Kornimate/medical-research-clean huggingface dataset:
safety, efficacy and tolerability of vilazodone in patients with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (gad).


Eligibility criteria:
inclusion criteria: * male and female, 18 - 70 years of age * currently meet the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for generalized anxiety disorder (gad) * minimum score of 20 on the hamilton rating scale for anxiety (ham-a) exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control * patients with a history of meeting dsm-iv-tr criteria for: * any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode; * any depressive episode with psychotic or catatonic features; * panic disorder with or without agoraphobia; * obsessive-compulsive disorder; * schizophrenia, schizoaffective, or other psychotic disorder; * bulimia or anorexia nervosa; * presence of borderline personality disorder or antisocial personality disorder; * mental retardation, dementia, amnesia, or other cognitive disorders * patients who are considered a suicide risk

Keywords: generalized anxiety disorder gad
effect of virtual reality combined with balance training on biodex balance system in female with fibromyalgia

Conditions: Virtual Reality

Summary: is there an effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia .

purpose: to study the effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia . background: fibromyalgia (fm) is a chronic disorder defined by report of chronic widespread pain including axial pain and presence of multiple tender points on physical exam . beyond the defining criteria.a recent survey reported balance problems as one of the top 10 most debilitating symptoms with prevalence of 45%. balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance . biodex balance system is a relatively new instrument that can be used for the assessment and management of balance dysfunction. preliminary studies reported positive effects of balance training on biodex balance system for the improvement of balance function. virtual reality based therapy (vrbt) could be effective as a non-pharmacological alternative intervention to reduce pain in women with fm. it improves dynamic balance, as it is an active therapy that requires engaging in physical activities during the sessions.vrbt requires autonomous movement of different body parts that can increase muscle tone and the perception of pain-free movement favoring the elimination of restrictions to movement included in the cerebral body scheme due to continued pain.

Eligibility criteria:
inclusion criteria: * women patients from age 35 to 50 years old * all patients describe a history of pain spreading in all quadrants of the body for at least three months and pain is caused by digital pressure in at least 11 out of 18 allogenic points, called tender points exclusion criteria: * old neglected fracture * malignant diseases * neurological diseases. * uncontrolled diabetes
acute gastrointestinal bleeding peripheral pulse volume changes

Conditions: GastroIntestinal Bleeding

Summary: the purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically.

the maximum change in volume of a limb segment during the cardiac cycle - pulse volume - will be monitored non-invasively along with standard vitals in patients with a suspected gastrointestinal bleed undergoing endoscopy. pulse volume and vitals will be collected prior to and following endoscopy up to the point of dismissal from the endoscopy unit so that the data may be correlated with the endoscopic and clinical findings.

Eligibility criteria:
inclusion criteria: - adults (age \>18yr) undergoing emergent endoscopy for active gi bleeding. exclusion criteria: * patients with pre-existing heart failure (ejection fraction \<40%), cardiac rhythm abnormalities and peripheral vascular disease. * patients with underlying implanted cardiac electrical devices and spinal cord stimulators.
t-cell repertoire sequencing: assessing pembrolizumab efficacy in advanced non-small lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: this is a single site, non-randomized trial for the assessment of intravenous (iv) pembrolizumab (also known as mk-3475) combined with pemetrexed/platinum-based chemotherapy in subjects with advanced or metastatic non-squamous non-small lung cancer (nsclc) who have not previously received systemic therapy for advanced disease and in whom directed therapy is not indicated. approximately 30 subjects will be enrolled in this trial to examine the clonality and diversity dynamics matched with disease response evaluated by recist 1.1.

subjects will receive pembrolizumab 200 mg combined with pemetrexed and platinum (investigator's choice of cisplatin or carboplatin), as indicated below: pembrolizumab 200 mg + pemetrexed 500 mg/m2 (with vitamin supplementation) + cisplatin 75 mg/m2 or carboplatin auc 5, all on day 1 every 3 weeks (q3w) for 4 cycles followed by pembrolizumab 200 mg + pemetrexed 500 mg/m2 q3w until progression. treatment with pembrolizumab and pemetrexed will continue until 35 trial treatments have been administered, documented disease progression or unacceptable adverse event(s). patients will be stratified according to clinical and histopathological parameters: 1. pd-l1 status (pd-l1 \>/= 1 or \ 65 3. smoking history yes vs no 4. platinum chemotherapy: cisplatin vs. carboplatin 5. immune-related adverse events (iraes). tcr repertoire clonality and diversity will serve as an assessment measure for treatment response, along with pet/ct-scans, tumor exomal profile and ctdna dynamics.

Eligibility criteria:
inclusion criteria: * participant (or legally acceptable representative if applicable) provides written informed consent for the trial. * have measurable disease based on recist 1.1. lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. * eastern cooperative oncology group (ecog) performance status of 0 to 1. * adequate organ function. exclusion criteria: * pregnancy or breastfeeding * aberration in a known targetable molecular driver. * received prior therapy with an anti-pd-1, anti-pd-l1, or anti pd l2 agent or with an agent directed to another stimulatory or co-inhibitory t-cell receptor. * received prior systemic anti-cancer therapy for metastatic disease. * received prior radiotherapy within 2 weeks of start of study intervention. * major surgery within 14 days. * diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. * known additional malignancy that is progressing or has required active treatment within the past 3 years. * known active cns metastases and/or carcinomatous meningitis. participants with previously treated or asymptomatic brain metastases may participate provided they are radiologically stable.

Keywords: t-cell repertoire ctdna
study evaluating changes in mammographic breast density

Conditions: Osteoporosis

Summary: the objective of the study is to evaluate quantitative changes in mammographic breast density from baseline to 24 months in postmenopausal women receiving daily doses of either bza 20 mg/ce 0.45 mg, bza 20 mg/ce 0.625 mg, raloxifene or placebo. the primary endpoint in this study is the change in mammographic breast density between baseline and month 24 for each group.


Eligibility criteria:
inclusion criteria: * subjects who have completed all scheduled evaluations in protocol 3115a1-303-ww. * completed 24 months of treatment in protocol 3115a1-303. * had a mammogram at the baseline visit and at the month 24 visit in protocol 3115a1-303, and both are original films that are technically acceptable for reading. * was at least 80% compliant with test article administration during protocol 3115a1-303. exclusion criteria: * had a mammogram at either baseline or month 24 during the 3115a1-303 study that was technically unsatisfactory. * one or both mammograms were digitized when they were obtained during the 3115a1-303 study. * had more than one mammogram at either the baseline or month 24 visit of study 3115a1-303.
the role of repetitive trans cranial-magnetic stimulation in craving reduction among opioid use disorder patients

Conditions: Substance Use Disorders

Summary: repetitive trans-cranial magnetic stimulation (rtms) is a relatively safe and non-invasive method to modulate neuronal activity; rtms uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue. administering high frequency rtms to the left dorsolateral prefrontal cortex is possible to increase brain activity in the stimulated area and to change brain activity in associated regions that are part of the same neural circuit which may reduce craving.


Eligibility criteria:
inclusion criteria: 1. age range: 18-45 years old 2. gender: males 3. opioid use disorder according to the dsm-5 (early abstinence starting 1 week up to 1 month). exclusion criteria: 1. presence of other serious mental illness (e.g.; psychotic disorders, bipolar affective disorder, depression with psychotic features). 2. patients with any other serious medical illness. 3. previous treatment with repetitive trans- cranial magnetic stimulation. 4. patients with contraindications to rtms as cardiac patient with pacemaker.
pilot study of reset-o to treatment-as-usual in acute care settings

Conditions: Opioid-use Disorder

Summary: this randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reset-o, for patients being started on buprenorphine in acute care settings.

this randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (tau) group or a reset-o+tau group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. study enrollment will last for 3 months after discharge from the acute care setting. participants in the reset-o+tau group will be provided with the reset-o app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. the app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. all participants will be assessed at study intake and every month during the 3-month intervention.

Eligibility criteria:
inclusion criteria: * 18-65 years old * opioid use disorder * eligible for buprenorphine treatment * has reset-o compatible mobile device exclusion criteria: * pregnancy * significant psychiatric comorbidity
vaginal tactile imaging in assessment of pelvic floor conditions before the delivery

Conditions: Pelvic Floor; Perineal Rupture; Obstetric Trauma

Summary: the mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of pelvic floor disorders(pfd). injury to the perineum, vaginal supportive tissues, and pelvic floor muscles cause pain, infection, and dyspareunia, as well as pelvic organ prolapse(pop).pregnancy and vaginal delivery are considered as a main risk factors in weakening the pelvic floor support and development of sui, ai, and pop. cs is not only available countermeasure to reduce occurrence of obstetric trauma. tactile imaging allows acquisition of 3d stress-strain data and 3d elasticity imaging or soft tissues.

the long - term of this project is to develop, validate, and integrate into clinical practice a new paradigm and a novel device to simultaneously measure the biomechanical properties of various pelvic structural components that are impacted during vaginal delivery, and to develop a risk prediction model of maternal birth injury. ultimately, such a model will enable individualized patient counseling regarding the mode of delivery and/or the need for obstetrical interventions to reduce child birth trauma. the approach will utilize the vaginal tactile imaging technology that the investigators have developed and validated for clinical use. the benefits to physicians, patients and society are expected to be significant because the painful event in woman's life , given the large proportion of women suffer pfd caused by childbirth. this new system may open a new technical capability in woman's healthcare and change the established clinical practice.

Eligibility criteria:
inclusion criteria: * non-pregnant women (princeton urogynecology, princeton, nj) * pregnant women after completed 35th week of pregnancy with fetus in vertex position and premise of vaginal delivery (division of maternal-fetal medicine, rutgers robert wood johnson medical school, new brunswick, nj) exclusion criteria: * prior perineal surgery * hiv or hepatitis b positive serology * warty lesions on the vulva * extensive varicose veins on the vulva * aactive skin infection or ulceration within the vagina/vulva * presence of vaginal septum * severe hemorrhoids * stillbirth or extensive congenital abnormalities of the fetus

Keywords: pelvic floor, perineal rapture, obstetric trauma
paricalcitol over inflammatory parameters on chronical kidney disease patients

Conditions: Chronic Kidney Disease

Summary: use of paricalcitol in stage vd chronic kidney disease patients, over the effect of inflammatory and oxidative stress parameters.

use of paricalcitol in stage vd chronic kidney disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. this study uses paricalcitol (vitamin d) versus atorvastatin versus paricalcitol plus atorvastatin treatments.

Eligibility criteria:
inclusion criteria: * vd ckd patients using haemodialysis during 3 or more months. * tunnelized-bearer permanent catheters on haemodialysis at last 6 months previous at the beginning of the study. . * kt stable, over 45 litres on both sexs. * patients in treatment wiht atorvastatin * patients without infectious or inflammatory processes over 8 weeks. * two consecutive pth \< than 400 pg/ml; ca\<10.2 and p \<7.0 mg/dl. exclusion criteria: * patients \> 18 years. * pregnant women. * patients hospitalized 4 weeks before the beginning of the treatment. * immunosuppressor intake.

Keywords: chronic kidney disease vd-stadium. inflammatory patterns paricalcitol atorvastatin
a dispensing clinical trial of test contact lens against marketed contact lens

Conditions: Myopia

Summary: evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.

evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.

Eligibility criteria:
inclusion criteria: * has had a self-reported oculo-visual examination in the last two years. * is at least 18 years of age and has full legal capacity to volunteer. * has read and understood the information consent letter. * is willing and able to follow instructions and maintain the appointment schedule. * is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * currently wears soft contact lenses. * requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25d steps). * has no more than 0.75 diopters of refractive astigmatism. * has clear corneas and no active ocular disease. * has not worn lenses for at least 12 hours before the examination. * has a usable pair of spectacle lenses if required for transportation to the site for the initial visit exclusion criteria: * has never worn contact lenses before. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study. * known allergy to a product used in this study (ex. shellfish allergy) * is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
effects of brain stimulation on higher-order cognition

Conditions: Schizophrenia

Summary: the purpose of this study is to better understand the neural correlates of higher-order cognition, both in the healthy brain and in schizophrenia, and to determine how these mechanisms are modulated by transcranial direct current stimulation (tdcs) at frontal and occipital scalp sites. testing the effects of tdcs at these scalp sites on cognitive task performance will help us understand the roles of the brain regions corresponding to these sites during higher-order cognitive processing (language comprehension, cognitive control, and related attention and memory processes). behavioral and electrophysiological (eeg) measures will be used to assess cognitive performance. the investigator's overarching hypothesis is that stimulating prefrontal circuits with tdcs can improve cognitive control performance, and ultimately performance on a range of cognitive tasks, as compared to stimulating a different cortical region (occipital cortex) or using sham stimulation. this study is solely intended as basic research in order to understand brain function in healthy individuals and individuals with schizophrenia. this study is not intended to diagnose, cure or treat schizophrenia or any other disease.


Eligibility criteria:
inclusion criteria: * participants must be able to sufficiently speak and understand english so as to be able to understand and complete cognitive tasks. * all subjects must have the ability to give valid informed consent. inclusion criteria for patients with schizophrenia only: * diagnosis of schizophrenia, schizophreniform or schizoaffective disorder * no medication changes in the prior month * no medication changes anticipated in the upcoming month * stable outpatient or partial hospital status * normal iq (\>70; iq will be measured by administering the wechsler abbreviated scale of intelligence (wasi) test) exclusion criteria: * pacemakers * implanted electrical (brain and spinal) stimulators * implanted defibrillator * metallic implants * skin damage or skin conditions such as eczema at the sites where electrodes will be placed * hair styles hindering the placement of electrodes * cranial pathologies * head trauma * epilepsy * mental retardation * any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (als), multiple sclerosis (ms), stroke, cerebral palsy, any dsm-5 axis i psychiatric disorder (for healthy control subjects), autism) * uncorrected vision problems that would hinder cognitive testing (this also pertains to subjects with color blindness in tasks where discriminating colored objects/items is necessary for successful performance) * pregnancy * substance dependence in the past six months * substance abuse in the past month

Keywords: schizophrenia eeg tdcs dorsolateral prefrontal cortex cognitive control language transcranial direct current stimulation
a safety and efficacy trial of tthx1114 in people with ced

Conditions: Corneal Endothelial Dystrophy

Summary: expanded access, open label study at a single dose level in patients with ced that in the opinion of the investigators might benefit from tthx1114


Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older * subjects who are women of childbearing potential (wocbp) must be using an acceptable method of birth control (see section 6.4.3) * proposed study eye that has been diagnosed with an ocular condition that, in the opinion of the investigator, could possibly benefit from tthx1114 administration, and has a measurable efficacy endpoint * fellow eye with 20/100 bcva or better * no concurrent ocular or medical condition that would impair the assessment of safety and efficacy exclusion criteria: * prior exposure to tthx1114 * intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (note: this includes all components and excipients of the study drug) * current or recent (e.g., the 28 days prior to study day 0) participation in any other, interventional clinical research study * history of: * ocular cancer (including melanoma) * herpetic keratitis * documented and repeated elevated iop in either eye * posterior polymorphous corneal dystrophy (ppcd; aka schlichting dystrophy) * uveitis * use of any concomitant medications that may interfere with the assessment of safety and efficacy * any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study
determinants of sleep quality in spanish population (ssqd study)

Conditions: Sleep Quality

Summary: introduction: sleep disorders are a growing concern for public health, being related, among others, to an increased risk of cardiovascular diseases or poorer cognitive functioning. in addition, these might have a possible impact on aspects related to personal motivation and quality of life. however, few studies have analyzed the possible determinants of sleep quality in the adult population as a whole, establishing patterns based on these. objective: to evaluate the determinants of sleep quality in a representative sample of the general adult population aged 25 to 65 years old and to establish patterns of sleep quality based on lifestyles, psychological factors, morbidities and biological markers. methodology: design: this is a descriptive observational, cross-sectional study that will include a representative sample of 500 people aged 25 to 65 years old from the city of salamanca (spain) selected by random sampling stratified by age and sex. study variables: a visit lasting approximately 90 minutes will be carried out. the determinants of sleep quality will be assessed using both objective and self-reported methods. variables related to life styles will be assessed: physical activity, diet and toxic habits including tobacco smoking or alcohol use. morbidity data will also be collected, and psychological factors such as anxiety will also be assessed. serum melatonin levels will be determined as a biological marker related to sleep quality.


Eligibility criteria:
inclusion criteria: * age 25-65 years old * sign the informed consent exclusion criteria: * patients with terminal disease * any clinical condition that would interfere with study procedures

Keywords: life style psychological factors melatonin