Kornimate/medical-research-clean huggingface dataset:
modulation of muscle protein metabolism by essential amino acids

Conditions: Old Age

Summary: the investigators plan to explore the ability of amino acids, the building blocks of proteins in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. the investigators will investigate how rapidly after one meal the human body is ready to make use of a second meal and look at the molecular mechanisms underlying this. the investigators will look at these phenomena in older men as this group is known to be subject to a gradual loss of muscle mass and strength.

muscles can stay very constant in size for much of adult life yet dramatic wasting is seen in advanced age and ill health. a better understanding of how muscles regulate their size will help design treatments to slow wasting in disease and to promote active aging. we plan to study a group of older men, \~70yrs, the age at which muscle bulk starts to decrease, to observe how the muscles respond to feeding. we will provide a drink that contains the digested products of proteins from which muscles are built. taking blood samples and some tiny biopsies of muscle (done under local anaesthesia) will allow us to measure muscle turnover and we will be able to measure for how long after a meal muscles actively take in nutrients before becoming "full". we will also measure how long the muscle remains "full" before it returns to a state where it can again be stimulated to take in nutrients. we will also explore if leucine, one of the component parts of protein (especially in meat and dairy products) and a food widely used supplement, can promote the early re-stimulation of muscle by eating.

Eligibility criteria:
inclusion criteria: * male * 65-75yrs * bmi 18-28 exclusion criteria: * type 2 diabetes mellitus * neurological disease * significant cardiac, hepatic or renal disease * active malignancy * medication inc. corticosteroids, nsaid use, beta adrenoblockers.

Keywords: old age sarcopenia amino acid muscle
pharmacist-led intervention to improve tb treatment and outcomes

Conditions: Tuberculosis, Pulmonary; HIV Coinfection

Summary: the goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group the main question\[s\]it aims to answer are: 1. to evaluate the impact of pharmacist-led educational intervention on treatment adherence among patients with ptb using the health belief model theory and mars-5. 2. to evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with ptb. 3. to evaluate the impact of pharmacist-led educational intervention on hrqol among patients with ptb. participants will be interviewed to measure the level of adherence. if there is a comparison group: the enrolled patient will be counselled and educated by the pharmacist on the therapy and the benefits of adherence (control group). enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. (experimental group).

in 2019, tuberculosis (tb) remained the leading cause of death due to a single infectious pathogen. an estimated 10 million people had tb worldwide, with 1.2 million tb fatalities among human immune deficiency virus (hiv)-negative people and 208, 000 deaths among hiv-positive people. literature indicated that treatment adherence for coinfections diseases is difficult due to the complexity, low tolerability, and extended duration of current treatment regimens, especially for both drug-susceptible and drug-resistant tb. there is a need for continuing the quest for low-cost, reliable, and acceptable measures of adherence for the treatment of tb and hiv co-infection. a qualitative approach and pharmacist-led intervention are needed to improve the adherence level of medication for tb patients. the study is aimed to investigate the degree of adherence and evaluate its impacts on clinical outcomes in tb and hiv co-infected patients. to determine the uptake and usage of the intervention, the study will include nested qualitative and economic evaluation sub-studies as well as a process evaluation. a longitudinal study design will adopt to carry out the present study, involving tb and hiv co-infected patients in either the pharmacist-led intervention (adherence and medication reminder, follow-up reminders, and counselling) or control arm. to determine the uptake and usage of the intervention, the study will include theoretical and conceptual models and theories. the study will conclude with targeted efforts of pharmacist led intervention to improve and sustain excellent adherence in the real-world clinical setting which is critical for maximizing the effectiveness of each medication and treatment. these innovative technologies can thereby be harnessed to improve adherence to tb and hiv regimens in malaysia and worldwide.

Eligibility criteria:
inclusion criteria: * men and women aged 18 years or more. * newly bacteriologically confirmed tb case. exclusion criteria: * pregnancy and any medical condition unrelated to tb
study solace sepsis

Conditions: Septic Shock; Intracranial Hypertension

Summary: a pilot, randomized, double-blinded, controlled study of hemodynamic and acid base effects of 0.5m sodium lactate and 3% saline solutions in septic shock patients

this study investigates two resuscitation fluids that are being used off label for the treatment of patients suffering from septic shock and also in patients with intracranial hypertension in intensive care.

Eligibility criteria:
inclusion criteria: * subjects will be eligible for the trial if they meet all of the following criteria: 1. age criteria: 18 - 90 years 2. septic shock - sepsis 3 criteria : 1. acute change in total sofa score ≥ 2 due to infection 2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmhg 3. blood lactate level ≥ 2 mmol/l within last 24 hours 3. likely need for fluid resuscitation 1. poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (\< 0.5 ml/kg/hour for at least 6 hours) iii. central venous o2 saturation \< 70% iv. clouded sensorium/poor mentation 2. dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and / or stroke volume variation2, both \> 12% iii. distensibility index of inferior vena caval diameter \> 12% 4. signed the relevant informed consent form exclusion criteria: * subjects will not be eligible for the trial if they meet any of the following criteria: 1. poor transthoracic echo windows 2. actual body weight \> 160 kg 3. hypernatremia: \[na\] \> 150 meq/l 4. cardiac tamponade 5. uncorrected severe valvular heart disease or life-threatening arrhythmia 6. moribund patients likely to die before the study protocol is completed 7. patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on ph \ 7.0mmol/l 8. severe liver dysfunction defined by total serum bilirubin \> 120 umol/l 9. pregnancy and lactation

Keywords: intracranial hypertension septic shock
public health impact of unilateral spatial neglect

Conditions: Spatial Neglect

Summary: this multi-center project aims to quantify the socio-medical costs associated with unilateral spatial neglect (usn) resulting from acquired brain injury (stroke) and to measure the effects of usn rehabilitation on functional autonomy, quality of life and psychological well-being of patients affected by this syndrome, considering the repercussions on a psychological level and on the quality of life of caregivers. to this end, the experimenters will administer to right brain-injured patients - with (experimental group) or without (control group) usn - who undertook a rehabilitation process, a series of questionnaires: activities of daily living (adl), barthel index; instrumental activities of daily living scale (i-adl:), the health related quality of life questionnaire (eq-5d-5l), the geriatric depression scale (gds), and the state-trait anxiety inventory (stai-y). the aforementioned tests will be administered before the start of the rehabilitation (baseline) and after one month, 3, 6 and 12 months after the end of the rehabilitation. the impact of usn and its treatment on the psycho-physical well-being of the caregiver will be measured through the caregiver burden inventory questionnaire, which will be administered with the same timing (baseline, 1-3-6-12 months after rehabilitation). the costs of usn will be surveyed through an ad-hoc questionnaire, which includes a version intended for patients and one for caregivers, in order to identify the resources consumed due to the disease and the expenses taken during the observation period, to be estimated subsequently in monetary terms (€).


Eligibility criteria:
inclusion criteria: * age \> 18 years; * right brain injury due to stroke (of ischemic or hemorrhagic origin); * disease duration ≥ 10 days; * participation to a rehabilitation program; for stroke patients with usn: - clinical diagnosis of usn, placed by the specialist of reference, on the basis of clinical indicators and the results obtained by the patient in the routine neuropsychological evaluation (by means of a battery of standardized psychometric tests calibrated in the italian population). exclusion criteria: * other brain disorders
phase 1 study of imp321 (eftilagimod alpha) adjuvant to anti-pd-1 therapy in unresectable or metastatic melanoma

Conditions: Stage IV Melanoma; Stage III Melanoma

Summary: the purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as imp321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.


Eligibility criteria:
main inclusion criteria * histologically confirmed diagnosis of locally advanced (unresectable stage iii) or metastatic (stage iv) melanoma * currently receiving anti-pd-1 therapy with pembrolizumab and after 3 cycles achieved asymptomatic irpd (slowly progressive, not requiring urgent intervention, and stable performance status) or sub-optimal response (irsd, irpr) as demonstrated in imaging assessments performed within 6 weeks prior to study start * female or male 18 years of age or above * ecog performance status 0-1 * evidence of measurable disease as defined by response evaluation criteria in solid tumours (recist) version 1.1 10. adequate laboratory criteria main exclusion criteria * more than four prior lines of therapies for advanced or metastatic disease. * prior pd-1/pdl-1 targeted therapy * currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug * currently receiving systemic chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (other than pembrolizumab) or less than 4 weeks since completion of these therapies and first dose of study treatment * history of iraes from ipilimumab of ctcae grade 4 requiring steroid treatment * known cerebral or leptomeningeal metastases * serious intercurrent infection within 4 weeks prior to first dose of study treatment * active acute or chronic infection * history or evidence of interstitial lung disease or active non-infectious pneumonitis * active auto-immune disease requiring immunosuppressive therapy * hiv positivity, active hepatitis b or hepatitis c * continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment
a study to assess the effect of cellcept (mycophenolate mofetil) and reduced corticosteroids in controlling symptoms of myasthenia gravis

Conditions: Myasthenia Gravis, Generalized

Summary: the efficacy and safety of cellcept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. during the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18 to 80 years of age; * diagnosis of myasthenia gravis; * history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle; * duration of myasthenia gravis symptoms (including ocular symptoms) \<=10 years; * prednisone dose \>=20 mg/day (or equivalent alternate-day dose) for \>=4 weeks. exclusion criteria: * female patients who are pregnant, breastfeeding, or lactating; * regularly scheduled plasma exchange (pe) or intravenous immunoglobulin (ivig) treatment, or pe or ivig treatment within 2 weeks prior to randomization; * any prior clinically significant use of cellcept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.
effect of pelvic floor muscle training included in general fitness classes during pregnacy

Conditions: Pregnancy; Urinary Incontinence

Summary: to investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.

pregnancy and childbirth are known risk factors for development of female urinary incontinence (ui). studies have found that pelvic floor mucle trainig (pfmt) is effective in preventing and reducing ui during pregnancy and after childbirth. however, in a recent study, no effect was found when pfmt were taught in a general fitness class without former palpation of the pelvic floor muscles (bo y haakstad, 2011).

Eligibility criteria:
inclusion criteria: * nulliparous with singleton baby * not suffering from urinary incontinence * giving birth at hospital universitario de fuenlabrada * able to comunicate in spanish * being healthy and able to exercise following american college of obstetricians and gynecologists (acog) guidelines exclusion criteria: * multiparity * at risk of premature birth * following another exercise program

Keywords: urinary incontinence pregnancy pelvic floor muscle training
the effect of gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients

Conditions: Type2 Diabetes With Depressive Mood

Summary: the aim of this study is to investigate the effect of gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.

the prevalence of depressive disorder is higher in individuals with chronic diseases, and the screening and management of depression is emphasized. diabetes mellitus (dm) is a class of chronic disease and the incidence of dm has been increasing. according to previous study, 31.1% of patients with dm accompanied with depressive disorders which was higher than that of subjects without dm. furthermore, dm as well as depression is known for risk factor for dementia. the choline metabolism involves in neuropathology of depressive disorders and individuals with depressive disorders showed the lower level of choline concentration. choline alphoscerate is cholinergic precursor and showed the favorable clinical results in dementia management. as pseudodementia can be presented as depressive disorder and choline alphoscerate would be an option for these cases. therefore, the aim of this study is to investigate the effect of gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients * age ≥ 50 * glycemic control: hba1c ≤ 10.0% * 10 ≤ beck depression inventory (bdi) \<30 points * participants who can undergo contraception in case of being in childbearing period * understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent exclusion criteria: * type 1 diabetes, secondary diabetes, gestational diabetes * ongoing dementia treatment or anti-depressive disorder medication * uncontrolled psychiatric disorder * bdi ≥ 30 points * heavy alcoholics * underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis) * allergy or hypersensitivity to target medication or any of its components * renal failure, moderate or severe renal impairment (estimated glomerular filtration rate \< 30 ml/min/1.73 m2), or ongoing dialysis * abnormal liver function (ast/alt \> x3 upper normal limit) * history of alcohol or drug abuse in the previous 3 months * premenopausal women who are nursing or pregnant * human immunodeficiency virus (hiv) or human immunodeficiency virus (aids) * chronic pancreatitis or pancreatic cancer
follow-up of osteo-articular biomarkers after spa therapy in a population with knee osteoarthritis and their correlation with the clinical evolution

Conditions: Knee Osteoarthritis

Summary: spa therapy is used in the treatment of various diseases and mainly osteoarthritis. knee osteoarthritis is a very common rheumatic disease whose prevalence increases with longer life span and is a public health problem. the forestier and al. study highlighted the actual benefit and confirmed the improvement of the quality of life and pain of the knee osteoarthritis patients from 6 months of spa treatment.\[1\] a significant decrease of 30% in the rate of serum hyaluronic acid at 6 months after the end of the spa therapy was also highlighted in the canteloup et al study.\[6\] this study aims to measure different osteoarticular biomarkers (hyaluronic acid, coll2-1 and ctx1) before, at the end of the spa therapy and 6 months after the spa therapy and correlate with the clinical evaluation.


Eligibility criteria:
inclusion criteria: * patient with knee osteoarthritis defined according to the recommendations of the american college of rheumatology (acr): * painful articulation and at least one of the following three criteria: age \> 50 years and/or articular crepitation and/or morning stiffness less than 30min * and radiographic sign of gonarthrosis with osteophyte (on x-rays of less than 3 years). * patient can come to the final visit at 6 months and living within a perimeter of 30km around dax. * patient affiliated to a social security scheme. exclusion criteria: * osteoarthritis limited to patellofemoral joint. * a previous spa therapy of less than 6 months. * spa therapies with double indication rheumatology and phlebology. * patient with osteoporosis. * a known hepatocellular failure or known acute or end-stage renal failure. * severe depressive syndrome, psychotic syndrome, immune deficiency, cardiopathy, evolutive neoplasia or infection. * infiltration and/or viscosupplementation \< 6 months. * change in anti-osteoarthritis treatment of less than 3 months. * patient under tutorship or curatorship.

Keywords: knee osteoarthritis spa therapy osteo-articular markers
minor salivary gland transplantation for cicatrizing conjunctivitis

Conditions: Cicatrizing Conjunctivitis; Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum; Sjogren Syndrome; Mucous Membrane Pemphigoid; Chronic Graft Versus Host Disease; Chemical Burn to Eye

Summary: this is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.

cicatrizing conjunctivitis can be the common presentation of many ocular surface diseases as stevens-johnson syndrome (sjs), mucous membrane pemphigoid (mmp), chemical burn, sjogren syndrome, chronic graft-versus-host disease (gvhd) and ocular trauma. ocular dryness in combination with symblepharon and corneal opacity in these patients could lead to the poor visual and life quality, and less favorable prognosis of ocular reconstruction. this study aims to prospectively evaluate the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis. the investigators evaluate the saliva-tear productivity (functional outcome) and the survival of graft (anatomical outcome) every three months. the investigators would also validate whether minor salivary gland transplantation is beneficial for the participant prior to further ocular reconstruction as limbal transplantation and corneal grafting.

Eligibility criteria:
inclusion criteria: * age 20-85 years old * unilateral or bilateral cicatrizing conjunctivitis * severe aqueous deficiency dry eye ( schirmer i test result of less than 2mm) * chronic ocular surface disease score (cocs) over 3 points * oxford scheme over grade iii exclusion criteria: * active ocular infection * active corneal melting * severe xerostomia (modified schirmer i test result of less than 25mm)
trial to compare urinary continence recovery after robotic radical prostatectomy with or without rhabdosphincter reconstruction.

Conditions: Urinary Incontinence

Summary: this is a prospective randomized controlled trail to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not. a hundred forty-six patients with clinically localized and histological confirmed prostate cancer will be enrolled. continence recovery is defined in the present study as declared urinary continence (absence of incontinence episodes) in the physician interview as no pad use. continence rates will be explored also by epic, iciq-sf, ipss questionnaires 1, 6 and 12 months after the procedure. the sexual function as the secondary objective will be assessed by shim questionnaire.


Eligibility criteria:
inclusion criteria: * histological confirmation of prostate cancer * localized or locally advanced prostate cancer * informed consent signed exclusion criteria: * presence of urinary incontinence prior to the procedure * previous radiation therapy of the prostate or pelvis * presence of any prostatic surgery prior to the procedure * prior medical history of psychiatric diseases or drug addiction * any condition that contraindicates a radical prostatectomy

Keywords: prostate cancer urinary incontinence radical prostatectomy rhabdosphincter robotic surgery