Kornimate/medical-research-clean huggingface dataset:
post-traumatic stress disorder treatment using transcranial direct current stimulation (tdcs) enhancement of trauma-focused therapy : a two-arm randomized controlled multicentric study.

Conditions: Post-traumatic Stress Disorder

Summary: post-traumatic stress disorder (ptsd) is an anxiety disorder that can develop after exposure to a terrifying event or ordeal in which there was the potential for or actual occurrence of grave physical harm. traumatic events that may trigger ptsd include violent personal assaults, natural or human-caused disasters, accidents, and military combat. people with ptsd have persistent frightening thoughts and memories of their ordeal, may experience sleep problems, feel detached or numb, or be easily startled. its lifetime prevalence is quite high, with 7-8% in various studies and 4% in french studies. the current ptsd treatment usually involves antidepressants as serotonin-specific reuptake inhibitors (ssris) and cognitive behavioral therapies, such as exposure therapy to trauma-linked elements (memories, feelings and thoughts) so the fear associated to the traumatic event can decrease. but the therapeutic response stays partial, even combining these treatments. to improve the ptsd treatment efficiency, innovative approaches are being explored like new drugs or cerebral stimulation. this project aims to assess the efficacy of a less known but promising therapeutic strategy for ptsd : the use of transcranial direct-current stimulation (tdcs) to enhance the trauma-focused therapy results.


Eligibility criteria:
inclusion criteria: * having a chronic ptsd (for more than 3 months and less than 10 years) without modification of ssri long-term treatment for more than 4 weeks * between 18 and 65 years-old * effective contraception for women, or inability of procreate because of medical or surgical reasons * able to give his written informed consent * affiliation to a social security system * not participating to another study with psychoactive substance exclusion criteria: * partially-sighted or partially deaf person requiring equipment * person with brain injury or neurological disease (epileptic, tumoral, vascular, degenerative), diagnoses in personal history or recognized as hereditary * addiction to psychoactive substance for the last 6 months * any treatment which could interact with tdcs effects on cortical reactivity (citalopram, amphetamine, l-dopa, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan or other n-methyl-d-aspartate (nmda) receptor antagonists, d-cycloserine, carbamazepine, flunarizine, calcium channel blockers) * pregnancy and lactation * any intracephalic metallic material * person who can't conform to tests instructions * person suffering from bipolar disorder, chronic or acute delusional disorder * any circumstances making the person unable to understand the trial features, purposes or consequences
cognitive and aerobic resilience for the brain

Conditions: Mild Cognitive Impairment

Summary: this is a randomized controlled trial (rct) of the effectiveness of cognitive and exercise training versus control condition on cognitive function in older adults with mild cognitive impairment (mci).

exercise and cognitive training hold promise for delaying progression of mci. exercise improves cognitive ability, brain function, and brain structure in older adults. cognitive training has been shown to durably improve mental abilities and functional status in older adults. in addition, persons with mci respond to some forms of cognitive training just as robustly as healthy older adults. this pilot study is a 4 group design with a home-based multi-modal physical exercise intervention, cognitive training, combined cognitive and physical training, and a social contact control enrolling older adults with mci. this pilot study is designed to be consistent with current recommended approaches to establishing trial feasibility. if the aims are achieved, it will provide a conceptual and practical rationale to support a large, multi-site, randomized clinical trial to test the efficacy of combined physical and cognitive training in delaying time to a clinical diagnosis of dementia.

Eligibility criteria:
inclusion criteria: * subjective memory complaint * minimal impairment in daily function per functional activity questionnaire (faq) * sedentary * english speaking * access to telephone exclusion criteria: * dementia or alzheimer disease * stroke, past 12 months * myocardial infarction, past 12 months * angina * parkinson disease * multiple sclerosis * epilepsy * aids * brain tumor, infection, or surgery * brain injury with \> 30 minute loc * schizophrenia * bipolar disorder * cancer with short life expectancy * current chemotherapy or radiation therapy * depression * alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men * prescription of aricept or namenda, past or present * self-reported difficulty reading a newspaper (low visual acuity) * low hearing or communicative ability (examiner-rated) that would interfere with interventions and outcome assessments * prior involvement in similar cognitive training studies, programs, or online training * prior use of online brain training or brain fitness programs * unable to pass the exercise assessment and screening for you (easy) * living in nursing home * scheduling conflicts with intervention schedule * unwilling to use a computer or be on video conferencing * baseline blood pressure of systolic \> 180 * baseline blood pressure of diastolic \> 100 * baseline pulse of \ 100 * unable to provide informed consent

Keywords: mild cognitive impairment randomized controlled trial cognitive training exercise training cognition physical performance disability mood
the effects of body mass index on erector spinae plane block analgesia

Conditions: Pain; Pain Postoperative; Pain Acute; Erector Spinae Plane Block; Lumbar Disc Herniation; Body Mass Index

Summary: in recent years, obesity has become one of the leading health problems worldwide. it is known that obesity can cause various diseases and negatively impact the quality of life. therefore, many conditions believed to be affected by obesity and relevant to patients\&#39; quality of life have been scientifically investigated and continue to be researched. one of these conditions is postoperative pain, with studies in the literature indicating that postoperative pain levels increase in parallel with each unit increase in bmi. the incidence of lumbar disc herniation (ldh) is on the rise and adversely affecting the quality of life. the primary surgical intervention for ldh is discectomy. in recent years, various less invasive techniques, such as microdiscectomy, have been described to improve both surgical and analgesic outcomes. however, even with microdiscectomy surgery, postoperative pain may occur, and its control should be well-managed. inadequate pain control can lead to unwanted effects of postoperative pain. regional analgesia techniques may be preferred for effective analgesic treatment after spinal surgery. methods such as paravertebral block, erector spinae plane block (espb), thoracolumbar interfascial plane block are widely used for analgesia in spinal surgery. the effectiveness of these regional techniques may vary depending on various factors, one of which is bmi. the hypothesis in this study is that as bmi increases, the level of pain in patients may also increase. as a result, this study aims to investigate the relationship between bmi and postoperative pain levels in patients undergoing standard ldh surgery, anesthesia, and analgesia.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * asa physical status i-ii-iii * bmi 18 to 40 kg/m2 * elective ldh surgery exclusion criteria: * patient refusing the procedure * patients who have previously undergone spinal surgery * chronic opioid or analgesic use * patients who will operate under emergency conditions * patients who will not undergo ldh surgery
quality of life in children with hiv infection

Conditions: HIV Infections

Summary: the purpose of this study is to characterize the quality of life (qol) and longitudinal patterns of change in qol outcomes in children and youth with hiv infection; to identify demographic, social, disease status, treatment, and health care utilization factors that predict longitudinal changes in outcomes; to develop a conceptual model that characterizes the effects of specific factors that predict longitudinal changes in qol; and to characterize the influence of hiv symptoms on qol outcomes in the domains of health perceptions, physical, psychological, and social role functioning.

this is a phase iii study. this study will use national data available through a prospective, observational, longitudinal study of children and youth (n=1,993) from birth to 25 with hiv infection (pediatric aids clinical trials group protocol 219/219c) to develop knowledge about the quality of life (qol) and the factors that affect it in order to be able to implement effective nursing interventions and clinical programs to support and improve qol in this vulnerable population of children.

Eligibility criteria:
inclusion criteria * children and youth with perinatally acquired hiv infection * enrolled in pactg 219/219c * completed quality of life assessment exclusion criteria --hiv exposed, not infected

Keywords: adolescence hiv infection pediatric aids quality of life hiv
quality control of ce-certified phonak hearing aids - 2018_42

Conditions: Hearing Loss; Sensorineural Hearing Loss

Summary: phonak hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. afterwards, and prior to product launch, the phonak hearing systems undergo a final quality control in terms of clinical trials. this is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. this will be a clinical evaluation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

in this study one ce-labeled phonak receiver-in-the-canal (ric) devices is investigated. the experimental device will be investigated regarding sound quality perception ot the t-coil program. a secondary objective of this study is the investigation of the overall system stability in daily life situations. the experimental device contains direct connectivity functionality and a t-coil. the combination of a wireless chip for bluetooth streaming and a t-coil in one housing can cause audible artifacts on the t-coil, which shall be investigated within this study. this will be a clinical evaluation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years, moderate to severe hearing loss) * good written and spoken (swiss) german language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * willingness to wear receiver in the canal hearing aids * informed consent as documented by signature * owning a compatible smartphone exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments in stäfa (switzerland) * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * known psychological problems * central hearing disorders
intraoperatively observed site of origin and growth pattern of medulloblastoma

Conditions: Medulloblastoma

Summary: the goal of this observational study is to provide accurate and systematic data on the site of origin and growth pattern of medulloblastoma from a neurosurgical perspective. by integrating intraoperative, radiological and genetic classification data, this study will contribute to our current understanding of the development, site of origin and growth pattern of medulloblastoma and advance the predictive accuracy of radiogenomics models. patients with histologically confirmed medulloblastoma who undergo surgical resection at a high-volume center with expertise in pediatric neurosurgery will be included. the main questions it aims to answer are: * is there a significant difference between the intraoperatively observed site of origin and the preoperatively or postoperatively radiologically assessed site of origin of medulloblastoma? * how does the intraoperatively observed site of origin align with the site of origin associated with the molecular group based on the developmental cell lineage concept of medulloblastoma? * does incorporating the intraoperatively observed site of origin as a feature improve the predictive accuracy of radiomic models for molecular group classification? participants will: * undergo intraoperative assessment of site of origin and growth pattern by an experienced pediatric neurosurgeon. * have their site of origin and growth pattern evaluated on pre- and postoperative magnetic resonance imaging by an neuroradiologist with expertise in pediatric brain tumors.


Eligibility criteria:
inclusion criteria: * patients who are referred for surgical resection of a medulloblastoma at a hospital with expertise in pediatric neurooncology * both pediatric patients (aged \ 18 years at the time of diagnosis) exclusion criteria: * patients who are preoperatively admitted with severe tumor hemorrhage accompanied by clinical deterioration are excluded because these patients frequently do not receive magnetic resonance imaging as would be necessary for the present study, and the intraoperative assessment of the sto is limited in accuracy due to decreased visibility caused by the intra- and extratumoral hemorrhage. * if an intraoperative complication occurs (e.g. bleeding) which impairs visibility of the neuroanatomic structures and does not allow an accurate assessment of the sto, the patient is excluded. * if the histopathological and molecular analysis does not confirm the diagnosis of a mb, the patient has to be excluded as well.

Keywords: medulloblastoma
combination of recombinant human il-21 (ril-21) and sunitinib in stage iv renal cell carcinoma patients

Conditions: Cancer; Renal Cell Carcinoma

Summary: this phase 1/2a trial is conducted in europe. the first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of ril-21 when administered in combination with sunitinib. the second part, scheduled to start in september 2008, is a randomised 2-arm trial comparing the anti-tumour effect of ril-21 plus sunitinib with sunitinib alone.


Eligibility criteria:
inclusion criteria: * histologically verified and surgically incurable stage iv renal cell carcinoma * ecog performance status of 0 or 1 (i.e. good performance status) * life expectancy of at least 3 months exclusion criteria: * prior systemic therapy for metastatic disease * radiotherapy within the last 4 weeks prior to start of treatment * receipt of any investigational drug within 3 months of starting treatment * history of any other active malignancy within five years prior to enrolment
th9507 in patients with hiv-associated lipodystrophy

Conditions: HIV Infections; Lipodystrophy

Summary: hiv lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (art) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg th9507, a growth hormone releasing factor (grf), to hiv patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (vat) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (sat). this study is aimed at further assessing the efficacy and safety of 2 mg th9507 in a larger population of hiv patients treated with art and experiencing an excess of abdominal fat accumulation.


Eligibility criteria:
inclusion criteria: * ages 18 to 65 years inclusive * hiv positive; cd4 cell counts \>100 cells/mm3; viral load \<10,000 copies/ml (stable for 8 weeks) * on stable art regimen for at least 8 weeks prior to randomization * have evidence of abdominal fat accumulation defined by the following anthropometric cut off values: * for males: waist circumference \> 95 cm and waist to hip ratio \> 0.94; * for females: waist circumference \> 94 cm and waist to hip ratio \> 0.88. * females of childbearing potential not pregnant or lactating; normal mammography within 6 months of study. * signed informed consent exclusion criteria: * body mass index \< 20 kg/m2 * opportunistic infection; hiv-related disease within 3 months of study. * history of malignancy; active neoplasm. * prostate-specific antigen (psa) \>5 ng/ml at screening * hypopituitarism; history of pituitary tumor/surgery; head irradiation; head trauma that has affected the somatotropic axis. * untreated hypothyroidism * type 1 diabetics and type 2 diabetics on oral hypoglycemic or insulin sensitizing agent within 6 months of study * alt or ast \> 3 x uln; serum creatinine \> 133 mmol/l (1.5 mg/dl); hemoglobin more than 20 g/l below lln; fasting blood glucose \> 8.33 mmol/l (150 mg/dl); fasting triglycerides \> 11.3 mmol/l (0.99 g/dl). * untreated hypertension * change in anti-hyperlipemic regimen within 3 months prior to study * change in testosterone regimen and/or supraphysiological dose of testosterone * estrogen therapy * anoretics/anorexigenics or anti-obesity agents within 3 months of study * growth hormone (gh); gh secretagogues; growth hormone releasing factor (grf) products; igf-1; or igfbp-3 within 6 months of study. * drug or alcohol dependence or use of methadone within 6 months of study entry * participation in a clinical trial with any investigational drug/device within 30 days of screening.

Keywords: hiv lipodystrophy abdominal fat accumulation growth hormone releasing factor/growth hormone releasing hormone treatment experienced
clinical utility of cdmt among villagemd providers

Conditions: Chronic Disease; Drug Drug Interaction; Medication Adherence

Summary: this is a health system-level research study of physicians and care providers. the purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and other) of a subset of common patient care indications.

the results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. the data from this study will be submitted to a national journal for publication. the study plans to enroll up to 150 physicians. upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as clinical performance and value vignettes (cpv®). cpvs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. in each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of cpv administration to be approximately 45 - 60 minutes. all responses to the cases will be completed online and will be kept confidential. over 2 cpv administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours. if physicians are randomized to the intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of cpv administration. they are asked to review these materials before moving to the next cpv administration round. the time to review educational materials is estimated to be approximately 15 minutes. depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll in a follow-on study. if they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Eligibility criteria:
inclusion criteria: * licensed primary care provider (pcp) (md, do, np, pa) currently practicing in the following areas: a) internal medicine b) family medicine * have practiced as a pcp in internal or family medicine for greater than 2 but less than 30 years * practicing in a community / non-academic based practice setting * ≥ 40 patients under care weekly * commonly treats patients with congestive heart failure/atrial fibrillation, diabetes, hypertension, and copd * practicing in the united states * english-speaking * access to the internet * informed and voluntarily consented to be in the study exclusion criteria: * non-english speaking * not a licensed primary care provider * unable to access the internet * not practicing in the u.s. * do not voluntarily consent to be in the study
qstat in trauma and obstetric hemorrhage

Conditions: Blood Loss Massive; Trauma; Post Partum Hemorrhage

Summary: this study will evaluate the performance of the quantra system comprised of the quantra hemostasis analyzer with the qstat cartridge in trauma patients and obstetric patients with postpartum hemorrhage.

the quantra system is a fully integrated and automated in vitro diagnostic device which uses seer sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. the qstat cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. this includes the trauma, obstetric hemorrhage and liver transplant populations. the cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system. this prospective, observational pilot study will evaluate the performance of the quantra system with the qstat cartridge as compared to comparable measures using conventional viscoelastic testing methods.

Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age * subject is a trauma patient experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury.and is a candidate for a rotem test to be performed to access coagulopathy. or -subject is an obstetric patient experiencing post-partum hemorrhage based on one of the following conditions: estimated blood loss during delivery \>1000 ml; placental abruption with hemorrhage of any quantity; clinically suspected dic; pregnancy resulted in fetal demise with hemorrhage of any quantity; or is under consideration for administration of tranexamic acid for treatment of hemorrhage. exclusion criteria: * subject is younger than 18 years of age * subject presents for a procedure intended to abort a pregnancy for reasons other than medical necessity * subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit * subject is currently enrolled in a distinct study that might confound the results of the proposed study * subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

Keywords: viscoelastic testing coagulation quantra hemostasis