Kornimate/medical-research-clean huggingface dataset:
ptcs-based precision treatment strategy on recurrent high-grade gliomas

Conditions: Recurrent High Grade Glioma

Summary: this trial is an open-label, single-arm, phase 0/1 study of high-grade glioma that aims to evaluate the feasibility, preliminary efficacy and safety of the precision treatment strategy.

the investigators have established a precision treatment strategy, that select chemotherapeutic drugs or targeted drugs based on information from ptcs drug-screening or/and bioinformatic prediction. in this study, the investigators are going to exploit this strategy for the precision treatment of recurrent high-grade gliomas. the investigators will evaluate the feasibility, safety and preliminary efficacy via collecting the indexes comprising clinical presentation, results of imaging examination, clinical assays, kps, neurological score, etc.

Eligibility criteria:
inclusion criteria: * 1 at the age of 18\~75, regardless the gender * 2 the lesion of primary surgery was diagnosed as who ii\~iv glioma by histologic pathology * 3 received radiotherapy and temozolomide-based chemotherapy within 5 years * 4 recurrent and respectable gliomas, and have been neurosurgically resected * 5 the resected recurrent gliomas was identified as who iii\~iv glioma by histologic pathology * 6 none postoperative standard therapeutic regimens can be followed when participating the recruitment * 7 can understand the trial's content and sign informed consent exclusion criteria: * 1 having other untreated malignant tumors * 2 the amount of resected tumors is not enough for genomic sequencing or ptcs drug screening * 3 received carmustine implants within 6 months prior to enrollment * 4 subjects with active hbc, hcv or hiv infection * 5 subjects with uncontrolled cardio- or cerebro- vascular diseases * 6 subjects with uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes * 7 subjects with other conditions in their active phase that would interfere trial participation * 8 subjects receiving immunosuppressants after organ transplantation * 9 subjects with unstable pulmonary embolism, deep venous embolism, or other major arterial and venous thromboembolic events that occur within 30 days before the enrollment, or receiving anticoagulant therapy * 10 subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment * 11 subjects with other conditions that would interfere participating in the trial at the investigator's discretion * 12 subjects with medical conditions that affect signing the written informed consent or complying with the research procedures; or patients who are unwilling or unable to comply with the research procedures

Keywords: precision medicine organoid-based drug screening bioinformatic prediction for drug response
high blood pressure and sleep apnea in diabetic macular edema

Conditions: Diabetic Retinopathy

Summary: macular edema remains a major cause of vision impairment in diabetic patients. its pathogenesis is multifactorial and incompletely understood. systemic factors seam to play a role in this pathogenesis, including high blood pressure. the objective of the study is to evaluate the effect of an intensified intervention on blood pressure and sleep apnea with that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.

patients with type 2 diabetes and macular edema involving the center of the macula in both eyes will be randomly assigned to receive conventional treatment in accordance with national guidelines or to receive intensive treatment, with a systematic screening for sleep apnea and /or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected. the primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year. secondary outcomes will be the percentage of patients having a 2 etdrs lines or more-increase in visual acuity at one year, number of ocular interventions in each group, prevalence of sleep apnea and uncontrolled high blood pressure in the intervention group.

Eligibility criteria:
inclusion criteria: * patient with type 2 diabetes, aged 18 years or more * bilateral diabetic macular edema involving the center of the macula with central retinal thickness 300 µm or more exclusion criteria: * patient with type 1 diabetes * tractional macular edema * patient with renal insufficiency : clearance of creatinin \< 30 ml/min according to cocroft or mdrd, patient under dialysis * other causes for macular edema (uveitis, epiretinal membrane) * proliferative diabetic retinopathy requiring panretinal photocoagulation at inclusion * cataract surgery or panretinal photocoagulation during the 6 months before inclusion, laser photocoagulation at the posterior pole or intra ocular steroid injection during the 3 months before inclusion * any ocular condition precluding access to the posterior pole, or ocular pathologies not related to diabetes (age related macular degeneration venous occlusion...) * previous vitrectomy in the eyes * pregnant or breast-feeding female

Keywords: diabetic retinopathy macula edema sleep apnea high blood pressure
neoadjuvant triplet chemotherapy regimen in patients with resectable colorectal cancer

Conditions: Colorectal Cancer

Summary: colorectal cancer is an aggressive malignancy with a poor overall outcome. the purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or s-1 or capecitabine in patients with resectable colorectal cancer.

this is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or s-1 or capecitabine in patients with resectable colorectal cancer.fifty patients will be enrolled in this trial. the primary objective of this study is to determine the 3-year disease-free survival of the patients.

Eligibility criteria:
inclusion criteria: * histologically verified colorectal cancer * clinical stage t4n0-2m0、ct1-3n2m0 or m1(liver metastases only) * age: 18-70 years * ecog 0-2 * adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease) * no prior cancer and/or chemotherapy * signed informed consent exclusion criteria: * patients with a history of prior malignancy * pregnant or lactating patients * known or suspected brain metastasis

Keywords: 5-fluorouracil irinotecan oxaliplatin colorectal cancer neoadjuvant chemotherapy
short vs long arm cast for distal radius fractures: the verona trial

Conditions: Radius Fracture Distal

Summary: this study prospectively compares the performance of an above-elbow cast (long arm cast) and a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal radius fractures.

the choice of cast length in conservative management of distal radius fractures still represents a much debated controversy. classic teaching was to immobilize the elbow to reduce risk of secondary displacement; however, short arm casts are felt to be equally effective with less complications and higher patient comfort. there is currently no conclusive evidence for or against immobilization of the elbow in patients treated with cast immobilization.

Eligibility criteria:
inclusion criteria: * diagnosis of distal radius fracture * indication to conservative treatment * need for manipulation to reduce fracture exclusion criteria: * open fractures * existence of any skin lesion or wound that would impair cast treatment * neurovascular deficits * bilateral fractures * association with any other fracture of the homolateral arm

Keywords: cast treatment above-elbow cast below-elbow cast long arm cast short arm cast
an observational study of the safety of topiramate in adults and children with epilepsy

Conditions: Seizures, Epileptic

Summary: the purpose of this observational study is to evaluate the safety of topiramate in adults and children with epilepsy (or seizures) who have not received or have not responded to treatment with previous antiepileptic medication.

topiramate is a medication that is approved for the treatment of seizures. in accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. this is a multi-center, open-label observational safety study to collect information regarding the dosage, tolerability and effectiveness of topiramate in adults and children with epilepsy (or seizures). patients who have not received previous treatment for epilepsy or for whom previous treatment was ineffective or intolerable will receive 6 months of treatment with topiramate. topiramate will be given at low doses initially and gradually increased as needed for each patient to control seizure activity. safety evaluations (incidence of adverse events and laboratory tests) and assessment of patient health status will be performed throughout the study. effectiveness will be evaluated by recording the frequency of seizures occurring during the study. patient and physician satisfaction with topiramate treatment will also be recorded. at the end of the study, the treating physician may continue treatment with topiramate in responding patients as appropriate. the study hypothesis is that topiramate will be effective in achieving and maintaining control of seizure activity and is well-tolerated. observational study - no investigational drug administered.

Eligibility criteria:
inclusion criteria: * patients who have not received previous treatment with antiepileptic medications or patients who did not respond to previous treatment with antiepileptic medications, defined as a lack of effectiveness of the medication(s), or the inability to take the medication(s) due to adverse effects exclusion criteria: * patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor and are manageable * patients with a hypersensitivity to topiramate or to some of its components * patients who should not take topiramate for reasons listed in its approved summary of product characteristics (printed information about a medication that describes its actions, side effects and intended patients) * patients who are uncooperative or for whom obtaining compliance with study visit schedules and procedures and information required by the study would be difficult

Keywords: seizures epilepsy topiramate epilepsy in children
patient preference in blood pressure therapy

Conditions: Arterial Hypertension

Summary: written surveys of patients with high blood pressure are designed to determine how they would likely decide if, in addition to taking medication, they had another option to treat their hypertension. the alternative treatment option is renal sympathetic denervation using catheter ablation. this new treatment method is not yet used in the standard care. currently, studies are being conducted in specific centers to demonstrate the efficacy of this treatment. questionnaires are used to determine the preference of patients for one or the other option of hypertension treatment. so far, there are no findings.


Eligibility criteria:
inclusion criteria: * untreated hypertension * treated hypertension with one or more medications exclusion criteria: * illiteracy

Keywords: hypertension renal denervation preference shared decision making
additional effects of mental imagery along with task oriented training on kinesiophobia in patients with stroke

Conditions: Stroke, Cardiovascular

Summary: the objective of this study to determine the effect of mental imagery and task oriented training on kinesiophobia in stroke patients. and to determine the association of kinesiophobia with gait and balance in stroke patients. patients will be divided into experimental and control group. randomized participants will be allocated into control and experimental group. the experimental group will receive 20 minutes of mi training followed by 25 minutes of tot for a total of 45 minutes, 5 days per week for 6 weeks.

cerebrovascular accident (cva),commonly known as stroke , occurs when blood flow to the brain is disrupted , either by a clot or by rupture in a blood vessel .it can lead to severe neurological damaged or even death. a stroke can cause neurological deficits in various domains of brain areas, include motor, sensory/perceptive, visual, language, intelligence and emotion. motor deficits are one of the most common and disabling consequences of stroke. kinesiophobia is a psychological condition characterized by an excessive, irrational fear of movement and physical activity due to the belief that it will increase pain or worsen a pre medical condition. it can be a common obstacle to rehabilitation and recovery for individuals with various musculoskeletal or neurological conditions, including stroke. mi has been recognized as an effective adjunct therapy to physical rehabilitation for various neurological conditions, including stroke. task-oriented training is a widely adopted approach in stroke rehabilitation, which emphasizes the practice of functional tasks to promote motor skill learning and improve motor function. however the potential benefits of combining mental imagery with task-oriented train-ing have not been fully explored. therefore studying the additional effects of mental imagery along with task-oriented training on kinesiophobia in patients with stroke is important for developing more effective and comprehensive rehabilitation interven-tions for stroke populations.

Eligibility criteria:
inclusion criteria: * hemiplegic stroke patients * age above 45 * both genders * patients having score \>17 on tempa scale of kinesiophobia * patients of score \>21 on berg balance scale exclusion criteria: * • communication deficits and unable to follow instructions * a history of serious or unstable cardiac condition * severe musculoskeletal problem and unable to stand or walk * history of other neurological diseases or unilateral neglect

Keywords: mental imagery, kinesiophobia, task oriented training
study of the tolerability, pharmacokinetics, and pharmacodynamics of ins50589 intravenous infusion in healthy volunteers

Conditions: Cardiovascular Disease

Summary: the objectives of this study are to look at the safety and tolerability of the experimental drug, how people process the drug, how the drug affects people, and to identify a dose or doses to study in subsequent future studies.

the purposes of this trial are to determine if administration of ins50589 intravenous infusion is well tolerated, to determine the pharmacological effects of ins50589 at different doses, and to identify an appropriate dose for later efficacy studies. more specifically, the objectives are to: * evaluate safety and tolerability * evaluate pharmacokinetics of ins50589 and its major metabolite(s) * evaluate effects of ins50589 on platelet function at various dose levels * evaluate potential relationship between plasma concentrations of ins50589 and various pharmacodynamic endpoints * identify one or more dose levels of ins50589 for future studies

Eligibility criteria:
inclusion criteria: * have body mass index (bmi) between 18.5 kg/m2 and 35 kg/m2 and body weight no greater than 120 kg. * if female, must not be pregnant or lactating, and if of childbearing potential or sexually active, must use acceptable method of birth control. exclusion criteria: * have clinically significant acute or chronic disease (e.g., coronary artery disease, diabetes, chronic renal insufficiency, asthma). * have major surgery within eight weeks of dosing. * have overt viral illness within four weeks of dosing. * have tendency or history in family of tendency for bleeding. * have clinically significant abnormalities on clinical laboratory tests (chemistry, hematology, urinalysis). * have taken aspirin or any other non-steroidal anti-inflammatory drug (nsaid) within 10 days prior to admission to study facility. * have ever taken or received any of the following for medical conditions: (antiplatelet compounds including clopidogrel, ticlopidine, dipyridamole, tirofiban, eptifibatide, abciximab, adenosine, and prostacyclin) or (anticoagulants including vitamin k antagonists, thrombin inhibitors, heparins, hirudin or related compounds, argatroban and factor xa inhibitors) * have a clinically significant ecg abnormality.

Keywords: bleeding blood transfusion surgeries
lisdexamfetamine dimesylate (ldx) pilot cognition study to evaluate the utility of a standardized battery of tests in adults with attention-deficit hyperactivity disorder (adhd)

Conditions: Attention-Deficit Hyperactivity Disorder

Summary: to evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with adhd.


Eligibility criteria:
inclusion criteria: 1. subject meets diagnostic and statistical manual of mental disorders fourth edition; text revision (dsm iv tr) criteria for a primary diagnosis of adhd (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews dsm-iv-tr criteria with at least 6 of the 9 subtype criteria met. 2. subject has been previously treated for adhd with an adequate course of amphetamine therapy with no history of intolerance, or lack of efficacy, as determined by the investigator. 3. subject does not have any physical disability (eg. colorblindness, limitations with use of one or both hands, etc) that would interfere with the subject's participation in or performance on any of the neuropsychometric tests. for a number of these tasks speed is a key factor thus subjects cannot have any obvious impediments/impairments in the use of their hands.

Keywords: adhd
extension study of talampanel for amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this will be an open label treatment extension phase in patients with als who have previously participated in the double blind, placebo-controlled als-tal-201 study. this study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of als-tal-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). it will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.


Eligibility criteria:
inclusion criteria: * patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of als-tal-201. * women must be postmenopausal, surgically sterile, or using adequate birth control methods. * patients must be willing and able to give written informed consent prior to performing any open-label study procedures. exclusion criteria: * patients with ecg signs of brugada syndrome and/ or complete or incomplete right bundle branch block * patients using any of the following: * chronic use of lithium carbonate * chronic use of mecasermin (rhigf-1) * chronic use of minocycline * chronic use of more than 600mg/day coenzyme q10 * chronic use of any marketed drug, if its use was not clearly indicated for any underlying medical condition other than als (symptomatic drugs for als and supplements allowed) * patients participating in any other investigational drug study and use of any other investigational drug * patients taking drugs that may interact with talampanel * females who are pregnant or nursing. * females of child-bearing potential who do not practice medically acceptable methods of contraception. * any condition of the patient which the investigator feels may interfere with participation in the study.

Keywords: talampanel open-label study amyotrophic lateral sclerosis
effectiveness of injury prevention guidelines in recreational runners

Conditions: Sports Injury

Summary: the aim of this trial is to investigate the effectiveness of specific training programs on the incidence of injuries in recreational runners. 408 runners between the ages of 18 and 55 years, will be recruited and randomly allocated to either the intervention group or control group. the intervention group will perform the training program twice a week in addition to their regular training. injury data will be collected as the injuries occur and documentation of injury will follow a predetermined definition of injury. participants will submit weekly reports of their running distance, frequency, running-related pain, as well as successful performance of the assigned training program for the intervention groups. the primary outcome is the incidence of injuries in all groups.

injuries and especially overuse injuries within recreational running are a common occurrence with higher incidence rates in novice runners but also in recreational runners training for a specific event. the mechanisms behind overuse injury development are thought to be multifactorial and certain parameters have shown to increase injury risk in recreational runners. the aim of this trial is to target these specific parameters and implement training programs to which recreational runners will adhere for a period of 18 weeks. about 408 male and female recreational runners, aged 18-55 years will be randomly allocated to one either the intervention (int) or control (con).the int group will perform an exercise program containing muscle control and foamrolling exercises in addition to their regular training, twice a week. the con group will continue as per usual with their training. training data will be collected on a weekly basis from all groups and pain and injury information will be submitted by the participants upon occurrence. the primary outcome measure is the number of sustained injuries in both groups. participants will be recruited in december 2018 and the intervention will start in january 2019 for a period of 18 weeks, ending in may 2019. data analyses are anticipated to be completed in september 2019.

Eligibility criteria:
inclusion criteria: * healthy male and female recreational runners with an average weekly running distance of at least 15km. exclusion criteria: * injury to the lower extremities during the past 6 months.

Keywords: running-related injury