Kornimate/medical-research-clean huggingface dataset:
problem-solving therapy for patients with chronic disease and poor mental well-being in general practice

Conditions: Mental Health Impairment; Diabetes Type 2; Ischemic Heart Disease

Summary: in denmark the vast majority of patients with chronic ischemic heart disease and/or type 2 diabetes are managed in general practice. 20% of the patients suffer from poor mental health. problem-solving therapy (pst) is a psychotherapeutic method that is proven effective in adults with poor mental health. pst can be provided in general practice. the main objective of this study is to test effectiveness of providing pst to this group patients.

20% of patients with type 2 diabetes and/or chronic ischemic heart disease have poor mental health. since these patients are managed in general practice interventions targeting poor mental health in these patients should be delivered in here. problem-solving therapy (pst) is a well-established psychotherapeutic method that can be delivered by health care providers in general practice. the main objective of this study is to test the effectiveness of delivering pst for patients with t2d and/or ihs who suffer from poor mental health. we hypothesize that the patients' mental health will be improved after treatment with pst. health care providers from 12 general practices are trained in pst and subsequently provide pst for patients with t2d and/or ihs and poor mental health. patients are recruited at the annual control visit for the chronic disease. all patients are screened for impaired mental health with the who-5 questionnaire. patients with a score below 50 are offered pst. the study is conducted as a stepped wedge cluster-randomised controlled trial with a one-year follow-up. in this design clusters are stepped wise exposed to the intervention. initially all general practices are in the control group. after four months half of the recruited gps attend the pst training programme and switch to performing the intervention. after an additional four months the remaining gps are educated in pst and all gps now perform the intervention. both general practitioners and practise nurses will perform pst consultations. the power calculation is based on: * the primary outcome (phq-9 score at 6 and 12 months. the minimal clinical effect is 5 points) * icc is estimated to 0,05. based on these assumptions we will include 188 patients with ihs or/and t2d (we expect 25% overlap) to obtain a power of 90%.

Eligibility criteria:
inclusion criteria: * +18 years * diagnosed with ischemic heart disease and/or type 2 diabetes * poor mental health defined as who-5 well-being index \<50 points exclusion criteria: * severe mental illness including psychotic disease and suicidal behaviour * unable to read and understand danish
effectiveness of pemf in patients with chronic radicular pain due to lomber disc herniation

Conditions: Lumbar Disc Herniation

Summary: the aim of this study is to investigate the effectiveness of pulse magnetic field therapy on pain, functional status, and quality of life in patients with chronic radicular pain due to lumbar disc herniation.

pulsed electromagnetic field therapy (pemf) is a non-invasive, painless treatment for various injuries, bone related conditions and pains. however, further studies on pemf effects on low back and radicular pain is needed due to lack of studies in this area.

Eligibility criteria:
inclusion criteria: * age 18-65 * unilateral radicular pain for at least 3 months * severity of radicular pain with visual analog score of at least 4/10 * written informed consent exclusion criteria: * pregnancy or lactation * cardiac pacemaker, or any metal implants or electronic devices anywhere in the body * history of surgery or algological procedure of the lumbar region * physical therapy within the last year due to back pain * previous pemf treatment * malignancy or suspicion * polyneuropathy (diabetic or other) * connective tissue disease * presence of inflammatory joint pain * fibromyalgia * presence of open surface wound * tuberculosis, mycosis, or viral disease * presence of pain in another region of the body with higher severity than radicular back pain * use of drugs other than paracetamol-derivative simple analgesics (nonsteroidal aanti inflammatuar, central effective, or narcotic analgesics), or less than three weeks since the discontinuation of these drugs * advanced mood disorder * radiographic evidence of grade 2 spondylolisthesis, presence of spinal instability, and advanced degenerative spondylarthrosis
china stemi care project

Conditions: ST-Elevation Myocardial Infarction

Summary: the china st-elevation myocardial infarction (stemi) care project (cscap) aims to improve the reperfusion treatment rate and shorten the total duration of myocardial ischemia by establishing a regional stemi treatment network covering the whole-city region, whole-city population, and whole-disease process step by step. the cscap is a prospective, multicenter registry involving three phases. a total of 18 provinces, 4 municipalities, and 2 autonomous regions in china were included. patients with stemi who met with the third acute myocardial infarction definition and the chinese stemi diagnosis and treatment guidelines were enrolled and the estimated number is over 50,000. phase 1 (cscap-1) focused on the in-hospital process optimization of primary percutaneous coronary intervention (ppci) hospitals. phase 2 (cscap-2) focused on the ppci hospital-based regional stemi transfer network, including emergency medical services and non-ppci hospitals. phase 3 (cscap-3) focused on the whole-city stemi care network construction by promoting chest pain center accreditation. systematic data collection, assessment of quality of care, and subsequent improvement were implemented throughout the project to continuously improve the quality of care for patients with stemi. cscap is the first project that focused on establishing a regional stemi emergency care network in china to help understand the condition of stemi care in china extensively. moreover, its objective was to optimize the quality of stemi care through in-hospital process optimization (2012-2013), ppci hospital-based regional stemi transfer network construction (2015-2018), and construction of the whole-city stemi care network step by step (2018-2021). however, hospitals were not randomly selected in cscap, which might be because of the lack of representatives to some degree. alternatively, it focused on providing a tailored quality-of-care improvement plan based on the conditions of different regions.


Eligibility criteria:
inclusion criteria: * stemi patients exclusion criteria: * none
a first time in human study to evaluate the safety, tolerability and pharmacokinetics of gsk1399686

Conditions: Inflammatory Bowel Diseases

Summary: a first-time-in-human study to evaluate the safety, tolerability and pharmacokinetics of gsk1399686 after single and repeated oral dosing in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy as determined by a responsible physician * male, or only for the rdf cohort female of non-childbearing potential, between 18 and 65 years of age. * body weight greater than 50 kg (110 lbs) and bmi within the range 18.5-29.9 kg/m2 (inclusive). * qtcb or qtcf \< 450 msec * capable of giving written informed consent exclusion criteria: * the subject has a positive pre-study drug/alcohol screen * history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units * urinary cotinine levels indicative of active smoking or regular use of tobacco * a positive pre-study hepatitis b surface antigen or positive hepatitis c antibody * a positive test for hiv antibody * the subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives of the investigational product * exposure to more than four new chemical entities within 12 months * use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including st john's wort) within 7 days * consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices within 7 days * subject is receiving hormone replacement therapy * history of sensitivity to any of the study medications * history of sensitivity to heparin or heparin-induced thrombocytopenia

Keywords: pharmacokinetics phase 1 first time in humans ibd safety human volunteers
comparison of 22mhz and 18mhz high-frequency probes for the ultrasound study of temporal arteries in patients suspected of having giant cell arteritis

Conditions: Giant Cell Arteritis

Summary: evaluation of the structural features of temporal arteritis using two frequencies probes: 18 and 22mhz.

comparison of the results obtained by using 2 different frequencies probes in the diagnosis of giant cell arteritis

Eligibility criteria:
inclusion criteria: * sedimentation rate\> 50 mm/h or recent unusual headache or unusual fever, recent visual trouble or jaw claudication, or induration temporal arteritis exclusion criteria: * previous diagnosis of giant cell arteritis and relapse of the giant cell arteritis and opposition to participate

Keywords: ultrasound, giant cell arteritis
prevention of ptsd iii: neurocognitive training of emotional regulation

Conditions: Post Traumatic Stress Disorder; Major Depression; Anxiety Disorders

Summary: the proposed work will evaluate the ability of neurocognitive retraining of executive functions and emotional regulation to reduce neurocognitive dysfunctions that follow trauma exposure and thereby prevent ptsd. the scientific rationale for this work is the hypothesis that impaired emotional regulation interferes with the expected recovery from the early responses to traumatic events, leading into a chronic disorder. in an initial phase the investigators will recruit 20 recently traumatized participants among trauma survivors admitted to a general hospital emergency room and test the planned intervention's acceptance and right 'dosing'. in the second phase the investigators will enroll 80 recent survivors into a randomized controlled study of the new intervention. the intervention will consist of web-based neurobehavioral training interventions that instill an emotional bias toward positive stimuli, improve emotion recognition and labeling, reduce resistance to emotional distraction, and enhance executive functioning. control participants will complete web-based video games that do not have emotion-regulatory benefits. outcome measures will include improvement in neurocognitive functioning and in ptsd symptoms.


Eligibility criteria:
inclusion criteria: * adult survivors of traumatic events consecutively admitted to a general hospital emergency department exclusion criteria: * chronic ptsd at the time of the traumatic event. current and lifetime psychotic or bipolar illness, current substance abuse save alcohol, medical condition precluding participation.

Keywords: post traumatic stress disorder (ptsd) major depression secondary prevention neurocognitive retraining randomized controlled trial
irreversible electroporation(ire) for unresectable head and neck neoplasms

Conditions: Head and Neck Neoplasms

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

by enrolling patients with unresectable head and neck 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 head and neck neoplasms.

Eligibility criteria:
inclusion criteria: * head and neck 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 head and neck neoplasms
effect of an individualized patient support program on treatment satisfaction in fingolimod-treated patients with rrms

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: a 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study in rrms patients to assess the impact of an individualized patient support program (psp) on treatment satisfaction and to evaluate whether this individualized support improves satisfaction and with it adherence to medication compared to standard care.


Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this trial have to fulfill all of the following criteria: 1. written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed. 2. male or female subjects aged 18 - 65 years. 3. subjects with relapsing remitting ms defined by 2010 revised mcdonald criteria. 4. patients with expanded disability status scale (edss) score of 0-6.5. 5. patients under fingolimod therapy, according to german label, for at least 6 months at study visit 1 (day 1). exclusion criteria: patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. patients, who are registered in any patient support program (e.g. extracare) 2. patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site. 3. any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion 4. history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin 5. patients who have received an investigational drug (excluding fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer. 6. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum) 7. women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.13.6 for details). 8. simultaneous participation in another clinical trial. patients, who have already been randomized into this trial earlier must not be included a second time. study personnel or first degree relatives of investigator(s) must not be included in the study.
study comparing rovalpituzumab tesirine versus topotecan in subjects with advanced or metastatic small cell lung cancer with high levels of delta-like protein 3 (dll3) and who have first disease progression during or following front-line platinum-based chemotherapy (tahoe)

Conditions: Small Cell Lung Cancer

Summary: the purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic sclc with high levels of dll3, who have first disease progression during or following front-line platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * participant must have histologically or cytologically confirmed advanced or metastatic small cell lung cancer (sclc) with documented first disease progression during or following front-line platinum-based systemic regimen * tumor must have high delta-like protein 3 (dll3) expression defined as having ≥ 75% tumor cells staining positive according to the ventana dll3 (sp347) ihc assay. * participant must have measurable disease, as defined per response evaluation criteria in solid tumors (recist) version 1.1. * participant must have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * participant must have recovery to grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration. exclusion criteria: * participant has a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with new york heart association class (nyha) iii - iv within 6 months prior to their first dose of study drug. * participant has known leptomeningeal metastases. * participant has received more than one prior systemic therapy regimen for sclc. * participant had a serious infection within 2 weeks prior to randomization, including any grade 3 or higher viral, bacterial, or fungal infection. * participant has a history of active malignancies other than sclc within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated. * participant had prior exposure to topotecan, irinotecan or any other topoisomerase i inhibitors.

Keywords: small cell lung cancer (sclc) delta-like protein 3 (dll3) rovalpituzumab tesirine topotecan metastatic
topical 2% povidone-iodine gel in verruca vulgaris

Conditions: Warts

Summary: this is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. all warts will be treated two times per day (bid) for12 weeks. approximately 90 subjects will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study. * male or female ≥ 8 years old. * subject has a clinical diagnosis of verruca vulgaris (common warts). * subject has up to 6 warts located on the trunk or extremities exclusion criteria: * subject has clinically atypical warts on the trunk or extremities. * subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.) * subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.
lcprot: proteomics longitudinal cohort study on lung cancer

Conditions: Lung; Lung Cancer; Cancer; NSCLC

Summary: this study will utilize tissue and peripheral blood samples for proteomics analysis and establish a longitudinal proteomics cohort at multiple critical treatment time points to explore the research value of proteomics in the diagnosis and treatment of lung cancer. the study includes key time points such as screening, postoperative efficacy prediction, and efficacy prediction after medication.


Eligibility criteria:
inclusion criteria: 1. signing of the informed consent form; 2. male or female, aged 18-75 years; 3. patients with lung nodules confirmed by ct examination; 4. good preoperative pulmonary function cooperation and complete reporting; 5. preoperative chest single/dual phase ct scans without significant artefacts and with complete imaging; 6. the interval between preoperative pulmonary function and single/dual phase ct scans does not exceed one month. exclusion criteria: 1. poor preoperative pulmonary function cooperation or missing reports; 2. preoperative chest single/dual phase ct scans exhibit significant artefacts or image omission; 3. the interval between preoperative pulmonary function and single/dual phase ct scans exceeds one month; 4. complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.); 5. coexisting with other severe functional impairments; 6. patients with obstructive lesions such as airway or esophageal stenosis; (8) medication use before pulmonary function testing that does not meet the cessation guidelines; (9) pulmonary function report quality graded d-f.

Keywords: lung cancer proteomics protein nsclc
tools for anxiety and depression screening in epilepsy

Conditions: Epilepsy

Summary: a randomized trial to compare patient-completion success of redcap and electronic health record (ehr)-based anxiety \& depression instrument delivery methods. study hypothesis is that the screening completion proportion will vary across the 4 modalities tested.

in this randomized study of four modalities, we will compare twilio text message delivery via redcap versus (vs.) redcap email survey links vs. ehr portal questionnaires with reminder message vs. current standard delivery ehr portal questionnaires without reminder. screening instruments will be delivered by randomized method 7 days prior to scheduled clinic visit and outcomes occur by the time of the scheduled clinic visit. the study setting is the wake forest comprehensive epilepsy center, with 2 clinic sites where adult patients are served (atrium health wake forest baptist main campus, atrium health high point medical center). ehr portal questionnaires without reminder is the current standard care screener delivery method. an exploratory supplement randomizing individuals to text message versus email survey link was later added.

Eligibility criteria:
inclusion criteria: * visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site exclusion criteria: * no exclusions

Keywords: anxiety depression screening tools
evaluation of a kit for the prediction of the risk of graft versus host disease

Conditions: Hemopathy

Summary: this study is a proof of concept that will assess the predictor's kit performances. the test will be performed by several technicians, in immunological laboratories of several sites in france. in this study, "couples" of donor / recipient in the frame of a graft of csh will be included.

the hematopoietic stem cell (hsc) graft is the only curative treatment for lots of hematologic diseases, malignant or not, particularly leukemias. the acute graft versus host (agvh) reaction is the most frequent complication, and could concern until 50% of recipients. it is mainly linked to immune characteristics of the donor which will act versus the graft recipient. there is a huge need of a technology that could predict the risk of agvh, especially in order to select a donor in case of several possibilities, in order to reduce morbidity and mortality of graft. the predictor' kit allows to predict acute and severe forms of graft versus host disease before the graft of peripheral hematological stem cells, by the assesment of inkt cells expansion.

Eligibility criteria:
main inclusion criteria for donors : * being a relative of the recipient patient, or being registered on the national registry of the volunteers for bone marrow donation * being candidate for a donation of hematologic stem cells with a hla compatibility 10/10 main inclusion criteria for recipient : * being candidate for a donation of hematologic stem cells with the following criteria: * hla compatibility 10/10 with the donor * suffering from malignant or non-malignant hemopathy in first remission * myeloablative or reducted intensity conditioning * classic scheme of immunosuppression decreasing main exclusion criteria: * participation to a therapeutical protocol in the 30 last days