Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of morning versus evening intake of simvast controlled release (cr) tablet in patients with hyperlipidemia

Conditions: Hyperlipidemia

Summary: the purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of simvastatin controlled release tablet 20mg for 8 weeks in patients with hyperlipidemia. this study will investigate equivalence of the low-density lipoprotein(ldl) cholesterol percent change.


Eligibility criteria:
inclusion criteria: * aged between 19 and 75 * defined as a fasting 100mg/dl≤ ldl cholesterol \<220mg/dl and triglyceride level\<400 mg/dl * need drug therapy by ncep atp iii guideline * signed informed consent exclusion criteria: * has a hypersensitivity to hmg-coa reductase inhibitor or simvastatin * has a presence or history of alcohol abuse or drug abuse * active gallbladder disease within 12 months * pancreatitis or hepatic dysfunction (alt or ast levels \> 2xunl) * hba1c≥ 9% in type 2 diabetes mellitus patients * sbp \ 160mmhg * dbp \ 100mmhg * myocardial infarction or revascularization procedure within 6 months * has significant cardiovascular disease * malignant tumor within 5years * has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia * uric acid level \> 9 mg/dl * thyroid stimulating hormone ≥ 2xunl * active peptic ulcer disease * cpk levels \> 3xunl * creatinine level \> 2 mg/dl * negative pregnancy test for women of childbearing age and agreement to use contraception while on study * had participated other clinical trial within 4 weeks * need systemic administration of corticosteroids intermittently
the arcas study: auditory rhythmical cueing for gait in acute stroke

Conditions: Stroke

Summary: difficulties with walking is a common and distressing problem following stroke and can lead to reduced independence. research suggests that using an auditory cue, such as a regular beat or pulse, as part of rehabilitation can improve walking. it is also recommended that early rehabilitation following stroke delivers the bestoutcome for patients. study aim:to determine whether the use of auditory cueing in early stroke rehabilitation is feasible during a balance and gait therapy programme. study participants: adults following acute stroke with walking problems. participants must be able to sit unsupported and stand with assistance of 1 or 2 people. they will be recruited from the acute stroke unit at north tyneside general hospital 2 days to 4 weeks following stroke. a total of 12 participants will be recruited. study setting: acute stroke unit - north tyneside general hospital and participants homes if they are discharged within the study period. intervention:participants will receive auditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 / week for 3 weeks within the physiotherapy gym on the stroke unit or at home if discharged within the intervention period. the 30 minutes will consist of balance exercises and walking practice using auditory cueing with a metronome. measures:1. what the participants and the therapists think of the intervention will be assessed by questionnaires. the questionnaires contain open and closed questions and have been developed specifically for this study. 2.the stroke survivors trunk control, balance and walking will be assessed before and after the intervention. study duration: 12 months future plans: this study will be used to inform a larger study testing if the intervention works and how much it costs


Eligibility criteria:
inclusion criteria: * adults (\> 18 years) following acute stroke (any subtype) with residual mobility problems * within 2 days - 4 weeks post-stroke. * be able to sit unsupported and stand with assistance of 1 or 2 people * able to provide informed consent to participate in the study. exclusion criteria: * unable to follow the intervention due to cognitive or language impairment. * other medical problems affecting walking and balance (e.g. parkinson's disease, severe osteoarthritis and cardiopulmonary conditions).
assess vitamin d levels in those with & without thyroid cancer

Conditions: Thyroid Cancer

Summary: the purpose of this study is to evaluate vitamin d levels in thyroid cancer patients with active disease compared with thyroid cancer patients in remission and patients with thyroid nodules.

thyroid cancer is the most common endocrine related malignancy, increasing in incidence in recent years. there are relatively few, well known factors, both genetic and environmental, which predispose to the development of thyroid cancer. vitamin d deficiency has been associated with other cancers, but the association between vitamin d and thyroid cancer is unknown. we plan to do a case control, pilot study to evaluate the relationship between vitamin d levels and thyroid nodules, thyroid cancer in remission, and active thyroid cancer.

Eligibility criteria:
inclusion criteria: * cases: history of papillary, follicular, follicular variant of papillary, or hurthle cell thyroid cancer (both active disease and in remission). * controls: individuals with a thyroid nodule, matched to cases for age, bmi, season of vitamin d measurement. * participating in university of nebraska medical center thyroid tumor and cancer collaborative registry database. exclusion criteria: * pregnant or breast feeding women * medullary thyroid cancer * anaplastic thyroid cancer

Keywords: thyroid cancer thyroid nodules vitamin d
a trial in painful diabetic peripheral neuropathy with grt3983y

Conditions: Painful Diabetic Neuropathy

Summary: this trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (dpn).


Eligibility criteria:
inclusion criteria: * symmetrical painful diabetic peripheral neuropathy exclusion criteria: * history of hypersensitivity, allergy or contraindication to opioids and acetaminophen * confounding painful conditions * significant vascular disease * history or risk of seizure * chronic disease that might effect drug absorption, distribution, metabolism, or excretion * female subjects who are being pregnant or breastfeeding * evidence or history of alcohol, medication, or drug abuse

Keywords: analgesia diabetic neuropathy neuropathic pain painful chronic pain
cancer stem cell specific aptamer's ability to detect blood circulating cancer stem cells and its role as a predictor of prognosis in pancreatic cancer

Conditions: Pancreatic Neoplasm

Summary: the treatment performance of pancreatic cancer has not changed significantly over the past 20 years and is still less than 10%. in addition, 80-90% of pancreatic cancer patients are found to be already advanced at the time of diagnosis, and it is the best malignant tumor in the human body with a 5-year survival rate of less than 10% and a median survival period of less than 1 year. however, early diagnosis of pancreatic cancer is still difficult, and there is no effective treatment other than surgery, so the increase in long-term survival rate over the past 20 years has been insignificant or stagnant. the response rate to anticancer drug treatment after surgery or anticancer drug when surgery is not possible is only around 20%, so it is very urgent to discover new biomarkers in predicting drug resistance and recurrence after surgery and predicting prognosis in advance. minimally non-invasive diagnostic techniques are very important to detect and track cancer progression in the clinic. in particular, histological diagnosis and analysis have limitations in carcinomas, such as pancreatic cancer, which are small and distant, making it difficult to obtain tissue samples. ca 19-9, a prognostic marker for existing pancreatic cancer, 1) has low specificity for early diagnosis of pancreas, 2) is not detected in lewis a, b antibody-negative patients, and 3) shows false positive in cases with cholangitis at the same time. because it has many disadvantages, the development of prognostic biomarkers in blood is urgently needed. recently, a study has been reported that the presence or absence of detection of circulating tumor cells is directly related to the prognosis of pancreatic cancer patients, and can be used for monitoring the patient's treatment response and for recurrence after surgery. in particular, the process of cancer metastasis consists of epithelial-to-mesenchymal transition and migration of cancer cells into the blood, and the existence of cancer stem cells is very important for metastasis and drug treatment resistance. eventually, it is known to cause pancreatic cancer metastasis and recurrence. cancer stem cells have the ability to self-renew, the capability of developing, multiple cell lineages, and the potential of extensive proliferation, and the ability to detect cancer stem cells in the blood is important in pancreatic cancer patients who are at high risk of metastasis and recurrence. it is a non-invasive screening tool. comparatively evaluate the treatment response and prognosis of pancreatic cancer patients according to the characteristics and subtypes of circulating cancer cells.


Eligibility criteria:
inclusion criteria: * men and women over 20 years of age * patients diagnosed with pancreatic cancer histologically or radiologically exclusion criteria: * non-pancreatic cancer * patients who failed to obtain informed consent from the patient
effects of a carbonated water enriched with amino acids and chromium picolinate (good idea®) on glucose homeostasis.

Conditions: Postprandial Hyperglycemia; Metabolic Syndrome; Type 2 Diabetes Mellitus

Summary: it has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. based on these findings, a flavored sparkling water product called good idea® with a proprietary blend of five amino acids and chromium picolinate has been developed. this product, along with an identical placebo, are included in this study to evaluate the effects on postprandial blood glucose in healthy, overweight adults when consumed with a standardized, high glycemic test meal. the study will be conducted in a cross-over design, double-blinded and placebo controlled, including 45 participants. the primary endpoint of the study is the incremental area under the curve (iauc) for capillary blood glucose within 180 minutes after ingestion of the meal.


Eligibility criteria:
inclusion criteria: * male or female 18 to 50 years of age * bmi 25-29.9 (±0.5) kg/m² * agree to maintain consistent dietary habits and physical activity levels for the duration of the study * healthy as determined by medical history and information provided by the volunteer * willingness to complete questionnaires and follow instructions associated with the study and to complete all visits * has given voluntary, written, informed consent to participate in the study exclusion criteria: * elevated fasting blood glucose (at or above 6.1 mmol/l) * women who are pregnant or breast feeding * any medical condition(s) or medication(s) known to significantly affect glucose metabolism. significance to be assessed by the qi * use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. significance to be assessed by the qualified investigator (qi). participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician. * known type i or type ii diabetes, including women who previously have had gestational diabetes. * use of antibiotics within 2 weeks of enrollment * metabolic diseases and/or chronic gastrointestinal diseases (ibs, crohns etc.) * allergy to ingredients included in investigational product, placebo or standardized meal * participants restricted to a vegetarian or vegan diet * intolerance to lactose or gluten * individuals who are averse to venous catheterization or capillary blood sampling * currently active smokers (or using other tobacco products, and e-cigarettes) * unstable medical conditions as determined by qi * participation in other clinical research trials * individuals who are cognitively impaired and/or who are unable to give informed consent * acute infection * any other condition which in the qi's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
the china m-protein screening project in first-degree relatives of myeloma patient - the chaperone study

Conditions: Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance

Summary: the goal of the china monoclonal gammopathy screening project in first-degree relatives of patients with multiple myeloma (chaperone) study is to assess the clinical significance of screening for monoclonal gammopathy (m-protein) in first-degree relatives of patients with multiple myeloma in china population, and establish a prospective cohort of individuals with monoclonal gammopathy of undetermined significance (mgus), a precursor conditions to multiple myeloma. we will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

the chaperone study aims to assess the clinical significance of screening for monoclonal gammopathy in first-degree relatives of patients with multiple myeloma in china. the main objectives it aims to answer are: * main research objectives: to study the prevalence of mgus, the time of disease progression, and its influencing factors in first-degree relatives of multiple myeloma patients in china. * secondary study objective: to explore the clinical/genomic/epigenetic features, survival, and quality of life of mgus patients in first-degree relatives of multiple myeloma patients in china. all participants will receive m-protein screening by serum electrophoresis. individuals with detected m-protein will undergo further diagnostic tests, and patients with mgus will be carefully assessed and followed up.

Eligibility criteria:
inclusion criteria: 1. male or female over the age of 18; 2. first-degree relatives (including parents, children, and biological siblings) have multiple myeloma diagnosed by the international myeloma working group (imwg) myeloma diagnostic criteria; 3. understand the purpose and procedure of this trial and voluntarily participate in this screening study; 4. participants should be willing and able to follow the study follow-up plan and other protocol requirements. exclusion criteria: patients with a known diagnosis of plasma cell diseases, such as mgus, smoldering myeloma (smm), or multiple myeloma

Keywords: monoclonal gammopathy of undetermined significance multiple myeloma early tumor screening
pharmacokinetics and pharmacodynamics study of rpc1063 in rms

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of rpc1063 in rms.

the purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of rpc1063 in patients with relapsing multiple sclerosis (rms) following multiple-dose administration of the two different dosing regimens that are being evaluated in the phase 3 rms studies.

Eligibility criteria:
key inclusion criteria: * ms, as diagnosed by the revised 2010 mcdonald criteria * exhibits a relapsing clinical course consistent with rms and history of brain mri lesions consistent with ms * expanded disability status scale (edss) score between 0 and 6.0 key exclusion criteria: * primary progressive ms * clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk

Keywords: ms rms multiple sclerosis relapsing multiple sclerosis
improving response to chemotherapy by adding physical exercise in the neoadjuvant setting of breast cancer patients

Conditions: Breast Cancer

Summary: one of the recommended treatments for breast cancer is neoadjuvant chemotherapy (nct), however, only 20% of the patients subject to this therapy present pathologic complete response (pcr). if exercise-induced tumour size reductions observed in preclinical studies translates to humans, physical training could emerge as a way of increasing rates of pcr to nct, which would be a valuable clinical achievement. the present randomized controlled trial primary aim is to assess the impact of a physical exercise intervention the nct efficacy. following a parallel-arm design, 86 women with primary bc will be allocated 1:1 to a nct + exercise (experimental) or nct alone (control) group. the primary outcome is the rate of pcr in each group. secondary outcomes include treatment tolerability and compliance, tumour infiltrating lymphocytes, ki67, immune, inflammatory, matricellular and myogenic markers, physical fitness, accelerometry, quality of life and body composition.


Eligibility criteria:
inclusion criteria: 1. being female gender; 2. age equals or greater than 18 years old; 3. having a newly diagnosed histologically confirmed breast carcinoma ia-iiic; 4. planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-her2 drugs; 5. being followed by the oncology department of the chvng/e; 6. medical oncologists consents the practice of physical exercise; 7. the patient is capable of providing written informed consent; 8. the participant accepts to be allocated to the control or experimental group, according to the randomization. exclusion criteria: 1. previous cancer diagnostic; 2. evidence of synchronous oncologic disease; 3. physical or psychiatric contraindication to the practice of physical exercise.

Keywords: breast cancer neoadjuvant chemotherapy physical exercise pathologic complete response immune system
elastic band resistance training on physical fitness and risk of falls in elderly.

Conditions: Falls; Old Age; Debility; Hospitalisation; Resistance Training; Physical Fitness

Summary: a lack of studies has applied elastic band resistance training exercises on hospitalized elderly, so the effect of elastic band resistance training exercises on physical fitness and risk of falls was unclear. therefore, the purposes of this study were to investigate the effectiveness of elastic band resistance training on improving physical fitness and reducing the risk of falls in hospitalized elderly with high risk of falls. this study is an experimental study. the experimental group was given 3 times a week for 2 consecutive weeks of elastic band resistance training, while the control group was given regular rehabilitation exercises. the differences in physical fitness and fall risk between the two groups were examined.


Eligibility criteria:
inclusion criteria: 1. elders are over 65 years old and admitted to this medical ward due to acute/chronic disease 2. elders have no physical impairment 3. elders have a clear cognition, can follow movement commands in chinese or taiwanese 4. elders have greater than 4 points in lower extremity muscle strength measured by the manual muscle power test 5. elders have greater than 45 points in the morse fall scale, which indicate a high risk of falling exclusion criteria: 1. unclear consciousness 2. unable to follow the execution of elastic band resistance training 3. with restricted activities, musculoskeletal disorders, or nerve diseases 4. unsuitable athletic trainers
treatment of ulcerative colitis with ciprofloxacin and e. coli nissle

Conditions: Ulcerative Colitis

Summary: purpose: the purpose of the study is to investigate if treatment with ciprofloxacin for one week followed by therapy with e. coli nissle (ecn) for seven weeks can influence disease activity among ulcerative colitis patients with disease flare-ups compared to placebo controls.

ulcerative colitis (uc) is a chronic inflammatory bowel disease where existing treatments have proven to result in numerous side effects. an important causal factor for the development of the disease is an autoimmune cellular response against bacteria in the colon. as a possible treatment, manipulation of the bacterial flora has been studied using the probiotic bacterium escherichia coli nissle 1917 (ecn). studies on uc patients have shown that treatment with ecn is equally good at maintaining remission as the standard treatment with mesalazine. furthermore, treatment with antibiotics such as ciprofloxacin have been studied for treatment of uc and some, but shortlived, effect has been described. patients are randomized to one of four treatment-arms: ciprofloxacin-ecn, ciprofloxacin-placebo, placebo-ecn or placebo-placebo. disease activity are quantitated with colitis activity index (cai) and quality of life by the inflammatory bowel disease questionnaire (ibdq). also, dietary interviews to examine the patients' dietary intake are completed and the patients' fecal-calprotectin-concentrations will be measured. hundred subjects with ulcerative colitis will be recruited for the study. standard medical care and therapies will be continued throughout the study

Eligibility criteria:
inclusion criteria: * age, \>/=18 years and diagnosed with ulcerative colitis * cai score of \>/=6 (active uc) exclusion criteria: * pregnant or breastfeeding females * known sensitivity to ciprofloxacin * subjects who participate in another clinical trial * positive stool sample with any enteric pathogens, parasites or clostridium difficile * treatment with systemic corticosteroids or biologic therapy

Keywords: ecn, nissle, mutaflor, ulcerative colitis, antibiotics, inflammatory bowel diseases
blocks for intertrochanteric fracture repair surgery

Conditions: Intertrochanteric Fractures

Summary: this single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

this single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks. patients are high risk individuals scheduled for intratrochanteric fracture repair, with contraindications to spinal anesthesia. one group will receive general endotracheal anesthetic, the other femoral and lateral femoral cutaneous nerve with deep sedation. mortality, morbidity (major cardiovascular incidents,delirium, pneumonia), pain scores and opioid consumption will be recorded.

Eligibility criteria:
inclusion criteria: * intratrochanteric fracture * need for surgery * contraindications for spinal anesthesia exclusion criteria: * allergy to local anesthetics

Keywords: intratrochanteric fracture general anesthesia femoral nerve block lateral femoral cutaneous nerve block