Kornimate/medical-research-clean huggingface dataset:
the use of nutropin depot in hiv-infected adult males

Conditions: HIV Infection

Summary: this is a pilot study. we will treat 10 hiv-infected adults (1/2 with lipoatrophy) with gh depot for one year. results will be compared to data from 10 hiv patients (1/2 with lipoatrophy), treated with nutropin aq subcutaneously. the primary endpoint of the study is to determine the effect of gh depot on body weight and lean tissue mass (ltm). the secondary endpoints are to document changes in: 1) whole body protein turnover (wbpt), 2) gluconeogenesis, 3) bone mineral density and markers of bone turnover, 4) fat distribution (lipoatrophy), 5) thymus size, 6) t-cell subsets, and 7) tnf-µ levels. adverse events, such as glucose intolerance and edema, will be monitored at every visit.

patients will be recruited from the hiv clinics at university of texas southwestern medical school and the veterans administration hospital by direct invitation from dr. margolis (adult hiv clinic director and university director for the nih-actg). we will recruit 20 hiv-infected adult males who have been treated with stable protease inhibitor therapy regimen for the past 6 months. one half of the subjects will have evidence of lipoatrophy (as defined by the actg29). each subject will have baseline (bl) measures made, and then will start on gh depot or subcutaneous aq. patients will be followed every two weeks for the first six weeks, then every three months for the remainder of the study. study parameters to be measured include (also see flow chart in appendix): * baseline, 3, 6 and 12 months: ogtt, testosterone level, whole body protein turnover, hepatic glucose production and gluconeogenesis measures, dxa scan (for measuring lean tissue mass and bone density), bone mineral markers, resting energy expenditure, calorie count, t cell subsets, tnf µ levels. * every 3 months: igf-1 (will obtain every 2 weeks for first 6 weeks), body weight, and post-prandial glucose level. * baseline, 6 and 12 months- ct scan for measurement of thymus size

Eligibility criteria:
inclusion criteria: * adult males ≥ 18 years of age * mild to moderate lipoatrophy * stable protease inhibitor therapy for at least six months. exclusion criteria: * con-current supra-infection with acute illness defined by fever or bacterial culture * malignancy * females * diabetes mellitus * cns tumors.
evaluation of sonelokimab in patients with active psoriatic arthritis naive to biologic disease-modifying antirheumatic drug

Conditions: Arthritis, Psoriatic

Summary: this is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

m1095-psa-301 is a phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Eligibility criteria:
inclusion criteria: 1. participants must be ≥18 years of age . 2. participants have a confirmed diagnosis of psoriatic arthritis (psa) per the 2006 classification for psoriatic arthritis (caspar) criteria with symptoms for ≥6 months before the screening visit. 3. participants have moderate to severe active disease (defined by a 68 tender joint count \[tjc68\] of ≥3 and a 66 swollen joint count \[sjc66\] of ≥3). 4. participants have current active plaque psoriasis (pso) or a dermatologist-confirmed history of plaque pso. 5. participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the screening visit. exclusion criteria: 1. participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. participants who have a diagnosis of chronic inflammatory conditions other than pso or psa. 3. participants with a diagnosis of inflammatory bowel disease. 4. participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the baseline visit. 5. participants who have an established diagnosis of arthritis mutilans. 6. previous exposure to sonelokimab. 7. participants who have ever received any biologic immunomodulating agents for psa or pso, whether investigational or approved.
minerals and botanicals for acute stress

Conditions: Stress; Anxiety

Summary: the objective of this acute intervention study is to examine the potential of minerals combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective parameters) under conditions of acute stress in moderately stressed individuals

botanicals in isolation or combined, will be administered with a mineral and vitamin complex to moderately stressed, healthy adults in a parallel groups fashion in this randomised placebo controlled trial. oscillatory brain activity (eeg) during rest and performance on cognitive tasks of attention will be examined after treatment intake under conditions of acute laboratory stress. the effects of treatments on stress responses (cardiovascular, subjective and cortisol responses) will also be assessed.

Eligibility criteria:
inclusion criteria: * adults capable of giving informed consent * male and female * ≥18 - ≤50 years of age (premenopausal if female) * effective contraception taken in females * women in luteal menstrual phase * body mass index (bmi) ≥18 and ≤30 kg/m2 * normal vision or corrected to normal * moderately stressed (subjective report) exclusion criteria: * no known intolerance to minerals, vitamins or botanicals * intake of prescribed medication except contraceptives * intake of any regular medication/supplements * history of significant hypertensive, hepatic, renal, pulmonary, gastro-intestinal, endocrinological, neurologic, haematological, psychiatric (inc. mood disorders), cardiac or allergic disease which is clinically relevant to the study * hypertension (self-report or resting blood pressure \>160/95 mmhg) * diabetes (t1 or t2) * smoking more than occasional cigarettes (\>5/day) * pregnant or lactating * previous participation in a stress study involving the trier social stress test * night-working/shift work * recreational drug use

Keywords: stress anxiety cortisol vitamins botanicals minerals
impact of ecmo cannula chlorhexidine-impregnated dressings to decrease extracorporeal membrane oxygenation-cannula related infection rate

Conditions: Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication; Acute Respiratory Distress Syndrome; Infections

Summary: the dressing-ecmo trial is a prospective, open-label, multicenter, controlled trial randomizing patients who received percutaneous ecmo to cannula chlorhexidine-impregnated dressing vs standard dressing. the study goal is to determine if cannula chlorhexidine-impregnated dressings can reduce the number of cannula major-related infections with or without bloodstream infection

open-label, multicenter, randomized, controlled trial. this study will be conducted in patients with cardiogenic shock or acute respiratory distress syndrome receiving percutaneous ecmo for less than 24h. all consecutive eligible patients will be proposed to participate. they will be randomly allocated in a 1:1 ratio to conventional cannula dressing, or cannula chlorhexidine-impregnated dressing, using an online, central randomisation service, to ensure allocation concealment. blocked randomization will be performed using random block size. randomization will be stratified according to center and ecmo type (i.e veno venous or arteriovenous). in both groups, peripheral blood sample will be cultured daily from first day on ecmo to 48h after ecmo removal, death on eco or ecmo day 30 whichever occurs first. in case of ecmo cannula infection suspicion, deep samples of the cannula will be cultured according to the usual procedure.

Eligibility criteria:
inclusion criteria: * patients with cardiogenic shock or refractory acute respiratory distress syndrome ecmo va or vv ecmo for less than 24 hours. * ecmo duration \> 48 hours * obtained written informed consent from the trusted person or family member/relative. depending on the emergency consent, randomization may take place and consent of the trusted person/relative/family will be obtained as soon as possible. the patient will be asked to give his/her consent for the continuation of the trial when hid/her condition will allow. * affiliation to a social security system (excluding state medical aid) exclusion criteria: * age \<18 years * initiation of ecmo for more than 24 hours * surgical (i.e. non percutaneous) cannulation * patient moribund on day of randomization, saps ii \>90 * known allergy to chlorhexidine * antibiotic prophylaxis at ecmo cannulation

Keywords: ecmo cardiogenic shock ards infection
fraction of oxygen on induction of anesthesia in infants

Conditions: Apnea

Summary: invesetigators evaluated the effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants. invesetigators assigned infants to a 7 cmh2o positive end expiratory pressure (peep) with fraction of inspired oxygen 80% or 0 cmh2o peep with fraction of oxygen 80% group. anaesthesia was induced with 0.02 mg kg atropine, 5 mg kg thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6 mg kg rocuronium. thereafter, 80% oxygen was provided via face mask with volume-controlled ventilation of 6 ml kg tidal volume, and either 7 cmh2o or no positive end-expiratory pressure. after 3 min of ventilation, the infants' trachea was intubated but disconnected from the breathing circuit, and ventilation resumed when pulse oximetry reached 95%.


Eligibility criteria:
inclusion criteria: * we included paediatric patients aged 12 months or less about to receive general anaesthesia with endotracheal intubation. exclusion criteria: * neonates, former preterm infants with gestational age less than 60 weeks at the day of surgery, with previous history of respiratory disease, those with anticipated difficult mask ventilation or intubation and those with upper respiratory infection within 3 weeks were excluded.
stool processing kit (spk) evaluation for pediatric tuberculosis (tb)

Conditions: Tuberculosis

Summary: this is a prospective, multicenter cohort study in which the accuracy and the diagnostic yield of the stool processing kit (spk) in combination with xpert ultra mtb/rif (ultra) on stool samples will be assessed using a microbiological reference standard and a composite reference standard among children with signs and symptoms of pulmonary tuberculosis.

find and partners have developed a simple stool processing kit (spk) that will enable processing of large numbers of stool samples, removal of pcr (polymerase chain reaction) inhibitors which can be used at level 1 health facilities in low and middle income countries. the spk is not a diagnostic kit as such but rather a sample processing method. this study aims to determine the sensitivity and specificity of xpert ultra mtb/rif (ultra) combined with spk for tb detection using microbiological confirmation on respiratory specimens (defined as sputum, naso-pharyngeal aspirate, and/or gastric aspirate) as the reference standard. the investigators will further evaluate operational characteristics, including implementation considerations that will be needed for the potential rollout of the spk. additionally, a comparison of the performance of the spk with up to two other centrifuge-free stool processing methods will be done on the same stool samples. the first is a method developed by researchers at the kncv tuberculosis foundation (single one step stool) which does not require any additional reagents other than the ultra sample reagent. the second is a method developed by the pediatric asian african network for tuberculosis and hiv research (panther) group, the optimized sucrose flotation method. another diagnostic candidate, the urine fujifilm silvamp tb lam (fujilam) test will be assessed during the study. therefore, if the sensitivity of any of these tests is shown to be promising this may support further research and provide other alternatives to respiratory samples.

Eligibility criteria:
inclusion criteria: * children of 14 years of age or younger * written parent/guardian consent and child assent based on age and national ethical guidelines * willingness to have a study follow-up visit * clinical suspicion of active pulmonary tb\* or microbiological confirmation of active tb disease referred from non-study health facilities * chest x-ray suggestive of tb, or weight loss or failure to thrive within 3 months not solely due to inadequate feeding, or another non-tb cause, or any cough with loss of weight, or cough alone \>=14 days, or persistent (\>1 week) and unexplained fever exclusion criteria: * anti-tb treatment for \>5 days or any antibiotic with anti-mycobacteria activity within 60 days prior to enrollment including children on isoniazid preventive therapy * (confirmed) extra-pulmonary tb only

Keywords: diagnostics children
study of speech disorders , voice and swallowing in primary dystonia oromandibular

Conditions: Dystonia, Primary; Dysarthria; Dysphonia; Dysphagia

Summary: to better define the clinical characteristics of oromandibular dystonia, we aimed to study voice, speech and swallowing disorders in idiopathic oromandibular we planned to include consecutive patients followed in lille movement disorders department for idiopathic oromandibular dystonia and matched, healthy control subjects. voice and speech disorders had to be assessed with the phonetic analysis, perceptive analysis and motor examination modules of the "batterie d'evaluation clinique de la dysarthrie" (clinical evaluation of dysarthria), the grade, rough, breathy, asthenic, strained scale, and a computer recording. activities of daily living had to be assessed with the oromandibular dystonia questionnaire, the voice handicap index and the deglutition handicap index.


Eligibility criteria:
inclusion criteria: * both groups: man or woman age \> 18 years french social security french speaking: fluent * oromandibular dystonia group: idiopathic oromandibular dystonia (focal or associated to other dystonic symptoms) * healthy controls group: same age +/- 2 years than a patient from the oromandibular dystonia group normal clinical examination exclusion criteria: * both groups: any pathology making the orthophonic evaluation difficult property protection regime deprivation of liberty -oromandibular dystonia group: abnormal neurological examination, except dystonic features * healthy controls group: history of brain lesion abnormal neurological examination swallowing difficulties
serum ngal levels in hemodialysis (hd) patients; relation to iron status, hd and intravenous (iv) iron administration

Conditions: Renal Failure Chronic Requiring Hemodialysis

Summary: the purpose of this study is to assess changes in serum levels of the siderophore binding protein ngal by hemodialysis without and with intravenous iron administration

serum and urine levels of the siderophore binding protein neutrophil gelatinase associated lipocalin (ngal) are increased in a number of renal diseases, but has not been evaluated yet in dialysis patients. since ngal is suggested to be related to inflammatory processes and iron homeostasis, which are a major problem in dialysis patients, this study aims to assess the relation of serum ngal levels in hemodialysis (hd) patients to iron status, inflammation, hemodialysis and intravenous(iv) iron administration. our hypothesis is that serum ngal levels in hd patients are related to iron status and inflammation and may change following hemodialysis and/or acute or chronic iv iron administration. the specific aims are: 1. to assess the relations between basal serum ngal levels to iron, dialysis, and inflammation related parameters. 2. to assess the effect of hd on serum ngal levels and their relation with with iron, dialysis and inflammation related parameters. 3. to assess the effects of weekly 100 mg iv iron in the first hour of hd on serum ngal levels, and the relation of pre iv iron serum ngal levels with iron, oxidative stress and inflammation related parameters. these assessments will be performed in the first weekly hd.

Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients exclusion criteria: * acute disease (infection, thrombosis, ischemia, bleeding) * hepatitis b, hepatitis c or hiv * intravenous iron administration or packed red cell transfusion in the last 4 weeks prior to the study

Keywords: neutrophil gelatinase associated lipocalin hemodialysis iron inflammation oxidative stress
a retrospective register study to map the frequency of short duration atrial fibrillation (af) among all patients admitted to roskilde sygehus in denmark in 2010

Conditions: Type of Atrial Fibrillation; Medical History; Current Treatment; Complications

Summary: retrospective observational study of patients with atrial fibrillation admitted to roskilde university hospital in 2010.

the study is a retrospective register study of all patients discharged from roskilde hospital with a primary diagnosis of af in 2010. all data will be collected from the patient's medical records and only data from this specific admission will be recorded. no follow-up of the patients after discharge will be performed in this study. the study does not involve any randomization or any drug testing.

Eligibility criteria:
inclusion criteria: * atrial fibrillation exclusion criteria: * none

Keywords: atrial fibrillation registry
validation of a french version of the pisq-r

Conditions: Pelvic Organ Prolapse; Urinary Incontinence; Fecal Incontinence

Summary: the main objective of this study is to perform the linguistic validation of the french version of the pisq-r questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

step 1: establish a french translation of the original questionnaire (english\> french. step 2: perform a first set of comprehension tests with a panel of 15 patients. step 3: establish a revised questionnaire. step 4: perform a second series of comprehension tests with a panel of 10 other patients. step 5: determine the final questionnaire. step 6: perform a back-translation (french\> english. step 7: send the final version of the questionnaire and the questionnaire back-translated to the specific committee of the iuga for final approval.

Eligibility criteria:
inclusion criteria: * the patient is able to read and understand french * the patient must be insured or beneficiary of a health insurance plan * patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. exclusion criteria: * patient is pregnant * the patient is under judicial protection, under tutorship or curatorship * the patient does not understand french

Keywords: linguistic validation of the pisq-r questionnaire
effects of a new knee brace for treatment of the knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to evaluate the immediate effects of a knee brace with a new mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis patients. the effects of this new brace is compared to a stabilizing brace and a typical valgus knee brace. the investigators recruited 24 knee osteoarthritis and they have to wear each of the three braces during three months. a fifteen days wash-out period is given after each three months. biomechanical evaluation is carried out before and after each three months. this evaluation consisted of three questionnaires (koos, womac and medical outcome score short form-36 (mos-sf36)), a motion analysis with an optoelectronic system, then a 6-min walk test. during motion analysis, ten gait trials are executed without brace and ten with the brace.


Eligibility criteria:
inclusion criteria: * symptomatic medial knee oa (kellgren-lawrence grade i, ii or iii) according to clinical and radiological criteria of the american college of rheumatology * knee pain \> 31/100 (western ontario and mcmaster universities arthritis index - womac) * moderately active * varus knee alignment equal or superior to 2° exclusion criteria: * severe knee oa (k-l grade iv) * rheumatoid arthritis or other inflammatory arthritis * avascular necrosis * history of periarticular fracture or septic arthritis * bone metabolic disease * pigmented villonodular synovitis * cartilaginous disease * neuropathic arthropathy * synovial osteochondromatosis * total or partial knee arthroplasty * flexion contracture of ipsi- or contra-lateral knee greater than 15° * hip or ankle joint damage with mobility limitation * obesity (bmi ≥ 40) * intra-articular corticosteroids injection in the affected knee during the two previous months * reduced mobility (charnley class c)
the value of systematic biopsies during vertebroplasty for the treatment of osteoporotic vertebral fractures

Conditions: Vertebral Compression Fracture; Myeloma; Bone Metastases; Malignant Bone Tumour; Lymphoma; Plasmocytoma

Summary: background : vertebral fracture is the most common complication of osteoporosis. vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures, providing consolidation, rapid pain relief and preventing secondary vertebral collapse. performing a biopsy at the same time as the operation does not lengthen the procedure or increase the risk of complications. the question therefore arises as to whether it is cost-effective diagnostically: are non-osteoporotic vertebral lesions detected when biopsies are taken? methods: the investigators carried out a single-centre retrospective study at nice university hospital. from january 2016 to march 2022, 1729 biopsies were performed during 1439 vertebroplasty procedures on 1120 patients. the pre-operative laboratory work-up included a blood count, a c-reactive protein assay and a coagulation test. the imaging work-up systematically included mri, unless contraindicated, in which case ct alone was performed. vertebroplasty was performed in an interventional ct suite under dual ct and fluoroscopic guidance. the systematic biopsy sample was then sent to the anatomopathology department for analysis. findings : the samples detected cancer in 35 patients, including 5 (0.44%) for whom the pre-operative work-up had not raised any suspicion. all the incidental findings were haemopathies, including 4 myelomas and one lymphoma. conclusion : these results highlight the good performance of mri in distinguishing osteoporotic vertebral fractures from solid tumour metastases. however, an exhaustive pre-operative work-up does not seem to be able to formally rule out an underlying malignant lesion. the investigators therefore recommend that biopsies be taken systematically when performing vertebroplasty.


Eligibility criteria:
inclusion criteria: * all patients who underwent a vertebroplasty with bone biopsy exclusion criteria: * non-vertebral bone biopsies * not performed during vertebroplasty