Kornimate/medical-research-clean huggingface dataset:
comparative glucose clamp study of wockhardt's insulin human regular for injection and actrapid, in healthy subjects.

Conditions: Diabetes

Summary: the aim of this trial is to demonstrate bioequivalence of wosulin r to actrapid with regard to its total and to its maximum serum insulin concentrations.

the purpose of this study is the comparative evaluation of the pharmacodynamics and pharmacokinetics of two recombinant regular human insulin injections administered intravenously in healthy volunteers under the conditions of euglycemic clamp.

Eligibility criteria:
inclusion criteria: 1. healthy male or female subject 2. age between 18 and 45 years (both inclusive) 3. considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator. 4. body mass index (bmi) between 18.0 and 35.0 kg/m2 (both inclusive) 5. non-smoker, defined as no nicotine consumption for at least one year. 6. signed and dated informed consent obtained before any trial-related activities. exclusion criteria: 1. previous participation in this trial or other clinical trials within the last 3 months. 2. pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures. 3. clinically significant abnormal hematology or biochemistry screening tests, as judged by the investigator. 4. any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the investigator. 5. history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. in particular, subjects with significant cardiovascular disease, anemia (below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial. 6. history of alcohol or drug abuse within the past 5 years and/or any positive test for drugs of abuse at screening. 7. positive test for hepatitis b or c or hiv positive at screening or in the past. 8. use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants. 9. use of any insulin product in the past. 10. use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. occasional use of acetaminophen will be permitted. 11. blood donation of more than 500 ml (or considerable blood loss) within the last 12 weeks. 12. history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 13. known or suspected allergy to trial products or related products. 14. mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.

Keywords: diabetes, healthy volunteers
right bundle branch block after surgical closure of ventricular septal defect

Conditions: Bundle-Branch Block; Heart Septal Defects, Ventricular

Summary: the most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent. therefore the aim of this study is to investigate if this group of patients has inferior outcomes compared to the group without this arrythmia after surgical closure and compared to a group of healthy control subjects. all patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography during exercise, and 4. mri. the perspective is the ability to point out a group of patients with a possible need of further intervention, and additionally to increase the awareness of protecting the electrical system of the heart during the operation.

right bundle branch block is an exceedingly frequent complication in heart surgery, and especially in patients who have undergone surgical closure of a ventricular septal defect which is the most common congenital heart disease. how this bundle branch block effects the right ventricle of the heart on a long-term basis for this group of patients, is still unknown. as a part of a phd-study we therefore will try to illustrate this by echocardiography, mri, exercise testing and other investigations 15 to 20 years after the surgical procedure. the study population thus consists of three different groups: 1. patients whom undergone surgical closure of ventricular septal defect without postoperative right bundle branch block, 2. vsd-operated patients with right bundle branch block and 3. healthy controls with no significant medical issues matched on age and sex. by carrying out the tests mentioned the right ventricles systolic function, diastolic function, the patients maximal exercise capacity and a lot of other parameters will be evaluated in the three groups of patients and compared amongst each other. the perspective therefore is the ability to point out a specific group of patients with an inferior outcome and with a possible need for further intervention. an additional perspective is to increase the awareness of protecting the bundle branch during the operation.

Eligibility criteria:
inclusion criteria: * operated for vsd in the period from 1990 to 1995 on aarhus university hospital skejby exclusion criteria: * no chart to be found * no ekg to be found * known bundle branch block prior to the surgery * other arrythmias * use of ventriculotomy * other disease than vsd * pacemaker or other metallic implants * pregnancy

Keywords: right bundle branch block ventricular septal defect echocardiography mri exercise testing
identification of visual dependence in pppd patients with the aid of virtual reality.

Conditions: PPPD

Summary: the aim of this study is to evaluate whether increased visual dependence can be identified with the help of virtual reality (vr). increased visual dependence is a general term for patients with increased dependence on vision in maintaining their balance. patients suffering from persistent postural perceptual vertigo (pppd) often suffer from increased visual dependence. this in turn leads to complaints such as visual vertigo, agoraphobia and fear of falling. visual dependence is normally measured using the optokinetic after nystagmus (okan) and the rod and disc test (rdt). in this study, these two tests are performed with the aid of virtual reality.

the aim of this study is to evaluate whether increased visual dependence can be identified with the help of virtual reality (vr). visual dependence is normally measured using the optokinetic after nystagmus (okan) and the rod and disc test (rdt). in this study, these two tests are performed with the aid of virtual reality. the okan is measured by eye tracking, a key item already used daily in instruments such as video nystagmography (vng) and video head impulse test (vhit). another test representative of visual dependence is the rod and disc test (rdt). in the rdt, patients are asked to complete a visual task so that researchers gain more knowledge about visual dependence. until now, these tests have been performed using a large set-up and many different materials. moreover, the exact underlying mechanism of visual dependence in pppd patients is still unknown. the aim of this study is to investigate whether virtual reality can be a useful tool when performing the okan and rdt. in this way, a better understanding of visual dependence is sought. this study aims to determine the normative values for the okan and rdt performed with the aid of virtual reality. therefore, a healthy group of individuals will be compared with pppd patients as they suffer from visual dependence. to evaluate the effectiveness of the okan and rdt via vr, the results will be compared with the scores of the visual vertigo analogue scale (vvas), a questionnaire to assess visual dependence.

Eligibility criteria:
inclusion criteria: * all patients with chronic vertigo (\>3 months) exclusion criteria: * minors * patients with a history of epilepsy. * patients with an alcohol use disorder

Keywords: virtual reality pppd rod and disc test optokinetic after nystagmus visual dependence
recombinant bovine basic fibroblast growth factor for the treatment of radiation induced oral mucositis

Conditions: Stomatitis

Summary: radiation therapy is one of the treatments for nasopharyngeal carcinoma . the most common side effects of post-radiation may be radiation-induced oral mucositis . when severe, oral mucositis increases the risk of infection and may affect clinical outcomes due to treatment interruption, dose reduction, and reduced treatment compliance. in china, a quadruple mixture of dexamethasone, gentamicin, vitamin b12, and lidocaine is commonly used in patients who begin to have radiation-induced oral mucositis . however, the incidence of radiation-induced oral mucositis remains high. recombinant bovine basic fibroblast growth factor is a multifunctional cell growth factor that stimulates the growth of cells derived from mesoderm and neuroectodermal cells and thus has a wide range of biological activities. the drug has different degrees of promotion on the three stages of the wound repair process, namely the local inflammatory reaction stage, cell proliferation and differentiation, granulation tissue formation stage and tissue reconstruction stage. the purpose of this randomized controlled trial was to evaluate the efficacy of recombinant bovine basic fibroblast growth factor as an intervention in radiation-induced oral mucositis for the treatment of nasopharyngeal carcinoma , with a commonly used quadruple mixture (from dexamethasone, gentamicin , vitamin b12 and lidocaine composition) were compared.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed and previously untreated nasopharyngeal carcinoma 2. age ≥ 18 years and ≤ 65 years. 3. karnofsky performance status (kps) score ≥ 70 4. planned to receive radiotherapy alone or concurrent chemoradiotherapy 5. adequate bone marrow function: while blood cell \>= 3,000/μl, absolute neutrophil count \>= 1,500/μl, hemoglobin \>= 100g/l, platelet \>= 75,000/μl. 6. life expectancy of \>= 3 months. exclusion criteria: 1. younger than 18 years old or older than 70 years old 2. pregnancy or lactation 3. severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes 4. have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases 5. refuse to give up smoking/drinking/betel chewing 6. suffering from other active infection diseases and in need of treatment. 7. known allergic reaction to any component of recombinant bovine basic fibroblast growth factoor or quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin b12, and lidocaine, or severe allergic constitution.

Keywords: radiation therapy nasopharyngeal carcinoma
evaluation of the effect of the ai500™ single-dose gel medical device in patients with reduced knee function

Conditions: Pain, Acute; Pain, Chronic; Knee Injuries; Knee Osteoarthritis; Knee Arthritis; Knee Pain Swelling

Summary: evaluation of the effect of the ai500™ single-dose gel medical device in patients with reduced knee function

the aim of this post-market confirmatory interventional clinical investigation is to evaluate the performance and safety of ai500™ single-dose gel in patients with reduced knee function.

Eligibility criteria:
inclusion criteria: 1. signed patient informed consent form (icf). 2. male or female aged ≥ 18 years at the time of the signature of icf. 3. presenting with reduced knee function caused by osteoarthritis flare-ups, meniscal injuries, ligament injuries, inflammation of soft tissues, assessed as 20-45 rating according to the womac function scale. 4. willingness to follow all study procedures, including attending all site visits, tests, and examinations. 5. willingness to follow indications. exclusion criteria: 1. use of analgesics within the 24 hours prior to v0. 2. damaged, infected, or ulcerated skin in the area of treatment. 3. ongoing cutaneous allergies. 4. serious and chronic pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) or lesions including cancer with/without ongoing antitumor therapy. 5. patients suffering from muscular dystrophy. 6. patients presenting with bone fractures or severe injuries (including locked knee). 7. severely disabled arthritic patients using a wheelchair. 8. allergy to device components (sodium hyaluronate; shpolypeptide- 6; glycerin; propylene glycol; ethylhexylglycerin; panthenol; peg-40 hydrogenated castor oil; sodium hydroxide; xanthan gum; phenoxyethanol; benzoic acid; carbomer; dehydroacetic acid; disodium edta). 9. immune system illnesses. 10. uncontrolled systemic diseases. 11. known drug and/or alcohol abuse. 12. mental incapacity that precludes adequate understanding or cooperation. 13. participation in another investigational study. 14. pregnancy or breastfeeding. 15. patients with both knees affected/damaged.

Keywords: knee pain hyaluronic acid peptides non-invasive
quality of life and psychogenic nonepileptic seizures.

Conditions: Psychogenic Nonepileptic Seizures (PNESs)

Summary: the goal of this study is to identify the prognostic factors of quality of life in patients with psychogenic non-epileptic seizures

this is a monocentric prospective study. our main objective is to identify prognostic factors associated with an improvement of quality of life on the qolie-31 and short form health survey "sf-36" at six months from the diagnostic. we hypothesized that the absence of pnes during the last three-months before the six months follow-up visit is the best prognostic factor for an improvement of quality of life all adult (\>15 years and 3 months) patients diagnosed with pnes will be prospectively included. all patients will undergo standard of care and have consultation with neurologist and a psychiatrist trained for this type of disease, as it is usually made for these patients (no intervention allocated in the context of the research). . announcement of diagnostic will be standardized and adapted to each patient. clinical and demographic data will be collect as well as medical and psychiatric history. all patients will undergo prolonged electroencephalogram (eeg) under video monitoring allowing the diagnostic of pnes and ruling out epilepsy. different neurologic and psychiatric scales will be collected (quality of life in epilepsy - 31 quotes (qolie-31), short form health survey (sf-36), montreal cognitive assessment (moca), beck depression inventory (bdi2), beck anxiety index (bai), clinician administrated post traumatic stress disorder scale (caps), chilhood trauma questionnaire (ctq), epworth). all patients will be oriented to psychiatric or psychological follow-up. patients will undergo a one, three and six months follow-up and will be evaluated the number of seizure, their severity, and psychiatric or psychological follow-up will be evaluated. patients will undergo scales (qoli-31, sf-36, bdi2, bai).

Eligibility criteria:
inclusion criteria: * male or female adults (15 years and 3 months old) * psychogenic nonepileptic seizures (pnes) diagnosed as "probable" , "clinically established" or "documented" according to "lafrance and al." criteria * having benefited a prolonged electroencephalogram recording under video control * patient information and collection of non-opposition (patient or legal guardian) * the patient or caregiver will be able to perform reliably the crisis diary and make the difference between pnes and epileptic seizure after investigator or co-investigator information. * affiliated to a social insurance... exclusion criteria: * patients for whom pnes have not been diagnosed * refused to participate * the patient or his caregiver isn't able to perform reliably the crisis diary and don't make the difference between pnes and epileptic seizure after investigator or co-investigator information

Keywords: psychogenic nonepileptic seizure, quality of life
prognostic value of biochemical markers in cerebrospinal fluid for functional outcome of spinal cord injured patients

Conditions: Spinal Cord Injuries

Summary: the project is aimed to develop predictive indices of spinal cord injury severity through the analysis of cerebrospinal fluid of patient collected during acute injury.


Eligibility criteria:
inclusion criteria: * presence of cervical and thoracic spinal cord injury * need to be submitted to spine surgical stabilization with posterior approach exclusion criteria: * prior to recruitment, in the acute phase, treatment with steroid therapy

Keywords: spinal cord injuries cerebrospinal fluid
the effect of norepinephrine on the development of pressure injury

Conditions: Pressure Injury

Summary: norepinephrine mainly increases mean arterial pressure among intensive care patients. it may be an essential risk factor in developing pressure injuries. however, there are still conflicting findings in the literature. this study aimed to examine the effect of norepinephrine infusion on the development of pressure injuries among patients in adult intensive care. this retrospective and correlational study was conducted between march 2021- may 2022. the electronic patient data were obtained from 289 adult patients (case group n=149; control group n=149) treated with and without norepinephrine in the intensive care unit, respectively. the demographic and clinical characteristics were evaluated using descriptive statistical methods (number, percentage, mean, standard deviation). a logistic regression model was established to estimate the dependent variable (development of pressure injury) with the independent variables.


Eligibility criteria:
inclusion criteria: the sample consisted of all patients * over 18 years old * who did not have pressure injuries upon admission to the intensive care unit. patients who received norepinephrine and received norepinephrine infusion for at least 48 hours during their stay in icu were included in the case group (n=149), and patients who did not receive an infusion were included in the control group (n=140). exclusion criteria: the sample excluded of all patients * less than 18 * who have pressure injuries during admission * who had norepinephrine infusion less than48 hours during their stay in the intensive care unit.

Keywords: pressure injury norepinephrine vasopressor intensive care development
reducing perinatal anal incontinence through early pelvic floor muscle training: a prospective pilot study

Conditions: Perinatal and Postpartum Anal Incontinence

Summary: anal incontinence affects up to 20% of gravid women during and immediately after pregnancy. it can lead to embarrassment, poor self-image, lifestyle changes, in addition to poor hygiene and increased risk for genitourinary tract infection. these women suffer from a combination of loss of fecal and/or flatal control, with increasing frequency as pregnancy progresses. though anal incontinence may subside in the postpartum period, a subset of women will have continued anal incontinence or recurrence of anal incontinence with subsequent pregnancies or as they age. as of december 2012, only one study has explored the effects of pelvic floor muscle training (pfmt) on reducing the development of this condition in the pregnant population. however, that study took place in scandinavia with little demographic correlation to a us population and lacked postpartum followup. although their results showed little effect of pfmt on anal incontinence, they recommended further research to be performed prior to making definitive conclusions. multiple studies have explored the effects of pfmt on urinary incontinence, and the general consensus shows a positive benefit, with a 50% incidence reduction. this study will serve as an initial test to explore whether such a positive relationship holds for anal incontinence throughout pregnancy and postpartum period for a diverse population. the format will be a prospective feasibility trial comprised of a one-time intensive in-person pelvic floor muscle training course at the first prenatal visit with at home instructions for continued exercise. this group will be compared to a control group which receives a hand-out regarding pfmt but no personalized instruction. the progress of the participants and their symptoms of incontinence will be monitored during pregnancy and at the postpartum visit using standardized validated pelvic floor questionnaires, based on previously designed surveys. a sample size of 100 parous women ages 20-35 year old will be randomized to an intervention and "control or standard therapy" group. the investigators' hypothesis is that the intervention group will show a 50% risk reduction, similar to the urinary incontinence studies. the results of this study will then allow us to design a broader intervention study for which to study the effects of pfmt and anal incontinence during pregnancy and the postpartum period.


Eligibility criteria:
inclusion criteria: * parous women * ages 20-40year old * a new ob visit prior to 20 weeks gestation * confirmed singleton live intrauterine pregnancy exclusion criteria: * prior history of anal incontinence or prolapse * history of surgery or procedures for urinary or anal incontinence or pelvic organ prolapse * tobacco use * diabetes mellitus * history of sexual trauma * chronic cough * chronic constipation based on rome criteria * known connective tissue disorder

Keywords: anal incontinence pregnancy-associated pelvic floor disorders
intrawound administration of vancomycin in tha

Conditions: Hip

Summary: the purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total hip arthroplasty.


Eligibility criteria:
inclusion criteria: 1. age over 18; 2. total hip arthroplasty for advanced hip diseases including femoral neck fracture, developmental dysplasia of hip, and osteonecrosis of the femoral head. exclusion criteria: 1. diminished mental capacity 2. vancomycin allergy 3. chronic kidney disease stage iii and stage iv
melatonin in acute stroke

Conditions: Stroke, Acute; Ischemic Stroke

Summary: this study will measure interleukin 6 (il-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep.

stroke is a major cause of debilitation in the first world, with few therapeutic options when it comes to improvement in quality of life and morbidity, besides physical and occupational therapy. it affects people of all nationalities, creeds, and socioeconomic classes through a narrow array of mechanisms. with all those mechanisms, a common outcome is shared: derangement of the brain parenchymal architecture. this derangement is non-selective in its destruction with obscuration of the blood brain barrier and the glymphatic system, and with bleeding as a common sequela; the oxidative stress of the hemoglobin-heme-iron compound causing further injury. this study will measure interleukin 6 (il-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep. any increased time spent in a restful state because of melatonin increases the clearance of waste products after a catastrophic event, like in stroke.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the neuroscience critical care unit with a confirmed ischemic stroke * patients with a clinical history and examination consistent with an ischemic stroke (stroke must be confirmed by a brain ct and/or mri scan) * eligible patients will have been treated with tpa and/or thrombectomy. exclusion criteria: * prisoners * patients with severe cognitive impairment and/or aphasia (if no family member is available to sign consent) * recent (\<1 month) infection * pregnant females