Kornimate/medical-research-clean huggingface dataset:
efficacy of vortioxetine on cognitive dysfunction in working patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * the patient has mdd, diagnosed according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr™) recurrent major depressive disorder (mdd) (classification 296.3x). * the patient has a madrs total score ≥26. * the patient has had the current major depressive episode (mde) for ≥3 months. * the patient is aged ≥18 and ≤65 years. * the patient is employed full or part-time (defined as minimum 50% full time working hours per week). part time work should not be due to a medical or mental illness other than mdd. * the patient has been in the current job/position for at least 3 months. * the patient has no plans to change jobs or retire within treatment period. * the patient is not on a sick leave, and at the screening and randomisation visits, there are no plans to send the patient on a sick leave. * the patient is not receiving disability benefits. exclusion criteria: * the patient has a score ≥70 on the dsst (number of correct symbols) at the baseline visit. * the patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly at the baseline visit. * the patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests. * the patient is diagnosed with reading disability (dyslexia). * the patient has a history of lack of response to previous adequate treatment with vortioxetine or paroxetine. * the patient has any current psychiatric disorder or axis i disorder (according to dsm-iv-tr™ criteria) other than mdd, as assessed using mini. * the patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of current episode (dsm-iv-tr™ criteria). * the patient has borderline, schizotypal, schizoid, paranoid, or histrionic, antisocial personality disorders (axis ii) as comorbid or primary diagnosis (dsm-iv-tr™ criteria). * the patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (dsm-iv-tr™ criteria). * the patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (dsm-iv-tr™ criteria). other protocol-defined inclusion and exclusion criteria may apply.
autonomic modulation and facial expression in autism spectrum disorder

Conditions: Autistic Disorder; Autism Spectrum Disorder

Summary: background: the autism spectrum disorders (asd) can be related with abnormalities in cortical structures and cause behavior imbalances. in addition, as soon as the diagnosis is done, the better will be the prognosis. in this context, heart rate variability (hrv) stands out, which is a non-invasive tool representing autonomic modulation, with potential prognostic value. the literature showed there are no changes in hrv at rest using linear methods of analysis, but changes can be identified during tasks. nonlinear methods of hrv are more sensitive and provide additional information to the linear. objective: to analyze autonomic modulation using nonlinear and linear indexes of hrv in children with asd at rest and during tasks in comparison to typical children. in addition, to correlate hrv analysis between them, also between behavior and severity of the disease. methods: this study involves both typical children and children with asd. autonomic modulation will be performed using nonlinear indices (extracted from poincaré plot, detrended fluctuation of tendency analysis and recurrence plot) and linear indices of hrv in the time (rmssd e sdnn) and frequency domain (lf, hf, vlf). the tasks consist in games to identify and recognize faces and facial expressions. behavior and severity of the disease will be evaluated using the autism behavior checklist and the childhood autism rating scale respectively. statistical analysis: to identify differences between moments and protocols two-way analysis of variance will be used along with the bonferroni post-test or dunn post-test according to the data distribution. statistical significance will be set at 5%.


Eligibility criteria:
inclusion criteria: * children with autistic disorder or typical development. exclusion criteria: * participants that do not participant of all evaluations. * participants with an error superior to 5% in the rr intervals series.

Keywords: autonomic nervous system sympathetic nervous system heart rate
safety of prolonged administration of triticum monococcum in celiac disease

Conditions: Celiac Disease

Summary: preliminary studies on safety profile of triticum monococcum (tm, a variety of ancient wheat) have provided conflicting results with some in vitro and ex vivo studies consistent with non toxicity and other suggestive of toxicity. we recently reported results of a single administration of 2.5 grams of tm in 12 celiacs in remission on gluten free diet (gfd), while assessing symptoms and changes of intestinal permeability. although results of intestinal permeability were inconclusive tm, but not other type of gluten, was clinically well tolerated. the aim of the present study was to assess safety of 60 days of administration of tm (100 grams of water biscuits per day accounting for about 6 grams of gluten from tm) as judged on clinical, serological and histological parameters in celiac disease patients on remission after 1 year of gfd.


Eligibility criteria:
inclusion criteria: * adult celiac patients on gluten free diet (gfd) for at least one year * strict adherence to gfd * negative celiac related serology * normal duodenal histology defined as marsh class 0-ii * willing to participate and adhere to study protocol * sign of the informed consent exclusion criteria: * pregnancy

Keywords: celiac disease gluten gluten free diet triticum monococcum
exploratory fmri study on the treatment for impulsive aggression in children with adhd

Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Impulsive Aggression

Summary: the purpose of this study was to evaluate the effect of 4-week spn-810 treatment on brain functioning in patients aged 8-12 years with adhd and associated feature of impulsive aggression (ia). this was achieved using functional magnetic resonance imaging (fmri) in conjunction with the point subtraction aggression paradigm (psap) task, a behavioral aggression paradigm in which subjects are provoked by having money indirectly taken from them by a fictitious opponent, simulating an aggression response.

approximately 30 subjects aged 8-12 diagnosed with adhd and associated feature of ia were recruited in this study. the psap is a behavioral aggression test used to evaluate behavioral response related to impulsive aggression. the task was combined with functional mri to evaluate the change in brain activity measured as bold signal (blood oxygenation level-dependent) from baseline to the end of the treatment with spn-810. the level of neurotransmitters glutamate and gaba were also measured using magnetic resonance spectroscopy (mrs). additionally, the improvement and severity in impulsive aggression behaviors were assessed using validated scales.

Eligibility criteria:
inclusion criteria: * otherwise healthy male or female subjects, aged 8-12 years, inclusive, at the time of screening with primary diagnosis of adhd and currently receiving monotherapy treatment with an optimized us food and drug administration (fda)-approved adhd medication. * impulsive aggression (ia) confirmed at screening using the r-moas and the vitiello aggression scale. exclusion criteria: * current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or related disorder, personality disorder, tourette's disorder, fetal alcohol syndrome, or psychosis not otherwise specified. * currently meeting dsm criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder. * known or suspected iq \<70, pregnancy, substance or alcohol abuse. * known history of implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal shunt, cardiac pacemaker, orthodontic braces, or implanted medication port. visual and hearing (≥25 db) impairment. * pre-existing medical or psychological conditions that preclude being in the mri scanner (e.g., claustrophobia, morbid obesity, or marked anxiety about the procedure).
active vs passive distraction on procedural pain in the pediatric emergency department

Conditions: Pain Response

Summary: the investigators proposed study will investigate the efficacy of tablet computer distraction as an analgesic for the pain associated with various painful procedures in the emergency department. since prior studies have shown that distraction by a parent or nurse can be an effective analgesic, there is reason to believe that tablet computer distraction will similarly reduce pain. participants in the control group will receive a cartoon on the tv monitor in the patient room, while participants in the study group will receive a more immersive distraction of playing a game or watching a cartoon (for children too young to play a game) on a tablet computer. data from this study will help inform best practices for administering painful procedures in a way that minimizes pain.


Eligibility criteria:
inclusion criteria: healthy pediatric patients in the university of chicago emergency department who are undergoing insertion of a peripheral intravenous line, intramuscular injection, fingerstick, subcutaneous injection, laceration repair (sutures, tissue adhesive, and staples), nail avulsion, or abscess incision and drainage. exclusion criteria: non-english speaking, over the age of 18 trauma, have come in for asthma-related complaints, are being resuscitated, are neurosurgical/neurology/seizure patients, or patients in whom use of distraction would interfere with the procedure
open label trial of perifosine in patients currently being treated on perifosine trials in solid tumors or multiple myeloma

Conditions: Non Small Cell Lung Cancer; Solid Tumors; Metastatic Breast Cancer; Sarcomas

Summary: this is an open label trial for patients currently enrolled in other perifosine trials.

perifosine is an oral anticancer agent with limited toxicity and a novel mechanism of action that is distinctly different from cytotoxic chemotherapies. it has been shown to inhibit and otherwise modify signaling through a number of pathways including akt, p21, and jnk. perifosine has been tested in phase i and phase ii settings in a variety of dosing schedules including daily, weekly, and daily following a loading dose. in general, it has been well tolerated with dose-related nausea, vomiting, diarrhea, and fatigue being the most commonly observed toxicities. perifosine has induced partial responses or stable disease in solid tumors including but not limited to renal cell, sarcoma, and hepatocellular carcinoma. perifosine is currently being studied in multiple diseases as a single agent as well as in combination with other cancer therapies. as studies are closed there are patients that have achieved a partial response or stable disease.

Eligibility criteria:
inclusion criteria: * patients must be currently receiving treatment with perifosine on a previously approved protocol. * patients must have had at least one evaluation following the initiation of treatment and have stable disease, partial response or complete response. * patient is willing to sign a new consent regarding the protocol no exclusion criteria are described.

Keywords: perifosine
hla-haploidentical peripheral blood stem cell transplantation with post-transplant cyclophosphamide and bortezomib

Conditions: Hematological Malignancy

Summary: now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (gvhd) like post transplant cyclophosphamide , tacrolimus, mycophenolate . recently bortezomib has also been shown to inhibit dendritic cells maturation and function and possesses a number of other favorable immunomodulatory effect that can prevent gvhd and help enhance immune reconstitution. this study is to assess the engraftment rate in patients with hematologic malignancies who need allogeneic stem cell transplant but do not have a suitable matched related or unrelated stem cell donor and will get t-cell replete hla-haploidentical allogeneic peripheral stem cell transplantation using post transplant cyclophosphamide and bortezomib


Eligibility criteria:
inclusion criteria: * 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\</= 7/8 allele match at the a, b, c, dr loci with a minimum match of 5/10 is required) is identified * candidate for stem cell transplant in a malignant hematological condition * karnofsky performance scale 0-1 * available donor able to undergo a peripheral blood stem cells collection * bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (ast) or alanine aminotransferase (alt) \</= 200 iu/ml for adults. * serum creatinine clearance \>/=60 ml/min (calculated with cockroft-gault formula) * diffusing capacity for carbon monoxide (dlco) \>/= 45% predicted corrected for hemoglobin. * left ventricle ejection fraction \> 40%. * patient or patient's legal representative, parent(s) or guardian should provide written informed consent. exclusion criteria: * adult who has a suitable related or unrelated donor or cord units available for transplant. suitable donors include 8/8 (hla-a,b,c and dr, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation * hiv positive; active hepatitis b or c * patients with active uncontrolled infections. * liver cirrhosis * uncontrolled central nervous system involvement by tumor cells * positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. * inability to comply with medical therapy or follow-up
the guard trial - part 1: a phase 3 clinical trial for prevention of proliferative vitreoretinopathy

Conditions: Proliferative Vitreoretinopathy

Summary: the guard trial is a multi-center, randomized, controlled, adaptive phase 3 clinical trial of repeated intravitreal injections of adx-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.


Eligibility criteria:
inclusion criteria: 1. subject is 18 years or older of any gender or race 2. subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury 3. subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits 4. subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial exclusion criteria: 1. history of severe non-proliferative or proliferative diabetic retinopathy 2. other planned eye surgery during the course of the trial 3. participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment

Keywords: adx-2191 recurrent retinal detachment open globe injury
prehabpal: a digital tool to help older adults prepare for cancer surgery

Conditions: Colon Cancer

Summary: this is a multi-center, randomized trial investigating the use of prehabpal web app versus a written surgery prehabilitation instructions among individuals aged 65 years and older preparing for colon cancer surgery. prehabpal is a web app designed with, and for, older adults preparing for surgery at university of california, san francisco (ucsf). this app has the potential to fill a crucial clinical gap for older cancer patients by designing an individualized prehabilitation program and providing prehabilitation coaching.

primary objective: i. determine the effectiveness of prehabpal in delivering prehabilitation and improving outcomes for elders who undergo colorectal cancer surgery. secondary objectives: i. determine the impact of prehabpal on surgical outcomes and functional recovery compared to standard written surgery prehabilitation materials. outline: participants will be randomly assigned to 1 of 2 conditions. study participation will continue for up to 12 weeks, with intervention 7-21 days before surgery and a follow-up visit 8 weeks after surgery.

Eligibility criteria:
inclusion criteria: 1. male or female \>=65 years of age at time of evaluation for colorectal cancer resection. 2. documentation of a colorectal diagnosis as evidenced by the following criteria: a. biopsy proven colorectal cancer or unresectable neoplastic polyp. 3. written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. 4. self-reported access to the internet. 5. participant has at least seven days prior to surgery date to optimize for surgery. 6. english language proficient. exclusion criteria: 1. no english language proficiency. 2. no internet access. 3. documented diagnosis of dementia or alzheimer's disease. 4. surgery scheduled within 7-days. 5. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.

Keywords: web app older adult prehabilitation
the effect of pre-operative videotape before a planned cesarean section on anxiety level

Conditions: Anxiety; Cesarean Section Complications; Pain, Postoperative; Analgesia

Summary: the study aim is to examine the relationship between providing information to women prior to elective cesarean delivery and anxiety levels around surgery. the patients will be assigned into two groups - intervention and control. in the intervention group - the day before surgery the women will watch a pre-prepared video showing in detail the course of events around the operation. the level of anxiety, pain level and intake of analgesics will be compared between the two groups

women will be recruited for research at the time of admission preoperatively. according to randomization women will be divided into two groups - intervention and control in the intervention group - the day before surgery the women will watch a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation - from the woman's perspective - from the time they were admitted to the department, preparation for surgery, entrance to the operating room, anesthesia procedure, surgery itself, post-operative recovery and recovery course in maternity ward. the movie will be shown to the patient by one of the study investigators. in the control group - women will receive general information about the surgery as part of the routine informed consent process, without watching a pre- prepared film. the level of anxiety, pain level and intake of analgesics will be compared between the two groups

Eligibility criteria:
inclusion criteria: * first cesarean surgery exclusion criteria: * women who have had surgery beyond age 2 years * women with anxiety disorders * women with comorbidity that might alter cortisol and catecholamine excretion, * women with comorbidity associated with severe pain that might distort pain ratings * women with psychiatric comorbidity that might reduce the ability to understand the videotape and questionnaires * women who consume any medication that might affect urinary excretion of cortisol * women undergoing cesarean surgery due to obstetric complication (gestational hypertension, pre-eclampsia, gestational diabetes mellitus)
study of the efficacy and safety of bupivacaine tts patch in patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: this study will evaluate the efficacy and safety of bupivacaine tts (bupivacaine patch) compared to placebo in patients with chronic low back pain.


Eligibility criteria:
inclusion criteria: 1. diagnosis of chronic low back pain for more than 3 months 2. if taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for the study duration 3. pain intensity score greater than or equal to 5 out of 10 at the first visit 4. able to apply patches at home 5. able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study 6. females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study exclusion criteria: 1. history of, or ongoing, alcohol or drug abuse 2. positive drug test for alcohol, illicit drug use or opioids 3. primary diagnosis of chronic low back pain due to neuropathic pain 4. history of back surgery or plan for back surgery 5. use of opioids within 2 weeks of the first visit and during the study 6. previous ineffective use of lidocaine patches 7. morbid obesity 8. moderate or severe depression 9. an open skin lesion within the painful area where patches will be applied 10. patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain 11. pregnant or breastfeeding females

Keywords: chronic low back pain
treatment of patients with chronic hepatitis c with pegintron as monotherapy or in combination with ribavirin (study p04437)(completed)

Conditions: Hepatitis C, Chronic; Hepacivirus

Summary: in february 2002, a french consensus conference on the management of patients with chronic hepatitis c in france was organized. the jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. three years after these recommendations, it is of interest to understand the evolution of hepatitis c management in france in real clinical practice. this observational study will permit the identification of patients who are treated and will provide information on the use of pegintron/ ribavirin.

to assure a good representation of participants treated for hepatitis c, participants who meet the inclusion criteria will be enrolled on a consecutive basis.

Eligibility criteria:
inclusion criteria: * adult participants starting a treatment with pegintron for the treatment of chronic hepatitis c. exclusion criteria: * concomitant participation in a clinical trial for the treatment of hepatitis c.
burnout syndrome among anesthesiologists in turkey: a cross-sectional study

Conditions: Burnout, Professional; Burnout, Psychological

Summary: burnout syndrome is a condition in which an individual experiences loss of self-esteem, chronic fatigue, feelings of helplessness, and hopelessness in their professional work life and human relationships. this study aims to evaluate the prevalence of burnout syndrome among anesthesiologists working in turkey, analyze the potential causes and adverse consequences of this syndrome's increase, and provide recommendations for its reduction.


Eligibility criteria:
inclusion criteria: i. agreed to participate by completing the online survey form. ii. proficient in the turkish language. iii. anesthesiology and reanimation specialists currently practicing in the republic of turkey. exclusion criteria: i. users who do not provide consent to share the requested information in the survey form.