Kornimate/medical-research-clean huggingface dataset:
cohort construction for preterm infants with growth retardation and its influencing factors

Conditions: Problem With Growth of an Infant

Summary: in this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. the regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. the influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed.

preterm infants are at high risk of stunting due to premature birth, insufficient intrauterine nutrient reserves, burden of various diseases after birth, and persistent nutrient liabilities. the growth retardation of premature infants at different developmental stages has an important impact on both short-term survival and long-term health. the growth and development data of premature infants during hospitalization and after discharge are very limited in foreign countries. domestic researches on growth retardation of preterm infants only involve retrospective cross-sectional studies during hospitalization, and lack of prospective follow-up study data on growth and development data of premature infants during hospitalization and after discharge. in this cohort, prospective clinical cohort study was used to establish a follow-up cohort of preterm infants with different gestational ages. the regular monitoring indexes of physical development and neuropsychological development of preterm infants from birth to 3 years after birth were collected. the influencing factors of preterm infants' development at different stages were recorded, and the high-risk factors leading to different stages of preterm infants' growth retardation were analyzed. in order to provide a strong scientific basis for the development evaluation and intervention of premature infants in china, a systematic and scientific clinical cohort study method was explored to improve the overall medical quality and medical level of the department and further promote the development of the discipline.

Eligibility criteria:
inclusion criteria: * all preterm infants born less than 37 weeks during the study period exclusion criteria: * congenital malformations or genetic diseases various surgical treatments during the newborn period interrupted treatment or discharged automatically
v501 safety and efficacy study in japanese women aged 16 to 26 years (v501-110)

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia; Adenocarcinoma in Situ

Summary: this study evaluated the long-term safety of quadrivalent human papillomavirus (hpv) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (cin), adenocarcinoma in situ, and cervical cancer related to hpv in japanese women.


Eligibility criteria:
inclusion criteria: * healthy japanese females * not pregnant at screening and agree to use effective contraception through month 7 of the study * lifetime history of 0 to 4 male or female sexual partners * no oral temperature ≥37.5 centigrade within 24 hours prior to injection exclusion criteria: * received a marketed hpv vaccine * prior abnormal papanicolaou smear (pap) or biopsy showing cin * known history of positive test for hpv * known history of genital warts * received immune globulin or blood products within 6 months prior to first injection or plan to receive any through month 7 of the study * history of splenectomy, known immune disorders, or receiving immunosuppressives * immunocompromised or diagnosed as having human immunodeficiency virus (hiv)
food modification to alter glycaemia and insulinaemia

Conditions: Diabetes

Summary: the study specifically aims to determine glycemic and insulinemic response of added low gi ingredients, beta-glucan, resistant starch and isomaltulose to foods.

there will be a total of 9 test sessions and each session will last up to 3 hours. at each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations. subject will be served the test food and to consume within15 minutes. following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.

Eligibility criteria:
inclusion criteria: * healthy males * chinese ethnicity * age ≥21 and ≤ 40 years * body mass index between 18.5 to 25 kg/m2 * normal blood pressure ≤140/90 mmhg * fasting blood glucose \<6.0 mmol/l * in general good health exclusion criteria: * current smoker * have metabolic diseases (such as diabetes, hypertension etc) * have glucose-6-phosphate dehydrogenase deficiency (g6pd deficiency) * have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics) * have an ongoing infection or currently undergoing treatment at the time of screening * have known chronic infection or known to suffer from or have previously suffered from or is a carrier of hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv) * have active tuberculosis (tb) or currently receiving treatment for tb * intolerances or allergies to any foods * partake in sports at the competitive and/or endurance levels * intentionally restrict food intake
comparison of cti ablation prior to or after la ablation for af

Conditions: Atrial Fibrillation

Summary: this study is designed to determine if cti prior to cpva/pvi/linear lesions/fractionation results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic drug therapy compared to cti after cpva/pvi/linear lesions/fractionation.


Eligibility criteria:
inclusion criteria: * continuous/persistent atrial fibrillation exclusion criteria: * age\<18 * congenital heart disease * pacemaker or icd implant * previous ablation
virtual reality study - covid-19 protocol

Conditions: Healthy Aging

Summary: the overarching goal of this pilot clinical trial is to use a novel virtual reality (vr)-based intervention that simultaneously engages physical and cognitive activity aimed at improving brain and cognitive outcomes in older adults. physical activity is a promising lifestyle intervention for mitigating cognitive decline or delaying onset of dementia. however, to fully leverage beneficial brain effects of physical activity, training the brain to learn and engage in a cognitively stimulating environment may be the key to enhanced brain and cognitive outcomes.


Eligibility criteria:
inclusion criteria: * 50-85 years old * able to walk without assistance * fluent in english * no ferromagnetic metal in body * able to participate in moderate aerobic physical activity exclusion criteria: * severe brain injury/ head trauma * pacemakers or metal implants * claustrophobia * contradictions to magnetic resonance imaging (mri)/ positron emission tomography (pet) brain scans * opposition to blood draws

Keywords: virtual reality vr cognitive activity physical activity bike cycling intervention usc brain health
comparative evaluation of external chest wall fixator treatment effectiveness in patients with rib fractures

Conditions: Rib Fractures; Trauma

Summary: this study aimed to investigate the effect of external chest wall fixator on patients' pain level, complication development and hospital stay in patients with rib fractures.patients who were admitted due to trauma and had serial rib fractures were evaluated. standard treatment was applied to the control group. external chest wall fixator was applied to the case group in standard treatment. pain levels of the patients, development of complications and duration of hospitalization were recorded.

basis of treatment for rib fractures is pain control and physiotherapy. external chest wall fixators may provide a new approach as part of multimodal treatment. this study aimed to investigate the effect of external chest wall fixator on patients' pain level, complication development and hospital stay in patients with rib fractures. patients who were admitted due to trauma and had serial rib fractures were evaluated. there were 14 patients in case group and 20 in control group. standard treatment was applied to the control group. external chest wall fixator was applied to the case group in addition to standard treatment. pain levels of the patients, development of complications and duration of hospitalization were recorded. pain levels of the patients were evaluated using the visual analogue scale and the pain level was scored between 0 and 10.

Eligibility criteria:
inclusion criteria: * patients with serial rib fractures after trauma * patients without extrathoracic pathology exclusion criteria: * patients with less than 3 rib fractures * patients with extrathoracic injuries * patients with bilateral rib fractures * patients with flail chest * patients with hemothorax or pneumothorax requiring drainage with tube thoracostomy at first admission

Keywords: rib fracture external chest wall fixator trauma
effects of ventavis in patients with pulmonary hypertension (ph) secondary to chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Summary: this is a phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled iloprost in patients with pulmonary hypertension secondary to copd. the main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. other efficacy and safety endpoints will additionally be analyzed.


Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to initiation of any study mandated procedure 2. male or female ≥ 40 and ≤ 75 years of age 3. women of childbearing potential1 must use a reliable method of contraception 4. clinical diagnosis of moderate to severe copd, with an obstructive pattern on pulmonary function tests 5. current or past smokers of ≥ 10 pack years 6. ability to perform exercise testing without supplemental oxygen (in the best opinion of the investigator) 7. confirmed pulmonary hypertension by right heart catheterization (rhc) exclusion criteria: 1. other causes of pulmonary hypertension than copd 2. bmi \> 35 kg/m2 3. conditions considered as contraindications for cardiopulmonary exercise testing (cpet) and/or inability to pedal on a cycle ergometer 4. pregnant or nursing 5. currently (within 30 days prior to rhc) taking specific pulmonary arterial hypertension (pah) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost) 6. participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to rhc visit 7. known concomitant life-threatening disease with a life expectancy \< 12 months 8. known hypersensitivity to iloprost or any of the excipients of the drug formulations

Keywords: ph copd
a study to evaluate the efficacy and safety of rivaroxaban venous thromboembolism (vte) prophylaxis in ambulatory cancer participants

Conditions: Neoplasms

Summary: the purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (dvt), asymptomatic lower extremity proximal dvt, symptomatic lower extremity distal dvt, symptomatic upper extremity dvt, symptomatic non-fatal pulmonary embolism (pe), incidental pe, and venous thromboembolism (vte)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a vte.

this is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, superiority study comparing the efficacy and safety of rivaroxaban with placebo for primary prophylaxis of venous thromboembolism (vte) in ambulatory adult participants, with various cancer types who are scheduled to initiate systemic cancer therapy. the study consists of 3 phases: screening phase (14 days), double-blind treatment phase (180 days) and follow up phase (30 days). the duration of participation in the study for each participant is approximately 32 weeks.

Eligibility criteria:
inclusion criteria: * have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease * have an eastern cooperative oncology group (ecog) performance status of 0-2 * have a khorana thromboembolic risk score greater than or equal to (\>=) 2 * creatinine clearance (crcl) \>= 30 milliliter per minute (ml/min) * plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care exclusion criteria: * diagnosis of primary brain tumors * known history of brain metastases * bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding * hematologic malignancies with the exception of lymphoma * platelet count less than (\<) 50,000/millimeter\^3 (mm\^3), life expectancy of less than or equal to (\<=) 6 months

Keywords: cancer rivaroxaban venous thromboembolism
inflammation-induced cns glutamate during breast cancer treatment

Conditions: Breast Cancer

Summary: the purpose of this study is to try and provide data linking the impact of increased inflammatory cytokines as a result of chemotherapy and their relationship with increased levels of cns glutamate and related behavioral and cognitive consequences in breast cancer patients. the investigators will use neuropsychiatric assessments, blood sampling and magnetic resonance spectroscopy (mrs) to collect study data.

approximately 70% of women with breast cancer experience behavioral and/or cognitive symptoms during treatment with chemotherapy and approximately 30% of women continue to experience these symptoms months to years after treatment completion. there is mounting data to suggest that inflammation may be involved and indicate that chemotherapy-treated breast cancer patients exhibit higher inflammatory markers than non-chemotherapy-treated patients, and inflammatory markers including interleukin (il)-6 and soluble tumor necrosis factor (stnfr2) have been associated with chemotherapy-induced depression and fatigue.

Eligibility criteria:
inclusion criteria: * female breast cancer patients will have undergone surgery (lumpectomy or mastectomy) with or without neoadjuvant or adjuvant chemotherapy * age between 21-65 years exclusion criteria: * taking trastuzumab

Keywords: cognitive dysfunction inflammation fatigue decreased motivation
long-term safety and tolerability of inclisiran in participants with hefh or hofh who have completed the adolescent orion-16 or orion-13 studies

Conditions: Heterozygous or Homozygous Familial Hypercholesterolemia

Summary: the purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with hefh or hofh who have completed the orion-16 or orion-13 studies.

this is an open-label, single arm, multicenter study designed to evaluate long-term safety and tolerability of inclisiran. in addition, the study will provide participants the opportunity to have continued access to treatment with inclisiran.

Eligibility criteria:
key inclusion: * male and female participants with a diagnosis of hefh or hofh who completed the orion-16 or orion-13 studies * per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the orion-16 or orion-13 studies key exclusion: * participants who in the feeder inclisiran orion-16 and orion-13 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment * any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk

Keywords: kjx839 heterozygous familial hypercholesterolemia homozygous familial hypercholesterolemia familial hypercholesterolemia fh inclisiran pediatric
reev sense for gait analysis in post-stroke gait impairment (sens-ag)

Conditions: Stroke; Gait Disorders, Neurologic

Summary: the purpose of this study is to evaluate the clinical performance of the investigational reev sense gait tracker to measure gait features in subjects with post-stroke gait impairment. reev sense is intended to be used by trained healthcare professionals as a simple procedure adapted to clinical routine. the reference method for performance comparison will be motion capture.

reev sense is a medical device, with pending fda and ce certifications in class 1. it is a connected gait tracker set primarily on the leg or foot, and eventually on lower limb locations. it contains an accelerometer, a certified standard battery and motion analysis algorithms that will rapidly compute easy-to-use walking analyses accessible to healthcare professionals on a mobile app. standard gait biomarkers such as velocity, stride length, or stance and swing times will be computed. however, reev has also developed a new biomarker, the knee position predictor (kpp), which will provide a more accurate quantification of each individual gait profile. the present reev sense study is the first to test subjects with a pathological context, i.e. with post-stroke ambulation deficit. performance of reev sense has already been established in healthy volunteers in comparison to the reference motion capture system, indicating good technical and metrological performance. the study will take place at the mit center for clinical and translational research (cctr), a reference center with a fully equipped gait lab. each participating volunteer will be equipped with reev sense and the reference motion capture system. the participant will be asked to walk at a comfortable self selected pace for about 15 minutes back and forth along a 10m walkway. he or she may rest at any time during the walking session. reev sense and motion capture data will be recorded automatically and simultaneously during the same walking session.

Eligibility criteria:
inclusion criteria: * post-stroke gait disorder. * must be able to walk independently with or without the support of a cane or rollator. * history of stroke more than six months ago. * be 18 years of age or older. exclusion criteria: * subject unable to give consent. * subject unable to understand the tests.

Keywords: stroke gait analysis accelerometer gait impairment
virtual reality in electrophysiology laboratory (ep)

Conditions: PVC - Premature Ventricular Complex; Ablation

Summary: the purpose of this study is to evaluate the use of virtual reality (vr) technology as adjunct to routine anesthesia care for patients undergoing electrophysiology (ep) procedures.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * patients scheduled for electrophysiology procedure with mac. * subject willing to participate and able to provide informed consent. exclusion criteria: * age \< 18 years old. * history of motion sickness or blindness.

Keywords: virtual reality
quality of life in patients with and without a parastomal bulge

Conditions: Quality of Life; Parastomal Hernia

Summary: it is not well-established whether a parastomal bulge impacts stoma patients hrqol or if hrqol differs according to the underlying disease or type of stoma. in this large cross-sectinal study stoma patients with and without a parastomal bulge are asked about their health-related quality of life and stomarelated quality of life. stoma patients are identified in the danish stoma database and contacted two times by email. non-responders are sent a paper booklet.

a cross-sectional study of patients registered in the danish stoma database capital region (dsdcr), with permanent or temporary enterostoma after surgery performed between 2011 and 2016. via a unique personal identification number registered in dsdcr patients will be contacted by e-mail using the e-boks system, an official electronic distribution system covering around 80% of the danish adult population. the e-mail will contain information about the study and a personal link to surveyxact, an online survey program allowing for direct electronic data entry by patients. first reminder will be sent after one week and a second reminder again one week later. if necessary, a third reminder additionally three weeks later will be sent to patients by post, including a paper booklet of the questionnaires as described below. for patients without e-boks, dsdcr will be linked to the danish civil registration system via the unique personal identification number, providing information on patient's addresses. information on the study and a paper booklet of questionnaires will be sent to patients by post. a reminder will be sent by post after three weeks if necessary. hereafter, no further attempts will be made to contact the patients. to include other relevant variables in the analysis of data, data from the danish anaesthesia database (dad) and the danish colorectal cancer database will be linked. quality of life will be assessed using stomaqol and sf-36. colostomy impact score will also be obtained. patients will self-report a parastomal bulge and information such as education, alcohol consumption, physical activity and civil status.

Eligibility criteria:
inclusion criteria: * permanent active sigmoideostomy, transverseostomy, jejunostomi or ileostomy * temporary active sigmoideostomy, transverseostomy, jejunostomi or ileostomy exclusion criteria: * age younger than 18 years * stoma closure at follow-up * death

Keywords: quality of life hernia parastomal bulging stoma cross-sectional