Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of t.r.u.e. test® fragrance mix and thimerosal allergens:bioequivalence of pvp formulations

Conditions: Dermatitis, Contact

Summary: open, prospective, multi-center study to evaluate the bioequivalence of povidone (pvp) formulations of 2 t.r.u.e. test allergens: fragrance mix and thimerosal.

bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.

Eligibility criteria:
inclusion criteria: * current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to fragrance mix and/or thimerosal. * all subjects must be adults (18 years of age or older) and otherwise in good health. * pre-menopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion. * informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations. exclusion criteria: * subjects unable to meet inclusion requirements. * women who are breastfeeding or pregnant. * topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area. * systemic treatment during the last 7 days with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents. * treatment with ultraviolet (uv) light (including tanning) during the previous 3 weeks. * acute dermatitis outbreak or dermatitis on or near the test area on the back. * subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). * subject participation in clinical trials of investigational drugs, treatments, or devices, other than t.r.u.e. test, during this study or 3 weeks prior to inclusion in this study.

Keywords: bioequivalence thimerosal fragrance mix pvp formulation contact dermatitis
reduced-dose conditioning regimen containing tbi in hsct treating elderly patients with aplastic anemia

Conditions: Aplastic Anaemia; HSCT; TBI; Old Age

Summary: the tbi-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. the overall survival rate, gvhd-free survival rate, all-cause mortality,et al were studied. the modified conditioning regimen included tbi 2gy, -7d, busulfan 3.2mg / kg-6d ; fludarabine 30mg / m2 / d-5 \~ -1d ; cyclophosphamide 25-30mg / kg / d-5 \~ -2d ; atg ( rabbit ) 2 mg / kg / d-5 \~ -1d.


Eligibility criteria:
inclusion criteria: * ( 1 ) diagnosis of aplastic anemia, including very severe aplastic anemia, severe aplastic anemia, chronic aplastic anemia and hepatitis-associated aplastic anemia. ( 2 ) age older than or equal to 50 years old. ( 3 ) informed consent can be signed by themselves. ( 4 ) hiv negative, hbv, hcv negative. ( 5 ) informed consent must be signed before the start of the study procedure. informed consent must be signed by the patient or immediate family members who are 18 years old or older. considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family. exclusion criteria: * ( 1 ) patients who underwent more than one time of transplantation before enrollment ; ( 2 ) uncontrolled infection, mechanical ventilation or hemodynamic instability at the time of enrollment ; ( 3 ) diagnosis of clinically significant severe liver dysfunction ( defined as child-pugh c grade ) within 5 days before enrollment ; or within 5 days before enrollment, ast or alt was 5 times higher than the upper limit of normal, or serum total bilirubin was 2 times higher than the upper limit of normal ; ( 4 ) end-stage renal insufficiency was diagnosed within 5 days before enrollment, and creatinine clearance rate was less than 10ml / min. ( 5 ) simultaneous diagnosis of moderate hepatic insufficiency and moderate renal insufficiency ( moderate hepatic insufficiency was defined as child-pugh b grade ; moderate renal insufficiency was defined as creatinine clearance rate less than 50ml / min ). ( 6 ) in addition to localized basal cell or squamous cell skin cancer or treatment conditions ( such as lymphoma ), there are active solid tumor malignant tumors. ( 7 ) there was active hiv replication before enrollment. hcv antibody positive, hcv-rna positive, or hbsag positive could be detected within 90 days before enrollment. the serological response to hiv or active hepatitis c virus is known to be positive. ( 8 ) having a mental illness or other condition that does not cooperate with the requirements of research, treatment and monitoring. ( 9 ) unable or unwilling to sign the consent form. ( 10 ) patients with other special conditions who were assessed as unqualified by the researchers.

Keywords: aplastic anemia hsct old age conditioning regimen
cognition in postoperative total hip arthroplasty and total hip resurfacing patients

Conditions: Cognition

Summary: transient cognitive changes after surgery may be due to many different factors. it is estimated that between 5-29% of patients undergoing orthopedic surgery experience a transient decline in their cognition. fat and bone marrow debris embolization can cause cognitive changes if they enter the cerebral circulation in significant numbers. during total hip arthroplasty the placement of the femoral stem leads to a rise in intramedullary pressure which can cause fat and bone marrow debris to embolize into the systemic circulation. total hip resurfacing arthroplasty avoids entrance into the femoral canal. the purpose of this study is to assess transient cognitive changes after total hip arthroplasty and compare them to patients undergoing total hip resurfacing arthroplasty. we hypothesize that patients undergoing total hip resurfacing arthroplasty will experience less transient cognitive changes due to the avoidance of violating the femoral canal during the procedure.


Eligibility criteria:
inclusion criteria: 1. male and non-pregnant, non-lactating, female subjects who are 18 and older 2. subjects who are able and willing to provide informed consent 3. subjects deemed able to comply with study schedule visits and procedures 4. subjects undergoing elective tha procedures 5. subjects undergoing elective total hip resurfacing arthroplasty 6. subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination. exclusion criteria: 1. subjects with or with a history of parkinson's disease 2. subjects with a history of depression as reported in their past medical history 3. subjects with a history of dementia as reported in their past medical history 4. subjects currently using antidepressants 5. subjects currently using antipsychotic medications

Keywords: transient cognitive decline following orthopaedic surgery
perioperative eeg-monitoring and postoperative delirium in patients undergoing cardiovascular surgery

Conditions: Delirium

Summary: postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. however the pathogenesis of postoperative delirium is poorly understood. multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. the aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram.


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years 2. normal cognitive function at the time of enrollment evidenced by a mini-mental state examination (mmse) score of more than 24 of 30 3. chinese mandarin as the native language 4. providing informed consent exclusion criteria: 1. pre-existing delirium assessed according to the confusion assessment method (cam) 2. history of neurological or psychiatric disease 3. impaired vision or auditory function which may effect the assessments 4. unwillingness to participate in the study
arc intellicare for telerehabilitation

Conditions: Parkinson Disease; Multiple Sclerosis; Stroke

Summary: in the last 5 years, the available literature evidence has indicated that, in terms of clinical efficacy, telerehabilitation can give comparable results compared to face-to-face rehabilitation. studies of post-stroke patients have revealed some benefits of telerehabilitation, such as the ability for patients to self-record pain, mood and activity. telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of some abilities, such as motor function, activities of daily living (adl), and independence; it is less effective, however, for the recovery of balance control. published reviews concerning, in particular, neurological/neurodegenerative diseases show that telerehabilitation systems are effective in maintaining and/or improving some motor aspects, such as balance and gait, and non-motor aspects, such as mood and quality of life; they also increase patient satisfaction, so in the long term they appear to be beneficial, convenient and satisfying for patients and operators. arc intellicare is a device undergoing certification as a class i medical device (dm), already clinically tested during two uncontrolled clinical feasibility studies: arcangel study (post-stroke, clinicaltrials.gov identifier: nct03787433) and ricominciare study (post-covid19 and parkinson's disease, clinicaltrials.gov identifier: nct05074771).


Eligibility criteria:
inclusion criteria: * patients with diagnosis of parkinson's disease with hoehn\&yahr staging 1-3 * diagnosis of multiple sclerosis with extended disability scale score 3.5-6 * diagnosis of ischemic stroke in the past 12 months exclusion criteria: * history of falls * dementia * epilepsy
24 week efficacy and 3-year safety and efficacy of secukinumab in active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active psoriatic arthritis despite current or previous nonsteroidal anti-inflammatory drug (nsaid), disease-modifying antirheumatic drug (dmard) therapy and/or previous anti-tumor necrosis factor alpha (tnfα) therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of psoriatic arthritis (psa) classified by classification criteria for psoriatic arthritis (caspar) criteria. * rheumatoid factor and anti-cyclic citrullinated peptide (ccp) antibodies negative. * diagnosis of active plaque psoriasis or nail changes consistent with psoriasis. * inadequate control of symptoms with nsaid. exclusion criteria: * chest x-ray or chest magnetic resonance imaging (mri) with evidence of ongoing infectious or malignant process. * subjects taking high potency opioid analgesics. * previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (il-17) or il-17 receptor. * ongoing use of prohibited psoriasis treatments / medications. * subjects who have ever received biologic immunomodulating agents except for those targeting tnfα. * previous treatment with any cell-depleting therapies.

Keywords: psoriatic arthritis ain457 psa acr caspar pasdas secukinumab autoinjector
reduction in arrhythmia burden with left atrial posterior wall ablation for persistent af

Conditions: Atrial Fibrillation

Summary: rablap-af will compare pulmonary vein isolation (pvi) in combination with posterior wall isolation (pwi) for patients with persistent atrial fibrillation (af).

ablation for af has a high success rate for patients with paroxysmal af, but success rates for persistent af remain significantly lower. these patients frequently have more advanced disease in their left atrium than those with paroxysmal af. a common practice is to perform left atrial pwi in addition to pvi in order to reduce af recurrence. this approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. the investigators hope to fill this gap with rablap-af. the investigators will randomise patients with advanced atrial disease 1:1 to pvi+pwi or pvi alone. all patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of pwi and compare arrhythmia burden before and after ablation.

Eligibility criteria:
inclusion criteria: * age 18 to 80 (inclusive) * patients with symptomatic advanced persistent af, defined as: * af which does not spontaneously terminate and requires medical intervention (antiarrhythmics or dccv) to terminate, and * recurs following cardioversion, and * is associated with evidence of left atrial cardiopathy, defined as at least mild left atrial enlargement on imaging (echo, ct or mri) as defined by standard values (for example british society of echocardiography or european equivalent) - in the event of uncertainty, principal investigator discretion is allowed. exclusion criteria * any previous catheter (or surgical) ablation for af (previous ablation for atrial flutter or focal atrial tachycardias are allowable) * an indwelling atrial septal defect occluder device or anatomical structure that pre-vents free access to the left atrium * severe left ventricular systolic dysfunction (ejection fraction less than 35%) * recent stroke/transient ischaemic attack within 3 months * inability, unwillingness or absolute contraindication to taking an oral anticoagulant medication * severe kidney function impairment (egfr less than 30ml/min/1.73m2) * morbid obesity with a body mass index ≥40 * extreme frailty (a score of 7,8 or 9 on the rockwood clinical frailty scale) * severe valvular heart disease of any kind as assessed by the investigator, with or without a prosthetic valve in place * pregnancy

Keywords: atrial fibrillation posterior wall isolation ablation persistent atrial fibrillation
a trial to assess the effect of an intervention integrating contingency management (financial incentives) to enhance hepatitis c treatment uptake following dried blood spot hepatitis c rna testing among people with recent injecting drug use attending needle and syringe programs

Conditions: Hepatitis C, Chronic

Summary: a pilot two-arm, individual-level, randomised controlled trial to assess the effect of an intervention integrating contingency management (financial incentives) to enhance hepatitis c treatment uptake following dried blood spot hepatitis c rna testing among people with recent injecting drug use attending needle and syringe programs: the amplify study


Eligibility criteria:
inclusion criteria: 1. participants have voluntarily signed the informed consent form 2. 18 years of age or older 3. recent injecting drug use (previous six months) exclusion criteria: 1) inability or unwillingness to provide informed consent
prophylactic olanzapine versus placebo for prevention of postoperative delirium after joint replacement surgery

Conditions: Delirium

Summary: in this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium.

postoperative delirium is a serious and common (20% to 60%) complication in orthopedic surgery patients. in this study we investigate whether prophylactic administration of olanzapine can prevent delirium from occurring after knee or hip replacement in high-risk patients \> 65 years of age. this is a randomized, double-blind, single center, placebo-controlled study.

Eligibility criteria:
inclusion criteria: * high risk for delirium age \> 65 history of delirium medical comorbidities ability to give informed consent exclusion criteria: * dementia alcohol abuse current use of an antipsychotic allergy to olanzapine

Keywords: delirium, atypical antipsychotics, olanzapine, orthopedic
a serum galectin-3 levels in placenta accreta spectrum pregnancies

Conditions: Placenta Accreta, Third Trimester

Summary: placenta accreta spectrum (pas) represents a significant cause of maternal morbidity and mortality, causing complications that surpass those posed by most routine obstetric issues. as such, early detection and proper management of pas can significantly improve pregnancy outcomes. this study provides an in-depth examination of the serum levels of galectin-3, a β-galactoside-binding protein, in women experiencing placenta accreta spectrum compared to those with normal pregnancies.

placenta accreta spectrum (pas) represents a significant cause of maternal morbidity and mortality, causing complications that surpass those posed by most routine obstetric issues. as such, early detection and proper management of pas can significantly improve pregnancy outcomes. this study provides an in-depth examination of the serum levels of galectin-3, a β-galactoside-binding protein, in women experiencing placenta accreta spectrum compared to those with normal pregnancies. galectin-3 has been implicated in various physiological processes such as cell-cell interaction, cell-matrix adhesion, and immune responses. moreover, recent evidence suggests an increased level of galectin-3 is also associated with inflammation, fibrosis, and adverse outcomes in several pathological conditions like cardiovascular diseases and cancer. these multiple roles of galectin-3 underline its potential implications and predictive ability in many pathological conditions including pas disease progression during pregnancy. in obstetric context, research on the role and level of galectin-3 is sparse. this study aims at filling this gap by comparing the serum galectin-3 levels in pas and normal pregnancies. it seeks to investigate whether there is a significant difference between the two cohorts, which could highlight the potential use of galectin-3 as a possible biological marker in predicting or diagnosing placenta accreta spectrum.

Eligibility criteria:
inclusion criteria: * pas diagnosis exclusion criteria:systemic diseases (e.g. chronic hypertension, diabetes, hypothyroidism, chronic renal-liver diseases, etc.), autoimmune disorders, multiple pregnancies, or the presence of fetal structural and chromosomal anomalies. cholestasis of pregnancy, preterm delivery, or evidence of chronic and active infection. -
implant and external radiation for prostate cancer with or without hormonal therapy: a prospective randomized trial

Conditions: Prostate Cancer

Summary: determine the role of androgen deprivation therapy in high risk patients receiving 45 gy of pelvic radiotherapy plus a pd-103 boost and the impact of the duration of adt in hormonally-manipulated patients.

in calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. although the vast majority of men will be diagnosed with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. however, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy. prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2). several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).

Eligibility criteria:
inclusion criteria: * high risk patients - two to three of the following: psa 10-30 ng/ml, gleason score greater than or equal to 6, clinical stage greater than or equal to t2c (2002 acjj). * ct of the abdomen and pelvis and bone scan without evidence of metastases. * an enzymatic prostatic acid phosphatase must be obtained prior to randomization. * a serum testosterone must be obtained prior to initiation of androgen deprivation therapy. * no prior pelvic external beam radiation therapy for prostate cancer or other malignancies. * no prior androgen deprivation therapy. * minimum 5 year life expectancy. * no other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years. exclusion criteria: * exclusion criteria will be limited to patients who do not meet the above eligibility criteria.

Keywords: radiation therapy brachytherapy prostatic neoplasm
a study to assess the effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients (0476-075)

Conditions: Asthma

Summary: a study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.


Eligibility criteria:
inclusion criteria: * males or females between the ages of 18 and 70 with asthma
evaluation of psychotherapeutic intervention model in nursing

Conditions: Anxiety Generalized

Summary: this study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis ineffective coping. for this purpose, validity and reliability studies of the assessment tools will be carried out initially, and then a randomized controlled study will be conducted.

this study aims to evaluate the efficacy of the psychotherapeutic intervention model in nursing on patients with nursing diagnosis of ineffective coping (international classification of nursing practices (icnp)/north american nursing diagnostic association (nanda)). for this purpose, first of all, validity and reliability studies of "coping" and "self-esteem", which are the results of noc (nursing outcomes classification), will be conducted, and then a randomized controlled study will be conducted (turkish version). 200 patients will be included in the validity and reliability phase of the study, which was conducted in a hospital outpatient psychiatric setting in turkey. the randomized controlled second phase will be carried out, single-blind, nurse-led, with approximately 20 patients with anxiety randomized to intervention (n=10) or control groups (n=10). the usual treatment and care will be compared with the application of the psychotherapeutic intervention model previously developed in nursing.

Eligibility criteria:
inclusion criteria: * 18-64 years old, * literacy, * having applied to the psychiatry outpatient clinic, * being regularly treated in a psychiatry outpatient clinic, * having a medical diagnosis of generalized anxiety disorder, * having at least one of the defining characteristics of the nursing diagnosis of ineffective coping according to the nursing process. exclusion criteria: * medical diagnosis of dementia or psychotic spectrum disorder, * cognitive disorder, * confused state of consciousness * psychomotor agitation, * moderate or severe intellectual disability * expressing suicidal thoughts * suicide attempt in the last month * continuing psychological counseling at the moment.

Keywords: nursing outcomes classification psychotherapeutic intervention patient outcome psychiatric nursing anxiety generalized coping self esteem