Kornimate/medical-research-clean huggingface dataset:
effect h2 water on qol of patients receiving radiotherapy for high grade gliomas.

Conditions: Malignant Glioma

Summary: this is a pilot randomized control trial (rct) to explore the effects of hydrogen rich water on quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with temozolomide.

this will be a pilot trial exploring the ability of molecular hydrogen to improve quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with temozolomide. hydrogen has an excellent safety profile, has antioxidant properties and reduces inflammatory events in the tissues. it has been postulated in previous studies that continuous consumption of hydrogen water reduces oxidative stress in the brain by lowering the concentration of the reactive oxygen species, resulting in the improvement of adult neurogenesis or the stimulation of neural proliferation, leading to the prevention of the decline in the learning and memory. this will be a double blinded, placebo-controlled trial. eligible and willing subjects will be randomly assigned in a 2:1 ratio to be treated with either hydrogen or placebo, to receive hydrogen or placebo, additionally to all standard-of-care treatments. the treatment with hydrogen or placebo will start the day before chemoradiation therapy starts, and continue for six weeks. the effects of drinking hydrogen water on the quality of life will be assessed using the eortc qlq-c30 and the eortc qlq-bn20 questionnaires at baseline, at 6 weeks, 6 months, 12 months, 18 months and 24 months.

Eligibility criteria:
inclusion criteria: * aged 18 years old or over * new diagnosis of a malignant glioma (hgg) either by a biopsy or craniotomy * kps of at least 70 * being able to fill out quality of life questionnaire exclusion criteria: * other major diseases of the central nervous system, including history of prior brain tumors, alzheimer's disease, parkinson's disease, demyelinating disease, inflammatory brain or vascular disease, traumatic encephalopathy, or idiopathic intracranial hypertension, anxiety/depression. * pre-existing neurological disability, unable to read or write * severe comorbidities likely to result in patient dying within 3 months * prior history of head/neck radiation therapy * other active cancer or history of other cancer diagnosed within 5 year. * inability to safely tolerate the 1500 ml- 2000ml fluid load (po water) associated with study medication\* * pregnancy or nursing. * treatment with another investigational drug within the last 30 days that may interfere with this study's medications\* * hypersensitivity to temozolomide and or it's active agent- dacarbazine

Keywords: neuroprotection hydrogen antioxidant malignant glioma
assessing performance on speech tasks via crowdsourced participants

Conditions: Cognitive Impairment; Mild Cognitive Impairment

Summary: the purpose of the study is to examine the properties of the automatic story recall test (asrt) and its parallel variants, as well as letter fluency and category fluency cognitive tests. tests will be completed in crowdsourced populations, to derive normative data, and examine test properties in demographically diverse and cognitively impaired participants recruited and tested online.

the amyweb study will validate speech tasks developed by novoic in different population samples, including normative samples, samples recruited for enhanced demographic diversity, and participants with reported cognitive impairment. participants will be research volunteers recruited online and via crowdsourcing platforms. six rounds of recruitment will be completed, evaluating different parallel variants of the automatic story recall task (asrt), and fluency tasks. during each recruitment round participants will complete a speech test battery and questionnaires during one assessment (baseline). speech tasks will be recorded and later analyzed on novoic's technology platform. all assessments will be fully online and remote.

Eligibility criteria:
inclusion criteria: * first language must be english * residing in the usa * willing to participate in a study investigating speech and dementia * able to provide informed consent * access to personal computing device that is capable of audio and video recording, and able to connect to the internet since key research questions are focused primarily on older-age speech and cognition, initial recruitment will be focused on older adult age brackets, which may be extended to younger adulthood if the desired sample sizes are not attained. exclusion criteria: * no formal exclusion criteria will apply at the point of recruitment and testing. however, participants with a reported history of neurological conditions or head injury, and current depression will be excluded from normative data development.
an extended treatment study of mt-3995 in patients with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: this study aims to evaluate the safety and efficacy of mt-3995 administered over the longer term, following mt-3995-j05 study.


Eligibility criteria:
inclusion criteria: * written informed consent for participation before the completion of mt-3995-j05 study * completion of mt-3995-j05 study exclusion criteria: * uacr of ≥300 mg/g cr with an increase of ≥30% in mt-3995-j05 study * symptomatic and clinically significant hypotension * qt prolongation or torsades de pointes * new york heart association (nyha) class iii or iv heart failure * patients who are judged to be unsuitable for participation based on their safety profile in mt-3995-j05 study

Keywords: diabetic nephropathy
continuation trial evaluating the tolerability and activity of fk228 in patients that completed prior study with fk228

Conditions: Carcinoma, Renal Cell; Prostatic Neoplasms

Summary: the purpose of this study is to evaluate the safety and tolerability of extended treatment with fk228 in patients with metastatic renal cell carcinoma or hormone refractory prostate cancer who have at least demonstrated stable disease on prior fujisawa sponsored fk228 clinical trials.

this is a phase ii, non-randomized, open-label, single arm, continuation trial.

Eligibility criteria:
inclusion criteria: * patient has completed 6 cycles of therapy in a prior fujisawa-sponsored fk228 clinical trial; * patient has immediate past participation (not to exceed 21 days from day 15 of cycle 6 in the previous study) in a prior fujisawa-sponsored fk228 clinical trial; * patient has demonstrated stable disease, partial response or complete response as best overall response in their prior fujisawa-sponsored fk228 clinical trial. exclusion criteria: * patient has been on a prior fujisawa-sponsored fk228 clinical trial, left the trial and then received alternative anti-neoplastic therapy

Keywords: fk228 hormone refractory prostate cancer
calcium electroporation for treatment of cutaneous metastases

Conditions: Cutaneous Metastases

Summary: the purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.

double-blinded phase ii clinical study. we will compare the effect of calcium electroporation for the treatment of cutaneous metastases with standard treatment: electrochemotherapy with intratumoral injection of bleomycin. separate randomisation will be performed and the lesions will be treated with either intratumoral injection of calcium or bleomycin. it is a once only treatment and the patients will be followed up for 6 months. it is a non-inferiority study and we accept a difference in response on 15%.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * histological confirmed cutaneous metastases of any histology. * at least 1. cutaneous metastases between 0,5 to 3cm, available to electroporation. * patient should have been offered standard treatment. * at least 2 weeks since chemotherapy or radiotherapy. * performance status \>2 (ecog). * life expectancy \>3 months. * platelet count \> 50 mia/l. * international normalized ratio (inr) \<1,2. * men and women of reproductive age must use effective contraception during the study. * patient should be able to understand participants information. * signed, informed consent. exclusion criteria: * previously treatment with bleomycin \> 200.000 units/m2. * allergy to bleomycin. * clinically significant coagulopathy. * pregnancy or lactation. * participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.

Keywords: cutaneous metastases
etoricoxib vs aceclofenac in the treatment of patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: comparison of lower dosage etoricoxib (60 mg daily) with aceclofenac (100 mg bid) for their efficacy and safety in the treatment of rheumatoid arthritis (ra).

this was a single medical center, parallel-group, randomized controlled trial, which conducted for eight weeks. in this study, 40 patients of ra were randomly assigned to two different treatment groups (etoricoxib and aceclofenac), and 20 patients were enrolled for each group. in addition to baseline data collection, objective assessment tools were used to evaluate for efficacy and safety. the primary endpoint was american college of rheumatology 20% improvement criteria (acr20) , secondary endpoints were the acr 50,70, disease activity score 28 (das 28), european league against rheumatism (eular) response criteria, the number of tender and swollen joints, physician's global assessment, patient's global assessment, pain scores, the short form health survey (sf-36) health questionnaire and etc. in addition, all adverse reactions were recorded and all the results were analyzed in the intention to treat (itt) manner.

Eligibility criteria:
inclusion criteria: * diagnosis as rheumatoid arthritis exclusion criteria: * 1. pregnant or breast-feeding women. 2. chemotherapy or radiation therapy in cancer patients

Keywords: etoricoxib aceclofenac efficacy safety taiwanese
preoperative immunonutrition in patients undergoing elective colorectal surgery for neoplasm

Conditions: Cancer of Colon; Nutrition Related Cancer

Summary: enhanced recovery after surgery (eras) protocols were developed to standardize perioperative practice in colon surgery to reduce morbidity, improve recovery, and shorten length of stay (los). better protocol adherence translates into fewer readmissions and complications, and better 5-year survival. preoperative elements, especially nutrition and immunonutrition, are topics that need further development to become the standard of care. it has been widely reported that the prevalence of malnutrition reaches 40% in cancer patients at the time of diagnosis. impaired nutritional status at the time of surgery and cancer-induced inflammation, along with postoperative inflammatory responses to major surgery, increase the risk of postoperative complications, along with a decrease in perceived quality of life. immunonutrition can modulate inflammation and reduce postoperative infections and shorten length of stay by counteracting the immune response induced by cancer. adipose tissue has been shown to be a relevant source of inflammatory mediators, which may play a role in the promotion of tumor cachexia. the present study is a multicenter randomized control study (rct) designed to evaluate the effect of preoperative immunonutrition in patients with colorectal cancer eligible for elective minimally invasive procedures, evaluating in particular surgical site infection and length of hospital stay. a biopsy of subcutaneous adipose tissue and visceral adipose tissue will also be performed, in order to evaluate the differences between inflammatory infiltrate, degree of fibrosis and cross-sectional area of adipocytes compared to controls.


Eligibility criteria:
inclusion criteria: * primary colorectal neoplasms eligible for elective surgery, undergoing minivasive resections. * 20 to 85 years old, with no difficulties in oral intake * bmi ranging from 18 to 40. exclusion criteria: * emergency surgery, * converted procedures, * major intraoperative complications, * concomitant chronic disease such as chronic renal failure, rheumatic and hematological disease, chronic inflammatory bowel diseases, * synchronous cancer, * previous bowel resections or bariatric surgery, * presence of preoperative stoma.
diagnostic accuracy of ct-ffr compared to invasive coronar angiography with fractional flow reserve

Conditions: Coronary Disease

Summary: invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. fractional flow reserve (ffr) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. coronary computed tomographic angiography (ccta) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. computational fluid dynamics combined with anatomical models based on ccta scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called ct-ffr. in this project new mathematical algorithms are developed for computation of ct-ffr. the main objective of this study is to determine the diagnostic accuracy of ct-ffr values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.


Eligibility criteria:
inclusion criteria * proven stenosis by ccta that require further investigation with invasive coronary angiography i.e. patients with estimated stenosis ≥30- 50%. * informed consent exclusion criteria: * patients with unstable coronary artery disease. * previously treated with pci or coronary surgery. * severe renal impairment i.e. gfr \<30ml / min * contrast allergy * contraindication to adenosine / nitroglycerin / beta-blocker * bmi\> 40 * patients referred on the basis of technically unsuccessful cta, motion artifact or similar

Keywords: diagnostic techniques, cardiovascular coronary angiography fractional flow reserve, myocardial echocardiography, stress
study to evaluate the efficacy and safety of p-3058 10% nail solution in the treatment of toenail onychomycosis

Conditions: Onychomycosis

Summary: the purpose of this study is to determine whether p-3058 nail solution is a safe and effective treatment for onychomycosis.


Eligibility criteria:
inclusion criteria: * written informed consent * patients aged 12 years and older of any race. * males or females. * patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail. * patients with a positive koh examination and culture positive for dermatophyte exclusion criteria: * presence of "yellow spikes" on the target nail. * presence of dermatophytoma on the target nail. * presence of nail thickness exceeding 2 mm. * patients with proximal subungual involvement * patients with severe plantar or moccasin tinea pedis * patients with nail abnormalities due to other conditions * patients with life expectancy less than 2 years. * chemotherapy, immunosuppressive therapy in the 12 weeks prior to screening visit (v1). * systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to screening visit (v1). * hiv infection or any other immunodeficiency. * alcohol or substance abuse. * patients with history of allergic reactions to terbinafine or its excipients. * woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.

Keywords: onychomycosis nail fungus
predictive value of the insulin-like growth factor-1 (igf-1) generation test for the growth response to growth hormone treatment (pred-igf)

Conditions: Idiopathic Short Stature

Summary: the evaluation of a standardized diagnostic test to predict the growth response in a 1 year trial with growth hormone (gh) treatment (carried out in the context of regular patient care) in non gh deficient short children with low serum insulin-like growth factor-1 (igf-1).


Eligibility criteria:
inclusion criteria: * age 2.0 - 9.0 years for females, 2.0 - 10.0 yrs for males. * prepubertal stage (tanner 1 for breast (b1) in females, or tanner 1 for genitals (g1) for males). * bone age \< 10 'years' (males) or \< 9 'years' (females) according to greulich and pyle. the bone age will be read by the pediatric endocrinologist responsible for the pre-study screening visit. * height sds \< -2.5 for ethnically adequate references. for children of dutch or western european origin the 1997 nation-wide references for dutch children will be used. for children of moroccan or turkish origin, the respective reference charts will be used. for children of other ethnicities, the 1977 north american (nchs/who) reference will be used, as these charts have been accepted by who as world-wide standard from the age of 5 years. exclusion criteria: * has a history of hypersensitivity to growth hormone or phenol (conservative added to gh in nutropinaq), or drugs with a similar chemical structure. * has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. * has a birth weight and/or length below -2 sds for swedish reference charts. patients will not be excluded due to an unknown birth weight or length. * has a known cause of short stature, or any significant concomitant disease that is likely to interfere with growth or with the study schedule/objectives, or is a known contraindication to gh treatment.
clinical outcome study of the triad allograft for posterior lumbar fusion

Conditions: Pain; Stenosis; Spondylolisthesis

Summary: the purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the triad allograft. results of the triad allograft will be compared to those of other anterior lumbar interbody fusion (alif), transforaminal lumbar interbody fusion (tlif), and posterior lumbar interbody fusion (plif) surgeries. patient participation is based on the physician determination that the patient requires one of these surgeries. participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. clinic procedures will be related to standard of care except for the completion of several study questionnaires: 1. back pain questionnaire; 2. oswestry disability index questionnaire; 3. short form-36 (sf-36) survey; 4. visual analog pain scale (vas); and 5. the modems patient satisfaction survey. outcome measurements: 1. the patient's pain is scored by a vas normalized to 100; 2. patient function is based on oswestry scores; 3. general health is assessed by sf-36 completion; and 4. overall patient satisfaction will be determined by the completion of the modems.


Eligibility criteria:
inclusion criteria: 1. voluntary consent for an observational study 2. one of the following diagnoses: * isthmic spondylolisthesis, * degenerative spondylolisthesis, * pseudoarthritis, * severe foraminal stenosis, and * prior failed discectomies 3. single, two, or three level fusions 4. patients require treatment by tlif or plif posterior fusion as determined by surgeon. pedicle screw instrumentation will be placed in all cases. exclusion criteria: 1. infection at operative site 2. severe osteoporosis 3. inability to return for follow-up.

Keywords: transforaminal lumbar interbody fusion posterior lumbar interbody fusion isthmic spondylolisthesis, degenerative spondylolisthesis pseudoarthritis severe foraminal stenosis
immune response following covid-19 in hemodialysis patients

Conditions: Dialysis; Complications; COVID-19; Cytokine Storm

Summary: patients with chronic kidney disease (ckd), particularly those undergoing hemodialysis (hd), are at high risk of a severe form of covid-19. this study aims to characterize the inflammatory and antiviral response during sarscov2 infection in adult

inclusion criteria were (1) adult (\>18 years old) patient on hd \> 6 months, and (2) infection by sars-cov-2. diagnosis of covid-19 was assessed by reverse-transcriptase-polymerase chain reaction (rt-pcr) for sars-cov-2 in nasopharyngeal swab or by typical covid-19 radiological images on thoracic computerized tomography (ct scan). severe forms of covid-19 were defined as requiring oxygen therapy, admission in intensive care unit (icu) or death primary end point : \* characterization the cytokine's profile at the early (day 7) and inflammatory (day 14) phase of covid-19 in hd patient secondary end points : * analyse the kinetic of the antiviral response (type i and iii interferon ) between the early (day 7) and inflammatory (day 14) phase of covid-19. * analyse the kinetic of proinflammatory cytokine response between the early (day 7) and inflammatory (day 14) phase of covid-19. * define an antiviral signature associated with severe form of covid-19 * define an anti inflammatory signature associated with severe form of covid-19 cytokine's profile is define by the measure of 28 cytokines by luminex technology

Eligibility criteria:
inclusion criteria: * adult (\>18 years old) patient on hd \> 6 months, and * infection by sars-cov-2. diagnosis of covid-19 was assessed by reverse-transcriptase-polymerase chain reaction (rt-pcr) for sars-cov-2 in nasopharyngeal swab or by typical covid-19 radiological images on thoracic computerized tomography (ct scan). the date of diagnosis was defined as the day when rt-pcr or ct-scan confirmed the diagnosis. exclusion criteria: * inability to give consent

Keywords: dialysis cytokine covid-19