7 days prior to the scheduled excisional procedure. during surgical excision, the savi scout system will be used to locate the reflector, which will be removed along with the surrounding breast tissue. final data analysis will be completed within 1 month after the last patient is treated. final assessment of the surgical results will be completed by the surgeon during a routine follow-up visit within 1 month following the surgical excision or lumpectomy procedure. main objective: to show that the savi scout technique can be used to safely and effectively locate a non-palpable breast lesion during a localized excisional biopsy or lumpectomy procedure. up to 10 sites and 150 patients will be enrolled.

Eligibility criteria:
inclusion criteria: * • patient has a non-palpable breast lesion that requires excision * lesion depth ≤ 3 cm from the skin surface in the supine position * patient is scheduled for excision or bct at a participating institution * patient is between the ages of 18 and 90 years * patient is female * patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study * for lesions requiring multiple reflectors for localization, they must allow for reflectors to be placed ≥ 1cm from one another relative to the coronal plane subject exclusion criteria an individual who meets any of the following criteria will be excluded from participation in this study: * patient had a previous ipsilateral breast cancer * patient has multicentric breast cancer * patient has stage iv breast cancer * patient has been treated with neoadjuvant chemotherapy * patient is pregnant or lactating exclusion criteria: -

Keywords: lumpectomy breast conserving surgery
drug interactions between silimarine and darunavir/ritonavir

Conditions: HIV

Summary: this is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.

the silimarine is the main component of milk thistle (sylibum marianum), a medicinal herb which, due to its attributed hepatoprotective properties, is widely used by hiv infected patients 15 patients on stable antiretroviral therapy including darunavir/ritonavir 600/100 mg twice a day during four weeks will be enrolled. after their inclusion in the study, patients will receive treatment with silimarine (150 mg every 8 hours) from day 1 until two weeks later (day 14). on days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the administration of darunavir/ritonavir, and darunavir and ritonavir concentrations in plasma will be determined by high performance liquid chromatography using a validated method.

Eligibility criteria:
inclusion criteria: * patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 mg twice daily for at least 4 weeks * hiv viral load in plasma \<50 copies / ml * absence of acute infections and / or tumors in the three months prior to inclusion. * subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments. exclusion criteria: * any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction. * active alcohol consumption (\> 50 g / day) or illicit drugs (except cannabis).

Keywords: darunavir silimarine interaction
narrow dental implants in multiple fixed prosthesis: a controlled clinical trial

Conditions: Edentulous Alveolar Ridge

Summary: the objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. the hypothesis of the study is that narrow dental implants under the evaluated conditions, have the same survival rate and clinical performance than the standard diameter implants.


Eligibility criteria:
inclusion criteria: * patients of legal age (\>18 years) of both sexes. * clinical need of multiple fixed alveolar ridge rehabilitations. * clinical suitability to insert, at least, one narrow dental implant splinted to a standard diameter dental implant. * signature of the informed consent exclusion criteria: * presence of an active infection * being under active treatment with, or have received in the las 30 days treatment with radiotherapy, chemotherapy, immunosuppressors, systemic corticosteroids and/or anticoagulants. * presence of severe haematologic disorders. * chronic treatment with non steroidal anti-inflammatory drugs (nsaid) or other aniinflammatory drugs. * previous diagnosis of chronic hepatitis or liver cirrhosis. * presence of diabetes mellitus with improper metabolic control (glycosylated haemoglobine higher that 9%). * patients subjected to dialysis. * presence of malignant tumours, haemangioma or angioma in the surgical area. * history of ischaemic cardiopathy in the las year. * pregnancy or plan to getting pregnant during the study. * metabolic bone disease * patientd receiving treatment with oral or intravenous biphosphonates. * any other condition incompatible with the participation in the study,

Keywords: edentulous narrow alveolar ridges
co-production and feasibility rct of intervention to improve the mental health of children with a social worker

Conditions: Parent-Child Relations; Child Mental Disorder; Child Maltreatment

Summary: feasibility rct to ask: can the investigators coproduce, with parent collaborators, a new service, infant parent support (ips), to improve the mental health of children with a social worker? can the investigators test the feasibility of an rct of ips compared with services as usual?

questions addressed: can the investigators coproduce, with parent collaborators, a new service, infant parent support (ips), to improve the mental health of children with a social worker? can the investigators test the feasibility of an rct of ips compared with services as usual? considered for entry: parents of children aged 0-5 who have mental health concerns, social workers, and a multi-agency support plan. inclusion criteria: any family in the glasgow or bromley trial sites with a child aged 0-5 years with mental health concerns, a social worker, and a multi-agency support plan. exclusion criteria: at the outset of the trial there were no exclusion criteria. over the course of phase 1, the following exclusion criteria have emerged: * if the child has a child protection plan or is on the child protection register * if the family are in the process of 'stepping down' from a cpp or cpr * if the child is currently engaged in therapeutic work. intervention: infant parent support (a multidisciplinary infant mental health team aiming to improve the mental health of children aged 0-5 with a social worker). primary outcomes phase 1: coproduction, with parents of children who have a social worker, of the ips intervention. phase 2: recruitment and retention (at 3 and 6 months) to a feasibility rct. secondary outcomes phase 1: preliminary mapping of service context. phase 2: * improvement in the organisation, access, and quality of services, for children with a social worker and mental health issues. * examination of putative primary and secondary outcomes for a future definitive rct of ips (see below) * development of a parent-supported outcome measure and a parent-supported experience measure for use in a future definitive rct * exploration of whether it is possible to expand into new sites to conduct a successful phase iii trial.

Eligibility criteria:
inclusion criteria: * any family in the glasgow or bromley trial sites with a child aged 0-5 years with mental health concerns, a social worker, and a multi-agency support plan. exclusion criteria: at the outset of the trial there were no exclusion criteria. over the course of phase 1, the following exclusion criteria have emerged: * if the child has a child protection plan or is on the child protection register * if the family are in the process of 'stepping down' from a cpp or cpr * if the child is currently engaged in therapeutic work.
pharmacokinetics of td-4208 in patients with severe renal impairment

Conditions: Renal Impairment

Summary: this multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal renal function or severe (egfr \<30 ml/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the pharmacokinetics (pk) of td 4208.


Eligibility criteria:
inclusion criteria: for renal impairment group: * subject has severe renal impairment (egfr \<30 ml/min/1.73 m2) for normal renal function group: * subject is in good health exclusion criteria: * women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study. * subject has received an investigational drug (or medical device) within 30 days * subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or pk of the investigational drug; or is unable to comply with the study protocol.

Keywords: renal impairment renal insufficiency
in vitro analysis of human urine with the cloudcath device

Conditions: Urinary Tract Infections

Summary: this is a multi-center feasibility study to assess the in vitro function of the cloudcath device that is being developed to derive clinically-relevant information from the optical characteristics of urine.

specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection. to evaluate the performance of the cloudcath device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months. each sample will be divided into multiple aliquots. one part will be analyzed using the cloudcath device and reference devices. another part may be submitted to an independent lab for standard analytical tests.

Eligibility criteria:
inclusion criteria: * provide a signed informed consent * patient has an implanted urinary catheter (i.e., foley, texas, ureteral) exclusion criteria: * any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study * currently taking antibiotics for any reason other than for treatment of urinary tract infection (uti) * suprapubic bladder catheter implanted
use of intra-aortic balloon pump before surgery for acute myocardial infarction

Conditions: Acute Myocardial Infarction; Coronary Artery Disease; Coronary Bypass Graft Stenosis of Autologous Vessel; Troponin; IABP - Disorder of Intra-Aortic Balloon Pump

Summary: the optimal timing of surgery in patients with acute myocardial infarction (ami) and the utilization of preoperative intra-aortic balloon pumps (iabp) in these patients are subjects of ongoing discussion and disagreement. this study aimed to investigate the effects of preoperative iabp on troponin levels, surgical timing, and intraoperative and postoperative outcomes for patients with ami who undergo coronary artery bypass grafting (cabg).

percutaneous coronary intervention (pci) is the first treatment for myocardial ischemia; however, if left main coronary artery disease, multivessel disease, or complex architecture disable pci, 10% of patients may need coronary artery bypass grafting (cabg). abstinence from surgical reperfusion in patients with acute myocardial infarction (ami) may be justified due to surgery's 50% mortality rate. an intra-aortic balloon pump (iabp) can help patients who have ongoing ischemia and high cardiac enzymes because it changes the way the heart uses oxygen by increasing coronary blood flow and lowering afterload. some guidelines do not recommend the use of iabp in patients with ami except for mechanical complications or shock. nevertheless, it is commonly acknowledged that the specific criteria for employing iabp differ among clinics and are determined by clinical expertise. patients with ami who have impaired coronary perfusion and require surgical revascularization can benefit from preoperative intra-aortic balloon pump (iabp) support. this intervention leads to reorganization of coronary perfusion, resulting in a decrease in elevated troponin levels and quicker myocardial recovery.

Eligibility criteria:
inclusion criteria: * patients who have had acute myocardial infarction and have been decided on coronary surgical revascularization exclusion criteria: * mechanical complications of acute myocardial infarction (such as a ruptured chordal or ventricular septum) * peripheral arterial disease * renal failure * history of cerebrovascular accident * acute cardiogenic shock and cardiac arrest * reoperation and combined operations

Keywords: acute myocardial infarction coronary artery bypass surgery intra-aortic balloon pump high-sensitivity cardiac troponin i
the analgesic effect of intrathecal hydromorphone injection on spinal anesthesia

Conditions: Pain Measurement; Visual Analog Pain Scale

Summary: the purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone injection for postoperative pain relief after knee arthroscopic surgery.

sixty patients who were undergoing unilateral knee arthroscopy randomly received unilateral spinal anesthesia with 0.5% hyperbaric bupivacaine 6 mg combined with normal saline 0.05 ml or hydromorphone 2.5, 5 or, 10 μg/0.05 ml. the verbal numerical rating scale (vnrs) pain scores were measured at 30 minutes and 2, 4, 6, 12 and 24 hours postoperatively, and the side effects of hydromorphone were recorded.

Eligibility criteria:
inclusion criteria: * asa class i-ii (age range: 18-72 years) * informed consent obtained patients exclusion criteria: * the exclusion criteria included evidence of neurological or neuromuscular disease, respiratory or cardiac disease, diabetes mellitus or peripheral neuropathy, as well as those patients who were receiving chronic analgesic therapy or who had infection at the intended site of spinal needle insertion or who had hypersensitivity to amide local anesthetics or opioids