Kornimate/medical-research-clean huggingface dataset:
study to estimate the effects of hepatic impairment on the pharmacokinetics (pk) of pf-07321332

Conditions: Hepatic Impairment

Summary: the study is to estimate the effect of hepatic impairment on the plasma pk of pf-07321332/ritonavir. findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of hepatic impairment.


Eligibility criteria:
inclusion criteria: * male and female participants who are classically healthy having no clinically relevant abnormalities. no known or suspected hepatic impairment * stable hepatic impairment that meets the criteria for class b of the child-pugh classification exclusion criteria: * any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection). * participants who have been vaccinated with covid-19 vaccines within the past week of dosing * a positive urine drug test, for illicit drugs, at screening * history of sensitivity reactions to ritonavir or any of the formulation components of pf-07321332 or ritonavir. * egfr \<60 ml/min/1.73m2 based on the chronic kidney disease-epidemiology collaboration (ckd-epi) equation * aspartate aminotransferase (ast) or alanine aminotransferase (alt) level ≥ upper limit of normal (uln) (for healthy participants); ast or alt \> 5x uln (for hepatic impairment participants) * albumin \> uln (for healthy participants); * prothrombin time \> uln (for healthy participants); * total bilirubin level ≥1.5 × uln \[note: participants with a history of gilbert syndrome (and hence elevated total bilirubin) are eligible provided direct bilirubin level is ≤ uln).

Keywords: covid-19 sars-cov-2
efficacy and safety study of mp-513 in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of mp-513 (teneligliptin) in patients with type 2 diabetes based on the change of hba1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.


Eligibility criteria:
inclusion criteria: * patients who are 20 - 75 years old * patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * patients whose hba1c is 6.5 - 9.5% * patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug. exclusion criteria: * patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (cushing disease, acromegaly, etc) * patients with class iii/iv heart failure symptoms according to new york heart association (nyha) functional classification * patients with serious diabetic complications * patients who are habitual excessive alcohol consumption. * patients with severe hepatic disorder or severe renal disorder. * pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Keywords: insulin resistance
glycemic and satiety response study of fibre-enriched pudding products

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. this is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product.

the purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. this is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product. to accomplish this, a randomized, double-blinded, placebo controlled, crossover study design will be used, in order to determine the different effects of a variety of fibre-enriched pudding products on markers of type 2 diabetes and satiety response, versus low-fibre control puddings.

Eligibility criteria:
inclusion criteria: * men/women * age 18-70 years * canrisk questionnaire score ≥21 (brief questionnaire that identifies risk of diabetes) * bmi ≥25 and \<40 kg/m2 * prior use of acetaminophen exclusion criteria: * smokers * food allergies or any life-threatening allergy (food or otherwise) * acetaminophen allergy * gastrointestinal conditions or illnesses (including, but not limited to, lactose intolerance, celiac, crohn's, ulcerative colitis (uc), irritable bowel disorder (ibd)) * serious major medical condition (i.e. renal, liver) * pregnant or breastfeeding * food neophobia scale score between 30 and 54 (food neophobia scale is a questionnaire which is intended to screen out individuals who are unsure of consuming new products) * tfeq-cr \>16 (tfeq is a questionnaire to screen for restrained eaters) * alcohol consumption\>4 drinks/sitting * medication or natural health products (nhps) used for diabetes (glycemic control) * medication or nhps contraindicated with acetaminophen * recent or intended significant weight loss or gain (i.e. \>4 kg in previous 3 months)

Keywords: risk for type 2 diabetes mellitus fibre postprandial glucose postprandial insulin postprandial acetaminophen satiety
prediction model of cardiac risk for dental extraction in elderly patients with cardiovascular diseases

Conditions: Cardiovascular Diseases; Elderly Patients; Tooth Extraction

Summary: this study intends to investigate the relevant risk factors of perioperation complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems. hypothesis:preoperative parameters could predict postoperative complications.

this study intends to investigate the relevant risk factors of perioperative complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems. we hope that the benefits will include less patients becoming seriously postoperative complications and mortality after teeth extraction surgery.we also hope the information will help doctors understand the preoperative risks better and therefore make better informed decisions.this may also reduce the overall cost of surgery for patients and hospitals.

Eligibility criteria:
inclusion criteria:1.adults ≥60 years age 2.males with cardiac diseases 3.females with cardiac diseases 4.listed for teeth extraction surgery - exclusion criteria: * 1.patient with malignant arrhythmia 2.age \<60 years age 3.adults with learning disabilities or dementia 4.patient unwilling/unable to consent 5.prisoners

Keywords: cardiovascular diseases prediction model dental extraction elderly patients
integrated care of co-morbidities vs standard care after ahrf in the intensive care unit

Conditions: Acute Hypercapnic Respiratory Failure

Summary: the study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of acute hypercapnic respiratory failure (ahrf). this study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. all interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in ahrf survivors.


Eligibility criteria:
inclusion criteria: * consent form signed * acute hypercapnic respiratory failure defined as paco2 \> 6.3 kpa requiring invasive or non-invasive mechanical ventilation in the icu exclusion criteria: * age \< 18 years old * known or suspected neuromuscular diseases * pregnancy * iatrogenic respiratory failure (i.e. drug overdose, ahrf after starting opiates or increasing opiates dose) * life expectancy \< 3 months * confusion or major psychiatric illness * patient unable to be weaned from niv
evaluation of the water vapor thermal therapy system for the treatment of benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: to evaluate the efficacy and safety of the water vapor thermal therapy system for the treatment of benign prostatic hyperplasia under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. the primary safety endpoint will be device-related (serious) adverse events. the primary effectiveness endpoint will be changes (treatment group vs control group) from baseline in international prostate symptom score (ipss) 3 months after medical device intervention.


Eligibility criteria:
inclusion criteria: * men aged 45-80 years (inclusive) with symptoms secondary to bph and requiring invasive intervention. * international prostate symptom score (ipss) ≥13 points. * maximum urinary flow rate (qmax): ≤15 ml/s, with a minimum urine volume of ≥125 ml. * post-urination residual urine volume (pvr): ≤250 ml. * prostate volume measured by mri: 30\~80 cm³ (including 30 cm³ and 80 cm³). * voluntarily participate in the clinical trial and sign the informed consent form. exclusion criteria: * malignant lesions of the urinary system, such as prostate cancer or bladder cancer, or other systemic advanced malignant tumors (e.g., gastric cancer, liver cancer, lung cancer). * patients with difficulty inserting instruments due to urethral stenosis or bladder neck contracture. * severe coagulation disorder. * urinary incontinence caused by reduced sphincter function or severe urge urinary incontinence. * patients with a history of severe cardiovascular disease, including but not limited to: * second/third-degree heart block. * severe ischemic heart disease. * congestive heart failure with new york heart association (nyha) heart function grade ≥ ii (mild physical activity limitation; comfortable at rest, but normal activities can cause fatigue, palpitations, or dyspnea). * prostate biopsy within 2 months before enrollment. * unstable angina, myocardial infarction, transient ischemic attack, or cerebrovascular accident in the past 6 months. * patients with previous invasive prostate treatment, such as: * radiofrequency (rf) ablation. * balloon dilation. * microwave therapy. * laser treatment. * electroreception. * prostate urethral stent. * suspension procedures. * history of previous rectal surgery (except hemorrhoidectomy) or history of rectal disease that affects the treatment method or efficacy evaluation in this study. * acute urinary and reproductive system infections that are not effectively controlled. * neurogenic bladder or neurological diseases that affect bladder function, sphincter function, or detrusor function, as assessed by the researcher. * bladder stones. * subjects who cannot undergo mri examination. * subjects who are: * currently participating in clinical trials. * have participated in other drug clinical trials within 3 months. * have participated in other medical device clinical trials within 30 days. * other situations that the researcher believes are unsuitable for participation in the study.

Keywords: water vapor thermal therapy
clinical safety and efficacy of fecal microbiota transplantation (fmt) in the treatment of alzheimer's disease

Conditions: Fecal Microbiota Transplantation

Summary: to investigate the clinical safety and efficacy of fmt in ad patients, as well as the changes in the gut microbiota of ad patients before and after fmt.


Eligibility criteria:
inclusion criteria: * the patients (aged 50-85 years) exhibited cognitive decline persisting for over six months; * primarily characterized by recent memory impairment and accompanied by reduced daily living abilities; * mmse scores ranging from 3 to 26; * mri findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures. exclusion criteria: * patients were excluded if they had severe visual, hearing, or language impairments; * tumors; * hepatic/renal dysfunction. * with conditions mimicking ad symptoms-such as normal pressure hydrocephalus, vascular dementia (vd or vad); * parkinson's disease dementia (pdd)-were also excluded; * patients who had participated in clinical drug trials within the past 30 days or consumed folate and vitamin b12 at doses exceeding twice the recommended intake were ineligible.
the effects of apathy on different forms of fatigue

Conditions: Apathy; Fatigue

Summary: 60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the cmrr (centre mémoire ressources et recherche) in nice university hospital and from the " fragilily " platform of the nice university hospital. after verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity. afterwards, participants will have to complete assessments and questionnaires to evaluate apathy (apathy motivation index, apathy inventory), perceived fatigue (fatigue severity scale, borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (perceived stress scale) and depression (geriatric depression scale). regarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game 'tap-piscine'). the total duration of the evaluation is a maximum of 2 hours.


Eligibility criteria:
inclusion criteria: * men or women aged between 65 and 85 years old coming for consultation at the rmc and the fragility platform * dsm-5 diagnosis: minor neurocognitive disorders * subject must read and write in french. * subject must be registered in the national social security scheme. * ability to sign free and informed consent. for the 'apathetic' group: - presence of apathy/emotional symptoms: at least 2 criteria according to the diagnostic criteria for apathy and a score higher than 8.5 in the mbi affective dimension. for the 'non-apathetic' group: - absence of apathy/emotional symptoms: no criteria according to the diagnostic criteria for apathy and a score of less than 8.5 in the mbi affective dimension. exclusion criteria: * motor or sensory disabilities likely to interfere with the tests. * presence of major psychiatric disorders (e.g., schizophrenia, major depressive episode, bipolar disorder) * patient under guardianship, curatorship or under legal protection
efficacy and cost analysis of steroids in treatment of otitis media with effusion

Conditions: Otitis Media With Effusion

Summary: we intend to study the cost of treatment, efficacy and adverse effects for otitis media with effusion.

treatment groups would be: 1. cefpodoxime + oxymetaxoline drops + levocetirizine 2. fluticasone intranasal spray 3. short term oral steroids 4. wait and watch

Eligibility criteria:
inclusion criteria: * history of mild ear ache or decreased hearing for three or more months, plus * intact and immobile tympanic membrane by pneumatic otoscopy * type b tympanogram exclusion criteria: * any external ear condition that hampers visualization of tympanic membrane * lost to follow up
prevalence and factors associated with the occurrence of depression six months after an endovascular treatment of intracranial aneurysm

Conditions: Intracranial Aneurysm

Summary: during the last decade, the embolization has become the treatment of choice for ruptured intracranial aneurysms, to improve the neurological outcome of patients. at the same time, for his safety, she also became the technique allowing prophylactic treatment of unruptured intracranial aneurysms discovered incidentally during imaging exams. regarding patients with ruptured intracranial aneurysms, patients who survive often have a reduced quality of life while one in two has a good neurological outcome after embolization. depression, anxiety and fatigue, whose the psycho-social impact is important, are often cited. this description has often been done without considering the realized type of treatment (surgery or embolization) and mostly of neurological and functional status of the patient remotely (disability or not in daily activities). regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and embolization is programmed. they would present an cognitive impairment in one case in five at 1 month of treatment. if depression, fatigue and difficult return to working life are logically found in patients with severe sequelae (disability in daily activities) of their ruptured intracranial aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms. a precise status of these populations is necessary, especially as the discovery and treatment of their intracranial aneurysms is often early (between 40 and 60 years) and that their good neurological status should allow "a priori" to return easily at the active life.

describe the prevalence of depression among patients treated for intracranial aneurysms, especially in patients with a favorable neurological outcome at 6 months (mrs inferior or egal to 1). study factors associated with the presence of depression in patients treated for intracranial aneurysms, especially in patients with a favorable neurological outcome at 6 months (mrs inferior or egal to 1)

Eligibility criteria:
inclusion criteria: * patient with endovascular treatment for intracranial aneurysm (ruptured or unruptured) * patient older than 18 years * patient consenting to participate to the study * patient enrolled in the national healthcare insurance program exclusion criteria: * patient with anterior treatment for intracranial aneurysm * bipolar disorder, schizophrenia or schizoaffective disorder diagnostic
don't treat ghosts anti-mrsa antibiotics in osteomyelitis without identified mrsa

Conditions: Osteomyelitis

Summary: osteomyelitis is described as infection and inflammation of the long bone or bone marrow, often due to an open wound, operation, or invasive trauma.1 it is invasive and involves hematogenous seeding or contiguous spread of the infectious organism

this disease can be classified by location of infection, extent of spread, chronicity, and source of infection.3,4 osteomyelitis can be caused by a variety of organisms, most commonly gram-positive staphylococci. osteomyelitis is associated with a high rate of relapse, high disease burden, and high health care costs.3 following confirmation of disease via imaging and histopathologic examination, treatment consists of antibiotic therapy and, often, surgical intervention.3,5,6 treatment with antibiotic therapy is often administered for 4-6 weeks when surgical intervention is not performed.6 antibiotic selection should be guided by microbiology and antimicrobial susceptibilities.4 thirty to sixty percent of osteomyelitis cases are caused by staphylococcus aureus.

Eligibility criteria:
inclusion criteria: * • admission to any mhs hospital between april 1, 2017 and april 1, 2023 * \> 18 years of age * documented osteomyelitis location of the lower limb via icd-10 code * documented imaging of lower limb osteomyelitis during index admission * planned intravenous (iv) antibiotics for at least 4 weeks exclusion criteria: * • iv antibiotics for less than 24 hours inpatient * planned surgical intervention documented at admission * patients receiving monotherapy with an anti-mrsa agent * positive mrsa culture during index admission * current outpatient antibiotic use on index admission * repeated hospital admission during study period
effects of traditional thai massage on pain and pain related parameters in patients with upper back pain

Conditions: Myofascial Pain Syndrome

Summary: the purpose of this study is to determine the effect of thai massage on pain related parameters including pain intensity, 24 hours pain intensity, pressure pain threshold, anxiety, muscle tension, cervical range of motion, pain frequency, patient satisfaction and side effect in patients with chronic upper back pain associated with myofascial trigger points


Eligibility criteria:
inclusion criteria: * male or female * age between 18 - 50 years old * the participants have experienced spontaneous upper pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition. * the participants will be able to follow instructions. * good communication and cooperation. exclusion criteria: * a history of the following diseases or disorders: * cervical radiculopathy * contraindications of traditional thai massage * contagious skin disease * injury or inflammation of muscle * bone fracture and/or joint dislocation * open wound * uncontrolled hypertension * drug and/or alcohol intoxication
nexus evaluation primary trident ii uncemented shell

Conditions: Arthritis of Hip; Hip Dysplasia; Hip Arthropathy; Hip Osteoarthritis

Summary: this is a prospective cohort study assessing the survival of a new acetabula component which is based on the original trident acetabular system (cementless shell) which is used for total hip arthroplasty. the manufacturer recently introduced the evolution of this product, the trident® ii acetabular shell which was launched in 2017. this implant is ce marked and is now widely available for the uk market, however has minimal clinical outcomes data to support its use. as part of a stepwise introduction of devices to orthopaedic practice. this study will report the 10 year implant survival and patient functional outcomes of this new implant.

125 patients will be recruited at a single-centre as part of a, phase-4 post-market surveillance, prospective cohort study this is a 10-year study of the trident ii acetabular component as part of total hip replacement at the royal infirmary of edinburgh, nhs lothian. patients will receive a trident® ii acetabular component as part of primary total hip arthroplasty at the study centre. this component is ce marked and widely available for use by uk surgeons. the trident® ii shells are ha coated, cementless, press-fit acetabular shells composed of a titanium (ti-6al-4v) substrate featuring a cpti roughened surface with purefix™ ha. the cup is available in a range of sizes and is indicated for primary and revision procedures. a standard operative technique will be employed by all study surgeons, using the posterior approach. the routine post-operative patient care protocol of the study centre will be employed. 10 year implant survival is the primary aim, but in addition functional and radiographical outcome will be assessed a 1, 2, 5, 7 and 10 years.

Eligibility criteria:
inclusion criteria: 1. patients undergoing planned primary total hip arthroplasty with standard implants, suitable for the use of the uncemented trident® ii acetabular component. 2. patients aged 18-75 3. patients willing and able to comply with the study protocol 4. patients that provide informed consent exclusion criteria: 1. patients not meeting study inclusion criteria 2. bone stock that is inadequate for support or fixation of the prosthesis 3. patients with a body mass index (kg/m2) \>40 4. procedures performed for pain relief in those with severely restricted mobility

Keywords: arthroplasty uncemented hip trident ii