Kornimate/medical-research-clean huggingface dataset:
eluxadoline bile acid malabsorption (bam) study

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: this study will evaluate the possibility of a differential effect of eluxadoline on altered bowel function in irritable bowel syndrome with diarrhea (ibs-d) participants with and without evidence of bile acid malabsorption (bam).


Eligibility criteria:
inclusion criteria: * adult men or women aged 18 to 75 years inclusive with a diagnosis of ibs-d per rome iv criteria. * participants with evidence of bam must have a fasting serum 7a-hydroxy-4-cholesten-3-one (7αc4) level ≥ 52.5 ng/ml or total fecal bile acid (ba) \> 2337 micromoles/48 hours (positive result) at screening or within 1 calendar year prior to screening. * participants without bam must have a fasting serum 7αc4 level ≤ 47.1 ng/ml or total fecal ba \< 2200 micromoles/48 hours (negative result) at screening or within 1 calendar year prior to screening. * has an average daily bristol stool form scale (bsfs) score ≥ 5.0 or ≥ 25% of diary entry days with a bsfs score of 6 or 7 during the 14 days prior to day 1. * women of childbearing potential must use hormonal or double barrier contraception or maintain a monogamous relationship with a vasectomized male partner from the date of informed consent until 24 hours after final dose of study drug. * completed the electronic diary (ediary) on ≥ 10 of the 14 days prior to day 1. * has not used loperamide rescue medication on \> 3 of the 14 days prior to day 1. exclusion criteria: * has a diagnosis of ibs with a subtype of irritable bowel syndrome with constipation (ibs-c), mixed ibs, or unsubtyped ibs per rome iv criteria. * does not have a gallbladder. * has known or suspected biliary duct obstruction, or sphincter of oddi disease or dysfunction. (participants with a history of gallstones may be enrolled). * has a history of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3 alcoholic beverages per day. * has a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction. * has a history of mild, moderate, or severe hepatic impairment according to child-pugh classification. history or current diagnosis of inflammatory or immune-mediated gastrointestinal (gi) disorders. * has celiac disease or a positive serological test for celiac disease. * has known lactose or fructose intolerance associated with diarrhea, abdominal pain or discomfort, that could confound assessments in the study. * women who are currently pregnant or nursing, or plan to become pregnant or nurse during the study. * has known allergies or hypersensitivity to opioids.

Keywords: ibs-d bam
short-term psychodynamic psychotherapy in serious physical illness

Conditions: Malignant Neoplasm; Carcinoma; Palliative Care

Summary: life-threatening physical illness may powerfully re-activate existential conflict. there is little evidence to date on the effectiveness of relationship-focused therapies in this patient group.the aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.

severely physically ill patients may experience existential distress symptoms including helplessness, hopelessness, death anxiety, perceived burdensomeness and a sense of pointlessness. the latter can significantly interfere with end-of-life care processes and outcomes (receipt of treatment according to preferences, expression of desire for hastened death). so far, empirically tested psychotherapeutic programs in advanced life-threatening illness have predominantly been ultra-short and applied supportive and resource-oriented techniques. psychodynamic treatment allows to address clinically significant existential distress through its conceptualization from early relational life experiences. the aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.the inverstigators will 1. analyse the feasibility of the treatment, and 2. investigate changes in process- and patient-relevant outcomes over the course of the treatment the inverstigators will conduct a single-group pre-post study with five assessment points in which 50 adult patients diagnosed with advanced cancer will receive a manualized psychodynamic short-term therapy. target parameters are assessed by diagnostic interviews, focus interviews, self-assessment questionnaires as well as electronic patient records. for research objective b) the investigators will compare the intervention group with a matched comparison group of a longitudinal cohort sample (nct04600206). matching will be based on stress level, demographic, and medical parameters across the 5 assessment points.

Eligibility criteria:
inclusion criteria: * 18 years and older * uicc stage iv solid tumor * informed consent * current physical condition that allows for at least 12 therapy sessions * indication: presence of a mental disorder with existential stress and limitations in coping capacity exclusion criteria: * acute suicidality * psychotic disorder (icd-10: f2 diagnosis) * substance dependence or abuse (icd-10: f1 diagnosis) * structural deficits that interfere with attending to regular appointments * other psychotherapeutic treatment * severe cognitive impairment * severe physical impairment * insufficient german to give informed consent and complete self-report questionnaires

Keywords: advanced cancer death anxiety demoralization existential distress mental disorders
chronic rhinosinusitis classification proposal

Conditions: RHINOPLASTY; NASAL SURGICAL PROCEDURES

Summary: chronic rhinosinusitis (crs) is a debilitating disease that remains (smell, nasal patency, flow) because currently treatment protocols available to us are with a limited efficacy. the assessment of the response to surgical treatment protocols and monitoring the become of patients treated with only drugs should allow investigators to identify the predictive patient's profile for the response. with this prospective data, this study would allow investigators to make a classification of chronic rhinosinusitis.

chronic rhinosinusitis (crs) is a debilitating disease that remains (smell, nasal patency, flow) because currently treatment protocols available to us are with a limited efficacy. for many years, practitioners have tried to identify a universal therapeutic protocol. it turns out that no treatment (functional endoscopic surgery, antifungal therapy, medical treatment with antibiotics / corticosteroids) does not resolve all of the symptoms and their effectiveness is variable from one patient to another. the most plausible explanation is that the term "rhinosinusitis" includes various different pathophysiological mechanism entities, requiring different treatment. like certain skin or lung diseases, chronic inflammation of the sinuses may have different origins, allergic or extrinsic (infectious). it is therefore important to determine the type of inflammation responsible for adapting the management. first, it is important to determine from all forms of crs (with or without polyps), those associated with allergic inflammation and infectious ones. the presence or absence of polyps does not appear to be a determining factor of the type of inflammation. however, the criteria - allergy and asthma - could provide guidance to an allergic mechanism. the study aims to distinguish different phenotypes crs according to clinical, anatomical criteria and biological criteria. clinical classification obtained would assess and predict more finely treatment response and target according to the phenotype, the best supported. surgery is one of the therapeutic options in the treatment of rhinosinusitis, but the term satisfaction of healing and patient comfort is variable, a finer and precise distribution of patients will allow us to better predict the success of the surgery and therefore the offer targeted patients. primary objective : to assess the response to surgical treatment of rhinosinusitis and the outcome of these patients in order to highlight predictors of success of surgery. secondary objectives: assess chronic rhinosinusitis phenotype by score snot 22 (importance of symptoms) which assesses the average severity of different groups assessing the future of non-operated patients

Eligibility criteria:
inclusion criteria: * patients with bilateral chronic rhinosinusitis evolving for more than 3 months with diffuse sinus opacities scanner. exclusion criteria: * rhino sinusitis unilateral * background total or functional ethmoidectomy (but not polypectomy) * immunodeficiency or immunosuppression in patients
analysis of ocular complications of aids patients in ophthalmic consultation

Conditions: Ocular Complications in AIDS Patients, Such as Fundus Opportunistic Infections, Microangiopathy, and Uveitis

Summary: through a cross-sectional descriptive analysis of ophthalmic consultation of aids patients in the past 3 years, the basic characteristics of patients were described according to whether there was fundus change, and the clinical characteristics and risk factors of cmvr patients with or without rd were compared.

patients were divided into normal group, opportunistic infection group, microangiopathopathy group and uveitis group according to the presence of fundus lesions and the types of fundus lesions. the basic information and characteristics of patients in different groups were described. the factors that may be related to ocular fundus disease of aids patients were found by statistical analysis.

Eligibility criteria:
inclusion criteria: * aids inpatient undergoing ophthalmic consultation exclusion criteria: * non-hiv infected patients

Keywords: ocular complications of aids
prolonged bed rest versus early raising in vertebral osteomyelitis

Conditions: Infectious; Spondylitis

Summary: infectious vertebral osteomyelitis are infectious diseases of the vertebral bone, intervertebral disc and/ or adjacent tissue. most of cases are due to hematogenous dissemination of pathogen but direct inoculation is an aetiology after surgery. majority of cases concern adults after 50 years and the annual incidence ranging between 0.5 and 2.4 cases per 100 000 habitants in europe but seems to increase during last 20 years. the infectious spondylodiscitis is an important source of morbidity and mortality. the treatment is based on pathogen adapted antimicrobial therapy, which may be associated with bedrest. surgical act is necessary when neurological complication occurs or when vertebral column instability is too important. the immobilization in bed is use to limit pain and neurological complications. however, the immobilization is based on few literature data and causes important complications especially in elderly. the of immobilization in nancy universitity hospital changed in 2019 after institutional recommendations based on expert opinion which recommend an early verticalization of uncomplicated spondylodiscitis. the investigators aimed to evaluate the consequences of this practice change on the hospitalization duration and complication rates due to spondylodiscitis and immobilization.


Eligibility criteria:
inclusion criteria: * infectious spondylodiscitis proven by radiological exam * infectious spondylodiscitis with microbiological documentation exclusion criteria: * patient included in corosive study * vertebral prosthetic device infection * infectious spondylodiscitis relapse

Keywords: infectious vertebral osteomyelitis spondylodiscitis bed rest early raising verticalization immobilization
interpretation and optimization of nutrition in the intensive care units

Conditions: Nutritional Support

Summary: despite recommendations, inadequate nutritional intake in intensive care unit (icu) patients remains frequent and can lead to complications such as infections, increased length of stay, prolonged weaning from ventilation, increased long-term mortality, and decreased quality of life after intensive care. studies have shown that patients only receive up to 50-60% of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as icu procedures, physical therapy, transport for imaging or invasive procedures outside the icu, and nutrition intolerance. furthermore, this discrepancy between prescribed and delivered nutrition may go largely unnoticed, due to issues concerning inadequate manual or automated monitoring of delivered nutrition. a joint "call to action" by aspen, the academy of nutrition and dietetics, and the american society of health-system pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house clinical decision support systems and the interfaces between electronic health records (ehrs), automated preparation devices and pharmacy systems. nutrow® is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements, real-time calculation and monitoring of calorie and protein prescriptions, real-time calculation and monitoring of calories and protein truly delivered to patients, and information feedback to prescribers. feedim® is a medical device data system (mdds), designed by dim3, which transmits information from enteral feeding pumps to third-party software, such as nutrow®. the aim of the study is to assess whether the joint use of nutrow-feedim improves the achievement of nutritional objectives in icu patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein.


Eligibility criteria:
inclusion criteria: * age 18 and over. * french social security system registration. * first stay in icu * admitted to the lille university hospital surgical icu for at least 3 days. * active enteral and/or parenteral nutritional support prescription * patient and/or next-of-kin informed about the study and having consented to participation in the study. exclusion criteria: * age under 18 * burn patient * admitted to the icu with a prior active enteral/parenteral nutritional support before day 3, except trophic nutrition * dying patient, not-to-be-resuscitated order, or other treatment limitation decision at icu admission * adult under guardianship * department of corrections inmate

Keywords: intensive care unit protein calorie malnutrition refeeding syndrome clinical decision support systems
precision treatment with angiotensin converting enzyme inhibitor

Conditions: Hypertension

Summary: angiotensin converting enzyme inhibitors (acei) are the first-line treatment for high blood pressure and congestive heart failure, and have excellent effects in improving the prognosis of cardiovascular diseases. however, acei is frequently discontinued due to its adverse reaction. the adverse reaction to acei is not uncommon, especially in asians. discontinuation of acei is known to increase the risk of poor prognosis of cardiovascular diseases. biomarkers for predicting adverse reaction to acei have not yet been developed. recently, genes related to adverse reaction to acei have been identified. this study is a randomized prospective study, in which the experimental group decides whether to administer the drug based on genetic information, and the control group decides whether to administer the drug without the information. in the experimental group, participants who are predicted to have a high risk of adverse reation to acei will receive angiotensin receptor blockers (arb), and those who are predicted to have a low risk of adverse reaction will receive acei. control group will receive acei. the frequency of adverse reaction will be investigated between control and experimental groups. in the genotyping and control groups, at least 45 and 31 will be enrolled, respectively, and after drug administration, a phone follow-up will be conducted at 3 weeks, followed by a visit at the 6th week, and the study will be terminated.


Eligibility criteria:
inclusion criteria: * men and women over 20 years of age and less than 79 years of age * hypertension * no history of acei use exclusion criteria: * acute coronary syndrome, cerebrovascular accident, symptomatic peripheral artery disease, or coronary revascularization in the past three months * decompensated heart failure * systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg * hemoglobin a1c \>9.0% * thyroid dysfunction * serum transaminase \>2 times the upper limit of normal levels * serum creatinine \>2.0 mg/dl * cancer * pregnant or breast-feeding women, and women of childbearing potential * patients who refused to participate
covid-19 vaccines and the menstrual cycle

Conditions: Menstrual Irregularity

Summary: the study aimed to explore the effect of different covid-19 vaccines on menstrual cycle

this is a descriptive cross-sectional study that took place between september 2021 and december 2021. the study aimed to explore the effect of different covid-19 vaccines on menstrual cycle. it used an anonymous questionnaire distributed via social media platforms; facebook, twitter, and whatsapp across different cities of jordan. a total of 732 responses were received with a 59% response rate. the questionnaire was distributed over four months directed at women who have received at least one dose of the covid-19 vaccine and who live in jordan. it took 10 minutes to complete all the questions. data collection did not involve direct contact with participants to prevent the spread of covid-19.

Eligibility criteria:
inclusion criteria: * 18 years and older * less than 40 years * healthy women * received covid-19 vaccine exclusion criteria: * women who did not receive the vaccine * those living outside jordan (those cannot fill the form) and during analysis.
management of anticoagulants and antithrombotics in patients with csdh

Conditions: Chronic Subdural Hematoma; Anticoagulant-induced Bleeding; Thromboembolic Stroke; Cardiovascular Stroke

Summary: primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (csdh). these data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * informed consent * evidence of csdh which needs surgery * patients taking antithrombotics or anticoagulants exclusion criteria: * previous surgery for csdh

Keywords: chronic subdural hematoma anticoagulants antithrombotics thromboembolic disease cardiovascular risk
community-based, peer-delivered prep for female sex workers in rural uganda: the peers for prep (p4p) study

Conditions: HIV/AIDS

Summary: the overall goal of the p4p: peers for prep (pre-exposure prophylaxis) study is to pilot test a peer-led and delivered intervention for biomedical hiv prevention that is tailored to women who engage in sex work in southwestern uganda. this study will evaluate whether this intervention is feasible, acceptable, and increases uptake of biomedical prevention.

the investigators have collaborated with key stakeholders to develop a community-based, peer-led intervention to provide biomedical prevention products (e.g. pre-exposure prophylaxis \[prep\] and post-exposure prophylaxis \[pep\]) for women who engage in sex work in southwestern uganda. a single-arm pilot trial will evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention. the intervention is designed to reduce stigma associated with attending clinics (via community-based delivery by peers), leverage peer support to foster adherence, and reduce barriers to prevention services (through access to prep, hiv self-testing, and pep from trusted peers).

Eligibility criteria:
inclusion criteria: * female sex at birth * self-identified as commercial sex worker; exchange of sex for goods or money in last 3 months; or work or live in setting associated with sex work * age \>=18 years (or mature minor \>=15 years) * hiv-negative by country-standard rapid testing algorithm exclusion criteria: * contraindication to country-recommended prep regimen per national guidelines * unable or unwilling to provide informed consent * participation in another hiv prevention study

Keywords: biomedical hiv prevention peer mentor intervention women engaged in sex work uganda
self efficacy, walking ability, gait speed and physical activity in people with chronic lung disease

Conditions: Chronic Lung Disease; Self-efficacy

Summary: most patients with chronic lung disease underestimate their actual walking ability due to low confidence. to better understand the relationships between lung function, self-efficacy for walking (confidence in ability to walk a defined distance), actual walking ability for the same distance gait speed and physical activity level-pal- (total energy expenditure/resting metabolic rate). quality of life, self efficacy for activity questionnaires, physical activity level measurement, 4-meter gait speed and 6-minute walk distance will be measured.


Eligibility criteria:
inclusion criteria: * men and women 40 years and older * diagnosis of any chronic lung disease as evidenced by pulmonary function testing completed within the prior 12 months * able to walk independently and successfully complete the 6-minute walk assessment exclusion criteria: * unable to walk without assistance or complete the 6-minute walk assessment * patients unable to comprehend and accurately respond to the study questionnaires either by written or spoken communication * patients diagnosed with or treated for a lower respiratory tract infection or copd exacerbation within the prior 30 days

Keywords: chronic lung disease exercise self-efficacy
efficacy of thymosin alpha 1 on improving monocyte function for sepsis

Conditions: Sepsis

Summary: the purpose of this study is to determine whether thymosin alpha 1 is effective on improving monocyte function and has the desired pharmacologic activity for sepsis

part 1: to observe the function of thymosin alpha 1 in sepsis patients via improving phagocytosis, bacteria eradication and antigen-presenting on monocyte part 2: pharmacokinetics of thymosin alpha 1 for sepsis

Eligibility criteria:
inclusion criteria: 1. written informed consent from the patients or their next of kin for patients unable to consent 2. age ≥18 yrs 3. presence of sepsis/ septic shock according to sepsis 3.0 exclusion criteria: 1. pregnant or lactation period. 2. age \<18 yrs 3. receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month. 4. history of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation; 5. acute pancreatitis with no established source of infection. 6. not expected to survive 28 days because of end-stage diseases. 7. participation in another clinical trial.

Keywords: thymosin alpha 1; sepsis; monocyte; pharmacokinetics
study of ce-224,535 a twice daily pill to control rheumatoid arthritis in patients who have not totally improved with methotrexate

Conditions: Arthritis, Rheumatoid

Summary: ce-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. blocking this gateway prevents the cells from pushing out 2 chemicals called il-1 and il-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. it is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis


Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis * incomplete response to methotrexate exclusion criteria: * must not be on biologic therapies * no recent infections

Keywords: rheumatoid arthritis dmard methotrexate