Kornimate/medical-research-clean huggingface dataset:
escitalopram for the treatment of obsessive compulsive disorder (ocd)

Conditions: Obsessive Compulsive Disorder

Summary: the purpose of this study is to assess the efficacy of escitalopram in the treatment of obsessive compulsive disorder and to determine the optimal treatment dose.

background and purpose: obsessive compulsive disorder affects approximately 3% of the population. treatment options include the selective serotonin reuptake inhibitors (ssris), dual serotonin and norepinephrine reuptake inhibitors, and behavioral therapy. a recent double-blind, placebo-controlled trial demonstrated that citalopram is effective in the treatment of ocd. escitalopram is a new ssri that may be more effective than other ssris for the treatment of major depression and may have fewer side effects. this study aims to assess the efficacy of escitalopram for the treatment of ocd. comparisons: subject y-bocs pre-post treatment. we will also compare the improvement of subjects across the three different medication levels: 10 mg, 20 mg, and 30 mg.

Eligibility criteria:
inclusion criteria: * diagnosis of ocd by dsm-iv * age 18-65 * y-bocs greater than 20 * written informed consent * females of childbearing potential must have a negative serum or urinary beta-hcg test. exclusion criteria: * pregnant women or women of childbearing potential who are not using a medically accepted means of contraception. * patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk. * serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. patients on anticoagulant therapy. * history of seizure disorder * comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder * if there is a history of substance abuse, patients in remission at least 6 months. * currently being treated with behavioral therapy, specifically exposure and response prevention, for ocd. * other medications for medical disorders that may interfere with escitalopram * current major depression or prescribed an antidepressant for major depression within the past 12 months. * taken an ssri medication within 2 weeks of beginning the study (4 weeks for fluoxetine). * more than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another ssri in the past.

Keywords: obsessive compulsive disorder escitalopram ssri open label
diabetes virus detection project, intervention with gad-alum

Conditions: Diabetes, Type I; Enterovirus Infections; Autoimmunity

Summary: the purposes of this study are to test whether gad vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of gad vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (t1d).

the aetiology of type 1 diabetes is unknown. both genetic and environmental factors seem to be important for the destruction of insulin producing beta cells in the pancreas. increasing indirect evidences exist that picornaviruses may either directly or indirectly through autoimmune processes destroy beta cells. new sensitive assays have been developed to detect these viruses and to study the immunological processes, especially t-cell function. microsurgical technology has been refined, now making pancreatic biopsies a safe procedure. this study focuses on advanced in depth studies of immunology and virology in pancreatic tissue and small intestine at an early stage of disease.

Eligibility criteria:
inclusion criteria: * newly diagnosed classical type-1 diabetes * positive gad antibodies * fasting c-peptide \>0.1 mmol/l * insulin dosage \>0.1 u/kg bodyweight/day exclusion criteria: * pregnancy * weaning * other chronic diseases than diabetes * any regular medication except oral contraceptives * psychiatric disturbances

Keywords: insulin
a trial comparing interpersonal therapy to exposure therapy for ptsd due to military sexual trauma (mst) in male and female military personnel

Conditions: PTSD

Summary: the purpose of this study is to compare two kinds of therapy for posttraumatic stress disorder (ptsd): exposure therapy (et) and interpersonal psychotherapy (ipt). the results of this study will allow us to see if ipt and et are equally effective in treating ptsd due to military sexual trauma, with the long-term goal of making ptsd treatment effective for as many people as possible.


Eligibility criteria:
inclusion criteria: * english-speaking * military sexual trauma (mst) survivors, with mst defined as actual or threatened sexual violence, from vietnam era to current operation iraqi freedom/operation enduring freedom/operation new dawn * diagnosed with ptsd consequent to mst, with a minimum caps score \> 40 * medically stable at time of study enrollment (for persons with chronic injuries and that any disability present does not prevent attendance of weekly outpatient therapy sessions) * ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments * stable on psychotropic medication for the prior 60 days exclusion criteria: * lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder * participation in a clinical trial or concurrent evidence-based treatment for mst-related psychiatric conditions or ptsd during the previous 3 months * current evidence of significant unstable medical illness or organic brain impairment such that the patient could not attend sessions regularly or complete assessments * patients who in the investigator's judgment pose a current homicidal or suicidal risk * current or history of substance dependence in the past 90 days.

Keywords: ptsd military sexual trauma exposure therapy interpersonal psychotherapy treatment
diagnostic performance of breast cancer screening second reading process assisted by ai

Conditions: Breast Cancer

Summary: the goal of this clinical trial is to compare, for the second reading of screening mammograms, the standard of care with an ai assisted scenario. the main questions it aims to answer are: * will the experimental pathway be non-inferior to the standard pathway? * will the experimental pathway be economically superior to the standard pathway? participants will receive screening mammograms, as part of the breast cancer screening program. researchers will compare the interpretation made by the second reader in the standard pathway with the ai assisted interpretation made by a different reader in the experimental pathway.

all mammograms eligible for a second reading, and included in the study, go through 2 arms: * conventional second reading by a radiologist accredited to do second reading in france (l2 control arm), * second reading assisted by the ai (l2-ai experimental arm): mammograms will be read by the ai first and only if deemed suspicious, a radiologist accredited to do second reading in france will review them. the most pejorative assessment among the two arms is used as the final decision: if both arms consider the mammogram as negative, the participant won't be recalled, if one arm consider the mammogram as positive, the participant will be called back for further examinations. clinical performances and economical impacts of both scenarii will be compared.

Eligibility criteria:
inclusion criteria: * affiliated to the french social security system * whose mammograms meet the following characteristics: 4 (2 per breast, cc and mlo) meeting local regulatory standards and with correct dicom metadata, * whose mammograms have been determined to be normal or to have benign lesions by the radiologist who performed the first reading of the images (l1) in the framework of the organized breast cancer screening program * having expressed her willingness to participate in the study, to undergo all the procedures and to make herself available for the expected duration of their participation, * having completed and signed the informed consent form. exclusion criteria: * woman with breast implants, * with clinical symptoms of breast cancer, * with a history of breast surgery (breast reduction or surgery for benign lesion), * pregnant or breastfeeding, * with medical conditions that may interfere with her ability to understand the requirements of the protocol or give informed consent, * deprived of liberty by judicial or administrative order, * participant whose mammogram images have at least one of the following defects: poor quality of the images, non-standard mammography (projection, magnification, compression), ml/lm/sio/xccl or xccm view.

Keywords: artificial intelligence breast cancer screening second reading
early versus later re-valving in tetralogy of fallot with free pulmonary regurgitation

Conditions: Tetralogy of Fallot; Pulmonary Regurgitation

Summary: tetralogy of fallot (tof) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. about 25 children are born with this condition in denmark every year. corrective surgery is usually performed within the first year. in 50 % of patients, enlargement with a patch is necessary to achieve relief of the outflow tract obstruction. this however results in severe pulmonary regurgitation, which eventually leads to volume overload, right ventricular dysfunction and arrhythmia. to avoid these late complications, pulmonary valve replacement with a prosthesis if performed when patients meet the current guideline criteria. most patients meet the guideline criteria for revalving when they are between 20 and 30 years of age. the current guidelines however, are based solely on retrospective studies and novel research reveals that in more than 50 % of patients who are treated according to current practice, right ventricular volumes and function as well as exercise capacity and burden of arrhythmia do not normalize or improve. 500 patients with tof will be enrolled in a multicentre, cross-sectional study, which will yield information about the long-term outcomes after initial repair of tof, as well as suggestions about the optimal timing for re-valving. among patients included in the cross-sectional study, 120 patients with free pulmonary regurgitation, will be randomized evenly for early or later re-valving with at least 10-years of follow-up, for evaluation of long-term efficacy and safety of early re-valving.


Eligibility criteria:
inclusion criteria: 1. tof with pulmonary stenosis repaired with a tap within the first two years of life. 2. rvot anatomy is suitable for implantation of an adult sized conduit ( 18 mm homograft or contegra graft) as assessed by mri. exclusion criteria: 1. tof with pulmonary atresia, tof with common atrioventricular canal, tof with absent pulmonary valve syndrome, major aortopulmonary collateral arteries and other significant associated anomalies. 2. palliation with a shunt (blalock-taussig or central) at any time. 3. the patient is symptomatic. 4. sustained supraventricular or ventricular arrhythmia. 5. rvedvi \> 140 ml/m2 as assessed by mri (appendix 1). 6. rvesvi \> 60 ml/m2 as assessed by mri. 7. rvef \< 50 % as assessed by mri. 8. moderate or severe tricuspid regurgitation as assessed by echocardiography or mri. 9. significant residual lesions requiring intervention (e.g. ventricular septal defect, aortic regurgitation, branch pulmonary artery stenosis). 10. co-morbidity preventing exercise testing (e.g. genetics, neuro-cognitive dysfunction, physical disability). 11. contraindication for mri (e.g. permanent pacemaker, intra-cardiac defibrillator, intracranial ferro-magnetic device). 12. pregnancy at time of inclusion. 13. age \< 12 or unable to comply with instructions given during mri or exercise testing.
a follow-up colonoscopy examination in patients who had previously undergone screening colonoscopy

Conditions: Colonic Cancer

Summary: * to determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy * to determine the optimal time interval for re-screening in average risk individuals * to determine potential baseline characteristics that predicts adenoma recurrence

colorectal cancer (crc) is the second commonest cancer in hong kong, and tends to be increasing. screening for colorectal cancer can reduce the cancer incidence and mortality by detecting early lesions. however, the best interval for a follow up colonoscopy, particularly for those with normal baseline colonoscopy, remains largely unknown. this study aim to determine the prevalence of colonic neoplasm in average-risk patients who had previously undergone screening colonoscopy and the optimal time interval for re-screening.

Eligibility criteria:
inclusion criteria: * subjects who are previously participated in one of our two screening colonoscopy studies \[sung, gastroenterol 2003; leung, ajg 2004\] * asymptomatic on first screening colonoscopy * age\>50and \<75 * no family history of crc * no other colonoscopy except the baseline screening colonoscopy exclusion criteria: * subjects who refused consent * subjects who are not warrant follow up colonoscopy

Keywords: colonic adenoma, colonic advanced neoplasm
myback - a behavior change informed exercise program to prevent low back pain recurrences

Conditions: Low Back Pain

Summary: low back pain is a common heath condition with high rates of recurrence and huge associated costs. research has focused its efforts on analysing the effects of interventions while knowledge about effective secondary prevention strategies is limited. myback study aims to analyse the effectiveness of a tailored exercise and behavioural change program (myback program) in the secondary prevention of low back pain, and evaluate acceptability, feasibility and determinants of implementation by the different stakeholders, as well as the implementation strategy of the myback program, through a hybrid type i, randomized, controlled and multicentre study of effectiveness and implementation in the context of primary health care.


Eligibility criteria:
inclusion criteria: * recovered (within the last 3 months) from an episode of non-specific lbp (with or without leg pain and of any duration) * recovery from an lbp episode is defined as having a pain score of "0" or "1" on a 11-point numeric pain rating scale for, at least, 30 consecutive days * age between 18 and 65 years; * read and speak the portuguese language; * having a mobile phone capable of receiving and sending text messages; * no medical contraindication to exercise. exclusion criteria: * diagnosis, or symptoms consistent with, severe depression or other psychiatric condition, * pregnancy * spinal surgery in the last 6 months

Keywords: low back pain recurrences exercise behaviour change primary health care
n-acetyl-cysteine (nac) in early phase schizophrenia spectrum psychosis

Conditions: Schizophrenic Psychoses

Summary: the investigators seek to examine the effect of add-on n-acetyl-cysteine (nac) in the early phase of schizophrenia spectrum illness in collaboration with researchers kim do, phd, and philippe conus, md in switzerland. modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. therefore, studying new treatments that could target changes occurring during this period is of critical importance. aims: does add-on nac treatment in early psychosis influence: * positive and negative symptoms * extrapyramidal side-effects of other medication * plasma concentration of glutathione * mismatch negativity, a physiological marker

the study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (do et al., 2010). n-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.

Eligibility criteria:
inclusion criteria: * capacity to provide informed consent * dsm iv tr diagnosis of schizophrenia, schizophreniform, schizoaffective * psychiatric and medical stability * prescribing clinician's premission to participate, assurance of medical stability * having met threshold criteria for psychosis on caarms (comprehensive assessment of at risk mental states scale) psychosis subscale * up to 12 months of antipsychotic treatment exclusion criteria: * severe medical comorbidities * previous cerebral trauma * substance induced psychosis or organic psychosis * mental retardation * nac allergy * pregnancy, females and males planning pregnancy * treatment with antioxidants * insufficient command of english

Keywords: schizophrenia schizoaffective schizophreniform early schizophrenia spectrum psychosis
estimate the effect of lersivirine on the pharmacokinetics of abacavir/lamivudine in healthy subjects

Conditions: Healthy Volunteers

Summary: this will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects. * body mass index (bmi) of 17.5 to 30.5 kg/m2. * total body weight \>50 kg (110 lbs). exclusion criteria: * history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. * treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * history of hypersensitivity to abacavir, lamivudine and/or lersivirine.

Keywords: lersivirine uk-453 061 nnrti abacavir lamivudine combivir pharmacokinetics drug interaction hiv aids
performance evaluation of malaria plus rdts

Conditions: Malaria

Summary: since their introduction in the late 90's, rapid diagnostic tests (rdts) have dramatically improved our ability to control malaria, but proved insufficient to support elimination efforts because of their limited sensitivity, especially for p. vivax. in addition, the spread of p. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of p. falciparum-specific hrp2-based rdts. an existing partnership between standard diagnostics (sd), find, path, and bill and melinda gates foundation (bmgf) is addressing these limitations by developing two novel malaria rdts with an analytical sensitivity ten times higher than the currently available malaria rdts: a p. falciparum-specific test targeting both the hrp2 and pfldh antigens (pf plus), and a p. falciparum/p. vivax combo test additionally targeting the pvldh antigen (pf/pv plus). these new combo tests with improved sensitivity may become promising diagnostic tools for the detection of malaria, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of p. vivax malaria. in this study, the investigators will perform a prospective evaluation of pf plus and pf/pv plus tests in malaria-endemic countries to assess their clinical performance for detection of malaria in their intended-use settings.


Eligibility criteria:
inclusion criteria: * presenting at the study site with fever (axillary temperature ≥37.5°c) or a history of fever during the preceding 72 hours period * presence of symptoms and signs other than fever suggestive of malaria * aged 5 years or older * freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17) * willing to provide finger prick blood sample at enrolment exclusion criteria: * presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by who guidelines
emdr for depressed people with multiple sclerosis

Conditions: Multiple Sclerosis; Depression

Summary: several studies have reported high rates of depression in people with ms. depressive symptoms represent a serious threat to quality of life and well-being. furthermore, findings from the literature suggest that mechanisms underneath depressive features and loss of physical functions in ms could be related. the current study aims at investigating the feasibility of a fairly new type of psychotherapy known as "eye movement desensitization and reprocessing" (emdr) on depression in people with ms. the goal of this intervention is to reduce the long-lasting effects of distressing memories by developing more adaptive coping mechanisms, through bilateral sensory stimulation. together with the study on clinical measures, brain mechanisms of change will be assessed with mri. fifteen depressed or mildly depressed people with ms will be recruited. participants will be assessed for depression, and quality of life, before and after the intervention. participants will also undergo an mri for brain structural and functional assessments before and after the emdr intervention. the main aim of the study is to verify that emdr is a feasible psychotherapeutic approach for people with depression and ms and to collect preliminary data on the efficacy of this type of intervention in reducing the depressive symptoms and improving the quality of life. the study, however, will not be limited to the analysis of outcome differences. the use of mri assessments, in fact, will allow to explore possible brain change modifications related to depression reduction and/or symptoms modifications.


Eligibility criteria:
inclusion criteria: * diagnosis of relapsing-remitting or progressive ms. * presence of depressive symptomatology, with hads scores \> 8, confirmed by hdrs scores (clinical interview) \> 14. * no change of pharmacological treatment in the 3 months before the enrolment. * ability to communicate and to understand tasks. * no clinical relapses or use of steroid treatment during the 4 weeks before the enrolment. * provided informed consent for study participation. exclusion criteria: * severe co-morbidity that would reduce life expectancy to less than one year (i.e. end-stage oncological diseases or severe cardiac dysfunction). * severe neuropsychological impairment evaluated with the mmse. * psychosis or dissociative disorders. * no current psychotherapy treatment * pregnancy.

Keywords: multiple sclerosis depression emdr qualiti of life mri
evaluation of anesthetic techniques in outpatient total joint replacement surgery in an integrated health care delivery system

Conditions: Anesthesia Morbidity; Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: the study is a retrospective cohort study of adult patients undergoing outpatient primary unilateral total knee or total hip replacement surgeries from 2017 to 2019 assessing for difference in anesthetic techniques and outcomes.

the study is a retrospective cohort study of adult patients undergoing outpatient primary unilateral total knee or total hip replacement surgeries from 2017 to 2019. the purpose of the study is to evaluate the effects of anesthetic techniques for primary total joint replacement in northern california kaiser permanente. the primary objective is to determine if there are clinically and statistically significant differences between the outcomes of general anesthesia and neuraxial anesthesia.

Eligibility criteria:
inclusion criteria: * asa 1 - iv patients * age \> 18 * primary total hip/knee replacement exclusion criteria: * total joint replacement for oncologic tumors * emergent surgery * age \< 17 * pregnant female * neuraxial anesthesia conversion to general anesthesia * revision total joint replacement * bilateral total joint replacement

Keywords: retrospective cohort anesthetic technique total joint arthroplasty