Kornimate/medical-research-clean huggingface dataset:
detection of luminal and mucosa-associated microbiome in healthy controls vs. local and systemic inflammation

Conditions: Human Microbiome

Summary: this study should reveal differences in composition of luminal and mucosa-associated microbiome of the human gastrointestinal tract.therefore bacterial species of different intestinal location sites (small intestine and colon) isolated of biopsies were compared to bacterial composition of stool samples. additionally the bacterial composition of healthy persons, patients with inflammatory bowel disease and with liver disease (liver cirrhosis) will be compared to detect influence of local and systemic inflammation on microbiome.

a dysbiosis of human gut microbiome is discussed in the pathogenesis of many disorders, also including gastrointestinal (e.g. inflammatory bowel disease, ibd) or liver diseases (e.g. liver cirrhosis) . a detailed analysis of intestinal bacterial patterns might reveal important findings for understanding disease pathogenesis. thereby many studies only analysed the luminal microbiome of stool samples, whereas mucosa-associated bacteria have possibly a greater impact on human health and immune system . to determine the differences of luminal and mucosa-associated bacteria, stool and mucosa samples (via biopsies) will be collected. thereby biopsies are taken of different intestinal locations (small intestine and colon) to detect variations along intestinal tract. an additional comparison of bacterial patterns in patients with chronic, local (ibd) and systemic inflammation (with liver cirrhosis) or without intestinal inflammations (healthy controls) should reveal the influence of microbiome on or by inflammation processes.

Eligibility criteria:
inclusion criteria: * healthy volunteers with indication for cancer screening without gastrointestinal symptoms * patients with inflammatory bowel disease (crohn's disease and ulcerative colitis) * patients with indication for evaluation of liver transplantation (ltx) exclusion criteria: * other gastrointestinal disease, e.g. celiac disease, gastrointestinal tumors * antibiotic treatment within 6 weeks before gastroscopy / colonoscopy
the effect of obesity and weight loss in heart failure with reduced ejection fraction.

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Obesity; Overweight

Summary: this study looks at the effects of weight loss in people who have heart failure with reduced ejection fraction (hfpef) and are overweight or obese. the main questions it aims to answer are whether weight loss in this group of people improves: * the heart's shape and how well it pumps blood * the person's quality of life and how much they can exercise participants will attend 2 study visits, separated by 3-6 months. the intervention period takes place in between the 2 study visits. each study visit may involve measurements including: symptom and quality of life questionnaires body measurements such as height and weight blood tests ultrasound scans of the heart (echocardiogram) magnetic resonance imaging (mri) scans of the heart 6 minute walk test participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. the control group will continue standard care. the diet group will be enrolled in a weight loss program supervised by the study team. participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. the products will consist of formula soups, shakes and porridges. this diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.


Eligibility criteria:
inclusion criteria: * heart failure determined by left ventricular ejection fraction 20-45% * body mass index \> 27.5kg/m\^2 exclusion criteria: * contraindications to magnetic resonance imaging * nyha class iv * pregnancy, planned pregnancy or lactating * significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease * any other conditions which may potentially compromise the safety or scientific validity of the study

Keywords: heart failure weight loss low energy diet reduced ejection fraction
sleep disordered breathing and lung transplantation

Conditions: Sleep Disordered Breathing; Lung Transplantation

Summary: the purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients.

all patients with end-stage respiratory failure who are referred for lung transplantation and are older than 18 years old are enrolled. we collect: * medical history * blood pressure * anthropometrics * pulmonary function * arterial blood gas * questionnaire (qol, ess) * sleep diary * polysomnography

Eligibility criteria:
inclusion criteria: * patients with end-stage respiratory failure who are referred for lung transplantation * informed consent from patient exclusion criteria: * patients who are declined for lung transplantation * patients \< 18 years old

Keywords: sleep disordered breathing lung transplantation
bright light therapy during residential alcohol withdrawal

Conditions: Alcohol Use Disorder; Alcohol Withdrawal

Summary: this is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.

all eligible patients will be offered and explained the study by a psychiatrist/addictologist during the consultation (or teleconsultation) to schedule a 14-day hospitalization for alcohol withdrawal (maximum 3 months before hospitalization). patients will be randomized centrally to one of the following two treatment conditions (blind maintained by a nurse independent of the assessment), on day d0 of inpatient treatment for withdrawal (standardized withdrawal over 14 days with hydration, vitamin b1, benzodiazepines in gradual decrease before stopping and according to signs of withdrawal): 1. active light therapy (10,000 lux). 2. placebo light therapy (with filter \<10 lux). every morning in the room (patient in a single room), at 8 am, for 30 min, for the entire duration of withdrawal, i.e. 13 days (start on d1) and stopped on d14. no change in usual care apart from this intervention. after checking the inclusion and non-inclusion criteria and obtaining consent, patients will be randomized (ratio 1:1) between the groups with active light therapy or placebo, by connecting to a randomization website (redcap software) using a randomization list prepared in advance, balanced by block of randomly variable size

Eligibility criteria:
inclusion criteria: * patients must be aged from 18 to 65 years old and have a diagnosis of alcohol use disorder * patients must be intreated for alcohol withdrawal, for at least two weeks * patients must report heavy drinking episodes in the past month * patients must be able to understand medical information and consent to the treatment * patients must be considering a goal of abstinence from alcohol exclusion criteria: * ophthalmic pathology (cataract, macular degeneration, glaucoma, retinitis pigmentosa) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.) * subjects who have already received light therapy in the last 6 months * lactating of pregnant women * psychiatric comorbidity requiring an intreatment, or risk of manic episode (subjects with depressive or anxious symptoms compatible with an out-treatment can be included) * substance use disorder other than alcohol and/or tobacco * severe cognitive impairment (moca \< 10) * patients being under legal protection measure
pain response during examination for retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for rop at 6 weeks old. they will be randomized blindly to receive 2 ml of 12.5% dextrose in water (d12.5w) orally five minute before examination (intervention group) or nothing (control). nips scale will be applied two minutes before examination and two minutes after examination.


Eligibility criteria:
inclusion criteria: * all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age exclusion criteria: * the ones that died before 6 weeks old

Keywords: prematurity retinopathy of prematurity pain very low birth weight infants
via disc np registry

Conditions: Discogenic Pain; Back Pain; Back Pain, Low

Summary: registry is to observe and trend patterns of care and outcomes for patients treated with via disc np.

the registry is intended to collect data for patients having received treatment with via disc np.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * understand and sign the informed consent form (as applicable) * via disc np injection is scheduled for 1 or more levels exclusion criteria: * via disc np injection is not performed

Keywords: back pain
trial of ic351 in female scleroderma patients with raynaud's and sexual dysfunction

Conditions: Systemic Sclerosis

Summary: purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, ic351. study is designed to gather information regarding the possible usefulness of ic351 as a treatment of several blood vessel features of scleroderma. this includes raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma


Eligibility criteria:
inclusion criteria: * female with diagnosis of scleroderma * stable sexual relationship with male partner or be sexually active * raynaud phenomenon at least 6 times per week * willing to attempt sexual activity 1/month during study period exclusion criteria: * severe internal organ problems related to scleroderma * other gynecologic problems * serious depression * receiving other experimental and raynaud treatments

Keywords: systemic sclerosis scleroderma raynaud phenomenon
eye surface properties after using dexamethasone drops with and without preservatives in patients after cataract surgery

Conditions: Cataract; Surgical Injury; Healing Wound

Summary: the goal of this interventional, real world data study is to evaluate the impact of preservatives on the post-cataract ocular surface. the main question is to learn about an effect of preservatives on the eye surface. the study aims to answer some important questions: * if the usage of preservatives has an impact on the eye surface healing process after cataract surgery * if patient comfort and quality of life improve more or more rapidly with preservatives-free eye drops. participants will be asked to undergo standard procedure of peri-cataract surgery care and in addition to survey about the ocular surface state. researchers will compare group that takes preservatives-free dexamethasone 0.1% with standard dexamethasone 0.01% solution to see if post-surgery eye surface healing properties differ from both groups.


Eligibility criteria:
inclusion criteria: * cataract surgery required defined previously by the eye-care specialist * good and clear visibility of the anterior chamber in the pre-surgery status (enables investigators to assess the anterior chamber cell intensity) * consent to the study protocol exclusion criteria: * diagnosed glaucoma * diagnosed previous allergy * diagnosed diabetic retinopathy or maculopathy * previously diagnosed dry eye disease that requires treatment with multiple artificial tears * permanent usage of the eye drops other than artificial tears * non-compliance to the study protocol
advanced bradycardia device feature utilization and clinical outcomes ii

Conditions: Standard Bradycardia Pacing Indication

Summary: the purpose of this study is to characterize the utilization of diagnostics capabilities in st. jude medical pacemakers to manage patients with a standard bradycardia pacing indication.

the study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, mri scanning capabilities and clinical outcomes of patients implanted with sjm pacemakers. the total duration of the study is expected to be approximately 30 months. the clinical study will be conducted in up to 160 centers across europe, middle east, africa, (emea region) and asia, australia and new zealand (asia-pac region). approximately 2016 subjects will be enrolled in this study. subjects will be followed for 1 year after pacemaker implant.

Eligibility criteria:
inclusion criteria: * patients who have been implanted with an sjm assurity mri™, endurity mri™ or other sjm mri compatible pacemakers in the emea region within 30 days or patients implanted with an accent mri™, assurity mri™, endurity mri™ or other sjm mri compatible pacemakers in the asia-pac region within 30 days. * patient is geographically stable and willing to comply with the required follow-up schedule. * patient is not pregnant or planning to become pregnant during the course of the study. * patient is \> 18 years of age exclusion criteria: * patient's life expectancy is less than 1 year
safety and immunogenicity study of intramuscular ccs/c-adjuvanted influenza vaccine in elderly

Conditions: Influenza

Summary: to examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (vaxisometm=ccs-cholesterol \[ccs/c\]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (im).


Eligibility criteria:
inclusion criteria: * 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry, male or female; * able to comply with all the study requirements; * in stable good health as determined by medical history; physical examination; clinical judgment of the investigator. * have adequate renal function (renal clearance of at \> 30ml/min) * have normal liver function (hepatic transaminases \[alt and ast\] \< 43 u/l) * have hemoglobin \> 11.5 g/l exclusion criteria: * any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: cancer, except for localized skin cancer; * advanced congestive heart failure; acute exacerbation of chronic obstructive pulmonary disease (copd); autoimmune disease, acute or progressive hepatic disease; acute or progressive renal disease with a renal clearance of at \< 30ml/min ; severe neurological or psychiatric disorder; history of guillain barré syndrome; severe asthma. * clinically significant symptoms of neurological disease; untreated hypertension; increased liver enzymes. * history of any anaphylactic reaction and/or serious allergic reaction following a vaccination

Keywords: vaccination, influenza prevention
ct-angiography prior to diep flap breast reconstruction

Conditions: Breast Cancer

Summary: this study will investigate whether or not preoperative computed tomography (ct) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (diep).


Eligibility criteria:
inclusion criteria: * planning breast reconstruction with diep flap * age 18 to 75 years exclusion criteria: * mild to moderate loss of kidney function (estimated glomerular filtration rate (egfr) \< 60) * decisionally challenged * pregnant * hepatic failure

Keywords: diep flap deep inferior epigastric artery perforator flap
child and adolescent psychiatric personality structure

Conditions: Personality Disorders; Social Withdrawal of Childhood or Adolescence; Psychosocial Impairment

Summary: the study plan outlined here represents an investigation of instruments on the patients treated in the acute ward of child and adolescent psychiatry at the university medical center hamburg eppendorf (uke). the psychosocial burden of the affected children and adolescents is evident due to the severity of the disorders leading to specific admission. the psychosocial burden can be defined as "psychological, social, or school-occupational functional impairment \[...\] that has arisen as a consequence of a mental disorder, a specific developmental disorder, or an intellectual impairment". the current research project aims to survey the severity of psychosocial distress, personality functioning impairment, and social withdrawal. a better knowledge of these factors may contribute to a more suitable, specialized treatment offer on the acute ward in the medium term.

children and adolescents who receive inpatient psychiatric treatment are counted among the most impaired in society. in addition to the usually very severe mental disorders, the patient:s often have psychosocial risk factors and traumatic life events in their history. as demand for psychiatric-psychotherapeutic care increases, many inpatient services have been driven to reduce costs, while parallel pressures to measure outcomes and effectiveness have increased. the call for evidence-based practice underscores the need to use valid and reliable measurement tools to capture changes in symptoms and functionality during short-term interventions and their effectiveness. measuring this change allows for the evaluation of the interventions as a whole and identifying areas for improvement. acute care units are a particular type of inpatient setting. the main goal of treatment is to stabilize the patient:s by reducing acute psychiatric symptoms, suicide risk, and danger to others. the challenge of care for this target group is to do justice to heterogeneous initial situations and offer customized help for each child and adolescent. the use of instruments to record psychosocial stress and personality disorders increases the chance that at least some of those affected can be prevented from developing a chronic course and thus long-term psychosocial impairment utilizing tailored interventions.

Eligibility criteria:
inclusion criteria * patients treated in the acute ward of the department of child and adolescent psychiatry, psychotherapy, and psychosomatics at the university medical center hamburg-eppendorf * patients with a principal diagnosis of a psychiatric disorder (icd-10-gm-2016: f10 - f90). * patients under 18 years of age. exclusion criteria * patients with organic, including symptomatic mental disorders (f00 - f09) * dementia / cognitive impairment (iq \< 70) * lack of german language skills * severe visual or hearing impairment (uncorrected).

Keywords: acute adolescent psychiatric units
influence of routinely adding ultrasound screening in medical department

Conditions: Heart Disease; Dyspnea; Aortic Disease; Kidney Disease; Liver Disease

Summary: ultrasound (us) is widely used as a diagnostic tool in a hospital setting. in a medical department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia, hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall bladder/bile tract, urine tract and venous thrombosis are common. us is the key diagnostic tool in these diagnosis, and on early diagnosis is crucial with respect to the patients well-being and inpatients workflow. 1. the aim is to study the clinical use of pocket-size us as a screening diagnostic tool in an medical department with respect to inpatients workflow and diagnostics. method: patients admitted (in certain preset periods) to department of medicine will be randomized to routinely adding an ultrasound examination with pocket-size device by residents on call. time to definitive diagnosis, time to definitive treatment and time to discard will be recorded. us findings will be validated against standard echocardiography, or standard us/ct/mri performed at the radiological department.


Eligibility criteria:
inclusion criteria: * patients admitted to dep. of medicine at levanger hospital exclusion criteria: * not able to give informed consent

Keywords: echocardiography heart failure ultrasonography pocket-size device aorta education
an evaluation of a gender specific insole to provide relief from knee pain due to osteoarthritis or general anterior knee pain in male subjects when used in foot wear over a period of four weeks

Conditions: Osteoarthritis, Knee

Summary: the primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time. the secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. the safety and tolerability of the test articles in terms of adverse events (ae) will also be investigated.


Eligibility criteria:
inclusion criteria: * male subjects with age 18 to 70 years and a self-reported foot size between 8 and 14 * subjects with regular knee pain * subjects with a baseline pain level of pain of ≥20 mm to ≤90 mm on 100 mm vas scale at baseline (visit 1) * subjects must be able to walk unaided by cane or walker. exclusion criteria: * subjects with knee pain which is due to a recent injury
observational study to assess intravitreal aflibercept injections used in a "treat and extend" regimen in treatment-naïve wet age-related macular degeneration patients

Conditions: Wet Age-related Macular Degeneration

Summary: the purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previously untreated patients diagnosed with wet age-related macular degeneration.

data will be collected from the medical files retro- and prospectively. if patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.

Eligibility criteria:
inclusion criteria: * diagnosis of wet age-related macular degeneration. * no prior therapy for wet age-related macular degeneration. * patients for whom the decision to initiate treatment with ivt-afl in a t\&e regimen was made as per routine clinical practice. * patient age \>55 years of age exclusion criteria: * participation in an investigational program with therapeutical interventions outside of clinical routine practice. * patients with eye diseases e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye. * concomitant ocular or systemic administration of drugs up to 3 months before commencement of ivt-afl treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-vegf agents. this includes patients receiving a different anti-vegf agent for the fellow eye
single doses of mk-0941 in type 2 diabetics (mk-0941-027)

Conditions: Type 2 Diabetes

Summary: this study will evaluate the safety and tolerability of single doses of mk-0941 based on assessment of clinical and laboratory adverse experiences


Eligibility criteria:
inclusion criteria: * female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control * diagnosis of type 2 diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent * no treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin * in good health (except for type 2 diabetes) * willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat) * nonsmoker exclusion criteria: * history of stroke, chronic seizure or major neurological disorder * history of cancer * history of type 1 diabetes * recent history of eye infection * glaucoma or blindness * eye surgery (by incision or laser) within the past three months