Kornimate/medical-research-clean huggingface dataset:
effects of linagliptin in addition to empagliflozin on islet cell physiology

Conditions: Type 2 Diabetes Mellitus

Summary: the primary aim of this exploratory mechanistic study is to investigate the effects of empagliflozin and linagliptin on alpha- and beta cell physiology in t2dm patients. this study aims to evaluate the effect of the dpp-iv inhibitor linagliptin (as compared to placebo) in addition to the sglt-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.

this study will be performed as a multi-center study which includes 2 centres. 44 subjects with t2dm are to be included according to the defined in- and exclusion criteria. subjects has to be on a stable metformin therapy and will receive in a first step empagliflozin for 30 days. both therapies (metformin and empagliflozin) will be continued for another 30 days and subjects will be randomized to receive in addition linagliptin or placebo for 30 days. subjects will come for two inhouse periods to their corresponding study center and will undergo an hyperglycaemic clamp test as well as a meal test in each of the periods.

Eligibility criteria:
inclusion criteria: 1. male or female subject with diabetes mellitus type 2 2. diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months 3. hba1c 7.0%-9.9%, both inclusive 4. diabetes duration of at least 24 months) exclusion criteria: 1. history of diabetes mellitus type 1 2. gfr (as calculated by the cockcroft-gault equation) \< 60 ml/min at screening 3. systolic blood pressure outside the range of 100-160 mmhg or diastolic blood pressure above 95 mmhg at screening
comparing functional outcomes in individuals using micro-processor controlled orthosis versus stance control orthosis

Conditions: Spinal Cord Injuries; Poliomyelitis; Post-polio Syndrome; Arthritis; Lower Motor Neurone Lesion

Summary: the study will specifically evaluate the potential of the c-brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.


Eligibility criteria:
inclusion criteria: * lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma. * prior active and compliant use of unilateral knee-ankle-foot orthosis (kafo) or stance control orthosis (sco). * age 18 - 80 years. * demonstrate a reciprocal gait pattern using the sco and c-brace trial tools. * cognitive ability to understand and the willingness to sign a written informed consent. * subjects must be able to demonstrate the ability to turn the global positioning sensor (gps) and actigraph units on and off and sufficient memory ability to wear the devices each day during use of the orthoses. exclusion criteria: * passive ankle range of motion (prom) of the lower extremity requiring the knee-ankle-foot orthosis (kafo) of less than 2 degrees. * body weight \>275 pounds. * unstable neurological or cardiovascular/pulmonary disease, cancer. * knee flexion contracture resulting in the inability to actively use c-brace or sco. * participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.
evaluation of the standard g6pd rapid test for assaying the enzymatic activity of g6pd in french guiana

Conditions: Paludism

Summary: in french guiana, malaria is endemic and two species predominate: p. falciparum and p. vivax. the treatments against plasmodium vivax malaria are: nivaquine for 3 days against circulating blood parasites and primaquine for 14 days against parasites dormant in the liver. primaquine can cause iatrogenic hemolytic anemias in patients with favism, i.e. g6pd deficiency. this anemia can be severe enough to cause the death of the deficient patient. thus, the who and hcsp recommendations indicate that a quantitative assay of the activity of this enzyme should be carried out before its prescription. this deficiency is a recessive inherited disease linked to the x chromosome characterized by more or less low levels of enzymatic activity which depends on the genotype of the patients but not only because the phenotype depends on the level of activation of the x chromosome for each cell. currently, obtaining a g6pd assay in french guiana is a long process since it is done in mainland france and the pre-analytical conditions are quite demanding. thus, in areas of transmission of p. vivax, patients usually have a bout of revival before being prescribed primaquine. this period includes: dosing g6pd at a distance from access, obtaining the result and then the nominal atu to finally obtain and deliver the primaquine.

this is a interventional,prospective, multicenter, cross-sectional and comparative study. to achieve this study, the following will be done: * selection of subjects according to their g6pd activity from the list of participants previously included in the elimalar palustop study and from known lhupm patients in cayenne following a request for a g6pd dosage, whether or not related to malaria. * collection of clinical data from participants (sex, age, ethnicity of parents and grandparents). * collection of blood samples from subjects showing g6pd activity of the following three categories "severe deficiency", "intermediate", "normal". * determination of g6pd activity by the "standard g6pd" technique from sd biosensor versus the reference enzymatic method

Eligibility criteria:
inclusion criteria: * people with a known level of g6pd activity. * people or their legal representatives who have received information on the research and have signed a written consent to participate in the study * people aged over 18 for the "intermediate" and "normal" categories, * people aged two years and over for the "severe deficit" category. exclusion criteria: * people with an unknown level of g6pd activity, * people or their legal representatives who refused to participate in the study, * people aged under 18 for the intermediate and normal categories, * children under 2 years old for the "severe deficit" category, * people with a hemoglobin level below 11g / dl for men and 10g / dl for women and children. * people who received a transfusion less than 4 months before the proposal to participate in the g6pd study

Keywords: paludism french guiana g6pd rapid diagnostic test standard g6pd
clinical trial comparing epidurals and local anaesthetic wound catheters in patients having bowel surgery

Conditions: Pain

Summary: the purpose of this study is to find out whether the use of painbuster® (a local anaesthetic wound catheter) can be used instead of epidurals for patients having bowel surgery in an enhanced recovery programme. the investigators want to find out whether or not using this device means people need to stay in hospital for less time after surgery.


Eligibility criteria:
inclusion criteria: * all patients who are undergoing either laparoscopic or open colorectal resection will be considered eligible for the study. exclusion criteria: * patients under 18 years of age * pregnant females * patients undergoing an abdominoperineal resection * patients unable to understand english

Keywords: eras local anaesthetic wound catheter painbuster epidural colorectal surgery enhanced recovery program
a tailored internet intervention to reduce skin cancer risk behaviors among young adults

Conditions: Skin Neoplasms

Summary: skin cancer is the most common cancer in the us, with over a million new cases diagnosed yearly. young adults are increasingly at risk of melanoma. contributing to the increasing skin cancer risk is the fact that us adolescents have the lowest skin protection rates of all age groups and also demonstrate increased exposure to natural and artificial uv radiation. innovative interventions are needed to have an impact on skin cancer risk among young people. unlike previous interventions, our skin cancer risk reduction intervention will be tailored (or personalized) to each individual participant and delivered via the internet. the intervention will emphasize appearance concerns, which are known to be the primary motivation for uv exposure and lack of skin protection among young adults. this will be accomplished in part through the use of personalized facial images showing uv damage as well as computerized age progression demonstrations. primary aim 1. to examine the efficacy of a tailored intervention delivered via the internet designed to increase skin protection and decrease sun exposure behavior among young adults at moderate to high risk of developing skin cancer. participants will be randomized to the tailored intervention, the skin cancer foundation website, or an assessment only condition. aim 2. to evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family history of skin cancer), appearance consciousness, and past exposure and protective behaviors moderate intervention effects. aim 3. to evaluate whether integrative model constructs (uv-related knowledge, risk perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects. the goals of future research would be to enhance the tailored intervention, for example, by adding additional contacts or internet technologies or features, disseminate the intervention, assess the longevity of effects, and/or adapt the tailored intervention for use with other cancer risk behaviors or at risk groups.


Eligibility criteria:
inclusion criteria: * age 18-25 years old * moderate to high risk of skin cancer (cut-off of \>=27 on the brief skin cancer risk assessment tool) exclusion criteria: * history of skin cancer

Keywords: prevention or control
an observational monocentric study investigating the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients

Conditions: Psoriasis

Summary: the purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.


Eligibility criteria:
inclusion criteria: * age from 18 years on, male or female * established diagnosis of psoriasis * etanercept either on monotherapy or in combination with acitretin (neotigason®), given according to the current eu smpc including the safety measures. * patients who give informed consent for this study

Keywords: anti-tnf therapeutic drug monitoring immunogenicity
transdiagnostic cognitive biomarkers

Conditions: Pain; Depression

Summary: the overall objective of this study is to determine the feasibility of identifying transdiagnostic biomarkers of cognitive function mediated by neuromodulation of the dorsolateral prefrontal cortex that are translatable across disease groups in order to more accurately phenotype clusters of cognitive dysfunction. completing behavioral paradigms with electrophysiology and tms is a challenging frontier. this study focuses on the feasibility of such an endeavor for those with chronic pain or depression as well as healthy controls.

this study aims to test the feasibility of procedures aimed at discovering transdiagnostic biomarkers for cognitive impairment in chronic pain and depression. fifteen healthy control participants and 15 participants from each disease group (chronic pain, depression) will be recruited. using a task-based fmri, tms will be targeted for priming of the left dlpfc. eeg will be used during our behavioral paradigm to compare changes in dlpfc function before and after primed tms.

Eligibility criteria:
arm 1, healthy controls: inclusion criteria: * have access to the online study platform. exclusion criteria: * under 18, non-english speaking arm 2: pain and depression: inclusion criteria: * pain or depression exclusion criteria: * pregnant women
pre-flight evaluation of adult patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of the study is to investigate the relationship between hypoxemia achieved during hypoxia altitude simulation test and sea level values of pulmonary function, arterial blood gases, pulse oximetry and cardiopulmonary exercise test variables. in addition, to study the effect of slow walk in a hypoxic environment, comparable to slow walking along the aisle.


Eligibility criteria:
inclusion criteria: * cystic fibrosis * \> 16 years * sputum test negative for burkholderia cepacia and/or methicillin resistant staphylococcus aureus exclusion criteria: * ongoing infection

Keywords: blood gas response exercise gas exchange hypoxia altitude simulation test pulmonary function
monitoring drug efficacy in patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: this study will explore the different factors associated with drug response to acetylcholinesterase (ache) inhibitor (donepezil) and nmda receptor antagonist (memantine) in patients with alzheimer's disease.

these patients will be grouped according to the medications prescribed by their attending physician at baseline, 3rd month, and 6th month of follow up: 1. alzheimer's disease patients given ache inhibitor monotherapy 2. alzheimer's disease patients given combination therapy of ache inhibitor and nmda receptor antagonist they will be observed for treatment response for up to 6 months.

Eligibility criteria:
inclusion criteria: * newly diagnosed with mild or moderate dementia using the montreal cognitive assessment and clinical dementia rating (cdr) performed by a licensed psychometrician * clinically diagnosed by an expert adult neurologist as having probable ad using the national institute of neurological and communicative disorders and stroke and alzheimer's disease and related disorders association (nincds-adrda) criteria * treatment naive for any acetylcholinesterase inhibitors or memantine or those who have not taken any acetylcholinesterase inhibitors or memantine in the last three months for any reasons except for adverse drug reaction * age 65 years old * residing in the national capital region * able to read and understand written and spoken english and filipino exclusion criteria: * with structural or vascular causes of dementia other than subcortical lacunes (2 or less) as seen in plain ct scan * dementia diagnosis other than ad as determined by an expert adult neurologist * with untreated depression or related psychiatric disorders in the last 6 months * use of systemic antibotics in the previous three months prior to providing fecal specimens * use of corticosteroids, immune stimulating medications, and immunosuppressive agents within the past 2 weeks or those who regularly need them for immune-related disorders * use of proton-pump inhibitors, h2-receptor antagonists, h2-receptor antagonists, tricyclic antidepressants, narcotics, anticholinergic medications, laxatives or anti-diarrheal in the past 4 weeks * large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) * major dietary change during previous month (defined as eliminating or significantly increasing a major food group) * major gi tract surgery in the past 5 years, with the exception of cholecystectomy and appendectomy * major bowel resection at any time * active uncontrolled gi disorders or diseases, including inflammatory bowel disease, indeterminate colitis, irritable bowel syndrome, persistent infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, recurrent clostridium difficile infection, untreated helicobacter pylori infection, chronic constipation

Keywords: multiomics drug response
for prevention of diarrhea in patients diagnosed with metastatic colorectal cancer treated with chemotherapy

Conditions: Neoplasm Metastasis; Colorectal Neoplasms

Summary: the diarrhea prevention with an investigational drug trial, will evaluate whether adding an investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. the standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as cpt-11, camptosar), 5-fluorouracil (also known as 5fu), and leucovorin (also known as lv). preclinical data from animal models suggest that the investigational drug may offer an effective means for preventing cpt-11/5fu/lv-induced diarrhea. it is also hypothesized that the investigational drug-mediated anti-angiogenesis could induce a favorable tumor response.


Eligibility criteria:
inclusion criteria: * diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease and present or past histological documentation of adenocarcinoma of the colon or rectum. * tumor must be measureable. * resolution of all acute toxic effects of any prior radiotherapy or surgical procedure. * ecog performance status 0 or 1. age \>= 18 years. * required baseline laboratory. * negative pregnancy test. * willingness and ability to comply with the treatment plan. exclusion criteria: * current enrollment in another clinical trial. * prior adjuvant therapy for colorectal cancer \<= 6 months prior to randomization. * prior systemic anticancer therapy or intra-arterial cytotoxic chemotherapy given as treatment for metastatic colorectal cancer. * known allergy to cpt-11, 5-fu, lv, celecoxib, other cox-2 inhibitors, non-steroidal anti-inflammatory drugs (nsaids), salicylates, or sulfonamides. * chronic concomitant use of full-dose aspirin, other nsaids or other cox-2 inhibitors for a chronic nonmalignant condition. * a requirement for chronic concomitant use of low-dose (cardioprotective) aspirin. * chronic oral steroid use for treatment of a non-malignant condition. * known ulceration of the gastric or duodenal mucosa \<= 30 days prior to randomization. * need for concomitant fluconazole or lithium. * any known significant bleeding disorder. * active inflammatory bowel disease or chronic diarrhea.
balloon expandable transcatheter aortic valve implantation without predilation of the aortic valve

Conditions: Aortic Valve Stenosis

Summary: there is limited experience for the balloon expandable thv (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, bav). therefore we aim to verify results of a small case series published by wendler et. al. to examine hard endpoints such as the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a multicenter registry. we aim to compare the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (varc2).

prior to the deployment of transcatheter heart valves (thv), balloon aortic valvuloplasty (bav) is usually performed under rapid right ventricular pacing (burst \>180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. aortic valve predilation is aiming at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. however, bav has been shown to have a number of potentially detrimental effects, such as: * functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral, and renal ischemia. * in patients with a reduced left ventricular ejection fraction (lvef), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (sirs). both are associated with a high periprocedural mortality. * bav has been identified as a major source of thrombotic and valvular material and increases the risk for coronary obstruction with subsequent myocardial infarction and stroke. * the local trauma in the left-ventricular outflow tract caused by bav may potentially contribute to aortic root rupture.

Eligibility criteria:
inclusion criteria: * patients with an indication for tavi as to the edwards thv ifu * eligible for tabi with and without bav * signed informed consent exclusion criteria: * logistic euroscore i \>50% * mitral or tricuspid valvular insufficiency (\> grade ii) * previous aortic valve replacement * uncontrolled atrial fibrillation * left ventricular or atrial thrombus by echocardiography * recent cerebrovascular event (within the last 3 months) * high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)

Keywords: thv bav pre-dilation aortic valve stenosis
sleepiz one+ vs. capnography and electrocardiography

Conditions: Sleep Apnea; Asthma; COPD; Hypertension; Diabetes; Respiratory Disease; Cardiovascular Diseases

Summary: respiratory rate (rr) and heart rate (hr) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. effective management of chronic diseases relies on detecting pathological changes early, with rr being among the most sensitive predictors of patient deterioration. therefore, vigilant monitoring of rr and hr is vital for improving patient outcomes. the primary aim of this study is to provide a thorough comparison of the performance of sleepiz one+ algorithms and end-tidal carbon dioxide measurement (etco2) capnography for measuring respiration rate and electrocardiography (ecg) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, chronic obstructive pulmonary disease (copd), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. additionally, the investigators will evaluate the performance of rr estimation against the thoracic effort belt and the hr against the pulse oximetry.


Eligibility criteria:
inclusion criteria: patients: * age \>=18years * informed consent as documented by signature * one (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.) healthy volunteers * age \>=18years * informed consent as documented by signature * no diagnosed chronic medical condition exclusion criteria: patients * previous enrolment into the current study, * cardiac pacemaker or another implanted electrical device * women who are pregnant or breastfeeding * inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant healthy volunteers: * previous enrolment into the current study, * cardiac pacemaker or another implanted electrical device * women who are pregnant or breastfeeding * inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant * presence of diagnosed chronic medical condition