Kornimate/medical-research-clean huggingface dataset:
effects of soft tissue lengthening on gait in children with spasticity

Conditions: Muscle Spasticity

Summary: this research project is being conducted to investigate changes in secondary impairments, functional mobility skills, and gait variables in children with spasticity following selective percutaneous myofascial lengthening. the research project proposed here will be the first to use instrumented three-dimensional motion analysis to investigate the effects of selective percutaneous myofascial lengthening on gait kinematics and kinetics. the objectives of the study are to: 1. compare gait kinematics and kinetics in children and young adults with lower extremity spasticity before and after selective percutaneous myofascial lengthening to determine the effects of this procedure on functional mobility. 2. identify changes in impairments and activity limitations following selective percutaneous myofascial lengthening . 3. identify changes in a family or caregivers perceived quality of life after their child's selective percutaneous myofascial lengthening . the aim of this study is to identify and describe the specific changes in secondary musculoskeletal impairments, activity limitations, and gait kinematics and kinetics after a selective percutaneous myofascial lengthening procedure. gait kinematics and kinetics includes the motion of joints and body segments, and force and power, at each lower extremity joint, respectively. the results of this study will provide preliminary information on how this form of soft tissue lengthening affects functional mobility skills in children with spasticity. the study is expected to run for two years and the primary study endpoint is when participants have completed their second post- operative data collection session.


Eligibility criteria:
inclusion criteria: * scheduled for an selective percutaneous myofascial lengthening procedure, * between the ages of 4.0 and 20.11 years old, * lower extremity spasticity, * able to ambulate 50 feet without a rest, with or without an assistive device, and with or without ankle foot orthoses (afos) and * able to follow one step directions. exclusion criteria: * botox injections into any lower extremity muscle within three months of the scheduled selective percutaneous myofascial lengthening procedure, * lower extremity orthopedic surgery within 6 months of the scheduled selective percutaneous myofascial lengthening procedure, * visual impairment that interferes with maintaining a straight path while ambulating, * uncontrolled seizure disorder * a change in medication that affects spasticity or ability to follow one step directions within three months of the scheduled selective percutaneous myofascial lengthening procedure.
comparison of gsk biologicals' dtap-ipv candidate vaccine to dtap and ipv separately administered vaccines in terms of immune response and safety

Conditions: Diphtheria; Acellular Pertussis; Tetanus

Summary: the aims of this study are to compare the immunogenicity and safety of the gsk biologicals' combined dtap-ipv vaccine with separate administration of dtap and ipv vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with mmr vaccine in subjects who had previously received four doses of infanrix, three doses of poliovirus-containing vaccine and mmr vaccination.


Eligibility criteria:
inclusion criteria: * healthy children between and including 4 and 6 years of age. * previously received 4 doses of gsk biologicals' dtap, 3 doses of ipv vaccine and 1 dose of measles, mumps, and rubella vaccine. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period. * chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period * administration of immunoglobulins and/or blood products within 3 months prior to vaccination.
bad news- diagnosis: epilepsy in childhood

Conditions: Epilepsy in Children

Summary: "bad news" are defined as"any information which adversely and seriously affects an individuals' view of future. families of chronic ill children are exposed to a high stress load. this project is to investigate the stress burden directly after diagnosis of epilepsy in childhood and coping capabilities in the course of time and how quality of communication at the time of diagnosis effects stress perception and coping behaviour in the following 12 months. perceived/ experienced advisory skills of the physician will be assessed by parents and children (older than eleven) on the basis of spikes - a six-step protocol for delivering bad news. the subjective perception regarding quality of dialogue in relationship to childrens and their parents quality of life and their coping strategies will be assessed.


Eligibility criteria:
inclusion criteria: * newly diagnosed epilepsy (according to international league against epilepsy (ilae) criteria): * at least two unprovoked epileptic fits at intervals of at least 24 hours or * one unprovoked epileptic fit and a recurrence risk of at least 60% or * epilepsy syndrome exclusion criteria: * children with intensive care treatment as inpatients * parents with insufficient german language capabilities * parents and children with exposure to traumatic events in the past three months that could probably lead to post traumatic distress (loss of a loved person, severe traffic accident, raid, violence, sexual assault, war)

Keywords: spikes - a six-step protocol for delivering bad news advisory skills
effect of antioxidant vitamins on coagulopathy and nosocomial pneumonia after severe trauma

Conditions: Coagulopathy; Nosocomial Pneumonia

Summary: the purpose of this study is to determine the effect of antioxidant vitamins (vitamins c and e) on the development of coagulation derangements and nosocomial pneumonia after severe trauma in patients.


Eligibility criteria:
inclusion criteria: * adult trauma patients admitted to the emergency department at the university of alabama at birmingham (uab) hospital * blunt or penetrating injury * uab highest trauma activation exclusion criteria: * age \< 19 years of age * patients with known bleeding diathesis or who are concurrently taking anticoagulant medication * patients with known liver disease * minor patients * pregnant patients (known or suspected pregnancy) * patients who are incarcerated * patients who lack a surrogate
evaluation of a combination of plant extracts (bsl_ep028) on joint mobility

Conditions: Joint Diseases

Summary: the aim of this trial is to study the effect of the combination of plant extracts (bsl_ep028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. this is a preliminary study whose purpose is to gather information for future studies.

the natural aging process involves several body changes that can affect to the mobility of subjects. among them, those that affect the joints may have the greatest impact on mobility. with age, there is a progressive loss of the cartilage that covers the joints, as well as the synovial fluid, which in turn increases the stiffness of the ligaments and tendons that allow joint mobility, which implies a reduction in muscle tone and bone strength. this joint degeneration produces pain and discomfort, which leads to stiffness and restriction of movement. therefore, and as a consequence of this loss of mobility, subjects decrease their physical performance, which can affect their mood and vitality. all of these may lead to a loss of quality of life and to an increase of the risk of future adverse health events, such as disability, institutionalization, hospitalization and the need for home medical care. for all these reasons, and considering the increase in the ageing population worldwide, it seems relevant to develop new strategies to improve joint mobility, physical performance and vitality that are safe for the consumer, affordable and not associated with undesirable side effects. in this regard, natural plant extracts have been widely used as a traditional remedy to reduce joint pain, reduce fatigue and improve mood and physical performance.

Eligibility criteria:
inclusion criteria: * healthy men and women that have joint discomfort (womac score \>20) exclusion criteria: * consumption of pharmacological treatments on an ongoing basis that may affect joint mobility (chondroprotectors, corticoids and/or interarticular therapy or infiltrations). * having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative osteoarthritis made by a rheumatologist/traumatologist * consuming nutritional supplements containing antioxidant substances * consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or scheduled basis and will continue to do so during the study, even if they do not have pain. * being unable to perform the physical tests required in the study. * have an allergy to some component of the study product.

Keywords: plant extract joint mobility physical performance vitality
helmet cpap versus hfnc in acute cardiogenic pulmonary edema

Conditions: Cardiogenic Pulmonary Edema

Summary: this study objectively held to compare the physiological outcomes in the non-invasive (niv) treatment of acute cardiogenic pulmonary oedema (acpe) patients in the emergency department (ed) delivered by helmet cpap (hcpap) and hfnc.patients will be randomized to receive either hcpap or hfnc.

non-invasive ventilation(niv) has different types of interfaces that had been used in acute hypoxaemic and hypercapnic respiratory failure. the appropriate interface is necessary to provide comfort and lead to the success of niv. helmet continuous positive airway pressure (hcpap) is an niv interface that allows the provision of high airway pressures with a minimal leak. hfnc which delivers heated humidified high flow oxygen provides a good alternative to the conventional niv in terms of comfort

Eligibility criteria:
inclusion criteria: all patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema. exclusion criteria: 1. age less than 18 years old 2. low gcs (less than 8), altered mental status 3. hemodynamic instability, impending cardiopulmonary arrest 4. use of vasopressors, inotropes 5. exacerbation of asthma or chronic respiratory failure 6. urgent need for endotracheal intubation 7. absence of airway protective gag reflex 8. elevated intracranial pressure 9. tracheostomy 10. pregnant 11. upper airway obstruction 12. injuries or surgery to head and neck less than 6 months upon presentation 13. claustrophobia 14. blind or poor vision 15. medico-legal related cases

Keywords: non invasive ventilation pulmonary edema high flow nasal cannula helmet cpap respiratory failure hyperaemia
chitosan phonophresis on cervical in smartphone addicted users

Conditions: Cervical Pain

Summary: a phonophoresis-based drug delivery system is a synchronous approach to improve local drug penetration in neuromuscular diseases associated with neuronal damage, excruciating pain, and local inflammation. chitosan, a semi-synthetic material, is obtained by partial deacetylation of chitin amines, resulting in copolymers of n-acetylglucosamine and n-glucosamine. its use has been explored in various biomaterial and medical applications. chitosan has emerged as a cost-effective, biocompatible, and biodegradable material with many desirable biological properties, improvement of homeostasis and antiviral potential. chitosan was found to suppress pro-inflammatory cytokines and decreased peripheral nerve edema, the polycationic nature of chitosan allows it to absorb protons, which reduces inflammation and provides an analgesic effect.

the patients will randomly be divided into two equal groups; the control group which will receive the selected exercise program and the study group will receive the same exercise training program in addition to chitosan phonophresis, three times per week for four weeks.

Eligibility criteria:
inclusion criteria: * their age will be ranged from 16-18 years * body mass index will be 26.58 kg/m2. * used a smart phone for more than 1 year for at least 2 hours per day * complaining of neck pain after using a smart phone, addiction to smart phone in accordance with the smart phone addiction scale (sas) exclusion criteria: * any previous head and neck injuries or surgeries * any congenital abnormalities or symptomatic deformity in either the cervical or the lumbar spine * any uncorrected visual or auditory problems, dizziness, vertigo and headache * any systematic diseases, any addiction to alcohol, any additive drugs and sedatives within 48 hours previous to tests * body mass index of subjects over25 kg/m2.
orall administered probiotics to improve the quality of the vaginal flora of women with breast cancer and chemotherapy.

Conditions: Breast Cancer

Summary: the aim of this study is the improvement of the vaginal flora by at least two grades of the nugent scale after application of oral probiotics.

the aim of this study is the improvement of the vaginal flora by at least two grades of the nugent scale. improvement of nugent scores should be considered the primary end point of the study. the outcome of the study would be considered positive if significantly more women in the verum cohort achieve such improvement than in the placebo cohort.

Eligibility criteria:
inclusion criteria: only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks postoperative, without vaginal bleeding without abnormal vaginal discharge, only women with nugent scores between 4 and 6 exclusion criteria: patients with diarrhoea, constipation, vaginal or urinary tract infection requiring antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.

Keywords: chemotherapy vaginal flora
evaluation of levemir® for the treatment of type 1 and 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using levemir® under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * type 2 diabetes * candidates of use of a basal insulin as part of their diabetes regimen exclusion criteria: * unwilling to adhere to therapy or follow up * pregnancy
vitamin d and cardiovascular events in rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Cardiovascular Disease

Summary: the aim of the study is to evaluate cardiovascular events during long-term follow-up in rheumatoid arthritis. the primary outcome "any cardiovascular event" will be evaluated using systematic audits of patient records, and will be associated to low levels of vitamin d at baseline, to investigate the hypothesis that low levels of vitamin d can be part of a prediction model for cardiovascular disease in rheumatoid arthritis.

cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (ra), and among these patients, the prevalence of hypo-vitaminosis d is high. low levels of vitamin d have been associated with elevated cardiovascular risk in healthy subjects. the objective of this study is to evaluate the risk of cardiovascular events in patients having low 25ohd-total levels at baseline compared to patients with sufficient levels, in an aggressively treated closed cohort of early-diagnosed ra patients. the primary outcome will be the proportion of patients with any cardiovascular event, evaluated using systematic journal audits. logistic regression models will be applied to test the hypothesis that there are more cardiovascular events in patients enrolled with a low level of vitamin d (\< 50 nmol/l). secondarily, cox regression models, based on survival analysis, will be applied, to determine the extent to which independent variables (including different levels of vitamin d at baseline) predict not only whether a cardiovascular event occur, but also when it will occur.

Eligibility criteria:
inclusion criteria: fulfilling acr1987 (american college of rheumatology 1987 classification criteria for rheumatoid arthritis) criteria for ra, disease duration \< 6 months, 2 or more swollen joints and age between 18 and 75 years - exclusion criteria: glucocorticoid treatment 4 weeks prior to inclusion, previous use of dmards, malignancy, diastolic blood pressure \> 90 mm hg, elevated serum creatinine, infections with parvovirus b19, hepatitis b, c and hiv, and any condition contraindicating the study medication. -

Keywords: rheumatoid arthritis cardiovascular event cardiovascular mortality vitamin d
bay86-5046 (betaseron), non interventional studies

Conditions: Multiple Sclerosis

Summary: this study aims to investigate adherence to therapy among patients treated with betaferon who are using the betaconnect autoinjector.


Eligibility criteria:
inclusion criteria: * patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome. * patients must be on treatment with betaferon or the decision to treat patients with betaferon has been made by the attending physician. * patient and attending physicians must have agreed on the usage of the betaconnect auto-injector device * written informed consent must be obtained. exclusion criteria: * patients receiving any other disease modifying drug. * contraindications of betaferon described in the summary of product characteristics.

Keywords: rrms cis
a research study looking into blood and urine levels of the medicine nnc0194-0499 in the body and how well it is tolerated in participants with reduced kidney function and normal kidney function

Conditions: Non-alcoholic Steatohepatitis (NASH)

Summary: novo nordisk is developing the study medicine nnc0194-0499 for the treatment of non-alcoholic steatohepatitis (nash). nash is a serious disease where fat, inflammation and scar tissue builds up in the liver. in this study the blood and urine levels of nnc0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) nnc0194-0499. participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). the study will last for about 66 days including a screening phase of up to 28 days prior to dosing.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-80 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 18.5-39.9 kilogram per meter square (kg/m2) (both inclusive). * meeting the pre-defined estimated glomerular filtration rate (egfr) values based on the chronic kidney disease epidemiology collaboration (ckd-epi) equation according to kidney disease: improving global outcomes (kdigo) 20121, 2 standardized to the individual body surface area (bsa). group description egfr (ml/min) 1. normal renal function greater than or equal to 90 2. mild renal impairment 60 - 89 3. moderate renal impairment 30 - 59 4. severe renal impairment 15 - 29 not requiring dialysis 5. end-stage renal disease (esrd) less than 15 or requiring dialysis treatment renal group 5 (esrd). * participants requiring dialysis treatment should be on treatment with haemodialysis. exclusion criteria: * any disorder, except for conditions associated with renal impairment, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening. use of the following are allowed: routine vitamins, occasional use of paracetamol, ibuprofen and topical medication not reaching systemic circulation. * use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (imp). * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or esrd).
rosuvastatin versus atorvastatin in the treatment of hypercholesterolaemia in african american subjects(aries)

Conditions: Hypercholesterolemia; Dyslipidaemia

Summary: the purpose of this study is to compare the effect of 6 weeks of treatment with rosuvastatin with 6 weeks of treatment with atorvastatin in african american subjects with hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * fasting low density lipoprotein level as defined by the protocol. * self described african american race * fasting triglyceride level as defined by the protocol. exclusion criteria: * the use of lipid lowering drugs or dietary supplements after visit 1. * active arterial disease eg unstable angina, or recent arterial surgery * blood lipid levels above the limits defined in the protocol. * uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Keywords: cholesterol low density lipoproteins dyslipidaemia rosuvastatin crestor atorvastatin lipitor african american
tele-group cognitive behavioural family intervention (tgcbfi) for people with schizophrenia and their families

Conditions: Schizophrenia; Psychosis

Summary: this mixed-method study aims to examine the feasibility of delivering tgcbfi programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgcbfi in reducing expressed emotion. the research questions are as follows. 1. what are the feasibility, acceptability, and safety of conducting a tele-group cbfi programme for people with schizophrenia and their family caregivers? 2. what effect does tgcbfi have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme? 3. what effect does tgcbfi have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?


Eligibility criteria:
inclusion criteria: service users * diagnosis of schizophrenia-spectrum disorders, based on icd-10 made by the treating clinicians * aged 18 to 64 * able to communicate in cantonese family caregivers * aged 18 or above * able to communicate in cantonese * live with service users exclusion criteria: service users * have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder * live in hostel family caregivers -have active psychiatric conditions