Kornimate/medical-research-clean huggingface dataset:
dose escalation of pol6326 in combination with eribulin in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: pol6326 will be given by i.v. infusion over 2 hours. treatment will occur on days prior to, on the day of and on days after treatment with eribulin. different doses and dosing frequencies will be investigated


Eligibility criteria:
inclusion criteria: * histologically confirmed invasive cancer of the breast. * presence of at least one measurable lesion per recist 1.1 criteria * stage iv disease by ajcc criteria (7th edition). * her2 negative (ihc 0,1 or fish her2:cep17 ratio \< 2.0) * must have had treatment with at least 2 but no more than 3 previous regimens in the metastatic setting. previous treatment must have included an anthracycline and taxane in either the adjuvant or metastatic setting. * at least 21 days from the completion of any previous cytotoxic chemotherapy or biological therapy at time of initiation of pol6326. * ecog performance status \< 2 exclusion criteria: * previously received eribulin. * peripheral neuropathy \> grade 2. * receipt of any other investigational agent within the 28 days prior to day 1. * receipt of colony stimulating factor filgrastim, pegfilgrastim, or sargramostim within 14 days prior to day 1. * radiation therapy within the 14 days prior to day 1. * severe concurrent illness or psychiatric illness/social situation that would limit compliance with study requirements. * history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. * pregnant or breastfeeding. * known hiv positivity on combination antiretroviral therapy; these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy

Keywords: overall survival progression free survival
24-hour iop-lowering effect of brimonidine 0.1%

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: this study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * patients with open-angle glaucoma or ocular hypertension exclusion criteria: * allergy to brimonidine * inability to complete 24 hour stay for monitoring
hysteroscopic surgery; retrospective cross-sectional study of reproductive outcome

Conditions: Hysteroscopic Metroplasty and Myomectomy

Summary: study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive performance of patients with infertility and /or miscarriages

retrospective study and analysis of the reproductive outcome in patients who underwent hysteroscopic surgery for infertility at jordan university hospital and al-noor fertility centre in amman, jordan in the period september 2016-october 2021. patients were followed up for a minimum of 6 months after surgery. resection of uterine septum or submucosal fibroids were included. data was obtained from the electronic and paper-based clinical files for patients who were operated upon at these hospitals. patients who missed follow up after the operation will be contacted by phone or invite them for a clinic review to know of their fertility status and pregnancy outcome.

Eligibility criteria:
inclusion criteria: * those with primary or secondary infertility of more than 1 year with normal seminal fluid analysis, normal female hormonal profile, patent fallopian tubes bilaterally (as confirmed by hysterosalpingography hsg), normal thyroid function, no previous uterine surgery and no medical diseases. * cases with recurrent miscarriages were those with 2 or more first or second trimester miscarriages of an apparently normal singleton fetus with no hormonal, endocrine or maternal or paternal karyotype abnormalities and with no previous history of term pregnancy(s). exclusion criteria: * all patients who were operated upon outside the context of infertility (heavy bleeding...etc), patients with combined (maternal and paternal) infertility factors, * patients with history of any number of term pregnancy, * previous uterine surgery, * patients with medical diseases, * those with abnormal female hormonal profile, * those with other potential factors for infertility including endometriosis * patients with incomplete or missing data and could not be contacted. * patients who had myomectomy or septal resection done using bipolar hysteroscopy
pharmacogenetic study in patients received iron chelating agent

Conditions: Hemosiderosis

Summary: to investigate effect of genetic variations on the toxicities and find optimal target population, the investigators planned to analyze the genetic polymorphisms of udp-glucuronosyltransferase.

transfusion-associated iron overload induces systemic toxicity. recently, deferasirox, a convenient long acting oral agent, has been introduced in clinical practice with promising efficacy. however, some patients experience drug-related toxicities and cannot tolerate it. to investigate effect of genetic variations on the toxicities and find optimal target population, we planned to analyze the genetic polymorphisms of udp-glucuronosyltransferase 1a (ugt1a) subfamily, multi-drug resistance-associated protein 2 (mrp2) and breast cancer resistance protein (bcrp) among pediatric patients received deferasirox.

Eligibility criteria:
inclusion criteria: 1. patients who received deferasirox because of transfusion associated iron overload (transfusion associated iron overload was defined as ferritin ≥ 1,000 ng/ml in patients who needed over 8 units of rbc transfusions per a year). 2. patients with written informed consents exclusion criteria: patients or parents refusal
exercise treatment with standard therapy for metastatic breast cancer

Conditions: Hormone Receptor Positive Metastatic Breast Cancer

Summary: this study will test any good and bad effects of aerobic exercise performed while you are receiving the usual first-line treatment for metastatic breast cancer. the researchers think that exercise helps delay the development of resistance to hormone therapy while slowing the growth of tumors.


Eligibility criteria:
inclusion criteria: * patients with histologically-confirmed, hr-positive (er and/or pr), her2-negative metastatic breast cancer (mbc) * postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression * receiving first line endocrine-based therapy (tamoxifen, aromatase inhibitor, or fulvestrant; concurrent molecular therapy also allowed) * sedentary (i.e., \<60 minutes / week of exercise) * age \>18 years * bmi ≥ 18.5 * cleared for exercise participation as per screening clearance via par-q+ * cleared for study participation as per screening consultation with an msk exercise physiologist * willingness to comply with all study-related procedures * patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled exclusion criteria: * life expectancy \<6 months * enrollment onto any other therapeutic investigational study * mental impairment leading to inability to cooperate * concurrent participation in weight loss or other exercise programs

Keywords: exercise 19-113
pupillary unrest in ambient light, and relationship to opioid-induced respiratory depression

Conditions: Opioid; Intoxication, Perception Disturbance (Acute); Acute Pain; Overdose of Opiate; Respiratory Depression; Safety Issues

Summary: volunteers will receive a weight-based opioid (remifentanil) infusion for 10 minutes. in the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. after a washout period, the experiment will be repeated in each subject (second run). the two runs differ only by presence versus absence of verbal interaction.

healthy volunteers aged 20-55 will receive a weight-based opioid (remifentanil) infusion for 10 minutes. vital signs including spo2, transcutaneous co2, and respiratory rate will be continuously measured. in the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. after a washout period, the experiment will be repeated in each subject (second run). the two runs differ only by presence of ongoing verbal interaction versus complete avoidance of verbal interaction. incidence of respiratory depression will be compared in the two protocols with or without verbal interaction. correlation between pupil diameter and pupillary unrest with estimated opioid concentrations will be determined by regression. difference between pupil measurement versus opioid concentration regressions will be compared by chi2.

Eligibility criteria:
inclusion criteria: * healthy * able to provide informed consent exclusion criteria: * active substance use disorder * prior opioid use disorder * opioid use within 30 days.
evaluation of treatment efficacy by circulating tumor cell phenotype surveillance in breast cancer patients

Conditions: Breast Neoplasms; Neoplastic Cells, Circulating; Chemotherapy Effect

Summary: the phenotype of circulating tumor cells (ctcs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. the aim of this observational study is to assess the efficacy of ctcs surveillance in predicting the prognosis of breast cancer patients.

the aim of this observational study is to assess the efficacy of ctcs surveillance in predicting the treatment response of neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. this study also aims to evaluate the efficacy of ctcs surveillance in predicting invasive-disease free survival (idfs), overall survival (os) and metastasis. additionally, this study evaluate the expression of pdl1 and foxc3 on ctcs.

Eligibility criteria:
inclusion criteria * the age is more than 18 years old; * pathology confirmed malignant breast tumor; * no clinical diagnosis of other malignancies, unstable complications or uncontrolled infection; * life expectancy is greater than 6 month; * the main organ function is normal; * the subjects volunteered to participate in this study, signed informed consent, followed up with good compliance. exclusion criteria * patients who had suffered from other malignant tumors; * with uncontrolled bacterial, viral or fungal infections; * with physical or mental disorders * without or limited civil capacity; * infected with human immunodeficiency virus (hiv)； * circumstances in which the investigator considers it inappropriate to participate in this study.
improving cognition after cancer

Conditions: Breast Cancer Survivors; Cognitive Dysfunction

Summary: this study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

many breast cancer survivors experience problems with mental abilities such as memory, attention, and concentration (known as cognition). increasing physical activity has been shown to improve cognition in adults; however, little is known about whether this is helpful for cancer survivors as well. this study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

Eligibility criteria:
inclusion criteria: * breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer * self-report difficulties with cognition since their cancer diagnosis * self-report low levels of moderate to vigorous physical activity * have a fitbit compatible device with internet * breast cancer was treated with chemotherapy and/or hormonal therapy exclusion criteria: * medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention * currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months * unable to commit to a 12-month study
safety and efficacy of mee-hu medicus

Conditions: Urinary Tract Infections

Summary: primary objective: is evaluation of the investigational product's safety and evaluation of its effect, in combination with antimicrobial treatment, on urine culture (microbiological cure, no microbial growth on 24-48 hrs culture). the secondary objective: is evaluation of the investigational product's effect, in combination with antimicrobial treatment, on disease related symptoms (clinical cure, disappearance of symptoms and signs).

design: randomized, double blind, placebo controlled multicenter study. recurrent urinary tract infection patients will blindly receive mee-hu medicus, or matching placebo, orally, daily, for 10 days, adjunct to the empirical antibiotic. population: male and female patients over 18 years old diagnosed with recurrent urinary tract infection. sample size: 200 patients, 100 from each center.

Eligibility criteria:
inclusion criteria: male and female patients over 18 years old - symptomatic urinary tract infection (pain, dysuria, frequency, urgency, fever) confirmed by urine analysis (pyuria, which is defined as urine wbc \>10). - negative pregnancy test and absence of vaginal discharge. - recurrent urinary tract infection 2 times or more in the last 6 months or 3time or more in the last year. - signed informed consent. exclusion criteria patients unable or unwilling to provide their free consent to participate in the study - patients known or suspected to be hypersensitive to medications that will be used in the study. - simultaneous participation in other studies. - patients on palliative care, terminal illness. - evidence of acute or chronic prostatitis or pyelonephritis. - history of antimicrobial use in the last 72 hrs. - patients with renal transplantation.
long term safety of teriflunomide when added to interferon-beta or glatiramer acetate in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[ifn-β\] or glatiramer acetate \[ga\] in patients with multiple sclerosis \[ms\] with relapses. secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and magnetic resonance imaging \[mri\] parameters. this study is the extension study of the pdy6045 (nct00489489) and pdy6046 (nct00475865) studies. participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.

the duration of the extension study per participants was 40 weeks broken down as follows: * 24-week double-blind treatment period, * 16-week post-treatment elimination follow-up period.

Eligibility criteria:
inclusion criteria: * pdy6045 or pdy6046 participant who: * completed the week 24 visit of either study pdy6045 or pdy6046, * was still meeting eligibility criteria for receiving treatment, * had agreed to continue stable dose of interferon-β \[ifn-β\] or glatiramer acetate \[ga\] and consented to continue on treatment. exclusion criteria: * any known condition or circumstance that would have prevented in the investigator's opinion, compliance or completion of the study the above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial.
pulmonary hypertension in lymphangioleiomyomatosis

Conditions: Lymphangioleiomyomatosis; Pulmonary Hypertension

Summary: this is a descriptive study of patients with lymphangioleiomyomatosis and precapillary pulmonary hypertension.

descriptive study of patients with lymphangioleiomyomatosis and precapillary pulmonary hypertension this will include modality of diagnosis of llymphangioleiomyomatosis, results of right-sided heart catheterization, and pulmonary function tests

Eligibility criteria:
inclusion criteria: * lymphangioleiomyomatosis (definite or probable), either sporadic or associated with tuberous sclerosis * precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmhg, wedge capillary pulmonary pressure less than 15 mmhg, pulmonary vascular resistance higher than 3 wood units) exclusion criteria: * post capillary pulmonary hypertension * other identifiable causes of pulmonary hypertension (ex: thromboembolic disease) * not willing to participate

Keywords: lymphangioleiomyomatosis pulmonary hypertension
effect of proximal blood flow arrest during endovascular thrombectomy

Conditions: Stroke; Occlusion, Cerebrovascular

Summary: endovascular thrombectomy (evt) has become the standard of care for large vessel occlusion in acute ischaemic stroke (ais). during clot-retrieval, simultaneous balloon inflation within the internal carotid artery offers transient proximal blood flow arrest, potentially preventing distal clot migration or embolisation to new vascular territories. retrospective studies indicate that this may improve complete vessel recanalisation rates and may translate to improved functional independence. however, lack of high-quality evidence demonstrating the efficacy of simultaneous balloon inflation has led to clinical equipoise with heterogeneity of practice globally.


Eligibility criteria:
inclusion criteria: * age ≥18 years * acute ischemic stroke presenting with a neurological deficit of (nihss ≥2) * intracranial arterial occlusion of the distal internal carotid artery or middle cerebral artery (m1/m2 segments) demonstrated with on clinical neuroimaging such as: computed tomography angiogram (cta), magnetic resonance imaging angiogram (mra), or digital subtraction angiography (dsa). * aspects score of \>4 or by locally accepted ischaemic core/penumbra mismatch using computed tomography perfusion or magnetic resonance (ctp or mr) imaging. * modified rankin scale, mrs\<3 * intention to treat with aspiration only or combination technique of stent-retriever + aspiration in the first pass attempt during endovascular thrombectomy exclusion criteria: * severe stenosis (\>90%), or tandem occlusion of the ipsilateral extracranial internal carotid artery. * previously deployed stents in the ipsilateral internal carotid artery. * dissections of the ipsilateral internal carotid artery. * unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas). * subject participating in a study involving an investigational drug or device that would impact this study.

Keywords: stroke large vessel occlusion balloon guide catheter flow arrest mechanical thrombectomy endovascular thrombectomy
myoinositol plus l-tyrosine, selenium and chromium in pcos

Conditions: Polycystic Ovary Syndrome; Menstrual Problem; Hirsutism

Summary: pcos patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg l-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. all patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. most of them during the treatment improved their symptoms.


Eligibility criteria:
inclusion criteria: ° pcos patients exclusion criteria: * thyroid dysfunction * hyperprolactinemia * adrenal hyperplasia * patients taking oral contraceptive * any other endocrinological pathologies
blood pressure response to sodium in the diet

Conditions: Hypertension

Summary: previous studies have demonstrated that single nucleotide polymorphisms (snps) of the sodium-bicarbonate co-transporter gene (slc4a5) are associated with hypertension. we tested the hypothesis that snps in slc4a5 are associated with salt sensitivity of blood pressure in 185 whites consuming an isocaloric constant diet with a randomized order of 7 days of low sodium (na+) and 7 days of high na+ intake. salt sensitivity was defined as a ≥7-mm hg increase in mean arterial pressure during a randomized transition between low and high na+ diet. a total of 35 polymorphisms in 17 candidate genes were assayed, 25 of which were tested for association. association analyses with salt sensitivity revealed 3 variants that associated with salt sensitivity. of these, 2 snps in slc4a5 (rs7571842 and rs10177833) demonstrated highly significant results and large effects sizes, using logistic regression. these 2 snps had p values of 1.0×10-4 and 3.1×10-4 with odds ratios of 0.221 and 0.221 in unadjusted regression models, respectively, with the g allele at both sites conferring protection. these snps remained significant after adjusting for body mass index and age (p=8.9×10-5 and 2.6×10-4 and odds ratios 0.210 and 0.286, respectively). furthermore, the association of these snps with salt sensitivity was replicated in a second hypertensive population. meta-analysis demonstrated significant associations of both snps with salt sensitivity (rs7571842 \[p=1.2×10-5\]; rs1017783 \[p=1.1×10-4\]). in conclusion, slc4a5 variants are strongly associated with salt sensitivity of blood pressure in 2 separate white populations.

subjects are placed on an isocaloric diet, one week with high sodium(300meq) and one week with low sodium(10meq), in randomized order. twenty-four hour urine sodium and urine creatinine levels verify diet compliance. blood pressure measurements are recorded during each diet week by automated blood pressure monitoring system. each blood pressure is taken in the right arm 3 times while the subject is sitting quietly for 45 minutes .

Eligibility criteria:
inclusion criteria: * ages 18-70 (inclusive) * sex male and female * race caucasian and african-american/black * bmi 18.-0-29.9 * bp normal exclusion criteria: * hypertension * blood pressure \> 140/90 mmhg

Keywords: blood pressure hypertension salt sensitivity