Kornimate/medical-research-clean huggingface dataset:
a crossover study with hexalacton in patients with type 1 diabetes and microalbuminuria

Conditions: Diabetes Mellitus; Nephropathy; Blood Pressure

Summary: a double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (hexalacton (r)) for 60 days followed by 60 days treatment with placebo(or opposite). primary aim: albuminuria, an expected decrease during hexalacton treatment. secondary aim: ambulatory blood pressure, gfr, plasma-renin, angiotensin, aldosteron.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * age 18-80 years * microalbuminuria exclusion criteria: * blood pressure\> 160/100 mmhg * persistent macroalbuminuria * pregnancy or in risc of this * p-potassium\>5.7 mmol/l * eplerone treatment
exploring the recovery function of sleep in neurodegeneration

Conditions: Neurodegenerative Diseases

Summary: the overall objective of this study is to identify the best approach for assessing the recovery function of sleep in neurodegenerative diseases associated with abnormal protein aggregation with regard to the conception of future intervention studies. to this end, the investigators will follow an exploratory approach in a preferably broad data set collected in patients with neurodegenerative diseases associated with abnormal protein aggregation and in healthy humans.

first, the investigators want to assess the relationship between sleep parameters (e.g. sleep intensity) and behavioral/cognitive performance and subjective measures (e.g. sleep quality, mood, and sleepiness) in patients with neurodegenerative disorders associated with abnormal protein aggregation. healthy subjects will be assessed for procedure validation and reference purposes. second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.

Eligibility criteria:
inclusion criteria: * good general health or confirmed diagnosis of neurodegenerative disease associated with abnormal protein aggregation along international criteria * age above 18 years * in ambulant setting: ability to apply the ambulant eeg device for the duration of the study, either alone or with help of co-habitant if moca \< 20 exclusion criteria: * failure to give informed consent * inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits * known or suspected non-compliance, drug- or medication abuse * inability to hear the tones to be applied during sleep in auditory stimulation experiments * skin disorders/problems/allergies in face/ear area that could worsen with electrode application * regular intake of drugs that may alter the relationship between sleep and outcome variables under investigation (opioids, benzodiazepines and z-drugs (nonbenzodiazepines)). * clinically significant concomitant disease states * too high (disease) burden for patients * additional non-medical exclusion criteria may be defined for certain cognitive tasks (e.g. no glasses during experiments involving eye tracking)

Keywords: parkinson's disease huntington's disease mci neurodegenerative diseases sleep auditory stimulation
gene expression profiling in human gastric intestinal metaplasia mucosa and duodenal mucosa

Conditions: Gene Expression Profiling; Gastric Intestinal Metaplasia; Duodenum

Summary: to analyze the genome pattern in human gastric intestinal metaplasia mucosa and duodenal mucosa.


Eligibility criteria:
inclusion criteria: * patients scheduled for gastroendoscopy examination exclusion criteria: * esophageal, gastric or duodenal cancer or other malignancy history of upper gi tract surgery coagulopathy or bleeding disorders allergy to fluorescein sodium
a pilot feasibility trial of thyroid hormone replacement in dialysis patients

Conditions: Thyroid Disease; Kidney Diseases, Chronic

Summary: hypothyroidism, defined by elevated thyrotropin (tsh) levels, is a common endocrine complication of chronic kidney disease that has been associated with impaired quality of life and cardiovascular complications. while levothyroxine is one of the most frequently prescribed medications in chronic kidney disease patients, little is known about its efficacy and safety in this population. this study will investigate 1) whether levothyroxine adequately lowers thyrotropin (tsh) levels to therapeutic target ranges, and 2) if thyroid hormone replacement improves quality of life and cardiovascular markers, without leading to wasting in dialysis patients.


Eligibility criteria:
inclusion criteria: * prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level. exclusion criteria: * hyperthyroidism, active treatment with thyroid hormone replacement, prior thyroid malignancy, active pregnancy, active coronary ischemia or atrial fibrillation, osteoporosis, inability to provide consent without a proxy.
early prevention of childhood obesity: an active pregnancy

Conditions: Pregnancy

Summary: the main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring.

the environment where the fetus growths up is essential for the risk of developing some diseases in later life, such as obesity. exercise has showed being useful in the prevention on excessive maternal weight gain which is linked to fetus weight.

Eligibility criteria:
inclusion criteria: * being healthy and able to exercise following american college of obstetricians and gynecologists (acog) guidelines * being able to communicate in spanish * giving birth at hospital universitario de torrejón, hospital universitario de puerta de hierro and hospital universitario severo ochoa (madrid). exclusion criteria: * multiparity * obstetrician complications * being interested in the study after 16 weeks * not being regular in physical exercise program * younger than 18 years old
clinical significance of smear or culture positive for candida spp. from sputum three times a week

Conditions: Pulmonary Candidiasis

Summary: the definition of pulmonary candidiasis is still unclear.in china, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. the investigators hypothesize that patients who present respiratory symptoms and lung infiltrates together with smear of culture positive for candida spp. from sputum three times a week can not be diagnosed as pulmonary candidiasis.


Eligibility criteria:
inclusion criteria: * 85ys\>age\>14ys * apache ii\<25 * lung infiltrates together with at least one of the following symptoms:cough, sputum, dyspnea with or without fever * smear or culture positive for candida spp. from sputum exclusion criteria: * pregnancy * hypersensitivity to fluconazole * isolated candida was non-sensitive to fluconazole * severe liver or renal diseases who can not tolerate fluconazole treatment * with at least one of the following high risk factors:organ transplantation, neutropenia\>10ds, long term glucocorticoids therapy(equal to prednisone 30mg/d longer than 2 weeks), immunosuppressive therapy within 30ds, aids * with one of the microbiological evidence:isolation of candida spp. from blood or other kinds of sterile site(not including urine), filamentous fungi isolated from sputum or balf, cryptococcus isolated from sputum or csf, galactomannan antigen positive twice for blood * probable or possible pulmonary aspergillosis * definite oral or esophageal candidiasis
value on survival of liver volume after an acute decompensation of an alcoholic cirrhosis

Conditions: Alcoholic Cirrhosis; Alcoholic Liver Disease

Summary: investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). our hypothesis is that patients with a "small" liver have a lower survival compared to patients having a "normal" sized liver.

in this observational, prospective and multicentre clinical trial, investigator seek to determine the prognostic value of liver volume during an acute decompensation. investigator plan to enroll admitted adult patients with acute decompensation of an alcoholic cirrhosis (abstinent or not), followed for one year or until death or liver transplantation. liver volume will be evaluated using ct-scan or mri reconstructions.

Eligibility criteria:
inclusion criteria: * adult patients * patient suffering from alcoholic cirrhosis (withdrawn or not) * patient admitted in emergency for an alcoholic cirrhosis decompensation only * prescription for a cutting imaging (ct scan or mri) during hospitalisation * alcohol consumption of more than 3 units per day for men and 2 units for women in average, over at least the last 5 years before the cirrhosis diagnosis * patient suffering from decompensated cirrhosis defined by at least one of the following criteria : model for end-stage liver disease (meld) score above or equal to 15, ascites needing iterative punctures, symptomatic bacterial ou fungal infections, acute digestive bleeding due to portal hypertension, hepatic encephalopathy defined by a west haven score above or equal to 2 exclusion criteria: * nodule with typical criteria of hepatocellular carcinoma * b or c viral infections actives * presence of transjugular intrahepatic portosystemic shunt (tips) * presence of an occlusive thrombosis of the porta or one of the principal branches * presence of a thrombosis of the sus-hepatic vein * active extra-hepatic malignant tumor * decompensated cardio-vascular disease * patient unwilling to participate to the study

Keywords: liver volume alcoholic cirrhosis liver transplantation
culture-based multicomponent cognitive training program

Conditions: Nursing Caries

Summary: to provide care without exacerbating behavioral and psychological problems and preventing functional decline, a multi-component, cognitive training program was designed. the purpose of this study is to test the effectiveness of this multi-component, cognitive training program in day care centers for elderly people with dementia to prevent cognitive function decline, self-care abilities decline, and behavior problems or the development of depressive moods.

the purpose of the study is to test the effectiveness of this multi-component, cognitive training program in day care centers for elderly people with dementia to prevent cognitive function decline, self-care abilities decline, and behavior problems or the development of depressive moods. this study was a 4-month cluster-randomized controlled trail. participants who met sample selection criteria were recruited and assigned to either the experimental group or the comparison group, depending on the day-care center they attended. subjects in the experimental group were received with the multi-component, cognitive training program (mcctp) via research assistants (ras) and caregivers of day care center for 8 weeks, then provide by caregivers of day care center for 8 weeks, as well as ras provided assistance for activity process.

Eligibility criteria:
inclusion criteria: 1. persons aged 60 years and over, (2) living in their own home, (3) with or without a hearing device and able to speak mandarin or taiwanese, (4) attending a day care centre at least three days per week, (5) cognitively impaired as determined by a score of 22 or lower on the mini-mental state examination (mmse), and (6) self or legal proxy agreed to participate in the study. exclusion criteria: - persons were excluded if they were bedridden and unable to sit in a wheelchair or had one or more acute illnesses during the data collection period causing them to be unable to return to the day care centre.
imipramine and pregabalin combination in painful polyneuropathy

Conditions: Polyneuropathy

Summary: polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. the hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone. this is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. the study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.


Eligibility criteria:
inclusion criteria: * age between 20 - 85 years. * characteristic symptoms of polyneuropathy for at least 6 months. * polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests. * total pain intensity rating of at least 4 on a 0-10 points numeric rating scale. * pain present at least 4 days a week. * for diabetics: diabetes diagnosis for at least 6 months and stable metabolic control for at least 3 months. * for other secondary polyneuropathies: stable for at least 6 months. * for fertile females: adequate anticonceptive treatment. * written informed consent. exclusion criteria: * other cause of pain. * contraindications against imipramine. * allergic reactions towards imipramine or pregabalin. * known adverse reactions during imipramine or pregabalin treatment. * pregnancy. * severe systemic disease. * ongoing treatment with antidepressants, antipsychotics, anticonvulsants, opioids, propranolol, kinidine, monoamine oxidase inhibitor. * inability to follow study protocol.

Keywords: polyneuropathy neuropathic pain treatment
a registered cohort study on charcot-marie-tooth disease

Conditions: Charcot-Marie-Tooth Disease

Summary: the aim of the study is to analyze the natural history data data from charcot-marie-tooth disease and related disorders in china, to assess the clinical, genetic, epigenetic features of patients with charcot-marie-tooth disease, and to optimize clinical management.


Eligibility criteria:
inclusion criteria: * patients with the clinical diagnosis of charcot-marie-tooth disease * genetic diagnosis of patients with charcot-marie-tooth disease * unrelated healthy controls exclusion criteria: * decline to participate. * other peripheral neuropathy caused by trauma, immunity and toxicosis.
ras peptide profiles in patients with treatment-resistant arterial hypertension

Conditions: Hypertension

Summary: this study evaluates ras peptides profiles in patients with treatment resistant arterial hypertension.

selective quantification of ras peptides in human plasma triggered investigations evaluating whether ras peptides could be used as clinical biomarkers in patients receiving antihypertensive treatment. drug-specific ras profiles first characterized in healthy normotensive subjects (ekbb 255/12; clinicaltrials.gov id nct01771783) are presently investigated in patients with newly diagnosed arterial hypertension (eknz 2015-081; clinicaltrials.gov identifier (id) nct02449811). with this observational study ras peptide profiles will be characterized in patients with treatment resistant hypertension. data generated by this study will show whether ras peptide profiles merit further evaluation as clinical biomarkers in this complex patient group.

Eligibility criteria:
inclusion criteria * office blood pressure ≥ 140/90 mmhg and mean 24 hour blood pressure \>130/80 mmhg on average, or \>135/85 mmhg during the day, or \> 120/70 mmhg during the night, despite concurrent use of 3 antihypertensive agents at optimal doses, including one diuretic or * office blood pressure and 24 hour mean blood pressure controlled with four or more medications * age ≥ 18 years * ability to understand research procedures and to provide written informed consent exclusion criteria * known secondary arterial hypertension at time of inclusion or diagnosis of secondary hypertension after study inclusion during routine work-up of treatment resistant hypertension * known obstructive sleep apnea at time of inclusion * history of, or clinically relevant or uncontrolled cardiovascular disease (other than arterial hypertension), namely myocardial infarction within last 3 months or valvular heart disease with clinically relevant reflux or heart failure * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the research project or compliance with the research plan.

Keywords: treatment-resistant
pelvic sentinel node detection using indocyanine green learning curve

Conditions: Endometrial Cancer

Summary: according to esgo-estro-esmo guidelines, pelvic sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri. nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling. the aim of the study is to assess the success of sentinel lymph node detection according to shrec-trial surgical strategy.

introduction: according to esgo-estro-esmo guidelines, pelvic sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri. the aim of the study is to assess the success of sentinel lymph node detection according to shrec-trial surgical strategy. patients and method: all patients presenting with early figo stage and low, intermediate, high intermediate or high risk endometrial carcinoma will be prospectively enrolled. sentinel lymph node mapping will be performed using laparoscopic approach and cervical indocyanine green injection. based on the surgical algorithm for detection of pelvic sentinel lymph node in endometrial cancer from persson and coll., we designed a study with a target of 70% to 90% of bilateral detection rate . thirty patients will be included over 18 months.

Eligibility criteria:
inclusion criteria: letter of non objection endometrial carcinoma stage figo i-ii whatever the histological subtype. esgo-esmo-estro 2021 risk classification : low, intermediate, high intermediate, high laparoscopic approach. exclusion criteria: participation refusal medical contraindication to laparoscopic approach. stage figo \> ii suspected indocyanine green allergy

Keywords: endometrial cancer
multicomponent program for the integrated management of chronic pain and depression in primary care

Conditions: Depressive Disorder; Musculoskeletal Pain; Chronic Pain

Summary: this study evaluates whether the implementation of an integrated clinical program for chronic musculoskeletal pain and depression behave better clinical outcomes than the usual approach in primary care

chronic musculoskeletal pain and depression are extremely common and relevant pathological conditions, and frequently presented as comorbid processes multiplying the impact on health, worsening the prognosis and complicating the care. the integrated management of both disorders is an opportunity to achieve better clinical outcomes. aim: to determinate whether the implementation of an integrated clinical program for chronic musculoskeletal pain and depression behave better clinical outcomes than the usual approach in primary care methods design: cluster randomized clinical trials with two arms: 1. intervention: integrated program for depression/chronic pain, and 2. control usual care. settings: primary care centers in tarragona, spain. patients: adults with moderate/severe musculoskeletal pain (brief pain inventory/pain intensity scale \> 4 points), with more than three months of evolution and current diagnostic criteria for major depression episode (dsm-iv). sample: a total sample of 330 patients (165 control arm and 165 intervention arm) divided into 42 clusters of 8 patients. cluster composition: patients registered with the same doctor. intervention: structured program with integrated management for depression/ pain with three main components: 1. optimized care of major depression, 2. case management, and 3. group psychoeducational intervention. measurements: "blind" interviews at 0, 3, 6 and 12 months. main outcomes: * depressive symptoms (hopkins symptom checklist-20): severity, response rate and remission rate. * pain symptoms (brief pain inventory). intensity and interference, response rate. * disability by psychological problems (sheehan disability inventory) * quality of life related to health (euroqol-5d).

Eligibility criteria:
inclusion criteria: * registered patient of a participant doctor * chronic musculoskeletal pain moderate to severe (bpi\>4), with more than 3 months of duration despite having received analgesic treatment * meeting the diagnostic criteria for major depression (dsm iv) at the time of recruitment. exclusion criteria: * patients with mental, physical, language limitation or concurrent illness that prevents understanding/participation in the assessments of the study. * patients with serious or terminal illness. * patients whit psychotic disorder, bipolar disorder or dependence disorder. * pregnant or lactating patient * patients diagnosed of fibromyalgia or somatization disorder * patient in a process of claim for a work disability * intervention for a joint prothesis planned forn next 12 months.

Keywords: primary health care, patient education, care managament
nalirifox combined with pd-1 sequential radiotherapy versus nalirifox as conversion therapy of locally advanced pancreatic cancer

Conditions: Locally Advanced Pancreatic Cancer

Summary: the purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of nalirifox combined with pd-1 sequential radiotherapy versus nalirifox for conversion therapy for locally advanced pancreatic cancer


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confi rmed pancreatic cancer; 2. ecog performance no more than 1; 3. radiographically assessed as locally advanced pancreatic cancer according ; 4. no previous anti-tumor therapy; 5. able and willing to provide a written informed consent. exclusion criteria: 1. prior anti-tumor therapy of any kind; 2. known to be symptomatic central nervous system metastasis and/or cancerous meningitis. 3. patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs; 4. patients with bleeding tendency; 5. pregnant or lactating women.

Keywords: nalirifox conversion therapy locally advanced pancreatic cancer