Kornimate/medical-research-clean huggingface dataset:
feasibility study of new subcutaneous glucose sensor with recording devices

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: the purpose of phase 3 group is to evaluate the impact of acetaminophen on the performance of guardian sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.

the study is a multi-center, prospective single-arm design without controls. all subjects will be assigned to treatment for 11 days of sensor wear. each subject will wear 4 guardian sensor (3)s, and each will be connected to a guardian link (3) transmitter and/or guardian connect transmitter. subjects will not use sensor glucose values for diabetes management. on days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (bg) using a home glucose meter approximately every 20 minutes for 5 hours. subjects will be asked to take one gram of acetaminophen orally on days 3, 5, and 6 of sensor wear. on day 11, devices will be removed, data uploaded from the study meter and transmitter or recorder, skin assessment will be performed, and the subject's participation in the study will be completed.

Eligibility criteria:
inclusion criteria: 1. subject is 18-75 years of age at time of screening 2. a clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months 3. subject is using insulin to treat their diabetes 4. subject agrees to comply with the study protocol requirements 5. subject is willing to perform self-monitoring of blood glucose approximately every 20 minutes during fst exclusion criteria: 1. subject has history of allergy to acetaminophen or has been told by health care provider they may not ingest acetaminophen 2. subject reports history of liver cirrhosis or problems with liver that a health care provider told them they should not use acetaminophen because of liver disorder. 3. subject is unable to tolerate tape adhesive in the area of sensor placement 4. subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, staphylococcus infection) 5. subject is actively participating in or plans to enroll in an investigational study (drug or device), other than this study, wherein they have received treatment from an investigational drug or device 6. subject has a positive urine pregnancy test at time of screening 7. subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study 8. subject is unwilling to participate in study procedures.

Keywords: acetaminophen
physical exercise program in obese and overweight pregnant women

Conditions: Pregnancy

Summary: obesity and overweight have become an epidemic in the world and its prevalence between pregnant women is especially dangerous. having a high body mass index (bmi) is also associated with depression disorders and its serious complications during this period.

the aim of our study is to assess whether a specific exercise program during pregnancy has a positive effect on maternal mood and other pregnancy outcomes.

Eligibility criteria:
inclusion criteria: * being healthy and able to exercise following american college of obstetricians and gynecologists (acog) guidelines * being able to communicate in spanish * giving birth at hospital universitario de fuenlabrada * having a body mass index (bmi) greater than 24.9 exclusion criteria: * multiparity * obstetrician complications * being interested in the study after 18 weeks * not being regular in physical exercise program (minimum adherence 80%) * younger than 18 years old

Keywords: overweight, obese, pregnant, depression, outcomes
autologous t cell vaccine (tcv) for multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: this is a 1 year study to evaluate the efficacy, safety, and tolerability of tovaxin t cell therapy in subjects with a clinically isolated syndrome (cis) and relapse-remitting multiple sclerosis (rr-ms).

a 2 arm, 52 week parallel-group of tovaxin versus placebo in subjects with cis or rr-ms. subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. eligible subjects will be enrolled to receive either tovaxin or placebo and will complete baseline assessments. randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. subjects will be monitored by cbc, serum chemistries, urinalysis, expanded disability status scale (edss), msfc, msqli, magnetic resonance imaging (mri), and monitor myelin reactive t cells for safety, efficacy, and tolerability of tovaxin.

Eligibility criteria:
inclusion criteria: * aged 18 to 55 years old * presence of myelin reactive t cells at screening * diagnosis of cis with screening mri that fulfils the barkhof criteria - dissemination in space * diagnosis of ms within the past 10 years according to the mcdonald criteria (2005) * baseline edss score between 0 and 5.5 inclusively exclusion criteria: * unable to produce t cell vaccine * disease-modifying treatment for ms during the last 30 days and 60 days for steroidal treatments * diagnosis of progressive-relapsing, secondary progressive, or primary progressive ms * planned pregnancy, currently pregnant, or breastfeeding * any prior treatment with total lymphoid irradiation, cladribine, t cell or t cell receptor vaccination

Keywords: phase 2b tovaxin clinically isolated syndrome (cis) relapse-remitting multiple sclerosis (rr-ms)
effects of travatan z and xalatan on ocular surface health

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with sofzia® preservative system or xalatan once daily for 12 weeks.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye). * use of bak (benzalkonium chloride) containing intraocular pressure (iop) lowering medication for a minimum of one year, including latanoprost (xalatan®) monotherapy for at least 6 months prior to visit 1. * iop controllable and stable on the study medication alone (both eyes). * believed to have ocular surface disease (osd). * tear break-up time (tbut) of ≤ 6 seconds in the study eye. * willing and able to discontinue the use of any topical ocular medication other than the study medication or bak free artificial tears for the duration of the study. * other protocol-defined inclusion criteria may apply. exclusion criteria: * current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs. * current use of punctual plugs. * women of childbearing potential not using reliable means of birth control. * women who are pregnant or lactating. * suspected or diagnosed with sjogrens's syndrome. * current use of any brand of artificial tears containing bak. * use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to visit 1, or an anticipated change in dosing regimen of medications during the course of the study. * intraocular conventional surgery or laser surgery in study eyes less than six months prior to visit 1. * current use of contact lenses within 30 days of visit 1. * participation in any other investigational study within 30 days prior to visit 1. * other protocol-defined exclusion criteria may apply.

Keywords: ocular surface health osdi tfbut glaucoma ocular hypertension corneal staining
gestational diabetes management based on planned behavior theory

Conditions: Diabetes Mellitus, Gestational

Summary: our study was planned as a randomized controlled trial in order to determine the effect of planned behavior theory based training model on diabetes management and pregnancy outcomes in women with gestational diabetes mellitus.

the trial will be conducted to evaluate the effectiveness of the model and to determine the impact of the planned behavior theory based educational intervention on diabetes management and pregnancy outcomes.the research will be conducted in women's training and research hospitals in istanbul. the sample group will be 70 subjects calculated by power analysis. case and control groups will be determined by simple randomization. sampling selection criteria; 24-28. they are pregnant women who are diagnosed with gdm between the weeks of gestation, can communicate in turkish, are literate, have no gdm in their previous pregnancies, have a personal contact number and e-mail address, and plan to give birth at the hospital where the study will be conducted. research data will be collected by the researcher between the 28th week of gestation and the 12th week of postpartum through the diabetes intention, attitude and behavior questionnaire, personal data collection form, metabolic control variables form, maternal and infant pregnancy results form. case group; in addition to the training given in the hospital, the training for gestational diabetes based on planned behavior theory will be given in three stages. figures, percentage distributions, chi-square test, student t-test and analysis of variance will be used in the analysis of the data. as a result of the intervention made to the case group; it is expected to decrease complications due to diabetes in mothers, babies and newborns, to provide maternal metabolic control, to control the mother's weight and to shorten the duration of hospital stay.

Eligibility criteria:
inclusion criteria: * sample selection criteria describe pregnant women with personal contact information available who are diagnosed to have gdm between the weeks of 24-28 of their pregnancy, literate and capable of communicating in turkish, not diagnosed to have gdm in their previous pregnancies, planning to deliver the child in the hospital where the research is to be conducted. exclusion criteria: * not having had a cesarean delivery before.

Keywords: education, nursing pregnancy complications complications, labor diabetes, pregnancy-induced
molecular genetic study of mayer-rokitansky-kuster-hauser syndrome

Conditions: Mayer Rokitansky Kuster Hauser Syndrome

Summary: in order to understand the molecular mechanisms leading to mayer-rokitansky-kuster-hauser syndrome (mrkh), the research team has to identify molecular bases of this anomaly. toward this goal, the research team would like to include in the study patients with mrkh syndrome, as well as their healthy relatives, in order to perform genetic analyses, especially whole exome sequencing. this study has been set up in order to collect biological samples from patients with mrkh and their relatives.

the mrkh is a congenital and rare malformation characterised by the absence of the uterus and of 2/3 of the vagina. the incidence is 1 in 4500 female children (46,xx) and a genetic component has been identified. in order to understand the molecular mechanisms leading to this disease, the research team has to identify the genetic abnormalities. this study will be led by the research team of the imagine institute and the clinical teams associated with the reference center for rare diseases pgr (rare gynecologic diseases). both groups are based on the necker hospital campus, and already closely collaborate on research into mrkh syndrome. this collaboration will allow to : i) collect biological samples from the propositus and their relatives, ii) have a medical expertise. the clinicians involved in the study will recruit patients, whose participation will involve providing a biological sample, ie, a blood sample and/or uterine tissue collected during surgical ablation, in the event that surgery is performed during clinical follow-up of the patients. no specific intervention will be planned for the purposes of this study. in order to perform genetic analysis on trios, the healthy relatives of the patients (parents, brothers, sisters) will also be included. blood samples will be taken once for healthy relatives. genetic analysis, especially whole exome sequencing, will be performed on blood samples by the research team of imagine institute.

Eligibility criteria:
inclusion criteria: * patient with mrkh syndrome or healthy relative of patient included * having signed the informed consent form (or parents in case of patient under 18 years) exclusion criteria: * refusal to participate in genetic analyses * participation in a therapeutical clinical study in the 30 days prior to inclusion in the present study.
comparison of dyslipidemia among diabetics versus non diabetics in haemodialysis patients

Conditions: Dyslipidemias

Summary: * how dyslipidemia common among diabetic and non- diabetic haemodialysis patients. * how differ dyslipidemia types among diabetic and non- diabetic in haemodialysis patients. (qualitative difference).

diabetes mellitus (dm) is a metabolic disease , a consequence of defects in insulin action, secretion, or both, and there are complications associated with it, such as nephropathy, retinopathy, neuropathy, cardiovascular complications ,cerebrovascular and peripheral arterial disease. diabetic nephropathy, which occurs in about one third of type 2 diabetic patients, is the most common factor leading to end-stage renal disease (esrd) . a very common metabolic abnormality associated with diabetes is dyslipidemia, which is characterized by a spectrum of quantitative and qualitative changes in lipids and lipoproteinsseveral previous studies have pursued linking blood glucose levels to serum lipid activities. the etiology of dyslipidemia appears to be centered on the increased large tag-rich very low-density lipoprotein-cholesterol (vldl-c) and its impaired clearance. american diabetic association (ada) defines dyslipidemia as hypercholesterolemia ≥200 mg/dl of serum total cholesterol, hypertriglyceridemia ≥150 mg/dl of serum triglyceride, reduced high density lipoprotein cholesterol (hdl-c) \<40 mg/dl for men and \<50 mg/dl for women, elevated low density lipoprotein cholesterol (ldl-c) ≥70 mg/dl and high tc to hdl-c ratio of ≥4.5. normal plasma lipids and lipoprotein metabolism is critical for cellular cholesterol homeostasis and protection against atherosclerosis, renal disease and other complication . a study found that people with high blood pressure and overweight or obesity have a higher risk of developing dyslipidemia ,early detection and effective control of blood lipid levels can reduce the morbidity and mortality of cvd in patients with dm. therefore, it is important to determine the factors associated with dyslipidemia.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 60 years. * patients undergoing regular conventional haemodialysis for more than 6 months exclusion criteria: * peritoneal dialysis * haemodiafilteration * acute kidney injury * nephrotic syndrome * hypothyroidism * familial hypertriglyceridemia. * acute pancreatitis * connective tissue disease. * decompensated liver disease * active malignancy.

Keywords: haemodialysis diabetes mellitus
the effect of a nurse-led continuous support program on neurodevelopment of preterm infants

Conditions: Preterm Infant

Summary: the objective of the study is to establish a continuous nurse-led integrated support program and to exam its impact on preterm infant neurodevelopment. research hypotheses include:1. the continuous nurse-led integrated support will have significant impact on preterm infant neurodevelopment; 2.the support program will also have positive effect on parent psychological well-being.

the objective of the study is to establish the continuous nurse-led integrated support program as well as exam its impact on neurodevelopmental health of preterm infants. research hypotheses: 1. compared to control group, the preterm infants in the interventional group will experience significantly better performance on neuromotor, cognitive and social-emotional function at corrected age of 3 month; 2. in comparison with those receiving routine support, parents receiving nurse-led continuous support will have significantly higher parental self-efficacy and exhibited better psychological well-being; 3. maternal parenting self-efficacy will mediate the relationship between nurse-led support and preterm infant neurodevelopment.

Eligibility criteria:
inclusion criteria: * preterm infants born between 28-36 weeks of gestation; * parents residing in the same region for at least 5 years; .parents agree to participate in the study. exclusion criteria: * infants with severe perinatal brain injury; * infant with congenital anomalies
mirna and relevant biomarkers of bc patients undergoing neoadjuvant treatment

Conditions: Breast Cancer

Summary: microrna (mirna) is a type of endogenous non-coding rna. they are responsible for post-transcriptional regulation and participate in many vital biological processes. expression profiling has shown that mirnas can distinguish between normal breast and tumor tissues. in recent years, circulating mirnas have become promising biomarkers based on their stability and their non-invasive testing and feasibility in clinical practices.

current reports showed that serum microrna expression could be used as an early marker for determining the breast cancer risk. the concentrations of some circulating micrornas in human breast cancer have been correlated with tumor development and progression. aberrant mirna expression may be involved in drug resistance to various chemotherapeutic agents in breast cancer. therefore, we hope to investigate the value of mirnas in predicting the effect in breast cancer neoadjuvant treatment.

Eligibility criteria:
inclusion criteria: 1. early breast cancer patients; 2. stage ii-iii disease; 3. sign informed consent form; 4. receive neoadjuvant treatment; 5. age between 18-75. exclusion criteria: 1. women during pregnancy; 2. metastasis patients or stage iv breast cancer patients; 3. male breast cancer patients; 4. inflammatory breast cancer patients; 5. patients with neoadjuvant endocrine treatment.

Keywords: breast cancer biomarker neoadjuvant treatment microrna response
effect of chemotherapy vs no chemotherapy pre-transplant to mds undergoing allo-hsct

Conditions: Myelodysplastic Syndrome; Chemotherapy

Summary: allogeneic hematopoietic stem cell transplantation (allo-hsct) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (raeb-1), refractory anemia with excess blasts-2 (raeb-2) and acute myeloid leukemia (aml) secondary to myelodysplastic syndrome (mds). at present, the necessity of chemotherapy pre-transplantation for raeb-1, raeb-2 and aml secondary to mds (bone marrow blast cells less than 50%) undergoing allo-hsct remains in discussion. in this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with raeb-1, reab-2 and aml secondary to mds (bone marrow blast cells less than 50%) undergoing allo-hsct are evaluated.

allo-hsct appears to be an efficient tool to cure patients with mds and aml secondary to mds. decitabine and/or chemotherapy pre-transplantation could reduce the blast cells in bone marrow and improve the complete remission rate. however, decitabine and/or chemotherapy had side effects and might increase treatment-related mortality. at present, the necessity of chemotherapy pre-transplantation for raeb-1, raeb-2 and aml secondary to mds (bone marrow blast cells less than 50%) undergoing allo-hsct remains in discussion. in this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with raeb-1, reab-2 and aml secondary to mds (bone marrow blast cells less than 50%) undergoing allo-hsct are evaluated.

Eligibility criteria:
inclusion criteria: * raeb-1, reab-2 and aml secondary to mds (bone marrow blast cells less than 50%) undergoing allo-hsct * 14-65 years exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: chemotherapy
effectiveness of the functional hand splint and specific tasks in the domiciliary environment applied to children with unilateral cerebral palsy

Conditions: Hemiplegia and Hemiparesis; Cerebral Palsy Infantile

Summary: the main objective: to determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation. hypothesis: the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.

randomized clinical trial with blinding of the evaluator and the person analyzing the data. a home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. the assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.

Eligibility criteria:
inclusion criteria: 1. diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis). 2. ages between 5 and 12 years. 3. levels i-iii of the manual ability classification system (macs) 4. levels i-iii of the gross motor function classification system (gmfcs) 5. able to understand and respond to verbal instructions. exclusion criteria: 1. cognitive impairment identified by the school report. 2. hand orthopedic surgery in the last 6 months. 3. neuropharmacological intervention in the last 6 months. 4. allergy to upper limb orthosis material. 5. affectation of the manual function not due to the neurological condition (trauma, burn ...). 6. current treatments not compatible with the study. 7. other significant neurological affections (crisis, severe visual impairment ...).

Keywords: cerebral palsy hemiplegia upper-limb splint home-based social participation