Kornimate/medical-research-clean huggingface dataset:
effectiveness of trauma-focused cognitive behavioral therapy in treating children with post-traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: this study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder.

each year approximately 5 million children in the united states are exposed to some form of traumatic event, and nearly 40% of these children will go on to develop post-traumatic stress disorder (ptsd). there are a number of traumatic events that have been shown to cause ptsd in children, including natural disaster, physical or sexual abuse, loss of a loved one, and witnessing an act of violence. children with ptsd may experience persistent generalized fear and anxiety, recurrent nightmares, mood swings, withdrawal, and depression. if left untreated, ptsd can cause serious distress for those affected, resulting in emotional, academic, and social problems. trauma-focused cognitive behavioral therapy (tf-cbt), a form of psychotherapy that focuses on trauma, may be the most effective means of improving ptsd screening and treatment in community-based mental health services. although tf-cbt has shown success in treating children with ptsd in the research setting, its use in community clinics remains limited. this study will compare the effectiveness of tf-cbt versus treatment as usual (tau) in treating children with ptsd in community clinics. the study will also develop a community collaboration between a community mental health agency and an academic institution, both in new york city, to address childhood trauma and ptsd and to enhance research in community clinics. participation in this study will last about 3 months. potential parent and child participants will first undergo initial assessments, which will include interviews and questionnaires concerning symptoms of ptsd. eligible participants will then be assigned randomly to receive tf-cbt or tau. participants in both groups will attend 12 sessions over 3 months. tf-cbt sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their ptsd. tau sessions will include routine community clinic care and will not involve a trauma-focused treatment component. upon completion of treatment, participants will complete repeat interviews and questionnaires.

Eligibility criteria:
inclusion criteria: * seeking services at jewish board of family and children's services outpatient clinics * meets dsm-iv criteria for ptsd * stable on medication for 1 month before study entry * english-speaking exclusion criteria: * active suicidality or anyone whose life circumstances might be considered peri-traumatic (e.g., active current abuse) * uncontrolled psychosis * severe mental retardation or severe brain damage * severe language comprehension barriers

Keywords: treatment ptsd
neointimal features in patients with restenosis of calcified lesions

Conditions: Coronary Artery Calcification; Restenosis; Neointima; Neoatherosclerosis

Summary: previous studies have suggested that restenosis (rs) after stenting is mainly due to smooth muscle cell proliferation and migration, but recent evidence suggests that in-stent restenosis（isr） is associated with a number of factors. coronary artery calcification is an independent predictor of ischaemia-mediated revascularisation 1 year after percutaneous coronary intervention (pci) following rs.the characteristics of new neointima in patients with in-stent restenosis of calcified lesions are important issues to explore

the characteristics of the endothelium after des following implantation of calcified lesions have always been of interest to us. its inherent peculiarities make the new endothelium of calcified lesions different. firstly, the presence of calcification makes the neointima heal slowly. in addition des has an anti-proliferative effect, which further diminishes the healing ability of the neointima of calcified lesions and impairs the barrier function of the endothelium. this may have a similar pathway to the formation of neointimal atherosclerosis or heterogeneous endothelium within the neointima. secondly, stents with calcified lesions can be accompanied by incomplete stent expansion, stent fracture and stent misalignment. these conditions may accelerate the occurrence of restenosis within the stent. thirdly, there are different types of calcified lesions. different types of calcified lesions may heal and restenosis in different ways. it is therefore understood that calcified lesion healing has a number of pathways that exist in contradiction. these are issues that need to be explored in depth.

Eligibility criteria:
inclusion criteria: 1. the patient is older than 18 years. 2. the patient had undergone coronary angiography at our hospital for pci and had first isr with drug-eluting stent implantation. 3. calcified lesion greater than 5 mm in length. 4. stent implantation time greater than 30 days. exclusion criteria: 1. bridge vessel lesions following coronary artery bypass grafting. 2. planned modification of the dapt regimen for medical reasons or other surgical procedures requiring modification within 3 months of the index procedure. 3. patients undergoing heart transplantation. 4. significant angiogenic lesions in the target vessel that may prevent stent delivery and deployment. 5. bifurcation disease lesions involving collateral branches ≥ 2.5 mm in diameter. 6. lesions deemed by the investigator to be unsuitable for oct imaging (e.g., extremely curved, very distal lesions). 7. serum creatinine \> 2.0 mg/dl at the time of treatment. 8. greater than three types of stent implantation. 9. subjects with malignancy or other co-morbidities (i.e., severe liver, kidney, lung, or pancreatic disease with a life expectancy of less than 18 months or which may result in protocol non-compliance).

Keywords: coronary artery calcification isr neoatherosclerosis
postoperative treatment after endoscopic sinus surgery

Conditions: Sinusitis

Summary: objective: even though postoperative debridement is commonly considered as an essential part of endoscopic sinus surgery (ess), the scientific data on the efficacy or the optimal timing of debridement is limited. in the present study, the effect of repeated debridement during the first week after ess on the endoscopic and subjective outcome was evaluated. study design: open, prospective, randomized, controlled clinical trial with two parallel groups. methods: a total of 90 patients suffering from either recurrent or chronic maxillary sinusitis were randomized into two groups after ess. in the active group, the nasal cavities were debrided three times on the first postoperative week, while in the control group the patients were debrided only once on the 7th postoperative day. the primary outcome measure was the presence of scarring in the middle meatus at four weeks after ess.


Eligibility criteria:
inclusion criteria: * a total of 90 patients (age 18-70 years), who underwent ess in kuopio university hospital, kuopio, finland were included in this study. * the patients suffered from either recurrent or chronic maxillary sinusitis and had american society of anaesthesiologists physical status 1 or 2.{{331 sakland,m. 1941; }} exclusion criteria: the patients were excluded if they had: * undergone previous sinus surgery or if they had severe nasal polyposis (radiological opacification more than 50 % of the sinuses (lund-mckay classification) * hemorrhagic diathesis * liver or kidney dysfunction * chronic malnutrition * alcoholism or inflammatory bowel disease. other exclusion criteria were pregnancy and ongoing anticoagulant therapy.
immune responses to gluten

Conditions: Celiac Disease; Malabsorption Syndromes; Digestive System Disease; Intestinal Disease; Gastrointestinal Diseases; Gluten Sensitivity; Celiac Disease in Children

Summary: this is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.

this is a multi-site open-label single dose gluten challenge study. participants will provide a blood sample for measurement of cytokines before and 4 hours after eating gluten powder.

Eligibility criteria:
inclusion criteria: 1. on a gluten-free diet for ≥ 4 weeks 2. willing to consume gluten for research 3. for the celiac disease arm, diagnosis confirmed by serology and/or histology exclusion criteria: 1. pregnancy 2. wheat allergy 3. type 1 diabetes 4. bmi z-score \< -2 5. history of more than minimal symptoms following gluten exposure on a gluten-free diet 6. comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results

Keywords: gluten cytokine t cell immune response
safety and efficacy evaluation of a new contact lens disinfecting solution in soft contact lens wearers

Conditions: Myopia; Astigmatism; Hyperopia; Refractive Error

Summary: the purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.

subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Eligibility criteria:
inclusion criteria: * normal eyes (other than correction for visual acuity); * successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: soflens® 38, proclear dw, frequency 55, acuvue® oasys™, air optix aqua, o2 optix, air optix for astigmatism, air optix aqua multifocal, biofinity®, purevision®, purevision®2; * best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye; * other protocol-defined inclusion criteria may apply. exclusion criteria: * any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study; * need to wear contact lenses on an extended wear basis (ie, overnight) during the study; * use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to visit 1; * history of intolerance or hypersensitivity to any component of the investigational products; * use of all over-the-counter (otc) or prescribed topical ocular medications within 7 days prior to visit 1; * moderate, severe, abnormal, or other ocular findings; * current or history of ocular infection, severe inflammation, or disease within 6 months prior to visit 1; * any systemic disease at visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions; * use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen; * ocular surgery within the last 12 months; * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses contact lens solution soft contact lenses
patterns of prescribing and monitoring of palbociclib

Conditions: Metastatic Breast Cancer; Advanced Breast Cancer; Estrogen Receptor-positive Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Summary: the purpose of this study is to determine if patients with er+, human epidermal growth factor 2 negative (her2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.

this study was a retrospective, single-center study that included women receiving palbociclib for the treatment of er+, her2- advanced breast cancer. exclusion criteria were the presence of brain metastases or active enrollment in a palbociclib clinical trial. the primary endpoint was the proportion of patients who were maintained on a palbociclib dose according to the adjustment schedule in package insert recommendations. the secondary endpoints were the number of patients dose adjusted for hematologic toxicities, the number of patients experiencing neutropenia, duration of therapy, progression-free survival (pfs), and adherence to manufacturer monitoring recommendations.

Eligibility criteria:
inclusion criteria: * women at least 18 years old * er+, her2- advanced breast cancer * receiving palbociclib exclusion criteria: * brain metastases * on palbociclib clinical trial
evaluate safety and the oncolitic adenovirus vcn-01 activity in patients with refractory retinoblastoma

Conditions: Retinoblastoma, Recurrent

Summary: phase i study, single site, open label with dose escalation, for evaluate safety and the oncolitic adenovirus vcn-01 activity in patients with refractory retinoblastoma.

phase i clinical trial, single-center, open-label, dose-escalation study, to evaluate the safety of the vcn-01 and, secondarily, its anti-tumoral activity. the trial sample consists of approximately 13 patients aged between 1 and 12 years old.

Eligibility criteria:
inclusion criteria: 1. patients with retinoblastoma with a somatic mutation of the generb1 and active tumor in a single eye, or germinal mutation of rb1 with active tumor/s in an eye and the contralateral eye unaffected, enucleated or without tumor activity. in both cases, relapsed or refractory with the use of systemic, intraarterial or intravitreal chemotherapy or radiotherapy, in accordance with the availability at his/her referral site, in whom enucleation is the only recommended treatment under opinion of the medical team treating the case at the originating referral site. 2. normal renal function: serum creatinine: \<45μmol/l (0-2 years); \<57μmol/l (3-6 years); \<60μmol/l (7-10 years); \<80μmol/l (11-13 years). 3. normal hepatic function: serum alt: \<0,52μkat/l (de 9 months -12 years); serum ast: 61-80 g/l (8 months - 5 years); 63-83 g/l (5-9 years); 63-82 g/l (9-12 years). 4. adequate marrow reserve manifested in an absolute neutrophil count\> 1000 / mm3, platelets\> 100,000 / mm3 and hemoglobin\> 8 g / dl, without transfusional or cytokine support at least one month prior to study entry. 5. age greater than one year and less than 12 years at the time of inclusion in the study. 6. informed consent form signed. exclusion criteria: 1. presence of factors that require immediate enucleation of the affected eye such as glaucoma, rubeosis iridis, anterior chamber involvement. 2. comorbidities: uncontrolled epilepsy with anticonvulsant treatment, cardiac disease not compensated by treatment. 3. active infections. 4. other chronic or active acute diseases that under the criterion of the researcher were an exclusion criterion. 5. history of having received attenuated or live vaccines in the 30 days prior to inclusion in the study. 6. any cause of immunosuppression. 7. trilateral retinoblastoma. 8. extraocular spread. 9. history of having received treatment for retinoblastoma with chemotherapy or radiation therapy by any means within 30 days prior to inclusion in the study. 10. patients who can not complete the study procedures for reasons psychological or social. 11. pregnancy. female patients with procreative potential should be agree to undergo a blood or urine pregnancy test and the result should be negative to enter the study.

Keywords: gene therapy
the effect of plasma-air-filtration on the incidence of surgical site infections in orthopaedic surgery

Conditions: Orthopaedic Surgery (30 Minutes or Longer)

Summary: the study is a multicenter, double-blind, randomized, controlled trial conducted at six major university and teaching hospitals with a catchment population of approximately 2 million. in the current study it has been hypothesized that a non-invasive air cleaner utilizing a plasma chamber can significantly reduce the incidence of surgical site infections (ssis).

despite operating in clean theaters, surface sterilization, and antibiotics, surgical site infections (ssi) after orthopaedic surgery have an estimated incidence of 1-4%. this feared complication is associated with long-term antibiotics, repeated surgeries, prolonged hospital stays, economic burden and a poorer end result for individual patients. it is therefore of great importance to prevent ssi.while skin bacteria and contaminated surfaces have generally been claimed to be the main cause of infections, there are estimates that approximately 20% of hospital-acquired infections are air-transmitted, making this an interesting intervention target. novaerus is an air-cleaner that sterilizes the air particles through a plasma chamber. air in the operating theatre is pumped through the chamber (80-380 m3/hr) and by using a small current it transforms the gas in the vicinity of the electrode into plasmaand eradicates any bacteria that pass through.the small size of the machine allows it to fit into any operating theater without interfering with existing equipment. this technology can reduce the number of colony forming units (cfu) when in hospital settings. in non-randomized settings it has been correlated to reduced respiratory infections, reduced personnel sick-leave, and absence of severe infectious outbreaks. its effect has not been validated in randomized controlled trials. both local and national registry data will be used according to availability.

Eligibility criteria:
inclusion criteria: * all patients that undergo a 30 minute or longer orthopaedic surgery exclusion criteria: * the following surgeries will be excluded: already infected surgical site, defined as: icd-codes indicating infection, open fractures, traumatic wounds, vacuum assisted wound therapy * patients that have had antibiotics prescribed 2 weeks or less prior to surgery * patients that have actively marked their hospital charts with an added privacy notice
satisfaction, qol,health status & clinic outcomes for patients attending msk triage clinics in rheumatology

Conditions: Musculoskeletal Pain; Rheumatologic Disorder

Summary: the aim of this study is to measure the impact of musculoskeletal (msk) complaints on the quality of life and general health of msk patients attending msk triage clinics. the investigators will also record the proposed management options for patients' complaints. this will be achieved by asking patients to complete questionnaires (msk hq) at musculoskeletal triage clinic appointment, by undertaking a clinical assessment, by recording the proposed management plan and assessing if patients have follow up appointments for the same complaint in the following year. the investigators will also measure patient satisfaction using vsq 9 questionnaire. after a year the investigators will repeat the msk hq to assess the longterm impact of msk triage appointment on the msk complaint.

at present there is no data available to describe the impact of musculoskeletal (msk) disease on the quality of life and general health for patients attending rheumatology msk triage clinics in suh and ohlm or in similar service around ireland. a new questionnaire (msk hq) has been developed which has been validated in use with this population. this will be completed by the patient on the day of the appointment and again a year later. their number of visits to secondary care in the year after their visit will also be captured and analysed. this information will inform the health service of the outcomes of these patients and the impact of their msk disease on the health service. it will also help with resource allocation and planning for future services, which will ensure the best service for these patients in the future. alongside this, patient satisfaction and feedback is vital to ensuring service quality and quality improvement. the vsq 9 will be used to measure patient satisfaction in this study to evaluate if patients are satisfied with the service they have received on the day. the repeated msk hq will help identify if their triage clinic appointment was beneficial to their quality of life.

Eligibility criteria:
inclusion criteria: * 18 years and over * patients who attend the musculoskeletal triage clinic in rheumatology. * patients who can answer the study questionnaires independently. exclusion criteria: * under 18 years * patients who present with red flag conditions, inflammatory disease or non-musculoskeletal conditions. * patients who cannot answer the study questionnaires independently.

Keywords: physiotherapy triage musculoskeletal pain patient satisfaction vsq 9 msk hq
dexamethasone in preventing hearing loss in patients receiving cisplatin

Conditions: Malignant Neoplasm; Ototoxicity

Summary: this randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss.

primary objectives: i. investigate the potential protective effect of intratympanic dexamethasone administration on cisplatin-induced ototoxicity. outline: patients are randomized as to which ear receives dexamethasone. patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear. after completion of study treatment, patients are followed up before each cisplatin treatment and then at 1 and 3 months after the last cisplatin treatment.

Eligibility criteria:
inclusion criteria: * planned cisplatin treatment restricted to the following treatment course criteria: * dose: \> 50 mg/m\^2 * frequency: every (q)3-q4 weeks * cycles: 7 maximum exclusion criteria: * previous cisplatin treatment * previous or concurrent radiation treatment to the head and neck region * previous or existing pathology of the external or middle ear which would preclude auditory testing and/or intratympanic dexamethasone delivery * previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, meniere's disease, autoimmune inner ear disease) * previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma) * recent steroid treatment within the last month