Kornimate/medical-research-clean huggingface dataset:
evaluate the effect of respace™ hydrogel on reducing rectal radiation dose in radiotherapy for cervical cancer

Conditions: Uterine Cervical Neoplasms

Summary: this phase ii clinical study plan to recruit 100 subjects, 1:1 divide them into experimental group and control group, and the cumulative d2cc dose for rectum during brachytherapy will be recorded and compared.

this phase ii prospective, multicenter, randomized, parallel-controlled, superiority clinical study will select more than three hospitals with national clinical trial institution qualifications as clinical trial centers, plan to recruit 100 subjects, 50 in experimental group and 50 in control. the patients in expermental group will receive brachytherapy after the hydrogel injection while patients in control group will receive brachytherapy without hydrogel. the aim of the study was to evaluate whether the use of respace™ hydrogel results in a reduction of radiation exposure to the anterior rectum, and to assess its safety.

Eligibility criteria:
inclusion criteria: * • patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3d brachytherapy. * karnofsky score ≥ 70. * subjects aged ≥ 18 years and ≤ 75 years. * subjects must be able to cooperate in completing the entire study. * the subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate mri. * no contraindications to ct scanning. * subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form exclusion criteria: * •subjects who have received prior pelvic radiotherapy. * subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.) * subjects with other primary malignancies * subjects with contraindications to radiotherapy, as determined by the investigators * subjects with injection site infections. * subjects who are allergic to the ingredients of the device. * subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators * persons with severe mental illness, cognitive impairment and thinking disorders. * participants in other drug clinical trials or medical device clinical trials 1 month prior to screening * pregnant or lactating women or those who plan to get pregnant within the last six months * subjects who cannot be followed up as prescribed by the doctor * other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen

Keywords: cervical cancer hydrogel spacer
virtual reality-based therapy and barriers in cardiac patients

Conditions: Cardiovascular Diseases

Summary: the aim of this study is to investigate the chronic hemodynamic and autonomic repercussions of the insertion of vrbt in cr. to qualitatively analyze the perception of patients and physiotherapists regarding the use of vrbt, as well as their association with cr, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences.

introduction: despite the benefits that cardiovascular rehabilitation programs (cr) can promote, there are problems regarding adherence, which can be related to several factors, among them, motivation. alternative therapies can reflect on motivation and promote increased adherence to cr. in this context, virtual reality-based therapy (vrbt) appears as an option. additionally, chronic hemodynamic and autonomic repercussions of vrbt in relation to cv still need to be investigated. objective: to evaluate the chronic hemodynamic and autonomic repercussions of the insertion of vrbt in cr. to qualitatively analyze the perception of patients and physiotherapists regarding the use of trv, as well as their association with cr, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences. methods: cardiac patients or individuals with factors that regularly participate in cr will participate in this study. patients will be randomly allocated to cr + vrbt intervention or keeping the normal routine. interventions will be carried out three times a week for 12 weeks. the primary outcome will be to assess chronic hemodynamic repercussions (blood pressure, heart rate, respiratory rate, oxygen saturation and perceived exertion using the borg scale) and autonomic (linear and non-linear data). the secondary outcome consists of a qualitative assessment through a focus group with patients and a focus group with therapists, in addition, the new questionnaire developed to identify the influence of barriers on patients' adherence to cr will be applied.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cardiovascular disease. * clinical diagnosis of cardiovascular risk factors. exclusion criteria: * presence exacerbated signs or symptoms. * balance problems.

Keywords: sympathetic nervous system heart rate blood pressure virtual reality exposure therapy barriers to cardiac rehabilitation motivation adherence patient engagement perceived exertion oxygen saturation
a trial to investigate post prandial blood glucose control with fast-acting human insulin hinsbet® compared to insulin lispro (humalog®) and regular human insulin (huminsulin® normal) after ingestion of a standardized meal in subjects with t1dm

Conditions: Type 1 Diabetes Mellitus

Summary: this is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus. each subject will be administered individualised single subcutaneous doses of biochaperone human insulin (hinsbet®), insulin lispro (humalog®) and regular human insulin (huminsulin® normal) immediately before ingesting a standardised mixed meal. following trial drug administration, pk and pd assessments will be carried until 6 hours after start of the standardized test meal. the total trial duration for an individual subject will be up to 11 weeks.


Eligibility criteria:
inclusion criteria: * male or female subject aged 18-64 years (both inclusive). * type 1 diabetes mellitus (as diagnosed clinically) \>= 12 months. * treated with multiple daily insulin injections or csii \>= 12 months. * current total daily insulin treatment \< 1.2 (i)u/kg/day. * current total daily bolus insulin treatment \< 0.7 (i)u/kg/day. * bmi 18.5-28.0 kg/m\^2 (both inclusive). * hba1c \<= 9.0 % by local laboratory analysis * fasting c-peptide \<= 0.30 nmol/l. exclusion criteria: * known or suspected hypersensitivity to imps or related products. * type 2 diabetes mellitus. * previous participation in this trial. participation is defined as randomised. * participation in any clinical trial within 3 months prior to this trial. * clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the investigator considering the underlying disease. * presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator. * known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption. * unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial. * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods
the effects of anodal stimulation on echocardiographic outcome in patients with cardiac resynchronization therapy

Conditions: Heart Failure

Summary: to investigate the hemodynamic, inter and intraventricular desynchrony effects of anodal stimulation and triple site pacing compared with the usual dual site pacing by echocardiography and tissue doppler imaging.

thirty patients who underwent crt and had evidence of anodal stimulation will be included in the study. all patients undergo a conventional echocardiography after 10 minutes of continuous triple site pacing and after 10 minutes of continuous dual site pacing (customary biventricular pacing).echocardiography studies will be performed to measure dp/dt using continuous flow doppler velocity profiles of mitral regurgitation, lv volumes and left ventricular ejection fraction. left intraventricular desynchrony is assessed by using tdi.

Eligibility criteria:
inclusion criteria: * patients with biventricular pacemakers who met currently accepted indications for crt, including dilated cardiomyopathy with lv ejection fraction \ 120 ms. exclusion criteria: * patients with first generation crt device * integrated bipolar defibrillator device * atrial fibrillation during the screening phase * patients who cannot tolerate triple site pacing for several minutes (i.e diaphragmatic pacing) * patients with epicardial lv leads * patients with lv leads located out of the lateral or posterolateral areas

Keywords: cardiac resynchronization therapy anodal stimulation
novel oxygenation indices in robot-assisted laparoscopic surgeries

Conditions: Ventilator-Induced Lung Injury

Summary: in this study, changes in new oxygenation indices investigated by asar et al. will be compared with conventional oxygenation and saturation indices in patients undergoing robot-assisted laparoscopic surgery due to pneumoperitoneum and trendelenburg position.

during the intraoperative period, optimal oxygenation should be achieved while avoiding the harmful effects of hypoxia and hyperoxia in patients. the pao2/fio2 and spo2/fio2 ratios have been traditionally used to assess this condition. subsequently, oxygenation indices incorporating mean airway pressure have been developed, such as the oxygenation index (oi = (fio2 × pmean) / pao2) and oxygenation saturation index (osi = (fio2 × pmean) / spo2). more recently, asar et al. have defined 8 novel oxygenation indices using mean power (mp) and driving pressure (dp) instead of pmean (osi-mptot, oi-mptot, osi-δpinsp, oi-δpinsp, osi-mpdyn, oi-mpdyn, pao2/(fio2xpeep), and spo2/fio2xpeep). they compared the predictive power of these new indices for intensive care unit (icu) mortality in covid-ards (c-ards) patients with conventional oxygenation indices (pao2/fio2, spo2/fio2, oi, osi). oi-δpinsp, osi-δpinsp, and osi-mpdyn indices were found to have the highest predictive power for icu mortality. however, there is currently no study investigating the changes of these new indices during the intraoperative period.

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) class i-iii * age between 18-75 years * signed informed consent form exclusion criteria: * diagnosis of copd (chronic obstructive pulmonary disease) and asthma * history of thoracic surgery * body mass index (bmi) \> 35 * development of hemodynamic instability or desaturation (spo2 \< 92) during the operation

Keywords: trendelenburg robot-assisted laparoscopic surgery
development of population norms of the computerized neuropsychological assessment for effectiveness of the antipsychotic treatment in schizophrenia

Conditions: Schizophrenia

Summary: schizophrenia affects cognition, emotion, and behavior. neuropsychological assessment enables a better understanding of antipsychotic effectiveness and the brain processes, underlying cognitive functioning in schizophrenia. neurocognitive deficits in schizophrenia patients appears to explain up to 61% of the variance of functional outcome and is an important predictor of social reintegration (peuskens et al, 2005) and independent living activitiy (green et al, 2004). impaired social functioning within schizophrenia population has been associated with increased health-care costs. since social and occupational disability may generate the largest indirect costs of the illness, treatment of cognitive deficits has an enormous impact on the cost and disability associated with schizophrenia (mcgurk and mueser, 2004). however, the gap between cognitive science and clinical practice limits the implementation of cognitive assessment in the routine evaluation of schizophrenia patients. pharmaceutical industry initiated numerous large scale, multisite studies on the impact of novel antipsychotics on cognitive deficits in schizophrenia patients. the aim of this research is to develop population norms of the computerized neuropsychological assessment for effectiveness of the antipsychotic treatment in schizophrenia.


Eligibility criteria:
inclusion criteria: * an iq, which is within normal range. exclusion criteria: * psychiatric co-morbidity. * physical disability or illness. * a history of severe head injury.

Keywords: computerized neuropsychological assessment development of population norms of the computerized neuropsychological assessment
phaco versus small incision cataract surgery (sics) health economic study

Conditions: Cataract

Summary: to compare the health economic parameter and clinical outcome of phacoemulsification with small incision cataract surgery (sics)


Eligibility criteria:
inclusion criteria: * patient has senile cataract and require unilateral cataract extraction followed by implantation of an acrysof or pmma (polymethylmethacrylate) posterior chamber intraocular lens (iol); * pupil dilation ≧7 mm after mydrisis; * patient undergoing cataract surgery for the first eye; * va prognosis ≧6/12 exclusion criteria: * patients with history of ocular pathology or diabetic retinopathy; * patients with traumatic, subluxated and posterior polar cataract; * patients had ocular surgery in the past 6 months; * patients with significant intra-operative complications

Keywords: cataract
study on the value of endobronchial ultrasound elastography in the diagnosis of thoracic lesions

Conditions: Thoracic Lesions

Summary: the study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions

ultrasound elastography has been gradually used in clinic with the rapid development of ultrasonic technique,and presents a promising application prospect in differentiated diagnosis of benign and malignant disease.the aim of the study is to evaluate the accuracy of endobronchial ultrasound elastography in the diagnosis of thoracic lesions. conventional ultrasound and ultrasound elastography are respectively used to examine thoracic lesions before aspiration,then the images are saved as video clips. features of conventional ultrasound and parameters of ultrasound elastography are analysed and recorded by skilled worker. the investigators define the pathological results of ebus-tbna combined with results of six months follow-up as the "gold standard". the receiver operator characteristic curves are drawn to obtain area under the curve (auc) and the best diagnostic threshold values of each parameters. according to the best cutoff values, the investigators respectively calculate the accuracy, sensitivity, specificity, odds product of each parameters, and then compare them with each other to evaluate the value of ultrasound elastography

Eligibility criteria:
inclusion criteria: * hilar/mediastinal lymph lesions with a short axis more than 1 cm on thoracic computed tomography( ct) scan and/or positron emission tomography-computed tomography (pet-ct) * with normal coagulation function * with normal cardio pulmonary function and be able to tolerate bronchoscopy * no syphilis,acquired immune deficiency syndrome(aids) and other infectious diseases * willing and able to give written informed consent exclusion criteria: * unable to lie in bed * allergy to narcotics such as lidocaine. * suffering from cardiovascular and cerebrovascular disease, severe lung liver and kidney dysfunction, or after drug treatment cannot maintain the normal. * with abnormal coagulation function or take anticoagulant drugs within the previous week. * hematological abnormalities, fever or highly suspected active tuberculosis patients. * women in the menstrual period. * excessive anxiety and can not tolerate bronchoscopy. * other conditions that are not suitable for inclusion in the study.

Keywords: ultrasound elastography thoracic lesions ebus-tbna
healing effect of ziziphus honey on extracted tooth socket in humans by evaluating the levels of bmp-2 and opn

Conditions: Healing Wound

Summary: ziziphus honey can improve bone healing at extracted tooth sockets in humans by increasing salivary levels of bone markers, opn and bmp-2.

objectives of study: to study the effects of ziziphus honey on bone healing of extracted tooth socket in humans by comparing 1) levels of bmp-2 and opn in experimental and control groups at different intervals and 2) by radiographically measuring rbd of extraction sockets in experimental and control groups. aim of study: post extraction ridge resorption is a major concern for future tooth prosthesis or implant placement. honey can possibly help to improve bone healing and minimize ridge resorption after extractions. materials and methods: randomized controlled trial with simple random sampling of healthy individuals will be done. total number of 30 participants will be equally divided into experimental group and control group. after tooth extractions in both groups, ziziphus honey will be injected into extracted sockets of experimental group while control group will be left as it is. levels of bmp-2 and opn will be tested in saliva through elisa technique at day 0, 3 and 7 of tooth extraction and rbd will be measured on periapical radiographs at day 3, 21 and 40 in both groups. keywords: bone morphogenetic protein-2 (bmp-2), osteopontin (opn), relative bone density (rbd), enzyme linked immunosorbent assay (elisa).

Eligibility criteria:
inclusion criteria: 1. healthy patients of either gender with adult age 2. no known hypersensitivity to honey. 3. permanent maxillary or mandibular molars (first or second molars) exclusion criteria: 1. history of radiotherapy or chemotherapy 2. diabetic and hypertensive patients. 3. pregnant and lactating females. 4. smoking or consumption of alcohol 5. bone conditions like osteoporosis etc. 6. patients on oral contraceptives or steroid therapy 7. subjects taking antibiotics or nsaids within one week.
quest: quality of life and experiences of sarcoma trajectories

Conditions: Quality of Life; Sarcoma; Diagnostic Interval; Diagnostic Pathway; Care Needs

Summary: background: the prognosis of patients with rare cancers in general and sarcomas in particular suffers from delay in diagnosis. routes to diagnosis for sarcoma need to be quicker and more streamlined, but have neither been studied in detail in larger numbers before, nor in a direct comparison between two countries with different health systems. comprehensive assessment of diagnostic delays and its determinants, including demographic, clinical, psychosocial and health care system factors, is necessary to improve referral pathways and come to best practice and patient reported outcomes for sarcoma patients. research questions to be answered: this study aims to quantify diagnostic delay (including patient, general practitioner and system delay) and evaluates routes to diagnosis and referral to sarcoma expert centres in the netherlands and england; to comprehensively evaluate risk factors of diagnostic delay; determine the association between diagnostic delay and outcomes (health-related quality of life, quality-adjusted life years, patient satisfaction, tnm classification, time to local/distant relapse and overall survival); and to assess differences between both countries. this should lead to advices about faster referral where possible.

the researchers will conduct a longitudinal cohort study among all sarcoma patients (≥18 years of age) that will be newly diagnosed in 1.5 years period from october 1st 2017 to march 30st 2019 in one of the participating study centers (5 centers in the netherlands, 3 centers in england). patients will be invited before the start of treatment (with a two months eligibility window) and receive a questionnaire on diagnostic delay, risk factors and patient-reported outcomes. the questionnaire on patient-reported outcomes will be completed again 3 months, 6 months, 1-year and 2 years later. data collection will be done within profiles, an international registry for cancer patient reported outcomes (www.profilesregistry.nl). clinical data will be collected through cancer registries and the junior investigator will collect extra data from patients' records.

Eligibility criteria:
inclusion criteria: * age at diagnosis ≥ 18 years * diagnosis of sarcoma (histology confirmed by sarcoma histopathologist; according to icd-10-gm codes c40 and c41 for bone sarcoma and c49 for soft-tissue sarcoma) * able to communicate in english (or dutch) * mental capacity to provide informed consent and to participate in the study (as determined by the referring health care professional) * patients must be able to complete questionnaires themselves * patients must be under treatment or follow-up at one of the participating hospitals. exclusion criteria: * too ill to complete questionnaires (according to advice from (former) treating specialist) * patients with desmoids fibromatosis will be excluded because of the non-malignancy of the disease; and patients with gastrointestinal stromal tumours (gist; icd-10-gm codes c15-20, c26, c48 and c80) will be excluded.
the effects of high intensity interval exercise in obese

Conditions: Obesity; Endothelial Dysfunction

Summary: obesity is a complex and multifactorial disease. excess weight is related to endothelial dysfunction, inflammation and oxidative stress which increases the risk for cardiovascular diseases. high-intensity interval exercise can release vasodilatory substances and promote increased muscle blood flow.

this study evaluated the effects of the recovery interval duration (1 vs. 3 min) in high intensity interval exercise (hiie) on the hemodinamics responses in obese individuals. twelve obese subjects (27 ± 3.8 yrs) were evaluated, who underwent three experimental sessions with a randomized crossover design: one control session (no exercise) and two hiie sessions with the same workload (10 x 1min @92%vo2max / 1\[hiie 1\] or 3\[hiie 3\] min @0%). forearm blood flow (fbf) and blood pressure (bp) were measured before and after the experimental sessions. heart rate and relative perceived exertion were assessed during hiie.

Eligibility criteria:
inclusion criteria for the study were obesity and the conditions of being insufficiently active, non-smokers and without previous history of: heart disease, obstructive or restrictive pulmonary diseases, and orthopedic morbidities. fifty-one (51) subjects were evaluated for eligibility, and 39 subjects were excluded after an initial interview since they did not meet the aforementioned inclusion criteria.

Keywords: obesity aerobic exercise interval exercise