Kornimate/medical-research-clean huggingface dataset:
study of aro-atxn2 injection in adults with spinocerebellar ataxia type 2

Conditions: Spinocerebellar Ataxia Type 2

Summary: adult participants with spinocerebellar ataxia type 2 (sca2) who carry ≥33 cytosine, adenine, guanine (cag) repeats in the atxn2 gene, and who have met all protocol eligibility criteria will be randomized to receive a single dose of aro-atxn2 or placebo and be evaluated for safety, tolerability, pharmacokinetic (pk) and pharmacodynamic (pd) parameters.


Eligibility criteria:
inclusion criteria: * non-pregnant, non-lactating * diagnosis of symptomatic sca2 and ≥33 cag repeats in the atxn2 gene based on source verifiable medical records or genetic testing at screening * scale of assessment and rating of ataxia (sara) score ≤14 * coagulation parameters within normal ranges at screening * subjects of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. subjects must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later exclusion criteria: * uncontrolled hypertension (blood pressure \>160/100 mmhg) * history of having received stem cell therapy * clinically significant cardiac, liver, or renal disease * human immunodeficiency virus (hiv) infection (seropositive at screening) * seropositive for hepatitis b (hbv) or hepatitis c (hcv) at screening * intellectual disability or significant behavioral neuropsychiatric manifestation * any contraindications to lumbar puncture * presence of an implanted shunt for drainage of csf or an implanted central nervous system (cns) catheter note: additional inclusion/exclusion criteria may apply per protocol.
the effects of wbv on muscle stiffness and reflex activity in stroke.

Conditions: Stroke

Summary: spastic hypertonia is common after stroke. whole-body vibration (wbv) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in the management of spastic hypertonia post-stroke. this study aims to investigate the acute effect of wbv on leg muscle h-reflex, stiffness, and blood perfusion in people with chronic stroke.

spastic hypertonia is common after stroke. whole-body vibration (wbv) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in management of spastic hypertonia post-stroke. however, the potential effects of wbv on leg muscle stiffness in stroke rehabilitation remains unknown. scientific evidence is warranted to fill the knowledge gap. purpose this study aims to investigate the acute effect of wbv on leg muscle h-reflex, stiffness and blood perfusion in people with chronic stroke. methods individuals with chronic stroke will be recruited from community self-help groups and existing patient database. relevant information (e.g. demographic information, medical history) will be obtained from medical records and subject interviews. each subject will have to fulfill the following inclusion criteria: (1) diagnosis of chronic stroke, (2) community-dwelling, (3) able to follow simple verbal instructions. exclusion criteria are: (1) other diagnoses of neurological conditions, (2) significant musculoskeletal conditions (e.g. amputations), (3) metal implants in the lower extremity or spine, (4) recent fracture in the lower extremity, (5) diagnosis of osteoporosis, (6) vestibular disorders, (7) peripheral vascular disease, and (11) other serious illnesses or contraindications to exercise. this is a single-blinded randomized within-patient cross-over study. each participant was evaluated for the soleus h-reflex, stiffness and blood perfusion of the medial gastrocnemius (mg) using ultrasound on both sides before and after either a 5-minute wbv intervention (30 hertz, 1.5mm, knee flexed 60 degrees) or a no-wbv condition (5 minutes). the measurements were performed at baseline and every 1-min post-intervention up to 5 minutes. the outcomes generated included the soleus h/m ratio, shear modulus and vascular index (vi) of the mg muscle.

Eligibility criteria:
inclusion criteria: 1. adult with a diagnosis of a hemispheric stroke \>6 months, 2. medically stable, 3. able to stand independently for at least 1 minute and 4. mas score \>1 measured at the ankle plantar flexors. exclusion criteria: 1. brainstem or cerebellar stroke, 2. other neurological condition, 3. serious musculoskeletal or cardiovascular disease, 4. severe contracture of the ankle that the cannot be put in the neutral position. 5. metal implants or recent fractures in the lower extremities or spine, 6. fresh skin wound in lower extremities, especially popliteal fossa 7. other severe illnesses or contraindication for exercise.

Keywords: muscle stiffness ultrasound elastography h-reflex whole body vibration blood perfusion
intestinal flora sequencing for nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this study investigated the correlation between the changes in the intestinal flora and npc by an examination of the intestinal flora and multiple clinical indicators of the blood of 8 carefully screened patients of familial npc, 24 patients of sporadic npc and 27 healthy controls and a comparison of the differences in their intestinal flora structures and biological functions. by analyzing the function of the intestinal floras of npc patients, we aimed to provide a better biological marker for patients with familial and sporadic npc and constructed a disease prediction model for high-risk populations.

nasopharyngeal carcinoma (npc) is a malignant nasopharyngeal disease with a complicated etiology that occurs mostly in southern china. intestinal flora imbalance is believed to be associated with a variety of organ malignancies. currently, the relationship between intestinal flora and npc is not clear, although many studies have shown that intestinal flora can be used as a biomarker for many cancers and to predict cancer. to compare the differences in intestinal flora compositions and biological functions among patients with familial npc (npc_f), patients with sporadic npc (npc_s) and healthy controls (nor), we compared the intestinal flora dna sequencing and hematological testing results between every two groups using bioinformatic methods.

Eligibility criteria:
inclusion criteria: * npc patients with a first degree family history of npc * npc patients without any kind of tumor family history exclusion criteria: * informed refusal. * lack of necessary tests and patient test information is not detailed

Keywords: biomarker nasopharyngeal carcinoma familial sporadic intestinal flora
could hrv be a valuable predictor for cpap adherence?

Conditions: OSA; Autonomic Dysfunction; PAP; Adherence, Patient

Summary: this study aim to evaluate if the improvement of heart rate variability for the continuous positive airway pressure titration night can predict the short and long term continuous positive airway pressure adherence for patients with moderate to severe osa.

heart rate variability (hrv) represents autonomic regulation and had been used in varies situation, especially the associated with cardiovascular outcomes and psychological diseases. hrv was also well known associated with the severity of obstructive sleep apnea (osa) and could be improved after adequate treatments for osa. continuous positive airway pressure (cpap) is the first choice of treatment for osa and had been proved to able to improve hrv in osa patients. however, the cpap adherence is always problematic. many cpap predictors had been well documented but the hrv is never evaluated to be a potential predictor of cpap adherence. therefore, this study will evaluate the changes of hrv for polysomnography (psg) night, for cpap titration night to see if the changes of hrv in the cpap titration night could predict cpap adherence for osa patients in taiwan.

Eligibility criteria:
inclusion criteria: 1. aged:20\~75y/o 2. psg revealed moderate to severe osa (apnea hypopnea index \[ahi\] ≧15/hour) 3. had been completed cpap titration test exclusion criteria: 1. aged\ 75 y/o 2. mild osa, (ahi \<15/hour), or no osa (ahi\<5/hour) 3. unstable cardiopulmonary disease, psychological diseases, using sleep pills.
effect of caloric restriction and gastric bypass on resting metabolic rate

Conditions: Obesity

Summary: studies in overweight and obese subjects show a decline in resting metabolic rate (rmr) even after moderate caloric restriction. yet the onset and course of such a metabolic adaption is still unclear. lower resting metabolic rates were also reported after gastric banding bariatric surgery but have not yet been investigated in subjects after gastric bypass. the purpose of this study is to investigate the consequences on resting metabolic rate in subjects with obesity after moderate caloric restriction or gastric bypass.


Eligibility criteria:
inclusion criteria: * bmi ≥30 kg/m2 exclusion criteria: * marked weight reduction in the last 2 years (\>5% of initial body weight) * recent extreme fasting (during the last month) * manifest eating disorders (assignment to a specialist for eating disorders) * severe psychiatric disorders requiring treatment * pregnancy, lactation

Keywords: caloric restriction obesity gastric bypass resting metabolic rate
an exercise intervention to improve the eating patterns of preadolescent children at high risk for obesity

Conditions: Eating Behavior; Self-Regulation

Summary: children in rural communities experience significant obesity-related health disparities; they are 26%-55% more likely to be obese and less likely to have health insurance and access to weight management specialists than are their urban peers. geographic-specific disparities in obesity may be due, in part, to variations in eating behaviors. children in rural communities describe purchasing and consuming significantly more energy-dense, low-nutrient food items relative to their urban peers. existing behavioral strategies for improving children's ei patterns have largely been ineffective in reducing risk for excess weight gain. the primary aim of the proposed study is to test the effects of a brief, novel strategy for improving rural children's eating behaviors. specifically, the study aims to harness the well-documented benefits of an acute bout (20 min) of moderate physical exercise on children's executive functioning, and to see if these cognitive changes lead to better self-regulation of eating. if 20 min of moderate physical exercise is associated with observed improvements in preadolescent children's eating secondary to increases in executive functioning, these data may offer explicit targets for an obesity prevention trial in rural oregon elementary schools.


Eligibility criteria:
inclusion criteria: * 8-10 years (block recruited to ensure 50% female, 50% obese) * rural geographic location (≥ 10 miles from a city of ≥ 40,000) * understand english exclusion criteria * bmi \< 5th percentile * major medical condition, current full-threshold psychiatric diagnosis, or moderate suicide risk (e.g., plan or intent) * current or recent use (\< 3 months) of medication known to affect body weight or energy intake * recent brain injuries that would be expected to affect neuropsychological functioning * mobility impairments that would impede their ability to walk on a treadmill * estimated full-scale intelligence quotient score ≤ 70 * history of pregnancy * significant food allergies that would prevent them from safely consuming the study's breakfast and lunch meals * responses on a food preference questionnaire that suggest that they do not like (i.e., rated them below 6 on a scale from 1 to 10) at least 50% of the food items offered in the lunch test meal
navigating health insurance selection for ivf benefits

Conditions: Infertility

Summary: the purpose of this study is to evaluate the effectiveness of an educational intervention on health insurance literacy and utilization of in vitro fertilization (ivf) insurance benefits. the investigators hypothesize that the intervention is acceptable and satisfactory and will result in increased health insurance literacy and utilization of ivf benefits.


Eligibility criteria:
inclusion criteria: * employees eligible for health insurance coverage * reproductive aged (18 to 50 years) * intention to grow their family in the next year * primary language english or spanish exclusion criteria: * none

Keywords: infertility ivf health insurance
postprandial effects of functional bread

Conditions: Postprandial Hyperglycemia

Summary: this study investigates whether bread with added galactomannan, a soluble fiber, can reduce the postprandial glucose response in healthy overweight adults.

this single-blind crossover-designed study wants to investigate the postprandial effect of functional bread in healthy overweight adults. therefore, four types of bread, consumed by the participants, have added galactomannan in different amounts and viscosities, and one bread is the control bread. the participants arrive after an overnight fast and before the consumption of bread, a fasting blood sample is taken. after the ingestion, blood samples are taken at specific times. the area under the curve of the postprandial glucose is expected to differ between the functional breads.

Eligibility criteria:
inclusion criteria: * healthy, overweight adults (bmi between 25 and 30 kg/m2) exclusion criteria: * known diagnosis of diabetes mellitus type 2 * hba1c at screening ≥ 48 mmol/mol * other chronic diseases (heart disease, cancer) within the last 3 years * pregnancy and lactation * known drug or alcohol abuse * unwilling to follow the study requirements
evaluation of efficacy and safety of ferric carboxymaltose (fcm) in patients with iron deficiency anemia and impaired renal function

Conditions: Iron Deficiency Anemia; Impaired Renal Function

Summary: the primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (iv) iron, ferric carboxymaltose (fcm), compared to iv iron sucrose (venofer) in subjects who have iron deficiency anemia (ida) and impaired renal function.


Eligibility criteria:
inclusion criteria: * male or female subjects \> or = to 18 years of age. * chronically impaired renal function. * screening visit central laboratory hemoglobin \< or = to 11.5 g/dl. * screening ferritin \< or = to 100 ng/ml or \< or = to 300 when transferrin saturation (tsat) is \< or = to 30%. * if on an erythropoiesis stimulating agent(esa) a stable dose (+/- 20%) for 4 weeks prior to randomization. exclusion criteria: * known hypersensitivity reaction to any component of ferric carboxymaltose (fcm) or venofer. * previously randomized in a clinical study of ferric carboxymaltose (fcm). * requires dialysis for treatment of chronic kidney disease or is being considered for initiation of dialysis during the time period of this trial. * no evidence of iron deficiency. * any non-viral infection. * ast or alt at screening as determined by central labs greater than 1.5 times the upper limit of normal. * known positive hepatitis with evidence of active disease. * received an investigational drug within 30 days of screening. * alcohol or drug abuse within the past 6 months. * hemochromatosis or other iron storage disorders. * estimated life expectancy of less than 6 months, or for cancer patients, an ecog performance status greater than 1. * any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements. * pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.

Keywords: ida
gefitinib long-term survivor study

Conditions: EGFR Mutation Positive Advanced Non-small-cell Lung Cancer

Summary: the primary objective is to describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for gefitinib long-term efficacy as compared to rapid pd patients


Eligibility criteria:
inclusion criteria: for inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening: 1. provision of informed consent or ec approve informed consent waiver prior to any study specific procedures 2. histological or cytological confirmed locally advanced nsclc (stage iii b) or metastatic (stage iv) nsclc, not amenable to curative surgery or radiotherapy 3. egfr mutation positive 4. patients who continuously received gefitinib for at least 3 years without evidence of pd 5. patients with os ≥ 5 years from nsclc diagnosis will be preferred 6. collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue are optional); tumor tissue samples requirements: 1) slices requirements: \>1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole ffpe block; 2) tumor percentage \> 20% and necrosis \< 30% by pathology qc. for inclusion in the rapid pd group, the study subjects must fulfil the following criteria: 1. provision of informed consent or ec approve informed consent waiver prior to any study specific procedures 2. histological or cytological confirmed locally advanced nsclc (stage iii b) or metastatic (stage iv) nsclc, not amenable to curative surgery or radiotherapy 3. egfr mutation positive 4. patients who had undergone pd after gefitinib treatment≤3 months (rapid pd) 5. collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue samples are optional) ; tumor tissue samples requirements: 1) slices requirements: \>1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole ffpe block; 2) tumor percentage \> 20% and necrosis \< 30% by pathology qc. exclusion criteria: for the active patients, who must not enter the study if any of the following exclusion criteria are fulfilled 1. patients who disagree to participate this study. for the terminated patients, who must not enter the study if any of the following exclusion criteria are fulfilled 1. patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.

Keywords: egfr mutation; non-small-cell lung cancer;
effectiveness of relaxation techniques

Conditions: Stress, Psychological

Summary: the study aims to assess the validity of a relaxation app. this will be accomplished by obtaining self-report measures about mood and respiratory symptoms. we hypothesize that self-report in the relaxation app condition will be different from that of the relaxation only condition.


Eligibility criteria:
inclusion criteria: * student enrolled in smu * speaks english exclusion criteria: * must have an apple watch to use during time of participation in the study

Keywords: breathe breathing relax relaxation respiration stress
treatment of aggressive localized lymphoma

Conditions: B Cell Lymphoma

Summary: prospective and multicentric phase iii study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of chop 14 r regimen of chemotherapy , patients with agressive and localized b lymphoma , age 18 to 75 years.

chop 14 r regimen of chemotherapy is a good standard in the treatment of agressive and localized b lymphoma. interest of the radiotheraphy

Eligibility criteria:
inclusion criteria: * age \> 18 and \< 75 years * diffuse b large cell lymphoma , cd 20+ * ann arbor stage i or ii withe a bulk \<7 cm * stage i ou ii confirmed by the pet-scan * no previously treated * hiv negative * signed informed consent exclusion criteria: * age\ 75 years * other type of lymphoma * cd20 negative * ann arbor stage \>ii or bulk \> 7 cm * hiv positive * contraindication to rituximab use according to sm pc * containdication to antracyclin * cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma * refusal of sign the informed consent

Keywords: diffuse b larg cell lymphoma chemotherapy radiotherapy
effects of trf on obese patients with ckd stage 3-4

Conditions: Time Restricted Feeding; Renal Insufficiency, Chronic; Obesity

Summary: obesity is associated with glomerular hyperfiltration leading to renal impairment and is a risk factor for the progression of kidney disease.weight loss can reduce proteinuria and improve egfr.intermittent fasting is safe and effective, and in addition to improving body shape and weight in obese patients, it can also improve glucolipid metabolism, reduce proteinuria, improve kidney function and delay the progression of kidney disease.

kdoqi clinical practice guideline for nutrition in chronic kidney disease (ckd) uses a low-protein diet to reduce renal impairment and delay progression. the current research hotspot is dietary intervention. time-restricted feeding was used to intervene in the progression of ckd. it restrict the time of eating but not the eaten calories, which have a higher compliance and safety. studies have shown that intermittent fasting in obese patients with ckd is not only reduce body weight, but also improves glycolipid metabolism, reduces proteinuria and delays the progression of kidney disease. intermittent fasting is currently a scientific research hotspot, and there are few international studies on the implementation of intermittent fasting to delay the deterioration of renal function in obese ckd patients, and lack of data on chinese patients, which has great research potential. based on the above background, this study was conducted as an pilot clinical trial to explore the effects of intermittent fasting on obese patients with ckd and to observe its effectiveness, safety and compliance.

Eligibility criteria:
inclusion criteria: * age 18-65 years * ckd stage 3-4 and not on dialysis (egfr: 15-59ml/min/1.73m2) * bmi ≥ 25 kg/m2 * good reading and comprehension skills, simple smartphone operation and no communication difficulties * signed informed consent exclusion criteria: * pregnant and breastfeeding * end-stage diseases * acute and active diseases such as gastrointestinal bleeding or acute infections, serious decompensation with diseases such as cirrhosis decompensation stage, malignant tumor, serious heart and lung diseases, severe primary diseases of hematopoietic system, severe hypertension (systolic blood pressure ≥200mmhg, diastolic blood pressure ≥120mmhg) and difficult to control blood pressure, within 3 months after major surgery, such as open surgery * mental patients * using medium-high doses of hormones and immunosuppressants * participating in other researchers * taking other dietary therapies, undergoing weight loss treatment * vegetarian * type 1 diabetes and type 2 diabetes using insulin

Keywords: time-restricted feeding chronic kidney disease obesity