Kornimate/medical-research-clean huggingface dataset:
intra-operative lymphatic mapping in patients with invasive carcinoma of the cervix or endometrial carcinoma

Conditions: Cervical Cancer; Endometrial Cancer; Cervical Carcinoma

Summary: the purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes. early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. if needed, the uterus is also removed. the treatment also includes removing lymph nodes from the pelvis. endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries. the treatment also includes removing lymph nodes from the pelvis.

patients with figo stage i endometrial cancer or patients with figo stage i-iia invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy. ↓ injection of radioisotope and preoperative lymphoscintigraphy with tc99m either the day before or on the day of surgery by the nuclear medicine department. ↓ intraoperative lymphatic mapping with blue dye and gamma probe. ↓ hysterectomy, radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.

Eligibility criteria:
inclusion criteria: * patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage. * patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy. * patients with a performance status of 0, 1, 2, or 3 by the gynecologic oncology group criteria (appendix). * patients with stage i to \~iia invasive cervical cancer disease according to the international federation of gynecology and obstetrics (figo) clinical staging criteria (appendix). * patients with clinical stage i endometrial cancer * patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy * patients who have signed an approved informed consent. exclusion criteria: * patients with history of prior pelvic or para-aortic lymphadenectomy. * patients with stage iib-iv invasive cervical cancer by figo criteria. * patients with recurrent endometrial or cervical cancer. * patients with prior pelvic radiation. * any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy. * patients with a performance score of 4 by the gynecologic oncology group criteria or who are not good surgical candidates (appendix). * patients with grossly infected primary tumors. * patients with known allergy to triphenyl-ethane compounds. * patients with known deficiency of glucose-g-phosphate dehydrogenase. * patients with known hemolytic anemia from pyruvate kinase and g6pd deficiencies. * severe renal disease.

Keywords: cervix endometrium cervical carcinoma lymphatic mapping
autologous mesenchymal stem cell transplantation in cirrhosis patients with refractory ascites

Conditions: Immune Function in Blood; Liver Function in Blood; Variation of Ascites; Characters of Quality of Life; Child-Pugh Score

Summary: liver cirrhosis (lc) is the final destiny in chronic liver disease.the quality of life in liver cirrhosis patients with refractory ascites are very wretched. the objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (bmscs) transplantation via liver artery in child-pugh b and c stage of liver cirrhosis patients with refractory ascites. the immunomodulatory impact of mscs in fibrosis was confirmed, and several clinical studies have applied mscs to eliminate the progression of fibrosis. in this research the investigators will study the affect and influence of mscs in the patients,include assay of liver function,variation of ascites,child-pugh score etc.


Eligibility criteria:
inclusion criteria:inclusion criteria: aged 18\~65 years. ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite. exclusion criteria: history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment. prothrombin time is less than 30s. severe problems in other vital organs(e.g.the heart,renal or lungs). liver tumor on ultrasonography, ct or mri examination. pregnant or lactating women. imaging evidences of vascular thromboses. - exclusion criteria: -

Keywords: immun function liver function ascites quality of life child-pugh score
the effect of patient-family communication via audio recording

Conditions: Anxiety; Anxiety Depression (Mild or Not Persistent); Satisfaction With Care

Summary: the study was conducted as a randomized controlled blinded study. the sample consisted of 55 patient relatives (27 in the experimental group and 28 in the control group). the patient's relatives in the experimental group said what they wanted to say to their patient in line with the content determined by the researchers and recorded it using a voice recorder. the researcher played the recorded message to the patient, and the patient's feedback was conveyed to the patient's relative.

visitor restrictions in coronary intensive care units (cicus), which make it difficult for relatives to communicate with and support their patients, can lead to negative emotional reactions such as anxiety, depression and anger in family members. this study was conducted to determine the effect of playing the voice recording of the relatives to the patients hospitalized in cicu on the anxiety, depression and satisfaction levels of the relativesthe study was conducted as a randomized controlled single blinded study. the sample consisted of 55 patient relatives (27 in the experimental group and 28 in the control group). the patient's relative in the experimental group said what they wanted to say to their patient in line with the content determined by the researchers and recorded it using a voice recorder. the recorded message was played to the patient by the researcher and the feedback of the patient was conveyed to the patient's relative by the researcher. the relatives of the patients in the control group were routinely informed. the "patient relative introduction form", "hospital anxiety depression scale (hads)", "visual analog scale-anxiety (vas-a)" and "satisfaction scale of families of patients hospitalized in intensive care unit (fs-icu)" were used to collect the data.

Eligibility criteria:
inclusion criteria: * being able to speak and understand turkish, * being a first-degree relative of a patient hospitalized in the cicu with ami. exclusion criteria: * hearing and speech problems.

Keywords: anxiety family depression satisfaction intensive care unit
a study of cm310 in children patients with moderate-to-severe atopic dermatis

Conditions: Atopic Dermatitis

Summary: this is a multi-center, single arm, open-label study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.


Eligibility criteria:
inclusion criteria: * 12 years ≤ age ≤ 18 years * with atopic dermatis * voluntarily sign the informed consent form exclusion criteria: * weight \< 30 kg * major surgery planed during the study
computed tomography coronary angiography before stent implantation

Conditions: Stable Coronary Artery Disease

Summary: the purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris.

currently most percutaneous coronary interventions (pci) are planned and performed on the basis of invasive coronary angiography which provides the information that is confined to the vessel lumen. this limitation may be partially responsible for the unfavorable long term outcome and complications that occur in some patients. additional information on the disease burden in angiographically normal coronary segments adjacent to the lesion site could impact the treatment strategy and clinical results. imaging modalities that allow not only lumen but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds - ivus) and non-invasive (e.g. multislice computed tomography - msct) methods. ivus guidance of the coronary interventions is expensive and given its invasiveness is related to the additional risk. the number of patients who are referred for coronary angiography with significant stenosis diagnosed with msct is rapidly increasing. most interventional cardiologists are not familiar with coronary vessel images produced by msct. the aim of our study is to assess if the analyses of msct images before the pci may impact the treatment strategy and immediate results. the study will enroll subjects with significant coronary stenosis diagnosed with msct who are referred to the catheterisation laboratory for invasive angiography and pci. the study participants will be randomized into two groups: group 1 - the results of msct are analysed by the interventional cardiologist that is to perform angiography and pci. based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) group 2 - interventional cardiologist is blinded to the images obtained by msct. the pci procedure is performed solely on the basis of invasive coronary angiography in both study groups ivus will be performed before and after stent implantation. the operator will be blinded to the results of pre-pci ivus. the second ivus will be performed when angiographic results are optimal in the opinion of the operator. the results of the second ivus examination will be the efficacy measure of the two compared treatment strategies.

Eligibility criteria:
inclusion criteria: * stable coronary artery disease * planned stent implantation into single lesion in native coronary artery * planned stent diameter: 2.5-4.0 mm exclusion criteria: * women younger than 50 years * lesion location in left main coronary artery * atrial fibrilation or other significant arrythmia * severe chronic obturatory pulmonary disease * hyperthyroidism * known allergy to contrast media * glomerular filtration rate \< 30 * treatment of bifurcation lesion * stent implantation for in-stent restenosis

Keywords: computed coronary angiography stent implantation ivus
an asian study to assess the properties and profile of ticagrelor in patients with stable coronary artery disease

Conditions: Stable Coronary Artery Disease

Summary: the purpose of the study is to determine the drug characteristics of ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.


Eligibility criteria:
inclusion criteria: * any percutaneous coronary intervention, more than 3 months prior to randomization * previous documented acute coronary syndrome (acs), more than 3 months prior to randomisation * treatment with asa exclusion criteria: * acs, transient ischemic attack (tia), or stroke within the 3 months prior to randomisation * known concurrent disease of stroke or tia with atrial fibrillation * persons who are being treated with blood clotting agents that cannot be stopped

Keywords: stable coronary artery disease platelet aggregation
serological identification of celiac disease in kids

Conditions: Celiac Disease in Children; Pediatric Disorder; Health, Subjective; Growth Delay

Summary: the investigators aim to examine the feasibility of incorporating serological celiac disease (cd) screening into general pediatric outpatient clinics in sweden and through structured monitoring examine the effects of diagnosing and treating screening-detected cd. screening will be tailored to general pediatric outpatient clinics in the gothenburg metropolitan area with the goal to screen 1000 children over four months. screening for cd will be carried out by measuring tissue transglutaminase autoantibodies (tga) in blood. children who are persistently tga positive will be enrolled into a 6-12-month follow-up protocol responsible for diagnosing cd, installation of gluten-free diet and to assess their short-term impact upon the child's wellbeing. other components to assess include (i) the feasibility to incorporate cd screening into busy pediatric practices; (ii) parental/child interest in, and satisfaction with, participating in a cd screening program and (iii) identifying key considerations for a possible scaled-up, broad-based, cd screening.


Eligibility criteria:
inclusion criteria: * aged 2-17 years old * patient at pediatric outpatient clinics in gothenburg metro area * parental and adolescent consent to screening exclusion criteria for serological screening: * established celiac disease diagnosis * type 1 diabetes

Keywords: screening
an efficacy and safety study for the treatment of mild to moderate acute pain associated with ankle strain or sprain.

Conditions: Acute Pain From Ankle Sprain or Strain

Summary: this is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of k-103-ip compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.


Eligibility criteria:
inclusion criteria: * subject must provide informed consent before any study specific evaluation is performed. * subject is male or female aged 18 to 70 years, inclusive. * subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the screening visit. * subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (nrs), plus pain intensity score at rest that is less than upon monopodal weight bearing. exclusion criteria: * subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain. * subject has had an ankle strain or sprain to the same foot within 6 months before the screening visit. * subject has received topical analgesic medication within 24 hours before the screening visit. * subject has applied ice or compression to the injured area within 2 hours before the screening visit.
parkinson's kinetigraph as tool for dbs eligibility assessment

Conditions: Parkinson's Disease

Summary: the purpose of the study is to investigate the feasibility of using the commercially available parkinson's kinetigraph data logger (pkg) to quantitatively assess motor fluctuations in parkinson's disease (pd) patients. a reliable and objective assessment of motor fluctuations would support the general neurologists in the referral of pd patients to the deep brain stimulation (dbs) surgical centers and facilitate the dbs eligibility evaluation of pd patients usually done by the dbs specialists at the dbs surgical centers. as part of the routine clinical practice, pd patients are referred to the dbs surgical center (clinical site) to optimize their pd treatment and potentially receive a dbs therapy, and the principal investigator (pi), a dbs specialist, assesses their dbs eligibility following published expert evaluation criteria and assigns the patient to one of the following two groups (pi assessment): 1. dbs ready, if the patient presents severe motor fluctuations and/or clear dyskinesia history. 2. dbs not-ready, if the patient presents neither severe motor fluctuations, nor clear dyskinesia history. as part of routine clinical practice, the pkg responsible physician will provide the patient with the pkg to be worn for 6 to 10 days. based on the global kinetics corporation (gkc) algorithm applied on the data recorded by the pkg, a gkc representative assigned the patients to one of the above mentioned groups: dbs ready or dbs not-ready. the primary objective is to evaluate whether the gkc algorithm can differentiate dbs ready from dbs not-ready patients as assessed during the visit at the clinical site by the dbs specialist. the primary endpoint is therefore the percentage of agreement between the pi assessment and the gkc assessment (dbs ready or dbs not-ready) about the dbs eligibility of the pd patients.


Eligibility criteria:
inclusion criteria: * patients are diagnosed with pd. * patients are presented to the clinical sites to evaluate dbs candidacy or optimize their pd treatment eventually with dbs therapy. * patients are at least 18 years old. * patients are able to provide written data release consent as required by ethics committee (ec) institutions or local law and regulations. exclusion criteria: * patients have restricted movement, e.g. bed bound. * patients operate heavy machinery for prolonged periods. * patients have serious medical conditions that compromise safety or interfere with mobility in addition to pd (e.g. arthritis and rheumatisms). * patients have been already screened by stimulus or earlystimulus questionnaires * patients present no response to levodopa medication or have atypical parkinsonism. * patients have major medical or psychiatric illness other than stable, treated depression or anxiety that may jeopardize the patient's ability to give informed consent, follow study requirements, or that may confound the patient's diagnosis or assessments. * patients have major neurological diagnoses other than pd. * patients are not capable of following the required clinical instructions
association of perceived occupational performance and satisfaction, balance, gait, and fear of falling in older adult with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Gait; Balance; Occupational Problems

Summary: this study was designed to investigate the occupational performance and balance, gait, and fear of falling in older adults with mci. balance and gait of the older adults were assessed with the tinetti balance and gait test, fear of falling with the tampa scale for kinesiophobia and occupational performance with the canadian occupational performance measure (copm). the relationship between copm and other parameters was analysed by spearmen's test.


Eligibility criteria:
inclusion criteria: * people over 65 with mild cognitive impairment who could understand and follow instructions exclusion criteria: * individuals who were unable to participate in the study due to a chronic condition or the use of assistive devices such as wheelchairs or crutches
a study to evaluate pharmacokinetic parameters of eliglustat in healthy volunteers who are cyp2d6 extensive or poor metabolizers

Conditions: Gaucher's Disease

Summary: the primary objective of the study is to evaluate dose proportionality and pharmacokinetics for three different dose levels of eliglustat after single and repeated administration.

duration of the study for each subject will be between 42 to 79 days, including a screening period up to 28 days, 3 treatment periods of 7 days each period, a washup period of 7-10 days, and an end-of-study visit 8+/-2 days after the last administration.

Eligibility criteria:
inclusion criteria: * body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive. * certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, electrocardiograms (ecg)). * having given written informed consent prior to undertaking any study-related procedure * having given written informed consent prior to undertaking any study-related procedure exclusion criteria: participants are excluded from the study if any of the following criteria apply: * any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. the following classes of drugs administered within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy: * drugs that are strong inducers of cyp3a (eg, rifampin, carbamazepine, phenobarbital,phenytoin, st. john's wort). * drugs that inhibit cyp2d6 or cyp3a (eg, paroxetine, ketoconazole, fluconazole,ranitidine). * drugs that are substrates for p-gp (phenytoin, colchicine and dabigatran etexilate) or cyp2d6 (metoprolol, tricyclic antidepressants such as nortriptyline, amitriptyline, or imipramine, and phenothiazines such as perphenazine and chloropromazine). the above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
maximum expiratory pressure in induced cough as a predictor of extubation failure

Conditions: Airway Extubation

Summary: clinical trial for the evaluation of diagnostic tests. the sample was composed of adults under mechanical ventilation who passed the spontaneous breathing trial and was ready to be extubated. the maximum expiratory pressure measured in the usual way and the maximum expiratory pressure generated during the induced cough were taken as predictor variables. the outcome variable was extubation failure, measured at 72 hours and at 7 days.

after completing the spontaneous breathing trial (sbt), with the extubation decision defined by the physician in charge of the patient and maximal expiratory pressure (mep) as usually measured greater than 30 centimeters of water (cmh2o). following this, the patient was allowed to rest for 5 minutes in the same condition. with the patient in the supine position sitting 45 ° to 60 °, the closed suction catheter was removed, an elbow was placed at 90 ° and a bacterial filter in series with the endotracheal tube (et), an adapter was also coupled with a outlet port to the aneroid pressure gauge. in series an inspiratory unidirectional valve was placed that did not allow expiration. immediately 2 ml of physiological solution was slowly instilled through the port in the 90º elbow to trigger the cough reflex. the presence or absence of reflex cough and the mep during induced cough (mepic) value were verified. as a safety method, the procedures were stopped if the patient presented signs of intolerance such as respiratory rate (rf)\> 35 breaths per minute, saturation \ 140 beats per minute or increase of 20 % of resting levels.

Eligibility criteria:
inclusion criteria: * under mechanical ventilation via endotracheal tube in a period greater than 48 hours * passing the spontaneous breathing trial an be ready for extubation. * agree to participate in the study and sign the informed consent by the patient or family member exclusion criteria: * tracheostomized prior to admission to mechanical ventilation * history of neuromuscular disease * presence of unstable heart disease * received upper digestive surgery * presence of uncontained enterocutaneous fistula * candidates for non-invasive ventilation as a modality of interface exchange for extubation or as a preventive modality * patients who did not reach a mep (habitual) of 30 cmh20 since they are not extubated by the extubation protocol of our institution.

Keywords: airway extubation maximal expiratory pressure induced cough ventilator weaning