Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of levetiracetam versus placebo on levodopa-induced dyskinesias in advanced parkinson's disease

Conditions: Parkinson's Disease

Summary: the study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage parkinson's disease. the patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. efficacy measure is the modified aims.

the leledys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced parkinson's disease. the design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase iv study design. the hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in parkinson's disease. the patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. efficacy measure is the modified aims. main inclusion criteria are: * advanced parkinson's disease (hoehn \& yahr ii-iv) * age of 30 to 80 years * levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability * stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion * written informed consent main exclusion criteria are: * atypical parkinsonian syndromes * treatment with antipsychotics * epilepsia or seizure in the history * deep brain stimulation other than dbs in stn * pregnant or lactating women * severe dementia methods: * primary outcome measure is the modified aims * secondary outcome measures include updrs, safety, patient day record study medication: * levetiracetam (upt to 2000 mg / day) * matched placebo

Eligibility criteria:
inclusion criteria: * advanced parkinson's disease (hoehn \& yahr ii-iv) * age of 30 to 80 years * levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability * stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion * written informed consent exclusion criteria: * atypical parkinsonian syndromes * treatment with antipsychotics * epilepsia or seizure in the history * deep brain stimulation other than dbs in stn * pregnant or lactating women * severe dementia

Keywords: dyskinesias parkinson's disease levetiracetam treatment
a study of jmkx003948 tablets in patients with renal cell carcinoma

Conditions: Renal Cell Carcinoma Metastatic

Summary: this open-label phase 1 study will evaluate the safety, tolerability, pk characteristics and preliminarily efficacy of jmkx003948 tablets in patients with renal cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. has the ability to understand and willingness to sign a written informed consent form. 2. male or female from 18 years of age or older. 3. histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma. 4. has at least one measurable lesion per recist v1.1. 5. has a life expectancy of ≥ 12 weeks. 6. adequate organ function. exclusion criteria: 1. patients with known active cns metastases and/or cancerous meningitis. 2. has received any type of systemic anticancer monoclonal antibodies or other immunosuppressants within 4 weeks prior to the first dose. has received prior chemotherapy, targeted therapy, or other investigational therapy within 2 weeks prior to the first dose. 3. has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy. 4. has impaired heart function,or clinically significant cerebrovascular and cardiovascular disease. 5. subjects with dysphagia or known drug absorption disorders. 6. has a history of any other malignancy within 5 years. 7. has severe oncological complications. 8. is currently participating in other clinical studies. 9. subjects with be unsuitable for participation in the trial evaluated by investigator.
post-operative cognitive function following pelvic floor surgery

Conditions: Pelvic Organ Prolapse

Summary: the aim of this study is to assess cognitive function before and after surgery for pelvic organ prolapse using sensitive tests of various neurocognitive domains.

post operative cognitive dysfunction has been well described as a relatively common phenomenon with potentially long-lasting detrimental effects. however, there are currently limited data exploring the effects of gynecologic surgery on cognitive function. the population of patients treated surgically for pelvic floor disorders is typically older, and therefore at higher baseline risk for cognitive dysfunction. therefore, it is of interest to determine the effects of pelvic floor surgery and anesthesia on this patient population. the investigators plan to conduct a prospective cohort study to assess cognitive function before and after pelvic organ prolapse surgery using sensitive tests of memory and other neurocognitive domains. participants will be women undergoing surgery for pelvic organ prolapse. all participants will undergo cognitive tests at three time points: at their pre-operative clinic appointment, in the hospital the morning after surgery, and at their post-operative clinic appointment. in addition to the neurocognitive tests, patients will undergo a series of questionnaires regarding physical function, frailty, sleep quality, and incontinence symptoms.

Eligibility criteria:
inclusion criteria: women 60 years of age or older who are scheduled to undergo surgery for pelvic organ prolapse. exclusion criteria: * women who have a known baseline diagnosis of cognitive dysfunction or central nervous disorder * a mini-mental state exam (mmse) score of greater than 24 * non-english speaking * any severe visual or auditory disorder * alcoholism or drug dependence
phase ii trial of dose-dense paclitaxel and cisplatin as neo-adjuvant chemotherapy for operable stage ii and iia nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: a single arm, open-label phase ii is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.

this is an open-label, single-arm phase ii study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage ii, iia nsclc. paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on day 1 of each 14-day cycle. cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines. pegfilgrastim (neulasta) fixed dose of 6mg (0.6ml of a 10mg/ml solution) as a single subcutaneous injection on day 2 of each study cycle. all drugs will be given in 2-weekly cycle. three cycles of pre-operative chemotherapy are planned.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of nsclc * presence of clinical stage iia,iib or iia disease * tumor amenable to curative surgical resection * patients with clinically measurable lesions will be enrolled in this study. * no prior tumor therapy * performance status of 0-1 on ecog scale * patients compliance and geographic proximity that allow adequate follow-up. * medical fitness of patient, including respiratory function, adequate for radical nsclc surgery. exclusion criteria: * presence of clinical stage iiia disease, according to the revision by mountain cf of american joint committee on cancer. * treatment within the last 30 days with any investigational drug. * cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy. * active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. * pregnancy/breast feeding * serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator. * poorly controlled diabetes mellitus * second primary malignancy that is clinically detectable at the time of consideration for study enrollment. * history of significant neurological or mental disorder, including seizures or dementia.

Keywords: nsclc
a prospective and observational cohort study to evaluate the treatment model and medical economics of advanced gastric cancer chemotherapy in clinical practice in china

Conditions: Advanced Gastric Cancer

Summary: this is a multi-center, prospective and observational clinical study. eligible patients will accept generalized chemotherapy according to the investigator's assessment. information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study. recruited patients will fill out questionnaires about quality of life before initiation of treatment, at cycle 3 and completion of first-line treatment.


Eligibility criteria:
inclusion criteria: 1. the patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible. 2. the informed consent form is signed. 3. a specimen of tumor tissue (puncture biopsy or surgical specimen) is available. 4. ecog performance status is 0, 1 or 2. 5. the patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment 6. the patient is aged≥18 exclusion criteria: 1. the patient is known to be allergic to any study drug. 2. the patient is recruited in other clinical study or is planned to participate into other clinical study. 3. the patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).

Keywords: advanced gastric cancer chemotherapy quality of life treatment expense patients accepted first-line chemotherapy
op-1 putty for posterolateral fusions

Conditions: Degenerative Lumbar Spondylolisthesis

Summary: the trial was designed to demonstrate the comparability of the overall success rate in the op-1 putty treatment group to the autograft treatment group.

a controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (l3-s1) degenerative lumbar spondylolisthesis (grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received op-1 putty or autograft. this study was a one-sided, non- inferiority trial comparing the overall success between the op-1 putty group and the control autograft group.

Eligibility criteria:
inclusion criteria: 1. the subject has a diagnosis of degenerative lumbar spondylolisthesis of grade i or ii with spinal stenosis demonstrated by medical history, physical examination a n d radiographic imaging. 2. the subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest. 3. the subject requires one level lumbar fusion (l-3 to s-1). 4. the subject has a preoperative oswestry disability index of 30-100. exclusion criteria: 1. the subject has active spinal and/or systemic infection. 2. the subject is morbidly obese. 3. the subject has a known sensitivity to any component of the op-1 putty. 4. the subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion. 5. the subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Keywords: degenerative disc disease
the role of laryngopharyngeal reflux in ipf

Conditions: IPF; Reflux

Summary: the primary objective of this study is to show that the supraglottic index (sgi) is an easily-collected index that accurately identifies the presence and severity of laryngopharyngeal reflux (lpf) in idiopathic pulmonary fibrosis (ipf).

the study team hypothesizes the sgi will correlate more strongly with measures of ipf severity (at baseline and over time) than gastroesophageal reflux (ger) data derived from the esophageal detector channels of a ph/impedance probe.

Eligibility criteria:
inclusion criteria: * diagnosis of ipf * age 40-95 * able to read, speak, and understand english * if subjects are currently taking medication for reflux or gerd, they much be on a stable does for at least 4 weeks prior to consent. exclusion criteria: * patients who do not meet all inclusion criteria * pregnant females
the th17/treg cells and il-23/il-17 axis and early enteral nutrition in sepsis

Conditions: Sepsis; Immune System Disorder; Enteral Feeding

Summary: the investigators aim to evaluate the roles of th17/treg cells and il-23/il-17 axis in the mechanisms of early enteral nutrition (een) correcting immune imbalance of sepsis by means of improving the intestinal flora disturbance. the results of this study would lay the foundation for revealing the mechanisms of een improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of sepsis 2. within 3 days of sepsis onset before icu admission 3. no artificial nutrition (enteral or parenteral nutrition) were provided before icu admission exclusion criteria: 1. ileus 2. digestive tract hemorrhage 3. inflammatory bowel disease 4. abdominal hypertension (iap \>25mmhg) 5. cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction) 6. malnutrition or immunodeficiency 7. long-term use of hormones
pulmonary rehabilitation before lung cancer resection

Conditions: Lung Cancer; COPD; Chronic Obstructive Lung Disease; Emphysema

Summary: this study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe chronic obstructive lung disease (copd).


Eligibility criteria:
inclusion criteria: * patient is scheduled to undergo a surgery for non small cell lung cancer * moderate to severe copd * current or ex smoker of ten or more years exclusion criteria: * unable to perform exercise due to active cardiovascular, musculoskeletal or mental problems poorly motivated to attend the rehabilitation sessions or receive randomization.

Keywords: copd chronic obstructive lung disease lung cancer emphysema pulmonary rehabilitation
effects of cilostazol on plasma adipocytokine and arterial stiffness

Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome X

Summary: cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication. cilostazol inhibits phosphodiesterase iii (pde iii), which causes it to be a vasodilator and inhibitor of platelet aggregation. recently there were report of beneficial effect of cilostazol like vasodilation, lipid metabolism, and cytokine production. but there were few clinical studies that support these effects of cilostazol. the purpose of this study is to evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by pwv and plasma adipocytokines.


Eligibility criteria:
* eligible for study: 18 year and above, gender eligible for study: both inclusion criteria:type 2 diabetes patients with metabolic syndrome criteria of asian-pacific atp iii guideline * type 2 diabetes (at least 1 criteria below) 1. fasting blood glucose ≥ 126 mg/dl 2. postprandial 2hour glucose ≥ 200 mg/dl 3. random blood glucose ≥ 200 mg/dl with typical diabetes symptoms * metabolic syndrome : asian-pacific atp iii guideline 1. fasting blood glucose ≥ 110 mg/dl, or previously diagnosed type 2 diabetes 2. systolic and/or diastolic blood pressure ≥130/85 mmhg, or treatment of previously diagnosed hypertension 3. triglyceride ≥ 150 mg/dl, or specific treatment for this lipid abnormality 4. hdl-cholesterol \< 40 mg/dl for men and \< 50 mg/dl for women, or specific treatment for this lipid abnormality 5. waist circumference ≥ 90 for men and ≥ 80 for women exclusion criteria: * hypertensive patients with the use of ace inhibitor or arb * hyperlipidemic patients with the use of statin or fenofibrate * hepatic dysfunction * chronic alcohol or drug abuse * renal dysfunction * heart failure * patients who takes hormone replace therapy or steroid containing drugs * patients who take drugs like anticoagulant (warfarin), anti-platelet agent (aspirin, ticlopidin), thrombolytic agent (urikinase, alteplase), prostaglandine e1 , drugs inhibit cyp3a4 or cyp2c19, or drugs become substrate of cyp3a4 * patients who haves disease influencing the results of the study such as neurologic, digestive and neoplastic disease

Keywords: cilostazol type 2 diabetes mellitus metabolic syndrome adipocytokines arterial stiffness pulse wave velocity
efficacy and safety of ranibizumab with or without laser in comparison to laser in branch retinal vein occlusion

Conditions: Branch Retinal Vein Occlusion

Summary: this study will generate comparative data for 0.5-mg ranibizumab using prn dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to month 6 in patients with visual impairment due to me secondary to brvo. additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any study assessment is performed * diagnosis of visual impairment exclusively due to me secondary to brvo * bcva score at screening and baseline between 73 and 19 letters (etdrs) exclusion criteria: * pregnant or nursing (lactating) women * stroke or myocardial infarction less than 3 months before screening * uncontrolled blood pressure defined as systolic value of \>160 mm hg or diastolic value of \>100 mm hg at screening or baseline. * any active periocular or ocular infection or inflammation at screening or baseline in either eye * uncontrolled glaucoma at screening or baseline or diagnosed within 6 months before baseline in either eye * neovascularization of the iris or neovascular glaucoma in the study eye * use of any systemic antivascular endothelial growth factor (anti-vegf) drugs within 6 months before baseline * panretinal laser photocoagulation within 3 months before baseline or anticipated or scheduled within the next 3 months following baseline in the study eye * focal or grid laser photocoagulation within 4 months before baseline in the study eye * use of intra- or periocular corticosteroids (including sub-tenon) within 3 months before screening in the study eye * any use of intraocular corticosteroid implants (eg, dexamethasone \[ozurdex®\], fluocinolone acetonide \[iluvien®\]) in the study eye

Keywords: macular edema, branch retinal vein occlusion, visual impairment
effects of transcranial direct current stimulation on pain perception

Conditions: Pain

Summary: the purpose of this study is to determine whether a new medical technology can temporarily alter pain perception. the new technology is called transcranial direct current stimulation (tdcs).

healthy subjects underwent thermal pain tolerance testing pre- and post intervention. the intervention includes either anodal, cathodal, or sham tdcs for 20 minutes during a pain cognitive intervention \[either brief cognitive intervention (bci) or general pain education\]. the tdcs brand was the phoresor-ii auto (model pm850, iomed, salt lake city utah, usa) and the current was set to 2.0ma. electrodes were 4x4 cm sponge electrodes soaked in sterile saline. for anodal and cathodal tdcs, one electrode was placed over the left dlpfc (f3 from the eeg 10-20 system) located via the beam f3 measurement system and the other electrode was attached to the right shoulder. for sham tdcs, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tdcs and then ramped-down to 0ma for the duration of the 20-minute session.

Eligibility criteria:
inclusion criteria: inclusion criteria: * 100 health individuals recruited from charleston ,sc exclusion criteria: * can not be pregnant * no history of depression, chronic pain, seizers, suicidal implanted metal devices, history of brain surgery, loss of consciousness.

Keywords: healthy adults pain perception
efficacy and safety study to evaluate vadadustat for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (dd-ckd)

Conditions: Anemia; Dialysis-Dependent Chronic Kidney Disease

Summary: a multicenter, randomized, open-label, active-controlled phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (dd-ckd).

this is a multicenter, randomized, open-label, active-controlled phase 3 study of the efficacy and safety of vadadustat versus darbepoetin alfa for the correction or maintenance treatment in participants with anemia secondary to chronic kidney disease who have recently initiated dialysis treatment for end-stage renal disease.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to screening * mean screening hemoglobin between 8.0 and \<11.0 grams per deciliter (g/dl) (inclusive) * serum ferritin ≥100 nanograms per deciliter (ng/ml) and tsat ≥20% during screening exclusion criteria: * anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss * red blood cells transfusion within 8 weeks prior to randomization * anticipated to recover adequate kidney function to no longer require dialysis * uncontrolled hypertension * severe heart failure at screening (new york heart association class iv) * acute coronary syndrome (hospitalization for unstable angina, myocardial infarction); surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity); surgical or percutaneous valvular replacement or repair; sustained ventricular tachycardia; hospitalization for congestive heart failure; or stroke within 12 weeks prior to or during screening. * participants meeting the criteria of erythropoiesis-stimulating agent resistance within 8 weeks prior to or during screening defined as follows 1. epoetin: \> 7700 units/dose three times per week or \>23,000 units per week 2. darbepoetin alfa: \>100 micrograms per week (mcg/week) 3. methoxy polyethylene glycol-epoetin beta: \>100 micrograms (mcg) every other week or \>200 mcg/month * hypersensitivity to vadadustat, darbepoetin alfa or any of their excipients

Keywords: vadadustat akb-6548 anemia chronic kidney disease ckd chronic renal insufficiency renal impairment erythropoietin kidney renal oral anemia treatment hemoglobin hypoxia-inducible factor hif efficacy safety phase 3 cardiovascular
characteristics and clinical outcomes of anorexia nervosa : siriraj hospital experience

Conditions: Anorexia Nervosa

Summary: this study is aimed to determine clinical characteristics of patients with anorexia nervosa and outcome of treatment at sirirraj hospital.

data is derived from the medical records

Eligibility criteria:
inclusion criteria: * children and adolescents with newly diagnosed anorexia nervosa in siriraj hospiatl according to dsm iv criteria * treated by multidisciplinary teams e.g. pediatricians specialized in nutrition and psychology and psychologist exclusion criteria: * none

Keywords: anorexia nervosa siriraj hospital thai