Kornimate/medical-research-clean huggingface dataset:
adjuvant gemcitabine versus 5-fu/leucovorin based on hent1 immunostaining

Conditions: Pancreatic Cancer

Summary: human equilibrative nucleoside transporter 1 (hent1) is a membrane transporter which is a predicting marker for gemcitabine chemotherapy. however, there is a limited evidence of it as an indicator for adjuvant gemcitabine chemotherapy. in this study, investigators try to investigate the role of hent1 as a indicator of selection of adjuvant chemotherapy regimen between gemcitabine and 5-fluorouracil (5-fu).

after surgical resection of pancreatic cancer, the tissue is immunostained by hent1 antibody. the grades of immunostaining are categorized as 0 (0%), 1 (\ =50%). according to the grade, patients with grade 0 or 1 will be treated with 5-fu and those with grade 2 will be treated with gemcitabine. after the study, investigators will calculate the overall survival and recurrence free survival of the patients and investigate the role of hent1 as a predictive biomarker for adjuvant gemcitabine chemotherapy.

Eligibility criteria:
inclusion criteria: * patients with curatively resected pancreatic cancer * age between 18 and 75 * eastern cooperative oncology group performance score 0 or 1 * patients with compliance * patients with informed consent exclusion criteria: * patients refuse to enroll this study * patients with concomitant chemoradiation therapy * previous chemotherapy * pregnant or preparing a pregnancy * uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarction within 6 months * enrolled another clinical trial within 30 days * patients will be expected to be risk because of enrollment * patients without informed consent

Keywords: pancreatic cancer adjuvant chemotherapy hent1 gemcitabine
expanded access to upadacitinib

Conditions: Crohn Disease

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: - the participant must not be eligible for upadacitinib clinical trial.

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme
a study evaluating iniparib in combination with chemotherapy to treat triple negative breast cancer brain metastasis

Conditions: Estrogen Receptor Negative (ER-Negative) Breast Cancer; Progesterone Receptor Negative (PR-Negative) Breast Cancer; Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer; Brain Metastases

Summary: the purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when iniparib is used in combination with irinotecan. based on data generated by bipar/sanofi, it is concluded that iniparib does not possess characteristics typical of the parp inhibitor class. the exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-h2ax (a marker of dna damage) in tumor cell lines, induces cell cycle arrest in the g2/m phase in tumor cell lines, and potentiates the cell cycle effects of dna damaging modalities in tumor cell lines. investigations into potential targets of iniparib and its metabolites are ongoing.


Eligibility criteria:
inclusion criteria - 1. histologically-confirmed, er negative, pr negative and her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging. 2. ecog performance status of 0-2. 3. life expectancy of \>12 weeks. 4. no limit to prior therapies with last anti-cancer treatment ≥ 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to ≤grade 1 or baseline. 5. no active serious infection or other comorbid illness which would impair ability to participate in the trial. 6. stable or decreasing dose of steroids for ≥ 7 days. 7. interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy. 8. patients must have adequate organ function. exclusion criteria - 1. pregnant or breast-feeding 2. prior allergic reaction to iniparib 3. prior allergic reaction to irinotecan. 4. evidence of hemorrhage or impending herniation on baseline brain imaging 5. evidence of diffuse leptomeningeal disease on brain mri or by previously documented csf cytology-note: discrete dural metastases are permitted. 6. clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation. 7. concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy. 8. contraindication to gadolinium-enhanced mri imaging. 9. inability to comply with study and/or follow-up procedures.

Keywords: triple negative breast cancer brain metastasis bsi-201 iniparib
comparison of psychometric properties of three depression measures in patients with stroke

Conditions: Cerebrovascular Accidents

Summary: this study is going to comprehensively examine the psychometric properties of the three depression scales (hamilton depression scale (hamd), hospital anxiety and depression scale (hads), and beck depression inventory (bdi)) in stroke patients over a period of three years.

this study is going to comprehensively examine the psychometric properties of the three depression scales (hamilton depression scale (hamd), hospital anxiety and depression scale (hads), and beck depression inventory (bdi)) in stroke patients over a period of three years. this study will be divided into two parts. in the first part, we will spend 3 years in recruiting 200 consecutive patients with a diagnosis of first stroke onset to compare the validity, responsiveness, and acceptability of the hamd, hads, and bdi. all patients will be assessed using the three depression scales and other functional measures at 14, 30, 90, 180, and 365 days after stroke. in the second part, the inter-rater reliability of the three depression scales will be examined in the first year. sixty chronic stroke patients will be recruited in the study. furthermore, the other 60 chronic stroke patients will be recruited in the second year for examining the test-retest reliability and measurement error of the three depression scales. this study would be the first one to systematically compare the psychometric properties of the three depression scales in a long-term follow up study. the results of the study will be able to help clinicians and researchers select the most suitable depression scales for stroke patients. the results will also provide us references to develop a new depression scale, if needed, for stroke patients.

Eligibility criteria:
inclusion criteria: patients with a diagnosis stroke ability to complete questionnaires exclusion criteria: patients with other major diseases (e.g., cancer)

Keywords: depression psychometrics
can increased body mass index prevent adequate ultrasound examination for trisomy 21 risk assessment?

Conditions: Ultrasound Quality

Summary: determine cutoff bmi at which transabdominal sonography (tas) is not satisfactory for aneuploidy risk assessment.

obesity is a common public health problem which is increasing worldwide at an alarming rate. according to national nutrition survey statistics of 2007, the prevalence of obesity in the kingdom of saudi arabia was 23.6% in women and 14% in men. also the prevalence of overweight in the saudi community was determined to be 30.7% for men as compared to 28.4% for the women. first trimester screening between 11-14 weeks gestation is known to be an effective and reliable screening test for down syndrome and trisomy 18.first trimester screening allows earlier identification of the pregnancy at risk for fetal aneuploidy and anatomic defects, particularly, cardiac anomalies, therefore, providing an option of earlier diagnosis by chorionic villus sampling and analysis of amniocytes. the well-known association of obesity during pregnancy with a variety of maternal and fetal complications increases the importance of early aneuploidy screening. fetal aneuploidy risk assessment is based on a combination of maternal age, prior affected pregnancy or family history, maternal serum biochemical tests and fetal ultrasound markers. the impact of obesity on the quality of prenatal ultrasound examination is well established with a greater risk for suboptimal visualization, in particular, the fetal cardiac structures and the craniospinal structures only when body mass index above the 90th percentile. the quality of prenatal screening for aneuploidy via nuchal translucency thickness measurement is significantly limited among obese pregnant women, thus, increased risk of fetal anomalies. gandhiet al, have noted that increased bmi is not associated with suboptimal visualization of nuchal translucency, but it is associated with a longer time to perform the first-trimester ultrasound examination for aneuploidy risk assessment, increased need for transvaginal ultrasound examination for optimum nuchal translucency visualization. there is evidence suggesting that fetal anatomic evaluation in the low-risk gravida can be better accomplished in the first trimester using the transvaginal route, providing a valuable option for obese patients.

Eligibility criteria:
inclusion criteria: * women who have a live, intrauterine, singleton pregnancy between 11- 14 weeks gestation. exclusion criteria: * multiple gestation. * fetal size outside of nuchal translucency screening age (crown-rump length (crl) outside of 46-71 mm). * presence of a cystic hygroma. * fetal demise.

Keywords: ultrasound trisomy screening obesity
igg using in laparoscopic gastrectomy for locally advanced gastric cancer after neoadjuvant chemotherapy

Conditions: Gastric Cancer; Lymph Node Metastases

Summary: patients with locally advanced gastric adenocarcinoma (ct2-4a n-/+ m0) were selected as study subjects to investigate the safety, efficacy, and feasibility of icg near-infrared imaging tracing in guiding laparoscopic d2 lymph node dissection for gastric cancer after neoadjuvant chemotherapy by comparing injection icg group and non-injection icg group


Eligibility criteria:
inclusion criteria: 1. age from 18 to 75 years 2. primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. ct2-4a, n-/+, m0 at preoperative evaluation according to the ajcc cancer staging manual, 8th edition 4. no distant metastasis, no invasion of pancreas, spleen or other adjacent organs in the preoperative examinations 5. performance status of 0 or 1 on the ecog (eastern cooperative oncology group) scale 6. asa (american society of anesthesiology) score i to iii 7. written informed consent exclusion criteria: 1. women during pregnancy or breast-feeding 2. severe mental disorder 3. history of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. history of previous gastric surgery (including esd/emr for gastric cancer) 5. enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging. 6. other malignant disease within the past 5 years 7. history of previous neoadjuvant chemotherapy or radiotherapy 8. history of unstable angina or myocardial infarction within past six months 9. history of cerebrovascular accident within past six months 10. history of continuous systematic administration of corticosteroids within one month 11. requirement for simultaneous surgery for other disease 12. emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. fev1 (forced expiratory volume in one second)\<50% of predicted values 14. diffuse invasive gastric cancer 15. preoperatively, tumors involving the squamocolumnar junction or duodenum were confirmed 16. a history of iodine allergy 17. refuse laparoscopic surgery
self-compassion for children and caregivers

Conditions: Anxiety; Depression

Summary: the self-compassion for children and caregivers study aims to understand if an online course designed to help kids and their caregivers learn self-compassion is feasible, enjoyable, and helpful for well-being and relationships in families from diverse backgrounds. children ages 8-11 who have a caregiver willing to participate with them will: * attend 2 in-person study visits (about 1-1.5 hour each) that includes * a survey for caregiver and child * a brief computer puzzle challengetask while heart rate and sweat is recorded (child) * a brief discussion about how the challenge went * participate in a 6-session, online self-compassion course with other families (see back) * provide feedback about how the course went

this pilot study examines the feasibility, acceptability, and preliminary outcomes of the self-compassion for children and caregivers (sccc) program. twenty-four children ages 8-11 and a primary caregiver will be recruited from a racially diverse school community to participate in 6 1-hour group intervention sessions over 6 weeks. feasibility and acceptability data will guide program refinements; pre and post assessments will explore dimensional changes in anxiety/depression symptoms as well as potential physiological, relational/behavioral changes associated with sccc participation.

Eligibility criteria:
inclusion criteria - english speaking: * youth between the ages of 8 and 11 years old * youth are currently attending an elementary school in the madison metropolitan school district (mmsd). * accompanied by a willing and able caregiver (e.g., parent, grandparent, legal guardian) * access to an internet-enabled device * both parent and youth participants must be able to read/write in english * meet threshold (t greater than 59) for clinically significant anxiety and/or depression from either parent- or youth-report of symptoms inclusion criteria - spanish speaking: * youth between the ages of 8 and 11 years old * accompanied by an eligible caregiver participant * safe access to a computer or mobile device that can connect to the internet * visual acuity adequate to read text on a computer or mobile device * able to provide assent and complete surveys in spanish exclusion criteria - english speaking: * are unable to provide adequate informed consent and/or assent * parent or youth that is currently impaired by any medical condition that would prevent study participation * active self-reported psychotic disorder * current use of psychotropic medication is not exclusionary. however, certain medications that may impact physiology recordings may be excluded (e.g. those with direct impacts on the sympathetic nervous system). exclusionary medications will be decided on a case-by-case basis, per discretion of the pi, a pediatric psychiatrist exclusion criteria - spanish speaking: * previous completion of a mindfulness and self-compassion for children and caregivers (msc-cc) program
short term oral iron supplementation in systolic heart failure patients suffering from iron deficiency anemia

Conditions: Heart Failure, Systolic; Iron-deficiency Anemia

Summary: the purpose of this study is to determine the efficacy of ferrous sulphate (fs) tablets in improving iron stores and functional capacity in hf patients with iron deficiency anemia (ida).

the investigators conducted a double blind randomized controlled trial (rct) enrolling 54 heart failure (hf) patients (lvef \< 50%) with ida (ferritin \< 100 ng/ml or 100-300 ng/ml with tsat \< 20%) at outpatient clinic of national cardiovascular center harapan kita from january to july 2016. patients were randomized 1:1 to received fs or placebo for 90 days, the investigators then evaluated the change in 6-minute walking test (6mwt) distance as primary end-point and changes on n-terminal-pro brain natriuretic peptide (nt-probnp) and post 6mwt serum lactate levels as secondary end-points.

Eligibility criteria:
inclusion criteria: * age ≥ 18 year old * systolic heart failure patients without clinical sign of decompensation at outpatient clinic * new york heart association (nyha) functional class ii-iii able to perform 6mwt * lvef \< 50% * on heart failure therapy * haemoglobin (hb) \ 8 gr/dl * ferritin \< 100 µg/l or ferritin 100-300 µg/l dengan transferrin saturation (tsat) \< 20% * agree to participate exclusion criteria: * history of : active bleeding,infection, malignancy, haematological abnormality, peptic ulcer * history of myocardial revascularization (cabg/pci) within 3 month * acute coronary syndrome (acs), stroke,transient ischemic attack (tia) within 3 month * know to have allergic reaction to ferrous sulfate * history of intravenous iron administration within 1 month * permanent pace maker(ppm)/implantable cardiac defibrillator (icd)/cardiac resynchronization therapy (crt) * estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 * nt-probnp \> 4000 pg/ml (for patients without baseline data) or decreased level of nt-probnp \< 30% from baseline * increase level of serum alanine aminotransferase (alt)/ serum aspartate aminotransferase (ast)\> 3x normal value * moderate to severe primary valvular heart disease * congenital heart disease * right heart failure due to primary pulmonary hypertension, cor pulmonale, chronic thrombo-embolic pulmonary hypertension (cteph)

Keywords: systolic heart failure anemia iron deficiency
claudication evaluation during rowing exercises

Conditions: Peripheral Artery Disease

Summary: check the feasibility of the collection of reliable measures of tcpo2 the lower limbs in arteriopathy when performing rowing on effort.

obtaining curve values of tcpo2 interpretable when recording the effort by rowing on rowing. show the occurrence of ischemia in the lower limbs during recording effort by rowing on rowing

Eligibility criteria:
inclusion criteria: * referred for an oximetry exercise test * patient able to walk on a treadmill * patient covered by the french health insurance * patient able to understand the protocol * patient agrees to be involve in the protocol and sign the consent form exclusion criteria: * any heart issues during the last 3 months * pregnancy

Keywords: peripheral artery disease transcutaneous oxygen pressure claudication rowing ergometer
comparison of three methods of hemoglobin monitoring

Conditions: Blood Loss

Summary: the purpose of this study is to compare the hemoglobin results obtained with 1) the hemocue™, 2) the masimo sphb™, and 3) the ucsf clinical laboratory. the goal is to determine if these three values differ from each other during various levels of blood loss in the clinical care of patients for spine revision and hip revision surgery.

see above

Eligibility criteria:
inclusion criteria: * male or non-pregnant female 18 y/o or older * american society of anesthesiology classification 1, 2 or 3 * scheduled to undergo spine or hip revision surgery exclusion criteria: * pregnant or nursing * patients who in the study investigators clinical judgement would not be suitable for research.
treatment of depression in adults

Conditions: Depression

Summary: this study will determine how certain features of depressed individuals affect their responses to depression treatment.

major depression is a serious condition that can have devastating functional consequences. although numerous depression studies have been conducted, understanding of how best to achieve long-term recovery remains limited. this study will assess the mood, personality, pharamcokinetic and genetic characteristics of depressed participants to determine the effects of these features on treatment response. this study will be conducted at two international treatment sites, including the university of pittsburgh and the university of pisa, italy. participants will be randomly assigned to receive either interpersonal psychotherapy (ipt) or escitalopram pharmacotherapy for a minimum of 32 weeks or approximately 8 months. participants whose symptoms become stabilized will continue the initial treatment for another 6 months; those who do not will have the second treatment added to their regimen until remission occurs. clinical evaluations and questionnaires will be used to assess participants.

Eligibility criteria:
inclusion criteria: * diagnosis of major depression exclusion criteria: * history of manic or hypomanic episodes * history of schizophrenia or schizoaffective disorder * diagnosis of anorexia nervosa or bulimia nervosa * current psychosis * drug and/or alcohol dependence or abuse within 3 months prior to study entry. participants with episodic abuse related to mood disorders will not be excluded. * diagnosis of antisocial personality disorder * diagnosis of organic affective syndrome and uncontrolled medical illness * pregnancy * require inpatient treatment for suicidal risk or psychosis * history of an inability to tolerate any of the study treatments * currently receiving treatment with an effective antidepressant

Keywords: psychotherapy depressive disorder antidepressive agents citalopram
comparison of cytokines profile in aqueous humor and tear before and after ucp treatment

Conditions: Glaucoma; Ultrasound Cyclo Plasty; Aqueous Humor; Tear; Cytokines

Summary: glaucoma is the leading cause of irreversible vision loss in people aged 50 years and older worldwide, second only to cataracts. ultrasound cyclo plasty was first proposed as a new minimally invasive technique in the 1980 s. in recent years, many clinical studies at home and abroad have confirmed the effectiveness, safety and repeatability of ucp. the ciliary body is the target organ of ucp, and the range and accuracy of intraoperative destruction of the ciliary body are the key factors affecting the success or failure of the operation. the production of aqueous humor is closely related to the ciliary body. the dynamic balance of its production and discharge can affect iop, and its content can directly reflect the intraocular environment. besides,tears are easy to collect and can be used for follow-up. previous studies have shown that various proteins in aqueous humor or tear can provide a basis for the pathophysiological changes of glaucoma, and can also be a potential biomarker for predicting the success of anti-glaucoma surgery. at present, ucp related research focuses on its effectiveness and safety, mainly reflected in three aspects : postoperative intraocular pressure, number of anti-glaucoma drugs and complications, and lack of relevant indicators that directly reflect postoperative intraocular environment changes. the purpose of this study was to reveal the changes of cytokines in aqueous humor after ucp in patients with primary glaucoma, to analyze the possible causes of these factors, and to speculate the effect of their interaction on the surgical effect, in order to increase the predictability of ucp procedure.


Eligibility criteria:
inclusion criteria: * the patient was definitely diagnosed as glaucoma, no age or gender limitation, iop(intraocular pressure) ≥ 21mmhg under the maximum tolerated dose of antiglaucoma medication, or iop \< 21mmhg and glaucomatous optic nerve damage progressed. exclusion criteria: * other eye diseases that could affect iop; preoperative use of systemic steroid drugs; history of other anti-glaucoma surgery within 3 months; ocular infection 2 weeks prior to ucp