Kornimate/medical-research-clean huggingface dataset:
the optimization of medications in chronic heart failure using a website

Conditions: Heart Failure

Summary: heart failure (hf) is the most common hospital discharge diagnosis among older adults in the united states. strikingly, 2 in 5 patients are readmitted within 1-year following their first hf admission. this results in significant potentially avoidable costs to our already strained healthcare system since hospitalizations result in 70% of yearly hf management costs. one of the most common causes of readmission is lack of medication optimization. this study will determine the effectiveness of a medication optimization website.

in a prospective design, 100 patients will be randomized to the intervention or usual care in a 1:1 fashion. patients randomized to the intervention will receive an evidence-based medication recommendation intervention. outcome measures will be collected at baseline and at 2 weeks post-intervention.

Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction (lvef) \</= 40% exclusion criteria: * pregnancy * active cancer with a life expectancy less than 12 months * hospice * chronic inotropic therapy
virtual reality in invasive techniques in physiotherapy

Conditions: Pain

Summary: dry needling is a common physical therapy technique that uses solid acupuncture needles that are repeatedly inserted and removed into the human body. these techniques, despite their benefits, can cause pain. the objective of this study is to analyze the use of virtual reality as a distractor in invasive techniques in physiotherapy. the hypothesis is that the use of immersive virtual reality, evoking relaxation situations, will reduce the sensation of pain during and/or after the technique. to do this, healthy participants will be recruited and the participants will be divided into two groups (experimental and control). participants in the experimental group will undergo the dry needling technique on latent myofascial trigger points along with the use of immersive virtual reality. the same technique will be performed on participants in the control group but without the use of virtual reality. pain during and after puncture and strength after puncture will be evaluated.


Eligibility criteria:
inclusion criteria: * have at least one identifiable latent myofascial trigger point in the muscles studied exclusion criteria: * suffer any musculoskeletal or neural alteration that could alter the results obtained * suffer from belonephobia or extreme and uncontrollable fear of sharp objects

Keywords: pain dry needling virtual reality
rural interventions for screening effectiveness

Conditions: Breast, Cervical or Colorectal Cancer Screening Needed

Summary: this randomized clinical trial studies how well a tailored interactive digital versatile disc (dvd) with or without patient navigation works in improving screening rates in rural women for breast cancer, cervical cancer or colorectal cancer. a tailored interactive dvd and patient navigation may help rural women to learn more about cancer screening and to better understand the results.

primary objectives: i. compare the effectiveness of a tailored and interactive dvd (tidvd) versus (vs.) tidvd + telephone-based patient navigation (pn) intervention (tidvd + pn) vs. usual care (uc), to increase guideline-based cancer screening rates at 12 months post randomization for breast cancer (bc), cervical cancer (cc), and colorectal cancer (crc) among 1058 women age 50 to 74 living in rural northwest ohio and northeast indiana. ii. compare the cost effectiveness of the tidvd and the tidvd + pn intervention vs. uc, for adherence to each screening outcome or combination of screening tests. outline: patients are randomized to 1 of 3 arms. arm i: patients watch a tailored interactive dvd program and answer questions posed by the dvd program. arm ii: patients engage in tidvd and pn. arm iii: patients receive brochures that explain and provide encouragement for cancer screening. after completion of the study, patients are followed up at 2 and 12 months.

Eligibility criteria:
inclusion criteria: * be non-adherent to one or more recommended screenings for bc, cc, or crc by medical record review (mrr) * reside in one of 32 rural counties in indiana (in) or ohio (oh) * provide informed consent * able to speak/read english * have access to a dvd player or computer that can play dvds exclusion criteria: * have a personal or family history of any hereditary/genetic cancer syndrome such as brca1 and brca2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis * have a personal history of inflammatory bowel disease (crohn's disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancer * have a first degree relative with a history of breast or colorectal cancer * plan to move outside of the country within the next year * reside in a nursing home or other institution * are pregnant or intend to become pregnant during the study period

Keywords: rise
age and sex-specific prevalence of acquired valvular heart disease

Conditions: Valvular Heart Disease

Summary: the prevue-valve study will establish reliable, population-based estimates of valvular heart disease (vhd) prevalence among older americans and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of valvular heart disease (vhd).

with the aging population, the incidence and prevalence of vhd are increasing in the u.s. and other parts of the developed world. despite the availability of effective therapies and procedures to treat vhd, many patients remain (1) untreated due to undiagnosed vhd, or inadequate access to appropriate vhd care or (2) treated later than recommended due to diagnosis late in the disease course or barriers to prompt care for vhd. to optimize care for patients with vhd, it is therefore essential to (1) know the true prevalence of these conditions in order to align screening efforts with access to treatment; and (2) develop validated tools to more effectively screen and diagnose patients with vhd. in response to these unmet needs, the prevue-valve study will establish reliable, population-based estimates of vhd prevalence in the united states and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of vhd. the results of this study will enable the investigators to make tangible progress toward the goal of treating all patients with vhd at the optimal time. the study will be conducted in a sample of older individuals (i.e., age 65-85 years) that is representative of the u.s. population. the sample will be carefully curated to ensure traditionally underrepresented individuals are included and overrepresented, if possible. after obtaining informed consent, each participant will undergo a standard echocardiogram in order to identify vhd (specifically aortic, mitral, and tricuspid valve disease) and to quantify its severity using state-of-the-art methods in a core echocardiography laboratory. echocardiograms will be performed in participants' homes in an effort to reduce any barriers towards participation. a variety of complementary data (i.e. blood sample, electrocardiograms, and clinical inventory including a standardized health status assessment) will be collected while study personnel are with participants. formal statistical weighting methods will be applied to estimate the population prevalence of various subtypes of vhd (e.g., aortic stenosis, mitral regurgitation) from the raw data. in addition, the investigators will report the prevalence of vhd, including vhd subtypes, and describe the association between different blood analytes and ecg characteristics with vhd.

Eligibility criteria:
inclusion criteria: * age 65-85 * ability to provide informed consent * stably domiciled in a residence that can be accessed by study personnel exclusion criteria: * history of complex congenital heart disease

Keywords: valvular heart disease aortic stenosis aortic regurgitation mitral regurgitation tricuspid regurgitation epidemiology deep learning electrocardiogram artificial intelligence biomarkers
electrodermal activity and respiration in patients treated with spinal cord stimulation

Conditions: Failed Back Surgery Syndrome

Summary: this study is investigating skin conductance and respiration during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years old. * diagnosis of fbss (failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation. * cognitive and language functioning enabling coherent communication between the examiner and the participant. exclusion criteria: * patients with impaired skin integrity at the fingers. * patients with major psychiatric problems.

Keywords: spinal cord stimulation electrodermal activity
cvd 37000: immunity and microbiome studies at intestinal and systemic sites in ty21a vaccinated adults

Conditions: Typhoid Vaccination

Summary: this is an open-label, non-randomized study. the purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. patients having standard-of-care colonoscopies will be divided into 3 groups: group 1: vivotif typhoid vaccination then colonoscopy; group 2: colonoscopy, then vivotif typhoid vaccination, then follow-up colonoscopy; group 3: colonoscopy without vaccination. the vivotif typhoid vaccine used in this study is licensed by the food and drug administration (fda) for travelers to developing countries. volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid vaccine.


Eligibility criteria:
inclusion criteria: * age 18 years and older * undergoing colonoscopy for screening or surveillance for colorectal cancer at the university of maryland * provide written informed consent prior to initiation of any study procedures * healthy, as defined by considered fit to undergo outpatient elective colonoscopy by the referring health care provider exclusion criteria: * pregnancy or nursing mother * known coagulopathy or bleeding disorder preventing mucosal biopsy * history of crohn's disease or ulcerative colitis * surgical removal of the ileocecal valve or any part of the small or large intestine * allergic reaction to oral typhoid vaccine in the past * immunosuppression from illness or treatment, including * immune-deficiency disorders such as human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids) * leukemia, lymphoma, or cancers * immune suppressive medications or treatments, such as corticosteroids or radiation * receipt of any other vaccine two weeks prior to receipt of ty21a * positive urine pregnancy test (hcg) prior to colonoscopy or vaccination
a study to assess the effect of doctor's biome medical food in individuals with clostridium difficile infection

Conditions: Clostridium Difficile Infection

Summary: a randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of doctor's biome medical food (dbmf) in individuals with clostridium difficile infection (cdi)


Eligibility criteria:
inclusion criteria: 1. males and females of 30 - 75 years of age. 2. a qualifying episode of cdi as defined by: 1. ≥ 3 abnormal stools as assessed by bsfs score of 6 \& 7 in the last 24 hours. 2. a positive c. difficile stool toxin assay as assessed by c. difficile toxins a \& b - card\*. 3. the requirement of cdi standard of care (soc) antibiotic therapy (as per pi's discretion). 3) individuals willing to give voluntary, written informed consent to participate in the study. 4) individuals without/with antibiotic-associated diarrhea (indicated by use of antibiotics any time in last one week) will also be considered for the testing of c. difficile toxins exclusion criteria: 1. history or presence of terminal/end-stage renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders (which might confound the interpretation of the study results, or put the individual at undue risk). 2. history of peptic ulcer. 3. history of abdominal surgery within the previous 3 months. 4. presence of colostomy, gastric-tube, or naso-gastric-tube. 5. individuals requiring any gastrointestinal surgery planned during the next 3 months. 6. hiv, aids, primarily immunodeficiency, cancer 7. individuals with a very recent (\< 1 year) solid organ or bone marrow transplant. 8. individuals requiring blood transfusion or renal dialysis planned during the next 3 months. 9. unwilling to abstain using kombucha, sauerkraut, pickles and kimchi 10. individuals with the following food intolerance - gluten, lactose, and/or histamine. 11. heavy alcohol drinkers are defined as follows: for men, consuming more than 4 drinks on any day or more than 14 drinks/week. for women, consuming more than 3 drinks on any day or more than 7 drinks/week. 12. smokers. 13. females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 14. individuals who have participated in another clinical study(ies) with an investigational product within 90 days before screening, or who plan to participate in another study during the study period. 15. use of any supplements (may include probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplementation the last 30 days.
liposomal amphotericin b (ambisome) pharmacokinetics given as a single intravenous dose to obese patients (aspen)

Conditions: Morbid Obesity

Summary: dosing guidelines for liposomal amphotericin b (ambisome) in (morbidly) obese patients are not available. subsequently, the pharmacokinetic profile of ambisome in this specific patient population is still largely unknown. to build a valid pharmacokinetic model, obese patients with a bmi ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 1 mg/kg or 2 mg/kg ambisome (besides standard anti-bacterial prophylaxis) and a pk-curve will be drawn. these pk-values can then be compared to the pharmacokinetics of a normal-weight group.

* the overall trial design is a prospective, open-label, non-randomized, single-centre, single-dose, multiple dose level trial, (1 mg/kg and 2 mg/kg). * a total of sixteen patients with a bmi ≥40 kg/m2 undergoing bariatric surgery who receive a pre-surgery dose of ambisome 1 mg/kg (n=8) or 2 mg/kg (n=8) will be enrolled. * after enrollment of group 1 (1 mg/kg), an interim analysis on the safety of ambisome will be performed before proceeding to group 2 (2 mg/kg). * infusion time and concentration of ambisome will be 45 minutes (1 mg/kg group) and 90 minutes (2 mg/kg group) * a pk curve will be determined after administration of a single, pre-surgery dose of ambisome at t = 0.5, 0.75 (end of infusion group 1), 1.5 (end of infusion group 2), 2, 4, 6, 8, 10, 12, 24, 36, and 48 and (if feasible) 72 hours post infusion (n=12 samples) for group 1 (1 mg/kg), 8 patients.the pk curve of group 2 (2 mg/kg, 8 patients) will be similar to group 1, except for the t=1.5 hour sampling point, which will be end of infusion due to the infusion time of 90 minutes. * patients are considered to have completed the study if at least 9/11 samples of the pk curve up until 48 hours have been collected. * patients will be selected by the research team to have a good spread in weight bands.

Eligibility criteria:
inclusion criteria: 1. patient has a bmi ≥40 kg/m2 and is undergoing bariatric surgery 2. subject is at least 18 of age on the day of screening. 3. subject or legal representatives are able and willing to sign the informed consent before screening evaluations. exclusion criteria: 1. documented history of sensitivity to medicinal products or excipients similar to those found in the polyene preparation. 2. history of, or current abuse of drugs, alcohol or solvents (up until a maximum of three months before enrolment). 3. inability to understand the nature of the trial and the procedures required. 4. administration of nephrotoxic medication (aminoglycosids, immunosuppressants, antivirals, antineoplastic agents) up until a maximum of one month before enrolment.

Keywords: liposomal amphotericin b ambisome pharmacokinetics obesity bariatric surgery
airway ultrasound as a predictor for postextubation stridor in anterior cervical spine surgery

Conditions: Postextubation Stridor

Summary: literature on use of the ultrasound (us) in extubation decisions in cervical spine surgery is scarce.the aim of this study will be to evaluate the utility of us as an aid for decision making for extubation in elective cervical spine surgery (anterior approach) operations and as a predictor for postextubation stridor in these operations


Eligibility criteria:
inclusion criteria: * surgeries associated with either exposure of more than three vertebral bodies, * exposures involving the c2-c4 levels, * blood loss exceeding 300 ml * surgical time of more than five hours, exclusion criteria: * laryngotracheobronchial pathology, * severe cardiorespiratory disease, * admitted for redo-surgery * intubated prior to operation * patient with anesthetic risk factors include mallampati 3 or 4 and multiple intubation attempts
study to assess safety, tolerability, pharmacokinetic and pharmacodynamic properties of glpg1690 in subjects with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: a multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory phase iia study in subjects with idiopathic pulmonary fibrosis (ipf) to evaluate safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of glpg1690. male and female subjects aged 40 years or older will be screened to determine eligibility. the screening period will be up to 4 weeks. at baseline, eligible subjects will be randomized in a 3:1 ratio to glpg1690 or matching placebo administered for 12 weeks. the subjects will visit the study center at screening, baseline, weeks 1, 2, 4, 8 and 12 and for a follow-up visit 2 weeks after the last administration of study drug. planned assessments: adverse event reporting, clinical laboratory tests, vital signs, physical examination, 12-lead-ecg, pk blood sampling, biomarker blood/bronchoalveolar lavage fluid (balf), spirometry, st george's respiratory questionnaire, high-resolution computed tomography (hrct).


Eligibility criteria:
inclusion criteria: 1. subjects able and willing to sign the institutional review board (irb)/independent ethics committee (iec) approved informed consent form (icf) 2. male or female subjects of non-child-bearing potential aged ≥ 40 years 3. subjects with a chest hrct performed within 12 months prior to screening 4. subjects with ipf diagnosed by a multidisciplinary team 5. subjects with: a. forced vital capacity (fvc) ≥50% predicted of normal and b. diffusing capacity for the lungs for carbon monoxide (dlco) ≥ 30% predicted of normal corrected for hemoglobin 6. subjects with a forced expiratory volume in 1 second (fev1)/fvc (tiffeneau-pinelli index) ratio ≥ 0.70 (based on pre-bronchodilator spirometry 7. subjects on stable supportive care 8. subjects in stable condition exclusion criteria: 1. subjects with know hypersensitivity to any of the study drug ingredients 2. subjects with a history of or current immunosuppressive condition 3. subjects with a history of malignancy within the past 5 years 4. subjects with clinically significant abnormalities on ecg 5. subjects with acute ipf exacerbation within 6 weeks prior to screening 6. subjects with a lower respiratory tract infection requiring antibiotics with 4 weeks prior to screening 7. smoking within 3 months pre-screening 8. interstitial lung disease 9. history of lung volume reduction surgery or lung transplant 10. unstable cardiac or pulmonary disease other than ipf within 6 months prior to screening 11. subjects with abnormal liver function 12. subjects with abnormal renal function

Keywords: idiopathic pulmonary fibrosis glpg1690 autotaxin
liposomal based intranasal influenza vaccine:safety and efficacy

Conditions: Influenza

Summary: influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious among the elderly. a vaccine given as a nasal spray may improve compliance and local immunity.liposomes are lipid particles that may serve as carriers for the vaccine and together they enhance the local immune response in mice when given as nasal spray.this study aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to the commercial muscular vaccine.


Eligibility criteria:
inclusion criteria:healthy young(20-45years old) and elderly(65-95 years old) volunteers - exclusion criteria:known allergy to eggs and to the flu vaccine, pregnant and breast feeding women, chronic viral carriers, recently hospitalized persons -

Keywords: intranasal vaccination, influenza
study to evaluate the presence of lower urinary tract symptoms (luts) in prostate cancer patients scheduled to receive luteinizing hormone releasing hormone (lhrh) analogues

Conditions: Prostate Cancer

Summary: the intention of this study is to investigate how many patients with prostate cancer, planned to be treated with lhrh analogues without history of surgery or radiotherapy, are suffering from luts. in addition the effect of lhrh analogues on the improvement of theses primary luts symptoms over time will be investigated.


Eligibility criteria:
inclusion criteria: * adult men with locally advanced or metastatic prostate cancer scheduled to receive lhrh analogues. a patient who has completed an ipss questionnaire in his last visit, before the start of lhrh analogues, will be able to participate in the study. this last visit has to be done 6 months before the baseline visit. * patients having provided written informed consent * patients mentally fit for completing a self-administered questionnaire exclusion criteria: * any surgical or radiotherapy treatment performed at prostate level before the entry of the study * patient with castrate levels of testosterone ( \< 50 ng/dl) at his first ipss questionnaire * patients who are also participating in any other clinical study within the last 2 months before study entry * life expectancy of less than 12 months
phenomenological and psychopathological factors associated to hallucinations in parkinson's disease

Conditions: Parkinson Disease

Summary: this study aims to describe hallucinations prevalence in a sample of patients affected by parkinson's disease and consulting in an outpatient facility. an unique one hour interview will be offered to volunteers patients. patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics. the study hypothesis is that hallucinations prevalence in parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years-old * absence of opposition from the patient himself/herself or his/her legal representant for his/her participation to the study * patient without superior age limit with a diagnosis of parkinson's disease made according to the ukpdsbb criteria (uk parkinson's disease society brain bank clinical diagnostic criteria) * outpatient consulting in neurology at the charpennes'hospital exclusion criteria: * opposition to the study * deafness or blindness which could compromise the interview