Kornimate/medical-research-clean huggingface dataset:
global atrophie biomarker evaluation study (gabie)

Conditions: Age-related Macular Degeneration

Summary: to investigate the use of microperimetry and ss-oct in assessing the natural changes of retinal sensitivity and anatomy in the perilesional zone of geographic atrophy areas in patients with dry age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the study * age \>=60 years * ability (including a sufficient general health status according to investigators judgement) and willingness to undertake all scheduled visits and assessments including predefined methodology and standards utilizing microperimetry ga secondary to amd with no evidence of prior or active choroidal neovascularization (cnv) in the study eye * ga lesion in the study eye must reside completely within the faf imaging field (field 2- 30 degree image centered on the fovea) * bcva of 20/63 or better (snellen equivalent) using etdrs charts at starting distance of 4 m in the study eye * well demarcated area(s) of ga secondary to amd with no evidence of prior or active cnv in the study eye * the total ga lesion size \>=1.2 mm\^2 (approximately \>=0.5 disc area \[da\]) and \<=17.78 mm\^2 (approximately \<=7 da) and must reside completely within the faf imaging field (field 2-30 degree image centered on the fovea) * if ga is multifocal, at least 1 focal lesion must be \>=1.2 mm\^2 (approximately \>=0.5 da) * sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye exclusion criteria: * ga in either eye due to causes other than amd (for example, monogenetic macular dystrophies \[e.g., stargardt disease, cone rod dystrophy\] or toxic maculopathies \[e.g., chloroquine/hydroxychloroquine maculopathy\]) * receiving active treatment in any studies of investigational drugs for ga/dry amd in the study eye * mean sensitivity difference \> 3 db between the two microperimetry examinations in the screening visit. * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd in the study eye * previous laser photocoagulation for cnv, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye * prior treatment with visudyne ®, external-beam radiation therapy, or transpupillary thermotherapy in the study eye * history of prophylactic subthreshold laser treatment for amd in the study eye * further criteria apply.
effect of very early and rapid lowering cholesterol with evolocumab on left ventricular remodeling in patients with anterior stemi undergoing primary pci

Conditions: ST Elevation Myocardial Infarction (STEMI)

Summary: for patients with anterior st elevation myocardial infarction (stemi) undergoing primary percutaneous coronary intervention (pci), whether early application of proprotein convertase subtilisin kexin type 9 (pcsk9) inhibitors to rapidly reduce low-density lipoprotein cholesterol (ldl-c) before pci could effectively inhibit left ventricular remodeling has been rarely reported. the aim of this study was to investigate the effect of early application of pcsk9 inhibitors evolocumab to rapidly reduce ldl-c levels before primary pci treatment on left ventricular remodeling in stemi patients. eligible patients were randomly randomized 1:1:1 to one of the following three groups immediately after enrollment: (1) intensive statin group: rosuvastatin 20 mg per day, in addition to usual therapy; (2) combined intensive statin and pcsk9 inhibitor group: rosuvastatin 20 mg per day and subcutaneous injection of evolocumab 140 mg twice a month, for at least 3 months, and preferably 6 months; (3) pcsk9 inhibitor alone group: subcutaneous injection of evolocumab 140 mg, twice a month for at least 3 months and preferably 6 months.


Eligibility criteria:
inclusion criteria: * age 18-75 years * persistent chest pain or chest discomfort * onset within 12 hours * st-segment elevation ≥0.1 millivolt in two adjacent precordial leads, or a new-onset left bundle branch block with dynamic changes * primary pci is planned exclusion criteria: * contraindications to statins or pcsk9 inhibitors * prior intravenous thrombolytic therapy * prior use of statins, pcsk9 inhibitors or ezetimibe * cardiogenic shock * acute heart failure or pulmonary edema * prior chronic heart failure * severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \<30ml/min/1.73m2, or on dialysis) * prolonged (\> 20 minutes) cardiopulmonary resuscitation * definite mechanical complications (including ventricular septal perforation, or rupture of the papillary tendon bundle, or rupture of the left ventricular free wall) * malignant arrhythmias that are difficult to control with drugs * severe chronic obstructive pulmonary disease or respiratory failure * severe infection * neurological disorders * bleeding history of cerebrovascular, gastrointestinal, respiratory, urinary or other organs within the last month * active bleeding or bleeding diatheses * use of anticoagulants * malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year * pregnant or lactating women

Keywords: st elevation myocardial infarction percutaneous coronary intervention pcsk9 inhibitors left ventricular remodeling
use of critical-care pain observation tool and bispectral index for detection of pain in brain injured patients

Conditions: Intensive Care; Brain Injuries

Summary: brain injured patients are at high risk of pain due to the illness itself and a variety of nociceptive procedures in intensive care unit. since the disorder of consciousness, speech, and movement, it is usually difficult for them to self-report the presence of pain reliably. the critical-care pain observation tool (cpot) has been recommended for clinical use in the critically ill patients when self-report pain is unavailable. besides, it seems that the bispectral index (bis), a quantified electroencephalogram instrument, can be used for pain assessment along with the cpot tool in some nonverbal critical ill patients (e.g., intubated and deep sedation). however, the validity and reliability of cpot and bis for pain assessment in brain injured patients are still uncertain so far. so the aim of this research is to investigate the value of cpot and bis for pain evaluation in this specific patient group.


Eligibility criteria:
inclusion criteria: * patients with brain injury and artificial airway exclusion criteria: * age under 18 years, * quadriplegia, * administration of paralytic medications within 24 hours, * if the patient failed the quality test of bis signal, * impending death, * be included in any other research.
pain and acetaminophen in women study

Conditions: Overweight; Obesity; Healthy Adults

Summary: the purpose of this study is to evaluate the influence of acetaminophen on pain response and inflammation.

the purpose of this study is to evaluate the influence of weight stigma on emotional functioning and biomarkers of inflammation among overweight and obese women; and to determine the degree to which acetaminophen moderates the stigma-related effects. participants will provide blood spot and saliva samples upon arrival, and then be randomly assigned to consume either 1,000mg of acetaminophen in liquid form, or a placebo solution. participants then will complete a series of questionnaires assessing a variety of relevant psychological and behavioral constructs. after this participants will be randomly assigned to read one of two shorts stories and answer a series of questions about their reaction to the story. finally, participants will answer another series of questionnaires and provide a second saliva sample. participants will first be adult women in the columbus, ohio and surrounding areas with body mass indices considered overweight or obese. a smaller cohort of women with normal weight will be recruited at a later time for purposes of comparison.

Eligibility criteria:
inclusion criteria: * at least 18 years old and biologically female exclusion criteria: * due to the use of acetaminophen in this study, women who report current pregnancy will be excluded from the study due to potential negative effects on pregnancy. the following are additional exclusion criteria: 1. visual impairment that would impair one's ability to read to the extent that they could not read items on paper or a computer screen. 2. stopping schooling prior to completing ninth grade. 3. a history of liver disorder and/or alcohol abuse. 4. a current prescription of a drug that contains acetaminophen. 5. allergy to acetaminophen 6. a score on the patient health questionnaire - 9 depressive symptom scale of 15 or greater. 7. for normal weight participants, a history of overweight or obesity.

Keywords: weight stigma stigma overweight obesity acetaminophen inflammation analgesics anti-inflammatory
older adults' experiences of oral rehabilitation - a qualitative interview study

Conditions: Oral Health

Summary: the aim of this study is to gain knowledge and understanding about older adults' experiences of comprehensive oral prosthetic rehabilitation and their life situation before, during and after the treatment. this is both to deepen the knowledge gained in an ongoing interventional study, but also to increase the understanding of how to best meet older adults' needs when planning and performing oral rehabilitation in any dental surgery.

this qualitative study will be based on individual, semi-structured interviews using an interview guide focusing on the participants´ perceptions, experiences, and reflections. the interviews will then be analyzed with a descriptive content analysis method according to graneheim and lundman.

Eligibility criteria:
inclusion criteria: * completed prosthetic treatment in the original study 2-12 months ago * age 65-80 years at start of the original study * masticatory dysfunction (eichner's index b3-b4 or c1-c4) for original study * mini-mental-state-examination-test (mmse) score \>26 for original study exclusion criteria for the original study: * neuropsychological disease * severely impaired hearing or vision * poor knowledge of the swedish language * having had a stroke ≤ 6 months before inclusion no additional exclusion criteria for our study.

Keywords: qualitative study interview study quality of life patient experience oral rehabilitation
procalcitonin in cirrhotic patients at high risk for sepsis

Conditions: Cirrhosis; Ascites; Sepsis

Summary: infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. among cirrhotics, ascitic patients have the highest risk of death for sepsis. at the admission, no clear-cut clinical and biochemical features are helpful in diagnosing and prognostically stratifying those patients with sepsis. procalcitonin (pct)is a breakthrough marker presenting high sensibility and specificity in diagnosing bacterial infections in different clinical settings. the purpose of this study is to evaluate pct as a diagnostic and prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.


Eligibility criteria:
inclusion criteria: * liver cirrhosis regardless of aetiology * clinically relevant ascitic decompensation at time of hospital admission exclusion criteria: * high haematic ascites * ongoing antimicrobial therapy or stopped less than 7 days before admission * last hospital discharge within 7 days * surgery or trauma within 30 days from enrolment * hepatocellular carcinoma out of milan criteria * extra hepatic malignancies * immunodeficiency syndrome * pregnancy

Keywords: cirrhosis ascites decompensation bacterial infection sepsis procalcitonin pct
study evaluating the safety of xyntha in usual care settings

Conditions: Hemophilia A

Summary: the purpose of this study is to collect safety information associated with the use of xyntha in a usual care setting. upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. patients will be required to complete an infusion log for each xyntha infusion.

the study was terminated on may 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with refacto af. the termination of this study has no impact on subject safety or well being. the decision to terminate the trial was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * male patients 12 years of age and older. * patients transitioned to xyntha from other recombinant or plasma-derived fviii replacement products. * treatment history of 150 or greater exposure days to any fviii products prior to enrollment visit. * negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy. exclusion criteria: * bleeding disorder other than hemophilia a. * inhibitor titer greater than or equal to 0.6 bu during screening except for patients on immune tolerance induction therapy. * immunomodulatory therapy during screening period. * known hypersensitivity to hamster protein.

Keywords: hemophilia hemophilia a refacto xyntha moroctocog alfa bleeding disorder
analysis of biliary microbiota in hepatobiliopancreatic diseases compared to healthy people [microbilio]

Conditions: Pancreatic Diseases; Microbiota; Early Detection of Cancer; Dysbiosis; Biliary Tract Diseases

Summary: the performance of the microbiota is observed in all clinical and pathological stages of carcinogenesis, since its development, diagnosis and treatment, including prognosis and survival. however, it was found that there is a scarcity of studies on biliary microbiota and its relationship with hepatobiliopancreatic diseases. therefore, further investigation is necessary, since reaching the biliary microbiota may suggest ways for studies of biomarkers, diagnoses, tests and therapies in hepatobiliopancreatic diseases. for this, bile samples will be collected in cases and controls patients to characterize the microbiota and its variations according to the disease.


Eligibility criteria:
inclusion criteria: endoscopic retrograde cholangiopancreatography (ercp) candidates (case group) * patients over 18 years old complete * patients previously scheduled for ercp * cannulation of the bile duct, via the transpapillary route, with the aid of a papillotome with an end kept sterile until contact with the papilla liver transplant living-donor (control group) * patients over 18 years old up to 55 years * previously selected patients with scheduled surgery * bmi: 18 kg / m² to 28 kg / m² * blood typing identical to the recipient * absence of significant medical, psychiatric problems or previous abdominal surgery * normal laboratory tests: liver function tests, blood count, coagulogram, pregnancy test and serology for hepatitis b, c and hiv * normal imaging exams: ct of the abdomen and pelvis with liver volume (remaining volume - 30-40% of the total liver volume), mri with cholangioresonance exclusion criteria: * ercp candidates (case group) * use of antibiotics during ercp or in the last 2 months prior to the procedure * emergency ercp * pregnancy * uncorrected coagulopathy liver transplant living-donor (control group) * use of antibiotics in the last 2 months prior to the procedure * pregnancy * uncorrected coagulopathy
world health organization (who) , covid19 case series of post covid 19 rhino orbito cerebral mucormycosis in egypt

Conditions: Mucormycosis; Rhinocerebral (Etiology); COVID-19

Summary: objectives: identify and recognize clinical characteristics, pathophysiology, and management of a group of patients with rhino rhino-orbito-cerebral mucormycosis infection associated with covid 19 viral infection


Eligibility criteria:
inclusion criteria: * all patients with mucormycosis post covid 19 exclusion criteria: * the patient not suffered from covid 19
uniting couples in the treatment of eating disorders (unite)

Conditions: Binge-eating Disorder; Eating Disorder

Summary: the purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a novel couple-based intervention for binge-eating disorder (bed).

although current individual treatments exist for bed (e.g., cognitive-behavior therapy and interpersonal psychotherapy) about 20% of individuals who complete treatment and who are abstinent from binge eating post-treatment relapse within one year. in addition, dropout of bed treatment is high (approximately 10 - 33%), indicating that a significant number of individuals with bed fail to achieve relief from their symptoms. couple-based interventions, which enlist the support of a partner into the treatment setting, are effective for treating anxiety and depression--frequently comorbid conditions with bed. preliminary findings of couple-based treatment for anorexia nervosa suggests it assists in reducing drop out and improving outcome. thus, the investigators developed a novel couple-based intervention for adult bed (unite-bed edition) and plan to investigate it in an open treatment trial to examine it's feasibility, acceptability, and preliminary efficacy. both patients and partners will be involved in all psychotherapy sessions of the treatment. couples' progress will be followed for three months after completion of active treatment.

Eligibility criteria:
inclusion criteria: participant with bed: 1. subject currently meets criteria for bed or sub-threshold symptoms, according to the diagnostic and statistical manual of mental disorders (5th ed) 2. concurrent outpatient therapy and medical monitoring 3. health insurance coverage both members of the couple: 1. english speaking and able to read 2. involved in a committed relationship for at least 6 months regardless of sexual orientation (couple is not required to live together) 3. willing to participate in treatment exclusion criteria: participant with bed: 1) post-bariatric both members of the couple: 1. alcohol or drug dependence in the last year 2. current significant suicidal ideation 3. severe depression that would seriously interfere with functional capacity 4. developmental disability that would impair the ability to benefit from intervention 5. any psychosis, schizophrenia, or bipolar i disorder, unless stably remitted on maintenance therapy for at least 1 year 6. moderate to high levels of physical violence from either partner as reported on the conflict tactics scale-2 at pre-treatment 7. unwillingness to forgo non-protocol concurrent couples therapy 8. previously participated in the preliminary couples treatment study ucan: uniting couples (in the treatment of) anorexia nervosa (nct01740752)

Keywords: couples relationships binge eating eating disorder couple therapy
the use of cap-assisted forward viewing endoscopy for examination of the ampulla of vater

Conditions: Ampulla of Vater Intestinal-Type Adenoma

Summary: the aim of this study is to compare the visualization rates of the ampulla of vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.

the complete visualization of the ampulla of vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. there are limited data in the relevant literature regarding the effectiveness of the cap assisted forward viewing endoscope for accurate evaluation of the ampulla de vater. therefore, the aim of this study is to compare the visualization rates of the ampulla of vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.

Eligibility criteria:
inclusion criteria: * cap-assisted endoscopy * referral to endoscopic examination of ampulla of vater exclusion criteria: * patients with surgically modified anatomy. * obstruction of the upper gastrointestinal tract. * contra-indication for endoscopy. * absence of informed consent.

Keywords: endoscopy ampulla of vater duodenoscopy
devel. and eval. of an active surveillance decision aid for men with low or intermediate grade prostate cancer

Conditions: Adenocarcinoma of Prostate

Summary: the overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.

the overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer. specifically, we propose to conduct a clinical trial to compare the effects of a prostate decision dashboard versus usual care on: 1. patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer, 2. measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process, 3. the treatments selected, and 4. 3-6 and 9-12 month outcome assessments of clinical status, decision regret, cancer-related quality of life including worry, functional status, and treatment side effects.

Eligibility criteria:
inclusion criteria: * age: 40 to 85 years * sex: male * race/ethnicity: no restrictions * diagnosis: patients will be eligible for the study if they have not yet decided on a management plan and present with either: * localized, low grade prostate cancer, defined as gleason score ≤ 6, t1-t2a stage cancers, and psa values \< 10 ng/ml, or * intermediate risk prostate cancer, defined as gleason score = 7, t2b-t2c stage cancers (these tumors involve more of the prostate but do not extend beyond the prostatic capsule), or psa 10-20 ng/ml * willing to participate and able to give informed consent * able to adequately see the study intervention which is an interactive decision dashboard \& complete study-related questionnaires * able to understand english language adequately to use the decision dashboard and complete study-related questionnaires exclusion criteria: * unable to complete study-related tasks due to cognitive deficits or english non-fluency * unwilling to participate. * deemed clinically unsuitable for active surveillance as a prostate cancer management option

Keywords: prostate cancer adenocarcinoma