Kornimate/medical-research-clean huggingface dataset:
brain injury therapy of exercise and enriched environment

Conditions: Brain Injuries

Summary: the purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. the enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk. a series of tests that measure mental function and balance will be done before and after the exercise or the exercise/enrichment program will be done to measure efficacy.

traumatic brain injury (tbi) results in long-lasting physical and cognitive deficits. the purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. the environmental enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk on 8 different cultures. individuals will be evaluated using neuropsychological and physical tests before and after the intervention. testing will consist of repeatable battery for the assessment of neuropsychological status (rbans), trailmaking test (tmt), immediate post-concussion assessment and cognitive testing (impact), quality of life in brain injury questionnaire (qolibri), 10 meter walk, and the nih toolbox standing balance test. initial testing will include the disability rating scale to help balance groups (after random assignment) in terms of baseline ability. in rodents, exercise or an enriched environment after tbi improve cognitive function and motor function and the combination results in even greater improvement. the mechanism of cognitive improvement from exercise or environmental enrichment relates to increases in brain derived neurotrophic factor and neurogenesis in the hippocampus. an additional possible mechanism of the positive effects of exercise or enrichment is a reduction in inflammation. our hypothesis is that exercise or exercise with enrichment will result in better motor performance and improved cognitive ability.

Eligibility criteria:
inclusion criteria: * traumatic brain injury (tbi) person * 1 to 15 year post-tbi * initial glascow coma scale (gcs) of \< or = 12 * 18-75 years old * able to perform standardized exercise program exclusion criteria * inability to walk independently without assistive aids. * severe cardiovascular limitations limiting exercise of up to 5 metabolic equivalents.

Keywords: traumatic brain injury brain contusion craniocerebral trauma exercise therapy chronic brain injury environment impact cognitive therapy health facility environment
comparison of thermo-plastic versus carbon foot ankle orthosis to improve gait and reduce fatigue in post-stroke patients: a biomechanical and neurophysiological study

Conditions: Hemiparesis;Poststroke/CVA; Gait, Hemiplegic

Summary: approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the ground during walking. this impairment, termed as "foot drop", is caused by an association of weak dorsiflexors and increased spasticity and stiffness of the plantar-flexors. as a consequence, walking performances are reduced and energy cost of walking is deteriorated. this may increase performance fatigability, as the locomotion will be realized at a higher percentage of the subjects' capacities. in order to overcome these issues, different treatments are proposed. one of the most conventional solutions are the use of ankle foot orthosis (afo) and it is the most commonly prescribed device used to compensate for "foot drop". there is a very large choice of afo on the market which can be proposed to patients with foot drop. the aim of this study is thus to assess the mechanical effects of using a manufactured carbon afo in by comparison to a custom-made thermo-plastic afo on walking capacity (distance and energy cost), fatigue and "foot drop" control throughout the gait phase in patients with hemiparetic stroke.


Eligibility criteria:
inclusion criteria: * hemiparetic patients, walking with cm-afo * diagnosis of a first stroke since at least 6 months with medical conditions of stroke known, treatment proposed, cardio-vascular and neurological state stabilized * foot drop observed during the swing phase of gait, requiring the use of a custom-made plastic orthosis that has been used for at least 3 months and used for less than 2 years * muscle spasticity not higher than grade 3 according to the modified ashworth scale * sufficient motor ability and endurance to ambulate at least 15 m independently without afo * patient who signed a consent * patients affiliated or entitled to a social security system. exclusion criteria: * patients who did not have brain mri imaging after their stroke to confirm the diagnosis of stroke, * patients with an associated cerebellar syndrome, * patients with clinical brainstem involvement (cranial pair deficit), * patients with a neurological history other than stroke that has an impact on walking, * patients with unstable cardiovascular or respiratory disorders likely to induce gait disorders that may influence the performance of the tests to a greater extent than in the case of vascular hemiplegics, * patients with alcohol or drug dependence, * patients with psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant pathology, renal impairment, unstable or decompensated diabetes, severe, * patients with a history of associated disabling systemic disease, * patients who refused to sign the written consent, * patients with a current pregnancy, * patients under court protection.
extremity thermographic values in individuals with transtibial amputation

Conditions: Amputees; Amputation; Amputation Stump; Amputation of Knee; Vascularisation

Summary: the goal of this observational study is to compare thermographic values in the knee region of the healthy extremity and the amputated extremity and learn about the relationship between thermographic value and pain in the knee region of the amputated extremity. the main questions it aims to answer are: 1. do thermal values in the knee region of the amputated extremity and the intact extremity differ in individuals with transtibial amputation? 2. is there a relationship between the pain felt in the knee region of the amputated limb and the difference in thermal values between the extremities in individuals with transtibial amputation?

with amputation, anatomical and vascular changes occur in the distal part of the remaining limb. at this point, for individuals with amputation at the transtibial level, the knee joint in the amputated extremity is of critical importance as it is the most distal joint. while there is evidence that thermal changes observed in the knee region may be related to possible degeneration or pathological processes, there is not enough research on the amputee population. considering that individuals who have undergone lower extremity amputation are at greater risk than the general population for many health problems and considering the current evidence, we think that the evaluation of skin temperature, which is an indicator of cutaneous circulation, may be an important indicator in taking precautions for degenerative knee diseases. with the planned study, lower extremity temperature profiles and their relationship with knee pain will be evaluated for the first time during the post-amputation period. thermal infrared non-contact thermometer, which is non-invasive, cheap and easy to apply, will be used for the first time in lower extremity temperature measurements of amputees. objectives of the study, * thermal analysis results of both extremities will be compared and it will be investigated whether there is a difference between thermal values, which is one of the indicators of cutaneous blood flow; * by comparing the thermal values, it will be determined whether the thermal values differ in the amputee limb that has undergone major trauma and is exposed to prosthetic material that applies continuous compression, * the relationship between nociceptive pain and phantom pain felt in the knee region of the amputated limb and the thermal value difference between the extremities will be determined.

Eligibility criteria:
inclusion criteria: * having a unilateral below knee level amputation, * using a prosthesis and being able to walk with the prosthesis, * not having undergone any surgery related to the knees. exclusion criteria: * having bilateral amputation, * not being able to walk 10 minutes independently, * failure to consent to measurement of knee thermal temperature.
effect of diacerein in the metabolic control of patients with dm type 2 and secondary failure to metformin

Conditions: Diabetes-Related Complications; Diabetes Mellitus, Type 2; Insulin Resistance

Summary: considering that, diacerein is on the market for almost 20 years, being used continuously in elderly patients with osteoarthritis without present significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes and in a previously study from mexico. the aim of our study is to investigate the effect of diacerein, a medication with anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as interleukin 1 (il-1). administered for 12 weeks and the effect in the glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.

this proof of concept study aims to access the metabolic control in patients with type 2 diabetes mellitus and secondary failure to metformin. the study is a phase ii, multicenter, national, prospective, randomized, double blind, parallel groups, placebo comparative trial. unicamp (hospital of unicamp) is the coordinating center and we have the participation of the state university of feira de santana and the center for diabetes and hypertension in fortaleza. study objectives: to investigate the effect of diacerein administered for 12 weeks; glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment. the total number of patients will be approximately 60, 30 patients in each group.

Eligibility criteria:
inclusion criteria: * diabetes mellitus (dm) type 2 between 6 months to 10 years of disease * body mass index between 25 and 35 kg/m2 * fasting glucose between 120 and 250 mg/dl * glycated hb a1c greater than 7,5 % * taking metformin (dose above 1700 mg/day) with or without other secretagogue. exclusion criteria: * subjects with dm1 * subjects with dm2 using insulin * subjects with dm2 with chronic complications that already have clinical consequences * subjects with other types of diabetes * creatinine serum greater than 1.4 mg/dl (female) and 1.5 mg/dl (male) * history of heart disease and/or severe concomitant diseases such as liver, coronary artery, renal * history of severe psychiatric or neurological disorders * history of alcohol abuse and/or illegal drugs or psychotropic medicines in the past six months * hypersensitivity to any component of the of study drug and placebo formulation.

Keywords: diabetes diacerein
a study of gw406381 in volunteers with moderate hepatic impairment

Conditions: Pain

Summary: this study will assess the pharmacokinetics and tolerability of a single dose of gw406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers. the hepatically impaired and healthy groups will be given a single 20 mg oral dose of gw406381. blood samples for pk analysis will be collected pre-dose and over the 72 hours post dosing. subjects will be housed from the evening before dosing until 24 hours after dosing. a follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.


Eligibility criteria:
inclusion criteria: * healthy subjects or subjects with moderate hepatic impairment as defined by a child-pugh score of 7-9 * body weight less = 100 kg * body mass index (bmi) within range of 19 - 32 32kg/m2 exclusion criteria: * presence of any other significant disease * use of any medication within the 2 weeks prior to dosing, unless approved by both the investigator and gsk personnel

Keywords: hepatic impairment pharmacokinetics
vivanet study. a multicenter study of confocal reflectance microscopy in telemedicine

Conditions: Skin Cancer; Skin Lesions

Summary: the goal of this study is to test a protocol that uses clinical pictures, confocal reflectance microscopy images and dermoscopic information in a telemedicine platform. this protocol will test the technologies and diagnostic performance of dermoscopy and confocal reflectance microscopy in a randomized prospective multicenter study in five different centers in europe.

in vivo confocal reflectance microscopy (crm) is a non-invasive method for the in vivo (without cutting into the skik) examination of skin tumors. crm produces cellular images with resolution comparable to histopathology. the procedure is painless, takes about ten minutes and has no documented side effects. studies performed in the past decade have correlated crm features in benign (non-cancerous) and malignant (cancerous) skin lesions such as moles and melanomas, as well as features of inflammatory lesions (such as allergic skin reactions) to histopathology. dermoscopy is a complementary technique that has been proven to be superior to the naked eye for the diagnosis of melanoma as well as some non-melanocytic skin tumors. recently, correlation of dermoscopic and crm structures has focused interest in the research in different groups that show that both are complementary and render in combination a better understanding of skin disease. in this study, patients from several research centers in europe, with lesions suspicious for malignancy and scheduled for biopsy will be asked if they would like to participate in the study. if they consent to the study, first, a clinical photograph will be taken of the lesion. second, a dermoscopic image will be taken of the lesion, and third, crm images will be taken of the lesion. finally, the biopsy will be performed as per the standard of care. the images will be sent over a secure, private internet connection to physicians specially trained in the interpretation of dermoscopic and crm images. an electronic report will be completed and returned to the study coordinator, who will correlate the results with the histopathologic diagnosis.

Eligibility criteria:
inclusion criteria: * any skin tumor considered suspicious for malignancy under clinical non-aided examination * histopathologic study of the tumor or short term follow up (3 months) to confirm benignity * clinical information and images available * adequate imaging by dermoscopy and crm according to the protocol of the study * consent form signed by the patient exclusion criteria: * lesions with ulcerations obscuring more than 75% of the confocal mosaic field of view. * lesions with clinically appreciable scar. * lesions in locations not amenable to imaging with the confocal microscope.

Keywords: reflectance confocal microscopy dermoscopy clinical photos telemedicine
a bike application to support cardiac patient

Conditions: Coronary Artery Disease

Summary: the pilot study will investigate the usability of a mobile cycling application in a cardiac patient population during a one month study period. the application's effectiveness regarding ability to reduce fear and increase motivation to exercise will be assessed.

this pilot study investigates the use of a mobile cycling application for patients with a cardiac disease that was developed by the expertise centre for digital media of hasselt university in collaboration with the faculty of medicine \& life sciences of hasselt university. during the pilot study, the use of the cycling application and its impact on fear and motivation of patients with a cardiac disease during the rehabilitation is studied. the cycling application will be used on a smartphone, in combination with a wrist-worn heart rate monitor. during the study, the patients will use the cycling application for one month, in which they can make use of the cycling application each time they are cycling outdoor in their home environment. through questionnaires and interviews, the patients' experiences with respect to fear and motivation will be collected. furthermore, the usability of the cycling application is evaluated through these questionnaires and interviews.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease for which they received a percutaneous coronary intervention, coronary artery bypass grafting or drugs only. * patients that have completed the standard cardiac rehabilitation program * patients who have access to a computer and a wifi internet connection * patients that are able to go to the rehabilitation centre rego of jessa hospital * patients who signed the informed consent document exclusion criteria: * patients with a history of vf, sustained vt and/or supraventricular tachycardia during the last 6 months before enrollment. * patients who due to cognitive, neurological and/or musculoskeletal constraints are unable to ride a bicycle. * patients with a pacemaker. * non-dutch speaking patients * patients who simultaneously participate in another study

Keywords: human-computer interaction fear motivation usability
low-dose lenalidomide for non-severe covid-19 treatment trial

Conditions: COVID-19

Summary: double-blind randomized controlled clinical trial (rct) of low-dose lenalidomide in the treatment of elderly patients (\> 60 years of age) with mild to moderate clinical signs of covid-19 disease from the hospital universitario of getafe. the study will include patients of both sexes (\> 60 years of age) with mild to moderate clinical presentation of covid-19 (rox index \> 10). subjects will be randomly assigned to the experimental arm with lenalidomide (5 mg/24h, day 1, 3 and 5) or to the controlled arm. other concomitant medication for the treatment of covid-19 will be also considered.


Eligibility criteria:
inclusion criteria: * subjects \> 60 years of age * diagnosed case (pcr test for covid-19 if available) or covid-19 clinical symptoms (defined as fever, dry cough, dyspnea, chest radiography with compatible findings with covid-19) * lymphocyte count ≥ 0.2 x 103/µl and ≤1.0 x 103/µl. * neutrophil count ≥ 1.8 x 103/µl, platelets ≥ 150 x 103/µl. * rox ≥ 10 index * signed informed consent document * willing to comply with the lenalidomide risk minimization program (pregnancy prevention program approved) exclusion criteria: * absolute contraindication of lenalidomide use or hypersensitivity to the active ingredient or any of the excipients. * active neoplasia * previous autoimmune disease * concurrent infection of hbv, hcv or tuberculosis. * aspartate transaminase (ast) or alanine transaminase (alt) \> 3 times the upper limit of normal (uln). * bilirubin levels \> 1.5 times the uln * renal impairment with an estimated gf \< 30ml/min * venous thromboembolism events within the previous 3 years * significant active heart disease within the previous 6 months, including congestive heart failure (class ii-iv nyha), unstable angina or myocardial infarctions * sexually active subjects who refuse the lenalidomide risk minimization program * inability to comply with the working protocol under the responsible health professional opinion.
modified uterosacral ligament suspension in vaginal hysterectomy

Conditions: Modified Extraperitoneal Uterosacral Ligament Suspension; Vault Prolapse, Vaginal

Summary: introduction : the extraperitoneal uterosacral ligament suspension (uls) can be performed during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. in this study, the modified extraperitoneal uls technique was evaluated in terms of preventing cuff prolapse. methods / technique : forty patients with second and third-stage uterine prolapse who were operated were included in the study. during routine vaginal hysterectomy procedure performed on patients, after sacrouterine ligaments which are the first-bites and uteroovarian and round ligaments which are the last-bites have been sutured and knotted, these ligaments were marked with 4-distinct clemps to make the right and left, upper and lower separation. after vaginal cuff was closed the sutures hanged by the clamps were ligated together, and the cuff tissue was stretched to the apical line.


Eligibility criteria:
inclusion criteria: * stage 2 or 3 uterin prolapse exclusion criteria: * contrandication for surgery

Keywords: vaginal hysterectomy
pharmacokinetics, pharmacodynamics, and safety of maraviroc (uk-427,857) in patients with human immunodeficiency virus

Conditions: HIV Infections

Summary: to investigate the relationship between the pharmacokinetics and pharmacodynamics of uk-427,857 and its antiviral effects in patients with human immunodeficiency virus (hiv).


Eligibility criteria:
inclusion criteria: inclusion criteria: * male with hiv or surgically sterilized female with hiv showing no symptoms of hiv * weight between 50 and 90kg and within the permitted range for their height exclusion criteria: exclusion criteria: * subjects with a cd4 count less than 250cells/mm3 or hiv viral load of less than 5000 copies/ml * subjects with acquired immune deficiency syndrome (aids) or a previous aids diagnosis * subjects whose hiv infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion * subjects who have taken anti-retroviral drugs in the eight weeks prior to the study screening visit

Keywords: hiv treatment naïve
comparation of treatment strategies for ovf: teriparatide injection and pvp

Conditions: Osteoporosis, Postmenopausal; Vertebral Fracture; Quality of Life

Summary: this study aimed to compare teriparatide treatments and pvps, focusing on its effects on life qualities and effect/coast ratio and evaluate which method is better for patients.

osteoporosis and osteoporotic vertebral fracture (ovf)s are the common diseases that affect the qualities of senior people. the general treatments for ovfs including percutaneous vertebroplasty (pvp) operation and conservative treatments with pain killers. but with the widely used methods, the life quality of patients were still not satisfied. teriparatide has been proven to increase bone qualities in patients with severe osteoporosis and reduced the fracture possibilities. the investigators' previous clinical observation found teriparatide could be applied to treat fresh ovfs. 90 participants who diagnosed fresh ovfs were included in the trial. after they received each of three kinds of interventions mentioned in this study, the investigators followed up all these cases. once 30 cases goal reaches in a certain group, the data collection in that special will stop automatically. the quality of life, pain score and bmds will be evaluated in certain time during the trial.

Eligibility criteria:
inclusion criteria: * 1.postmenopausal women with osteoporotic fractures 2.treated with teriparatide 3.or treated with vertebroplasty 4.or treated with teriparatide after vertebroplasty 5.or treated with fosamax 6. willing to anticipate the trial exclusion criteria: * serious other illness or disease which effecting quality of life occurs later in treatment * unwilling to anticipate the trial