Kornimate/medical-research-clean huggingface dataset:
safety of ataciguat in patients with moderate calcific aortic valve stenosis

Conditions: Aortic Valve Stenosis

Summary: this study will determine whether ataciguat (hmr1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis. the primary focus of these studies will be on changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without passing out), and determining whether treatment with ataciguat results in significant reductions in blood pressure in this patient population.


Eligibility criteria:
inclusion criteria: * age \> 50 years * male or female sex * aortic valve area greater than 1.0 cm2 but less than 2.0 cm2 * aortic valve calcium levels greater than 300 arbitrary units from chest ct * ejection fraction \>50% exclusion criteria: * history of orthostatic intolerance or symptomatic hypotension * positive pregnancy test during screening visit * nitrate use or α-antagonist medication use within 24 hours * systolic blood pressure \<110 mm hg * mean systemic arterial pressure \<75 mm hg * severe mitral or aortic regurgitation * retinal or optic nerve problems * recent (≤30 days) acute coronary syndrome * oxygen saturation \<90% on room air * congenital valve disease * hepatic dysfunction/elevated liver enzymes * prescription of drugs known to alter nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate signaling (sildenafil, nitrates, etc.) * history of orthostatic intolerance * concomitant participation in other trials at mayo clinic or elsewhere.
surgiphor us in tsa

Conditions: Total Shoulder Arthroplasty; Shoulder Infection; Povidone Iodine

Summary: bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. surgiphor (sterile povidone-iodine) wound irrigation, is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively. the iodine dissociates from complex and has antimicrobial properties, causing cell death of bacteria, fungi, and viruses through interactions with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane. this study examines the use of povidone-iodine during primary shoulder arthroplasty.

the purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either surgiphor or sterile normal saline during primary total shoulder arthroplasty

Eligibility criteria:
inclusion criteria: * adults age \&gt;18 years * participants undergoing elective primary total shoulder arthroplasty * participants willing to provide written consent exclusion criteria: * history of prior surgery to the operative shoulder * known allergy to povidone iodine, iodine or shellfish * active clinical infection * participation in other clinical trials
dietary intervention to stop coronary atherosclerosis in computed tomography

Conditions: Coronary Artery Disease

Summary: the aim of the study is to determine, wheather strict dietary intervention with the use of the dash diet atop of optimal medical treatment reduces previously diagnosed coronary atherosclerotic lesions assessed witch coronary computed tomography.

a total of 180 patients with coronary atheroslerotc lesions confirmed in coronary computed tomography (cct) will be analyzed in a 12-month observation time. patients will be randomized to two groups in a 1:1 fashion. 1 - optimal medical treatment, 2 - strict dietary intervention with implementation of the dash diet atop of optimal medical treatment. cct scans will be performed at screening and at 12 months after randomization. computed tomography imaging data describing atheroslerotic lesions will be assessed.

Eligibility criteria:
inclusion criteria: * coronary atheroslerotic lesions confirmed in the screening ccta with reduction of the artery diameter less than 70% in 2 or more coronary artery segments * no indications for coronary angiography / revascularization (no documented significant ischemia of myocardium) * free and informed consent of the person concerned * willingness to follow the strict directions given by the investigators exclusion criteria: * any valvular heart disease requiring cardiac surgery (or expected cardiac surgery intervention within 12 moths) * diagnosis of dilated / hypertrophic cardiomyopathy * diagnosis of dm t. 2 * past cabg procedure * women in reproductive age * known genetic factors with a possible impact on the progres of coronary atherosclerotic lesions (e. i. congenital metabolic disorders, familial hyperlipidemias) * low quality of the ccta data

Keywords: coronary artery disease atherosclerosis dash diet
the effect of distraction methods on fear and anxiety in children before the covid 19 test

Conditions: Anxiety; Fear

Summary: aim: this research will be carried out to determine the effect of distracting methods on fear and anxiety in children before the covid test.

inroduction: in the literature review, it has been seen that the positive effect of different nanpharmacological methods is supported to reduce pain and anxiety caused by medical procedures. non-pharmacological methods are classified as physical methods, cognitive behavioral methods, and environmental or emotional intervention methods. in order to draw attention to another direction, which is among these methods; watching cartoons, inflating balloons, creating balloons by blowing foam, talking about things unrelated to the initiative, virtual reality glasses, listening to music, using kaleidoscope and distraction cards etc. is located. the subject of the study is the application of distraction methods in reducing the pain associated with short-term medical interventions.

Eligibility criteria:
inclusion criteria: * children who will be taken samples for covid 19 test * being between the ages of 5 to 10 years, * literate exclusion criteria: * having chronic diseasesvisual * audio, or speech impairments * mental disorders, * history of sedative, analgesic, or narcotic use within 24 h before admission * inflammatory disease during admission.

Keywords: covid-19 test nasopharyngeal swab collection pediatric nursing distraction methods
the comparison of pyy, ghrelin, glp1, glucose level, level of satiety, and ad libitum intake in obese and non-obese patients after breakfast with balanced macronutrient composition

Conditions: PYY; Ghrelin; Appetite; Gut Hormones; Obesity; VAS of Satiety; VAS of Hunger; GLP - 1

Summary: obesity can occur due to an imbalance of energy. this energy balance is greatly influenced by hunger and satiety. obese person cannot resist hunger, while non obese can control hunger. gut hormones, such as pyy and ghrelin, are associated with appetite and satiety control. this study's objective is to compare the effect of breakfast with balance composition on gut hormones, glucose and ad libitum intake four hours after breakfast between obese and non obese.. the research methodology was used a clinical trial with 18 obese women and 22 non obese women participants. subjects were given a balance breakfast (protein 12,4%, carbohydrate 68,2%, fat 22,6%). gut hormones (pyy, ghrelin, glp -1) level , glucose level and satiety level were measured at 0, 15, 60, 120, and 180 minutes after breakfast. ad libitum meal was given four hours after breakfast and measured after.


Eligibility criteria:
inclusion criteria: * bmi 25 - 30 (for obese am) * bmi 18,5 - 23 (for non- obese am) * with stable body weight within the last 6 months (body weight change less than 4 kg) * normal blood glucose level. exclusion criteria: * patients who never had breakfast * patients in weight loss program * patients consuming lipid-absorption inhibitor or appetite-suppressing drugs * patients that have had gastrointestinal tract resection.
transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia

Conditions: BPH; Lower Urinary Tract Symptoms

Summary: this study investigated the effectiveness and safety of soractelite ™- trans-perineal laser ablation (tpla) in the treatment of patients with symptomatic benign prostatic hyperplasia (bph) at 6 and 12 months follow-up

the purpose of this study was to investigate the effectiveness and safety of soractelite ™ - trans-perineal laser ablation (tpla) in the treatment of patients with symptomatic benign prostatic hyperplasia (bph) at 6 and 12 months follow-up. methods: patients with urinary symptoms secondary to bph underwent tpla under local anaesthesia in four centers. under us guidance, up to four 21g applicators were inserted in the prostatic tissue. each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size.

Eligibility criteria:
inclusion criteria: * male * ≥ 50 years of age * international prostate symptoms (ipss) ≥12 * peak urinary flow rate (qmax): \<15 ml * prostate volume: ≥ 30 ml, measured by transrectal ultrasound * post-void residual (pvr): \<400 ml * signed informed consent exclusion criteria: * mri signs of malignancy confirmed by biopsy investigation * urethral stenosis * serious coagulation disorders * inadequate compliance * ischemic pathology in the previous six months * active phase inflammatory pathology

Keywords: bph luts
metabolomic and proteomic fingerprinting in peri-implant diseases

Conditions: Peri-implant Mucositis; Peri-Implantitis

Summary: due to the limited efficacy of its treatment modalities, there is a stringent need to improve the prevention and early diagnosis of peri-implantitis. in fact, to date clinical and radiographic tools are not able to discern which patients are going to develop peri-implantitis and, among the ones already with peri-implantitis, which ones are currently loosing bone and which ones are going to progress. this project aims to analyze for the first time the whole large scale proteome and metabolome of peri-implant crevicular fluid (picf) with an integrated approach from implants with peri-implant diseases. twenty-five patients with at least one implant with peri-implant mucositis and one implant with peri-implantitis will be selected. for each of the selected participants, the picf from an implant with peri-implant mucositis and from an implant with peri-implantitis will be sampled two different times before treatment. one year after the corresponding treatment is provided, the picf of the treated implants with peri-implantitis will be sampled again. both proteomic and metabolomic profiling of the samples will be carried out. the most important strength of this project will be the ability to evaluate together the whole proteome and the whole metabolome and to integrate them in the same framework.


Eligibility criteria:
inclusion criteria: * at least one implant with peri-implant mucositis and one with peri-implantitis exclusion criteria: * previously treated implants to be included
impact of robot-assisted radical prostatectomy technique on short-term continence recovery

Conditions: Urinary Incontinence

Summary: to assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing robot assisted radical prostatectomy (rarp), each randomized to undergo rarp with vattikuti institute technique or retzius sparing technique.

traditionally, rarp is performed using a trans-peritoneal technique that pass anteriorly to the bladder. this technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. these structures include the pubo-prostatic ligament, santorini plexus, neurovascular bundle, and veil of aphrodite. recently, a "retzius-sparing" technique to perform rarp has beed described. this approach passes posteriorly to the bladder, through the space of douglas, which should minimize the damaged to the aforementioned structure. theoretically, the latter technique should improve post-operative urinary continence recovery. however, a randomized comparison between the "traditional" rarp and "retzius-sparing" rarp is still lacking.

Eligibility criteria:
inclusion criteria: * all patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the vattikuti urology institute (performed by single surgeon, mm) as the primary treatment modality * be able to read and speak english and be able to provide written informed consent exclusion criteria: * patients with high risk prostate cancer,defined as a biopsy gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml. * evidence of clinical nodal involvement (cn1) or metastatic disease (m1) * patients participating in a competing study * patients with pre-operative urinary incontinence.

Keywords: prostate cancer urinary continence robotic assisted radical prostatectomy vattikuti urology institute (vip) radical prostatectomy retzius sparing radical prostatectomy
inflammation: correlates and prognosis in framingham

Conditions: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Inflammation

Summary: to determine the relation between cardiovascular disease risk factors and systemic markers of vascular inflammation in the framingham study cohort.

background: recent epidemiologic evidence suggests that inflammation plays a major role in the development of coronary artery disease. high sensitivity c-reactive protein assays have been shown to be independent risk factors for the development of atherosclerosis. measurements of c-reactive protein also adds to the predictive value of lipid levels in determining the risk of cardiovascular disease. levels of inflammatory markers may also correlate with response to commonly used lipid lowering agents. the exact role of inflammation in coronary artery disease is not clear; however, it has been suggested that inflammation may be a marker of subclinical cardiovascular disease, or may indicate the presence of vulnerable plaque. in addition to being a possible causative agent in the development of atherogenesis, it has been postulated that inflammatory markers may reflect events that predict the development of myocardial events. the fact that agents such as aspirin and pravastatin, which are known to have anti-inflammatory effects, are effective agents in the prevention of atherosclerosis suggests the possibility that prevention of inflammation may play an important role in reduction of risk for cardiovascular disease. design narrative: the study assessed inflammatory markers in 3,765 men and women of the framingham study. the markers included inflammatory (c-reactive protein, fibrinogen, soluble intercellular adhesion molecule-1, endothelin-1, monocyte chemotactic protein-1, tumor necrosis factor-alpha) and oxidative stress markers (8-epi-pgf 2alpha, thromboxane b2). the relation between cvd risk factors and systemic markers of vascular inflammation was determined. the relations between inflammatory markers, endothelial dysfunction, and subclinical disease were analyzed. markers of inflammation were related to prevalent and incident cardiovascular disease events adjusting for standard risk factors. the central hypothesis was that inflammatory markers were independent risk factors for cardiovascular disease events with endothelial dysfunction operating in the causal pathway. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
control crohn safe trial

Conditions: Crohn Disease; Inflammatory Bowel Diseases

Summary: crohn's disease (cd) is a chronic disease with a heterogeneous clinical presentation, relapse rate and treatment response. insufficient control of mucosal inflammation results in irreversible bowel damage and complications and at present no markers are available to predict such a complicated disease course at diagnosis. therefore, to prevent overtreatment of low risk patients, step-up treatment with subsequent introduction of corticosteroids, thiopurines maintenance and tnf-blockers if a previous category fails is standard care. combination treatment with thiopurines and a tnf-blocker is more effective than monotherapy but associated with a higher risk for infectious complications. landmark studies convincingly showed an improved long-term outcome if the tnf-blocker infliximab is introduced early after diagnosis. the standard step-care approach thus prolongs steroid exposure and delays start of disease modifying biologicals in high risks patients. given the higher efficacy of combination therapy with a thiopurine of infliximab and potential allergic reactions and lower response rates after re-initiation of this chimeric biological, temporary monotherapy with this tnf-blocker has not been studied as first line treatment before. adalimumab is a humanised monoclonal antibody and subsequently, combination therapy of adalimumab + thiopurines has only a marginal effect on anti-drug anti-body formation. furthermore, combination therapy with adalimumab does not enhance the clinical response. therefore, periodic treatment with adalimumab in combination with close monitoring after drug-discontinuation, in newly diagnosed cd might improve outcome, reduce drug-related side effects while still preventing overtreatment. the aim of this study is to compare the long-term efficacy and safety of periodic adalimumab as initial treatment in newly diagnosed cd patients compared to standard step-care with corticosteroid/budesonide as the initial treatment


Eligibility criteria:
inclusion criteria: * newly diagnosed cd patients or cd patients with a flare, visiting the outpatient clinic or endoscopy ward of the participating centres * cd diagnosis according to ecco-guidelines + complete ileo-colonoscopy + complete small bowel imaging at diagnosis (mri or ct-enterography ) * naïve to biologicals * sufficient knowledge of dutch language * 18 years old ≤ 70 years old * smartphone with internet access * use of myibdcoach or willingness to start using myibdcoach exclusion criteria: * use of prednisone for longer than 4 weeks in the year before screening * use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening * use of thiopurines in the 3 years before screening * indication for primary treatment with biologicals or surgery * malignancy in 5 years before treatment. exception is adequately treated non-melanoma skin cancer * contra-indication for tnf-blockers or immunosuppressive agents * contra-indication for mri- and ct-enterography * patients with short bowel syndrome or an ostomy
reduction of post mastectomy pain with the jacki® recovery jacket

Conditions: Mastectomy

Summary: this research study is studying a garment called the jacki® recovery jacket that can be worn after surgery as a possible way to manage pain from surgical drains. the study intervention involved in this study is: -"jacki" recovery jacket

in this research study, the investigators are studying the jacki, a garment that can be worn post-mastectomy with pockets that hold post-surgical drains. the jacki was invented by a cancer survivor who leads a little easier recovery®, a non-profit organization in massachusetts, and may help participants manage the pain of post-surgical drains to increase comfort and ease of daily living. the jacket has not previously been tested in a research study. the investigators are hoping to learn whether the jacket is effective in reducing pain and discomfort from the time participants leave the hospital until they return to have their drains removed.

Eligibility criteria:
inclusion criteria: * patients who are ≥ 18 years old. * patients who speak and understand english. * patients who have had mastectomy with reconstructive surgery in one or both breasts. exclusion criteria: * co-morbid delirium * dementia * mental illness, or neurocognitive deficit prohibiting informed consent and/or ability to complete study procedures.

Keywords: recovery pain surgical drains
surveillance of influenza virus shedding and immunologic response in immunocompromised children and young adults

Conditions: Influenza Virus

Summary: influenza virus infections are a major cause of morbidity and mortality. the limited existing knowledge about the impact of influenza in immunocompromised patients suggests that they are at increased risk of influenza virus acquisition, of developing complications and of prolonged illness and viral shedding. however, some other data about the effect of antiviral agents on the infection course, and risk of resistance in immunocompromised children are lacking. the emergence of the pandemic h1n1 swine-origin influenza a virus has generated an additional need to study the epidemiology, clinical course and outcome of influenza infections in immunocompromised children. this study proposed to conduct a prospective observational clinical study to answer these questions.

this study aims to do the following; * to evaluate the frequency of influenza virus infections due to various subtypes in immunocompromised children and young adults at sjcrh * to describe and compare the clinical course and outcome of pandemic h1n1 influenza infection with that due to other influenza virus subtypes in immunocompromised children and young adults. * to evaluate the duration of influenza virus shedding in immunocompromised children and young adults. * to evaluate the immunologic response to natural infection with various subtypes of influenza virus including the pandemic h1n1 influenza a virus. * to evaluate the viral resistance to antiviral agents in relation to antiviral therapy. * to compare accuracy of rapid methods for influenza a subtyping and for determination of antiviral resistance.

Eligibility criteria:
inclusion criteria: * age \<= 21 years of age at the time of entry into the study. * body weight of 13 kg or greater * an immunosuppressed state due to cancer, sickle cell disease, hiv, or receipt of stem cell transplant * presentation with acute respiratory illness defined as recent onset of rhinorrhea, nasal and sinus congestion, pharyngitis, coryza, sinusitis, otitis media, dyspnea or shortness of breath, cough and/or a new radiographic pulmonary infiltrates. * proven influenza virus infection by virological testing of respiratory specimens using polymerase chain reaction (pcr) assay, direct antigen detection assay, or viral culture. exclusion criteria: * inability or unwillingness of research participant or legal guardian to give written informed consent.

Keywords: influenza virus
effect of different remineralization gels

Conditions: White Spot Lesion

Summary: the aim of the study is to treat white spot lesions that occur after orthodontic treatment. different gels will be used for remineralization. the study will consist of 45 people between the ages of 15-18. 45 people will be divided into 3 groups.

oral hygiene training will be given to each group and a toothpaste containing 1450 ppm fluoride will be given to brush their teeth twice a day. essix appliance with reservoir will be made by taking impressions from 30 patients. remineralization gel will be put into the essix appliance for 5-7 minutes twice a day for one month.

Eligibility criteria:
inclusion criteria: * patients aged 15-18 years, * presence of white point lesions, * volunteering to participate in the research. exclusion criteria: * not having received orthodontic treatment, * having a developmental anomaly affecting the enamel, * being allergic to milk, * having a syndrome affecting the oral cavity.