Kornimate/medical-research-clean huggingface dataset:
a pivotal clinical investigation confirming the safety and accuracy of the glyconics-ds in assessment of glycated nail keratin in individuals with unknown diabetes status and performance evaluation of the glyconics sw package

Conditions: Pre-diabetes; Undiagnosed Diseases

Summary: the main clinical study objective is to confirm the accuracy of the glyconics-ds spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. the study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. the 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, hba1c, as measured based on standardised, certified methodology.


Eligibility criteria:
inclusion criteria: * apparently healthy adults (≥18 years of age) with unknown diabetes status willing to participate in and provide a written consent for the study * willingness to undertake assisted assessment of glycaemia: by both the nir spectral measurements in a chosen middle fingernail, and hba1c (blood sample) * individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail. exclusion criteria: * individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as: * severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar). * haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular (local) laboratory assays for hba1c. * severe renal impairment (ckd stage iii-iv) or decompensated hepatic disease. * severe vitamin d deficiency (diagnosed or measured 25(oh)d3 \< 25 nmol/ml). * known severe immunodeficiency such as hiv, malignancy or other chronic condition significantly impacting assessment of glycaemia. * eating disorders (as per clinical assessment) * recent (within 28 days) blood donation * any other type of known diabetes than t2dm, if diagnosed (t1dm, gdm, mody, etc.) * any structural, deviating and visually detectable deviations in the appearance of the (only/ to be assessed) middle fingernail potentially impacting the spectra measurement, including: * nail dystrophy or deformity * severe nail infections (onychomycosis causing visual changes in the appearance of the nail). * rare hereditable conditions impacting the structure of keratin. * mechanical damage or marks on the surface of the nail after removal of nail polish. * use of acrylic or gel nail decoration and polish, which cannot be removed with acetone (use of acetone necessitates a 15 min post-removal wash-out time) * any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of hba1c value.
portal hypertension in non-alcoholic fatty liver disease: association with cardiovascular risk and identification of non-invasive biomarkers (thesis)

Conditions: Fatty Liver Disease

Summary: non-alcoholic fatty liver disease (nafld) is the most frequent cause of chronic liver disease in our environment. preliminary data suggest that portal hypertension may exist in the initial phases of nafld due to mechanisms that have not yet been elucidated. the clinical relevance of its development in these initial phases is unknown, while in more advanced phases new data are required to confirm the close relationship between portal hypertension and the risk of decompensation described in other etiologies. likewise, the influence of fibrosis and portal hypertension on the cardiovascular risk of patients with nafld is unknown. the aim of the present multicenter project is to characterize the presence of portal hypertension and the mechanisms involved in its development in the different stages of nafld, to assess the association between the degree of portal hypertension and the development of portal hypertension-related complications, to know the early cardiovascular risk in the different stages of the disease, and to identify noninvasive biomarkers of the presence and severity of portal hypertension.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * clinical suspicion of nafld. * severe (controlled attenuation parameter (cap) ≥330 db/m) or mild steatosis (cap: 298-317 db / m), and fibroscan® grade 2 fibrosis (m probe: 7-9 kpa; xl probe: 5-7.5 kpa) in patients with grade 1 or 2 obesity and insulin resistance (homa index\> 2.6) or diabetes mellitus. * fibroscan® grade 3 or 4 fibrosis (m probe:\> 9 kpa; xl probe:\> 7.5 kpa). * decompensated nafld cirrhosis (i.e. development of ascites, variceal hemorrhage, and/or hepatic encephalopathy) up to child b (9 points). * signature of informed consent. exclusion criteria: * concomitant liver disease and patients with acute on chronic liver failure. * excessive alcohol consumption (≥ 30 grams per day in men and ≥ 20 grams per day in women). * comorbidities (hiv infection, connective diseases, prothrombotic disorders) and/or drugs (didanosine, azathioprine, oxaliplatin) associated with the presence of idiopathic non-cirrhotic portal hypertension. * clinical history of cardiovascular disease (ischemic cardiomyopathy, atrial fibrillation, valvular defects, severe arterial hypertension, previous hospitalizations secondary to heart failure, cerebrovascular disease). * severe renal impairment, defined by creatinine clearance \<15 ml/min/1.73m2. * any previous or current thrombosis in any venous territory. * uncontrolled psychiatric illness * contraindication to liver biopsy or any of the complementary tests included in the project. * hepatocellular carcinoma that does not meet milan criteria. * pregnancy or breastfeeding * significant comorbidities that entail a functional limitation and/or a life expectancy of less than 12 months.

Keywords: non-alcoholic fatty liver disease
rfa plus carrizumab vs carrizumab alone for hcc

Conditions: Tumor Immunity; Immunosuppression; Radiofrequency Ablation

Summary: the study aims to find whether patients with advanced hcc can get more benefits from rfa +pd-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of pfs.

the study aims to find whether patients with advanced hcc can get more benefits from rfa +pd-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of pfs. 120 patients were enrolled into two groups respectively, the experimental group and reference group.

Eligibility criteria:
inclusion criteria: 1. age from 18-75 years 2. diagnosis as hepatocellular carcinoma from histology and cytology 3. bclc b-c degree 4. score of ecog ps: 0-2 5. child-pugh score: a or b 6. not suitable for resection or liver transplantation 7. have not received systemic therapy 8. have at least one evaluable target mass from ct or mri according to mrecist 9. the estimated survival time ≥ 12 weeks 10. patients with hbv infection having hbv-dna \<500iu/ml and standard anti-virus treatment. patients with hcv infection must receive standard anti-virus treatment. 11. the function of main organs normal 12. sign informed consent exclusion criteria: 1. have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. have incurable malignant tumor in five years. 2. have local ablation, tace or radiotherapy in 3 months before enrolled. 3. prepared to or have received organic or bone marrow transplantation. 4. uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices. 5. have hypertension and can't lower down to the normal level using blood pressure medication. 6. have type ii myocardial ischemia or myocardial infarction, uncontrollable arrhythmia. 7. have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction. 8. have gastrointestinal bleeding in 6 months 9. have abdominal fistula, gastrointestinal perforation or abdominal abscess 10. patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung. 11. routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g 12. patients have autoimmune disease 13. patients need corticosteroid or other immunosuppressant therapy 14. patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months 15. allergy to monocloning antibody 16. pregnant or breastfeeding female other patients not suitable to be enrolled in the study.

Keywords: rfa immunosuppressant hepatocellular carcinoma
microvascular cardiac allograft vasculopathy trial

Conditions: Cardiac Allograft Vasculopathy

Summary: the aim of the mcav study is a comprehensive characterization of the genetic, morphological and functional phenotype of isolated microvascular graft vasculopathy (mcav) after orthotopic heart transplantation (oht). the utilized methods include dynamic echocardiography, magnetic resonance imaging, invasive microvascular resistance measurements, histology, cellular calcium-signaling and magnetocardiography as well as molecular genetic expression analysis (mirna based).


Eligibility criteria:
inclusion criteria: * able to consent * written consent of the participant after clarification and sufficient time to think about participation * heart transplant recipient * indication for routine invasive diagnostics or due to symptoms * exercise tolerant in everyday life - cycling, climbing stairs at least 2 floors at a moderate speed without symptoms of exertion or dyspnea exclusion criteria: * addiction or other diseases that do not allow the patient to assess the nature and scope as well as possible consequences of the study * patients or their legal guardians who do not sign the declaration of consent or who cannot fully understand it due to a lack of german language skills * pregnant women, breastfeeding women * severe comorbidities affecting the mirna profile: diabetes mellitus, malignancy, end-stage renal disease with renal replacement therapy * contraindication to the stress test: signs of cardiac decompensation, angina pectoris, dyspnea, hyperthyroidism, gfr \<30 ml/min, peripheral arterial disease, pheochromocytoma, angle-closure glaucoma, prostate adenoma, paroxysmal tachycardia, tachycardia atrial fibrillation * evidence of an acute rejection or local wall motion disturbances in the resting echocardiography

Keywords: heart transplantation cardiac allograft vasculopathy
utilization of a knee brace with extension swing

Conditions: Osteo Arthritis Knee

Summary: the purpose of this research is to help determine if use of the guardian brace during prehab and post-op rehab after tka can help improve functional outcomes and reduce the incidence of post-operative flexion contractures which reduce knee range of motion after surgery.

this will be a prospective study with consecutive tka patients with pre-operative flexion contractures of 5 degrees or greater. patients will be randomized to one of two groups: 1) use of the guardian knee brace peri-operatively, and 2) no guardian brace use. pre-operative range of motion (rom) and leg strength will be tested (4 to 6 weeks pre-operatively and the week before surgery) as well as during the recovery period at 6 weeks and 3 months post-operatively. the study will attempt to quantify quadriceps and hamstring strength using a medical engineering tkr2000, which can digitally measure quadriceps and hamstring strength with accuracy equivalent to a biodex dynanometer. the tkr2000 also accurately measures terminal flexion and extension of the lower extremity. pre- and post-operative patient reported outcome measures (koos jr. score) will also be collected.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age * surgical candidates undergoing primary tka * surgical candidates with pre-operative flexion contracture of 10 degrees or greater * patient is willing to cooperate and follow study protocol and visit schedule exclusion criteria: * patient is pregnant * patient is unable to provide written consent * patient has psychiatric disorder that precludes safe study participation * patients with a prior history of surgery in the affected knee * vulnerable patient populations
early lymph node metastasis in t1/2 stage colorectal cancer: molecular and clinical insights

Conditions: Colorectal Cancer

Summary: the prognostic implications of lymph node metastasis in colorectal cancer patients at an early stage, specifically t1/2 stage, are relatively unfavorable. therefore, understanding the clinical and molecular traits relevant to metastasis in t1/2 stage are of substantial clinical importance.

patients were classified based on their lymph node staging, with an ancillary categorization into msi-h and mss subgroups. a comparative mutational study was performed among these groups, incorporating risk stratification and receiver operating characteristic curve analysis, with the aim of discerning the predictability of clinical features integrated with molecular characteristics for early metastasis in t1/2 stage colorectal cancer.

Eligibility criteria:
inclusion criteria: * men and women aged 18-75 years old; * clinical staged t2; * histologically proven colon or rectal adenocarcinoma. exclusion criteria: * patients over 80 years of age; * recurrent colorectal cancer; * multiple primary tumors; * distant metastasis.
incretins and metabolism

Conditions: Type 2 Diabetes

Summary: incretin hormones (glp-1 and gip) have insulin secretory effects on the pancreas that are glucose dependent. extrapancreatic effects of incretin hormones are reported, however the glucose dependency of these effects have not been examined. in type 2 diabetes, pancreatic endocrine function and incretin metabolism are impaired. the investigators hypothesize that extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in subjects with type 2 diabetes. healthy control subjects and type 2 diabetics will undergo pancreatic clamps. in brief, somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of insulin, glucagon, and growth hormone will be replace via infusion. metabolic flux will be studied during euglycemic and hyperglycemic stages of the pancreatic clamp. each subject will undergo 3 trials involving the co-infusion of either saline(control trial), glp-1, or gip. glucose metabolism will be assessed using 13c-glucose stable isotope methodology combined with indirect calorimetry and expired breath isotope ratio analysis. blood flow and flow-mediated dilation will be measured using ultrasound doppler. skeletal muscle and abdominal adipose biopsies will be taken to examine intracellular signalling.


Eligibility criteria:
inclusion criteria: * age 18-60 years * bmi 18-35 kg/m2 * ngt or t2dm as classified by ada criteria exclusion criteria: * insulin dependency * smokers * history of or presentation with cardiovascular disease, cancer, and chronic hematological, renal, hepatic, pulmonary disease * weight loss (\>2 kg in previous 6 months) * physical activity (\>150 mins/week)
the reclaim study.

Conditions: Chronic Migraine; High Frequency Episodic Migraine

Summary: the purpose of this study is to evaluate the safety and performance, including clinical benefit, of the primus system for the treatment of resistant migraine.


Eligibility criteria:
inclusion criteria: * diagnosis of migraine as defined by the ichd-3 classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening * failure of 3 or more preventive pharmacological therapies * stable on preventive migraine treatments * psychologically stable exclusion criteria: * concomitant invasive or non-invasive neuromodulation * previous exposure to an implantable neuromodulation device for headache * have an existing active implantable medical device nearby the implant location (e.g. dbs, cochlear implant) * use of onabotulinum toxin a injections for the treatment of migraine in the past 3 months. * use of steroid infiltrations or iv administration in the past 3 months. * not pregnant, nursing or not using contraception
schema therapy for chronic depression

Conditions: Chronic Depressive Disorder; Dysthymic Disorder

Summary: to compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.

a randomized, assessor-blind, single center, superiority trial will be conducted. participants will be referred to clinical psychologists in a private counseling office (senzoku stress coping support office, in japan). eligible participants will be women with chronic depression receiving psychiatric care. participants will receive schema therapy or active monitoring during 2 years. primary outcome will be treatment response. a total sample size of 64 (32 in each group) would be required to provide 80% power at a 2-sided significance level of 5% to detect a risk difference of 35% (response rate: 55% for schema therapy vs. 20% for active monitoring), assuming a dropout rate of 10%.

Eligibility criteria:
inclusion criteria: * persistent depressive disorder including chronic major depressive disorder and dysthymic disorder assessed by the structured clinical interview for dsm * scores of at least 14 on the grid-hamd * psychiatric treatment duration for depression of at least 3 years exclusion criteria: * psychiatric hospitalization within 30 days prior to the enrollment * ineligible to receive the protocol treatment during 2 years * schizophrenia * bipolar disorders * intellectual disabilities * neurocognitive disorders * substance-related disorders
erector spinae plane block versus retrolaminar block for analgesia in percutaneous nephrolithotomy

Conditions: Postoperative Analgesia; Pain Management; PCNL; Regional Anesthesia Block

Summary: the study will investigate the effects of ultrasound-guided espb and rlb on intraoperative and postoperative analgesia in patients undergoing pcnl to identify a safe and effective regional block method for postoperative analgesia

all the patients will be blinded to the intervention received in this study. all patients will receive standard general anesthesia technique with endotracheal intubation and muscle paralysis. postoperatively, all patients will receive analgesia in the form of non-steroidal anti-inflammatory drugs and paracetamol. in case the vas scores exceeded 4 in any group, the patients will receive rescue analgesia with 25 mg iv meperidine. in both groups, the espb and rlb will be performed after induction of general anesthesia using portable ultrasound device.

Eligibility criteria:
inclusion criteria: - patients scheduled for pcnl exclusion criteria: * daily consumption of analgesics * allergy to local anesthetics * liver dysfunction * infection or previous surgery in the vertebral region. * patient refusal * pregnancy

Keywords: postoperative analgesia pain erector spinae retrolaminar block pcnl
deep brain stimulation therapy and intestinal microbiota

Conditions: Deep Brain Stimulation; Gastrointestinal Microbiome

Summary: this study aims to observe the changes of intestinal microbiota after deep brain stimulation (dbs) therapy for parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of dbs.


Eligibility criteria:
inclusion criteria: 1. \> 18 years of age; 2. primary parkinson's disease diagnosed according to british brain bank criteria (hoehn and yahr); 3. deep brain stimulator therapy; 4. sign the informed consent. exclusion criteria: 1. use of probiotics or probiotics during the study; 2. use antibiotics against intestinal bacteria at present or within the last 1 month; 3. with cognitive dysfunction or mental illness; 4. with severe diseases or is not expected to survive for more than a year; 5. a history of gastrointestinal surgery; 6. aids patients, hepatitis b/c positive.
humidified high flow nasal cannula versus nasal intermittent positive ventilation in neonates

Conditions: Respiratory Insufficiency

Summary: the investigators hypothesize that the humidified high flow nasal cannula(hhfnc) is effective and safe as primary respiratory support in neonate with respiratory distress syndrome(rds). it is more convenient in hhfnc combined with kangaroo care.

today a new nursing principle proposed that is kangaroo care in neonate.many study showed kangaroo care may reduce pain、decrease the respiratory and heart rate among preterm infant.the recently study show it benefit to physical growth and neurodevelopment. respiratory failure remains a common problem in the neonatal intensive unit. as reported that early non-invasive ventilation is accompanied by significant improvement in subsequent lung development and alveolation.nasal continuous positive airway pressure (ncpap)、nasal intermittent positive pressure ventilation(nippv) and humidified high flow via nasal cannulas(hhfnc) are non-invasive ventilation models.but unfortunately, nippv and ncpap systems are not always easily applied or tolerated in the preterm infants.so it is not convenient in kangaroo care.recently a meta analysis concluded that nippv is more effective than ncpap in preterms respiratory diseases.maybe the investigators can reason that nippv is effective than hhfnc,but there is limited data about the comparison of nippv and hhfnc as primary respiratory support in neonate. the nippv group fail definition：1、fio2\>40%、map\>10 centimeter water column (cm h2o),but sao2\ 60 millimeter of mercury (mmhg)or partial pressure of arterial oxygen (pao2)\ 6 episodes requiring stimulation in 6 hours or requiring \>1 episodes of positive-pressure ventilation) 5.potential of hydrogen (ph)\ 40%、flow\>8 (litre,l)/min,but sao2\ 60mmhg or pao2\<45mmhg.4、severe apnea 5.ph\<7.2

Eligibility criteria:
inclusion criteria: 1. birth weight \> 1000 grams and \> 28 weeks gestation 2. have respiratory distress syndrome and need assistant ventilation exclusion criteria: 1. birth weight \< 1000 grams 2. estimated gestation \< 28 weeks 3. infants have contraindications for use of non-invasive ventilation 4. active air leak syndrome 5. infants with abnormalities of the upper and lower airways; such as pierre- robin, treacher-collins, goldenhar, choanal atresia or stenosis, cleft lip and/or palate, or 6. infants with significant abdominal or respiratory malformations including trachea-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia.

Keywords: nippv hhfnc rds neonate