Kornimate/medical-research-clean huggingface dataset:
virtual reality (vr) treatment for balance problems in traumatic brain injury (tbi)

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to evaluate the effectivenes of a home-based physical therapy program designed to improve balance following traumatic brain injury by incorporating the use of a virtual reality system.


Eligibility criteria:
inclusion criteria: * has sustained a documented tbi that required an inpatient rehabilitation program; * is at least one year post tbi; * is at least 18 and no more than 64 years of age at the time of enrollment; * is english or spanish speaking * is at least three months beyond completion of formal pt, including acute inpatient rehabilitation, outpatient and home-based therapy; * provides written medical clearance for participation in an in-home balance exercise program; * ambulates independently within the home (with assistive devices and/or orthotics as needed); * has active range of motion of bilateral upper extremities of at least 90 degrees of abduction to allow for control of the vr system; * completes a 15 minute trial using a vr system in the absence of a negative physical or behavioral reaction; * self-reports ongoing balance deficits and demonstrate such deficits by scoring at or below one standard deviation above the mean (75 or below) on the cb\&m; and * provides informed consent, or has a guardian available to provide consent. exclusion criteria: * has a history of another medical illness or neurological disorder which may affect balance; * has experienced a seizure within the last year; * has a history of psychiatric disorder requiring hospitalization; * is currently participating in another rct; * is currently using vr technology to address specific balance goals; * is unable to travel to craig for assessments throughout the study period; * is unable to communicate effectively to complete standardized assessments; * has cognitive impairment that precludes completion of baseline testing; * is unavailable to participate in 12 continuous weeks of therapy; * has no access to television able to connect to vr-gaming system; and * reports inadequate space required for vr-gaming system sensors.

Keywords: traumatic brain injury balance deficits virtual reality home-based therapy
igy efficacy on periodontitis patients

Conditions: Chronic Periodontitis

Summary: patients visiting national hospital of odonto-stomatology for treating periodontitis used a food supplement (lozenge) containing chicken egg antibody (igy) against porphyromonas gingivalis gingipains as an adjunct to conventional scaling and root planing (srp). after 8 weeks the patients were examined against. parameters including probing depth (pd), bleeding on probing (bop), number of p. gingivalis in periodontal pockets were evaluated and compared to the control group that had used placebo lozenges.


Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic periodontitis * had at least 2 interproximal site with pocket depth between 3 mm to 5 mm * nonsmokers with at least 20 natural teeth * bone loss and bleeding on probing * had not undergone periodontal treatments within 6 weeks before the study exclusion criteria: * patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months * had allergy to egg proteins

Keywords: igy periodontitis porphyromonas gingivalis gingipains efficacy
bgb-15025 alone and in combination with anti-pd-1 monoclonal antibody tislelizumab in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the primary objective of this study is to assess the safety and tolerability of bgb-15025 alone and in combination with tislelizumab; and to determine the maximum tolerated dose (mtd) or maximum administered dose (mad) and recommended phase 2 doses (rp2d) of bgb-15025 alone and in combination with tislelizumab in participants with advanced solid tumors.


Eligibility criteria:
key inclusion criteria: 1. phase 1a (dose escalation): participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused, and who have not received prior therapy targeting hpk1 2. phase 1b (dose expansion): participant with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors, including non-small cell lung cancer, esophageal cancer or gastric/gastroesophageal junction cancer (other solid tumors may be included) who have progressed following systemic anticancer therapies or have no prior systemic treatment for advanced disease 3. at least 1 measurable lesion as defined per recist 1.1. 4. eastern cooperative oncology group (ecog) performance status ≤ 1 5. adequate organ function as indicated by the following laboratory values up to first dose of study treatment: hemoglobin≥ 90 g/l, absolute neutrophil count ≥ 1.5 x 109/l , serum total bilirubin ≤ 1.5 x uln (\< 3 x uln for participants with gilbert syndrome ), ast and alt≤ 2.5 x uln key exclusion criteria: 1. active leptomeningeal disease or uncontrolled and untreated brain metastasis. 2. active autoimmune diseases or history of autoimmune diseases that may relapse 3. any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent 4. any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment 5. history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc. note: other protocol defined inclusion/exclusion criteria may apply.
the effect of a prolonged peripheral nerve block on the level of pain after a knee replacement

Conditions: Knee Replacement Surgery

Summary: the aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery

knee replacement surgery is one of the common orthopedic surgeries for the treatment of chronic knee pain. the period after knee replacement surgery is accompanied by moderate to severe pain that affects the patient's ability to quickly return to function. peripheral nerve blockers and analgesia of different types, administered as part of the anesthesia process, are optimal in controlling pain after surgery. after the surgery, the patients are admitted in the orthopedic inpatient department for 2-3 days on average after surgery for follow-up and early physical therapy necessary to achieve good results and return the patient to full function as soon as possible. the level of pain greatly affects the success rate of the patient's rehabilitation. thus, since the duration of peripheral nerve block activity does not exceed 8-16 hours on average, it is suggested to treat the patients with a prolonged peripheral nerve block (utilizing continuous adductor canal block) for 24 hours after surgery.

Eligibility criteria:
inclusion criteria: * female and male patients between the ages of 18 and 80 who have signed an informed consent form. * asa is less than 3 * spinal anesthesia exclusion criteria: * patients with sensitivity to the anesthetic.
an exploratory study of high-dose glivec in patients with cml-cp using molecular endpoints

Conditions: CML; Imatinib

Summary: this study is locally amended study from csti571k2301 to evaluate the efficacy and safety of high-dose glivec in korean patients group with chronic phase of cml. molecular response at 60 months after glivec administration will be described.


Eligibility criteria:
inclusion criteria: 1. tops(csti571k2301) participant patients who are taking glivec more than 400 mg daily as 30 july, 2010, the close date of tops 2. patients who provided written informed consent prior to participation to this study
pharmacokinetics and dynamics of nebulized dexmedetomidine

Conditions: Abdominal Cancer

Summary: the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.

inhalation of nebulized drug is an alternative route of administration that is relatively easy to set up, does not require venpuncture, but is associated with high bioavailability of the administered drug. information on the pharmacokinetics of dexmedetomidine in the pediatric population is very limited, especially in children. to the best of investigators knowledge, there are no published reports on the pharmacokinetics of nebulized dexmedetomidine in children.

Eligibility criteria:
inclusion criteria: * child aged 2-7 years * asa i or ii * scheduled for abdominal surgery * with average weight, height, normal serum albumin exclusion criteria: * patients with allergy to the study drug * patients with significant organ dysfunction * patients with cardiac arrhythmia * patients with congenital heart disease * use of psychotropic medication and mental retardation.

Keywords: pharmacokinitics nebulized dexmedetomidine preschool children
use of ultrasound for early identification of patients at risk of swallowing disorders acquired in the icu

Conditions: Patient Under Mechanical Ventilation

Summary: swallowing disorders (sd) are particularly common after extubation in the icu and may be associated with an increased risk of lung disease, increased length of hospital stay, and a higher risk of early reintubation. in contrast, early detection of sds has been shown to be associated with a decrease in these complications. thus, there is a need for rapid and reliable assessment of sds in icu patients before the withdrawal of mechanical ventilation. videofluoroscopy (vfs) and nasofibroscopy (nf) are the gold standard examinations for diagnosing sd. however, these two examinations are not feasible in intubated patients. in this context, ultrasound appears to be a promising alternative to identify patients at risk of sd after extubation. this examination can be performed at the intubated patient's bedside and can be used evaluate the mobility of the structures involved in swallowing. many studies have already shown the interest of ultrasound in the evaluation of sd but none has focused on intubated patients under respiratory assistance. the objective of the present study is to evaluate the value of ultrasound in identifying patients at risk of presenting sd after extubation. this monocentric study will take place in the intensive care unit (icu) of the dijon university hospital. the duration of participation in this research will be equal to the length of stay in the icu. during their stay, patients will undergo ultrasound and nasofibroscopy. information on the characteristics of the icu stay will be collected at discharge.


Eligibility criteria:
inclusion criteria: patient: * major * on mechanical ventilation for at least 48 hours * affiliated to national health insurance exclusion criteria: patient: * under legal protection (curatorship, guardianship, safeguard of justice) * pregnant, parturient or breastfeeding woman * refusal to participate by the patient or their proxy (or an immediate family member) * cognitive disorders incompatible with the understanding of instructions * previously diagnosed swallowing disorders * with a neurological condition at the origin of the sd (stroke, als...) * treated for a lesion of the aerodigestive tract (by surgery, radiotherapy or radio-chemotherapy) * presence of wounds or dressings on the areas to be evaluated that prevent ultrasound measurements * patient for whom a decision to limit or stop life support treatments has been taken collegially within the intensive care unit * with one or more contraindications to performing nf: * anatomical features not compatible with nf: mainly deviation of the nasal septum. * risk of significant otorhinolaryngological bleeding
study of efficacy and safety of gr1501 in patients with radiographic axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: the purpose of this trial is to demonstrate the clinical efficacy of gr1501 at week 16; and to demonstrate safety and tolerability of gr1501 compared to placebo in patients with radiographic axial spondyloarthritis at week 16 and long term safety up to week 48。 the main question it aims to answer is whether gr1501 injection was superior to placebo in the proportion of subjects with asas20 response at week 16 in patients with radiographic axial spondyloarthritis.

this is a randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of gr1501 injection in radiographic axial spondyloarthritis, as well as a confirmatory clinical trial of immunogenicity. this clinical trial was divided into four stages, namely screening period (w-4\~w0), core treatment period (w0\~w16), maintenance treatment period (w16\~w32), and follow-up period (w32\~w48). target population： radiographic axial spondyloarthritis who had a inadequate response to nsaids or have a history of intolerance to nsaids. primary outcome measure:percentage of participants achieving an asas20 response in week 16.

Eligibility criteria:
inclusion criteria: * diagnosis of radiographic axial spondyloarthritis (r-xspa) with sacroiliitis defined radiographically according to the modified new york criteria. * inadequate response, contraindications or intolerance to nsaids exclusion criteria: * total ankylosis of the spine * ongoing or serious infection * either a current diagnosis or a recent history of malignant disease * are pregnant or breastfeeding

Keywords: il-17a autoimmune disease
aflibercept in combination with docetaxel in metastatic androgen independent prostate cancer

Conditions: Prostatic Neoplasms; Neoplasm Metastasis

Summary: primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (maipc). the secondary objectives were: * to assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (psa) level, cancer related pain, progression free survival (pfs), tumor-based and skeletal events and health-related quality of life (hrql); * to assess the overall safety in both treatment arms; * to determine the pharmacokinetics of intravenous (iv) aflibercept in this population; * to determine immunogenicity of iv aflibercept.

the study consisted in 3-week treatment cycles until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. after disease progression, participants were to be followed every 3 months until death or the study cutoff date, whichever came first. the study cut-off date was event-driven and was defined as the date when 873 deaths had occurred.

Eligibility criteria:
inclusion criteria: * histologically- or cytologically-confirmed prostate adenocarcinoma; * metastatic disease; * progressive disease while receiving hormonal therapy or after surgical castration; * effective castration. exclusion criteria: * prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed \>3 years ago; * prior treatment with vascular endothelial growth factor (vegf) inhibitors or vegf receptor inhibitors; * eastern cooperative oncology group (ecog) performance status \>2. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: metastatic prostate cancer
educational materials for hiccups

Conditions: Hiccup

Summary: this is a research study about hiccup educational materials. the purpose of this study is to learn whether this type of research can be done.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age. * hiccups in the 4 weeks prior to phone contact (patient must confirm). * able to speak and read english. * has an e-mail address. exclusion criteria: - individuals \< 18 years of age.
the effect of plant sterols on the blood lipid profile of subjects with and at high risk of type 2 diabetes mellitus

Conditions: Vascular Diseases; Hypercholesterolemia; Diabetes Mellitus

Summary: double-blind, randomised, placebo-controlled, parallel group study with two intervention arms. the study will be conducted in 150 subjects and the primary objective is to show a fasting ldl-cholesterol and triglyceride lowering effect of plant sterols in subjects with established type 2 diabetes mellitus and subjects at high risk of developing type 2 diabetes.

the main aim of the study is to investigate the effect of plant sterols on fasting triglycerides and ldl-cholesterol concentrations. this study also aims to study the effect of plant sterols on fasting total cholesterol, hdl-cholesterol concentrations and lipoprotein (a). furthermore the effects of plant sterols on fasting blood glucose and insulin will be explored. at last, in a sub-group, at end of intervention the acute, chronic and acute upon chronic effect of plant sterols on postprandial blood lipids, glucose and insulin responses during a mixed meal challenge rich in fat and carbohydrates will be explored.

Eligibility criteria:
inclusion criteria: * triglycerides \>150 mg/dl or 1.74 mmol/l * ldl-cholesterol: subjects at high risk for developing t2dm: 115-190 mg/dl or 2.95-4.94 mmol/l. subjects with established t2dm that are on statins: 85-190 mg/dl or 2.15-4.94 mmol/l. * hba1c: subjects at high risk for developing t2dm: \<6.50% or ≥ 48 mmol/mol. subjects with established t2dm: ≤ 8.5% or ≤ 69 mmol/mol. * bmi \> 20.0 kg/m2. exclusion criteria: * recently (within 1 year) diagnosed with cardiovascular event(s) (stroke, tia, angina, myocardial infarction, heart failure), systemic inflammatory conditions * use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. ezetimibe, fibrates and niacin), to be judged by the principal investigator. * currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.

Keywords: plant sterols blood lipids
benign prostatic hyperplasia (bph) mobile application pilot study

Conditions: Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: this study assesses the feasibility, and acceptability of a (mobile) application for men presenting at their physician's office with luts/bph; starting with medical therapy and naïve for treatment. patients will be enrolled in the study by their physician (gp or urologist). the patients will receive a daily medication reminder including frequent feedback on medication adherence. furthermore, standard questionnaires will be filled out via the application. the hypothesis of this pilot study is that application is feasible and accepted in this group of patients.

rationale: one of the next developments in healthcare is digitalization, including (mobile) applications that could support healthcare providers. a significant number of aging men suffer from lower urinary tract symptoms (luts), often caused by benign prostate hyperplasia (bph). luts/bph is primarily treated by physicians (gps or urologists). optimal evaluation of patients with luts/bph, treatment selection and follow-up by the physicians and medication adherence are essential in the management of luts. this pilot project represents a strong collaboration between a urological association, urologists, and physicians in supporting healthcare improvement for luts/bph with the use of a (mobile) application. the hypothesis is that the (mobile) application can support the patient in medication adherence and improve the adherence by feedback and that the application can help to collect objective disease information with electronic questionnaires. objectives: the primary objective is to assess the feasibility, and acceptability of a (mobile) application for men presenting at their general practitioner/or urologist with luts/bph who are either: under treatment, or who may require medical therapy for the first time. the secondary objectives are to identify potential gaps, clarify controversial points of the application, to document the communication between patients, physicians and supervising urologists in order to optimize (if necessary) the application, to assess medication adherence and to record if treatment provided by physicians is in compliance with the guidelines recommendations.

Eligibility criteria:
inclusion criteria: * male * age ≥ 40 * bothersome luts * start of medical therapy for luts * either: 1. no previous luts/bph treatment (medical or invasive), or 2. under medical treatment * in possession of a smartphone, tablet or computer with internet connection * access to email * fluent speaking and reading of the national language * signed informed consent exclusion criteria: * previous luts/bph treatment with surgery * previous pelvic surgery or radiotherapy * history of neurological disease * history of bladder or prostate cancer * unable to provide informed consent * analphabet * unable to operate a smartphone/ tablet/computer * incapable of understanding the language in which the information for the patient is given

Keywords: smartphone application pilot mhealth