Kornimate/medical-research-clean huggingface dataset:
study to assess the safety, tolerability, and efficacy of idx-1197 in combination with xelox or irinotecan in patients with advanced gastric cancer

Conditions: Gastric Cancer

Summary: this is an open-label, phase 1b/2a study to evaluate the safety and tolerability of idx-1197 and determine the mtd and rp2d in combination with xelox or irinotecan in patients with advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach. * group 2, patients with recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach, who were treated ≥2 times with palliative chemotherapy before screening. * at least 1 evaluable lesion for the dose escalation part and at least 1 measurable lesion according to recist v1.1 for the dose expansion part. * eastern cooperative oncology group (ecog) performance status ≤1. * group 2 part c, patients should have ugt1a1 genotype tested during or prior to screening. exclusion criteria: * symptomatic central nervous system or uncontrolled brain metastasis * carcinomatous meningitis or its history. * for group 1, patients who are her 2 positive. * any other concurrent uncontrolled illness including, but not limited to, active or ongoing symptomatic infection requiring iv antibiotic treatment, uncontrolled diabetes, hepatic, renal, or respiratory illness. * severe or unstable angina, myocardial infarction or ischemia, symptomatic congestive heart failure, arterial or venous thromboembolism requiring coronary artery bypass graft or stent within the past 6 months or clinically significant cardiac dysrhythmia or new york heart association class ii \~ iv heart disease within 6 months of randomization. * uncontrolled hypertension * immunocompromised patients, such as patients known to be serologically positive for hiv. * patients with known active hepatitis b or c infection. * patients with known active or symptomatic pneumonitis, or history of non-infectious pneumonitis requiring steroids. * diagnosis of a myelodysplastic syndrome/acute myeloid leukemia or its suspicious characteristics. * any unresolved clinically significant common terminology criteria for adverse events (ctcae) grade ≥2 toxicity * resting ecg with measurable qtcf \&gt; 470 msec on 2 or more time points within a 24-hour period or family history of long qt syndrome. * current use of a cytochrome p3a4 inhibitor or inducer and strong uridine diphosphate (udp)-glucuronosyltransferase 1a1 (ugt1a1) inhibitors.

Keywords: 1197 idx-1197 venadaparib
screening study to identify pediatric patients with hunter syndrome who demonstrate evidence of central nervous system (cns) involvement and who are currently receiving treatment with elaprase®

Conditions: Hunter Syndrome

Summary: this study is being conducted to identify pediatric patients with hunter syndrome who have neurodevelopmental disease characteristics, who are currently receiving treatment with elaprase, and who may be suitable to participate in a clinical study with an investigational agent.


Eligibility criteria:
inclusion criteria: 1. the patient is male and is ≥3 and \<18 years of age 2. the patient is currently receiving weekly iv infusions of elaprase. 3. the patient, patient's parent(s), or legally authorized guardian(s) has voluntarily signed an institutional review board / independent ethics committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. the guardians' consent and subject's assent, as relevant, must be obtained. exclusion criteria: 1. the patient has a cns shunt. 2. the patient has received a hematopoietic stem cell transplant. 3. the patient is currently enrolled in a clinical trial. 4. the patient has a significant medical or psychiatric comorbidity(ies) that might affect study data or confound the integrity of study results.
does lowering eye pressure affect the results obtained from objective visual field testing?

Conditions: Glaucoma

Summary: a study to determine whether a patient's range of vision test results improve after their eye pressure is lowered by 30% or more by testing on a new machine called the accumap and how to learn how much the accumap's results change from one test to another within the same person. the investigators believe that multifocal vep readings (accumap)(and therefore visual function and ganglion cell function) improve after acutely lowering intraocular pressure.

accumap testing will be performed before and two to three hours after treatment is initiated to lower iop. in eye that have bilateral treatment, one eye will be assigned randomly to the study. the mean multifocal objective perimetry amplitude will be compared before and after iop reduction. also, the mean amplitudes of five circumferential zones will be compared before and after iop lowering. visual field testing and hrt testing will be performed before and after treatment as well if possible. paired t-tests will be performed no pre-and post-treatment mean mop amplitude values and circumferential zones to determine statistical significance. a second group of patients whose pressures will not be lowered will also be tested with accumap at baseline and two hours afterwards, in order to examine reproducibility of mean mop amplitude and mean circumferential amplitude. hvf and hrt testing will also be obtained on thes patients when possible.

Eligibility criteria:
inclusion criteria: * consecutive patients seen that have their intraocular pressures lowered by at least 30% over the course of two hours. exclusion criteria: * recent (within 6 weeks) intraocular surgery * visual acuity worse than 20/40 * pathology unrelated to glaucoma (retinal disease, stroke, brain tumor, etc) associated with visual field defect * prior corneal transplant, corneal edema, or corneal diseases such as keratoconus or dense scarring

Keywords: glaucoma intraocular pressure multifocal visually evoked potentials
erector spinae plane blockade in pediatric scoliosis surgery patients

Conditions: Scoliosis; Juvenile; Scoliosis; Adolescence

Summary: providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. the erector spinae plane block (espb) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. additionally, there are case reports describing the espb as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.


Eligibility criteria:
inclusion criteria: * asa i-iii * diagnosed with idiopathic scoliosis * undergoing single-stage posterior spinal instrumentation and fusion exclusion criteria: * thorascopic tethering procedure * two-stage procedure * abnormal developmental profile * congenital/neuromuscular scoliosis * requiring picu admission * known allergy to lidocaine * known cardiac, renal or liver disease or dysfunction * pre-existing pain complaints, i.e. on regular analgesic medications * current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to dsm criteria. * requiring non-standard post-op pain management * any history of seizures * unplanned staged procedure * weight \ 85th centile for age * porphyria

Keywords: erector spinae plane blockade pediatric scoliosis
this study investigate the impact of maternal covid-19 infection during birth on the childrens' physical and mental development.

Conditions: COVID-19

Summary: this study investigates the impact of the maternal covid infection during birth on the children's development: physical and mental outcomes. we would like to differentiate the effect from the viral infection and effect of the pandemic period, too.


Eligibility criteria:
inclusion criteria: * postitive maternal covid test during the birth * the newborn was cared at the semmelweis university after birth

Keywords: followup longterm outcome child development maternal covid-19
ed90 of epidural bupivacaine with lidocaine for the initiation of labor analgesia

Conditions: Labor Pain; Analgesia

Summary: to estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ed90) via the epidural (dpe or epl) technique in women undergoing labor after receiving a lidocaine "test dose"

the primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ed90) via the epidural (dpe or epl) technique in women undergoing labor induction or augmentation; we hypothesize that we will be able to determine the ed90 of bupivacaine for each technique with adequate precision to inform the optimal doses. we will be conducting this study in women who receive a prior lidocaine "test dose" used in standard clinical practice

Eligibility criteria:
inclusion criteria: * parturient with no major co-morbidities * singleton, vertex gestation at term (37-42 weeks) * less than or equal to 5 cm dilation * desire to receive epidural labor analgesia * numerical rating scale greater or equal to 5 (nrs 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request. exclusion criteria: * current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) * any contraindication to the administration of an epidural technique * history of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent * current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. history of uterine rupture). nb: exception-trial of labor after cesarean delivery (tolac) will be eligible. * evidence of anticipated fetal anomalies

Keywords: dural puncture epidural neuraxial analgesia bupivacaine local anesthetic
esophageal stump washout

Conditions: Esophageal Cancer; Gastrooesophageal Cancer

Summary: intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the esophagus and the cardia. the aim of the the study was to establish a method of mechanical lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer cells before doing the esophageal anastomosis.

see study protocol!

Eligibility criteria:
inclusion criteria: * histologically confirmed cancer of gastro-esophageal junction with indication for surgery exclusion criteria: * missing informed consent

Keywords: esophagus gastro-esophegeal junction cancer tumor seeding free viable tumor cells surgery intraluminal tumor cells stump washout
zero calorie drink products

Conditions: Obesity

Summary: this will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. this research trial will evaluate the effect of three different solutions on blood glucose level. one solution is plain water, the second a standard high glucose (sugar) solution used typically in diabetes testing, and the third a low calorie drink (zero coke). based on a prior study evaluating a diet for effective weight loss, we observed that patients who drank large volumes of diet soda did not lose weight as readily as those who did not drink diet soda. therefore, we propose to examine the actual effect of one diet soda (zero coke) on the body's glucose level and compare it to water and a high glucose solution. all participants in this study must have 3 glucose tolerance evaluations - one with each solution: water, high glucose, and zero coke.


Eligibility criteria:
inclusion criteria: * healthy, * asymptomatic individuals for diabetes and pre-diabetes, * especially for people at high risk of developing diabetes, * such as those with a family history of diabetes, * those who are overweight, * and those who are more than 40 to 45 years old exclusion criteria: * patients with chronic illnesses, especially diabetes
utrogestan versus nifedipine as tocolysis for preterm labor: a randomised controlled trial

Conditions: Preterm Labor

Summary: research hypothesis -incidence of preterm delivery is lower in women treated with oral micronized progesterone (utrogestan) as acute tocolysis agent compare to nifedipine group with fewer maternal side effect


Eligibility criteria:
inclusion criteria: • singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor. exclusion criteria: * multiple pregnancies * women with preterm prelabour rupture of membrane * fetal death * women with bad obstetric history * women with history of cervical incompetence * contraindication to nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to utrogestan * maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta * contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage * cervical dilatation of 3cm or more * patients with previous tocolytic treatment during this pregnancy * women who refuse to participate in this study

Keywords: preterm labor
does a high bmi affect supervised pelvic floor muscle training for improving symptoms in women with various stages of pelvic organ prolapse?

Conditions: Pelvic Organ Prolapse; Uterine Prolapse; Anterior Wall; Prolapse, Vaginal; Posterior Wall; Prolapse, Vaginal; Cystocele; Rectocele; Vault Prolapse, Vaginal

Summary: the trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy. candidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a nhs trust within greater manchester. the data collection occurred in january-june 2019 and ethical approval was granted by school research ethics, university of salford. treatment aims to ensure there is respect for their autonomy, treatment is fair (justice), no harm is done to the participant (nonmaleficence) and treatment benefits the participants (beneficence). participants are required to complete a consent form prior to their initial session. to ensure methodological quality, the strobe guidelines will be followed to make certain all apt information required is reported to allow for replication of the intervention. the trial aims to include (n=60) women with a diagnosed pelvic organ prolapse. they are required to complete 16 weeks of supervised pelvic floor exercises with a specialist physiotherapist as documented within the most recent nice guidelines. the outcome measures used will be the pelvic organ prolapse symptom score (popss) and this will be documented before and after the 16 week period. along side the popss, the patients body mass index and severity of pelvic organ prolapse will also be recorded and the results of this will be correlated post trial using the relevant data analysis testing methods.


Eligibility criteria:
inclusion criteria: * gynaecologist diagnosed women with a mild / moderate or severe pelvic organ prolapse * \>18 years old exclusion criteria: * unwilling or unable to provide informed consent (opt out of treatment) * unable to contract the pelvic floor muscles (determined by the treating physiotherapist) * history of pelvic cancer / or radiotherapy treatment within three months, * neurological or psychiatric disorders, * untreated urinary tract infections, * pregnant or planning to become pregnant or given birth within the past year, * recent vaginal surgery within twelve weeks or evidence of genital oedema, * suspected infection or fragility of the genital area as indicated by the referral source or patient reported at the initial assessment.

Keywords: pelvic floor muscle training pelvic physiotherapy pelvic floor exercises
study of natural history of human papillomavirus (hpv) infections in adult women with recurrent conizations in norway

Conditions: Infections, Papillomavirus

Summary: this is a register-based, epidemiological study of hpv type distribution in women aged 18 years and above with recurrent conization following a primary conization for high grade lesions/ microinvasive carcinomas. this study will involve data collection from different databases in the cancer registry of norway.

this protocol posting has been updated following protocol amendment 1 (02 april 2010). the sections impacted are: enrolment, outcome measures and eligibility criteria.

Eligibility criteria:
inclusion criteria: all subjects must meet the following criteria at study entry: * women aged 18 years and above at the time of the collection of the primary cone specimen; * who have undergone for the first time a conization due to high grade lesions or microinvasive cervical carcinomas, histologically diagnosed in 2003, with possible extension backwards in time; * availability of recurrent cone specimen with high grade lesions/ microinvasive cervical carcinomas or invasive cervical cancer; * availability in designated local laboratories of the primary and recurrent cone specimens; * the cone specimen was adequately preserved; * written informed consent obtained from the subject. if the subject is deceased, the cone and biopsy specimens will be used according to prior approval from the ethics committee. exclusion criteria: none.
developmental sequelae of severe chronic lung disorders

Conditions: Bronchopulmonary Dysplasia; Lung Diseases

Summary: to determine the impact of bronchopulmonary dysplasia (bpd) on childhood development, family functioning, and parental stress.

background: bronchopulmonary dysplasia in infancy has been shown to be related to less optimal physical and psychological functioning later in life. although infants with the disorder increased from 1978 to 1988, little was known about potential developmental problems early in life which might lead to the documented negative sequelae shown in previous research. design narrative: in this longitudinal study, infants were followed from birth and given standardized assessments of developmental and physical functioning. demographic, birth, and medical data were collected at baseline through chart review. standardized questionnaires measuring parental stress and family support were administered to the parents. infants were followed at eight months, and one, two, and three years at which time parental measures were repeated and standardized assessments made of the children's physical growth, medical status, cognitive, language and behavioral development. feeding behaviors were assessed through standardized observation and interview at each visit. data were evaluated descriptively as well as through a series of multivariate analyses of variance with repeated measures. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a multi-center bidirectional cohort study on total knee arthroplasty for the treatment of knee osteoarthritis

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the clinical benefits of different types of total knee arthroplasty (tka) in osteoarthritis treatment. the study aims to compare surgical outcomes, functional recovery, complication rates, and cost-effectiveness among personalized, semi-personalized, and conventional tka in a multi-center, bidirectional cohort study.

this study aims to assess the performance of personalized, semi-personalized, and conventional total knee arthroplasty (tka) procedures across different patient groups. this is a prospective cohort and controlled study involving 120 patients, including 40 in the experimental group receiving personalized tka, 40 receiving semi-personalized tka, and 40 in the control group receiving conventional tka. participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. they will be followed for one year post-surgery to assess clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. patients aged 50-80 years. 2. diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty. 3. willing and able to provide informed consent. exclusion criteria: 1. history of prior knee surgery or knee replacement. 2. severe knee deformity (valgus \>20° or varus \>15°) or instability. 3. severe contracture (\>25° flexion contracture). 4. undergoing total knee revision surgery. 5. rheumatoid arthritis diagnosis. 6. bmi \>35. 7. neuromuscular disorders affecting knee stability or gait. 8. pregnancy or lactation. 9. presence of significant comorbidities posing unacceptable risk. 10. active or recent severe infections or malignancy. 11. history of drug or alcohol abuse in the past six months.
biliary cancer in italy: a study on cholangiocarcinoma causes and risk factors

Conditions: Cholangiocarcinoma

Summary: multi-centric, observational, prospective study, designed for pts with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma.

patients will undergo basal blood sample exams regarding blood cell count, renal and liver function, tumor markers, inflammatory and metabolic state, along with a screening (and, if needed, a more in-depth laboratory analysis) for viral hepatitis infections. information will be collected about radiological, clinical and pathological features of the neoplasm at time of diagnosis, as well, at a later time, about its natural history. a two-step data analysis will be performed: task-1 analysis will define the risk factors landscape, task-2 analysis will examine the influence of etiology on clinical outcomes. anonymized data will be stored in a central database, kept at the leading centre.

Eligibility criteria:
inclusion criteria: * voluntary, written, dated and signed informed consent; * age ≥ 18 years; * histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma. exclusion criteria: * dementia or altered mental status leading to inability to understand or render the informed consent. * patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy) may be enrolled but will not be subject to data collection about bi-cause - study protocol version 1.0 oct 18th, 2015 10 blood laboratory tests (with the exception of viral screening) and natural history, and will not be factored in the data analysis of prognostic factors. performance status, life expectancy, tumour staging, tumour site (distal or hilar extrahepatic, intrahepatic), previous surgical resection, previous biliary stenting, previous radiotherapy are not part of inclusion/exclusion criteria.