Kornimate/medical-research-clean huggingface dataset:
safety study of enzalutamide (mdv3100) in patients with incurable breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer with accompanying pathology report; * submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides * received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only); * eastern cooperative oncology group performance (ecog) status of 0 or 1; * estimated life expectancy of at least 3 months exclusion criteria: * severe concurrent disease, infection, or comorbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment; * pregnant or lactating; * known or suspected brain metastasis or leptomeningeal disease; * history of another malignancy within the previous 5 years other than curatively treated in situ carcinomas; * for patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent cyp3a4 inducer or inhibitor.

Keywords: enzalutamide mdv3100 breast cancer
omegaven® as parenteral nutrition

Conditions: Cholestasis

Summary: the purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (pn) by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.


Eligibility criteria:
inclusion criteria: * greater than 14 days old. * have pn-associated cholestasis defined as at least 2 consecutive direct bilirubin \>2 mg/dl with anatomical or functional short gut (or \>4 mg/dl if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin \> 0.4. * patients will be pn dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require pn for at least 4 more weeks. * patients must have failed standard therapies for parenteral nutrition associated liver disease (pnald) including: cycling of pn, avoiding overfeeding, reduction/removal of copper and manganese from pn, advancement of enteral feeding, and use of ursodiol (i.e. actigall). * signed patient informed consent. * the patient is expected to have a reasonable possibility of survival. * no other known etiology of cholestasis other than pnald at time of omegaven® initiation. exclusion criteria: * causes of cholestasis other than pnald including but not limited to hepatitis c, cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency, prior to omegaven® initiation. * known fish or egg allergy * any of the contraindications to use of omegaven®: 1. active new infection at the time of initiation of omegaven® 2. hemodynamic instability 3. use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (nsaids) 4. active coagulopathy or bleeding 5. thrombocytopenia 6. unstable hyperglycemia 7. impaired lipid metabolism (triglycerides \>1000 mg/dl) while on 1 g/kg/day or less of intralipid 8. history of severe hemorrhagic disorders (ie. hemophilia, von willebrand disease, etc.) 9. unstable diabetes mellitus 10. collapse and shock 11. stroke/ embolism 12. cardiac infarction within the last 3 months 13. undefined coma status * enrollment in a clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team) * the parent or guardian of child is unwilling to provide consent or assent

Keywords: omegaven parenteral nutrition liver disease liver injury
the effects of drug candidate cs1 on lung structure and function utilizing fri

Conditions: Pulmonary Arterial Hypertension

Summary: explore the impact of drug candidate cs1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (pah). this sub-study for cs1-004 aims to utilize fri, an innovative, non-invasive imaging technology to visualize how long-term use of cs1 influences structural changes in pulmonary arteries. this sub-study seeks to provide valuable insights into the potential of cs1 to transform pah treatment in some patients enrolled in the expanded access program (cs1-004).


Eligibility criteria:
inclusion criteria: * participation in the cs1-004 clinical trial exclusion criteria: * inability to undergo a ct pulmonary angiography scan (i.e., claustrophobia) * individuals who are pregnant or who become pregnant during the sub-study * egfr \<30 ml/min/1.73m2 as calculated by modification of diet in renal disease (mdrd) * allergy to iodine contrast agents

Keywords: fluidda fri fri
sensitivity and specificity of ngs in detecting bmsi in patients with gastric, duodenal and small intestinal cancer

Conditions: Gastrointestinal Cancer

Summary: to study the sensitivity and specificity of ngs in detecting microsatellite state in blood and to evaluate its potential application in gastrointestinal cancer.

ngs can not only detect tissue samples, but also blood samples. for some inoperable cancer patients, the acquisition of tissue samples is difficult and traumatic. it is of great significance for the diagnosis and treatment of these patients to determine msi status by blood testing. in addition, the heterogeneity of malignant tumors is usually strong, blood testing can overcome the heterogeneity of tissue, and can dynamically monitor the patient's condition. 50 patients with gastric cancer, duodenal cancer and small intestinal cancer will be enrolled in the study. among them, 30 patients with msi-h and 20 patients with mss confirmed by ihc/pcr.the investigators will use 520 gene panel for ngs sequencing of tissue and blood samples from selected patients to study the sensitivity and specificity of ngs in detecting microsatellite state in blood.

Eligibility criteria:
inclusion criteria: * age (\>18 years old). * histologically diagnosed as gastric cancer, duodenal cancer or small intestinal cancer (stage iii, stage iv). * the status of dmmr/pmmr was confirmed by ihc/pcr. * with tissue and blood samples (including ctdna and white blood cells) that meet the requirements. * agree to provide demographic, medical history, pathological diagnosis, imaging diagnosis, tnm staging, ecog score and other information. exclusion criteria: * suffering from other malignant tumors at the same time. * others that the investigator consider that is inappropriate for this study.

Keywords: ngs bmsi gastrointestinal
the effect of individualized developmental care education

Conditions: Premature; Self Efficacy; Attachment; Maternal

Summary: this study aims to evaluate the effect of individualized developmental care education provided to mothers of premature infants on maternal self-efficacy and maternal-infant attachment. premature birth can be a stressful and anxiety-inducing experience for mothers, which may negatively impact their self-confidence and ability to establish an emotional bond with their baby. structured and individualized developmental care education provided in the neonatal intensive care unit (nicu) enhances mothers' knowledge and promotes their active participation in the care process, thereby strengthening their maternal roles. increased self-efficacy helps mothers to take a more active and conscious role in their infant's care, while stronger maternal attachment plays a critical role in the infant's emotional and neurodevelopmental health. therefore, the integration and dissemination of such supportive educational interventions within the healthcare system are essential steps that can positively influence both maternal and infant health outcomes.


Eligibility criteria:
inclusion criteria: * the mother must have a premature baby born between 22 and 32 weeks gestation, admitted to a level 3 nicu. * the baby's stay in the level 3 nicu must be at least one month. * the mother must not have any diagnosed psychiatric disorders. * the baby must not have severe congenital anomalies incompatible with life. * the mother must be literate and open to communication. * the mother must be willing and volunteer to participate in the research. exclusion criteria: * the baby's stay in the nicu must be at least one month.

Keywords: premature individualized developmental care attachment self efficacy maternal
effectiveness of transvaginal niche resection versus expectant management in patients with secondary infertility and a large uterine caesarean scar defect

Conditions: Caesarean Scar Defect

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of transvaginal niche resection in improving pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. the main questions it aims to answer are: 1. does transvaginal niche resection improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility? 2. what medical problems do participants have when taking transvaginal niche resection? researchers will compare transvaginal niche resection to expectant management (without any additional surgical intervention) to see if transvaginal niche resection works to improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. participants will: 1. undergo a procedure (transvaginal niche resection) within 2 week after randomization in the intervention group. women were advised to use contraception in the first 6 months following niche resection to allow uterine healing prior to subsequent pregnancy. 2. receive usual care at least 9 months which means no additional surgical intervention during this period in the control group. patients are allowed to become pregnant and to receive fertility therapies if indicated. any member of the control group who has not become pregnant after 9 months will be given the opportunity to undergo a transvaginal niche resection. 3. receive a standardized magnetic resonance imaging (mri) evaluation of the niches. niches will be evaluated at baseline in all groups and at 3 months after surgery. 4. be contacted by telephone at 6, 9 and 15 months to assess the primary and secondary outcomes.


Eligibility criteria:
inclusion criteria: 1. it was diagnosed by mri as a large niche (defined as niche with a depth of \&gt;50% of the myometrial thickness and a residual myometrial thickness (rmt) ≤3mm); 2. infertility secondary to niche (the inability to conceive within 12 months of unprotected intercourse or repeated failed ivf); 3. fertility requirements; 4. signed informed consent. exclusion criteria: 1. age below 18 years or over 49 years; 2. contraindications for intraspinal or general anaesthesia; 3. a (suspected) malignancy or combined benign lesions requiring hysterectomy; 4. atypical endometrial cells or cervical dysplasia; 5. uterine or cervical polyps; 6. submucosal fibroids; 7. hydrosalpinx.

Keywords: caesarean scar defect
effect of synbiotic on postoperative complications after liver transplantation

Conditions: Liver Disease

Summary: the purpose of this study is to evaluate the use of synbiotic in patients after liver transplantation and assess the effect of these agents on postoperative infections, antibiotic use, length of hospital stay, mortality and nutritional status.

all patients who are undergoing liver transplantation at the hospital de clinicas de porto alegre over the next 18 months will be informed of the purpose of the study. the patients or their legal guardians provided will written an informed consent for participation at the study. the patients will be allocated to the intervention or control groups by randomization in blocks. the intervention group will receive a synbiotic composition (lactobacillus acidophilus ncfm sd5221 10bilhões; lactobacillus rhamnosus hn001 5675 sd 10 billion; lactobacillus paracasei lpc sd 5275 - 37 10 billion; bifidobacterium lactis sd 5674 hn0019 10 billion; fructooligosaccharide 5.5 g) and the control group will receive 6 g of maltodextrin.the patients will received a synbiotic composition or maltodextrin for 15 days, twice times a day, after liver transplantation, when the patients are able to start feeding. patients will be evaluated for the occurrence of infections, need for additional antibiotics, length of hospital stay and mortality. the nutritional assessment will be carried out before and after surgery. all information will be collected and stored prospectively and the clinical trial will follow the instructions of the consolidated standards of reporting trials - consort 2010.

Eligibility criteria:
inclusion criteria: * all adults patients who are undergoing liver transplantation exclusion criteria: * patients on parenteral nutrition

Keywords: synbiotic infections probiotics liver transplantation
study comparing the tolerability of seroquel ir with seroquel xr in patients with bipolar depression

Conditions: Bipolar Depression

Summary: the purpose of the study is to compare the sedation profile one hour after dose administration between seroquel ir and seroquel xr.


Eligibility criteria:
inclusion criteria: * dsm-iv-tr documented bipolar i or bipolar ii, most recent episode depressed * outpatient status as enrollment exclusion criteria: * other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.

Keywords: inpatient bipolar depression quetiapine seroquel ir seroquel xr safety tolerability
efficacy of intravenous ibuprofen compared to intravenous ketorolac for pain control following arthroscopic knee surgery

Conditions: Pain

Summary: the purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (visual analog scale, vas)


Eligibility criteria:
inclusion criteria: * patients scheduled for knee arthroscopy exclusion criteria: * inadequate iv access. * history of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (nsaids), opioids or cyclooxygenase-2 (cox-2) inhibitors. * less than 18 years of age. * use of analgesics less than 8 hours prior to surgery. * patients with active, clinically significant anemia. * history or evidence of asthma or heart failure. * pregnant. * recent history of chronic opioid use. * concomitant use of probenecid. * inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an institutional review board \[irb\]), and agree to abide by the study restrictions and to return for the required assessments. * refusal to provide written authorization for use and disclosure of protected health information.

Keywords: post operative pain, pail relief
safety, pharmacokinetic and efficacy study of a 10% triple virally reduced intravenous immune globulin solution in patients with primary immunodeficiency (hypo- or agammaglobulinemia)

Conditions: Primary Immunodeficiency Diseases (PID); Agammaglobulinemia; Hypogammaglobulinemia

Summary: the purpose of this study is to determine the pharmacokinetics, efficacy and safety of immune globulin intravenous (human), 10% tvr (triple virally reduced) solution in subjects with primary immunodeficiency (pid) manifesting as hypo- or agammaglobulinemia. subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive gammagard s/d to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive igiv, 10% tvr solution.


Eligibility criteria:
inclusion criteria: subjects will be eligible for study entry if they: * are at least 18 years old * have a form of primary immunodeficiency (pid) as described by rosen et al, 1999 16 manifesting as agammaglobulinemia (x-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy * have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously * have serum igg levels greater than or equal to 5 g/l as determined by the local laboratory at screening * if female of childbearing potential, agree to employ adequate birth control measures during the study * have given written informed consent exclusion criteria: subjects will not be eligible for study entry if they: * had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study * suffer from documented selective iga deficiency with antibodies against iga * have an acute infection that requires intravenous antibiotic treatment (last treatment day should be seven days before study entry.) * are known to be infected with hiv, hcv, or hbv * are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style * suffer from congestive heart failure and receive on-demand treatment with furosemide * show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dl at baseline visit * received another investigational drug in the three weeks preceding study entry * in case of females, are pregnant or nursing mothers

Keywords: gammaglobulin
effectiveness of an integrated colorectal cancer screening in saudi arabia: a pragmatic randomized trial

Conditions: Colorectal Neoplasms; Colorectal Cancer; Colonic Polyp; Occult Bleeding

Summary: the global burden of colorectal cancer (crc) incidence among young age groups is rising and overwhelming. this new trend of young-onset crc incidence is evident in western countries. unfortunately, asian countries have shown the same epidemic shift in the past few years. as a consequence, this situation might necessitate revisiting the current screening program in this region. saudi arabia has a two-fold increase in crc incidence among young age groups in the last 18 years (9.6/100000 for male versus 9.3/100000 for female). this rising incidence ascribed to the lack of a screening program and suggested lowering crc screening to 40. the low awareness about risk factors, signs, and symptoms of the disease causes late presentation of crc cases. therefore, most presenting cases are associated with a poor prognosis and short survival. educational and screening programs are, by no means, considered valuable and essential as crc tends to affect younger age groups.

crc is cancer that starts in the innermost lining mucosa of the colon or rectum. according to the global cancer observatory (gco) 2018, crc incidence is the third (10.2%) globally, after lung and breast cancers (11.6%). in saudi arabia, 2010 report, the incidence was 10.4/100,000 that slightly higher in male groups. unfortunately, the incidence among young age groups is more than that in countries with high incidence. most of the crcs initially found as small benign growth or projections known as polyps inside the lumen of colorectal space. a polyp is precancerous if it is \>1 cm or the presence of more than two polyps, or if dysplasia present after the polyp removal. there are two main types of polyps: precancerous and hyperplastic polyps or inflammatory polyps, which are not precancerous. the early resection will prevent future cancer development and total cure. different lifestyle factors that could increase crc's risk include lack of regular physical exercise, a diet low in fruit and vegetables, a low-fibre and high-fat diet, diary intake during adolescence, overweight and obesity, alcohol consumption and tobacco use. adherence to crc screening is essential to limit crc cancer incidence and improve population health; and then, health providers need to understand the stages of the disease to recommend effective screening strategies.

Eligibility criteria:
inclusion criteria: * the participants will be individuals with an average risk of colorectal cancer, age: 40 years and above of both genders exclusion criteria: * individuals age less than 40 years or severely ill individuals
the therapeutic effect of thalidomide in syringomyelia

Conditions: Syringomyelia; Thalidomide

Summary: purpose: this phase ii clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia. primary outcome measure: the primary endpoint is the change of asia at week 12. the clinical efficacy is defined as asia increase ≥ 1 at week 12, as compared with that before thalidomide usage.

the pathogenesis of syringomyelia is poorly understood and duraplasty or shunting is not always effective. although it is generally thought that syringomyelia is simply an accumulation of csf from the subarachnoid space, the pathogenesis is likely to be more complex and may involve cellular and molecular processes. the investigators supposed that blood spinal cord barrier(bscb) might play a key role in the pathogenesis of syringomyelia, especially post-traumatic syringomyelia(pts), and that thalidomide, as an bscb protection-related drug, would reduce bscb damage and protect bscb in syringomyelia. primary objectives: this phase ii clinical trial aims to evaluate the indications, therapeutic effects and safety of thalidomide in refractory syringomyelia.

Eligibility criteria:
inclusion criteria: * contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects, * or non-effective response to duraplasty and shunting treatment in 12 months prior to study entry. * estimated life expectancy must be greater than 12 months. * routine laboratory studies: bilirubin \ /= 4,000 per cubic millimeter; neutrophils count \>/=1500 per cubic millimeter platelets \>/= 100,000 per cubic millimeter; hb \>/=110 gram per millilitres; pt, aptt, inr in a normal range. * ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document. * must be able to swallow tablets exclusion criteria: * evidence of tumor metastasis, recurrence, or invasion; * history of psychiatric diseases ; * history of seizures; * history of arteriosclerotic cardiovascular diseases (ascvd), e.g. stroke, myocardial infaction, unstable angina, within 6 months; * new york heart association grade ii or greater congestive heart failure; * serious and inadequately controlled cardiac arrhythmia; * significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, history of aortic dissection; * severe infection; * history of allergy to relevant drugs; * pregnancy, lactation, or fertility program in the following 12 months; * history or current diagnosis of peripheral nerve disease; * abnormal in liver and renal function; * active tuberculosis; * transplanted organs; * human immunodeficiency virus; * participation in other experimental studies.
an extension trial for patients with open-angle glaucoma who participated in the df6-cl-20-01 protocol.

Conditions: Open Angle Glaucoma; Intraocular Pressure

Summary: the purpose of this study is to evaluate long term safety and effectiveness of the streamline® surgical system

a retrospective, nonrandomized, open-label study to evaluate the long term safety and iop-lowering effectiveness of streamline® surgical system in patients with open-angle glaucoma who participated in the df6-cl-20-01 protocol.

Eligibility criteria:
inclusion criteria: participated in the df6-cl-20-01 trial. exclusion criteria: lost to follow up in the df6-cl-20-01 trial

Keywords: intraocular pressure glaucoma migs