Kornimate/medical-research-clean huggingface dataset:
a randomized study to compare the dosing schedule of infed in anemic patients.

Conditions: Anemia, Iron Deficiency

Summary: the purpose of this study is to establish which dosing schedule of infed (iron dextrose) is superior for the treatment of iron deficient anemia.

the purpose of this study is to establish which dosing schedule of infed (iron dextrose) is superior for the treatment of iron deficient anemia. the two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.

Eligibility criteria:
inclusion criteria: 1. patients over the age of 18 years old. 2. being treated by a sutter health physician. 3. hemoglobin of \< 10mg/dl for men and women 4. ferritin \</= 10ng/ml 5. patients in whom oral administration is unsatisfactory or impossible. exclusion criteria: 1. patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable. 2. anemia due to acute blood loss; menorrhagia is allowed. 3. patients with a current illness known to interact with iron status. 4. patients unwilling to consent to required blood draws. 5. patients who are viewed as unable to complete treatment, based on pi recommendation.
a clinical study to assess the efficacy and safety of three doses of vildagliptin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) in the range 22-45 * blood glucose criteria must be met * not currently on drug therapy for type 2 diabetes exclusion criteria: * type 1 diabetes * evidence of serious diabetic complications * evidence of serious cardiovascular conditions * laboratory value abnormalities as defined by the protocol * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
safety of spd417 combined with other psychotropic medications in the treatment of bipolar i disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to evaluate the safety of spd417 when given with other psychotropic medications to treat bipolar i disorder.


Eligibility criteria:
inclusion criteria: * dsm-iv criteria for bipolar i disorder * screening ymrs score =\>16 * women of childbearing potential agree to take adequate precautions against contraception * currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic exclusion criteria: * hospitalization required for treatment of psychiatric symptoms * patients who meet dsm-iv for ultra-rapid cycling * history of serious suicide attempt requiring medical intervention * female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening
postrual reduction with pillow in osteoporotic vertebral fracture

Conditions: Compression Fracture Spine; Osteoporosis Fracture

Summary: vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. however, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. in the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. we tried postural reduction using a soft pillow under the compressed level. this study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. we analyzed the degree of re-expansion according to the onset duration.


Eligibility criteria:
inclusion criteria: * single level osteoporotic compression fracture of thoracic and lumbar spine exclusion criteria: * can't tolerate the postural reduction by pillow * pathological spine fracture caused by tumor, infection. * multiple spine fractures * patient presented with neurological. deficits

Keywords: compression fracture, postural reduction, vertebroplasty
cost-efficacy of sealing moderate caries lesions in occlusal surfaces of primary molars

Conditions: Dental Caries

Summary: this protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. in this case, it could be preferable since it is less invasive. therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). finally, the acceptability could be another differential point between treatments.

this study aims to evaluate the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. 96 children aged 3-6 years will be selected. children must have at least one occlusal surface classified as scores 3 or 4 of international caries detection and assessment system (icdas). children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. after treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. the need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. the secondary outcomes will be the chil's acceptability to the treatment.

Eligibility criteria:
inclusion criteria: they will be included in this study children: * aged 3 years and 6 years and 11 months; * with complete primary dentition; * who have at least one active caries lesion score 3 or 4 icdas, in the occlusal molars surfaces. * who have assented to participate and whose parents have consented to their participation by signing the instrument of consent. exclusion criteria: * who have medical and / or behavioral conditions that require special considerations regarding handling / treatment; * who are involved in other research that may impact on this study; * whose parents that not agree in participate.

Keywords: dental caries primary tooth ionomer sealants glass ionomer restoration
feasibility of bronchial washing fluid for molecular testing with next generation sequencing in lung cancer

Conditions: Lung Cancer

Summary: this is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with next generation sequencing.

this is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using next generation sequencing in patients with nsclc.

Eligibility criteria:
inclusion criteria: * age ≥ 20 years * obtained written informed consent * no contraindication to bronchoscopy * subjects suspected of having lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology * subjects planning to undergo tissue or liquid biopsy for genetic alteration with next generation sequencing exclusion criteria: * subjects who withdraw informed consent * subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with next generation sequencing based on the investigator's judgement * subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion * subjects diagnosed with a benign lesion from the lung tissue lesion

Keywords: bronchoscopy liquid biopsy lung cancer next generation sequencing
gnt0006 gene therapy trial in patients with lgmdr9

Conditions: LGMDR9

Summary: phase 1-2 study including a dose escalation safety and proof of concept phase (stage 1, open label), followed by a double-blind, randomized, placebo-controlled confirmatory phase (stage 2)

multicenter, phase 1-2 study evaluating safety, pharmacodynamic, efficacy, and immunogenicity of gnt0006, an adeno-associated virus (aav) vector carrying the human fkrp transgene. this study will consist of 2 phases: an open-label dose escalation phase (stage 1) and a double-blind placebo controlled, randomized phase (stage 2), both with long-term follow-up (ltfu) period. stage 1 two dose cohorts will be enrolled sequentially and enrollment. an initial cohort of three (3) patients will receive a potentially effective dose, followed by a 2nd higher dose cohort of 3 patients. stage 2 after selection of the effective dose in stage 1, thirty-three (33) ambulant patients will be randomized at the optimal selected dose and followed up to the primary efficacy timepoint, i.e., one year after investigational medicinal product (imp) (or placebo) administration. at one-year post-imp administration (timepoint of primary interest for efficacy), patients enrolled in placebo group will receive active imp while patients randomized in the active imp group will receive a placebo infusion. all subjects will be followed for up to 5 years after active imp (gnt0006) administration.

Eligibility criteria:
inclusion criteria: * 1. female and male ambulant patients * 2. patients ≥ 16 years old * 3. documented lgmdr9 diagnosis based on clinical presentation and genotyping confirming the fkrp gene mutations * 4. moderate diaphragmatic muscle impairment exclusion criteria: * 1. detectable serum neutralizing antibodies against aav9 * 2. cardiomyopathy
the effect of exposure to maternal human milk odor on physiological state of preterms.

Conditions: Health Preterm Infants With no Active Disease; Human Milk Nutrition; Incubator Stay

Summary: mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant. provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.


Eligibility criteria:
inclusion criteria: * preterm infants at least 1 week of age * no active disease or treatment (like respiratory support) * place in incubator exclusion criteria: * active disease or treatment
the effect of neoadjuvant chemotherapy on physical functions

Conditions: Breast Cancer; Neoadjuvant Chemotherapy; Neoadjuvant Therapy

Summary: the aim of this observational study was to investigate the effect of neoadjuvant chemotherapy on physical functioning in individuals with breast cancer. the main question that the study aims to answer is how the physical functions of individuals are after neoadjuvant chemotherapy. demographic information of the participants will be recorded and their physical status will be evaluated by determining body weight and composition, 30-second sit-and-stand test, 9-step stair ascent and descent test, one-leg stand test, upper extremity muscle strength test, lower extremity muscle strength test, tissue dielectric constant measurement, lower extremity functional scale, global physical activity questionnaire and multidimensional fatigue rating scale. in these patients who are planned to receive neoadjuvant chemotherapy for breast cancer, measurements will be made before chemotherapy (t1) and after chemotherapy (t2).

as a result of the power analysis made from the reference study; when the effect size d=0.8, it was calculated that 80% power could be obtained at 95% confidence level when at least 42 people were included in the study. considering that a lower effect size can also be obtained, it is planned to complete the study with at least 46 participants by taking 10% more participants. the data will be analysed with spss 25.0 package programme. continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. when parametric test assumptions are met, the significance test of the difference between two means will be used to compare independent group differences; when parametric test assumptions are not met, the mann-whitney u test will be used to compare independent group differences. in dependent group comparisons, repeated measures analysis of variance will be used when parametric test assumptions are met; friedman test will be used when parametric test assumptions are not met. in addition, the relationships between continuous variables will be examined by spearman or pearson correlation analyses and the differences between categorical variables will be examined by chi-square analysis.

Eligibility criteria:
inclusion criteria: * individuals who are planned to receive neoadjuvant chemotherapy for breast cancer * acceptance to participate in the study exclusion criteria: * previous history of breast cancer * history of any other cancer * refusal to participate in the study * refusal to continue working

Keywords: physical functions breast cancer neoadjuvant chemotherapy physiotherapy fatigue physical activity
troponin elevation in consecutive patients with hip fracture

Conditions: Hip Fracture

Summary: the aims of this study is to study the occurrence of the troponin elevations, ecg changes, and cardiac symptoms in unselected consecutive patients with hip fracture. followup will be carried out up to one year period.


Eligibility criteria:
inclusion criterion: * hip fracture diagnosed in turku univeristy hospital between october 2009 and may 2010 exclusion criterion: * patient refusal

Keywords: patients with hip fracture
comprehensive geriatric assessment - can it improve quality of life

Conditions: Quality of Life

Summary: like most developed countries the population of sweden is getting older and consequently the number of individuals with chronic diseases will be an increasing challenge for its healthcare system. to improve care of the frail elderly, wards with a coordinated multidisciplinary team and multidisciplinary mobile teams were established several years ago. treatment and follow up is planned in accordance to the patients' medical, psychological and functional capabilities (comprehensive geriatric assessment = cga). there are to our knowledge only few studies concerning cga applicable to swedish conditions. we plan to conduct a swedish study that evaluates if care and treatment with a modified cga-model in an outpatient setting can improve quality of life for frail older people.


Eligibility criteria:
inclusion criteria: * age ≥65 years * live in own home * reason to believe that the health condition is not optimal or could be optimized * meet at least 2/6 of the following criteria: cognitive impairment, general tiredness or dyspnea, have fallen often/afraid to fall, need help with activities of daily living, hospital care ≥3 times within the last 12 months, care problems at home exclusion criteria: * psychosis * not understand the swedish language

Keywords: polypharmacy
closure of uterine incision by single or double layer technique

Conditions: Pregnancy

Summary: the study compares short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. the study is a randomized clinically controlled study.

objective: to compare short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. the study is a randomized clinically controlled study. design:follow-up by ultra sound of a randomised controlled trial. surgical technique was blinded for the investigator. setting: an obstetric department in a tertiary referral hospital, 2008-2013. participants: healthy nulliparous scheduled for elective caesarean section randomly assigned to closure of the uterine incision by single- or double layer techniques. intervention: a modified version of the misgav-ladach surgical technique was used. the women were examined by abdominal ultra sound before discharge from the maternity ward, and by vaginal ultra sound and hysterosonography minimum five month post partum. main outcome measure: thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound.

Eligibility criteria:
inclusion criteria: * women submitted to cesarean sectio exclusion criteria: * exclusion criteria were: former uterine operations such as myomectomy or surgery resulting in entering the cavity, fibroids located in the cervix or the cervicalcorporal border, inflammatory bowel disease, sle, rheumatoid arthritis, iddm, re-operations after inclusion or the cesarean section and more than three additional single sutures for hemostasis.
comparison of conventional dialysis and the allient system

Conditions: End Stage Renal Disease; Chronic Kidney Failure

Summary: the purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the allient system as compared to conventional hemodialysis.


Eligibility criteria:
inclusion criteria: * maintenance in-center hemodialysis * age greater than or equal to 18 years * has been on hemodialysis for at least 4 months * uses a standard single-pass dialysis machine with a high-flux dialyzer exclusion criteria: * hospitalization during the 8 weeks preceding enrollment * infection requiring antibiotic treatment during the 8 weeks preceding enrollment * central venous cather as dialysis access * uncontrollable blood coagulation anomalies * smokers * dialysis regimen other than 3 times weekly * in ability to understand the english language and give informed consent for participation in the study

Keywords: hemodialysis
real world study of pyrotinib in human epidermal growth factor receptor-2 (her2) positive breast cancer

Conditions: HER2-positive Breast Cancer

Summary: this non-interventional study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of her2 positive breast cancer in the real world.


Eligibility criteria:
inclusion criteria: 1. ≥18 years old with histologically confirmed her2 positive breast cancer. 2. documented her2 overexpression by local laboratory ,defined as immunohistochemistry (ihc) 3+ or fluorescence in situ hybridization (fish) positive. 3. physician has determined that treatment with pyrotinib is indicated. 4. traceable medical record available. exclusion criteria: 1. patients who are unable to understand the nature of the study and are unwilling to sign an informed consent . 2. pregnant or breast feeding patients 3. patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. 4. patients not suitable for this study under investigators' consideration.

Keywords: pyrotinib
hormonal and inflammatory changes during pregnancy in women with glucose metabolic disorders.

Conditions: Diabetes Mellitus, Type 2; Gestational Diabetes; Overweight and Obesity; Pregnancy in Diabetic; Insulin Resistance; Insulin Sensitivity; Pregnancy, High Risk

Summary: the first aim of this study is to describe maternal hormonal and inflammatory changes during pregnancy in women that differ metabolically (limited to women with type 2 diabetes, gestational diabetes and/or overweight). the second aim of this study is to examine maternal hormonal, inflammatory and metabolic factors associated with insulin sensitivity in human pregnancy.

this is a prospective observational study including app. 300 pregnant women from the outpatient clinics at department of obstetrics and gynecology at aalborg, odense and aarhus university hospital. the study includes 50 healthy normal-weight women, 150 healthy overweight women, 50 women with gestational diabetes and 50 women with type 2 diabetes. hormonal profiles and inflammatory markers will be measured at gestational week 8-10, 10-14, 18-22, 24-28 and 34-38. the blood samples will include hba1c, glukose, insulin, c-peptid, lipid profile, liver enzymes, creatinine, fgf-21, tsh, cortisol, human chorionic gonadotropin, estradiol, progesterone, prolactin, human placental lactogen, placental growth hormone, igf-1, igf-bp's, leptin, adiponectin, glp-1, gip, hs-crp, il-6, il-10, il-1α, ifn-ɣ, tnf-α, icam1, vcam and cd163. in addition to this, exosomes will be isolated precisely and profiling of the content of exosomes will be performed using in vitro assays. proteomics and mirnas sequencing will be employed. height, weight, and blood pressure will be measured at every visit and a urine sample will be collected. insulin sensitivity will be estimated using the homeostasis model assessment, is-homa, based on fasting insulin and glucose concentrations.

Eligibility criteria:
inclusion criteria: * pregnant women at the department of gynaecology and obstetrics at aarhus university hospital, aalborg university hospital or odense university hospital. * women have to be in 1 of 4 categories: healthy with a bmi \ = 25, diagnosed with gestational diabetes before gestational week 20 or diagnosed with pregestational type 2 diabetes exclusion criteria: * age \< 18 years * not able to read and understand danish * previous bariatric surgery * treatment with systemic corticosteroids
cccr-nk92 cells immunotherapy for non-small cell lung carcinoma

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this clinical investigation is to evaluate the safety and effects of cccr-modified nk92(cccr-nk92)infusions in previously treated advanced non-small cell lung carcinoma(nsclc).


Eligibility criteria:
inclusion criteria: * 1.male and female subjects with non-small cell lung carcinoma in patients with no available curative treatment options who have limited prognosis(≧3 months)with currently available therapies will be enrolled. * 2.the last cytotoxic drug, radiotherapy or surgery≧4 weeks. * 3.hb≧90g/l, anc≧1.5×10e9/l, plt≧80×10e9/l, tbil≦1.5×upper limit of nomal, alt/ast≦2.5×upper limit of nomal, alt/ast≦5×upper limit of nomal if have liver metastasis, cr≦1.5×upper limit of nomal or ccr≧60ml/min. exclusion criteria: * 1.pregnancy or breastfeeding. * 2.known hiv, hbv or hcv infection. * 3.active antoimmune disease. * 4.history of severe immediate hypersensitivity to any of the biological products including penicillin. * 5.severe psychiatric disorder which might interfere with the study treatment or examination. * 6.chronic heart failure nyha≧iii. * 7.simultaneous participation in another clinical trial within 4 weeks.