Kornimate/medical-research-clean huggingface dataset:
discerning pseudoprogression vs true tumor growth in gbms

Conditions: Glioblastoma

Summary: one-third of all primary brain tumors are astrocytomas, the most common type of glioma. grade 4 astrocytomas, more commonly known as glioblastomas (gbms), represent about 50% of all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates and median patient survival of just 12-15 months post-diagnosis. treatment response is assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance images (mri). however, radiation and chemotherapy cause inflammatory and necrotic changes which, like actual tumor progression itself, demonstrate contrast enhancement on the first post-treatment mri scan. this enhancement eventually subsides (typically within 6 months of treatment) and is known as pseudoprogression (psp). currently, there is no gold standard noninvasive tool for distinguishing between pseudoprogression and progressive disease. dynamic susceptibility-weighted contrast-enhanced perfusion mri (dsc perfusion mri) permits measurement of hemodynamic imaging variables. previous literature reports attempted to use some or all of these metrics to assess their utility in distinguishing psp from true cancer progression. these studies showed mixed results, likely due to a number of factors, including poor statistical power, poorly defined psp, analysis of multiple cancer grades and types, and varied analysis methodologies. the investigators aim to address these issues in this study.

see brief summary section

Eligibility criteria:
inclusion criteria: * participants must be 18 years of age or older. * participants must be able to read and comprehend the english language. * in agreement with the care providing physician, participants must be willing to have surgery to remove possible brain tumor. * participants must have a mri scan within 24 hours after the tumor is removed (if a tumor is confirmed). * participants must have the tumor analyzed by the laboratory and pathology departments and receive the diagnosis of glioblastoma. * participants must be willing to follow the stupp treatment protocol (this treatment plan and its' procedures are considered the standard for treating glioblastoma). (the stupp protocol is the name of the radiation and chemotherapy plan that has been found to help in many cases of glioblastoma.) * participants must be willing to follow any additional study procedures (including having all follow-up mris performed at st. vincent 86th st). exclusion criteria: * participants are less than 18 years of age. * participants have had surgery for your brain tumor and not received the diagnosis of glioblastoma * participants and care providing physician have decided not to follow the stupp protocol (treatment plan) for glioblastoma treatment. (deviations or interruptions are allowed if clinically indicated) * participants are not having a mri scan within 24 hours after brain tumor surgery. * participants are not willing to follow the study procedures.

Keywords: pseudoprogression brain cancer
a study to evaluate the impact of escitalopram on quality of life and social functionality in patients with major depressive disorder with anxiety symptom

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to evaluate the impact of escitalopram on quality of life and social functionality in patients with major depressive disorder with anxiety symptom.

this is an open-label (all people know the identity of the intervention), multi-center, prospective (a study in which the participants are identified and then followed forward in time for the outcome of the study), single-arm (all participants receiving one intervention) study. approximately 260 participants will be enrolled in this study. this study consists of two phases: screening phase and treatment phase. in the treatment phase, participants will receive escitalopram for 8 weeks: escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment. safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. the total study duration will be approximately 2 years.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder according to the american psychiatric association's diagnostic and statistical manual-iv, text revision (dsm-iv-tr) diagnostic criteria * minimum scores of 9 on sheehan disability scale * minimum scores of 14 on hamilton anxiety scale exclusion criteria: * history of primary or comorbid diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder, or dementia * presence of unstable serious illness and/or has a clinically significant renal or hepatic impairment, seizure disorders or any other disease which may be detrimental to the participant or the study * participant who have continuously taken psychoactive substances, antidepressants, anxiolytics, monoamine oxidase inhibitors, psychoactive herbal remedies, lithium, electroconvulsive therapy, carbamazepine in the past 2 weeks before the baseline visit * diagnosis of major depressive disorder who currently require treatment systematically within past 2 months from baseline * receiving pharmacological treatment, which is disallowed in the current approved chinese summary of product characteristics for escitalopram

Keywords: depressive disorder, major depressive disorder depression anxiety escitalopram quality of life social functionality
relationships and health in the oef/oif veteran population

Conditions: Stress Disorder; Marriage; Suicidal Ideation

Summary: the current study will explore relationships and health in the oef/oif veteran population. specifically, this study will examine ptsd symptom severity, traumatic brain injury, relationship satisfaction, leisure, general health ratings, feelings of burdensomeness and belongingness, and suicidal ideation.

united states military troops returning home from operation enduring freedom and operation iraqi freedom deployments are presenting with "invisible wounds". these "invisible wounds" include mental health conditions such as posttraumatic stress disorder and traumatic brain injury. recent literature has begun to explore how ptsd affects the service member, as well as their significant others. several studies have shown that veteran endorsement of ptsd symptoms is associated with decreased relationship satisfaction. prior literature has shown that spending time together and engaging in pleasurable activities as a couple are important strategies for enduring relationship quality and satisfaction. literature has demonstrated moderate relationships between ptsd and suicidal ideation. a previous study conducted by two of the investigators in this population showed that perceived feelings of burdensomeness and belongingness and identification of suicide as a potential strategy for dealing with these feelings. joiner has hypothesized that acquired capacity of painful experiences, perceived burdensomeness and thwarted belongingness are the three components of increased suicide risk. yet few studies exist that examine these constructs in the military population, though research indicates the clinical utility for exploring these constructs and related consequences.

Eligibility criteria:
inclusion criteria: * oef/oif veteran (at least one oef/oif deployment) * currently receiving or eligible to receive health care services at dvamc * in a current, established relationship for a duration of at least one year * age of 18-50 exclusion criteria: * inability to provide informed consent. * inability to adequately respond to questions regarding the informed consent procedure. * do not meet the inclusion criteria listed above.

Keywords: oef/oif veterans relationships
effect of suboccipital release in patients with fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: this study was designed to examine the efficacy of suboccipital release in patients with fms and to provide preliminary evidence regarding its effects on pain and qol by objectively measuring cortisol level in fms patien

forty female patients with fm ( age : 20- 45 years ) participated in the study after suing the consent form . participants were randomly allocated assigned into 2 equal groups ( control group \[ g1 \] and study \[g2 \] ) . group 1 received selected physical therapy programme. group 2 recieved suboccipital release. all participants were assessed for cortisol and pain level by using visual analogues scale and neck disability scale. also participants were assessed by pressure algometer for pain intensity. participants were assessed for qol by fibromyalgia impact questionnaire (fiqr) . treatment was done 3 sessions per weeks for successive 6 weeks pre and post assessment for all valuable were done

Eligibility criteria:
inclusion criteria: * women between 20-45 years old, (ii) diagnoses according to the 2016 american college of rheumatology criteria for fibromyalgia \[1\] * symptoms have been present at a similar level for at least three months (iii) absence of other disorders that causes similar symptoms: systemic lupus erethromatosis (sle), rheumatoid arthritis (ra) and lyme disease based on laboratory investigations (erythrocyte sedimentation rate (esr), anti anti-cyclic citrullinated peptide (anti ccp), antinuclear antibody (ana) and rheumatoid factor(rf)). * exclusion criteria: * any medical, neurological, or psychiatric illness, use of strong opioids or other painkillers except paracetamol and/or ibuprofen, benzodiazepine, illicit drug or alcohol use, recent use of cannabis, pregnancy, breast feeding, and the presence of pain syndromes other than fm. presence of other autoimmune disorders e.g.: rheumatoid arthritis and systemic lupus erethromatosus
surgical debulking of pituitary adenomas

Conditions: Pituitary Adenoma

Summary: this is a randomized, multicenter trial with stratification done by a single radiologist at the coordinating center (nyu), and patients with comparable disease will be randomized to sandostatin lar treatment administered 1 time per month by im injection for 3 months before (arm a) or, for non-cured patients, after (arm b) surgery. all patients will undergo transsphenoidal hypophysectomy. the impact of surgical debulking on responsiveness to sandostatin lar will be evaluated.the primary objective of this trial will be to determine whether surgery (debulking of pituitary adenomas) improves the response of patients with acromegaly to treatment with octreotide lar, when compared to octreotide lar therapy alone.

the current goal of treatment for people with acromegaly is normalization of both growth hormone (gh) and insulin-like-growth-factor-1 (igf-1) levels. normalization of gh and igf-1 levels attenuates the morbidity (hypertension, cardiovascular disease, sleep apnea, increased cancer risk, arthritis) and increased mortality associated with persistent gh and igf-1 elevation. the optimal approach to achieving these goals in patients with pituitary macroadenomas remains controversial. available treatment modalities include transsphenoidal hypophysectomy, medical therapy (somatostatin analogues and/or dopaminergic agonists), radiotherapy, or a combination or these interventions. no randomized trials have been conducted to investigate whether surgical debulking of pituitary macroadenomas enhances the efficacy of medical therapy. this study is designed to rigorously investigate whether surgical debulking increases the efficacy of a long-acting depot somatostatin preparation, sandostatin lar, so that evidence-based optimal care may be offered to patients with acromegaly.

Eligibility criteria:
inclusion criteria: * carry a diagnosis of de novo acromegaly with an elevated age and sex matched igf-i and gh \>1ng/ml at all time points during ogtt * have a pituitary macroadenoma * have clinical changes consistent with acromegaly * have a single random serum hgh of 12.5 ng/ml or greater * both the endocrinologist and surgeon must agree that the patient's health would not be compromised by a three-month period during which time octreotide lar is administered. * patients currently on dopamine agonist who agree to discontinue medication (2-6 week washout required) exclusion criteria: * pregnant or breastfeeding * documented loss of vision due to pituitary tumor * prior treatment for acromegaly other than dopamine agonists * inability to complete the protocol * intolerance to octreotide
prebiotic effects on glucose tolerance

Conditions: Diet Prevention of Metabolic Diseases

Summary: the primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. the test food products will be consumed in the evening and test variables will be determined the next morning. the study will apply a randomized crossover study design.


Eligibility criteria:
inclusion criteria: * bmi 18.5 - 25 kg/m2 * age 20-40 years * normal diet * healthy exclusion criteria: * fasting blood glucose \>6.1 * diagnosed or known disease * known gastrointestinal disorder * food allergies or intolerance * special diet regiments * smokers
glucose control in open heart surgery

Conditions: Hyperglycaemia During Perioperative Period; Heart Valve Diseases; Ventricular Dysfunction

Summary: the purpose of the study is to seek if there is difference to state glucose level in 80-120mg/dl or 200mg/dl in patients submitted to open heart surgery

hyperglycaemia in the intensive care unit and perioperative period has been accused to be one of the causes of worse clinical outcome. it is known that in open heart surgeries the glucose level must be set less than 200mg/dl, but new trials had set the glucose level lower than that: 140mg/dl in some studies and even lower (80-110mg/dl). our trial had the intention to seek if there is difference setting glucose level in 2 different ones would modifies clinical outcome.

Eligibility criteria:
inclusion criteria: * adult more than 21 years old * open heart surgery with cardiopulmonary bypass exclusion criteria: * renal dysfunction * reoperation * use of inotropic support * neurological dysfunction * chronic pulmonary obstructive disease * emergency or urgency

Keywords: hyperglycaemia open heart surgery intensive care unit
long-term exercise training therapy versus usual care in patients with schizophrenia

Conditions: Schizophrenia

Summary: patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life and self-efficacy. schizophrenia also leads to a high risk of dying from cardiovascular disease. explanatory trials suggest that exercise improves cognitive functioning, symptoms, and quality of life, and reduces the risk of cardiovascular disease. however, due to this illness, the participation in regular exercise is challenging. in this study it will be tested if patients with schizophrenia can participate in long-term exercise therapy, and whether long-term supervised exercise therapy is more beneficial than today's usual care.


Eligibility criteria:
inclusion criteria: * international classification of diseases (icd-10) schizophrenia, schizotypal or delusional disorders (f20 to f29) * able to carry out long-term exercise. * capable of giving informed consent. exclusion criteria: * contra-indication for exercise training and testing according to the american college of sports medicine (acsm) specifications (life threatening or terminal medical conditions; not able to carry out intervention or test procedures; current pregnancy; mothers less than 6 months post-partum). * patients under admittance to an acute psychiatric ward.

Keywords: exercise therapy cardiovascular disease risk
multidisciplinary home-based tele-rehabilitation intervention

Conditions: Parkinson Disease

Summary: falls in parkinson's disease (pd) are very frequent with often devastating consequences, increasing comorbidity, mortality, decreased quality of life and increased socio-health costs. in this national, single-center, single-blind, randomized, case-control study, non-demented patients with idiopathic pd with high risk of falling will be included. the main objective of this study is to determine the cost-effectiveness of a home-based, multidisciplinary tele-health intervention to decrease the risk of falling.

in this study, pd patients using multidisciplinary tele-health intervention (study group) will be compared to age, gender-matched pd patients receiving the best standard in-office clinical management (control group). both groups will be followed for 8 months. the main outcome will be the comparison of incidence of falls between the study and control groups. secondary outcomes will include the analysis of cost-effectiveness of multidisciplinary tele-health interventions. the results of this study will allow us to study the feasibility of remote health care to prevent falls in patients with pd, allowing equity in the distribution and access to specialized health care.

Eligibility criteria:
inclusion criteria: * non-demented patients * patients diagnosed with idiopathic parkinson´s disease * patients able to walk with a hoehn yahr stage \< 3 exclusion criteria: * non-ambulatory patients with parkinson´s disease * patients diagnosed with significant comorbidity (psychiatric, systemic, hearing or visual disturbances) according to the investigator criteria.

Keywords: falls cost-effectiveness qaly
bioequivalence of pramipexole extended release (ppx er) 1.5mg x 1 tablet once daily (q.d.) vs. ppx er 0.375mg x 4 tablets under fasted and fed conditions in japanese healthy volunteers

Conditions: Healthy

Summary: bioequivalence between ppx er 1.5 mg x 1 tablet q.d. and 0.375 mg ppx er x 4 tablets q.d. under fasted and fed conditions food effect of 1.5 mg er x 1 tablet q.d.


Eligibility criteria:
inclusion criteria: * japanese healthy male * 20 to 40 years of age * body mass index (bmi) between 17.6 and 26.4 kg/m2 (bmi calculation: weight in kilograms divided by the square of height in meters) exclusion criteria: 1. any clinical relevance findings of the medical examination as follows 1. blood pressure (systolic blood pressure is lower than 110 mmhg and diastolic blood pressure is lower than 60 mmhg at the screening in either a supine or a sitting position), 2. pulse rate, 3. electrocardiogram \[ecg\] 4. laboratory test parameters) of clinical relevance 2. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 3. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 4. history of orthostatic hypotension, fainting spells or blackouts 5. chronic or acute infections
project best: buprenorphine entry into substance abuse treatment

Conditions: Opioid-related Disorders; HIV Infections; Hepatitis C, Chronic; Depression

Summary: project best is a clinical project funded by the substance abuse and mental health services administration (samhsa) to increase treatment to opiate dependent patients with mental illness in new haven, ct and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes buprenorphine to track the success of buprenorphine for the maintenance of opiate dependence.

the investigators propose to create a prospective cohort that will track outcomes for an opiate dependent population on buprenorphine maintenance. individuals who have already decided to undergo buprenorphine treatment in project best will be invited to participate in the following data collection process. the investigators propose the following series of data collection to assess clients during their time in the cohort: gpra, supplemental instrument, asi, scid, cows, urine toxicology. patients who are enrolled will enter a standardized, manual based weekly counseling regimen. urine toxicology will be performed a minimum of twice monthly, but will not occur at the same times monthly to decrease the probability of sampling error. this is a prospective cohort to follow a group of individuals on buprenorphine treatment. the goal of this prospective cohort is to generate thoughtful observations. specific items of interest which will be compared with age, race matched historical controls on methadone will be: 1. changes in addiction severity over treatment time 2. changes in sexual risk behaviors and injection practices 3. improvements in urine toxicology 4. co-occurring mental illness

Eligibility criteria:
inclusion criteria: * opiate dependent by dsm iv criteria - to be determined by clinician - on buprenorphine through the project best program. exclusion criteria: * inability to adhere to study instruments.

Keywords: opioid dependence hiv/aids hepatitis c severe mental illness injection drug use
advancing stop: self-regulation therapy for opioid addiction and pain

Conditions: Opioid-use Disorder; Chronic Pain

Summary: the public health relevance of this proposed project is substantial given the current opioid abuse epidemic as identified by the centers for disease control (cdc). this study finalizes and tests a new psychotherapy treatment that is designed to treat chronic pain and opioid addiction at the same time in a format that could be easily used in a community addiction treatment setting. final products of the study will yield an integrated stop (self-regulation/cognitive-behavioral therapy (cbt) therapy for opioid addiction and pain) manual guided protocol, patient workbook, and therapist training protocol.


Eligibility criteria:
inclusion criteria: 1. 18-65 years old; 2. willing to adhere to study protocol including treatment sessions and assessments; 3. individuals have a history of co-morbid opioid use disorder and chronic pain; 4. cognitively able to participate and give informed consent. exclusion criteria: 1. acute or unstable psychotic disorder; 2. psychiatric hospitalization or suicide attempt in the past 3 months 3. patient has been diagnosed with an unstable cardiovascular condition including: myocardial infarction, arrhythmia, or poorly controlled hypertension in the past 3 months 4. lack of verbal and written english fluency 5. over the age of 65 since evidence suggests pain perception alters with age