Kornimate/medical-research-clean huggingface dataset:
effect of position change on pain, comfort and vascular complications after coronary angiography

Conditions: Angiopathy, Peripheral; Pain

Summary: today, complementary and alternative treatments are frequently used to maintain health and well-being, reduce symptoms of diseases, and provide relaxation. nurses contribute to the healing process by using pharmacological and nonpharmacological methods. pharmacological methods cause nausea, vomiting, respiratory depression, gastrointestinal and urinary system complications in individuals. therefore, nonpharmacological methods without side effects are gaining importance. nonpharmacological methods are easy and simple nursing interventions that do not have side effects, are cost-effective, can be easily taught to the patient, reduce pain and anxiety. they can also be used in addition to pharmacological methods and are preferred in patients who do not take medication or are unwilling to take medication. providing a safe position without vascular complications and back pain after the procedure is very important for both the patient and the nurse who cares for the patient. existing studies on post-intervention position changes have reported low incidences of bleeding and back pain, resulting in higher levels of patient comfort and satisfaction. these studies evaluated different angles of elevating the head of the bed and recommended further studies to evaluate the possibility of shifting patients to other positions after transfemoral cardiac interventions.

therefore, the aim of this study was to investigate the effect of position change after coronary angiography on pain, comfort and vascular complications.

Eligibility criteria:
inclusion criteria: * over 18 years of age * agree to participate in the study * not undergoing emergency coronary angiography * not consuming coffee or hypnotic drugs at least 12 hours ago * no history of chronic pain (e.g. arthritis) * not addicted to alcohol or drugs * no psychological problems (such as depression, anxiety disorder) * not using anxiolytics exclusion criteria: * • not willing to participate in the study * developing delirium during the follow-up period * developing complications after coronary angiography (such as bleeding etc.) * arrhythmia * hemodynamic instability * hereditary bleeding disorders * platelet count less than 100,000/mm3 * abnormal coagulation parameters (high inr and/or aptt) * history of percutaneous coronary intervention (pci) * multiple or bilateral punctures in the femoral artery * presence of hematoma on arrival after the procedure * radial access * bleeding at the access site or at the access dressing site * body mass index (bmi) ≥ 35 kg/m2 * back pain before treatment * patients with spinal cord disease * patients with vertebral disc disease
once daily (od) versus three times daily (tid) dosing with mesalazine granules for prevention of recurrence of ulcerative colitis (uc)

Conditions: Colitis, Ulcerative; Recurrence

Summary: this study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis


Eligibility criteria:
inclusion criteria: * signed informed consent, * men or women aged 18 to 75 years, * historically confirmed diagnosis of ulcerative colitis by endoscopy and histology, * patient being in remission, defined (according to rachmilewitz) as: clinical activity index (cai) \<= 4, and endoscopic index (ei) \< 4, * extent of inflammation during last acute episode was \>15 cm beyond the anal margin, * last acute episode ended within 3 months prior to study entry. exclusion criteria: * crohn's disease, * prior bowel resection leading to diarrhoea, * toxic megacolon, * gastric or duodenal ulcer, * haemorrhagic diathesis, * presence of symptomatic organic disease of the gastrointestinal tract (with the exception of haemorrhoids or hiatal hernia), * active colorectal cancer or a history of colorectal cancer, * serious other secondary illnesses of an acute or chronic nature, * asthma, * severe impairment of renal (e.g., serum creatinine \> 1.5 mg/dl) and/or liver functions (e.g., serum transaminase \[alt and/or ast\] or alkaline phosphatase \>=2x upper limit of normal \[uln\]), * application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous \[iv\] or topical rectal) within 30 days prior to baseline, * application of non-steroidal anti-inflammatory drugs (nsaids) as long term treatment (i.e. \> 6 weeks), other than acetylsalicylic acid (\<= 350 mg/day), or paracetamol, * known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs, * well-founded doubt about the patient's cooperation, * existing or intended pregnancy, breast-feeding, * women of child-bearing potential without adequate contraceptive protection, e.g., hormonal contraception, intrauterine device (iud), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. the investigator is responsible for determining whether the subject has adequate birth control for study participation, * participation in another clinical trial within the last 30 days,simultaneous participation in another clinical trial, or previous participation in this trial.

Keywords: maintenance 5-asa mesalamine mesalazine ulcerative colitis
exercise and socialization in post-partum depression

Conditions: Post Partum Depression

Summary: this community-engaged research project aims to address the critical need for alternative treatments of post-partum depression (ppd). the goal of this research is to investigate the efficacy of a novel 8-week intervention combing exercise with social support to reduce ppd symptoms. it is hypothesized that exercise in addition to social support will more effectively reduce ppd symptom severity compared to social support alone. by collaborating with ppd mothers, clinicians, researchers, and local fitness instructors, the researchers aim to develop an intervention that is accessible, culturally appropriate, effective, and increases treatment adherence. additionally, the researchers will investigate if mother-infant interactions during exercise can enhance bonding, thereby reducing the detrimental effects of maternal ppd on their off-spring.


Eligibility criteria:
inclusion criteria: * over the age of 18 years old * two-weeks to 12 months post-partum * epds over 10 * read and speak english * willing to supply contact information for their clinician and consent to their clinician being contacted in the event their depression worsens. exclusion criteria: * use of anti-depression medication(s) at time of enrollment * unable to give consent * prisoner, parolee, state probationer, or awaiting sentence for a felony conviction
clinical significance of computer aided image analysis in treatment response evaluation of lung cancer

Conditions: Lung Cancer

Summary: the investigators will evaluate the utility of computer aided image analysis in lung cancer with the aim of predicting treatment response and prognosis.

tumor biological behavior is the fundamental cause of heterogeneous prognosis. the features found on medical images are also reflections of the tumor biological behavior. however, the limitations in spatial and intensity resolution of the naked eye are two inevitable shortcomings of image interpretation by naked eyes, resulting in subjective and limited analyses of images. computer aided image analyses such as radiomic analysis and machine learning methods are emerging as promising image interpretation methods. the natural advantage of the unlimited spatial and intensity resolution of computers can overcome the shortcomings of visual inspection with the naked eye. moreover, the massive computing power of computer is also far greater than that of humans. this study will focus on the application of computer aided analysis in predicting treatment response and prognosis in lung cancer.

Eligibility criteria:
inclusion criteria: 1. patients \>= 18 years old 2. pathological diagnosis of nsclc between 2012 and 2019; 3. pet/ct or ct examination before any cancer-specific treatment; exclusion criteria: 1. a time interval between treatment and image examination greater than 1 month; 2. a history of other malignancies

Keywords: lung cancer image treatment response prognosis radiomic deep learning
suicide prevention among recipients of care

Conditions: Suicide; Suicide, Attempted; Suicidal Ideation; Social Support; Secondary Prevention; Patient Care Planning; Outpatients; Outpatient Clinics, Hospital; Mental Health Services; Mental Health; Mental Disorder; Loneliness; Emergency Service, Hospital; Depressive Disorder; Depression; Continuity of Patient Care; Ambulatory Care; Adolescent; Adult; Crisis Intervention

Summary: randomized controlled trial to determine the best brief suicide prevention intervention for adults and adolescents who screen positive for suicidal ideation or behavior in emergency departments or primary care clinics. aim 1: compare the effectiveness of two brief suicide prevention interventions (safety planning intervention plus structured phone-based follow-up from a suicide prevention hotline (spi+), versus safety planning intervention plus caring contacts (cc)) to (a) reduce suicidal ideation and behavior, (b) reduce loneliness, (c) reduce return to care for suicidality, and (d) increase uptake of outpatient mental healthcare services over 12 months among adult and adolescent patients screening positive for suicide in emergency departments (eds) and primary care clinics. aim 2: assess the acceptability of connection and support planning and the safety planning intervention, with or without follow-up among providers and clinical staff in eds and primary care clinics. aim 3: assess the acceptability of spi+ and sp+cc among adult and adolescent patients.


Eligibility criteria:
inclusion criteria: * patient at st. luke's health system emergency department or primary care clinic * 12-17 years old (adolescents) or 18+ years old (adults) * screened positive for suicide risk on c-ssrs (any response of "yes") during current visit, or current visit is related to a suicide attempt * access to a phone for the duration of the study with the ability to receive calls * the ability to send and receive email messages (required) and text messages (optional) * english or spanish speaking and reading exclusion criteria: * unable or unwilling to provide informed consent to participate * inappropriate for study participation based on the clinical judgment of provider

Keywords: brief interventions caring contacts care transitions follow-up emergency department primary care safety planning intervention safety plan suicide suicide prevention adult adolescent brief contact intervention
thorough corrected qt interval (qtc) study to evaluate possible effects of prucalopride on ecg parameters

Conditions: Constipation

Summary: this is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised study, stratified by gender and with a hybrid crossover group design, to compare treatment with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day (supratherapeutic dose) with placebo. a single oral dose of 400 mg moxifloxacin is included as a positive control in terms of the effect on cardiac repolarisation. study hypothesis: treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers will not increase qtc interval compared to placebo.

a total number of 120 healthy subjects (with an approximate 1:1 female:male ratio) are planned to be randomised. day 1: a baseline ecg profile. day 1: group 1 will receive prucalopride, group 2a will receive moxifloxacin, and group 2b will receive placebo. on day 5 (steady-state level is reached), a full ecg assessment day will be performed, enabling the comparison of prucalopride 2 mg with placebo. subsequently, the number of tablets will be escalated in all groups (blinded) with 1 tablet a day up to 5 tablets. on day 13 (steady state for the supratherapeutic dose level of 10 mg of prucalopride) another ecg assessment day will be performed, enabling a comparison of prucalopride 10 mg with placebo. group 2b will receive a single dose of moxifloxacin on day 15. all subjects will be discharged on day 16. subjects will remain in the cru throughout the treatment period. all subjects will return for a follow-up visit on day 30 (± 1 week) (approximately 14 days after the last dose).

Eligibility criteria:
main inclusion criteria: 1. healthy volunteers aged between 18 to 50 years. 2. body mass index (bmi) between 18 and 30 kg/m2. 3. female subjects must: * be of childbearing potential with a negative serum β-human chorionic gonadotropin (β-hcg) test at screening, and be willing and able to use medically acceptable double barrier methods of birth control, throughout the whole study; or * be postmenopausal; or * have received surgical sterilisation at least 6 months before screening; and * females must not be receiving hormone replacement therapy (hrt). main exclusion criteria: 1. abnormal qtcf and/or heart rate/blood pressure values at baseline. 2. subjects with ecg abnormalities that may interfere with the accurate assessment of the qt interval. 3. subjects with known cardiovascular disorders. 4. subjects with known clinically significant arrhythmias. 5. subjects with risk factors e.g., torsades de pointes. 6. subjects with clinically relevant, abnormal serum electrolytes or complete blood count (cbc) at screening. 7. female subjects who are lactating or pregnant. 8. subjects suffering from other significant medical conditions. 9. subjects with a known allergy or sensitivity to moxifloxacin, or to prucalopride. 10. subjects with a positive screening test for hepatitis b, hepatitis c, or hiv at screening.

Keywords: prucalopride safety study
comparison of a metal backed fixed-bearing tibial baseplate and an all-polyethylene tibia in total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: this study is designed to compare prospectively, in a randomized level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (mpt) tray with a moderately cross-linked polyethylene (xlk) insert to an all-polyethylene tibial (apt) design with gvf polyethylene. comparing these two designs will afford us information in the following areas: 1. does a mpt/xlk design have improved wear characteristics over a nonmodular apt/gvf design? 2. is there a clear clinical advantage to the mpt/xlk design in certain patient populations that justify its use over the apt/gvf design? answering these questions will allow surgeons to use both designs appropriately in different demand populations. this study is designed to address the questions of whether an mpt/xlk design offers improvement in wear characteristics, knee society scores, koos, womac, sf-36, or radiographic measures, over an apt design. the investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. a secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.

summary is detailed

Eligibility criteria:
inclusion criteria: * generally accepted clinical and radiographic criteria for total knee arthroplasty exclusion criteria: * significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator * routine contraindications to tka (active sepsis, charcot arthropathy) * patients whose mental function preclude them from responding to our standard questionnaires

Keywords: knee arthritis total knee arthroplasty total knee replacement metal backed tibial component all-polyethylene tibia modular polished tibial baseplate
intra-articular hyaluronic acid injection for therapy-resistant patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: patellofemoral pain syndrome (pfps) is the most common overuse injury seen in the athletic population, particularly amongst runners. the standard of care treatment for pfps is a comprehensive active rehabilitation program. eighty percent of patients with pfps report improvement in their symptoms with such a program. unfortunately, the remaining twenty percent fail to achieve adequate symptom relief with rehabilitation alone. considering the enormous number of individuals running for fitness, pfps represents a significant challenge to public health as the investigators strive to encourage active living in our society. a relationship between pfps and the development of patellofemoral osteoarthritis (pfoa) has been suggested in scientific literature. given that intra-articular viscosupplementation (hyaluronic acid) injections have shown clinically significant symptom improvement in knee osteoarthritis, and pfps is likely on the same spectrum, the investigators propose a trial for therapy-resistant pfps. hyaluronic acid is a naturally occurring molecule found in the synovial fluid of freely movable joints (such as the knee). it is believed to contribute to lubrication and cushioning in these joints. the composition of synovial fluid within arthritic joints is altered, resulting in reduced fluid viscosity and elasticity. one modern formulation of hyaluronic acid is hylan g-f 20 (synvisc-one, sanofi canada). this treatment is offered as a single injection and will be utilized in this clinical trial.


Eligibility criteria:
inclusion criteria: 1. adults aged 18-45 2. previously diagnosed with pfps that failed to improve with at least 6 weeks of active rehabilitation, supervised by physiotherapist. 3. retropatellar or peripatellar knee pain for a minimum of 2 months 4. pain aggravated by at least two of the following patellofemoral joint loading activities: squatting, running, ascending or descending stairs, or sitting with prolonged knee flexion 5. pain with patellar grind test on clinical examination 6. visual analog scale (vas) \> 4/10 with patellofemoral joint loading activities 7. normal knee x-ray exclusion criteria: 1. x-ray evidence of osteoarthritis or fracture 2. meniscal or ligamentous injury suspected clinical examination 3. previous knee surgery 4. history of patellar instability or positive patellar apprehension test 5. any contraindication to knee injection (overlying skin or joint infection, joint effusion, coagulopathy, previous adverse reaction etc.) 6. known allergy to avian products 7. previous knee injection within the last 3 months 8. pregnant or breastfeeding

Keywords: viscosupplementation hyaluronic acid synvisc synvisc-one patellofemoral pain syndrome pfps anterior knee pain runner's knee
combination of ibuprofen, g-csf and plerixafor as stem cells mobilization regimen in patients affected by x-cgd

Conditions: Chronic Granulomatous Disease X-linked (X-CGD)

Summary: this is a phase ii exploratory study conducted to evaluate the safety and efficacy of the combination of ibuprofen, g-csf and plerixafor as stem cell mobilization regimen in patients affected by x-cgd.

we designed a mobilization trial with the aim of collecting a sufficient number of hspc in x-cgd patients; it is well known that this procedure is challenging for these patients, potentially due to functional defects induced by their chronic inflammatory state. the combination of g-csf and plerixafor is considered state of the art for hspc harvest in gene therapy trials; we considered to add a non-steroidal inflammatory drug to increase hspc mobilization and reduce inflammation that could have a role in altering hspc content. if this trial confirms the synergistic effect of the three drugs under investigation, such a regimen will be considered for a hspc mobilization in future gene therapy trial for x-cgd patients.

Eligibility criteria:
inclusion criteria: * genetic diagnosis of x-cgd * 18-45 years of age * karnofsky index \> 80 % * adequate cardiac, renal, hepatic and pulmonary function. * negative thrombophilic screen and negative history for previous thrombotic events * written informed consent exclusion criteria: * previous bone marrow transplantation or previous gene therapy. * use of other investigational agents within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents). * ongoing ifn-γ treatment (within 4 weeks). * symptomatic inflammatory bowel disease. * symptomatic viral, bacterial, or fungal infection within 6 weeks of eligibility * neoplasia (except local skin cancer) or history of "familial" cancer * myelodysplasia or other serious hematological disorder * history of uncontrolled seizures and deep venous thrombosis * other systemic disease judged as incompatible with the procedure * positivity for hiv and/or hcv rna and/or hbsag and/or hbv dna * active alcohol or substance abuse within 6 months of the study. * contraindications to ibu, g-csf, plerixafor or pantoprazole administration

Keywords: chronic granulomatous disease x-linked ibuprofen mobilization regimen gene therapy
evaluation of a primary type 2 diabetes prevention programme

Conditions: Diabetes Mellitus

Summary: a type 2 diabetes prevention programme, named predias was developed. it consists of 12 lessons delivered as group sessions. die efficacy of predias was studied in a randomized controlled study with 12 month follow up. control group received written information about diabetes risk. primary outcome variable was weight reduction at 12 months follow up. secondary variables were impact of the intervention on glycemic parameters, lipids, eating and exercise behavior and other metabolic risk factors

the predias programme was developed based on the interventions used in the diabetes prevention study (dps, finland) and the diabetes prevention programme (dpp; usa). the main purpose of predias was to develop a prevention programme delivered as a group programme to improve cost-benefit ration of diabetes prevention programmes.

Eligibility criteria:
inclusion criteria: * impaired fasting glucose and/or * impaired glucose tolerance * overweight (bmi \> 26 kg/m²) exclusion criteria: * type 2 diabetes * severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months) * diagnosis of a current mental disease

Keywords: diabetes-prevention lifestyle modification behavior therapy self-management
continuation of traverse- lts12551 evaluating dupilumab safety in patients with asthma (long-term follow-up)

Conditions: Asthma

Summary: primary objective: to describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (traverse-lts12551).

duration per participant was until dupilumab approval for use in asthma and market availability to the participant, or a maximum of 144 weeks (i.e., about 3 years) after the start of treatment (visit 1), whichever came first.

Eligibility criteria:
inclusion criteria: * participants with asthma who completed the treatment period in the previous dupilumab asthma clinical study lts12551. * signed written informed consent. exclusion criteria: * participants who experienced any systemic hypersensitivity reactions to the investigational medicinal product in the previous dupilumab asthma study lts12551, which, in the opinion of the investigator, could indicate that continued treatment with dupilumab might present an unreasonable risk for the participant. * clinically significant comorbidity/lung disease other than asthma. * participants with active autoimmune disease or participants who, as per investigator's medical judgment, were suspected of having high risk for developing autoimmune disease. * history of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.