Kornimate/medical-research-clean huggingface dataset:
dexamethasone plus virtual reality exposure therapy for ptsd

Conditions: PTSD

Summary: evidence from preliminary studies suggests that people with ptsd have heightened fear responses and that cortisol suppression reduces this heightened fear. research has shown the drug dexamethasone (dex), a cortisol suppressor, reduces the startle response in civilians with ptsd. this current research proposal represents a blinded, randomized, placebo-controlled efficacy study with the goal of determining whether a drug that suppresses the stress hormone cortisol will increase the efficacy of exposure therapy. specifically, it is proposed that a dose of dex, given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (vre) therapy sessions, will significantly enhance the rate of response and possibly the efficacy of treatment. participants will be treated until they have experienced at least a 70% reduction in ptsd symptoms from baseline or up to 12 sessions or until they and their therapist agree treatment should be terminated, a minimum of 6 sessions to a maximum of 12 sessions. comprehensive multi-modal outcomes will be assessed by independent assessors blind to subject condition on interviews, self-report measures, and psychophysiological measures. participants will be assessed pre- and post-treatment and at a follow-up of 3, 6 and 12 months to assess long term effects.


Eligibility criteria:
inclusion criteria: 1. participants will be 60 males and females between ages of 21 and 65. 2. participants must meet dsm-v criteria for ptsd due to exposure to a trauma while serving in operation iraqi freedom and/or operation enduring freedom-afghanistan and operation new dawn. 3. patients must be literate in english. 4. patients must be medically healthy or medically stable such that the stress of vr and dex are not contraindicated. 5. participants must comprehend his or her role in the study and the risks involved in order to be entered. exclusion criteria: 1. patients with a history of mania, schizophrenia, or other psychoses; 2. patients with prominent suicidal ideation; 3. patients with current alcohol or drug dependence; 4. patients unable to tolerate wearing the vr helmet; 5. patients unwilling to take study medication; 6. patients on psychotropic medication(s) must have been on a stable dose for at least 2 weeks prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study. the concomitant use of psychotropic medications will be recorded and examined in data analyses. 7. patients with special medical conditions such as pregnancy, renal insufficiency, or a history of significant head injury 8. active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, sle, advanced cirrhosis, etc. (per clinical judgment of study physician) 9. patients stabilized on potentially data-obscuring medications (glucocorticoids).

Keywords: dexamethasone virtual reality military ptsd
transcranial direct current stimulation (tdcs) for facilitating swallowing improvement after an acute unilateral hemispheric stroke

Conditions: Dysphagia

Summary: the purpose of the research study is to investigate the effect of a brain stimulation technique called transcranial direct current stimulation (tdcs) in improving swallowing functions in subjects who develop dysphagia after a unilateral hemispheric infarction.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke * between 24-168 hours after onset * moderate to severe dysphagia based on swallowing assessment exclusion criteria: * preexisting swallowing impairment * intracerebral hemorrhage * pacemaker of other electrically sensitive device

Keywords: swallowing stroke
a study of shr6390 in advanced solid tumor patients

Conditions: Neoplasm

Summary: shr6390 is a small molecular, oral potent, selective cdk4/6 inhibitor. the purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of shr6390 in chinese advanced solid tumor patients by using a "3+3" dose escalation.preliminary efficacy will be also investigated in this study.


Eligibility criteria:
inclusion criteria: * pathologically confirmed solid tumor and failed from all standard treatment * eastern cooperative oncology group (ecog) performance status: 0-1 * life expectancy ≥ 3 months * adequate function of major organs, meaning the following criteria should be met within 14 days before randomization: * hemoglobin \> 110g/l * neutrophils \> 2.0×10\^9/l * platelets \> 100×10\^9/l * total bilirubin \< 1.5×the upper limit of normal (uln) * alt and ast ≤ 1.5×uln (≤ 5×uln, if existing liver metastases) * creatinine ≤ 1 uln * left ventricular ejection fraction (lvef) ≥ 50% * qtcf(fridericia correction) male≤450 ms, female≤470 ms * good compliance of patient by physician's judgement * signed and dated informed consent exclusion criteria: * previously received therapy of anti-tumor agent targeting at cdk4/6 * less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy * less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy) * having joined in other clinical trials within 4 weeks * uncontrolled/untreated brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed) * existing abnormal ctcae≥grade 2 resulted from previous treatment(except grade 2 alopecia) * uncontrollable symptomatic pleural effusion or ascites or require clinical intervention * require continous treatment by steroids * factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.) * existing uncontrollable hypokalemia or hypomagnesemia * history of serious allergy events or known being allergy constitution * active hbv or hcv infection (hbv virus≥10e4 copies/ml, hcv virus≥10e3 copies/ml) * history of immunodeficiency, acquired or congenital immunodeficiency, history of organ transplantation * history of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥grade 2 found in screening * female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test childbearing female who refuse to accept any contraception practice * determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,etc.) * history of neuropathy or dysphrenia, including epilepsy and dementia

Keywords: neoplasm, cycline-dependent kinase
study of ds-1001b in patients with gene idh1-mutated gliomas

Conditions: Glioma

Summary: this is a study to assess the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd) and anti-tumor activity of ds-1001b in patients with gliomas that harbor idh1-r132 mutations.


Eligibility criteria:
inclusion criteria: 1. has histologically confirmed glioma with an idh1-r132 mutation 2. has disease that has recurred or progressed following standard treatment including radiotherapy 3. has measurable lesion(s) as per rano criteria 4. has eastern cooperative oncology group (ecog) performance status of 0 to 2 exclusion criteria: 1. has significant symptoms of increased intracranial pressure 2. has another active neoplasm 3. has active infection requiring systemic treatment 4. has a history of severe cardiac disease 5. has had prior treatment with any inhibitor targeting mutant idh1 6. has had investigational drug treatment within 4 weeks prior to the first dose of study treatment 7. is a pregnant or lactating female

Keywords: ds-1001b idh1 mutation developmental phase i glioma
study investigating the long-term safety and tolerability of repeated doses of degarelix in prostate cancer patients

Conditions: Prostate Cancer

Summary: to investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

degarelix was not fda regulated at the time of the trial. after completion of the trial degarelix has been approved by the fda and is thus an fda regulated intervention (fda regulated intervention is therefore ticked "yes"). the data include participants from both the main study (fe200486 cs02; nct00819247) and the extension study fe200486 cs02a.

Eligibility criteria:
inclusion criteria: * has completed study treatment in study fe200486 cs02. * has completed visit 16 in study fe200486 cs02. * has not met any withdrawal criteria up to and including visit 15 in fe200486 cs02

Keywords: prostate cancer androgen ablation therapy
registry for patients undergoing aus surgery for female sui due to isd

Conditions: Urinary Incontinence; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms; Urination Disorders; Urologic Diseases

Summary: prospective collection of pre-defined parameters of aus surgery for female stress urinary incontinence due to intrinsic sphincter deficiency

this will be a prospective non-controlled cohort study evaluating the outcomes of artificial urinary sphincter (aus) implantation surgery (robot-assisted, laparoscopic, open or other) in female patients. the data collection will be undertaken from multiple centres in europe. the participation will be by open invitation from the urologists from the european society of female \& functional urology section of the european association of urology (esffu) to all its members along with other surgeons undertaking these procedures. the aim is to recruit a total of 150 patients in 2 years whereafter patients will be followed until the end of registry which is 5 years after inclusion of the first patient. there will be no restriction on the number of patients enrolled as long as they are consecutive. the aim is to have a long-term collection of the dataset from as many centres as possible. an initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed after 1 year by a nominated steering committee. thereafter, the evaluations will be performed after every year until end of registry.

Eligibility criteria:
inclusion criteria: * patient should be female and aged over 18 years. * the patient will undergo an initial aus implantation surgery (robot-assisted, laparoscopic, open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency. * participant is willing and able to give informed consent for participation in the registry * patient is able to complete the questionnaires. exclusion criteria: - participating center is unable to contribute consecutive patients.

Keywords: urologic surgical procedure female
dose-escalation study of intensity-modulated radiotherapy(imrt)in patients with unresectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a research study for pancreatic cancer. one way of improving the results of current standard treatments is to try new approaches. this study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (imrt), with chemotherapy. all subjects on this study will be treated with gemcitabine. this chemotherapy agent has been used for patients with pancreatic cancer. the researchers have already done studies using radiation therapy and gemcitabine. they want to build on the information they have from this previous research. the researchers want to find the best dose of imrt that can be given at the same time that patients are receiving gemcitabine. to do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. the goal of the research is to identify the highest dose of imrt that can be given at the same time as the chemotherapy without causing severe side effects.


Eligibility criteria:
inclusion criteria: * is the patient 18 years of age or older. * does the patient have histologically or cytologically proven carcinoma of the pancreas * is the tumor unresectable or medically inoperable * does the patient have a zubrod performance status of ≤ 2 (appendix i). * does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3 * does the patient have adequate renal function (creatinine \< 2 mg/dl) and hepatic function (bilirubin \< 3 mg/dl), with relief of biliary obstruction if present * is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy * if the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment * is the patient aware of the investigational nature of the therapy such that they can provide written informed consent exclusion criteria: * does the patient have a neuroendocrine tumor of the pancreas * does the patient have metastatic disease * does the patient have a history of abdominal radiation therapy * is there history of more than 1 month of therapy with single agent gemcitabine * has the patient used any investigational agent in the month before enrollment into the study

Keywords: patients who have confirmed cancer arising from the pancreas
cognitive remediation vr tool for people with mci: a feasibility rct

Conditions: Mild Cognitive Impairment; Cognitive Remediation; Virtual Reality; Psychiatric Rehabilitation

Summary: the need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the european union. our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (vr) technology for cognitive remediation (cr) in individuals with mild cognitive impairment (mci)

the european union emphasizes the need to promote research in active aging trough multidisciplinary and innovative approaches, addressing challenges related to neurodegenerative diseases in old adults. our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (vr) technology for cognitive remediation (cr) in individuals with mild cognitive impairment (mci). methods: a feasibility randomized controlled clinical trial will involve 30 individuals who are over 65 years old, both sex, who have received the diagnosis of mci, randomly assigned to experimental condition or control group. both groups will continue to receive standard pharmacological therapy (tau). the experimental group will undergo a 3-months cognitive remediation program with fully immersive vr with two sessions per week (each session of sixty minutes). the control group will continue with tau. feasibility will be assessed based on tolerability, including dropout rates and acceptability, (proportion of recruited participants among those considered eligible) and side effects. the preliminary measures of effectiveness will be evaluated on cognitive functions, quality of life, biological and social rhythms, anxiety and depressive.

Eligibility criteria:
inclusion criteria: * age 65 and above, a diagnosis of mci based on dsm-iv criteria \[american psychiatric association, 2000\] exclusion criteria: * failure to meet inclusion criteria, a diagnosis of epilepsy or severe visual impairments due to potential risks associated with extensive virtual reality stimulation, and severe illnesses impeding bi-weekly intervention attendance
early childhood attention battery in preterm children

Conditions: Attention-deficit; Prematurity

Summary: the aims of this project are: 1. to explore, using the ecab, if and in which measure the attentional abilities of young preterm children are different from term peers, whom reference data are already published27. 2. to correlate the ecab results with the "conner's teacher, rating scale- revised e conner's parent rating scale", one of the available diagnostic interview that helps to identify signs of attention deficit hyperactivity disorder (adhd) in young children, at the age of 6 years and over. 3. to study individual trajectories of attention pattern and development during age.


Eligibility criteria:
inclusion criteria: * gestational age (ga) \ 70 verified with wechsler scales performed within 6 months from the ecab, age at ecab assessment between 3 years and 5 years 11 months. exclusion criteria: * presence of major brain lesions, major motor or behavioral disorders, wppsi-iii subtest receptive vocabulary with a scaled score \<8.
developmental effects on children of women who take antiepileptic drugs during pregnancy

Conditions: Epilepsy; Seizure; Cognition Disorders

Summary: the purpose of this study is to determine if antiepileptic drugs (aeds) differ in their neurodevelopmental effects. specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which aed their mother takes during pregnancy?

this is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. there are 25 clinical centers as well as the database center. the women will be taking one of the following aeds: carbamazepine, phenytoin, valproate, or lamotrigine. cognitive and behavioral testing of the child will be done up to the age of 6 years. the study does not change the woman's doctor and does not interfere with the care of the treating physician.

Eligibility criteria:
* subject must be diagnosed with partial seizures and/or secondary generalization or primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic seizures) * subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate monotherapy. * mothers must not have a history of drug abuse (including alcohol) in the last year and have no sequelae of drug abuse. * mothers must be able to maintain an accurate seizure diary of major motor seizures * subjects must have an iq greater than or equal to 70 points. * subjects must have a history of a negative rpr and hiv. * subjects must not have progressive cerebral disease or presence of other major medical illness * subjects must not have exposure to known teratogens during pregnancy, except aeds. * subjects must not have poor compliance with prenatal care. * subjects must have adequate reading skills to perform the cognitive tests.

Keywords: epilepsy seizure pregnancy antiepileptic aed carbamazepine phenytoin valproate lamotrigine child behavior
panorama 2 observational study

Conditions: Heart Rhythm Disorders

Summary: understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for medtronic to be able to effectively develop new products and adjust existing products. in addition medtronic is committed to monitor the safety of its products throughout the entire life cycle to ensure maximum product reliability. the panorama 2 registry will enable medtronic to increase data collection of clinical practice with medtronic implantable cardiac rhythm and disease management (crdm) devices in various regions across the world and on product reliability of its crdm devices.


Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older (lower age limit dependent on local law: to be specified in country-specific addendum to the clinical investigational plan, if applicable) * patient or legally authorized representative provides signed and dated authorization and/or consent per institution and local requirements * patient will be treated with a commercially available implantable medtronic crdm device/ vitatron device within maximally 30 days after enrollment or within 3 days prior to enrollment exclusion criterion: • patient has exclusion criteria per local law (to be specified in country-specific addendum to the clinical investigational plan, if applicable)
ketamine for postoperative avoidance of depressive symptoms: the k-pass feasibility trial

Conditions: Postoperative Depression

Summary: this protocol describes a feasibility trial that will evaluate the feasibility of conducting a full-scale phase 3 trial testing the hypothesis that a postoperative sustained, low-dose ketamine infusion can prevent postoperative depressive symptoms when administered to a targeted population of neurosurgical patients with a history of depression.

this protocol describes a feasibility trial that will evaluate the feasibility of conducting a full-scale phase 3 trial. both the feasibility trial and the full-scale trial will follow a randomized, placebo-controlled, double-blinded, parallel design. the trial will follow a superiority design. this trial will take place at a single site (washington university in st. louis school of medicine/barnes-jewish hospital). following extubation, patients will be randomized to the intervention (ketamine group) or to control (control group). patients in the ketamine group will receive a bolus of ketamine 0.5 mg/kg intravenously over 10 minutes, followed by an infusion at 0.3 mg/kg/h for an additional 2 hours 50 minutes. patients in the control group will receive an equal volume of normal saline. patients, research staff performing assessments, and research staff performing data analysis will be blinded to treatment allocation.

Eligibility criteria:
inclusion criteria: 1. able to provide written, informed consent 2. aged 18 or older 3. scheduled for non-ambulatory surgery scheduled to last at least 2 hours at barnes-jewish hospital 4. past medical history of depression, defined as one or more of the following criteria 1. previous diagnosis by a psychiatrist or primary care physician in an outpatient or inpatient setting, by patient report or chart documentation 2. prescription of an oral antidepressant by a psychiatrist or primary care physician for a mood disorder exclusion criteria: 1. bipolar depression 2. concurrent use of a medication contraindicated with ketamine 3. emergent surgery 4. known or suspected elevation in intracranial pressure 5. current subarachnoid hemorrhage 6. carotid endarterectomy or arteriovenous malformation repair 7. allergy to ketamine 8. any condition in which a significant elevation of blood pressure would constitute a serious hazard (e.g., aortic dissection, pheochromocytoma) 9. known history of dementia 10. pregnancy or lactation 11. inability to converse in english 12. concurrent enrollment in another interventional trial
randomized evaluation of ten allergy skin prick test devices

Conditions: Allergic Rhinitis; Asthma; Food Allergy; Skin Testing

Summary: the goal of this study is to compare ten current and readily available fda approved allergy skin prick devices to determine the most sensitive and specific product and methods used for the diagnosis of allergic disease. the primary outcome will be to determine the analytical sensitivity and specificity of all ten skin prick devices by measuring wheal and flare response to histamine and control diluent in 1mm increments. secondary outcomes include comparison of skin prick technique, optimum histamine concentration, patient comfort, reproducibility, and the comparability of high-resolution digital images.


Eligibility criteria:
inclusion criteria: * adults aged 18-65 with or without allergic disease exclusion criteria: * severe concurrent illness * uncontrolled asthma * extensive eczema * urticaria * dermatographism * pregnancy * those taking antihistamines within the previous 10 days * topical steroids * immunomodulatory drugs * long term use of oral steroids

Keywords: allergic rhinitis allergy asthma food allergy skin testing skin prick test