Kornimate/medical-research-clean huggingface dataset:
chronic complaints after small umbilical hernia repair

Conditions: Chronic Pain; Ventral Hernia

Summary: there are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. the setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. the survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. we analysed 295 consecutive patients through a non-validated structured questionnaire.


Eligibility criteria:
inclusion criteria: * primary elective open non-mesh sutured umbilical or epigastric hernia repair exclusion criteria: * mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age \< 18 years, pregnancy

Keywords: pain, hernia, chronic, discomfort, retrospective
the effect of a father inclusive psychoeducation program on postnatal depression

Conditions: Pregnancy

Summary: study hypothesis: childbearing couples who receive the father inclusive psychoeducation program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year postpartum than those who receive the usual perinatal care.

background: having a first child is a key marker of the transition into parenthood that requires substantial adjustment of couples' life. a recent meta-analysis published in the journal of american medical association reports that both women (23.8%) and men (10.4%) suffer from perinatal depression \[1\]. the father's involvement during pregnancy can positively influence health outcomes not only for the man, but his partner, and their children \[1,2\]. however, the effectiveness of father's involvement in prenatal care in preventing paternal and maternal depression, is still unknown. aims: this study seeks to: (1) evaluate the effect of a father inclusive psychoeducation program for first-time chinese mothers and fathers on depressive symptoms (primary outcome), marital relationships and quality of life at 6 weeks, 6 months and one year postpartum; and (2) explore fathers' involvement, their perceived benefits of participating in the program and factors influencing the effectiveness of the program. methods: this study employs a longitudinal, randomized, pre and post-test design. a convenience sample of 576 couples will be recruited at antenatal clinics and randomly assigned to one of three groups: (1) the experimental group with both couples receives the intervention on top of usual perinatal care; (2) the comparison group with only the women receives the intervention on top of usual perinatal care; and (3) the control group receives usual perinatal care only. the intervention consists of a single 3-hour session during pregnancy and two telephone follow-up at postpartum week one and week two. primary outcome on postnatal depression will be assessed by edinburgh postnatal depression scale. secondary outcomes on marital relationship and quality of life will be assessed by dyadic adjustment scale and medical outcomes study short form 12-item health survey, respectively, at baseline, 6 weeks, 6 months and one year postpartum. process evaluation will be conducted at 6 weeks postpartum using individual telephone interview on 20 couples randomly selected from the experimental group.

Eligibility criteria:
inclusion criteria: * aged 18 or above; * first-time parents; * able to speak and read the chinese language; and * hong kong residents. exclusion criteria: * couples with past or family psychiatric history

Keywords: depressive symptoms, marital relationship, quality of life
insure: incidence free survival before and after implantable cardioverter defibrillator (icd) replacement

Conditions: Ventricular Fibrillation

Summary: the insure trial is a multi-center, prospective trial to collect information about adequate icd therapies in icd patients before and after their first elective icd replacement.

the insure trial is a multi-center, prospective trial to collect information about adequate icd therapies in icd patients before \& after their first elective icd replacement. for this purpose all consecutive icd patients will be included in the study, whose first implanted device is replaced due to icd battery depletion (i.e. arrival at battery indicator eri). icd replacements due to other reasons can be included if duration of first icd implantation was \> 3 years. all patients included in the trial are regularly followed up until delivery of their first adequate icd therapy. the collected data shall provide statistically valid information about the risk to patients who never have experienced adequate icd therapy before the icd replacement investigated in this study. in the future, these statistical risk data can give additional information to implanting physicians, such as whether an icd replacement can eventually be omitted in those patients who are at very low risk for the occurrence of icd therapies. all actually available guidant icds with ce certificate can be implanted in this trial.

Eligibility criteria:
inclusion criteria: * all elective icd replacements due to battery depletion of the first icd being implanted in the patient exclusion criteria: * non-availability to regular follow-up * age \< 18 years * pregnancy
needle free assessment of myocardial oxygenation in healthy subjects

Conditions: Coronary Artery Disease

Summary: this is a prospective pilot study to evaluate the safety, tolerability and efficacy of utilizing precise computer controlled gas challenge in healthy subjects for identification of coronary artery disease.

this study will establish the safe and tolerable level of high pc02 and low p02 for future studies as potential stressors for coronary artery disease assessment.

Eligibility criteria:
inclusion criteria: 1. adults ≥ 45 years of age 2. no known cardiac disease exclusion criteria: 1. low blood pressure (systolic blood pressure \< 100 mmhg) 2. inability to voluntarily increase their breathing rate if prompted to do so 3. persons with the inability to lie supine for 30-40 minutes 4. persons who are pregnant, nursing, or implanted with intrauterine devices (iud's) 5. persons with significant neurological, pulmonary, renal or hepatic disease 6. persons who have an abnormal cardiac rhythm or resting heart rate \>100/min 7. inability or unwillingness to provide informed consent
relationship between circulating tumor cell cultures' treatment response and clinical outcomes

Conditions: Cancer; Metastasis Lung; Metastasis to Liver; Circulating Tumor Cell; Gastrointestinal Cancer; Bladder Cancer

Summary: the purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (ctc) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease.

this study will isolate circulating tumor cells (ctcs) from blood samples taken from patients with liver and/or lung metastases who will receive systemic treatments. the ctcs will be cultured and given the same treatment as the patient received. the main goals of this project are 1) to assess ctc cultures' treatment response and compare the in vitro response to the clinical response, and 2) determine the sensitivity, specificity, positive predictive value (ppv) and negative predictive value (npv) of ctc cultures' response in predicting clinical response including complete response (cr), partial response (pr), stable disease (sd) and progressive disease (pd).

Eligibility criteria:
inclusion criteria: * patients with a metastatic solid tumor malignancy with either liver and/or lung metastasis. patients with newly diagnosed metastatic disease who have not had systemic therapy or are progressing on systemic therapy fitting one of the following cohorts: * patients had a tumor or liquid biopsy with molecular analysis (genomic analysis or other type of molecular characterization) resulting in a therapeutic target with planned targeted therapy by the patient's treating physician. * gastric cancer patients who have failed the first and second line chemotherapy. * bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment. * scheduled to initiate systemic treatment for management of their disease. the systemic treatment will be either cytotoxic chemotherapy or targeted therapy but not checkpoint inhibitor immunotherapy. * ≥18 years of age * written informed consent obtained and signed * able to have blood collection without excessive difficulty exclusion criteria: * patient unwilling or unable to complete informed consent * currently pregnant or lactating women * physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
outpatient parenteral antimicrobial therapy (opat)

Conditions: Infections

Summary: outpatient parenteral antimicrobial therapy (opat) has been recognised as a useful, cost-effective and safe alternative to inpatient treatment, but no formal opat unit existed in switzerland until recently. in december 2013 an opat unit was established at lausanne university hospital. the investigators plan to investigate the efficacy, safety and economicity of outpatient parenteral antimicrobial therapy administered at the new opat unit of the lausanne university hospital starting in january 2014 until december 2020.

some patients require parenteral antibiotic therapy, but are well enough to return home. outpatient parenteral antimicrobial therapy (opat) was first developed in the usa in the 1970s for patients with cystic fibrosis, before being adopted by other countries. it has been recognised as a useful, cost-effective and safe alternative to inpatient treatment. it is now a standard care in several countries and different national guidelines have been established. there are various models of care for opat and most opat centres provide hospital-centred nursing programmes or services based on nurses visiting the patient's home. a few centres have also shown that self-administration of intravenous antibiotic therapy is an effective and safe option for selected patients. furthermore, use of continuous infusion of antibiotics increases the number of feasible treatments. continuous infusion by pumps of antibiotics with a time-dependent killing mechanism is a practical option which has been described. in europe, even if many infectious disease specialists feel that opat is required, it is still underdeveloped because of lack of funding, lack of leadership and lack of coordination between hospitals and community care. in the last decades, programs to enhance care delivery on an outpatient basis in order to contain health costs have been developed in switzerland. however administration of outpatient intravenous antibiotic therapy for patients who require parenteral therapy, but are otherwise fit enough to go home, hasn't been used widely until recently. in december 2013, an outpatient parenteral antibiotic treatment (opat) unit was initiated at lausanne university hospital with the goal of offering an alternative treatment programme that is equally effective and as safe as inpatient treatment. the purpose of this study will be to investigate the efficacy, safety and economicity of treatments administered at the new opat unit of the university hospital of lausanne in the context of the swiss health system.

Eligibility criteria:
inclusion criteria: * patients referred to the opat unit of lausanne university hospital exclusion criteria: * unable to give informed consent * refusing participation
study evaluating the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of sam-315 in healthy adults

Conditions: Alzheimer Disease

Summary: to assess the safety and tolerability of ascending single oral doses of sam-315, an investigational drug, in healthy adult subjects. to obtain a preliminary pharmacokinetic (pk) and pharmacodynamic (pd) profiles of sam-315 in healthy subjects and to evaluate the effect of a high-fat meal on the pk of sam-315, an investigation drug, administered to healthy adult subjects.


Eligibility criteria:
inclusion criteria: * men and women of nonchildbearing potential aged 18 to 45 years * body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ecg). alanine aminotransferase (alt), aspartate aminotransferase (ast), and creatinine levels must be within the upper limit of normal for eligibility. exclusion criteria: * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ecgs, or clinical laboratory test results. * consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours and, grapefruit, grapefruit-containing products is prohibited 72 hours before study day 1.
fibrin sealant in esophageal surgery

Conditions: Anastomotic Leak

Summary: anastomotic leakage remains a major complication after esophageal surgery. amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. the investigators aimed to investigate feasibility of additional sealing by means of autologous fibrin sealant of the esophageal anastomosis.


Eligibility criteria:
inclusion criteria: * aged 18 - 90 years * scheduled to undergo elective minimal invasive esophageal surgery with thoracic or cervical anastomosis (i.e. ivor lewis, orringer or mckeown esophagectomy). * physical status (american society of anesthesiologists) of 3 or lower exclusion criteria: * other malignancies * previous esophageal surgery were excluded

Keywords: esophagogastric anastomosis fibrin sealant sealing
long term outcomes following hernia repair with mesh

Conditions: Abdominal Hernia

Summary: the objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.

this is a large scale registry of prospectively collected medical record data and self-reported outcomes for those patients undergoing abdominal hernia repair with mesh.

Eligibility criteria:
inclusion criteria: * abdominal hernia repair using mesh exclusion criteria: * less than 18 years old
evaluation of clinical and molecular biomarkers in immunotherapy treatment in gynecologic cancer

Conditions: Cervical Cancer; Endometrial Cancer

Summary: background: immunotherapy has changed the therapeutic approach for gynecologic gynecological malignancies such us endometrial and cervical cancer. despite literature data support the strong effect of immunotherapy in these cancers, a share of patients do not respond to immunotherapy. furthermore the extremely variable immune-related spectrum of toxicity in terms of events and timing makes it necessary to identify predictive factors for the development of these side effects. hyphotesis: to evaluate the presence of biochemical, bioumoral and or molecular predictive factors in patients affected by endometrial and cervical cancer treated with immunotherapy plus chemotherapy, immunotherapy plus tyrosine kinase inhibitors (tki) or immunotherapy alone. methodology: we will retrospectively collect data about patients affected by advanced, recurrent or metastatic endometrial cancer (ec) and recurrent cervical cancer (cc) treated with immunotherapy. we will investigate whether there is a statistically significant difference in the efficacy of immunotherapy according to biochemical, biohumoral and or molecular factors and survival outcomes. moreover, we will evaluate whether there is a correlation between biochemical, biohumoral and or molecular factors and immune-related adverse events (irae).


Eligibility criteria:
inclusion criteria: * females aged ≥ 18 years at the time of inclusion in the study. * patients diagnosed with advanced, metastatic or recurrent endometrial and cervical cancer treated at the fondazione policlinico universitario agostino gemelli irccs. * patients with histological confirmation of endometrial and cervical cancer, according to the histotypes suitable for immunotherapy. * patients previously treated under nominal use and/or expanded access program (eap) programs can be enrolled in the study. * patients who have received at least 1 dose of immunotherapy after starting treatment. * signature of the informed consent or declaration in lieu of the consent form where applicable exclusion criteria: * use of immunotherapy within an experimental protocol. * patients who continued therapy at another center.
biomarkers of aneurysm wall strength

Conditions: Abdominal Aortic Aneurysm

Summary: the purpose of this study is to identify possible in vivo biochemical and biological markers related to aortic wall strength.

rupture of an abdominal aortic aneurysm (aaa) is potentially lethal. prophylactic surgical repair is therefore warranted when the risk of rupture exceeds the risk of complications following surgery. aneurysm rupture occurs when the forces (stress) acting on the aneurysm wall surpass aneurysm wall strength. information on both wall stress and strength might therefore improve rupture risk assessment and patient selection for prophylactic repair. although aneurysm wall stress calculations are possible, no in vivo method exists to determine aneurysm wall strength. this study was designed to identify possible biomarkers of aneurysm wall strength

Eligibility criteria:
inclusion criteria: * patient scheduled for transabdominal aortic surgery exclusion criteria: * patient characteristics and aneurysm anatomy suitable for endovascular repair * previous aortic surgery

Keywords: aneurysm rupture
screening women with prior hpv for anal neoplasia

Conditions: HPV-related Lower Genital Tract Neoplasias; HPV-related Anal Neoplasias; Early Stage Lower Genital Tract Cancers

Summary: the goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in hiv uninfected women with a history of lower genital tract neoplasias and cancers.

this single arm trial will enroll 300 hiv uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, hpv testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. participants will undergo evaluation at baseline and then at 12 and 24 months. the investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. the trial is expected to run from 2021-2027.

Eligibility criteria:
inclusion criteria: * women with a history of pathologically proven high-grade genital hpv-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer) * documented hiv seronegativity * aged 35 years and older * seen in the mount sinai health system (mshs) or the harris health system (hhs) in houston * english or spanish speaking exclusion criteria: • prior history or high resolution anoscopy

Keywords: anal cancer anal precancerous anal high grade intraepithelial lesion anal cytology high resolution anoscopy anal human papilloma virus testing
personalized robotic neurorehabilitation for stroke survivors

Conditions: Stroke Acute

Summary: the aim is to carry out a first clinical study, to expand existing knowledge about the neurophysiological mechanisms underlying post-stroke recovery. the information acquired during this phase will be used as building blocks to develop customized protocols. understanding the mechanisms underlying stroke-induced motor deficits and motor recovery is mandatory to improve clinicians; ability to guide the repair of the affected neural structures. the motor system comprises a network of cortical and subcortical areas interacting via excitatory and inhibitory circuits, thereby governing motor behaviour. stroke lesions cause neural dysfunction both at the lesion site and in remote brain regions. abnormal interactions among cortical regions within the motor network contribute to the motor impairment after stroke. longitudinal analysis of neural activity and connectivity can help to understand the pathophysiology mechanisms underlying functional impairment and recovery after stroke. analysis of the data will try to extract biomarkers of plasticity and recovery that will be used to design customized therapeutic interventions.

consecutive stroke patients admitted to the stroke unit will be enrolled. both ischaemic and hemorrhagic strokes above 18-years of age will be recruited. a dedicated encrypted database will be developed, and the following items will be collected: age, sex, aetiology of stroke, toast classification, modified rankin scale before stroke and at the discharge from the stroke unit and after 3 months from the stroke (in survivors), nihss at the onset, at the discharge from the stroke unit, and after 3 months from the stroke (in survivors), neuroimaging studies at the onset (ct, angioct, mri) and the follow up, acute treatment (for ischaemic strokes, fibrinolysis, primary or rescue thrombectomy, standard care), comorbidity (diabetes, hypertension, smoking habits, heart disease, atrial fibrillation, etc), biochemical and genetic biomarkers from blood and urine. the clinical and biochemical section of our database will include "yes or no" dichotomic items agreed by all groups in a preliminary consensus phase, specifically designed to define the clinical features known to be relevant in strokes.

Eligibility criteria:
inclusion criteria: * unilateral motor deficit (with or without other stroke- related symptoms or signs) * radiological evidence of unilateral, supratentorial cerebral ischemic lesion (or lesions) in the same arterial territory * stroke occurred in the last 4 days * absent or slight disability before stroke estimated by a modified rankin scale 0-2 exclusion criteria: * history of severe cognitive impairment * psychiatric comorbidities * end-stage organic diseases like cardiopulmonary, hepatic, renal failure, neoplasms, and whatever condition that could strongly reduce life expectation

Keywords: stroke recovery biomarkers eeg machine learning upper extremities