Kornimate/medical-research-clean huggingface dataset:
cryolipolysis on localized adiposity

Conditions: Subcutaneous Fat

Summary: the aim of this study is to analyze the effects of a single session of cryolipolysis on localized adiposity on women's abdomen. this is a randomized controlled clinical trial that will include 28 women who will be randomly allocated into two groups: control group or intervention group. the following assessments will be performed in both groups: ultrasonography and body composition at baseline and 30, 60 and 90 days after randomization and blood analysis at baseline and 15 and 30 days after randomization. the expected main result at the end of this study is the reduction of the local subcutaneous fat tissue.

cryolipolysis is a non - invasive method for localized fat reduction wich uses low temperatures to induce an apoptotic and inflammatory response and consequent adipocyte death in the treated area. although the practice of this technique has been increasing, there are some gaps in the literature about the exact mechanism of action and only a few randomized clinical trials that proves its effectiveness and safety. then, the aim of this study is to analyse the effects of cryolipolysis on localized fat on women's abdomen. this is a randomized controlled clinical trial that will include 28 women who will be randomized to control group (cg) or intervention group (ig). the cg will perform the evaluation protocol with the following assessments: ultrasonography, thermographic analysis, blood analysis, bioimpedance and measurement of skinfold and abdominal circumference. the ig will receive a single cryolipolysis's session on lower abdomen and the evaluation protocol. the follow up for both groups is 90 days. expected main result at the end of the study is the reduction of the local subcutaneous fat tissue.

Eligibility criteria:
inclusion criteria: * female * age 18 to 45 or not being on menopause * sedentary according to international physical activity questionnaire * body mass index lower than 27 kg/m² * skinfold: more than 3 centimeters at the lower abdomen exclusion criteria: * cryoglobulinemia * cold urticaria * paroxysmal cold hemoglobinuria * raynaud disease * pregnancy and breastfeeding * cancer * vascular diseases * heart diseases * epidermal lesions at the site of application * autoimmune diseases * osteoporosis * metallic implants and pacemaker * alterations of sensibility * inflammatory process and active infection * abdominal hernia * abdominal muscle diastasis * diabetes * anemia * previous plastic surgery on the area * liver and kidney diseases * cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form
dental treatment and oral rehabilitation for adult individuals with intellectual disability in general anaesthesia

Conditions: Intellectual Disabilities (F70-F79)

Summary: this study evaluates the types of dental procedures performed in general anaesthesia for adult persons with intellectual disability, as well as factors affecting the decision to perform the dental treatment in general anaesthesia, factors contributing to tooth loss and possibilities to perform oral rehabilitation procedures

oral diseases are not life threatening and dental procedures usually do not pose significant risk to a patient. in situation where a patient does not tolerate dental treatment, and consequently general anaethesia (ga) is used, an intellectually disabled (id) patient with a condition that is routinely managed in the general population is exposed to significantly higher medical risk. quality of oral health care delivery for adults with id is considered inadequate and in need of constant improvement. therefore, the present study aims to analyse the type of dental treatment performed in ga and factors affecting the treatment. by its design this is an observational, epidemiological, retrospective study. a representative sample of the target population is realised by the assessment of approximately n=250 id adults treated at the dental clinic of vojvodina. a number of parameters such as severity of id, the presence of concomitant conditions, living arrangements, medical diagnoses, physical status according to the american society of anesthesiologists' classification (asa score), history of previous surgical/ga treatments and injuries/trauma, frequency of dental visits, procedures that were conducted in ga and during routine dental treatment (rdt), dental status including dmft (decay, missed, filled teeth index) and total number of extracted teeth and data about oral rehabilitation.the use of ga emphasizes the inequalities in persons with id, since it is always more radical compared to rdt. it is a frequent occurrence that with the use of ga only prevention of complications and pain relief are accomplished, resulting in a multiple teeth extractions. this approach inevitably leads to further dysfunctions in cranio-facial system, affecting all aspects of everyday life in persons with id.

Eligibility criteria:
inclusion criteria: * participants with id older than 18 years at the time of treatment in ga * participants who had at least one general anesthesia dental treatment. exclusion criteria: * participants who had dental treatment in ga due to physical condition, without id * participants younger than 18, * participants with id who had never had treatment in ga.

Keywords: dental care oral rehabilitation general anaesthesia tooth loss
accuracy of computer- guided implant surgery in partially edentulous patients.

Conditions: Dental Implant; Computer

Summary: the dental implant placed freehand with a digital planing is vastly increasing. the accuracy between the planned and the placed implants still not well determined. between a single implant and a full mouth rehabilitation, the precision is very wide. a precision scale must be settled according to each indication in order to offer the clinician a safety and a predictability for his procedures.

in this paper the investigators report an original research evaluating the accuracy of computer-guided implant placement in posterior edentulous mandibular spaces. in this randomized controlled trial, several factors were evaluated such as primary implant stability, possibility of immediate loading, displacement at crestal and apical levels, angle of deviation, surgical guide design, computer-aided design and computer-aided manufacturing accuracy, and variance between different implant macro-geometries and lengths. as exhaustive description of the assessment techniques as well as the statistic results were also presented in this article. nowadays, the use of guided surgery is vastly increasing in a daily dental practice. in the "era of digital dentistry", it is of utmost importance to evaluate the accuracy and precision of the computer-guided techniques in order to determine their limits, avoid risks (adjacent anatomical structures, limited crestal volume, immediate loading), and apply them in safe manner. evidence-based scientific data on this matter is still deficient. in these terms, the investigators consider it very interesting and of high clinical value for all oral surgeons and dental practitioners to evaluate in a clinical research the precision and distortion of computer-guided implant surgery.

Eligibility criteria:
inclusion criteria: * acceptable oral hygiene with no signs of active periodontal disease or local infection * american society of anesthesiologists (asa) physical status classification 1 and 2 * non or light smoking (\< 10 cigarettes per day) * acceptable intermaxillary space (44 mm minimum) * minimal crestal width of 5.5mm * minimal residual bone height of 10mm above the alveolar nerve canal exclusion criteria: * head and neck irradiation * bone grafted sites * severe bruxism * cone beam computed tomography with exaggerated artifacts * limited intermaxillary space

Keywords: dental implant accuracy computer-aided design (cad) guided surgery surgical guide surgical template computer-aided manufacturing (cam)
emdr psychotherapy to treat anxious-depressive symptoms in breast cancer patient

Conditions: Breast Cancer; Eye Movement Desensitization and Processing; Psychoterapy

Summary: the study will consist in an adjustment/adaptation of the "standard emdr protocol" for cancer disease, and most particulary for women who present a breast cancer and during adjuvant therapy. it will also test the faisability of the research, with a view to adjust the calendar and the ressources to put at disposal for a randomized control trial that follow. this study will also allow to test the need and acceptibility of this new psychotherapy for the patient, and to identify facilitators and obstacles : participation/rejection ratio, inclusion rythm, adhesion of the medical staff about the project


Eligibility criteria:
inclusion criteria: * being a woman aged of 18 years or more * having a primary invasive breast cancer * having undergo a mastectomy for a primary invasive breast cancer * being able to complete the questionnaires * being informed of the study and having signed the informed consent * being affiliated to a welfare system exclusion criteria: * having contraindications to recieve emdr psychotherapy (neurologic disorders, dissociatif states, oculomotor issues) * having started adjuvant treatments following surgery * having metastatic breast cancer * presenting physical polypathologies * having psychiatric antecedents (included anxiety and depressif disorders - assessed with m.i.n.i. (sheehan and al., 1997)). * having drug or alcohol addiction * being placed under the safeguard of justice, guardianship or trusteeship * being pregnant or breast-feeding

Keywords: breast cancer emdr
influence of hepatic steatosis on the therapeutic effect of entecavir in chronic hepatitis b patients

Conditions: Chronic Hepatitis B; Hepatic Steatosis

Summary: to investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in chronic hepatitis b patients.

chronic hepatitis b (chb) affects approximately 360 million persons worldwide and is the most common cause of liver disease and affects over 10% of the general population in china. hepatic steatosis is the main hepatic presentation of non- alcoholic fatty liver disease that is becoming another important liver disorder both in china and worldwide with economic development. it would be expected that hepatic steatosis might occur in chb patients and recent studies show the frequency of steatosis in chb ranges from 27% to 51%. however, the effect of steatosis on the anti-viral treatment in chb patients is still vague. the aim of this rct is to investigate the effect of steatosis on the therapeutic effect of entecavir in chronic hepatitis b patients. we will compare the anti-viral effect of entecavir among four groups: chb group with entecavir therapy, chb + steatosis group with entecavir therapy, chb + steatosis group with entecavir + essentiale therapy and chb + steatosis group with entecavir + vitamin e therapy. the speculated points are set as 3 months, 12 months and 15 months. liver biopsy will be carried out at beginning and the 12th month. other serum biochemical and viral markers are recorded as well as ct or ultrasound scan are repeated.

Eligibility criteria:
inclusion criteria: patients should be diagnosed with chronic hepatitis b infection and hepatic steatosis 1. chb infection * hbv-dna ≥ 1×105 copies/ml； * hbeag positive ； * alt between the 2-10 times of the upper limit level 2. hepatic steatosis according to the "guidelines for the assessment and management of non-alcoholic fatty liver disease in the asia-pacific region: executive summary", with test of ct scan or b ultrasound and confirmation of liver biopsy(in portion of patients) exclusion criteria: 1. those receiving antiviral treatment before the study 2. those on hepatoxic drug treatment, 3. those consuming alcohol regularly or excessively, 4. those diagnosed of cirrhosis, anti-hcv or anti-delta positive patients, 5. those diagnosed as having autoimmune or other metabolic liver diseases 6. those have wilson's disease, pbc, psc, ibd and other diseases that may influence the process and effect of therapy 7. those who are pregnant, have mental disorder and were received anti-viral treatment

Keywords: hepatic steatosis, chronic hepatitis b, entecavir
inferior vena cava (ivc) diameters before & after interscalene block

Conditions: IVC - Inferior Vena Cava Abnormality

Summary: the purpose of this study is to understand how changes to breathing patterns in the chest affect blood flow to the heart from the inferior vena cava in the abdomen. ultrasound of the upper abdomen will be used to visualize changes in breathing patterns in the chest and blood flow in the abdomen.

in recent practice, point-of-care ultrasound has been used to assess the size and respiratory variation of the inferior vena cava as a marker for volume status and fluid responsiveness. little investigation has occurred regarding the mechanism of observed respiratory variation. anesthetic plans for surgery (e.g. shoulder replacement) frequently employ interscalene injections to target and block the brachial plexus, which (on the same side) results in phrenic nerve palsy and paralysis of the diaphragm. the goal of this study is to examine the relationship between diaphragmatic function and variation in ivc diameter. specifically, the investigators will evaluate and compare the size and variability of the inferior vena cava by point-of-care ultrasound before and after brachial plexus block.

Eligibility criteria:
inclusion criteria: * adult (age \> 18 years) * scheduled to receive an interscalene block exclusion criteria: * any person with known, pre-existing phrenic nerve, diaphragmatic, or inferior vena cava anomaly. * patients who cannot be successfully imaged by ultrasound or who cannot participate in spirometry will additionally be excluded. * non-english speaking patients will be excluded as well as there is no research funding to translate consent forms. given that there is no potential benefit to participation in the study, this does not exclude these individuals from any potentially beneficial therapy.
a study to assess the effectiveness, safety, and pharmacokinetics of tmc435 in combination with peginterferon alfa-2a and ribavirin in hepatitis-c infected patients

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (explores what the body does to the medication) of tmc435350 in combination with peginterferon alfa-2a and ribavirin in genotype 1 hepatitis c virus infected japanese participants who have never received treatment for their hepatitis c infection.

this is a phase 2, randomized (the study medication is assigned by chance.), 5-arm, open label (all people know the identity of the intervention.), multicentre (study conducted at multiple sites) study. approximately, 84 participants will be randomized to 5 different arms in a 2:2:1:1:1 ratio. in treatment arms 1 and 2, participants will receive 12 weeks of triple therapy (use of 3 medications) with tmc435 50 or 100 mg once daily plus peginterferon alfa-2a and ribavirin followed by 12 weeks of treatment with peginterferon alfa-2a and ribavirin. in treatment arms 3 and 4, participants will receive 24 weeks of triple therapy with tmc435 50 or 100 mg once daily plus peginterferon alfa-2a and ribavirin. in treatment arm 5 (control group), participants will receive peginterferon alfa-2a and ribavirin for 48 weeks. this study will consist a screening phase of upto 6 weeks, treatment phase of upto 48 weeks and a post treatment follow-up period of 24 weeks. safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and cardiovascular safety.

Eligibility criteria:
inclusion criteria: * participants with documented chronic hepatitis c infection as evidenced by presence of hcv antibody at least 6 months (180 days) prior to the informed consent. - participants with genotype 1 hcv infection. - participants with plasma hcv rna level of ≥ 5.0 log10 iu/ml at screening. exclusion criteria: * participants diagnosed with hepatic cirrhosis or hepatic failure. - participants with any other liver disease than hepatitis c. - participants with infection/co-infection with non-genotype 1 hcv.

Keywords: hepatitis c hepatitis c virus interferon alfa-2a ribavirin viral rna
an open internet-based survey and natural language processing project analysing written monologues by headache patients

Conditions: Headache Disorders; Tension-Type Headache; Migraine Disorders; Cluster Headache; TACS; Secondary Headache Disorder

Summary: headache disorders are among the most prevalent medical conditions worldwide. the diagnosis of headache disorders is based on medical history taking. digital solutions such as natural language processing (nlp) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients. participants will provide a written description of their headache disorder. the results will hopefully lead to a better understanding of the potential use of nlp in headache disorders.


Eligibility criteria:
inclusion criteria: * 18 year or older * have a headache disorder with at least one headache attack over the last three months * voluntary participation * accepted the patient information sheet and gave informed consent

Keywords: migraine natural language processing headache
cholecalciferol in treating patients with myelodysplastic syndrome

Conditions: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Summary: rationale: cholecalciferol (vitamin d) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome. purpose: this phase ii trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.

objectives: * determine the efficacy of cholecalciferol, in terms of hematological improvement, in patients with low- or intermediate-risk myelodysplastic syndromes. * determine the effect of this drug on disease symptoms, fatigue, and the overall health-related quality of life of these patients. outline: this is an open-label, pilot study. patients receive oral cholecalciferol once daily. treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 36 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed myelodysplastic syndromes (mds) * must have undergone bone marrow aspirate and biopsy with karyotype within the past 3 months * international prognostic scoring system score of 0 or 1 patient characteristics: age * any age performance status * any life expectancy * more than 1 year hematopoietic * not specified hepatic * not specified renal * no history of hypercalcemia prior concurrent therapy: biologic therapy * prior stem cell transplantation allowed * no concurrent hematopoietic growth factors chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * more than 6 weeks since prior cholecalciferol supplements or analogs * more than 4 weeks since any prior therapy for mds (except supportive care) * no other concurrent therapy for mds

Keywords: previously treated myelodysplastic syndromes de novo myelodysplastic syndromes secondary myelodysplastic syndromes atypical chronic myeloid leukemia, bcr-abl1 negative myelodysplastic/myeloproliferative neoplasm, unclassifiable childhood myelodysplastic syndromes
a study to investigate the effect of cyp3a inhibition on the pharmacokinetics of ro7017773 in healthy participants

Conditions: Healthy Volunteers

Summary: the purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of ro7017773 in healthy volunteers.


Eligibility criteria:
inclusion criteria * healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ecg, hematology, blood chemistry, serology and urinalysis) as judged by the investigator. * male and women of non-childbearing potential (woncbp) exclusion criteria * history of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system (cns) infections (e.g., meningitis) * history of clinically significant hypersensitivity or allergic reactions * abnormal blood pressure * abnormal pulse rate * history or presence of clinically significant ecg abnormalities before study drug administration or cardiovascular disease * current or chronic history of liver disease, or known hepatic or biliary abnormalities * positive test for drugs of abuse or alcohol * evidence of human immunodeficiency virus (hiv) infection * presence of hepatitis b surface antigen (hbsag) or positive hcv antibody test result at screening or within 3 months prior to starting study treatment * participants who regularly smoke more than 5 cigarettes daily or the equivalent and are unable or unwilling not to smoke during the in-house period
optical angiography in glaucoma

Conditions: Glaucoma

Summary: glaucoma is one of the leading causes for blindness in industrialized countries. it is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. it has been speculated for a long time that vascular factors may also contribute to the pathogenesis of the disease. this concept has been supported by several epidemiological studies showing that small retinal vessel calibre are associated with the disease. in the recent years tremendous enhancements in the field of optical coherence tomography has been achieved. these developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. the proposed study tests the hypothesis that patients with glaucoma show altered vascular morphology compared to healthy subjects. this is of importance because it may clarify the degree of vascular involvement in glaucoma.


Eligibility criteria:
inclusion criteria: * diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated iop ≥ 21 mmhg on at least three measurements in the medical history. mean deviation in the visual field test \< 10db exclusion criteria: * normal ophthalmic findings, iop ≤ 20mmhg * no history of elevated iop * no signs of glaucomatous disc damage