Kornimate/medical-research-clean huggingface dataset:
a clinical trial to evaluate the efficacy and safety of choline alfoscerate compared to placebo in patients with degenerative mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this is a multi-center, randomized, double-blind, placebo-controlled, phase iv trial to evaluate the efficacy and safety of choline alfoscerate compared to placebo in patients with degenerative mild cognitive impairment.

subjects will be randomised in a 1:1 ratio to receive either choline alfoscerate or its placebo. investigational products(ip, choline alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.

Eligibility criteria:
inclusion criteria: 1. age ≥ 55 years 2. diagnosis of mild cognitive impairment due to alzheimer's disease that meets nia-aa criteria 3. diagnosed with mild cognitive impairment on snsb 4. delayed recall score of svlt ≤ "average -1.5 standard deviation" 5. k-mmse-2 score ≥ 24 6. the cdr score 0.5, and the memory item score 0.5 or 1 point 7. patients with caregivers who are in regular contact, can visit together 8. walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs) 9. sufficient vision, hearing, language skills, motor skills, and understanding to follow the examination procedure. 10. written informed consent exclusion criteria: 1. diagnosis of dementia (including secondary dementia due to alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., hiv, syphilis, creutzfeld-jacob disease), pixie disease, huntington's disease, parkinson's disease, etc.) 2. medication of dementia within the past three months 3. brain functional improvement medication in the past six weeks. 4. medication that may affect cognitive function during clinical trials 5. no studies (no regular school entrance), illiteracy 6. significant neurological conditions (such as stroke, multiple sclerosis, severe head trauma with loss of consciousness, cerebral palsy, cerebral tumor, cerebral infarction, spinal infarction or central nervous system infection) and/or evidence (ct or mri results performed within the past 12 months or during screening) 7. abnormal results from vitamin b12, thyroid stimulated hormone test (tsh), hiv-ab, and vdrl test contribute to or contribute to cognitive impairment of the subject 8. serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.

Keywords: mild cognitive impairment choline alfoscerate
the influence of different training regimens on electrical stability following myocardial infarction

Conditions: Ischemic Heart Disease; Congestive Heart Failure

Summary: the hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart.


Eligibility criteria:
inclusion criteria: * s/p acute myocardial infarction 14-30 days * ability to perform exercise exclusion criteria: * unstable angina * chronic atrial fibrillation * severely reduced lv function * nyha 4 * severe valvular disease
the impact of interactive, multifaceted approach education on congenital cataract

Conditions: Congenital Cataract

Summary: to evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction.

prospective study including parents of congenital cataract, randomized in two groups: health education program with an interactive, multifaceted approach versus conventional follow-up. a health education module consisting of a lecture and workshop was incorporated into a health-care course. a non-validated survey assessed knowledge. parental stress was assessed using self-questionnaires before and after training .at each moment we evaluated the level of anxiety, satisfaction of information quality and the comprehension-memorization of the data.

Eligibility criteria:
inclusion criteria: * children with regulated cataract surgery exclusion criteria: * difficulty in understanding the language * uncompleted questionnaires or badly filled in by two different people
tips in patients with decompensated liver cirrhosis

Conditions: Decompensated Liver Cirrhosis

Summary: this is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (tips) at hannover medical school. by collecting and analyzing clinical data as well as blood samples, the overall aim is to optimize tips therapy (e.g. specify selection criteria).


Eligibility criteria:
inclusion criteria: * liver cirrhosis * indication for tips insertion * treatment at the department of gastroenterology, hepatology and endocrinology of hannover medical school * informed consent exclusion criteria: * pregnancy or lactation * age \<18 years * lack of informed consent * symptomatic anemia with hb \<7g/dl

Keywords: portal hypertension tips refractory ascites variceal bleeding liver cirrhosis
an observational study of avastin (bevacizumab) in combination with xeloda (capecitabine) and oxaliplatin in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: this prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. data will be collected from each participant until disease progression occurs (for up to 30 months).


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * metastatic colorectal cancer * treatment in accordance with current summary of product characteristics and local guidelines exclusion criteria: * contraindications according to current summary of product characteristics and local guidelines
pediatric hydroxyurea phase iii clinical trial (baby hug) follow-up observational study ii protocol

Conditions: Sickle Cell Anemia

Summary: the baby hug treatment study was designed to see if treatment with the drug hydroxyurea (also called hu) in children with sickle cell disease could prevent organ damage, especially in the spleen and kidneys. there was also a chance that treatment could prevent painful crises, lung disease, stroke, and blood infection.

the current observational trial, follow-up study ((fus) ii includes enhanced neuropsychological, brain, cardiac, and pulmonary evaluations for this very well characterized cohort of subjects. measures of spleen and renal function and markers of dna damage will continue to be collected. assessment of other target organs in sickle cell disease including pulmonary and cardiac function will be performed in addition to evaluation of developmental aspects of sickle cell disease (scd) and potential hu toxicity.

Eligibility criteria:
inclusion criteria: * all subjects enrolled in the baby hug follow-up i study who participated for at least 24 months are eligible for the follow-up study ii exclusion criteria: * subjects that have received a stem cell transplant are not eligible for enrollment
incidence of pneumonia and related consequences in nursing home residents

Conditions: Pneumonia

Summary: in the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the french ehpad (etablissements d'hébergement pour personnes agées dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant reductions in the healthcare costs. in fact, although the number of pneumonia cases may be numerically limited, the consequences of each event are potentially catastrophic for both the patient and the healthcare system. unfortunately, to date, information about the incidence and economical effects of pneumonia in the older population living in the french ehpad are extremely scare. to adequately evaluate whether there is room to implement preventive interventions aimed at reducing the onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this specific population are needed. this first step is crucial towards the appropriate design and conduction of possible future large-scale intervention trials in the ehpad setting.


Eligibility criteria:
inclusion criteria: * groups iso-resources (gir) ranging between 5 (included) and 2 (included) * ability and willingness to participate to the study and to provide informed consent * agreement with the patient's physician about the enrolment to the study exclusion criteria: * refusal of the ehpad to participate * patients with severe disability (gir 1) * patients with no evidence of functional impairment (gir 6) * patients living in the participating ehpad for less than 30 days since the baseline study visit

Keywords: elderly
cross-cultural adaptation, evaluation and validation of wang qi's constitution of tcm questionnaire (for old person)

Conditions: Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person)

Summary: this is a cross-cultural adaptation, evaluation and validation study of wang qi's constitution in tcm questionnaire (for old person) in hong kong to investigate the content validity, construct validity and reliability of the ctcmq-c in cantonese speaking hong kong chinese elderly population.

the study includes two steps. firstly, translation of the questionnaire into cantonese, followed by cross-cultural adaptation. ten chinese medicine practitioners (cmps) and 30 patients will be recruited from the community and the outpatient clinics of hong kong baptist university (hkbu) to evaluate the constitution in tcm questionnaire (for old person) (cantonese version) (ctcmq-c) for content validity by the cognitive debriefing interviews. the content validity indices (cvi) of clarity, relevance and appropriateness of each item of the questionnaire rated by cmps and patients will be quantified. the interpretations of items and suggestions of rewording by the patients and cmps will be analyzed qualitatively to identify any item of the questionnaire that is not valid for the chinese population in hong kong. secondly following the validation study, 264 patients will be recruited. a validated ctcmq-c will then be generated and will be endorsed by expert panel to use in the subsequent cross-sectional and cohort studies to evaluate the preventive effect with chinese medicine approaches. the psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (cfa) and reliability of the ctmcq-c will also be tested.

Eligibility criteria:
inclusion criteria: * aged 65 and above; * hong kong residents; * capable of consenting and have agreed to participate. exclusion criteria: * not fulfill the above inclusion criteria; * having serious diseases with undesirable conditions that unable to complete the survey; * having serious mental and behavioral disorders.
positive pressure at induction of anesthesia in children

Conditions: Continuous Positive Airway Pressure; Hypoxia; General Anesthesia

Summary: scenario: hypoxemia is one of the most common adverse events during the induction of general anesthesia and may culminate with more serious complications such as cardiac arrest and death. pediatric patients, due to their anatomical and physiological characteristics, are more likely to develop hemoglobin desaturation levels. some preventive strategies are used during this period to reduce the chances of occurrence of adverse event. continuous positive airway pressure (cpap) may be useful during anesthetic induction in delaying the drop in oxygen levels in the blood by increasing this body gas reserves. objectives: to assess the effectiveness of cpap during anesthetic induction in increasing apnea time until hemoglobin saturation falls to 95% in children undergoing general anesthesia for elective surgery. methods: phase iii, parallel, randomized clinical trial to be developed at the teaching hospital of the federal university of pernambuco. patients (72) are divided into two groups (36 in each) in which all patients will spontaneously ventilate: group c will receive cpap and group a will use the open system. children of pre-school age with physical status i or ii, according to the american anesthesia society, candidates for elective surgery under general anesthesia will be included. patients with pre-existing parenchymal lung disease, cyanotic children or patients with oxyhemoglobin saturation \<95% prior to anesthetic induction and recent history (\<4 weeks) or active upper respiratory tract infection will be excluded. the descriptive statistical analysis will be carried out through measures of central tendency and dispersion for quantitative variables and via distribution of frequencies for qualitative variables. ethical aspects: this work will respect human rights, principles of bioethics, the resolution 466/2012 of the national health council and the statement from helsinki. submission and approval by the research ethics committee is required prior to data collection. keywords: continuous positive airway pressure, hypoxia, general anesthesia


Eligibility criteria:
inclusion criteria: * pre-school children, asa physical status i or ii, children undergoing general anesthesia for elective surgery exclusion criteria: * pre-existing parenchymal lung disease, children cyanotic or with oxyhemoglobin saturation less than 95% before anesthetic induction, recent history (\<4 weeks) or current upper respiratory tract infection
vitiligo treated with tl01 combined with tacrolimus ointment versus placebo

Conditions: Vitiligo

Summary: background vitiligo is a common, often distressing condition. many of the patients do not achieve sufficient effect from what is regarded as the treatment of choice at present, narrow band(nb)uvb(tl01). there are reports on some patients partly successfully treated with tacrolimus ointment. aim of the study we want to study whether tacrolimus ointment may give an additive effect on symmetric vitiligo in combination with nb-uvb. methods this is a double blind left/right comparative study with 6 months treatment time. patients are treated with whole body nb-uvb x 2 or x 3 weekly, in addition to tacrolimus ointment versus placebo every night on affected half body sites. to measure effects we use photodocumentation in addition to morphometric registration of symmetric target lesions every 6 weeks.


Eligibility criteria:
inclusion criteria: * patients aged at least 18 years with a stable, symmetric vitiligo exclusion criteria: * patients with segmental vitiligo, aged \< 18 years, known hypersensitivity to tacrolimus, pregnant or breastfeeding women

Keywords: vitiligo tacrolimus ointment 0.1% narrowband uvb (tl01)
insulin pump therapy in adolescents with newly diagnosed type 1 diabetes (t1d)

Conditions: Diabetes Mellitus, Insulin-Dependent

Summary: within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (mdi) using lantus insulin, or continuous subcutaneous insulin infusion (csii; pump therapy). the study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).

within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (mdi) using lantus insulin, or continuous subcutaneous insulin infusion (csii; pump therapy). the proposed protocol compares the changes in diabetes control between pump therapy and mdi treatment groups. more importantly, however, the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control, specifically focusing on changes in insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing). demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes.

Eligibility criteria:
inclusion criteria: * male or female patient between the age of 12 and 17 years inclusive at time of entry into study (i.e., after their 12th but before their 18th birthday) * type 1 diabetes mellitus for no more than 10 days * pubertal (tanner stage 2 or above) * the patient and parents or guardians should be able to do simple math calculations (necessary for pump management) * parent or legal guardian must give signed informed consent exclusion criteria: * no other chronic medical conditions (well-controlled thyroid disease is ok, and mild asthma is ok if the patient is not on chronic inhaled or oral daily corticosteroids) * exceptional psychological stress, more than expected for circumstances of having the new diagnosis of diabetes * inability or unwillingness to comply with requirements of the protocol

Keywords: type 1 diabetes diabetes new onset csii insulin sensitivity beta cell function beta cell preservation
gastrointestinal transit time in patients with severe acquired brain injury

Conditions: Brain Injury; Constipation

Summary: empirically patients with acquired brain injury (abi) are often constipated. this is a major clinical issue. nevertheless, this has only been sparsely studied. the investigators will measure gastrointestinal transit time (gitt) in 30 patients with abi, and compare this to healthy controls. secondly heart rate variability (hrv) is measured in these patients, and associations between hrv and gitt are investigated.


Eligibility criteria:
inclusion criteria: * abi: * moderate to severe traumatic brain injury (tbi) (glasgow coma scale (gcs) score 3-12 at admission) * or stroke * or anoxic brain injury * ability to swallow the capsules used to assess gitt * ability to give meaningful informed consent to participate in the study exclusion criteria: * major abdominal disorders * severe acute comorbidity * known cancer * pregnancy * known autonomic neuropathy * other known neurological disorder
a study in benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of benign prostatic hyperplasia (bph), measured by resistive index (ri) in the prostate transition zone.


Eligibility criteria:
inclusion criteria * present with benign prostatic hyperplasia * provide signed informed consent at the screening * agree not to use other treatment for benign prostatic hyperplasia, erectile dysfunction or overactive bladder (including herbal treatments) during the study exclusion criteria * have prostatic cancer or are being treated for cancer. * any condition that may negatively influence the transrectal ultrasound. * are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin). * any evidence of moderate to severe cardiac disease * have had any of the following in the past 90 days: chest pain (called unstable angina or angina) that requires treatment, heart attack also known as myocardial infarction, heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to open up blood vessels in the heart know as angioplasty or stent placement (percutaneous coronary intervention), positive cardiac stress test without effective cardiac intervention. * have very high or very low blood pressure. * have uncontrolled diabetes. * have certain problems with your kidneys, liver, or nervous system.
pioglitazone regress left ventricular mass in type 2 diabetes with ischeamia heart disease

Conditions: LVM; Type 2 Diabetic Patients With IHD; Endothelial Function

Summary: cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to ischeamia heart disease (ihd). most of the attention in treating ihd in type 2 diabetes is understandably directed toward treating coronary artery conditions. however there are other treatable culprits in these patients. left ventricular hypertrophy (lvh) is widespread in type 2 diabetic patients with ihd, even in the absence of hypertension. it is a strong predictor of cardiovascular events and all-cause mortality. in one study, the presence of lvh was a stronger predictor of mortality than either multivessel coronary disease or impaired left ventricular function. regression of lvh has been associated with an improved prognosis, independent of change in blood pressure (bp). therefore, cardiovascular events and mortality in type 2 diabetes with ihd might will be reduced if we can find novel therapies to regress lvh. pioglitazone can improve atherosclerosis. therefore, we hypothesied that pioglitazone can regress the left ventricular mass (lvm) in type 2 diabetes with ihd.therefore, in this study, we will treat patients with pioglitazone, and we will also metformin as control.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * aged 40～75 years old * with ihd exclusion criteria: * heart failure * renal failure * hypertension (\>130/80 mmhg) * hemoglobin a1c 9%

Keywords: type 2 diabetes left ventricular mass pioglitazone
collecting and storing biological samples from patients with ewing sarcoma

Conditions: Askin Tumor; Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Summary: this research study is collecting and storing samples of tumor tissue, bone marrow, and blood from patients with ewing sarcoma. collecting and storing samples of tumor tissue, bone marrow, and blood from patients with cancer to test in the laboratory may help the study of cancer in the future.

objectives: i. collect biological specimens, including associated demographic and clinical data, from patients with ewing sarcoma. ii. provide a repository for long-term storage of ewing sarcoma-related biological materials. iii. make collected specimens available to qualified researchers to understand the biology of ewing sarcoma and correlate these results with demographic and clinical data. outline: this is a multicenter study. patients undergo collection of tumor specimens, bone marrow, and peripheral blood at diagnosis. associated demographic and clinical data are collected and archived. patients who are not enrolled on a therapeutic clinical trial are followed annually.

Eligibility criteria:
inclusion criteria: * diagnosis of ewing sarcoma, including peripheral primitive neuroectodermal tumor and askin tumor * newly diagnosed or recurrent disease