Kornimate/medical-research-clean huggingface dataset:
study comparing tutomesh® repair to conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction

Conditions: Potentially Contaminated Hernia Repair; Potentially Contaminated Abdominal Wall Reconstruction

Summary: this is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (tutopatch® and tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction. the hypothesis is that using tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.


Eligibility criteria:
inclusion criteria: * patient presenting with an incisional hernia or complicated hernia contraindicating the use of non absorbable mesh: * infected incisional hernia: abdominal wall abscess, chronic fistula * incisional hernia with high septic potential: incisional hernia with strangulation of one or more intestinal loops, repair of incisional hernia during surgery requiring opening of the digestive tube (digestive resection, restoration of digestive continuity, gastro-intestinal perforation, peritonitis from digestive origin) * recurrent incisional hernia with problem of cutaneous healing * incisional hernia requiring important intestinal adhesiolysis * patients signing informed consent form after reading and understanding the information letter _ patients are more than 18 year old exclusion criteria: * patient with major anesthetic risk (asa 4) * patient suffering from immunodepression or under immunosuppressor treatment (corticoids...) * patients already enrolled in another study * patient suffering from severe disease not allowing a 1-year follow-up * patient refusing to be enrolled after consulting the information letter * patient presenting with a too large incisional hernia, superior to 140x200 mm * pregnancy

Keywords: bovine pericardium bioprosthesis contamination hernia repair abdominal wall reconstruction tutomesh tutopatch potentially contaminated hernia repair potentially contaminated abdominal wall reconstruction
safety and efficacy of high-dose leukocytapheresis using a large filter in refractory asthma

Conditions: Bronchial Asthma

Summary: extracorporeal leukocytapheresis (lcap) or granulocytapheresis (gcap) has been used in the treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown promising safety and efficacy. lcap and gcap seem to be effective for steroid-resistant inflammation. the investigators have already reported safety and efficacy of gcap in refractory asthma and expect the beneficial effect of lcap in refractory asthma. in this study, in order to improve the therapeutic effect of lcap by increasing the quantity of leukocytes that were removed, the investigators conducted a clinical study to investigate safety and efficacy of high-dose lcap performed using a larger filter and an increased dose of the blood volume per body weight treated, as an possible therapy for refractory asthma.


Eligibility criteria:
inclusion criteria: * patients fulfilled the 2001 criteria for refractory asthma in american thoracic society. exclusion criteria: * pregnant women. * patients with severe cardiovascular diseases. * patients with infective diseases. * patients with leukocytopenia or anemia.

Keywords: extracorporeal leukocytapheresis
efficacy, safety, and tolerability of spd489 in adults with schizophrenia and predominant negative symptoms

Conditions: Schizophrenia and Predominant Negative Symptoms

Summary: to explore the efficacy of spd489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the scale for the assessment of negative symptoms (sans).


Eligibility criteria:
inclusion criteria: * adults aged 18-55 * clinically stable schizophrenia and predominant negative symptoms * taking a stable dose of antipsychotic medication exclusion criteria: * clinically notable positive symptoms defined by panss

Keywords: schizophrenia
organ donation and hydrocortisone treatment

Conditions: Brain Death

Summary: brain death patients who are selected for organ donation very often suffer from haemodynamic instability. to treat this, high amounts of vasoactive drugs(norepinephrine) may be needed to raise blood pressure. however,norepinephrine may have negative influence on several organs causing reduced blood flow ischemia. our hypothesis is that hydrocortisone treatment may reduce the amount of vasoactive drugs needed to keep the blood pressure stable in patients selected for organ donation.

when patients are treated in the icu only as possible organ donators they will be assessed for eligibility for the study. iv hydrocortisone or placebo will be administered every 6 hours. several hormonal samples will be collected.

Eligibility criteria:
inclusion criteria: all have to be fulfilled * severe brain injury or subarachnoid hemorrhage which progrediates to brain death and patients are treated only as candidates for organ donation in the icu * no other reasons for treatment than organ donation * informed consent from official representative exclusion criteria: * age under 18 * pregnancy * corticoid treatment before study entry * adrenal insufficiency * hypophyseal insufficiency * treatment with etomidate one week before study entry * participating in an other study * no informed consent

Keywords: brain death subarachnoid hemorrhage traumatic brain injury brain injury intracerebral hemorrhage organ donation
the incidence of hepatitis b in diffuse large b-cell lymphoma/chronic lymphoid leukemia hbsag-positive treated with rituximab, chemotherapy and tenofovir alafenamide

Conditions: Large-B-cell Diffuse Lymphoma; Chronic Lymphoid Leukemia

Summary: in this study, we will evaluate the incidence of hepatitis b virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and taf in patients with diffuse large b-cell lymphoma/chronic lymphoid leukemia hbsag-positive.

this is a prospective, multicenter, interventional, single arm, evaluating the incidence of hepatitis b virus (hbv) reactivation within the first 6 months treatment period in hbsag positive patients treated for dlbcl/chronic lymphoid leukemia with rituximab, standard chemotherapy, and taf. approximate duration of the recruitment period based on the number of patients available the duration of the recruitment period has been estimated at 12 months. patients will receive rituximab+chemotherapy+taf for 6 months, followed by taf as monotherapy for further 12 months. all subjects will receive taf 1-3 weeks before rituximab+chemotherapy and withdrawn 12 months after the completion of chemotherapy. then patients will be also observed for further12 months

Eligibility criteria:
inclusion criteria: * signed written informed consent according to ich/eu/gcp and national local laws. * male/non-pregnant/non-lactating female subjects \>18 years old with newly diagnosed dlbcl/chronic lymphoid leukemia who are going to receive treatment with rituximab in combination with chemotherapy. * hbsag positivity, serum hbv-dna negative or positive (\<2000/iu), and normal liver function, including alanine aminotransferase(alt), aspartate aminotransferase(ast) and bilirubin. (inactive carriers). * no previous treatment with antiviral drugs for hbv infection. * patients with satisfactory renal function. exclusion criteria: * hepatic insufficiency for any reason * history of other liver diseases such as hepatitis c, d, autoimmune hepatitis, primary biliary cirrhosis, wilsons' disease * positive viral markers, such as igm antibody to hepatitis a virus, hepatitis c virus, igg antibody to hepatitis d virus, igm antibody to hepatitis e virus, or antibody to hiv * pregnant or breastfeeding women * other major systemic diseases, such as active infection, significant cardiac disease, neurological deficit or psychiatric disorder, that the investigators consider being a significant risk * patients with moderate or severe renal failure. * intolerance to any of the components of the therapeutic regimen. treatment with any investigational medicinal product (unapproved) in the last 30 days. * any other disorder that, in the investigator's opinion, makes the patient ineligible for recruitment or that could interfere in his/her participation or in the conclusion of the study.

Keywords: diffuse large b-cell lymphoma chronic lymphoid leukemia hbsag-positive rituximab chemotherapy alafenamide hepatitis b virus reactivation
ultra-rapid opiate detoxification using deep sedation and prior oral buprenorphine preparation.

Conditions: Opioid Addiction

Summary: the methods of detoxification under general anesthesia have been criticized because of limited data on safety and long-term follow-up. premedication with buprenorphine has been advocated to improve safety. in current study we want to evaluate the importance of buprenorphine preparation in rapid opioid detoxification process, under general anesthesia.


Eligibility criteria:
inclusion criteria: * opioid addiction exclusion criteria: * age \< 18 pregnancy
natural history study in patients with pde6a-, pde6b- and rho-linked retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the aim of the study is to apply a novel clinical investigation protocol in patients with phosphodiesterase 6a (pde6a), pde6b and rhodopsin (rho)-based retinitis pigmentosa. this novel, multimodal clinical examination protocol describes and correlates structural, functional and metabolic aspects during natural disease development. test-retest variability of new measurements as well as correlations of the structural, functional, and metabolic changes will be defined to be able to define well-suited readouts for safety and efficacy of future treatment developments before they reach the clinical phase.

hereditary retinal diseases such as retinitis pigmentosa are rare genetic diagnoses of the retina with chronic lifelong progression, often leading to blindness. progression varies greatly between individuals. pde6a, pde6b and rho related retinitis pigmentosa phenotypes are typical retinal dystrophies with early onset of rod dysfunctions and a rather slow progression of the cone dysfunction with progression to complete blindness in later adulthood. classical gene therapy could improve the function of the rods if successful, although the changes may only be very small and need to be measured using sensitive methods. in contrast, neuroprotective therapeutic approaches could slow down these slow processes even further, which would be extremely difficult to prove as clinical efficacy in a future clinical trial with very individual courses. in order to have clinical examination methods in the future that can prove the safety and efficacy of neuroprotective approaches, very sensitive examination methods are needed whose test variability is also known. in addition, a neuroprotective treatment method can positively influence the metabolic state of the retina, which, in contrast to slowing down a slow degeneration process, would be a demonstrable effect if the metabolism of the retina can be examined in a clinically relevant way. for these reasons, the investigators will focus on the above-mentioned genotypes of retinitis pigmentosa in a non-interventional study in order to collect and correlate structural, functional and metabolic examinations of the retina.

Eligibility criteria:
inclusion criteria: * age: from 5 years of age * patient with pde6a, pde6b, and rho-based retinitis pigmentosa * patient and/or legal representatives are willing and able to give written informed consent exclusion criteria: * severe general disease, that would make longer examinations not possible

Keywords: retinal diseases eye diseases eye diseases, hereditary retinal dystrophies retinal degeneration genetic diseases, inborn retinitis pigmentosa pde6a, pde6b, rho gene therapy trial
efficacy and safety of hrs9531 injection in type 2 diabetes subjects

Conditions: Type 2 Diabetes

Summary: to evaluate the efficacy and dose-response relationship of hrs9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.


Eligibility criteria:
inclusion criteria: 1. male or female subjects ,18-65 years of age, agreed and signed the informed consent 2. type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit. 3. treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening. 4. hba1c 7.5-10.5% (both inclusive) at screening visit. exclusion criteria: 1. presence of any clinically significant results in examination at screening visit. 2. uncontrollable hypertension. 3. a history of type 1 diabetes, specific diabetes, or secondary diabetes. 4. acute diabetic complications or severe hypoglycemia events within 12 months prior to screening. 5. history of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening. 6. any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix. 7. present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness. 8. surgery is planned during the trial. 9. mentally incapacitated or speech-impaired. 10. pregnant or lactating woman. 11. in the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
feasibility and acceptability of the clinical frailty scale in a swedish emergency department setting

Conditions: Frailty

Summary: the purpose of this study is to evaluate the feasibility and acceptability of the clinical frailty scale (cfs). the scale can potentially be adopted for daily use in the emergency department (ed) and have been evaluated with regard to feasibility to a certain extent, but have so far not been evaluated in the swedish emergency care context.

the cfs is introduced and tested as part of a quality-improvement process regarding elderly people within the three emergency departments (ed) of region östergötland. cfs is a 9-point scale developed within the canadian study of health and aging, a pictograph and a clinical description aids to assign scores from very fit to terminally ill. the scale enable clinicians to stratify elderly people's degree of frailty with the help of questions and clinical assessment. however, even excellent tools will not be used if they are too difficult or time consuming. the amount of papers addressing issues regarding feasibility and acceptability of the cfs in a clinical ed-setting is still limited, and for swedish eds non-existent. this study is part of a larger research project, data will be collected in three ways: a. all eligible patients who visit the ed for a period of six weeks will be enrolled, and subsequently assessed with cfs by one of their responsible health-care professionals (i.e. physician, registered nurse or nurse assistant). the number of screened patients divided by the total number of eligible patients will yield the screening rate. patient- and organisational related characteristics will be collected from the electronic health record. b. 100 patients will be assessed when someone from the research team is present to enrol patients and clock the assessments. these work shifts will be selected using the online application research randomizer, to randomly include all hours of the day as well as eligible health-care professionals. the research-team member will document the time to complete the assessment using cfs, which will give us the screening time. c. to assess acceptability, health-care professionals will be sent a questionnaire per email, including two reminders. the questionnaire will consist of likert scales, multiple-choice questions and open textboxes with the aim to explore facilitators and barriers for screening completion. primary aim: to explore the feasibility and acceptability of the cfs in a swedish emergency care context.

Eligibility criteria:
inclusion criteria: * has been in clinical work at the ed for the period of the current study exclusion criteria: * unwilling to provide informed consent

Keywords: frailty geriatric assessment emergency service feasibility studies geriatric emergency medicine
cigarette and e-cigarette flavors manipulations in the experimental tobacco marketplace

Conditions: Tobacco Use Disorder

Summary: this is a one-session study that participants complete remotely including consent, experimental tobacco marketplace purchases, and assessments to examine the effects of cigarette and e-cigarette flavors on cigarette demand and substitution in the experimental tobacco marketplace.

this study uses a mixed design (within-subject repeated measures and between-group). participants will be assigned to two different groups according to their preferred cigarette flavor (tobacco/menthol). every participant will complete behavioral tasks and make hypothetical purchases of tobacco products in an online store under four different scenarios: a) e-cigarette flavor restricted and cigarette flavor restricted, b) e-cigarette flavor unrestricted and cigarette flavor restricted, c) e-cigarette flavor restricted and cigarette flavor unrestricted, d) e-cigarette flavor unrestricted and cigarette flavor unrestricted.

Eligibility criteria:
inclusion criteria: * currently smoke at least 10 cigarettes per day * have smoked at least 100 cigarettes (lifetime), and * are 21 years of age or older. exclusion criteria: * inaccurate identification of usual brand of cigarette's as menthol or non-menthol

Keywords: cigarette e-cigarette behavioral economics tobacco control
inflammatory genetic polymorphism and acute lung injury after cardiac surgery

Conditions: Acute Lung Injury

Summary: acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. several genetic polymorphism of inflammatory mediators have been reported to be associated with severity of sepsis and ards, but the association of these inflammatory polymorphism and acute lung injury after cardiac surgery has never been reported. this study is performed to investigate the association of genetic polymorphisms including tnf -308a/g, il-10 -1082a/g and il-6 -572c/g and postoperative lung injury.


Eligibility criteria:
inclusion criteria: * chinese han unrelated population * adult patients * undergoing elective cardiac surgery with cpb exclusion criteria: * malignant tumor * autoimmune disease, immunodeficiency or immunosuppressive therapy * chronic renal disease (glomerular filtration rate \ a) * copd, tuberculosis or other chronic pulmonary diseases * anemia with hemoglobin lower than 90mmhg * bleeding disorders * postoperative pericardial tamponade requiring re-operation * postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.

Keywords: single nucleotide polymorphism cardiopulmonary bypass cardiac surgery
manual therapy with directed vestibular rehabilitation in patients with unilateral peripheral vestibular hypofunction.

Conditions: Peripheral Vestibular Disorder

Summary: randomized clinical trial with a control group that aims to evaluate the effects of a manual therapy protocol, together with a physical therapist-directed vestibular rehabilitation program, in patients with unilateral peripheral vestibular hypofunction. the intervention period will last approximately 4 weeks. outcome measures will be collected at baseline, just after the intervention, as well as 1 and 6 months after the intervention.

peripheral vestibular disorders are common in otorhinolaryngology practice. these patients often complain of vertigo and dizziness, as well as balance problems, causing an important impact on health-related quality of life. the objective of this study was to investigate the effects of manual therapy combined with physical therapist-directed vestibular rehabilitation in patients with unilateral peripheral vestibular hypofunction. the design of this study is a randomized controlled trial with two groups (experimental and control groups). the impact of dizziness on daily function and quality of life (dizziness handicap inventory), the fear of falling and the balance confidence (activities-specific balance confidence scale-16 items), postural control (stabilometric platform) as well as the intensity (visual analogue scale) and number of the vertiginous crisis will be determined. the intervention period will last four weeks. participants of the experimental group will receive 4 sessions of manual therapy together with physical therapist-directed vestibular rehabilitation, while participants of the control group will receive home-based vestibular rehabilitation. outcome measurements will take place at baseline, immediately after the intervention, one month and six months after the intervention. within-group and between-group data will be analyzed and interpreted.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years with a clinical diagnosis of unilateral peripheral vestibular hypofunction confirmed by video head impulse test (\< 0.8), referring balance impairments, postural instability, gait instability, vertigo, dizziness or motion sensitivity, able to understand and complete e instructions, programs, and protocols of this project, and providing a signed informed consent. exclusion criteria: * central nervous system, degenerative or cancer diseases, acute infection. * morphological/ functional alterations of the lower limbs, and/or morphological alteration of the cervical and/or suboccipital rachis. * conditions (i.e. neuromuscular disease or traumatism) that contraindicate the performance of the exercises and interventions of this study, as well as cognitive impairment that prevents the participants from understanding and completing the questionnaires and interventions. * positive results for the klein test and the rancurel test, or cerebrovascular alterations.

Keywords: manual therapy; vestibular rehabilitation; unilateral peripheral vestibular hypofunction; dizziness; balance confidence; postural control.
transcriptomic profiling in severely injured patients

Conditions: Trauma; Inflammation; Sepsis

Summary: discovery of differences in the host response in patients with systemic inflammation and sepsis, and identification of novel, specific markers by using a longitudinal clinico-transcriptomic approach.

the aim of this study is to link defined clinical phenotypes with data on rna obtained from blood samples by high throughput technologies. genetic and molecular characteristics of the immune system after severe trauma will be crosslinked to clinical aspects of posttraumatic organ failure, with the goal of identifying typical molecular "fingerprints". patients with and without sepsis or organ failure will be compared with the goal to develop a diagnostic test designed to predict the clinical course following severe trauma. criteria for study enrollment includes patient age ≥18 y, an injury severity score (iss) ≥ 17 points, and time from injury to admission \< 6 h. whole blood from trauma patients will be collected within the first 6 h after trauma (day 0) and on days 1, 2, 3, 5, 7, 10, 14, and 21.

Eligibility criteria:
inclusion criteria: * patient age ≥18 y * injury severity score (iss) ≥ 17 points * time from injury to admission \< 6 h. exclusion criteria: moribund patients with: * ph \< 7,1 or * lactate \> 15 mmol/l or * base deficit \> 15 meq/l

Keywords: transcriptome profiling