Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability and efficacy of rz-001 with valganciclovir (vgcv) in subjects with glioblastoma

Conditions: Glioblastoma

Summary: this is a phase 1/2a, open-label study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of rz-001 administered in combination with vgcv in subjects with htert-positive gbm.

the study consists of 2 parts: a dose-escalation part (part 1) and a dose-expansion part (part 2). part 1 consists of dose escalation exploring mtd/rp2d for intratumoral (it) injection. part 2 will consist of dose expansion exploring clinical activity for the optimal fixed dose based on the results of part 1.

Eligibility criteria:
inclusion criteria: * adult males and females * histologically-confirmed grade 4 astrocytoma, gbm, per the 2021 who classification of cns tumors. * htert positive expression confirmed during the screening period * ecog score of ≤ 2 * kps ≥ 60 * life expectancy ≥ 3 months exclusion criteria: * diagnosis of other malignant tumors within 5 years prior to rz-001 administration. * have extracranial metastases of the tumor cells * current or history of hiv positive * not suitable for inclusion judged by the investigator
observational copenhagen pancreatic cancer study

Conditions: Pancreatic Cancer

Summary: the primary objective of the copenhagen pancreatic cancer (copan) study is to describe the real-world population of patients with pancreatic cancer (pc). larger sample of longitudinal real-world data provides a unique opportunity for comprehensive exploration of the diagnostic and treatment journey for individuals diagnosed with pc and allows to investigate treatment outcomes and associated prognostic factors. furthermore, the study aims to identify determinants of treatment management and treatment outcomes, including patient-reported outcomes.

the study objective is to describe the real-world population of patients with pancreatic cancer by collecting longitudinal data that facilitates a more rigorous understanding of the pc. this research project will catalog different elements of a patient's diagnostic and treatment journey and identify unmet needs of patients with pc. the study aims to: 1. to compile detailed demographic information of patients with pc. 2. to document and analyze the clinical and disease characteristics at the time of diagnosis and beyond. 3. to track various treatment modalities employed, including surgery, chemotherapy, and radiation therapy. 4. to assess short-term and long-term outcomes, including survival rates, complications, and quality of life. 5. to identify prognostic and predictive factors within the real-world cohort. 8. to investigate the impact of pc and treatment on patients' quality of life. 4 study design this study of patients with pc will employ both a prospective, observational design and retrospective design to capture real-world data relating to health status and/or the delivery of health care routinely collected from a variety of sources. data will be collected longitudinally, allowing for a dynamic analysis of the disease trajectory.

Eligibility criteria:
inclusion criteria: histologically confirmed pancreatic cancer exclusion criteria: * none
nudging high emergency department utilizers to consider non-emergent healthcare resources

Conditions: Emergency Service, Hospital

Summary: the goal of this campaign is to reduce unnecessary ed visits by providing patients who are high ed utilizers (with a visit of any acuity) with alternative resources to manage their health outside of the ed. in this campaign, patients will be randomized to receive one of two types of outreach following discharge aligned with the goal. outreach may occur via (1) a phone call from a geisinger community health worker (chw) or community medical assistant (cma); current standard practice or (2) an interactive chatbot message providing similar information and questions to those provided by the chw/cma. the study team will measure whether ed use differs across patients in different outreach conditions. the study team will also examine whether patients followed through on the message-specific calls to action in the messages differently across conditions.


Eligibility criteria:
inclusion criteria: * geisinger health plan insurance or kaco membership * any pcp or no pcp * visit of any acuity * 4 or more ed visits in the past 6 months exclusion criteria: * institutionalized * cannot be contacted via the communication modality being used in the study (i.e., sms), due to insufficient/missing contact information in the electronic health record or because the patient opted out * admitted to hospital * eloped from ed * left ed without being seen * deceased prior to messaging * qualifies for more intensive care management due to higher-level category of complexity
multicenter registry comparing preoperative imaging for primary hyperparathyroidism

Conditions: Parathyroid Adenoma

Summary: the study aims are: 1. to compare the diagnostic performance of parathyroid four-dimensional ct (4d-ct), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism. 2. to compare 4d-ct, scintigraphy, and ultrasound for the ability to perform focused parathyroidectomy, and for rates of persistent hyperparathyroidism and complications from parathyroid surgery. methods the investigators will create a multicenter registry consisting of patients having parathyroid surgery for primary hyperparathyroidism from july 2009 to june 2016. initial participating centers include duke university medical center, university california los angeles (ucla) and university of arkansas for medical sciences (uams). there will be no intervention in the patient's treatment or imaging. the management will be determined by the surgeon or clinician supervising the patient's care. the registry will consist of patient data regarding basic demographics, history of prior neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). data will be entered into redcap with no phi. the investigators expect to include 3000 patients in the registry (1000 from duke).


Eligibility criteria:
inclusion criteria: * patients having parathyroid surgery for primary hyperparathyroidism from july 2009 to june 2016 exclusion criteria: * age less than 18 years * parathyroid carcinoma * secondary or tertiary hyperparathyroidism

Keywords: ct scintigraphy ultrasound
vitamin a supplementation in allogeneic stem cell transplantation.

Conditions: Graft Vs Host Disease; Vitamin A Deficiency; Vitamin D Deficiency

Summary: the investigators hypothesize that single oral high dose supplementation with vitamin a will reduce the incidence of moderate-severe chronic graft-versus-host disease (gvhd) compared with placebo.

hematopoietic stem cell transplantation (hsct) is an effective treatment strategy for many malignancies, marrow failure syndromes, and immune deficiencies in children, adolescents, and adults. vitamin a and its derivatives regulate growth and differentiation of intestinal cells, and vitamin a deficiency is associated with increased susceptibility to infection in both human and animal models. the investigators' preliminary data suggest lower vitamin a levels were associated with an increased incidence of gastrointestinal graft versus host disease (gi gvhd) in patients undergoing hsct. this study is a randomized double blinded comparison of vitamin a supplementation comparing a single large dose of vitamin a with a placebo.

Eligibility criteria:
inclusion criteria: * be 18 years of age or older * be scheduled for allogeneic stem cell transplant. * have a vitamin a level \< upper limit of normal for age. * be able to tolerate enteral vitamin dose administration. * have a total bilirubin level \< 1.5x uln and an ast and/or alt\< 3xuln for age * receiving pbscs as stem cell graft exclusion criteria: * ongoing raised intracranial pressure * liver cirrhosis * patients will be excluded if they are currently pregnant.
donepezil and brain activity patterns in those at risk for alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of the study is to examine patterns of brain activity in people who are at risk for memory problems (e.g., alzheimer's disease or dementia)before and after the medication donepezil. although genetic testing will be done, the results will not be shared with study participants. once the genetic testing is completed subjects may continue to the second phase of the study. during this time they will be asked to take the medication donepezil (which is approved by the fda for the treatment of alzheimer's disease). donepezil is not fda approved for healthy volunteers and is therefore considered investigational in this study.

hypothesis 1. cognitively intact individuals with normal brain morphology at genetic risk for developing alzheimer's' disease (ad) show alterations in brain activation patterns during tasks that require memory compared to similar individuals with lower risk for developing ad. 2. donepezil, a cholinesterase inhibitor, can normalize such brain activation patterns in subjects at risk for ad. specific aims 1. to replicate a recent study1, and compare brain activation in subjects genetically at risk for ad (carriers of the є4 allele of the apolipoprotein e gene (apoe)) with subjects at lower risk for ad (lacking the є4 allele) during tasks that require memory, via functional magnetic resonance imaging (fmri). 2. to determine if administration of a drug currently indicated in the treatment of ad, donepezil, can reverse fmri brain activation patterns of at risk subjects to patterns similar to those of subjects at lower genetic risk for ad.

Eligibility criteria:
inclusion criteria: * subjects may report experiencing subjective memory dysfunction, however they must be found by clinical evaluation to have no memory dysfunction * neuropsychological test battery in the normal range * ages 40-85 exclusion criteria: * dementia (mini-mental state exam less than 25/30) * left-handedness * current medication that could influence cognition * medical, psychiatric, and neurologic conditions, including cerebrovascular disease or uncontrolled hypertension * claustrophobia * surgical clips or implants * pacemakers or other implanted electronic devices * history of sheet metal work

Keywords: memory loss memory problems alzheimer's forgetfulness forgetting
detecting lesions in the oral cavity with thermal imaging

Conditions: Carcinoma, Squamous Cell

Summary: previous studies indicate that there are significant differences in the temperature of tumors and normal, adjacent tissues. the present study will test this hypothesis for lesions in the oral cavity. thermal images of the oral cavities of patients, undergoing examination in the department of oral and maxillofacial surgery of sheba hospital, will be compared to the diagnoses of the examining doctors. the results, apart from enhancing the delineation of oral cavity tumors, may help the decision to develop miniature thermal cameras to scan thermally, the gi tract.


Eligibility criteria:
inclusion criteria: * patients diagnosed in the department of oral and maxillofacial surgery as suffering from malignant or possibly malignant lesions. exclusion criteria: * none

Keywords: oral cavity carcinoma thermal imaging
pharmacokinetics and safety/tolerability profile of ckd-379

Conditions: Type II Diabetes Mellitus

Summary: a study to compare the pharmacokinetics and safety/tolerability between ckd-379 tablet and d759, d745, d150 combination

a randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of ckd-379 in healthy subjects under fed conditions

Eligibility criteria:
inclusion criteria: * between 19 aged and 50 aged in healthy adult * 50.0kg ≤ body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (bmi) ≤ 27.0kg/m2 exclusion criteria: * have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(type i or type ii diabetes mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, torsades de pointes etc.), mental illness * have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis * have a gastrointestinal disease(crohn's disease, ulcer ect.) history that can effect drug absorption or surgery * those who are pregnant or breastfeeding * those who are deemed inappropriate to participate in clinical trial by investigators
effect of multitarget tdcs for neuropathic pain

Conditions: Neuropathic Pain

Summary: this study aims to conduct a randomized controlled trial to evaluate the effect of multitarget transcranial direct current stimulation (tdcs) on pain, depression, anxiety, quality of life and sleep, in patients with neuropathic pain.

the present multicenter, randomized, double-blind, sham-controlled, parallel-group trial aims to evaluate the effect of multitarget transcranial direct current stimulation (tdcs) in patients with neuropathic pain. the patients will be randomized to receive one of 3 treatment arms: multitarget stimulation, single-target stimulation and sham stimulation. all patients received 20 minutes of active or sham tdcs once a day for 10 consecutive weekdays. in multitarget group, subjects will receive 2ma tdcs applied to m1 and dlpfc alternately, with each target stimulated for 5 sessions. in single-target group, 2ma tdcs will target m1 only. in sham group, subjects will receive sham tdcs. ramps up and down will be applied for 15 seconds each at the beginning and end of the session. the current will be 0 ma during the interval between the initial and final ramps.

Eligibility criteria:
inclusion criteria: 1. female or males aged between 18 and 75 years. 2. pain fulfilling the criteria for probable or definite neuropathic pain and scoring ≥4/10 at douleur neuropathique 4 questions. 3. pain duration of at least 3 months and average pain intensity scoring ≥4/10 at numeric rating scale. 4. stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial. 5. informed consent obtained. exclusion criteria: 1. pregnancy or lactation. 2. active central nervous system diseases including but not limited to brain tumour, intracranial hypertension, past or current epilepsy. 3. unable to complete the questionnaire due to language abilities or reduced cognitive functioning. 4. alcohol or substance abuse. 5. common contraindications for transcranial direct current stimulation including but not limited to skull defect, implanted device or metal in the brain, severe cardiopulmonary, renal or hepatic diseases. 6. unwilling to comply with the treatment or follow-up assessments. 7. participating in another clinical trial within 3 months prior to enrollment of this clinical trial. 8. any patient deemed unsuitable for enrollment by the investigators.
comparison of nebulized neostigmine/atropine versus lignocaine in treating acute post-dural puncture headache following subarachnoid block in parturient undergoing elective cesarean section. a randomized, clinical trial.

Conditions: Post-Dural Puncture Headache

Summary: post-dural puncture headache (pdph) is a common and debilitating complication of spinal anesthesia in pregnant patients undergoing cesarean sections, with an incidence ranging from 0.5% to 2% (1). the international headache society (ihs) defines pdph as a headache occurring within 4 days of a lumbar puncture, caused by cerebrospinal fluid (csf) leakage through the dural puncture (2). although the exact cause of pdph is not fully understood, it is thought to occur due to cerebrospinal fluid loss through dural tears, which leads to tension on pain-sensitive intracranial structures and reflex, uncontrolled cerebral vasodilation leading to severe agonizing tension headache (3). treatment options include proper hydration, maintaining a supine position, caffeine, paracetamol, nonsteroidal anti-inflammatory drugs (nsaids). many adjuvants have been questioned for their therapeutic effectiveness in enhancing conservative medical treatments, with conflicting results (4). for example, sumatriptan, theophylline and dexmedetomidine have been extensively studied. neostigmine has emerged as a promising pharmacological adjuvant for conservative management. neostigmine increases the serum level of acetylcholine via inhibition of cholinesterase (5). this action mediates cerebral vasoconstriction via nicotinic receptors, thus antagonizing the unopposed vasodilatation occurred due to dural tear. lidocaine, on the other hand, can mediate sphenopalatine ganglion block which is responsible for pain signals transmission from the face (6).


Eligibility criteria:
inclusion criteria: * 18-35 years old parturient with post partum headache after elective cs under spinal anesthesia with visual analog score (vas) ≥ 4 \[14\] and lybecker classification score ≥ 2 exclusion criteria: * pregnancy induced hypertension * emergency c.s * asthmatic candidates * previous history of migraine or trigeminal neuralgia * history of bronchial asthma * post partum hemorrhage * need for ga , failed spinal anesthesia * patient refusal
does inhaled busedonide or fluticasone impair adrenal function?

Conditions: Adrenal Insufficiency

Summary: inhaled corticosteroids are largely used in patients with asthma or chronic obstructive lung diseases. the purpose of this study is to determine if the use of inhaled corticosteroids is associated with suppression of endogenous cortisol production, as seen in patients treated with pharmacologic doses of oral or parenteral steroids.

the normalcy of the hypothalmic-pituitary-adrenal (hpa) axis of enrolled subjects will be assessed by low dose (1mcg) corticotropin (acth)stimulation test. serum cortisol levels will be measured before , 30 minutes and 60 minutes after 1 mcg acth intravenous injection.

Eligibility criteria:
inclusion criteria: * patients receiving inhaled busedonide or fluticasone at daily dose of 200-800 mcg ' for at least 4 weeks exclusion criteria: * patients receiving any corticosteroid therapy, except inhaled busedonide or fluticasone.
effects of cannabidiol (cbd) versus placebo as an adjunct to treatment in early psychosis

Conditions: Early Psychosis

Summary: this is an outpatient, single center, between-group, double blind, placebo controlled design. approximately 120 adolescents and adult patients will be randomized to either have their treatment augmented with cannabidiol oral solution (cbd) or with a matching cbd placebo for 8 weeks. the study will examine cbd as an augmentation strategy in early psychosis. it is hypothesized that cbd will improve symptoms, neurocognition, markers of inflammation and eating behaviors. importantly, moderators and mediators of the cbd effects will be explored.

participants will be randomly assigned in a 1:1 ratio to receive cbd or matching placebo as an add-on to antipsychotic medication in an 8 week double blind trial. in this study, cannabidiol oral solution (cbd) product will be used. this product is manufactured and supplied by gw pharmaceuticals. the formulation is a 100 mg/ml solution. the cbd compound will be dosed at 1000mg/day administered in two divided doses. the dose of cbd was selected based on previous controlled trials that demonstrate the efficacy of cbd in patients with schizophrenia. the maximum duration of the study from screening to follow up of outcomes and adverse events will be approximately 8 weeks. participants will receive either the cbd or placebo within this eight.weeks and will also complete pre-treatment, midpoint (week 4) and post-treatment testing (week 8).

Eligibility criteria:
inclusion criteria: * first episode psychosis (onset within the last 2 years) or attenuated psychosis syndrome (aps), stabilized with treatment for at least 8 weeks prior to initiating the trial consistent with the fda-nimh-matrics guidelines for clinical trial design for clinical enhancing drugs: * clinically stable and in a nonacute phase of their illness for at least 2 months, first episode psychosis participants will have been maintained on current antipsychotic for at least 6 weeks, with no change in antipsychotic dose for the previous 4 weeks while aps participants will be on the same treatment regimen (psychosocial or pharmacologic) for 4 weeks, * exhibit no more than moderate levels of positive symptoms (defined by ratings of ≤ 4) on panss items p1 (delusions), p2 (conceptual disorganization), p3 (hallucinatory behavior), p5 (grandiosity), p6 (suspiciousness), and g8 (unusual thought content), * no more than a minimal level of depressive symptoms as assessed by the calgary depression scale for schizophrenia (cdss) * acceptable diagnoses will include aps, psychosis nos, schizophreniform, schizophrenia, and schizoaffective per the structured clinical interview for dsm-v. exclusion criteria: * concomitant medical or neurological illness; * significant head injury; * impaired intellectual functioning iq\ 85 suggesting higher premorbid iq. * high suicidal risk assessed by the the columbia-suicide severity rating scale (c-ssrs)42 * pregnant women and those who do not agree to avoid becoming pregnant * patients requiring treatment with azelastine, azelastine; fluticasone, dronabinol, valproic acid, or divalproex sodium
autologous fecal therapy

Conditions: Infectious Disease of Digestive Tract

Summary: ten healthy volunteers will be recruited to receive either an autologous stool transplant or a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly, and safely, restore a patient's fecal microbiome after antimicrobial exposure.


Eligibility criteria:
inclusion criteria: healthy adults 18-70 years of age- exclusion criteria: history of allergic reaction to beta-lactam antimicrobials; any non-topical antimicrobial exposure or tube feeds as a primary source of nutrition in the past six months; pregnant or risk of becoming pregnant during the study period; gastroenteritis in the last 3 months; incontinent of stool; prior resection or alteration of the stomach; small bowel, or colon; unwillingness to receive an enema/fmt; known colonization with an mdro; anticipated change in diet or medications, or elective surgery, during the study period; or a history of an intestinal disorder -

Keywords: fecal microbiota therapy
a study of eoc237 in patients with advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: this research study is studying an investigational drug called eoc237 in patients with advanced solid tumor.

part 1 dose escalation: an open, single/multiple dose, multi-center phase i study to evaluate the safety, tolerability and pharmacokinetics of eoc237 in patients with advanced solid tumor. part 2 food influence research: to assess the effect of food on the pharmacokinetics of eoc237, by investigating the bioavailability following single dose administration under fed and fasted conditions.

Eligibility criteria:
inclusion criteria: * advanced solid tumors for which standard curative or palliative measures do not exist or are no longer effective. * expected survival≥ 3 months. * ecog performance status 0-1. * good organ and marrow function. exclusion criteria: * patients with a history of severe drug allergic reaction. * pregnant or lactating female subjects. * uncontrolled, significant intercurrent or recent illness. * corrected qt interval calculated by the fridericia formula (qtcf) \> 480 ms per electrocardiogram (ecg) * concomitant use of certain medications