Kornimate/medical-research-clean huggingface dataset:
radiation dose in percutaneuos coronary procedures through transradial approach using dedicated radiation shields

Conditions: Myocardial Ischemia

Summary: during percutaneous coronary interventions standard operator radio-protection is generally ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded glass suspended from the ceiling and leaded glasses. previous studies showed that adding a bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield on the patient, the radiation dose adsorbed by operators was significantly reduced even if was higher compared to transfemoral approach. no studies evaluated the effect of both adjunctive shields placed in the same patient. aim of our randomized study is to evaluate if the combination of a shield drape on the patient right arm and a pelvic lead shield during transradial percutaneous coronary procedures may reduce the radiation dose adsorbed by operators compared to the use of only one shield or none. all patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study. eligible patients will be randomized (using a computer generated randomization sequence) in 4 groups: 1. use of a pelvic shield drape 2. use of a shield drape on the patient right arm 3. use of a pelvic shield drape and a shield drape on the patient right arm 4. any adjunctive shield drape (only standard radio-protection) for each group a further internal randomization will be performed in order to compare the right or left radial transradial approach. each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax level outside the lead apron. since december 2013 the operators are equipped with a further dosimeter at head level. primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters. secondary end-point are: 1. radiation dose adsorbed by operators according to the radial access (right versus left) 2. radiation dose adsorbed by the patients 3. radiation dose adsorbed at head level.


Eligibility criteria:
inclusion criteria: all patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study exclusion criteria: 1. previous coronary artery by-pass 2. acute st elevation myocardial infarction 3. hemodynamic instability or cardiogenic shock 4. ischemic allen test.

Keywords: transradial approach shield drape radiation ptca
cerliponase alfa observational study in the us

Conditions: Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2

Summary: this is a multicenter, observational study for patients with a confirmed diagnosis of neuronal ceroid lipofuscinosis type 2 (cln2 disease), also known as tpp1 deficiency, who intend to be or are currently being treated with cerliponase alfa. patients receiving or expected to receive cerliponase alfa within 60 days of signing the informed consent form (icf) may be eligible to enroll in the study, assuming all regulatory requirements for sites that have agreed to participate and protocol inclusion criteria are met. data may be collected for all or some of the assessments as outlined in the protocol, dependent upon the clinic's and/or individual patient's standard of care.


Eligibility criteria:
inclusion criteria: 1. diagnosed with cln2 disease. 2. currently receiving or plan to begin treatment with cerliponase alfa. 3. written informed consent/assent obtained. exclusion criteria: 1. currently receiving treatment in another investigational device or drug study.

Keywords: batten's disease cln2 tpp1 enzyme
serum mir-122 as a real-time detection biomarker of drug-induced liver injury by chemotherapy

Conditions: Chemotherapeutic Toxicity; Malignant Tumor; Liver Injury

Summary: this is an open , multicenter, interventional clinical trial to conform the role of of mir-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.

the endorsed standard serum biomarkers, like alt, ast, total bilirubin, are not tissue-specific, and cannot detect drug-induced liver injury (dili) at a very early stage, thus unable to properly guide risk assessment and patient management. mir-122 is a liver-enriched mirna. many studies have demonstrated that mir-122 is a sensitive and specific biomarker when dili occurred. however, there is a lack of a standard quantification method for mir-122 and confirmatory studies using a comprehensive list of drugs and patients. the investigators have developed the mirna-derived fragment length polymorphism (mirflp) assay for the simultaneous quantification of multiple mirnas.the methodology improves detection reliability by eliminating intra-assay variables. in this study, the investigators will investigate the role of mir-122 as a real-time detection biomarker of drug-induced liver injury utilizing the mirflp assay. in addition, the investigators will try to identify the normal physiological range of mir-122 in healthy population and the relationship of mir-122 and hepatic failure in patients of intensive care unit.

Eligibility criteria:
inclusion criteria: for all the participants: * normal liver function biomarkers including alt,ast,alp,tbil before recruitment. * patients with liver disease:hepatitis b，hepatitis c，cirrhosis, hepatic failure and so on. for patients in chemotherapy group: * life expectancy at least 12 weeks * 40 patients received epirubicin-containing chemotherapy * 40 patients received paclitaxel-containing chemotherapy * patients received carboplatin-containing chemotherapy. * patients with congestive heart failure * unstable angina pectoris * previous history of myocardial infarction within 6 month prior to study entry * uncontrolled hypertension as determined by the investigator or high risk uncontrolled, arrhythmia. exclusion criteria: * patients previously received chemotherapy

Keywords: serum mir-122 drug-induced liver injury by chemotherapy malignant tumor patients
a study of open angle glaucoma or ocular hypertension in patients within scandinavia

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: phxa41 is not inferior to timolol in reducing intra-ocular pressure


Eligibility criteria:
inclusion criteria: * unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. * open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.) * iop of 22mmhg or higher obtained during the pre-study period. exclusion criteria: * history of acute angle closure. * severe trauma at any time. * intraocular surgery or argon laser trabeculoplasty within 6 months. * current use of contact lenses. * history of severe dry eye syndrome. * ocular inflammation/infection with three months of inclusion. * any condition preventing reliable applanation tonometry. * unacceptable finding at pre-study ocular examination as specified in the case report forms. * in investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status. * treatment of elevated iop with any topical b-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start. * cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block. * bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. * having participated in any other clinical study within the last month.

Keywords: open angle glaucoma ocular hypertension
ezpap therapy versus non-invasive ventilation therapy

Conditions: Non Invasive Ventilation

Summary: this study compared ezpap and noninvasive treatments of hypercapnic copd attacks.

in this study, the effectiveness of niv and ezpap treatments was compared in patients admitted to the emergency department due to hypercapnic copd exacerbation. blood gas was taken at the 4th and 24th hours of treatment to evaluate the effectiveness.

Eligibility criteria:
inclusion criteria: clinical diagnosis of chronic obstructive pulmonary disease dyspnea exclusion criteria: cardiac failure dead

Keywords: chronic obstructive pulmonary dissease non-invasive ventilation ezpap
hp 129xe mri for evaluation of clad in lung transplant recipients

Conditions: Lung Transplant Rejection

Summary: to evaluate the feasibility of hyperpolarized 129xe mri in lung transplant recipients and assess structural and functional pulmonary changes using hyperpolarized 129xe mri

lung transplantation is an effective treatment for end-stage lung disease. however, median survival post-ltx is 6 years. this is primarily due to chronic lung allograft dysfunction (clad). clinical management of ltx recipients is focused on identifying early risk factors for clad, by monitoring graft function with spirometry and transbronchial biopsies. however, both have significant limitations. hyperpolarized (hp) noble gas lung mri (3he and 129xe) allows mapping of both lung anatomy and function. 129xe-mri could provide a diagnostic tool that is able to detect clad more sensitively and earlier than the current gold standard measurements of spirometry and plethysmography, and thus allow a means to detect and prevent /slow down irreparable and irreversible damage to the lungs in the early stages of disease.

Eligibility criteria:
inclusion criteria: * patients, deemed clinically stable by the lung transplant team at uhn toronto lung transplant program (tltp), 18 years of age or older * double lung transplant recipient * for the 5 clad-free participants - at least 1 year of follow-up post-ltx and no substantial and persistent fev1 decline (as per the ishlt clad definition). * for the 10 participants with clad - prior diagnosis of clad made by the clinical team (member of the tltp). * pft measurements within 1 month of scan visit. * fev1 \> 1.0 l exclusion criteria: * currently pregnant or lactating * psychiatric or addictive disorders that would preclude obtaining informed consent or adherence to protocol * inability to travel to obtain mri scan * any contraindications to mri including but not limited to severe claustrophobia, implanted devices, aneurysm clips, neurostimulators (patients will be prescreened prior to registration). * baseline oxygen saturation of less than 88%. * requiring supplemental oxygen at baseline

Keywords: lung mri 129xenon lung transplant recipient chronic lung allograft dysfunction
listening for leisure after stroke

Conditions: Stroke

Summary: stroke is the biggest cause of disability in older adults. early poststroke rehabilitation focuses primarily on physical disability and activities of daily living. by contrast, relatively little research attention has been paid to the potential for cognitive rehabilitation and mood enhancing interventions in the early stages after stroke. low mood and cognitive difficulties with attention and memory are common post stroke leading to poorer recovery, emotional wellbeing and quality of life yet accessible and effective therapies are lacking. engagement in leisure activities may enhance recovery after stroke but participation in leisure activities is reduced following stroke. music listening is a low cost and accessible leisure activity that has been suggested to improve mood and cognition poststroke. the investigators speculate that music listening may enhance control of attention in a similar way to mindfulness interventions, that have been demonstrated to be beneficial in the treatment of mood disorders. the investigators propose that adding a brief mindfulness intervention to music listening might enhance the effect on control of attention, with positive effects on cognition and mood poststroke but the feasibility and acceptability of this intervention needs to be evaluated before attempting a further trial assessing the effectiveness of this intervention. the investigators aim to recruit 100 patients within two weeks poststroke. participants will be randomly assigned to receive an 8 week music listening alone, music listening with brief mindfulness or audiobook listening intervention alongside treatment as usual. neuropsychological assessment of cognition and mood will be performed at baseline, 3 months, and 6 months poststroke in addition, participants will be interviewed about their experience of engaging in the interventions.


Eligibility criteria:
inclusion criteria: * diagnosis of ischaemic stroke (confirmed clinically and/or radiologically and subclassified according to the oxford clinical stroke classification) * ≤14 days poststroke at time of recruitment (expression of interest to participate either verbally or in writing) * native english speaking exclusion criteria: * comorbid progressive neurological or neurodegenerative condition * major psychiatric disorder (prestroke history of mood disorder or stable antidepressant medication will not lead to exclusion) * history of major substance abuse problems * unable to give informed consent * unable to cooperate with the study protocol (e.g. due to severe aphasia, uncorrected impairment of hearing or vision, or illiteracy) * clinically unstable (e.g. due to major intercurrent illness).
prediction of functional disability in subjects with scapular dyskinesis

Conditions: Scapular Dyskinesis

Summary: background: patterns of scapular dyskinesis have unique scapular kinematics and associated muscular activation. the characteristics of scapular dyskinesis may be associated with functional disability. the investigators investigated whether the level of shoulder function and primary dysfunction items were different in each unique pattern of scapular dyskinesis. the factors associated with shoulder dysfunction in different patterns of scapular dyskinesis were identified. methods: participants with unilateral shoulder pain were classified as having a single dyskinesis pattern (inferior angle prominence, pattern i; medial border prominence, pattern ii) or a mixed dyskinesis pattern (patterns i+ii). clinical measurements with the flexilevel scale of shoulder function (flex-sf score), shoulder range of motion, anterior/posterior shoulder tightness, and pectoralis minor index were recorded. these clinical measurements, 3-d scapular kinematics (electromagnetic-based motion analysis), and associated muscular activation (electromyography on the upper, middle, and lower parts of the trapezius and serratus anterior muscles) during arm elevation were analyzed for associations with functional disability.


Eligibility criteria:
inclusion criteria: * subjects were from 18 to 50 years old and had unilateral shoulder pain around the shoulder complex, including the glenohumeral, scapulothoracic, sternoclavicular, and acromioclavicular regions, while performing shoulder movement. exclusion criteria: * subjects were excluded if they had a history of shoulder dislocation, fracture, or shoulder surgery within the past 1 year, or a history of direct contact injury to the neck or upper extremities within the past 1 month. subjects who had neurological disorders or demonstrated pain (vas\>3) during the overall testing procedures were also excluded.

Keywords: scapular dyskinesis kinematics
choice of the optimal treatment strategies for mid-low rectal cancer

Conditions: Rectal Neoplasms

Summary: the purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in china, and to conduct cost utility analysis (cua) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. the investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.


Eligibility criteria:
inclusion criteria: * pathologically confirmed rectal adenocarcinoma * located within 12cm below the anal verge exclusion criteria: * diagnosed with distant metastasis * multiple primary colorectal cancers * history of previous malignant tumors * pregnant or lactating women
19/5000 (synapsot21) predictive factors of sleep apnea syndrome in down syndrome

Conditions: Down Syndrome; Sleep Apnea, Obstructive; Polysomnography

Summary: the obstructive sleep apnea syndrome (osas) is frequently reported in subjects with trisomy 21. the consequences of this syndrome are expressed in various disorders such as cognitive and cardiovascular alterations. it is also reported a premature exhaustion with the achievement of various professional or recreational activities, as well as an increase in the frequency of daytime sleepiness. in trisomy 21, there are factors that are systematically associated with obstructive apnea. the identification of these factors would make it possible to diagnose osas earlier, under-diagnosed in the population with trisomy 21 even though these osas are associated with increased cardiovascular risks. the aim of this study is to identify the predictive factors associated with sleep apnea in the trisomy population in order to propose early detection. osas treatment in a young adult with down syndrome could reduce physical fatigue apparition during various activities, reduce daytime sleepiness, and have a positive impact on physical fitness, and therefore more broadly on health.

the predictive factors for osa that will be studied are: physical activity level, dentofacial disharmonies, blood parameters, motor disabilities, heart rate variability parameters measured during sleep and during autonomic nervous stimulation by orthostatic test. all these factors will be linked to the data obtained by: 1. polysomnography 2. by the joint use of seismocardiography osas lead to many associated disorders, which identified early can be better supported to limit the deleterious effects of this osas: (i) a sudden and repeated activation of the sympathetic nervous system triggered by sleep fragmentation (ii) intermittent hypoxia associated with osas may increase insulin resistance through the involvement of an inflammatory state and oxidative stress. (iii) a significant level of diurnal fatigue limiting activities, thus promoting a sedentary lifestyle and increasing cardiovascular risk factors. several secondary objectives will therefore be studied: 1. can osas be predicted by the existence of autonomic dysfunction? 2. can osas be predicted by specific biological disturbances? 3. can osas be predicted by the presence of a specific cranial structure? 4. can osas be predicted by an insufficient level of physical activity? finally does the use seismocardiography make it possible to identify quickly and early these risk factors linked to osas?

Eligibility criteria:
inclusion criteria: subjects with down syndrome, able to practice physical activity all participants have received information all have signed the consent form exclusion criteria: * pregnant women * pharmacological treatment altering autonomic nervous system (ans) * contra-indication to physical exercise, such as atlanto-axial instability

Keywords: autonomic nervous system heart rate variability physical activity exercise biological parameters cephalometry body composition actigraphy motor capacity physical fitness aerobic capacity seismocardiography
phase 3 study of imiquimod creams in the treatment of external genital warts

Conditions: Genital Warts

Summary: the purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (egw). the secondary objective of this study is to provide information on recurrence of egw. additionally the study will also look at any adverse events associated with the use of the creams. external genital and perianal warts are caused by the infection of human papillomavirus or hpv. hpv infection is a sexually transmitted disease (std). external genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. the warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. they often appear in clusters of three or four, and may grow and spread rapidly. they usually are not painful, although they may cause mild pain, bleeding, and itching.


Eligibility criteria:
inclusion criteria: * in good general health * diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts * negative pregnancy test (for women who are able to become pregnant) exclusion criteria: * women who are pregnant, lactating or planning to become pregnant during the study * evidence of clinically significant or unstable disease (such as stroke, heart attack) * have any of the following conditions: hiv infection; current or history of high risk hpv infection (e.g., hpv types 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas * have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation

Keywords: external genital warts perianal warts condylomata acuminata human papilloma virus hpv types 6 and 11
effect of public sector antiretroviral treatment programme on tuberculosis and immunization care

Conditions: Tuberculosis

Summary: a scale-up of public sector antiretroviral treatment (art) programmes may divert scarce resources from other priority primary care programmes like tuberculosis and childhood immunization. the purpose of this study is to compare the performance of tuberculosis (tb) and childhood immunization programmes in primary care facilities participating in the south african national antiretroviral treatment programme with those which have yet to be included in the art programme.

large-scale public sector antiretroviral treatment programmes, like those planned for sub-saharan africa, will compete for scarce resources, in particular scarce human resources, with other priority primary care programmes like tuberculosis and childhood immunization. this could lead to impaired performance in other priority programmes like childhood immunization while health workers are distracted by the demands of establishing and maintaining art programmes. on the other hand, art provisions may have positive spin-offs for related programmes like improved case detection of tuberculosis among hiv-positive patients seeking art. the impact of the art programme on primary healthcare more generally must be weighed against the benefits of providing antiretroviral treatment to those with aids. comparison: primary care clinics in the free state province, south africa. 15 clinics participating in the first phases of the national art programme will be compared with 24 clinics which have yet to be included in the national treatment programme. the unit of analysis will be the clinic although the outcome data will be collected from individual patients.

Eligibility criteria:
inclusion criteria: clinics: * intervention: 15 primary care clinics participating in the first phases of the national antiretroviral treatment programme * control: 24 primary care clinics yet to be included in the national antiretroviral treatment programme randomly selected after stratification for health district and ranking of clinic size. patients: * all patients attending tuberculosis and childhood immunization programmes at the above 39 clinics one year before and one year after antiretroviral treatment services commenced in these facilities. exclusion criteria: clinics: * clinics earmarked for the second year of the rollout of the antiretroviral treatment programme. patients: * none.

Keywords: pragmatic cluster non-randomized controlled trial antiretroviral treatment tuberculosis childhood immunization primary care resource-restricted settings