Kornimate/medical-research-clean huggingface dataset:
metformin versus standard of care treatment in pregnant women with prediabetes

Conditions: Prediabetes; Complicating Pregnancy

Summary: the purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

women in pregnancy are routinely screened for diabetes in the first trimester and those who fall into the prediabetes category by hemoglobin a1c level of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation will be approached for consent in our randomized trial. once consent is obtained, the subjects will be randomized 1:1 into two parallel groups, the metformin treatment group and the standard of care treatment group (routine prenatal care). a random number generator will allocate the participants to the study groups. women taking metformin will continue twice daily dosing for the duration of their pregnancy after randomization. those in the standard of care group will receive routine prenatal care. both groups will undergo routine gestational diabetes testing by 28 weeks. obstetric, maternal, and neonatal outcomes will then be assessed of both groups until the 6 week postpartum visit.

Eligibility criteria:
inclusion criteria: * pregnant women with hemoglobin a1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation * pregnancy and delivery care obtained at university of massachusetts (umass) memorial medical center * patients able to provide written informed consent exclusion criteria: * pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above * presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin * participants who are under the age of 18 * multiple pregnancy * patients already taking metformin for other indications * fetal defect noted on early dating ultrasound * miscarriage before randomization

Keywords: maternal outcomes neonatal outcomes metformin prediabetes pregnancy
taiwan cancer moonshot project

Conditions: Malignant Neoplasm of Body of Stomach in Situ

Summary: the aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform.

multiomic integrative analysis is an effective strategy to facilitate the investigation of molecular mechanism, cause, and early intervention of specific diseases. gastric cancer is specifically chosen for our research target to decrease its incidence and improve survival. to increase precision diagnosis, prognosis and precision therapy, patients from taiwan are selected as cohort subjects. the aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform. genome, transcriptome, genomic methylation, proteomics, and post-translational modification will be used to construct a map for determine the in-depth carcinogenesis of gastric cancer and strategies for cancer early diagnosis, prevention, and targeted treatments.

Eligibility criteria:
inclusion criteria: * lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer exclusion criteria: * other cancer types

Keywords: lung cancer breast cancer gastric cancer pancreatic cancer ovarian cancer
association of lumbar modic changes with chronic low back pain in southern european subjects

Conditions: Low Back Pain

Summary: in this case-control study, cases were chronic lbp patients aged 30-50 in whom a lumbar mri had been prescribed. controls were subjects aged 30-50 in whom a cranial mri had been prescribed for headache, who did not suffer from lbp and had no history of clinically relevant lbp. two hundred and forty cases and 64 controls were recruited consecutively in radiology services across six cities in spain. imaging findings and subjects' characteristics were gathered through previously validated instruments. radiologists who interpreted mris were blinded to subjects' characteristics. a multivariate logistic regression model was developed to assess the association of modic changes with lbp, adjusting for sex, age, body-mass index, lifetime exposure to smoking, physical activity, and disk degeneration.


Eligibility criteria:
inclusion criteria: * for all subjects: age between 35 and 50 years. * for subjects with lbp: having a diagnosis of chronic low back pain (of 3 or more months' duration) as the reason for an mri. * for subjects without lbp: subjects with a cranial mri (described as normal) for cephalalgia, and who had neither current lbp nor history of lbp. exclusion criteria were: history of spine surgery, current pregnancy, scoliosis with \>15º curvature, vertebral fractures, "red flags" for potential underlying systemic diseases (oncologic disease during the previous 5 years, constitutional symptoms -unexplained weight loss, fever, chills-, history of intravenous drug use, or immunocompromised host), or signs suggesting cauda equine syndrome (relevant or progressive paresia, loss of sphincter control or saddle anesthesia).

Keywords: modic changes chronic low back pain magnetic resonance imaging (mri) vertebrae intervertebral disc
effect of 13-week treatment with vildagliptin as add-on therapy to improve glucose variability in type ii diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (t2dm) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.


Eligibility criteria:
inclusion criteria: 1. informed consent read and signed before any protocol procedure. 2. free will to sign the informed consent. 3. male and female between 18 and 80 years. if female, patient must be non-fertile or of childbearing potential using a medically approved birth control method. 4. type 2 diabetes mellitus 5. patient under insulin treatment within 3 years with stable insulin nph (neutral protaminehagedorn) regimen at dose of at least 20 ui/day up to 40 ui/day for a minimum of 4 weeks prior to enrolment, only nph and glargine insulin are allowed. 6. hba1c between 7.5 to 9%. 7. fasting plasma glucose (fpg) less than 270 mg/dl. 8. body mass index (bmi) between 20 to 35 kg/m2. 9. free willing to take the vildagliptin tablets during the study. exclusion criteria 1. pregnant or lactating female or without birth control method if of childbearing potential. 2. type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., cushing's syndrome. 3. acute cardiovascular complications or metabolic complications within the past 4 months. 4. history cerebrovascular disease during the last year. 5. history of torsades de points, ventricular tachycardia or ventricular fibrillation. 6. ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery). 7. congestive heart failure requiring pharmacologic treatment. 8. any known serious heart condition. 9. alt and/or ast greater than three times the upper limit of the normal range. 10. serum creatinine levels greater than 1.5 mg/dl 11. malignancy including leukemia and lymphoma within the last 5 years other inlcusion/exclusion criteria may apply

Keywords: diabetes, type 2 diabetes, diabetes mellitus, insulin,
heart rate evaluation and resuscitation trial in preterm neonates

Conditions: Neonatal Resuscitation; Infant, Premature

Summary: the purpose of this study is to determine whether using electrocardiograms (ecgs) during resuscitation of preterm infants (less than 31 weeks gestation) will decrease the amount of time it takes from birth for heart rate (hr) to be above 100 beats per minute and oxygen saturations to be in the goal range, in other words to stabilize the infant. a few studies have been conducted which showed that ecgs are faster at detecting hr than pulse oximetry (po). sample sizes, however, have been small and only few extremely low birthweight infants have been included. it is unclear if use of ecg in these tiny preterm infants in addition to traditional techniques to determine hr will be beneficial and impact resuscitation and outcomes. the investigators propose a study where infants will be randomized to either using ecg in addition to po ± auscultation versus po ± auscultation only to assess hr during neonatal resuscitation. the investigators hypothesize that the group of infants randomized to ecg will be able to stabilize faster, i.e. achieve hr \> 100 beats per minute and oxygen saturation in goal range faster.


Eligibility criteria:
inclusion criteria: * preterm infants less than \<31 weeks gestation born at parkland hospital vaginally or by c/s * infant with congenital heart disease, congenital anomalies, or chromosomal abnormalities will be included unless comfort care has been agreed upon beforehand * resuscitation team present to attend delivery before birth exclusion criteria: * any infant with prenatally agreed upon comfort care since resuscitation will not be provided * any precipitous delivery since resuscitation team will not be in attendance prior to delivery

Keywords: electrocardiogram premature resuscitation
assesment of the endotracheal tube cuff pressure values in icu pateints before and after training seminar

Conditions: Respiratory Tract Diseases; Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Ventilator-Induced Lung Injury

Summary: there is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (etcp). the investigators plan on comparing two strategies for monitoring etcp in mechanically ventilated patients. nowadays etcp is evaluated once every 24 hours. next, the investigator want to conduct training for medical and nursing staff. after the training, etcp will be measured every 8 hours. the aim of the study is to prove that more frequent pressure control (3 times a day) reduces the occurrence of abnormal etcp.


Eligibility criteria:
inclusion criteria: * mechanically ventilated patients intubated in a medical intensive care unit exclusion criteria: * patient requiring prone positioning, tracheo-esophageal fistula, lung transplant and neutropenic patients

Keywords: endotracheal tube cuff pressure ventilator-induced lung injury traning
a clinical trial using spy elite system in planning tissue advancement flaps after ventral hernia repair

Conditions: Ventral Hernia

Summary: the purpose of this project is to assess the efficacy of the spy elite system (lifecell corporation, branchburg, nj, usa) in planning tissue advancement flaps and reducing wound complications after complex ventral hernia repairs. complex ventral hernia repairs are associated with a high rate of wound complications. to a large degree these complications are caused by creating tissue advancement flaps to close the abdomen, which can compromise the blood supply to the skin and subcutaneous tissues. the current standard of care for assessment of blood perfusion to the flaps is a surgeon's clinical judgment. it is, however, often inaccurate. the spy elite system was developed to address this problem. the spy elite system is a device that enables surgeons to visualize and evaluate tissue perfusion in real time. it can help the surgeon to identify optimal flap design and reduce the risk of postoperative wound complications related to tissue ischemia. the primary goal of this study is to evaluate the efficacy of spy elite system to aid a surgeon in creating tissue flaps with adequate blood supply through a prospective, randomized clinical trial. the spy elite system has been used successfully for assessing the viability of mastectomy flaps in breast surgery and has been shown to be extremely sensitive in predicting mastectomy flap necrosis. however, no clinical trial has been conducted in order to evaluate the efficacy of the spy elite system for assessing the viability of abdominal subcutaneous flaps in complex ventral hernia repairs.

more than 90,000 ventral hernia repairs are performed in the us annually. large ventral hernias often require a complex abdominal wall reconstruction including creating tissue advancement flaps. complex abdominal wall reconstructions are associated with up to 20% rate of wound complications including skin flap necrosis and wound breakdowns. prevention of skin necrosis and ischemia would significantly reduce the morbidity associated with these procedures.

Eligibility criteria:
inclusion criteria: * patients with ventral hernia that will require tissue advancement flaps at time of hernia repair * age ≥ 18 years * signed informed consent exclusion criteria: * asa score iv or above * age \< 18 years * patients with iodine allergy * patients with current wound or mesh infection * pregnant patients * patients with end stage renal disease
safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * ocular hypertension or glaucoma in both eyes * currently treated with brimonidine * requires iop-lowering therapy in both eyes exclusion criteria: * uncontrolled systemic disease * known allergy or sensitivity to brimonidine
adjuvant study of pyrotinib in her-2 positive breast cancer

Conditions: Locally Advanced Breast Cancer

Summary: this is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive her2-positive breast cancer after neoadjuvant chemotherapy plus anti-her2 target therapy. the main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed her-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.


Eligibility criteria:
inclusion criteria: * female, aged ≥18 and ≤70 years; * histologically confirmed invasive her2 positive breast cancer, early disease(stage ⅱa-ⅲ) ; * completed neoadjuvant therapy, including chemotherapy and trastuzumab; * residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy; * been or being treated for early breast cancer with standard of care duration of trastuzumab; * adjuvant treatment regimen needs to be determined before randomization; * duration from random time to the last use of trastuzumab≤1 year. * performance status- eastern cooperative oncology group (ecog) 0-1; * required laboratory values including following parameters:anc: ≥ 1.5 x 109/l; platelet count: ≥ 100 x 109/l; hemoglobin: ≥ 9.0 g/dl; total bilirubin: ≤ 1.5 x upper limit of normal, uln; alt and ast: ≤ 1.5 x uln; bun and creatine clearance rate: ≥ 50 ml/min; lvef: ≥ 50%; qtcf: \< 470 ms * signed informed consent form (icf) . exclusion criteria: * metastatic disease (stage iv) ; * gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; * progressive disease during neoadjuvant therapy; * subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption; * treated or treating with anti-her2 tki, including but not limited to pyrotinib, lapatinib and neratinib. * less than 4 weeks from the last clinical trial; * history of immunodeficiency, including hiv-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation; * subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) any heart diseases judged by investigator as unsuitable to participate in the trial; * female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period; * evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
mechanisms of weight loss in patients diagnosed with achalasia

Conditions: Achalasia

Summary: currently there are no existing data to determine why some achalasia patients lose weight while others do not. the purpose of this study is to gather data from patients diagnosed with achalasia to determine if differences may be identified between those who lose weight and those who do not that would help us better understand the mechanism of weight loss in this population.

patients either diagnosed with or being evaluated for achalasia and scheduled for standard clinic visits with the principal investigator as part of their routine care will be considered for participation in this study. blood work, vital signs, and 24-hour dietary recall will be collected over a period of one year. these data will lay the foundation for future scientific endeavors to : a) assess requirements for dietary and/or nutritional supplements; b) formulate an achalasia diet; c) develop clinical practice standards; and d) design an intervention study.

Eligibility criteria:
inclusion criteria: 1. subject is able to provide written informed consent to participate in the study before completing any study-related procedures 2. subject is male or female aged 18-75 years, inclusive at time of consent. 3. subject has a documented diagnosis of achalasia based on high resolution manometry and endoscopy report. 4. subject has been or will be scheduled to undergo either egd with pneumatic dilation or surgical myotomy as routine care for treatment of achalasia. 5. subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol. exclusion criteria: 1. subject has any condition or abnormality, current or past that, in the opinion of the principal investigator, would compromise the safety of the subject or interfere with or complicate the assessment of signs or symptoms of achalasia. such conditions may include psychiatric problems; neurologic deficits or disease; developmental delay; lung transplant; or previous gastroesophageal surgery. 2. subject has had previous pneumatic dilation of treatment of achalasia. 3. subject has had botulinum toxin (botox) injection for treatment of achalasia. 4. subject has a history or high risk of noncompliance with treatment or regular clinic visits.
temozolomide as a prophylaxis against brain recurrence in participants with metastatic breast cancer (p05225 am2)

Conditions: Breast Neoplasm; Brain Neoplasm; Second Neoplasm

Summary: the purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.

breast cancer is the second most common cause of brain metastases. overall survival after the development of brain metastases tends to be poor (6-8 months). over-expression of human epidermal growth factor receptor 2 (her-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk for brain metastases. temozolomide may be a good candidate for prophylactic chemotherapy because of its ability to cross the blood-brain-barrier, achieving high concentrations in the central nervous system (cns).

Eligibility criteria:
inclusion criteria: * diagnosis of metastatic breast cancer. * participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization. * no clinical sign of brain progression. * at least one of the following 3 conditions: her2 +++, young age (\< 50 years), and/or estrogen receptor (er)-/progesterone receptor (pgr)- * eastern cooperative oncology group (ecog) performance status ≤2. * life expectancy ≥3 months. * neutrophils ≥1.5 x 10\^9/l, platelets ≥100 x 10\^9/l, hemoglobin ≥9 g/dl, lymphocytes ≥1 x 10\^9/l. * bilirubin level either normal or \<1.5 x uln (upper limit of normal). * ast (aspartate aminotransferase) and alt (alanine aminotransferase) ≤2.5 x uln (≤5 x uln if liver metastases are present). * serum creatine \<1.5 x uln. * effective contraception if the risk of conception exists. exclusion criteria: * concurrent chronic systemic immune therapy not indicated in the study protocol. * any investigational agent(s) within 4 weeks prior to entry. * participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment. * clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months. * acute or sub acute intestinal occlusion or history of inflammatory bowel disease. * known grade 3 or grade 4 allergic reaction to any of the components of the treatment. * known drug abuse/alcohol abuse. * legal incapacity or limited legal capacity. * medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent. * women who are pregnant or breastfeeding. * any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).
thoracic ultrasound in the treatment of pleural effusion

Conditions: Pleural Effusion

Summary: the main objective of the study is to assess the cost-effectiveness ratio of two management strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a strategy without thoracic ultrasound.

comparison of two management strategies pleural effusions from diagnosis and during the first year of follow up care. patients are randomized into two groups, each group receiving a different management strategy. both strategies are compared: strategy a that involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care. it will be possible to have recourse to other tests (such as chest ct) if deemed necessary by the practitioner. strategy b, which consists of the usual care pleurisy and thus without use of ultrasound: gestures are guided either by chest radiograph or by ct chest as necessary in the treatment and monitoring. a systematic radiographic pleural after each gesture is performed. the management is inspired by the english recommendations currently validated and applied in anglo-saxon countries.

Eligibility criteria:
inclusion criteria: * patients hospitalized or seen in consultation with pleural effusion diagnosed clinically or radiologically whatever be its initial management. exclusion criteria: * patient with a neoplasia