Kornimate/medical-research-clean huggingface dataset:
post-menopausal women osteoporosis(phase iii)

Conditions: Postmenopausal Women Osteoporosis

Summary: the purpose of this study is to evaluate the efficacy and the safety of risedronate, cholecalciferol combination tablet in patients with osteoporosis

the purpose of this study is to evaluate the efficacy and the safety of monthly risedronate with cholecalciferol on 25 hydroxyvitamin d level and bone markers patients with osteoporosis.

Eligibility criteria:
inclusion criteria: 1. women osteoporosis 2. patients with a diagnosis of postmenopausal over 6 months if they had a bone mineral density t-score of \ 40 iu/l, with a reported hysterectomy 3. low levels of 25(oh)d \> 9 ng/ml 4. patients who give written consent of agreement to voluntarily participate in the clinical study 5. patients who can read and understand written instructions exclusion criteria: 1. patients who had contraindications to oral bisphosphonates, such as esophageal strictures 2. alt, ast ≥ 2×unl and serum creatinine ≥ 1.5×unl 3. low levels of 25(oh)d (less than 9 ng/ml). 4. previous use of oral bisphosphonates and vitamin d were allowed, but a washout period was needed, depending on the duration of treatment. two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin d users of \> 200 iu. 5. drug administration after diagnosing as alcoholic or psychical disease 6. patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation

Keywords: osteoporosis
safety and effectiveness evaluation of the apotech® diabetic body moisturizer

Conditions: Skin Diseases, Metabolic; Skin Care

Summary: safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.

safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. this study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product apotech®.

Eligibility criteria:
inclusion criteria: * subjects with controlled diabetes * any phototype and all skin types exclusion criteria: * pregnant women * subjects that not match the inclusion criteria
an investigational immuno-therapy study to determine the safety of urelumab given in combination with nivolumab in solid tumors and b-cell non-hodgkin's lymphoma

Conditions: Advanced Solid Tumors; Advanced B-cell NHL

Summary: the purpose of this study is to determine which doses of urelumab and nivolumab are safe and tolerable when they are given together.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * for dose escalation: * subjects with any previously treated advanced (metastatic or refractory) solid tumor type and b-cell non-hodgkin lymphoma * for cohort expansion: * subjects must have a previously treated advanced solid tumor or b cell non-hodgkin's lymphoma to be eligible * eastern cooperative oncology group (ecog) performance status of 0 or 1 * for certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy * women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men exclusion criteria: * known central nervous system metastases or central nervous system as the only source of disease * other concomitant malignancies (with some exceptions per protocol) * active, known or suspected autoimmune disease * uncontrolled or significant cardiovascular disease * history of hepatitis (b or c) * history of active or latent tuberculosis
the effect of preventive use of ondansetron in the cesarean section under spinal anesthesia

Conditions: Adverse Anesthesia Outcome

Summary: cesarean section is a frequent procedure in the obstetric surgery. the most widely used anesthesia technique for cesarean delivery is the spinal anesthesia the incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population. the aim of the study is to investigate the effect of the preventive use of ondansetron on the prevention of hypotension

cesarean section is a frequent procedure in the obstetric surgery. the most widely used anesthesia technique for cesarean delivery is the spinal anesthesia, in our institute over than 90% of the elective cesarean sections are under spinal anesthesia, however this kind of anesthesia frequently associated with, side effects that affect primarily the parturient and the fetal health. the incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population . most authors agree that hypotension presents when the systolic blood pressure decrease under 90 mmhg, or when there is a reduction from baseline of more than 20-30 %. augmentation of the intravascular volume with crystalloids and vasopressors is the cornerstone of the treatment of spinal anesthesia induced hypotension, the vasopressors usually used are the α and β receptors agonist ephedrine and the selective α agonist phenylephrine that, gain popularity in the last years, because it's more efficacy in maintaining the umbilical cord blood ph and the apgar score of the neonates. however many studies showed that it was inefficient and no intervention reliably prevents hypotension after spinal anesthesia for cesarean section and, bradycardia can occur from shift in cardiac autonomic balance toward the parasympathetic system from activation of left ventricular mechanoreceptors after sudden decrease in left ventricle volume causing the bezold jarish reflex (bjr). animal studies suggest that 5-ht( serotonin) may play an important factor associated inducing the bjr and this effect can be blocked at the 5-ht3 receptor using the serotonin inhibitor ondansetron, commonly used antiemetic . despite the fact that ondansetron was evaluated in the management of spinal anesthesia induced hypotension in large heterogeneity and small samples , the need for more investigation in big number of cesarean sections still needed. the aim of the study is to investigate the effect of the preventive use of ondansetron on the prevention of hypotension and the amount of vasopressor phenylephrine needed to control the hypotension after spinal anesthesia and the possible effect on the umbilical cord blood ph and the apgar score in one minute after delivery.

Eligibility criteria:
inclusion criteria: american society of anesthesia (asa) physical status i or ii exclusion criteria: preeclampsia cardiovascular disease

Keywords: cesarean section spinal anesthesia hypotension ondansetron
early intervention for morbidly obese patients after roux-en-y gastric bypass (rygb) surgery

Conditions: Weight Loss; Obesity

Summary: purpose and objective: to identify in the early post-operative period following laparoscopic roux-en-y gastric bypass patients likely to fail to progressively lose weight in expected fashion, and to institute intervention and assess for its efficacy. study activities and population group: patients identified to have "poor weight loss" (≤ 11% of excess weight loss) at 1 month will be randomized into a control versus study group. intervention for subjects randomized to the iv arm will be by enrollment in the back on track program. this is a seven-week group education, counseling, nutrition, exercise, and journaling program of the duke weight loss surgery center designed to help postoperative bariatric surgery patients who are failing to progressively lose weight resume an expected pattern of weight loss and improved overall outcome. data analysis and risk/safety: data will be collected and analyzed by the identified investigators. the goal of data analysis is to uncover any difference in the ewl of subjects who underwent intervention for falling in the lowest ewl quartile when compared with those who did not undergo intervention, and determine the statistical significance of any such difference. there are no physical risks associated with this study. there is, however, the potential risk of loss of confidentiality. every effort will be made to keep your information confidential.


Eligibility criteria:
inclusion criteria: * age 18 years and older * patient is scheduled and consented for laparoscopic roux-en-y gastric bypass as part of their routine medical care exclusion criteria: * younger than age 18 years * patient is disabled and unable to participate in an exercise program

Keywords: rygb intervention follow-up standard-of-care back on track program poor weight loss morbidly obese
knowledge about covid-19 infection in pregnant women

Conditions: Viral Infection

Summary: covid 19 is a pandemic infection developed in late 2019

it developed in china then spread worl wide

Eligibility criteria:
inclusion criteria: * pregnant women exclusion criteria: * non pregnant women
myo-inositol versus clomiphene citrate in pcos

Conditions: Ovulation Induction; Polycystic Ovary Syndrome; Clomiphene; Inositol

Summary: specific aim: to compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.


Eligibility criteria:
inclusion criteria: * rotterdam criteria for pcos (cf. the recent eshre guidelines): at least 2 out of 3 criteria should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified ferriman-gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/guidelines-and- legal/guidelines/polycystic-ovary-syndrome.aspx); pco ovaries on ultrasound (www.eshre.eu/guidelines-and- legal/guidelines/polycystic-ovary-syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe \>8 mhz) in both ovaries. * a first treatment cycle, possibly combined with intra uterine insemination (iui) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis afs score 1 or 2 * use of own or donor sperm. exclusion criteria: * tubal factors * uterine factors * endometriosis afs score 3 or 4 * moderate to severe male factor (as defined by each local center) * bmi \> 35
imaging and understanding bos in lung transplantation

Conditions: Bronchiolitis Obliterans Syndrome

Summary: this study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

this study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years. we will follow these patients at 6 months and 1 year with hyperpolarized helium-3 magnetic resonance imaging and image guided bronchial biopsies to detect early bos and to better understand bo disease progression. the biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to bos and to facilitate identification and validation of translatable pharmaceutical targets.

Eligibility criteria:
inclusion criteria: * lung transplantation within the last 10 years or being assessed for possible lung transplantation. * male or female * 0 to 25 years of age. exclusion criteria: * standard mri exclusion criteria as set forth by the cchmc division of radiology * inability to perform 10 second breath hold for 3he mri scan * bleeding disorders

Keywords: helium mri lung transplantation
roll versus magnetic seed for preoperative localization of non-palpable breast lesion: comparison between techniques.

Conditions: Breast Cancer

Summary: nowadays, breast conservative surgery (bcs) is the standard of care for patients affected by early breast lesions. screening programmes led to an increase of impalpable breast lesion detection rates. these patients are often eligible for bcs and an accurate preoperative localization technique for the detection of the lesion is required in order to guarantee a safe surgical excision. the primary goal of bcs is to obtain a complete resection of the tumor with disease-free surgical margins. the presence of tumor on surgical margins on postoperative histological examination of the specimen increases the risk of local recurrence and it requires a surgical re-excision. for all these reasons different techniques for localization of occult breast lesions have been developed over time. since '70s, the wire guided localization (wgl) technique has represented the gold standard technique; however, it has several limitations such as wire migration or fracture and patient's referred discomfort related to wire placement. other techniques have been proposed such as the roll and magnetic seeds. the roll consists of the injection of a radioactive substance into the breast lesion and the localization during surgery is allowed by using a handheld gamma probe. limitations of this technique are represented by the need of radioactive injection the day before surgery with subsequent longer hospitalizations and the possible spread of the radioactive substance into breast tissue leading to larger resections. the latest technological evolution is represented by magnetic seeds, small devices deployed into the lesion even up to more than 30 days before surgery and identified with a specific magnetic probe during surgery. currently there are several studies of comparison between the wgl and the more modern techniques. all of these data claim the effectiveness of the new "wire-free" methodics ensuring a safe surgical resection with tumor-free margins and, in some cases, a better aesthetic result. studies of comparison between the modern techniques are limited. there is no scientific evidence of the superiority of magnetic seeds compared to roll. the aim of this retrospective study is to compare roll with magnetic seed to assess their efficacy in the localization of non-palpable breast lesions.


Eligibility criteria:
inclusion criteria: * female patients between 18 and 85 years who underwent to breast conservative surgery for non-palpable occult breast lesions; * intraoperative localization of breast lesion with roll or magnetic seed; * preoperative diagnosis on histology or cytology of borderline lesion (b3 or c3) or malignant lesion (b4-b5 or c4-c5). exclusion criteria: * b2 or c2 at preoperative needle breast biopsy or fine needle breast aspiration. * breast tumor localization with clip for neoadjuvant chemotherapy.

Keywords: non-palpable breast lesion
time longitudinal study of the microbiome in colorectal cancer subjects

Conditions: Cancer Colon; Gastrointestinal Disease

Summary: researchers are trying to determine whether certain microbiome cause cancer or whether they are part of the microbiome in the gut due to the presence of cancer.

the purpose of this research is to learn about how the gastrointestinal bacteria (microbiome) can contribute to colon cancer, and how it may change due to colon cancer. in addition, we are going to study the features of the microbiome that can help predict recovery after colon resection. to do this, we are going to compare the microbiome from subjects with colon cancer to subjects without colon cancer. study participation involves collection of stool samples before and after your surgery, as well as samples of residual (left-over) colon tissue from your surgery. we would also like to collect optional samples from your follow-up colonoscopy. you may be in the study for up to 5 years.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patients undergoing bowel resection by any standard surgical approach. exclusion criteria: * female that are pregnant * currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks. * currently receiving or have received chemotherapy in the past 2 weeks.
effect of a bolus of 10 µg/kg of alfentanil on the pupillary pain index

Conditions: Pain; Anesthesia

Summary: this study aims to assess the pupillary pain index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.


Eligibility criteria:
inclusion criteria: * elective surgery under general anesthesia * written informed consent exclusion criteria: * chronic pain * preoperative analgesic drug * neurologic disease * ophtalmic disease
pemetrexed/cisplatin versus gemcitabine/cisplatin according to thymidylate synthase expression

Conditions: Non-small Cell Lung Cancer

Summary: this study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically confirmed nonsquamous nsclc * stage iiib, iv or recurrent nsclc * age ≥ 18years * ecog performance status of 0 to 1 * known ts immunohistochemical analysis data * at least one measurable lesion by recist 1.1 * no previous chemotherapy or therapy with egfr tkis for advanced nsclc * asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery * at least 2 weeks later after whole brain radiotherapy or palliative radiotherapy * adequate renal function: estimated creatinine clearance ≥ 50ml/min exclusion criteria: * patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy. * patients with post-obstructive pneumonia or uncontrolled serious infection

Keywords: thymidylate synthase
systematic screening for deep vein thrombosis in critically ill patients

Conditions: Deep Vein Thrombosis

Summary: background: venous thromboembolism (vte) is a common complication in critically ill patients, admitted to the intensive care units (icus). at the present time, there is no validated score to estimate risks and benefits of antithrombotic pharmacological prophylaxis in this subset of patients. aim of the study: investigating potential harms and benefits of a protocol for systematic screening of dvt in critically ill patients, admitted to an icu. expected relevance: systematic screening for deep vein thrombosis (dvt) through ultrasound (us) lower limb veins examination could help defining the indication to antithrombotic pharmacological treatment, but no protocol of systematic screening has been validated so far. furthermore, the screening could be associated with over-diagnosis and consequent over-treatment, as well as increased management burden for the caregivers and higher healthcare costs.


Eligibility criteria:
inclusion criteria: * age \>18 years old * admission to the icu exclusion criteria: * duration of stay in icu \<5 days * sars-cov-2 infection * established dvt or pulmonary embolism at admission * established coagulation disorder * presence of inferior vena cava filter at the admission * admission/discharge to the icu of another hospital
maternal left lateral position in fetal growth restriction

Conditions: Fetal Growth Restriction

Summary: the goal of this clinical trial is to learn if maternal left-lateral positioning in pregnancy works to treat fetal growth restriction. this study will also help us learn about the effects of left-lateral positioning on maternal metabolomics, maternal mental health, fetal cardiac function, and delivery outcomes. the main questions it aims to answer are: * does maternal left-lateral position in a pregnancy with fetal growth restriction improve the baby's growth? * how are maternal metabolomics, delivery outcomes, maternal mental health, and fetal cardiac function impacted by maternal left-lateral position? researchers will compare the intervention group to pregnancies with fetal growth restriction that receive standard of care (without left-lateral positioning) to see if left-lateral position improves fetal biometry in fetal growth restriction. participants will: * practice left-lateral position every day for 4 hours (cumulatively) with 10-mins stretching after every hour of left-lateral position, or continue to receive standard of care * visit the clinic once after 4 weeks for a follow-up research visit, and at the time of delivery tracking of the physical activity and adherence to left-lateral position at home in intervention group a will be done through a fitbit (smart watch) given during enrollment. a fitbit will also be given to participants in intervention group b, receiving standard of care, to monitor their physical activity trends at home.


Eligibility criteria:
inclusion criteria: * pregnant persons between 18 - 65 years of age, with a diagnosis of fetal growth restriction, with an estimated fetal weight less than tenth percentile * participants with a singleton pregnancy between 24- and 34-weeks' gestational age * participants with fluency in english or spanish language exclusion criteria: * patients with a known history of deep vein thrombosis, pulmonary embolism, or hypercoagulability disorder * patients with a pre-pregnancy bmi greater than 40 * pregnancy with severe abnormality in umbilical artery doppler flow, including absent end-diastolic flow (aedf) and reverse end-diastolic flow (redf) * patients receiving anticoagulation therapy * pregnancy with suspected chromosomal anomalies or a multifetal pregnancy * patients with an active status during pregnancy

Keywords: fetal growth restriction left lateral position
non-rebreather at flush rate compared to bag valve mask with assist

Conditions: Acute Respiratory Failure

Summary: this crossover investigation enrolls healthy volunteers and compares the exhaled oxygen content (feo2) between the non-rebreather mask at the flush rate and a bag-valve-mask device at the flush rate, used with active positive pressure assistance.


Eligibility criteria:
inclusion criteria: * age \>17 exclusion criteria: * pregnant * any facial hair more than stubble that might impede a mask seal