Kornimate/medical-research-clean huggingface dataset:
brain correlates of self-focused processing

Conditions: Social Phobia; Body Dysmorphic Disorder

Summary: the purpose of this study is to determine whether neuroimaging-based markers of maladaptive self-focused processing are better predictors of treatment response to cognitive-behavioral therapy than behavioral markers.

first, the investigators propose to identify the neural correlates of self-focused processing. the investigators will assess baseline resting state connectivity within the default network, as well as regional brain activation using a well-validated event-related fmri task that manipulates self-focused processing in patients with body dysmorphic and socially anxious symptoms, compared to healthy controls. this clinical sample was selected because such patients display heightened self-focused attention, and sampling individuals across these symptom dimensions will ensure greater variability on this dimension of maladaptive self-focused processing. second, the investigators will examine the neural correlates of self-focused processing as a predictor of treatment response. neuroimaging data will be acquired from patients with body dysmorphic and socially anxious symptoms during two scan sessions, before and after 12 weeks of individual cognitive behavioral therapy, and compared with healthy controls scanned twice at a 12 week interval. finally, the investigators will compare the prediction of treatment response between neural measures and behavioral measures of self-focused processing. the investigators will assess the behavioral correlates of self-focused processing using a self-reference effect paradigm, and assess their relation to treatment response. if the investigators hypotheses are borne out, the investigators will have new targets for treatment, a method to identify promising candidates for treatment, and sensitive surrogate markers of treatment response.

Eligibility criteria:
inclusion criteria: * men and women, age 18-45 * for patients: treatment-seeking individuals presenting with at least moderate levels of social anxiety/body dysmorphic symptoms, and a score of at least 1 sd above the mean on the public self-consciousness scale of the self-consciousness scale- revised * for healthy controls only: no current or lifetime history of psychiatric disorders, and score of below 1 sd of mean on the scs-r * right-handed, as determined by the handedness inventory * fluent in english, and willing to provide informed consent exclusion criteria: * positive mr screen * history of head injury, neurological disorder, or neurosurgical procedure * active suicidal or homicidal ideation * current or past manic/hypomanic episode or psychotic symptoms * active alcohol and substance dependence (as assessed by the scid-5-rv * current use of psychotropic medications, except antidepressants taken at a stable dose for 2 weeks, to maximize generalizability of sample * current cbt and/or formal mindfulness/meditation training * history of more than 10 sessions of cbt and formal mindfulness/meditation training

Keywords: attention cognitive behavioral therapy neuroimaging
efficacy and safety of iloperidone compared with placebo and active control in subjects with acute schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). other symptoms include a reduced ability to recall and learn new information. iloperidone is being development as a treatment for symptoms of schizophrenia. this trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia * panss-t of at least 70 at screening and baseline exclusion criteria: * clinically significant disease of the heart, kidneys, liver or gastrointestinal system * dsm-iv diagnosis of psychiatric disorder other than schizophrenia

Keywords: schizophrenia atypical antipsychotic psychosis
lepr polymorphism weight gain by mirtazapine in late life depression

Conditions: Major Depressive Disorder

Summary: patients with an episode of depression in late life prescribed mirtazapine recruited from a clinical sample will be monitored for weight and receive a blood test during their usual course of treatment to determine polymorphisms in a specific gene (lepr) thought to affect weight gain.


Eligibility criteria:
inclusion criteria: * patients older than 50 years * meeting criteria for a diagnosis of major depressive disorder (dsm iv code 296.2x or 296.3x) as confirmed by a score \> 20 on the ham-d 24 items scale and a structured clinical interview using the scid by a consultant psychiatrist exclusion criteria: * treatment resistant depression (as defined by failure to respond to ≥2 adequate antidepressant trials) * major depressive disorder with psychosis (296.x4) * those with depression who fulfill the chronic specifier (mde for \>2 years) * significant axis ii pathology * previous trial with mirtazapine * concurrent antipsychotic usage * comorbid dementia (as confirmed by mmse \< 24) * substance misuse including drug and/or alcohol dependence/abuse in the past 3 months * bipolar disorder * schizophrenia * obsessive compulsive disorder * post traumatic stress disorder * eating disorder * head injury * recent stroke (\< 3 months) * recent mi (\< 3 months) * currently actively participating in structured/formal psychotherapy * being non ambulatory * those actively suicidal * those incapable of informed consent

Keywords: mirtazapine
arthroscopic rotator cuff repair with platelet-rich plasma(prp) in large to massive tears

Conditions: Rotator Cuff Tear

Summary: * the purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with platelet-rich plasma(prp) and conventional rotator cuff repair in treatment of large to massive rotator cuff tears. * prp application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.


Eligibility criteria:
inclusion criteria: large to massive rotator cuff tear as a determined by clinical examination and mr prior to surgery. exclusion criteria: * previous history of shoulder surgery * acute trauma * chronic dislocation * pyogenic infection * rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head * showed abnormal serological test results * thrombocytopenia (platelets less than 15000 per microliter) * had been received anti-platelet medication * psychiatric problems that precludes informed consent or inability to read or write * other serious problems that preclude participation of the study
safety and efficacy of canakinumab prefilled syringes in frequently flaring acute gouty arthritis patients

Conditions: Acute Gouty Arthritis

Summary: this study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.


Eligibility criteria:
inclusion criteria: * 3 or more gout flares within last year * contraindication, intolerance or lack of efficacy for nsaids and/or colchicine * body mass index of less than or equal to 45 kg/m2 exclusion criteria: * use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, nsaids (such as aspirin), colchicine. * hemodialysis * live vaccine within 3 months before first dose * donation or loss of 400 ml or more within 3 months before first dose * gout brought on by other factors such as chemotherapy, lead, transplant, etc. * presence of other acute inflammatory arthritis such as rheumatoid arthritis * any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as hiv, hepatitis, tuberculosis and other infections/conditions * significant cardiovascular conditions such as uncontrolled hypertension * significant medical diseases such as uncontrolled diabetes, thyroid disease * history of malignancy of any organ system within the past 5 years * women who are pregnant or nursing * other protocol-defined inclusion/exclusion criteria may apply

Keywords: gout arthritis gout flare acute gout gouty rheumatic disease uric acid
model-informed precision dosing for linezolid

Conditions: Gram-Positive Bacterial Infections

Summary: study rationale: previous in vitro and retrospective in vivo studies suggest that optimal linezolid concentrations (between 2 and 7 mg/l) achieve clinical efficacy and microbiological eradication while minimizing side effects like thrombocytopenia and the emergence of resistance. no prospective or randomized clinical trial has confirmed these findings, and there is no consensus on how to adjust linezolid dosing to achieve optimal drug concentrations. objectives: the primary objective is to determine if model-informed precision dosing optimizes linezolid dosing to achieve therapeutic trough concentrations compared to a standard dose. secondary objectives include assessing the pk/pd profile, investigating the prevalence of linezolid resistance among gram-positive bacteria, assessing microbiological resolution of infection, and evaluating the safety and tolerability of linezolid. methodology: this study is an open, monocentric pilot randomized controlled trial with two arms: standard dose therapy versus dose adjustment based on model-informed precision dosing using therapeutic drug monitoring and pk/pd targets developed in tmdx software. sample size: 28 patients, 14 in each group. assumptions are based on only 25% of patients in intensive care achieving the optimal therapeutic range with standard dosing, compared to an expected 80% achieving this with model-informed precision dosing. selection criteria: adult patients (18+ years) already starting linezolid treatment for gram-positive infections, expected to require treatment beyond the next calendar day. exclusions include imminent death, expected or confirmed pregnancy, expected linezolid treatment of less than 4 days or more than 4 weeks. outcomes: the primary endpoint is defined as the difference in the proportion of patients in the intervention and in the control groups who maintained a trough linezolid concentration of 2 to 7 mg/l on day 7 and day 13.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. linezolid treatment is indicated or has been started due to pneumonia, skin or soft tissue infection; the patient has received no more than 2 infusions of 600 mg linezolid each 3. with written informed consent of the patient or 4. with written informed consent of his/her legal representative or 5. after using the option of inclusion via spouse according to § 1358 bgb or 6. after application of the independent consultant procedure 7. patients of childbearing age: negative pregnancy test exclusion criteria: 1. patients receiving antibiotics active against gram-positive bacteria at the same time of linezolid 2. infection other than pneumonia, skin or soft tissue infection, especially tuberculosis, endocarditis and osteomyelitis 3. death is deemed imminent and inevitable 4. pregnancy 5. lactation/breastfeeding

Keywords: linezolid pk-pd model tdm
total skin electron beam therapy (low-dose) for tumor clone eradication in early-stage mycosis fungoides

Conditions: Mycosis Fungoides; Cutaneous T Cell Lymphoma

Summary: primary cutaneous t-cell lymphomas are a group of peripheral t-cell lymphomas that primarily involve the skin. mycosis fungoides (mf) is the most frequent subtype. most patients with early-stage mf (i.e., patches and plaques of the skin without extracutaneous involvement) have a good prognosis but a subset of patients progress to incurable advanced-stage disease with an overall survival (os) less than 5 years and an impaired quality of life. we have recently identified the tumor clone frequency in lesional skin (measured by high-throughput sequencing of the tcrb locus) as the most important prognostic factor of progression-free survival (pfs) and os in a retrospective analysis on 210 patients with early-stage mf (p\<0.001). phototherapy is a standard therapeutic option in early-stage mf but fails to eradicate the tumor clone from the skin. low-dose total-skin electron-beam therapy (ldtsebt, 12 gy over a 3-week period) has been shown to be safe and highly effective in mf with an 88% overall response rate and a better safety profile compared to standard-dose total-skin electron-beam therapy, in a pooled analysis from 3 phase ii trials on 33 patients and a retrospective analysis of 12 patients treated with ldtsebt. we hypothesize that the use of ldtsebt is associated with a significantly higher 1-year pfs compared to conventional treatment with phototherapy. our secondary hypotheses are that ldtsebt is associated with a higher tumor t-cell clone eradication compared to phototherapy, and improves os and quality of life in patients with skin-limited mf. the main objective of this study is therefore to prospectively determine if ldtsebt is associated with a higher 1-year progression-free survival in patients with early-stage mycosis fungoides, compared to conventional treatment with phototherapy. the primary endpoint is pfs at 12 months after study inclusion.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histopathologically confirmed diagnosis of international society for cutaneous lymphomas (iscl) / european organisation for research and treatment of cancer (eortc) mycosis fungoides stage ib or iia exclusion criteria: * poor performance status: who performance status score \> 2 * physically unable to maintain the posture * patient with no health coverage * patient under guardianship or curatorship * previous history of dose-limiting radiation therapy in the field * previous history of dose-limiting phototherapy * previous history of melanoma, skin squamous cell carcinoma or basal cell carcinoma or other absolute contraindication to phototherapy (including a history of lupus, xeroderma pigmentosum, or porphyria) * pregnant or breastfeeding woman * contraindication to methoxsalen (severe liver, renal or heart failure)
a clinical trial of adaptive treatment for early smoking cessation relapse

Conditions: Cigarette Smoking; Smoking Behaviors; Treatment

Summary: this is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. most participants will receive some combination of these treatments, depending on individual response to each. all visits and study assessments will be entirely remote. all treatments will be provided free of charge for the first 12 weeks. after that, the study team will contact the participants 6 months after the first study phone call to complete another survey. the study lasts six months and will involve 8 surveys.

treatment seeking smokers across both alabama and south carolina (n=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination nrt (patch + lozenge), counterbalanced. using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination nrt. those who do not demonstrate early success will be randomized to a subsequent 4-week course of either a) continuation of same medication, or b) switch to the other fda approved option, either varenicline or combination nrt. the same process will repeat at week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. end of treatment outcomes will be assessed at week 12 at which time no more product will be offered. final follow-up at week 24 will ascertain all primary (cessation) and secondary outcomes.

Eligibility criteria:
inclusion criteria: * smokers who want to quit exclusion criteria: * non-smokers
effect of chlorhexidine-induced oral care on ventilator-related some respiratory system complications

Conditions: Ventilator Associated Pneumonia; Tracheobronchitis

Summary: ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.

the aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * admission in critical care with in 24 hours * having an endotracheal tube exclusion criteria: * history of chlorhexidine allergy * duration of mechanichal ventilation less than 48 h * confirmed diagnosis of pneumonitis before admission in the icu * transfer from another icu * receiving chemotherapy or radiotherapy * patients with immunodeficiency * patients with tracheostomies * required specific oral hygiene procedures * facio-maxillary or dental trauma/surgery * being pregnant
human phototoxicity test

Conditions: Sunscreening Agents

Summary: to determine the phototoxic potential of a topically applied article in human subjects.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a hipaa (health insurance portability and accountability act) authorization form in conformance with 45cfr (code of federal regulations ) parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator. exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis; * must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. * have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.
influence of periodontal treatment during pregnancy in adverse pregnant outcomes

Conditions: Periodontal Disease

Summary: the aim of this study is to evaluate the effects of treatment of periodontal disease during the second trimester of gestation in adverse pregnancy outcomes. pregnant patients during the 1st and 2nd trimesters at antenatal care in a public health center will be divided into two groups: nig- 'no intervention' or ig- 'intervention,' according to agreement in receive periodontal treatment during pregnancy. treatment will be performed by a single periodontist consisting of scaling and root planning (srp), professional prophylaxis (proph) and oral hygiene instruction (ohi). patients at nig will receive proph and ohi during pregnancy and will be referred for treatment after delivery. periodontal evaluation will be performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (pd), clinical attachment level (cal), plaque index (pi) and sulcular bleeding index (sbi) at baseline and 35 gestational weeks-28 days post-partum. primary adverse pregnancy outcomes to be addressed are: preterm birth (\< 37 weeks), low birth weight (\< 2.500 kg), late abortion (14-24 weeks) or abortion (\< 14 weeks). the results obtained will be statistically evaluated according to or, unpaired t test and paired t test. it is expected that periodontal treatment during the second trimester of gestation will result in decreased rates of adverse pregnancy outcomes.

all patients entering the study at the 1st and 2nd trimesters will be invited to participate in an oral health program, including oral hygiene instruction, caries diagnosis and treatment, and evaluation and treatment of periodontal conditions during the second trimester. those who refuse to receive periodontal treatment during pregnancy will constitute the 'no intervention' control group (nig), while those who agree in receiving dental and periodontal treatment during the second trimester of gestation will constitute the 'intervention' group (ig). patients are going to be evaluated by a single calibrated periodontist blinded in relation to periodontal treatment, which will be performed by another periodontist. treatment consists of scaling and root planning, professional prophylaxis and oral hygiene instruction. obstetrical data, birth weight and gestation duration will be recorded after examination and recording by the responsible obstetrician and nursery staff.

Eligibility criteria:
inclusion criteria: * confirmed singleton gestations * pregnancy of 9-24 * systemically healthy women * age range: 16-39 years old exclusion criteria: * non confirmed pregnancy * age inferior to 16 years or superior to 39 years * multiple gestations * smoking * alcohol or drugs abuse * history of congenital heart disease * current use of corticosteroids or antibiotics * presence of systemic conditions (eg: diabetes, hypertension, or genitor-urinary infections)

Keywords: periodontal disease pregnancy periodontal treatment