Kornimate/medical-research-clean huggingface dataset:
irreversible electroporation(ire) for uterine cervical neoplasms

Conditions: Uterine Cervical Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable uterine cervical neoplasms.

by enrolling patients with unresectable uterine cervical neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable uterine cervical neoplasms.

Eligibility criteria:
inclusion criteria: * uterine cervical neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable uterine cervical neoplasms
iron supplementation among low-income postpartum women

Conditions: Anemia

Summary: anemia is common among low-income women after they have given birth. anemia, or low hemoglobin in the blood cells, is usually caused by not having enough iron. blood cells usually carry oxygen to other parts of the body. without enough hemoglobin, the ability of blood cells to carry oxygen is decreased. memory and work may be impaired. the purpose of this study is to evaluate three methods of giving iron to prevent anemia among low-income women after they have given birth.

currently the centers for disease control and prevention recommendations to prevent iron deficiency advocate selective screening and treatment of anemia at about 6 weeks postpartum. however, among some groups, such as low income women, data suggest that anemia and iron deficiency are common. this study aims to evaluate the effectiveness of three stategies to prevent iron deficiency among low income postpartum women in mississippi. comparisons: clinics will be randomized to one of three strategies: 1)selective anemia screening and treatment of anemic women, 2)universal anemia screening and treatment of anemic women, or 3)universal iron supplementation of 65 mg a day for three months.

Eligibility criteria:
inclusion criteria: * postpartum girls and women, 2-6 weeks after birth * age 13 years or more * wic certified exclusion criteria: * sickle cell anemia * hemoglobin \< 7 g/dl

Keywords: anemia postpartum iron supplements
efficacy study of drug-eluting and bare metal stents in bypass graft lesions

Conditions: Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Summary: the aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting

a large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. while there is a plenty of data about the efficacy of des in complex lesions or diabetics, no randomized data exist about the efficacy of des in coronary artery bypass graft lesions.

Eligibility criteria:
inclusion criteria: * patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in cabg * written, informed consent by the patient or her/his legally-authorized representative for participation in the study. * in women with childbearing potential a negative pregnancy test is mandatory exclusion criteria: * cardiogenic shock * target lesion located in the native coronary vessels. * in-stent restenosis of cabg * target lesion located at internal mammary artery graft or free arterial graft * malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. * known allergy to the study medications: clopidogrel, rapamycin, paclitaxel, stainless steel. * inability to take clopidogrel for at least 6 months. * pregnancy (present, suspected or planned) or positive pregnancy test. * previous enrollment in this trial. * patient's inability to fully cooperate with the study protocol.
safety study of renal function in patients with chronic kidney failure taking lumiracoxib or diclofenac for arthralgia

Conditions: Kidney Failure, Chronic; Arthralgia

Summary: the purpose of this study is to determine whether the use of lumiracoxib in this particular population is associated with a decrease in glomerular filtration rate (gfr) compared to diclofenac; and to compare the magnitude of such impairment, if any, associated with use of lumiracoxib and diclofenac.


Eligibility criteria:
inclusion criteria: * chronic joint pain, requiring analgesia * pre-existing chronic kidney injury, stage k/doqi iii (gfr 30 - 59 ml/min) * in a stable phase of ckd (i.e. not aki, not hospitalized) * without contraindications for nsaid therapy * who have signed an informed consent exclusion criteria: * having received any nsaid 2 weeks prior to study start * history of / actual pud * patients with esrd (k/doqi iv, v or replacement therapy) * history of hypersensitivity or allergies to any of the treatments * history of / actual gi bleeding * with impaired liver function tests * using acei / arb

Keywords: kidney failure, chronic arthralgia nsaid diclofenac lumiracoxib safety
lateral arm free flap: a useful flap in the maxillo-facial surgeon's therapeutic armory, case series

Conditions: Reconstructive Surgery

Summary: lateral arm free flap harvesting has been well described, it however remains underused compared to other free flaps such as radial forearm and anterolateral thigh free flap. due to its easy harvesting, low donor site morbidity, versatility as well as useful possibilities of modifications it should be considered more often as valuable reconstruction option in head and neck defect. with this publication we want to describe the operative technique, illustrate it with postoperative pictures and describe the outcome with 8 of our cases operated at university hospital in lausanne, switzerland. the aim of this study is to be a useful tool for young surgeons and demonstrate the advantages of this useful flap in head and neck reconstructions.


Eligibility criteria:
inclusion criteria: * \> 18 years old * operated between 01 january 2021 and 12 december 2022 * lateral arm free flap operation for primary or secondary cervicofacial reconstruction * written informed consent exclusion criteria: * minor patients * no written informed consent

Keywords: free flaps reconstructive surgery microvascular surgery maxillofacial surgery
effectiveness of trauma therapy in patients with ptsd and comorbid psychotic disorder

Conditions: Post Traumatic Stress Disorder; Psychotic Disorders; Psychosis; Schizophrenia; PTSD

Summary: effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (ptsd) in patients with comorbid psychotic disorder

background and goals: patients with psychotic disorders often report traumatizing experiences in their biography and show symptoms of a trauma-related disorder. it is assumed that around 30 percent of patients with a psychotic disorder also meet the criteria for ptsd. for the vast majority of patients, psychosis is the focus of mostly pharmacological treatment, while ptsd is not part of the therapy. in a first randomized controlled study, van den berg's dutch working group was able to show that psychosis patients with comorbid ptsd who were given a classic trauma exposure procedure showed a high response to ptsd symptoms (van den berg et al., 2015). it is also important that in this study the trauma exposure did not lead to an increase in psychotic symptoms or undesirable side effects (e.g. suicidality). in order to examine the question of the generalizability of the effects, a randomized controlled study in the german-speaking health care system is necessary. in the following efficacy study in which psychosis patients with ptsd are treated using prolonged exposure. methods and results: it is a multicenter, controlled, prospective, randomized study (rct). it is investigated whether trauma therapy reduces ptsd and psychosis symptoms compared to the treatment-as-usual waiting group (tau). the primary endpoint is the severity of the ptsd symptoms between the baseline measurement and the 6-month follow-up. secondary endpoints are subjective ptsd symptoms, paranoia, hallucinations, and wellbeing.

Eligibility criteria:
inclusion criteria: * have a diagnosis of a post traumatic stress disorder (ptsd spectrum disorder (icd-10, f43.1, confirmed by scid-5 and caps) * have a diagnosis of a schizophrenia spectrum disorder (icd-10, f2, confirmed by scid-5) * patients will be reporting distressing ah for at least six months (to be beyond the startle and adjustment phase ) and score ≥ 3 on either item 8 or item 9 of the psyrats-ah; * be ≥ 18 years of age * good knowledge of the german language * willingness to participate in randomization and trauma-focused therapy exclusion criteria: * changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects) * any substance addiction with continued use other than nicotine and / or caffeine addiction * iq of 70 or less * acute suicidality * pregnant women

Keywords: pepsy prolonged exposure trauma psychotherapy
radical gastrectomy and hyperthermic intraperitoneal chemotherapy (hipec) in locally advanced gastric cancer

Conditions: Malignant Neoplasm of Stomach

Summary: the efficacy of hipec in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. the hypothesis of the trial is that radical gastrectomy plus hipec is superior to only radical gastrectomy in terms of overall survival.

to determine the efficacy of hipec in the treatment of locally advanced gastric cancer, patients are randomized into hipec group and control group. in hipec group, the patients undergo radical gastrectomy with d2 lymphadenectomy and hipec with paclitaxel and 5-fu. patients in the control group just undergo radical gastrectomy with d2 lymphadenectomy. patients in both groups receive 6 cycles of postoperative chemotherapy (sox or xelox) and are followed up for 5 years or until death. the trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Eligibility criteria:
inclusion criteria: * histological proved diagnosis of locally advanced gastric cancer. * no evidence of distant metastases or peritoneal metastases. * preoperative examination (ct/mri) demonstrated resectable gastric cancer with t3-t4 stage. * eligible for radical gastrectomy with d2 lymphadenectomy. * have not received cytotoxic chemotherapy or radiotherapy. * written informed consent is obtained prior to commencement of trial treatment. exclusion criteria: * existence of distant metastasis or peritoneal metastasis during surgery (m1). * any previous chemotherapy or radiotherapy * active systemic infections * inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * female patients who are pregnant or breast feeding
pathogenic study of adult immune enteropathies

Conditions: Celiac Disease; Autoimmune Enteropathy; Inflammatory Bowel Diseases

Summary: the study focuses the mechanisms underlying the loss of intestinal homeostasis in celiac disease, refractory celiac disease and other immune diseases such as monogenic enteropathy, inflammatory bowel diseases or drug induced intestinal diseases. mechanisms of transformation of lymphocytes leading to onset of lymphomatous complications of immune enteropathies will be investigated. mechanisms of loss of hepatic lymphocytic homeostasis will also be assessed in liver associated diseases.


Eligibility criteria:
inclusion criteria: * 18 years or over * affiliated to social insurance * signed informed consent exclusion criteria: * pregnancy * under guardianship * not able to sign informed consent

Keywords: celiac disease autoimmune enteropathy primary immunodeficiency intestinal lymphoma liver autoimmune diseases
neurocognition and work productivity in major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this study will investigate the relationships between subjective cognitive complaints, neurocognitive deficits, and work productivity in participants with major depressive disorder (mdd), before and after 8 weeks of treatment with an antidepressant medication. our hypothesis is that, in working participants with mdd of at least moderate severity, neurocognitive deficits will predict poorer work functioning and productivity.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of major depressive disorder as per dsm-iv-tr 2. current employment of at least 15 hours per week 3. baseline score of 23 or greater on the montgomery-asberg depression rating scale, indicating at least moderately severe depression 4. baseline score of 6 or greater on the british columbia cognitive complaints inventory, indicating at least moderate subjective cognitive complaints 5. competency to give informed consent exclusion criteria: 1. current receipt of short-term or long-term disability benefits from employer 2. serious suicidal risks as judged by the investigators 3. other dsm-iv-tr diagnoses: 1. organic mental disorders 2. active substance abuse/dependence, including alcohol 3. schizophrenia, paranoid or delusional disorders, or other psychotic disorders 4. (as primary diagnosis:) panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder 5. bipolar disorder 6. bulimia nervosa or anorexia nervosa 4. serious illness that is not stabilized, including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease 5. regular/current use of other psychotropic drugs and/or herbaceuticals 6. use of fluoxetine within 5 weeks of visit 1, monoamine oxidase inhibitors within 14 days of visit 1, and other antidepressants within 7 days of visit 1 (all to ensure adequate drug washouts prior to neurocognitive assessment) 7. previous treatment with desvenlafaxine 8. treatment-resistance in the current episode, as defined by failure (i.e., lack of clinically significant response) of 2 or more antidepressants given at therapeutic doses for at least 6 weeks 9. any history of treatment with electroconvulsive therapy 10. initiation of formal psychotherapy (e.g., cognitive-behavioural therapy or interpersonal psychotherapy) with 2 months of visit 1, or plans to start such psychotherapy during this study 11. current use of any other form of treatment for depression

Keywords: depression cognition occupational functioning productivity neuropsychology desvenlafaxine antidepressants
1-year study to assess the efficacy, safety, and tolerability of glycopyrronium bromide (nva237) in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (nva237) in patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: 1. male or female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure. 2. patients with moderate to severe stable chronic obstructive pulmonary disease (copd, stage ii or stage iii) according to the global initiative for chronic obstructive lung disease (gold) guidelines 2008. 3. current or ex-smokers who have a smoking history of at least 10 pack years. 4. patients with a post-bronchodilator forced expiratory volume in 1 second (fev1) ≥ 30% and \< 80% of the predicted normal, and post-bronchodilator fev1/forced vital capacity (fvc) \< 0.7 at visit 2 (day -14). 5. patients, according to daily electronic diary data between visit 2 (day -14) and visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3 (day 1). exclusion criteria: 1. pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test). 2. women of child-bearing potential, unless using an approved method of medical or surgical contraception. 3. patients requiring long term oxygen therapy (\> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 (day -21) or between visit 1 (day -21) and visit 3 (day 1). 4. patients who have had a respiratory tract infection within 6 weeks prior to visit 1 (day -21). 5. patients who, in the judgment of the investigator or the responsible novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition. 6. patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm\^3 (at visit 1, day -21) and onset of symptoms prior to age 40 years. 7. patients with a history of long qt syndrome or whose qtc measured at visit 1 (day -21) (fridericia method) is prolonged (\> 450 ms for males or \> 470 ms for females. other protocol-defined inclusion/exclusion criteria may apply to the study.

Keywords: copd nva237 glycopyrronium bromide
clinical efficacy of tnfa kinoid in crohn's disease patients

Conditions: Crohn's Disease

Summary: the safety and immunogenicity of the tnfα-kinoid (tnf-k) have been evaluated in a phase i-ii clinical study conducted in subjects with crohn's disease (cd). preliminary results of clinical efficacy are promising. the principal aim of the present study is to confirm the clinical efficacy of the tnf-k in subjects with moderate to severe cd. subjects with secondary resistance or intolerance to anti-tnfα monoclonal antibodies will be enrolled in this trial. in addition, the immune responses and the safety elicited by tnf-k will also be evaluated.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 65 years, inclusive. 2. have had a diagnosis of crohn's disease for at least 6 months. 3. moderate to severe active crohn's disease defined as a crohn's disease activity index (cdai) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved. 4. have developed secondary resistance to anti-tnfα therapy. exclusion criteria: 1. primary non-response to a previously received treatment directed against tnfα or intolerance related to the primary pharmacological effect of anti-tnfα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases. 2. history of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug. 3. treatment with immunosuppressive or immunomodulatory drugs
taurolidine in haemodialysis catheter related bacteraemia

Conditions: Renal Dialysis; Catheter-Related Infections

Summary: the purpose of this study is to determine whether taurolidine with heparin locking solution prevents recurrence of central venous catheter related blood stream infections in haemodialysis patients.

infections related to long-term haemodialysis catheters are associated with significant morbidity. a high proportion of those people initially treated with antibiotics to clear a catheter infection develop a second infection within six months, necessitating the removal and replacement of the dialysis catheter. this study will examine the efficacy of an antimicrobial catheter locking solution called taurolidine with heparin in preventing a second infection within six months of a significant infection. this solution will be compared with the solution used currently (heparin) which is left inside the catheter between dialysis sessions. this is a clinical study given that antimicrobial catheter locks are thought to reduce the risk of blood stream infections and the ultimate need for catheter change. however, there is concern that the absence of an anticoagulant in the lock solution increases the risk of catheter thrombosis, again requiring a change of catheter but for a separate reason. it is unclear therefore whether a solution containing both taurolidine (an antimicrobial) and heparin (an anticoagulant) will increase catheter survival. the results of this study will help guide the appropriate suse of locking solutions in the future.

Eligibility criteria:
inclusion criteria: * haemodialysis patients established on dialysis for greater than 90 days who dialyse in-centre at any of the satellite dialysis units of imperial college healthcare nhs trust * all patients with a recent catheter related bacteraemia with an identified organism grown on microbiological culture and treated without catheter removal will be eligible for inclusion. exclusion criteria: * those individuals in whom attempted catheter salvage is clinically not indicated. * unable to provide informed consent * known allergy to sodium citrate, heparin or taurolidine. * bleeding diathesis or physical cause for active bleeding.
korean crc screening study pt13599

Conditions: Colorectal Cancer

Summary: korean americans report the lowest and declined rates of colorectal cancer (crc) screening, compared to general population in the united states. the present study aimed to evaluate the efficacy of a community-based multifaceted intervention designed to improve crc screening among korean americans.


Eligibility criteria:
inclusion criteria: * participants were eligible to participate in this study if they: 1. were self-identified korean americans; 2. were 50 years and older; 3. did not have a colorectal polyp, crc cancer, or a family history of crc (first degree relative); and 4. non-adherent to crc screening guidelines (never had any crc screening or were overdue for screening). exclusion criteria:
impact of operation on fertility for women with severe endometriosis

Conditions: Deep Endometriosis; Infertility, Female

Summary: the effort study compares the impact on fertility of operation or fertility treatment (ivf, in vitro fertilization) in a multicenter randomized controlled trial. the study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. these women will be randomized to either of the two treatment groups: group a = operation or group b = fertility treatment (ivf). group a will be further divided postoperatively into spontaneous conception or ivf depending on the endometriosis fertility index score.


Eligibility criteria:
inclusion criteria: * rectosigmoid endometriosis and wish for surgery * pregnancy intention for at least 6 months * amh above 5 pmol/ml * maximum of 2 previous ivf treatments * male partner exclusion criteria: * endometriosis involving the ureter unilaterally or bilaterally (randomization unethical) * bmi above 32 * contraindication for ivf (untreated uterine factor infertility, untreated/maltreated systemic or malignant disease, oocyte aspiration severely riskful (e.g. severe abdominal adhesions) * no wish for randomization