Kornimate/medical-research-clean huggingface dataset:
a clinical assessment of glass carbomer cement

Conditions: Dental Caries Class II

Summary: this study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. teeth will be randomly assigned to one of the three restoration groups and the restorations will be evaluated clinically and radiographically every six months.

glass carbomer is a monomer free; carbomised nano-glass restorative cement developed from traditional glass ionomer cement (gic) and contains nano-sized powder particles of hydroxyapatite and fluorapatite. these materials claim to have improved mechanical properties and better bonding to dentin, in addition to continues fluoride release. the study is a randomized controlled clinical trial where teeth will be randomly assigned to one of the three restoration groups. following medical and dental history, bilateral bitewing radiographs will be taken for each patient to assess the presence of proximal lesions. suitable teeth will then be randomly assigned to one of the restoration groups. a single operator using local anesthesia and rubber dam isolation will then prepare standardized class ii cavities and place the designated restorations according to the manufacturer's instructions. the quality of the 3 types of restorations will be clinically evaluated at baseline and every six months for color match, marginal discoloration, anatomic form, marginal adaptation, and secondary caries using the criteria described by "cvar and ryge" (2005). the evaluation will be performed by 2 calibrated examiners. following placement of the restorations, bitewing radiographs will be taken to evaluate the restorations and will be repeated every six months for detection of recurrent caries.

Eligibility criteria:
inclusion criteria: * one proximal lesion in a primary molar. * radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin. * proximal contact with adjacent healthy or restored teeth. * occlusal contact with opposing healthy or restored teeth. * no indication for pulp therapy or other restorative treatment. * a predicted survival until exfoliation of 2 years. exclusion criteria: * radiographic evidence of caries extending into the inner half of dentin. * no proximal contact with adjacent healthy or restored teeth. * no occlusal contact with opposing healthy or restored teeth. * tooth indicated for pulp therapy or other restorative treatment. * a predicted survival until exfoliation of less than 2 years.

Keywords: proximal dental caries glass carbomer hydroxyapatite enhanced glass ionomer primary teeth
effect of pioglitazone on mitochondrial function in muscle and adipose tissue in humans

Conditions: Type II Diabetes Mellitus

Summary: mitochondrial dysfunction in skeletal muscle results in decreased muscle fatty acid oxidation, leading to conversion of fatty acids into triglycerides and its accumulation inside the muscle tissue. moreover, in adipose tissue mitochondrial dysfunction results in decreased fatty acid oxidation and triglyceride synthesis, leading to increased circulating fatty acid concentrations, which in turn also leads to lipid accumulation inside muscle tissue. lipid accumulation inside muscle tissue interferes with the insulin signaling pathway and causes insulin resistance. mitochondrial dysfunction in both tissues has therefore been proposed to play an important role in insulin resistance in humans. pioglitazone, a thiazolidinedione, is an fda approved medication for the treatment of type 2 diabetes. it improves muscle insulin sensitivity at least in part by lowering intramuscular lipid concentrations but the mechanism by which this occurs is unclear. in the present study, we shall therefore test the hypothesis that pioglitazone improves mitochondrial function in muscle and adipose tissue in humans who are insulin resistant.


Eligibility criteria:
inclusion criteria: 1. subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. 2. subjects may be of either sex with age as described in each protocol. female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period. 3. subjects must range in age from 18-65. 4. subjects must have the following laboratory values: * 2-hour ogtt plasma glucose 140-250 mg/dl * hematocrit ≥ 35 vol% * serum creatinine ≤ 1.6 mg/dl * ast (sgot) \< 2.5 times upper limit of normal * alt (sgpt) \< 2.5 times upper limit of normal * pt, ptt within the normal range exclusion criteria: 1. subjects must not be receiving any medications with known effects on glucose tolerance unless the subject has been on stable dose of such agents for the past three months before entry into the study. subjects taking systemic glucocorticoids will be excluded. subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. 2. history of clinically significant heart disease, including ischemic heart disease (new york heart classification greater than grade ii; more than non-specific st-t wave changes on the ekg) and congestive heart failure 3. history of peripheral vascular disease (history of claudication) 4. history of pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation). 5. history of peripheral edema 6. uncontrolled hypertension with systolic bp\>160 mmhg, diastolic bp\>100 mmhg 7. resting heart rate \>100 beats/min 8. autonomic neuropathy 9. heavy alcohol consumption (\> 2 drinks/day)
intra-abdominal pressure and insufflator effects in robotic surgery

Conditions: Post Operative Pain; Hemodynamic Instability; Hypercapnia; Complication,Postoperative; Intraoperative Complications

Summary: the main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position.

adult patients scheduled for robotic genitourinary or colorectal surgery are going to be enrolled in this study. patients will be randomized in three groups. in group i, conventional insufflators will be used with 12 mmhg intra-abdominal pressure; in group ii, valveless insufflators will be used with 12 mmhg intra-abdominal pressure and in group iii, valveless insufflators will be used with 8 mmhg intra-abdominal pressure. intraoperative data regarding airway pressures, lung compliance, hemodynamic parameters, arterial blood gas analysis, times of pressure loss and camera cleaning will be gathered. each patient will receive a standardized anesthesia and analgesia procedure with a intravenous morphine patient controlled analgesia (pca). postoperative pain will be monitored at 1st, 3rd, 6th, 12th and 24th postoperative hours and morphine consumption rates will be recorded. patient length of stay, time to first flatus, urine output, postoperative complications(graded by clavien dindo classification), preoperative and postoperative hemoglobin and creatinine levels will be filed.

Eligibility criteria:
inclusion criteria: * elective robotic surgery with intraabdominal insufflation and trendelenburg position (prostatectomy, hemicolectomy etc.) * asa (american society of anesthesiologists) physical status i-ii-iii exclusion criteria: * patients without consent * emergency surgery * bleeding diathesis * pregnancy or lactation * prior history of major abdominal/pelvic surgery * chronic kidney disease * chronic opioid consumption for chronic pain * inability to communicate with the patient due to language barriers or mental status

Keywords: robotic surgery intra-abdominal pressure insufflator postoperative pain postoperative complications intraoperative complications
incontinence analysis after holep using 28fr versus 22fr sheath

Conditions: Urinary Incontinence

Summary: the rationale for this study is to assess whether there is a difference in holep outcomes in smaller 22fr instruments compared to our standard 28fr sheaths.

this study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, holep performed with either 1) 22fr sheath set or 2) 28fr sheath set. after holep, data will be analyzed using chi-square test for incontinence vs no incontinence between 22fr and 28fr groups at 1 week, 4 weeks and 12 weeks post operatively.

Eligibility criteria:
inclusion criteria:• age \>18 years old undergoing holep for benign prostatic enlargement eligible for same day catheter removal exclusion criteria: * age \< 18 years old * existing stress or urge urinary incontinence * planned overnight admission or overnight catheterization
comparison of the effects of external electrical stimulation protocols in women with overactive bladder

Conditions: Overactive Bladder

Summary: the aim of our study is a comparison of the effects of external electrical stimulation protocols in women with overactive bladder (oab).

oab is a condition defined by the international continence society as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. external electrical stimulation has positive effects on oab. however, there are not enough studies on how often this stimulation is applied. studies are needed on this subject.

Eligibility criteria:
inclusion criteria: * being in the age range of 18-65 , * having diagnosed with oab, * being a volunteer exclusion criteria: * being pregnant, * presence of severe pelvic organ prolapse, * malignant disease, * urinary infection, * neurological disease, * have electronic and metal implant, * loss of sensation, * lumbosacral peripheral nerve lesion
study of safe blood transfusion volumes to correct acute severe anaemia

Conditions: Severe Anaemia

Summary: greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.

severe anemia (sa, hemoglobin \<6 g/dl) is a leading cause of pediatric hospital admission in africa, with significant in-hospital mortality. the underlying etiology is often infectious, but specific pathogens are rarely identified. guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes. we evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; tx30: n = 78) against the standard volume (20 ml/kg; tx20: n = 82) in ugandan children (median age 35.5 months (interquartile range (iqr) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin \>6 g/dl: primary outcome) and 28-day survival.

Eligibility criteria:
inclusion criteria: * severe anaemia(hb less than 6g/dl)at admission * guardian or parent willing/able to provide consent exclusion criteria: * malignancy * surgery * acute trauma * severe malnutrition
evaluation study for a non-contact biometer

Conditions: Cataract; Pseudophakia; Myopia; Hyperopia; Aphakia

Summary: the purpose of this study is to determine whether a new non-contact biometer, is as accurate as the the available gold-standard.

the features of a not yet commercial available new biometer will be compared to available contact and non contact biometers in different patient groups.

Eligibility criteria:
inclusion criteria: 1. 18 year or older 2. normal eye 3. cataract 4. corneal abnormality (scar, opacity, transplant) 5. refractive corneal surgery 6. pseudophakia 7. aphakia 8. silicon oil 9. refractive iol 2.-9. (at least one yes)

Keywords: biometry corneal opacity astigmatism refraction
prospective study of persistent dyspnea in recovered covid-19 patients

Conditions: Covid19; Dyspnea

Summary: we conducted a national, single center (hospital clínico universitario de valladolid, spain, valladolid), prospective study of patients with prior hospitalization because of covid-19 who were admitted between march 1st, 2020, and may 15th, 2020. all eligible patients underwent at least at first-time follow-up from the index event. exclusion criteria were age \< 18 years old, pregnant women, terminally ill patients, active sars-cov-2 infections, inability to exercise and previous known severe pulmonary or heart disease. patients underwent a clinical assessment for symptom burden, questionnaire for quality of life (kansas city cardiomyopathy questionnaire and sf-36), venous blood sampling, 6-minute walking test (6-mwt), tests of lung function (spirometry and diffusing capacity of the lungs for carbon monoxide) and treadmill cardio-pulmonary exercise testing (cpet). 48-hours before the test of lung function and the cpet, all patients yielded a negative result in the reverse transcription-polymerase chain reaction (rt-pcr) for sars-cov-2. for definitive analysis patients were assigned to the control group if they did not refer dyspnea at the time of the follow-up, a small asymptomatic out-patient control group without prior hospitalization was also included.


Eligibility criteria:
inclusion criteria: * signed informed consent * previous covid-19 hospitalization with successful discharged * availability of at least one follow up per clinical protocol exclusion criteria: * pregnant women * terminally ill patients * active sars-cov-2 infections * inability to exercise * previous known severe pulmonary or heart disease

Keywords: dyspnea covid19 cardiopulmonary exercise test
lipid-lowering effect of plant stanol ester yoghurt drinks

Conditions: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Summary: the aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects


Eligibility criteria:
inclusion criteria: * bmi \< 30 kg/m2 * moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l) * serum triglycerides \< 3 mmol/l. * normal liver, kidney and thyroid function * subjects must voluntarily sign the informed consent exclusion criteria: * use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention * lipid lowering medication * history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (cabg), percutaneous transluminal coronary angioplasty (ptca) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases * pregnancy or lactation * alcohol abuse * subjects with intolerance to any ingredient of the test products
training with brain-machine interfaces, visuo-tactile feedback and assisted locomotion for patients with chronic complete paraplegia

Conditions: Chronic Paraplegia

Summary: the purpose of this research is to compare the effectiveness of a training protocol integrating brain-machine interfaces, visuo-tactile feedback and assisted locomotion (referred to as the walk again neurorehabilitation protocol, or wanr), with classical physiotherapy training for patients with chronic complete paraplegia due to spinal cord injury.


Eligibility criteria:
inclusion criteria: * 1. discomplete spinal cord injury; * 2. traumatic etiology; * 3. american spinal injury association impairment scale(asia) a grade; * 4. the level of sci in t9-t12; * 5. ≥12 months post injury; * 6. considered independents to perform daily life activities: feeding, dressing, capability with wheelchair; * 7. emotional stability; exclusion criteria: * 1. absence of sci, or presence of multi-segmental injury; * 2. sci non-traumatic etiology; * 3. age\ 60 years; * 4. emotional instability; * 5. unavailable time to join the protocol activities; * 6. already enrolled in other research protocol; * 7. acute or chronic decompensated comorbidities (e.g. hypertension, diabetes, cardiomyopathy, chronic respiratory insufficiency, chronic renal insufficiency, hepatopathy, or any other neurological disorders besides the sci); * 8. alcohol/drugs abuse and dependence; * 9. psychiatric disorders (exception: treated depression); * 10.cognitive deficit; visual deficit; auditory deficit; * 11. incapacitating pain; * 12. pregnancy; * 13. presence of limb amputations (exception: hand distal phalanges); * 14. peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome); * 15. muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome); * 16. neuromuscular disease associated (ex: myopathy) or lower limb fractures within the past six months; * 17. movement disorders(e.g. ataxia); * 18. use of medication that can negatively impact on neurological/motor recovery; * 19. presence of joint deformities, presence of fractures; * 20. lower limb spasticity mas (modified ashworth scale)\>2; * 21. pressure ulcer: considering grade 3 or 4, injury size and body location; * 22. cephalic metallic /magnetic implants (exception: mri compatible implants); * 23. presence of cardiac or neural pacemaker; * 24. use of devices/tubes: tracheostomy, gastrostomy, nasogastric, long-term bladder catheterization, cystostomy, colostomy, totally implanted catheter system, arteriovenous dialysis fistula; * 25. severe osteoporosis (tscore\>-4); * 26. syringomyelia; * 27. lokomat or zerog training within the prior 3 months.
sleep, glycemic control, and insulin resistance in adolescents with type 1 diabetes

Conditions: Type1diabetes; Adolescent Behavior; Sleep

Summary: despite advancements in care, most adolescents with t1d have higher bmi and significantly higher hba1c than recommended and are markedly ir, placing them at increased risk for cvd1,2. thus, alternative approaches to improve and maintain glycemic control, ir, and bmi for adolescents with t1d are urgently needed. this proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. the goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (t1d; n = 40) and examine relationships with glycemic control, ir, vascular health, and bmi. further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with t1d.


Eligibility criteria:
inclusion criteria: * attending high school * diagnosis of type 1 diabetes \>1 year exclusion criteria: * current diagnosis of a sleep disorder (e.g., insomnia, osa) or abnormal scores on sleep disorders screening measures * regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin, other sleep aids) * hba1c ≥11 or \>14% for the previous 2+ measurements * iq\<70 or severe mental illness
multiple dose escalation study (14 days) to investigate safety, tolerability, pk and pd of vardenafil and bay60-4552

Conditions: Erectile Dysfunction

Summary: safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. in three treatments groups different dosages of bay 60-4552 and vardenafil will be given with patients with erectile dysfunction.


Eligibility criteria:
inclusion criteria: * the informed consent must be signed before any study specific tests or procedures are done * male patients with a history of erectile dysfunction (ed) for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the nih consensus report 1993. the diagnosis of 'erectile dysfunction' has to be confirmed by a physician * age: 18 to 70 years (inclusive) at the first screening examination * ethnicity: white * body mass index (bmi): equal to or above 18 and below 32 kg / m² * confirmation of the patient's health insurance coverage prior to the first screening examination / visit * ability to understand and follow study-related instructions exclusion criteria: * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * known hypersensitivity to the study drugs (active substances or excipients of the preparations) * known severe allergies, non-allergic drug reactions, or multiple drug allergies * any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the nih consensus report 1993 * history of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening * bleeding disorder * history of prostatectomy because of prostate cancer, including nerve-sparing techniques. clarification: any surgical procedures for the treatment of benign prostate hypertrophy (bph) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation * hereditary degenerative retinal disorders such as retinitis pigmentosa * history of loss of vision because of naion (bayer study 12912), temporary or permanent loss of vision, including unilateral loss of vision * history of uni- or bilateral hearing loss

Keywords: erectile dysfunction
fibrotic interstitial lung disease early recognition and strategic therapy study in china

Conditions: Interstitial Lung Disease (ILD)

Summary: this project aimed to: 1) construct a cohort of no less than 10000 cases of f-ild (including pneumoconiosis ≥3000 cases) with continuous regular follow-up to reveal the clinical phenotypes closely related to the development, progression and prognosis of pulmonary fibrosis; 2) systematically evaluate the safety and effectiveness of frozen lung biopsy, surgical lung biopsy/thoracoscopic lung biopsy and other techniques, and to optimize the histological diagnosis method of f-ild; 3) construct a set of artificial intelligence (ai) evaluation system for quantitative evaluation of pulmonary fibrosis and its severity, and develop application software; 4) excavate and verify important molecular targets for the formation of pulmonary fibrosis and identify biomarkers; 5) combined with clinical phenotype, imaging, pathology and biomarkers to establish f-ild early recognition and progress model, intervention strategies, guidelines and consensus, and applicated nationwide.


Eligibility criteria:
inclusion criteria: * diagnosed as ild exclusion criteria: * lack of chest ct * patients refused to participant