Kornimate/medical-research-clean huggingface dataset:
effects of intermittent dietary restriction on cardiometabolic risk in school-aged children

Conditions: Cardiovascular Syndrome, Metabolic

Summary: this randomized trial aims to evaluate the health-promoting effects of intermittent dietary restrictions, including intermittent low-carbohydrate diet (ilcd) and calorie restriction (icr), in school-aged children with cardiometabolic risk (cmr) compared with general health education based on dietary and physical activity guidelines for chinese children.

childhood obesity comorbid with one or more cmr factors, including hyperglycemia, dyslipidemia, and hypertension, predicts an increased risk for developing cardiovascular disease in adulthood. lifestyle interventions, including restricting dietary calorie intake and increasing physical activity, have been proposed as the first-line behavioral weight management approaches for pediatric obesity. long-term adherence to daily dietary restriction is challenging for young populations because they are in a particular period of physical and psychological growth and lifestyle formation. low-carbohydrate diet and icr have shown effectiveness in improving cardiometabolic health in adults, however, the evidence supporting the effects of these diets in pediatric populations remains limited. eligible participants will be randomized to receive intermittent dietary restriction, including an ilcd (carbohydrate intake ≤ 50 g/d for two days per week) or an icr (calorie intake is 500-600 kcal/d for two days per week), or general health education based on dietary and physical activity guidelines for chinese children in daily life. the total study duration will be 12 months consisting of a 3-month intervention phase and a 9-month self-maintenance phase.

Eligibility criteria:
inclusion criteria: * aged 7-18 years at baseline. * at least one of the following cardio-metabolic abnormalities: 1. prediabetes (impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol/l; or impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol/l). 2. lipid abnormalities (high-density lipoprotein cholesterol ≤ 1.04 mmol/l; or low-density lipoprotein cholesterol ≥ 3.37 mmol/l; or triglycerides ≥ 1.70 mmol/l, or total cholesterol ≥ 5.18 mmol/l). 3. elevated blood pressure (systolic/diastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic/diastolic blood pressure ≥ 120/80 mmhg). exclusion criteria: * previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation. * had a history of bariatric surgery. * used weight loss pills or supplements in the last three months. * other situations unsuitable for participation.

Keywords: intermittent carbohydrate restriction intermittent calorie restriction cardiometabolic risk children
effects of active video gaming on pre-handwriting skills of children with down syndrome.

Conditions: Down Syndrome

Summary: down's syndrome is a genetic disorder caused by trisomy 21. down's syndrome is most common genetic mental disability that affects children physically, mentally and functionally. it occurs due to an extra copy of chromosome 21. it involves a slightly flattened facial profile, low muscle tone upward-slanted eyes, and ligamentous laxity. central hypotonia, mental retardation and short stature are very common features of children with down's syndrome. children with down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills and , under-development of fine motor skills. active video gaming used different games that involve interactive session that can enhance cortical recognition, motor learning and functional profile of children with ds. the objective of this study is to determine the effects of active video gaming on pre-hand writing skills of children with down's syndrome. this will be a rct(randomized controlled trial).the sample size was 18 and the study design was a case-control trial. the inclusion criteria are children with down syndrome age 6 to 12 years both male and female patients are randomly selected and children with poor pre-hand writing skills. and the exclusion criteria for this study is children with any other neurological condition like (epilepsy, instability of atlantoaxial joints, cardiac anomalies,) vision, and hearing loss. two groups were randomly assigned and equally divided patients into each group. group a received pre-handwriting skills, like tracing alphabets and numbers, scribbling, coloring, painting, and group b received active video gaming and prehandwriting skills. for measuring each group developmental coordination disorder questionnaire tool is used. the session will be taken 30 mins thrice a week for (8consecutive weeks). data collected from different centers, raising sun institute of special education. autism resource center lahore. spss for windows software, version 25 will be used to analyze the data using statistical significance p=0.05. the shapiro-wilk test will be used to check the normality of data. keywords: active video gaming, down syndrome, computer game, fine motor skills, pre-hand writing skills, virtual reality gaming.

to determine the effects of active video gaming on pre-hand writing skills of children with down syndrome.

Eligibility criteria:
inclusion criteria: * age 5 to 14 years. * both male and female patient diagnosed with down syndrome. * able to understand and follow verbal command. * down syndrome children with pre-hand writing skills are not good. * difficulty in fine motor skills. exclusion criteria: * patients will have any neurological sign (epilepsy, instability of the atlantoaxial joint, cardiac anomalies, vision and hearing loss, speech loss. * musculoskeletal and mobility disorder.
telehealth: diaphragmatic vs. pelvic exercise in postpartum pregnancy-related pelvic girdle pain

Conditions: Postpartum; Pregnancy Related; Pelvic Girdle Pain

Summary: the goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.


Eligibility criteria:
inclusion criteria: * age between 20-65 years * postpartum ≥ 3 months * pain located in sacroiliac joints (i.e., pain located between the posterior iliac crest and gluteal fold) * pregnancy-related cause of pelvic pain that pain occurs during pregnancy or after delivery (i.e., not traumatic or degenerative cause) * at least 2 positive findings of 6 pain provocation tests for pelvic pain * score of active straight leg rise (aslr) test \> 0 exclusion criteria: * being pregnant or actively trying to get pregnant * having known causes of pelvic girdle pain, such as fractures and rheumatism * having undergone lumbar, pelvic, gynecologic or obstetric surgery * having current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy * having cancer * having cardiovascular disease * being diagnosed as having a psychiatric disease * active infection or infectious disease in the pelvis or abdomen * having experience with structured and supervised core or trunk exercise training programs.
an observational study of moderna covid-19 bivalent vaccines (original and omicron ba.4/ba.5) and 2023 updated mrna covid-19 vaccines (xbb.1.5)

Conditions: COVID-19

Summary: the goal of this observational study is to analyze binding antibody levels in adults in the united states (us) after receiving coronavirus disease 2019 (covid-19) bivalent boosters (original and omicron ba.4/5) and updated covid-19 vaccines (xbb.1.5).


Eligibility criteria:
inclusion criteria: * lives in the continental united states (us). * speaks, reads, and understands english. * is willing and able to submit vaccination card photo(s) or vaccination records. * is willing and able to self-collect capillary blood during the study period via an at-home whole-blood collection device. * is fully vaccinated against covid-19 per protocol specified criteria. exclusion criteria: * has been diagnosed with significant cognitive impairment or dementia. * is pregnant or planning to become pregnant during the study period. * primary mailing address is a post office box, army post office, fleet post office, or diplomatic post office address. * currently lives in a us military base located overseas, or us territories (puerto rico, us virgin islands, guam, northern mariana island, or american samoa). * is currently participating in a covid-19 vaccine clinical trial. * is currently receiving chemotherapy or has received chemotherapy in the past 6 months. * is currently taking steroids, such as prednisone, for any condition. * has been diagnosed with and taking immunosuppressants for rheumatoid arthritis, lupus or multiple sclerosis. * has received an organ transplant. * is currently undergoing dialysis of any kind (for example, hemodialysis or chronic ambulatory dialysis) for kidney disease.

Keywords: immunogenicity moderna mrna-1273 omicron vaccines
clinical assessment of two reusable silicone hydrogel contact lenses

Conditions: Refractive Errors

Summary: the purpose of this study is to compare the clinical performance of lid018869 soft contact with acuvue® oasys with hydraclear® plus (aohp) soft contact lenses over 30 days of daily wear.

subjects will be expected to attend 6 visits. subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. the total duration of a subject's participation in the study will be approximately 65 days.

Eligibility criteria:
key inclusion criteria: * current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * manifest cylinder less than or equal to 0.75 diopter in each eye. * best corrected distance visual acuity better than or equal to 20/25 snellen in each eye. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * monovision or multifocal lens wearer. * habitual senofilcon contact lens wearer (for example, acuvue oasys, acuvue vita) or commercially available lehfilcon a contact lens wearer (total30). * routinely sleeps in habitual contact lenses. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses
study of nimotuzumab combined with imrt in elder patients with cervical squamous cell carcinoma

Conditions: Cervical Squamous Cell Carcinoma

Summary: to evaluate the efficacy and safety of nimotuzumab combined with imrt in elder patients with locally advanced cervical squamous cell carcinoma

this is a perspective, multi-center, open-label and single arm study.

Eligibility criteria:
inclusion criteria: 1. age≥65 years old 2. histologically confirmed primary cervical squamous cell carcinoma in stage ib3-iva (figo 2018) 3. at least one measurable lesion according to recist 1.1 guideline 4. patients are intolerant to or refuse chemotherapy. 5. no serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. and the results of lab test meet the following criteria: hemoglobin ≥90g/l absolute count of neutrophils≥2×109/l orwhite blood cell count≥4.0×109/l； platelet count≥100×109/l； ast≤2.5×uln alt≤2.5×uln tbil≤1.5×uln； serum creatinine≤1.5×uln or crcl\> 60 ml/min(according tocockcroft-gault): serum creatinine≤1.5×uln female crcl=(140-age)×weight（kg）×0.85 / (72×scr mg/dl) 6. ecog score 0-2 7. expectancy of life is at least 3 months. 8. eligible for pelvic mri examination. 9. the patients voluntarily received nimotuzumab combined with radiotherapy. 10. patients can comply with the protocol and are willing to sign informed consent. exclusion criteria: 1. patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy 2. patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy. 3. patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk. .4)patients infected with hiv. 5)active hepatitis b (hbv dna quantitative test results exceed the detection threshold), or hcv infection (hcv rna quantitative test results exceed the detection threshold) 6)patients with severe underlying disease that makes it possible to safely receive the treatment. and the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (nyha grade iii and iv), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment. 7)patients with a history of prior malignancy other than cured basal cell carcinoma of the skin. 8)patients with crohn's disease and ulcerative colitis. 9)patients are allergic to nimotuzumab or its compounds. 10)patients with neurological or psychiatric abnormalities that affect cognitive ability. 11)intracavitary brachytherapy cannot be performed that was assessed by the investigator. 12)other factors were assessed by investigators to be unsuitable to this study.
melatonin as adjuvant therapy in breast cancer patients

Conditions: Stage II and III Breast Cancer

Summary: the study evaluate the effect of melatonin in improving quality of life and reducing post operative pain and chemotherapy-induced toxicity in breast cancer patients. this is a multi-center, randomized, double-blind, placebo controlled trial conducted in stage ii or iii breast cancer patients. mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. the patients are required to take the studied drugs at night (after 21.00 pm) on the first night prior to surgery and continue for 24 months. standard treatment is surgery followed by chemotherapy according to each center's standard protocol. study endpoints are qol (fact-b), pain (vas 0-10), adverse event frequency, sleep quality (vas 0-10), recurrence rate and progression-free survival.


Eligibility criteria:
inclusion criteria: * histologically proven stage ii or iii breast cancer * eastern cooperative oncology group (ecog) performance status (ps) ≤ 2 * platelet count ≥100,000 cells/mm3 * white blood cell count ≥ 3,000 cell/mm3 * hemoglobin ≥ 10 g/dl * serum creatinine ≤ 1.5 mg/dl * bilirubin ≤ 2 mg/dl * ast ≤ 2.5 times upper limit of normal (uln) * new york heart association grade ≤ 2 * written consent exclusion criteria: * received prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization, * had more than one type of cancer or brain metastasis * moderate neuropathy (ctcae grade ≥ 2) * active infection * uncontrolled complications (i.e. blood glucose \> 200 mg/dl, uncontrolled hypertension, unstable angina, history of congestive heart failure or history of myocardial infarction within one year).

Keywords: breast cancer melatonin adjuvant therapy quality of life pain sleep survival adverse events
a clinical trial assessing safety of mf101 for hot flushes

Conditions: Hot Flashes

Summary: this phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. women will be randomized to one of two oral doses of mf101 for 4 weeks. participants will be recruited at 3 clinical sites in the united states.

mf101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.

Eligibility criteria:
inclusion criteria (partial list): * postmenopausal women aged 40-65 years. * provide informed consent. * currently receive medical care from a health care provider. other inclusions apply. exclusion criteria (partial list): * history of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening. * unexplained uterine bleeding within 6 months prior to screening. * history of deep vein thrombosis or pulmonary embolism. * active liver disease or a history of impaired. * active gallbladder disease. other exclusions apply.

Keywords: hot flashes hot flushes vasomotor symptoms menopausal symptoms
to evaluate the characteristics of a breast cancer

Conditions: Breast Cancer

Summary: the purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer tumor microenvironment. the study is based around four cornerstone features of the pathologic microenvironment - hypoxia, reactive species (reactive oxygen and nitrogen species), hif-1 and vegf, which we term the hrhv axis. fifty breast cancer patients with planned surgical excision will be administered the hypoxia marker drug, ef5, 24-36 hr prior to surgical excision. ef5 is a non-therapeutic drug and provides no direct benefit to those patients enrolled in this pilot study. tissues obtained intra-operatively will be snap frozen and subsequently analyzed for ef5 binding. immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the hrhv axis will be examined. the association of the markers with the presence of hypoxia, as determined by ef5 positivity, will be determined. data from this pilot study will be used to establish the prevalence of markers of the hrhv axis in breast cancer. this information will be crucial for future human trials in which the hrhv axis is therapeutically targeted.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage 0 - iii invasive carcinoma of the breast * tumor size greater than 1-cm by radiological (mammogram/ultrasound or mri) evaluation * kps status ≥ 70 * bilirubin ≤ 1.5x normal * creatinine ≤ 1.8 * wbc \> 3000/mm\^3 and platelets \> 100,000/mm\^3 exclusion criteria: * pregnant or breast-feeding women * neoadjuvant chemo or hormonal therapy for existent breast malignancy * allergy to iv contrast dye * history of grade iii or iv peripheral neuropathy as defined by the nci ctc * previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy

Keywords: breast cancer ductal breast carcinoma in situ breast cancer in situ invasive carcinoma invasive ductal carcinoma invasive lobular carcinoma
effect of cold application and vibration in reducing pain during vaccination in children

Conditions: Pain; Pain, Acute; Vaccination; Children; Cold Application; Vibration

Summary: the study was designed as a randomized controlled experimental research with the purpose of determining the effect of using cold application and vibration in reducing pain during routine vaccination in children.

in the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain.in light of this information, this study aimed to examine the effect of by using cold application and vibration in reducing pain during routine vaccination in children. cold application and vibration will be done with buzzy. this study is a prospective, randomized and controlled trial. children aged 13 years who required routine vaccination were divided into three groups; placed under arm buzzy, placed in standard buzzy, and control. data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. the children's pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using wong-baker faces. the study population consisted of the children's during routine vaccination in children aged 13 years. sample of the study consisted of a total of 90 children who met the sample selection criteria and were selected via randomization method. children were randomized into three groups; placed under arm buzzy (n:30), placed in standard buzzy (n:30), and control (n:30). data were collected using the interview and observation form and wong-baker faces pain rating scale.

Eligibility criteria:
inclusion criteria: * children the ages of 13 years (planned to be included in the vaccination calendar program), * volunteering of the child and parent to participate in the study, * healthy children, * vaccination should be done by the same nurse, exclusion criteria: * the child has any acute or chronic disease, * the child has a mental disability, vision, speech or communication problems, * the parent has hearing, vision or verbal communication difficulties, * the child used analgesics in the last 6 hours, * infection, disruption of skin integrity and rash in the area where theapplication will be made, * exclusion criteria were that the parent or child wanted to leave the study at any point.

Keywords: pain vaccination child cold application vibration buzzy
alzer® and diamel® to prevent severe diabetes macular edema

Conditions: Diabetic Macular Edema

Summary: macular edema is the main cause of low vision in diabetics. they continue looking for new treatment alternatives. the nutritional supplement alzer, is a powerful antioxidant that together with diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. objective: to evaluate the therapeutic efficacy of the alzer diamel combination in mild and moderate macular edema. material and method: a randomized double-blind phase ii clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive alzer + diamel and another will receive placebo from alzer and diamel. all patients will undergo clinical, biochemical and ophthalmological evaluation during the study.


Eligibility criteria:
inclusion criteria: * diabetics type 2 insulin treated. * age between 18 and 65 years. * glycosylated hemoglobin (hb a1c) \<8% at the beginning of the investigation. * patients who express written voluntariness to enter the study with their signature of the informed consent document. * if woman of childbearing age, negative pregnancy test and use of barrier contraceptives. exclusion criteria: * pregnancy and lactation. * age over 65 years. * macular edema with vitreous-retinal traction or other cause (renal, arterial hypertension, post-surgical). * opacity of the refractive media that hinders the ophthalmological examination. * history of hypersensitivity to another similar product or one of its components. * patients at potential risk of not compliance the study (those who will travel during the period of the investigation or distance in their residence, outside the city). * subjects who are participating in another clinical trial patients with cognitive disorders or a mental disorder that hinders their follow-up.

Keywords: nutritional supplement diabetic macular edema diabetes alzer oxidative stress diamel