Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of multisensory stimulation virtual reality for stroke patients.

Conditions: Stroke

Summary: this was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.

this was single-blind randomized controlled intervention study. each stroke subject underwent screening period, baseline assessment period, intervention period, endpoint assessment period. the screening period include the verification of inclusion/exclusion criteria and the acquisition of informed consent. baseline and endpoint assessment period include motor function related scales were evaluated (muscle strength, muscle tone, fugl-meyer scale, berg balance scale); cognitive function related scale assessment \[brief mental state examination scale (mmse), montreal cognitive assessment (moca), drawing clock test, shape connection test a.b, standardized digital modal experiment, auditory word learning test\], emotional correlation scale assessment (hamilton depression scale, hamilton anxiety scale), and activity of daily living scale adl scale. meanwhile, quantitative evaluation of motor function three-dimensional gait detection and assessment of brain functional activation (fnirs tests and fmri) were synchronously completed. the intervention period included multi-sensory stimulation immersive vr+ treadmill training with suitable for training intensity in the experimental group and only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions). preliminary validation of effectiveness assessment includes fugl-meyer scale, berg balance scale, and three-dimensional gait detection. preliminary validation of the safety assessment includes fall and dizzy incidents.

Eligibility criteria:
inclusion criteria: 1. diagnosis of stroke by neuroimaging (ct or mri) assessment 2. 18-85 years old 3. be able to walk with minor assistance 4. can tolerate the rehabilitation training of this experiment 5. first stroke 6. be able to follow instructions to complete the test 7. patients who signed informed consent exclusion criteria: 1. the test could not be tolerated due to organic disease 2. there is a serious mental illness resulting in inability to cooperate with or tolerate this test 3. is participating in another clinical trial involving an investigational drug or physical therapy 4. patients who have not signed informed consent
effect of tnf-inhibition combined with conventional dmards on cervical pannus in patients with ra and cervical spine involvement

Conditions: Rheumatoid Arthritis

Summary: atlantoaxial subluxation (aas) is a complication of rheumatoid arthritis (ra) due to pannus formation around the odontoid process of c2 of the cervical spine. it occurs frequently in 15-30% of all ra patients. aas may occur relatively early in the course of disease within the first years. the diagnosis of aas identifies a patient population with a poor outcome. there is evidence that combination treatment with disease-modifying anti-rheumatic drugs (dmard) may retard the development of aas. however, it is not known whether treatment with inhibitors of tumor necrosis factor alpha (tnf) may lead to regression of cervical pannus and prevention or reduction of aas. clinical studies analysing the effectiveness of tnf-inhibitors combined with conventional dmard therapy, in the treatment of cervical spine involvement leading to aas, are needed. this proposal for a pilot study aims at assessing the feasibility of an mri-based measurement of pannus volume in patients before and after treatment with a tnf-inhibitor. primary objective: to show that measurements of pannus mass with mri is feasible. secondary objective: to assess whether pannus mass decreases measurably in patients treated with tnf-inhibitors. this pilot study is prospective, non-randomized. the choice of therapy at any time during the study is entirely up to the treating rheumatologist.


Eligibility criteria:
inclusion criteria: * ra fulfilling the criteria of the american college of rheumatology (acr) (revised 1987) * 18 years and older * cervical pain * recent mri with detectable atlanto-axial pannus exclusion criteria: * use of tnf-inhibitors 3 months prior to inclusion * previous treatment with any biologics other than tnf-blockers * history of inflammatory joint disease other than ra * history of active tuberculosis, histoplasmosis or listeriosis * history of lymphoma or other malignancies within 5 years * contraindication for the use of tnf inhibitors * comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial * history of demyelinating disorders * persistent or recurrent infections * pregnancy or breast feeding
vocs vs fit for colorectal cancer screening

Conditions: Colorectal Cancer; Colorectal Polyp

Summary: endogenous breath vocs (volatile organic compounds) are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening. some of these vocs are reversed in the venous blood stream and reach the lung alveoli where some of them are exhaled. colorectal cancer (crc) is one of the commonest tumours and is an important cause of cancer-related mortality. colonoscopy is the gold standard for the diagnosis of crc. screening with fecal immunochemical test (fit) is associated with a 13-18% crc-mortality reduction. aim of the study to compare the reliability of this breath analysis with immunochemically-based fecal occult blood test.

volatile organic compounds (vocs) are low molecular weight (\<1 kda) compounds which represent the final products of cell metabolism. their composition can be affected by several factors including diet, hormones, environment and the presence of diseases, in particular, cancer. endogenous breath vocs are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening. some of these vocs are reversed in the venous blood stream and reach the lung alveoli where some of them are exhaled. colorectal cancer (crc) is one of the commonest tumours and is an important cause of cancer-related mortality. colonoscopy is the gold standard for the diagnosis of crc, although its cost prevents its use for mass screening. furthermore colonoscopy is not well accepted by patients since it is an invasive exam. screening with fecal immunochemical test (fit) is associated with a 13-18% crc-mortality reduction in major randomized studies and is the most widely used non-invasive screening tool, showing fairly good specificity but a high variation in sensitivity (61-91%) and adherence to screening programmes rarely reaches 50-70% of the target population. recently the breath analysis has been demonstrated to be a new well accepted and non-invasive tool to detect colorectal cancer. the purpose of this trial is to compare the reliability of this breath analysis with immunochemically-based fecal occult blood test, which is the routinely employed tool for mass screening. a group of subjects adherent to the regional screening program for colorectal cancer prevention, who resulted positive to the fit, will be enrolled in this study, and will have a breath sampling before undergoing colonoscopy. the predictive ability of the breath test will be tested in a blind fashion in this selected group of high-risk subjects.

Eligibility criteria:
inclusion criteria: * patients with and without positive fit with a planned colonoscopy * patients included in the regional screening program for crc * written informed consent exclusion criteria: * pregnancy * inflammatory bowel disease * bowel prep * any psychiatric disease * previous (or still present) cancers in other organs
long-term use of mifepristone in the treatment of adenomyosis

Conditions: Adenomyosis; Mifepristone

Summary: the design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. the study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) , the subjects were randomly assigned to the following two groups: 1. study group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of menstruation) for 24 weeks; 2. control group: dafinil (triptorelin acetate) , 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.


Eligibility criteria:
inclusion criteria. * female, over 18 years old and not menopausal, agree to tripriline acetate and mifepristone treatment and informed consent * patients were diagnosed as adenomyosis by postoperative pathology, or those who did not undergo surgery but were diagnosed by auxiliary examination, such as ultrasonography and mri. * dysmenorrhea with or without menorrhagia * requiring preservation of the uterus or fertility * no other hormonal treatment for adenomyosis was received in the three months prior to treatment * normal or non-clinically significant cervical cytology results (6 months before the screening period) exclusion criteria. * pelvic pain and vaginal bleeding of unknown or non-adenomyosis causes * benign lesions such as endometrial polyp, submucous myoma or suspicious malignant tumors were diagnosed by ultrasonography * receiving other hormone drugs for adenomyosis * use other drugs that interact with tripriline acetate and mifepristone, and can not be stopped * patients with severe heart, liver, kidney disease and adrenal insufficiency; drug allergy or allergic constitution * participated in other clinical trials within 3 months, and other factors considered unsuitable for the trial * pregnant, lactating women and those who prepare for childbirth during the treatment or within six months after treatment * postmenopausal women.
combination 5-azacitidine and gemtuzumab ozogamicin therapy for treatment of relapsed acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: this study will test an experimental combination of the drugs mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against acute myeloid leukemia that has come back after treatment.

in the phase i portion of the study patients with a diagnosis of aml who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by mylotarg administered two times over two weeks in the phase ii portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the phase i portion of the study followed by mylotarg. a sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before mylotarg and the samples will be tested in the laboratory to determine response to treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsed aml * eastern cooperative oncology group (ecog) performance status 0-2, and life expectancy \> 3 months * ≥ 18 years old * previously untreated for current aml relapse * adequate organ function * written informed consent exclusion criteria: * pregnant or breast-feeding women * growth factors that support platelet or white cell number or function must not have been administered within the past 7 days * currently receiving another investigational drug * currently receiving other anti-cancer agents * uncontrolled infection * hiv positive * received previous therapy with either mylotarg or 5-azacitidine

Keywords: aml
follow-up trial to evaluate long-term safety and efficacy of brivaracetam in subjects suffering from epilepsy

Conditions: Epilepsy

Summary: this trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. the study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (pos)/primary generalized seizures (pgs).


Eligibility criteria:
inclusion criteria: * male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study * subjects with pos/pgs: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study * subjects with uld: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study * subjects for whom the investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected exclusion criteria: * severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject * poor compliance with visit schedule or medication intake in previous brivaracetam study * participation in any clinical study of another investigational drug or device during the study * pregnant or lactating woman

Keywords: brivaracetam epilepsy long term
a study to evaluate chronic hepatitis c infection in adults with genotype 1b infection

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this study is to evaluate the safety and antiviral activity of abt-450/ritonavir/abt-267 (abt-450/r/abt-267; abt-450 also known as paritaprevir; abt-267 also known as ombitasvir) and abt-333 (also known as dasabuvir) with and without ribavirin (rbv) in patients with chronic hepatitis c virus genotype 1b (hcv gt1b) infection without cirrhosis.

a randomized, double-blind, multicenter study to evaluate the safety and antiviral activity of the combination of abt-450/ritonavir/abt-267 (abt-450/r/abt-267) and abt-333 with and without ribavirin (rbv) in treatment-naïve, noncirrhotic participants with chronic hepatitis c virus genotype 1b (hcv gt1b) infection.

Eligibility criteria:
inclusion criteria: * females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile * chronic hepatitis c, genotype 1b-infection (hcv rna level greater than or equal to 10,000 iu/ml at screening) * subject has never received antiviral treatment for hepatitis c infection * no evidence of liver cirrhosis exclusion criteria: * significant liver disease with any cause other than hcv as the primary cause * positive hepatitis b surface antigen or anti-human immunodeficiency virus antibody * positive screen for drugs or alcohol * significant sensitivity to any drug * use of contraindicated medications within 2 weeks of dosing * abnormal laboratory tests

Keywords: interferon-free hepatitis c genotype 1b chronic hepatitis c hepatitis c virus hepatitis c treatment-naive paritaprevir ombitasvir dasabuvir viekira pak ribavirin
effectiveness of massage of the thoracic region in neck pain

Conditions: Neck Pain

Summary: neck pain is a common disorder in industrialized countries. manual therapy techniques have been commonly used in the treatment of this problem. actually, there is no research work that has evaluated the work well of treatment with soft tissue techniques (massage) applied to the dorsal paravertebral muscle in the management of neck pain. the goal of this study (clinical trial) is to compare the efficacy of a massage protocol performed on the dorsal region in subjects with mechanical neck pain. the researchers will compare: a group that will be treated with a local protocol of cervical manual therapy and therapeutic exercise along with the treatment(massage) of the thoracic region. another group that will be treated only with a local protocol of cervical manual therapy and therapeutic exercise. it is to see if the inclusion of treatment of the thoracic region improves the local intervention in cervical region.


Eligibility criteria:
inclusion criteria: * subjects with neck pain. * pain between 4 and 7 points according to a visual anological scale. * neck pain lasting more than three months exclusion criteria: * subjects who have suffered a whiplash injury. * subjects with neck pain and upper extremity pain. * subjects with a diagnosis of herniated disc. * subjects with fibromyalgia. * subjects with any cancer process.
japanese phase 3 study of aflibercept in neovascular glaucoma patients

Conditions: Glaucoma, Neovascular

Summary: to assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.


Eligibility criteria:
inclusion criteria: * japanese men and women aged 20 years or older, * patients diagnosed as having neovascular glaucoma (nvg) with neovascularization in the anterior segment (both iris and anterior chamber angle), * patients with intraocular pressure (iop) higher than 25 mmhg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization. exclusion criteria: * patients with angle-closure due to conditions other than neovascular glaucoma * patients with a known or suspected ocular or peri-ocular infection, * patients with severe intraocular inflammation in the study eye, * women who are pregnant, suspected of being pregnant or lactating, * patients with known allergy to aflibercept.
mapping the lumbar spine marrow adiposity

Conditions: Marrow Adiposity Lumbar Spine

Summary: the objective of this study is to describe the change in the percentage of fat in the lumbar spine.

the study of the distribution of bone marrow adiposity is little known in subjects who did not have pathology likely to alter the fat content of the vertebrae. or that fat content is potentially a reflection of brittle bones (osteoporosis, for example), and deserves to be known because it can be used to normalize the lipid fraction values with respect to age or from the level (l1 , l2, l3, l4 or l5) of the vertebra being studied.

Eligibility criteria:
inclusion criteria: * consecutive patients who underwent mri of the lumbar spine with sagittal sequencet1, t2 stir and ideal, good quality, in a clinical setting type back pain, spondylitis research, radicular syndrome ... * examinations conducted between 2014 and 2015 on the same equipment * major patient * having formulated their non-opposition exclusion criteria: * previous history of neoplastic disease * vertebral fracture * pathology reaching the vertebral body detectable by mri (disc lesion with rearrangements of the endplates (modic) * inflammation, * bone tumor, * fracture * refusal of participation
diet, exercise, and cardiovascular health among ethnic children

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to analyze data collected over a four year period on an initial cohort of 3 or 4 year old children and their parents in galveston, texas, and in augusta, ga, in regard to cardiovascular disease (cvd) physical risk factors and risk related behaviors.

background: little was known about tracking of cardiovascular disease (cvd) risk factors and risk related behaviors, or about predicting these variables in young children. tracking was an important issue because it reflected the extent to which the disease processes found among adults start in childhood, and whether behavioral or social factors could be used to interrupt that tracking. design narrative: in texas, physical risk factor data were collected at four annual clinics. data on childrens' physical activity and diet were collected for up to four times per year for the three years between the annual measurement clinics. similar data, although with some different measurement techniques, were collected in georgia. for this data analysis, specific longitudinal research questions addressed whether these physical risk factors (blood pressure, lipids, lipoproteins and body composition) and risk related behaviors (diet and physical activity) tracked across the annual assessments, whether a variety of behavioral and social factors (demographic characteristics and family function) affected that tracking, and whether relationships obtained among adults between physical risk factors and these other variables could be found in this age child. the testing of these relationships was enhanced by the availability of multiple assessments of blood pressures and body composition at each point for more reliable assessments, and by multiple assessments of diet and physical activity within each year. it was further enhanced by the availability of observational data on physical activity and diet, which overcame the limitations of the more common self report approach to measurement. models were developed in each data set and cross validated in the other. procedures were employed to determine reasons for differences and to revise the models to produce maximal fit in both data sets. the results of these analyses contributed to a better understanding of at what age, and with what factors, it was most appropriate to intervene to mitigate cvd.

Eligibility criteria:
no eligibility criteria
tpf machine learning algorithms

Conditions: Tibial Plateau Fracture

Summary: to adopt a machine learning technique to decide whether operative or non-operative treatment will result in the best patient-outcome.

the overall goal is to adopt a machine learning technique to decide whether operative or non-operative treatment will result in the best patient-outcome. the primary objectives are to identify the most suitable machine learning algorithm to predict the best treatment for future patients. whether conservative or operative treatment will lead to the best patient outcome, will be decided on the predicted koos score. several input factors, such as treatment (conservative or operative), number of fracture fragments, location of the fracture, soft tissue involvement,...for each patient will be used as training data for the algorithm. some of these input data will be derived from ct-scans. therefore, the ct scans will be segmented in mimics, for which uz leuven recently purchased licenses. the output variable of the training data will be the koos score of each patient. based on the input and output variable, the algorithm will determine a relation between these. for future patients of which the input variable are known, the output variable (=koos score) will be predicted both in case of operative and conservative treatment. we hypothesize that the prediction will be improved by adding more input data over time. to secondary objective is to identify clinical and radiological factors that help predicting the best treatment for future patients. as an outlook, the machine learning technique could be implemented in the future in clinical practice and utilized as a patient-specific planning tool for tibial plateau fracture management by aiding the surgeon to select the best treatment for a given case. the collected data in this registry will be used to validate the machine learning model. patients will not yet be treated based on the results of the developed model, the trauma surgeon is responsible to decide which treatment option is best for the patient.

Eligibility criteria:
inclusion criteria: * age \> 18 years * proximal tibia plateau fracture * patient is able to attend follow-up visits exclusion criteria: * age \< 18 years * bilateral fractures * neurologic disorders (ie paraplegia, cva, dementia etc.) * not understanding dutch or english