Kornimate/medical-research-clean huggingface dataset:
pain assessment during chemo-mechanical and smart burs caries removal versus atraumatic restorative treatment in carious primary molars

Conditions: Dental Caries in Children

Summary: the aim of the clinical trial is to assess pain during atraumatic restorative treatment (art), smart burs and chemo-mechanical caries removal (cmcr) in primary molars.

the principles of the caries removal have changed greatly in the last decade. the use of local anesthesia with conventional techniques"high-speed hand piece" increase the fear and anxiety of the child. minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia. in art, soft carious tissue is removed by hand instruments. although this technique is very simple. moreover, smart burs are more efficient in removal of soft infected dentine than art leaving the affected dentin intact; as when they touch hard dentin, they become dull. finally, the recent effective method of caries removal is cmcr. the chemical agent contains proteolytic enzyme which destructs partially degraded collagen, leaving the infected dentin soft and easy to be excavated. therefore, the aim of this study is to assess pain during atraumatic restorative treatment, smart burs and chemo-mechanical caries removal in primary molars.

Eligibility criteria:
inclusion criteria: * caries in second primary molars within enamel/ dentin without pulp disease. * there is a clear band of dentin coronal. * cooperative and healthy children. exclusion criteria: * presence of signs and symptoms of necrosis. * root caries. * history of spontaneous pain.
study evaluating desvenlafaxine succinate sustained release (dvs sr) in the treatment of major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the primary purpose of this study is to evaluate the efficacy and safety of two doses of dvs sr (50 and 100 mg/day) in the treatment of adults with major depressive disorder.


Eligibility criteria:
inclusion criteria: * a primary diagnosis of major depressive disorder, single or recurrent episode, without psychotic features. * depressive symptoms for at least 30 days before the screening visit. * outpatient men and women at least 18 years of age. exclusion criteria: * significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent. * any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation. * current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.

Keywords: mdd major depressive disorder depression
long term significance (survival) of lci in patients with cystic fibrosis

Conditions: Cystic Fibrosis (CF)

Summary: the current dream in cf research is to discover safe drugs that correct the basic defect and prevent lung disease, allowing patients without significant lung damage to live nearly normal lives with a dramatic increase in life expectancy and without the burden of current treatment. the compound vx-770 (ivacaftor ò) is hoped to be the first milestone along this way. progression of lung disease is now so gradual in many centres that sensitive indicators of early lung disease (small airways disease) are critically needed to assess the effects of such new treatments. in this context, assessment of ventilation inhomogeneity by the measurement called lung clearance index (lci) seems to be the most promising tool. however, to get approval by health authorities, new measures used in drug evaluation need to fulfill strict criteria. for lci, the investigators still need to prove its long term significance: how well does the lci measurement predict the long term lung disease course? therefore, in this study the investigators want to measure lci at baseline in a large patient cohort and establish how well it predicts the patients' disease course over the next 2 years.

patients with cf ( 6 years and older and fev1 above 40% predicted) will be invited to participate in this prospective non interventional study in 2 cf centers ( ucl and uz leuven). jointly we take care of more than 40 % of the belgian cf population. median fev1 of children (6 - \ 120) from these ctn centers is high ( around 100% pred), defining a study group of great interest in the current context. to assess the predictive value of lci over 2 years, the time to next pulmonary exacerbation will be evaluated in the entire cohort. to assess the predictive value of lci over 2 years, the time to next pulmonary exacerbation will be evaluated in the entire cohort. repeat lci measurements will be done at subsequent patient visits. 2 devices measuring the lci will be tested and compared : ecomedics and ndd. lci and spirometry will be measured in 120 healthy belgian children and young adults. these subjects must be free of respiratory symptoms for at least two weeks and will not have any chronic or recurrent chest problem.

Eligibility criteria:
inclusion criteria: * fev1(% predicted) \> 40% exclusion criteria: * fev1(% predicted) \< 40% * exacerbation during baseline measurement

Keywords: lung clearance index (lci)
eltrombopag in chronic itp

Conditions: Immune Thrombocytopenia

Summary: this study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.


Eligibility criteria:
inclusion criteria: 1. pediatric patients with chronic itp aged 1 to 17 years. 2. platelet count is less than 30×109 per liter. 3. patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or iv immunoglobulin. exclusion criteria: 1. patients with clinical and/or laboratory evidence of hepatotoxicity/liver decompensation (hepatotoxicity due to eltrombopag is defined as increased serum alanine aminotransferase ≥3 times the upper limit of normal (uln), aspartate aminotransferase ≥3 uln, alkaline phosphatase \>1.5 uln, total bilirubin \>1.5 uln) 2. patients with history of thrombotic/thromboembolic events.
the immediate effect of applying transcutaneous electrical nerve stimulation (tens) on sympathetic ganglion and gastrocnemius for popliteal blood flow

Conditions: Transcutaneous Electrical Nerve Stimulation (TENS); Popliteal; Blood Flow; Sympathetic Ganglia

Summary: this study aims to evaluate the immediate hemodynamic effects of transcutaneous electrical nerve stimulation (tens) on the popliteal artery and vein. vascular issues like paod and dvt are common in patients with diabetes, obesity, or immobility due to increased resistance and reduced blood flow. traditional treatments (medication or surgery) are not always feasible, prompting interest in tens as an alternative. although primarily used for pain relief, tens may enhance blood flow. this research compares different stimulation frequencies (80 hz vs. 4 hz) and sites (gastrocnemius muscle vs. thoracolumbar sympathetic ganglia) to identify the most effective configuration.


Eligibility criteria:
inclusion criteria: 1. healthy people 2. age: 18 years and above (inclusive) 3. body mass index (bmi) between 18.5 and 24 exclusion criteria: 1. unable to complete two interventions within a week 2. have contraindications to electrotherapy (for example: metal implants in the body, open wounds, pregnancy, sensory loss) 3. obvious varicose veins 4. unable to lie down for about 1 to 2 hours 5. taking drugs or nutritional supplements that affect autonomic nervous activity or vasodilation (for example: ginkgo biloba) 6. smoking 7. ankle and ankle index (abi) less than 0.9 or greater than 1.3

Keywords: transcutaneous electrical nerve stimulation (tens) blood flow sympathetic ganglia
oral superoxide dismutase (glisodin) to decrease melasma severity.

Conditions: Melasma

Summary: oxidative stress has been reported to play a role in melasma pathophysiology. the objective of the study is to compare oral superoxide dismutase (glisodin) to placebo, in combination to sunscreen to decrease melasma severity.


Eligibility criteria:
inclusion criteria: * clinically diagnosed melasma in adult patient * signed inform consent exclusion criteria: * pregnant women * other pigmentary disorder of the afce * use of depigmentant agent in the month before the inclusion * use of topical steroid, tretinoin, hydroquinone in the month before the inclusion * coeliac disease or allergy to gluten
immersive virtual reality simulation-effects of self-guided versus facilitator-guided debriefing

Conditions: Virtual Reality Simulation; Simulation-based Medical Education; Pediatric Emergency Medicine; Immersive Virtual Reality; Debriefing

Summary: the goal of this clinical trial is to find out whether self-guided and facilitator-guided virtual reality (vr) simulations are equally effective in helping medical students learn how to manage and treat critically ill children. the study will also investigate how medical students feel about the two training methods and examine how many experience cybersickness. the main questions it aims to answer are: * does self-guided vr simulation work as well as facilitator-guided vr simulation in teaching medical students how to manage critically ill children? * how do medical students experience the ease of use, workload, reflection on learning, and motivation in each training method? * how many students experience cybersickness? to answer these questions, researchers will compare the two training methods to evaluate if self-guided vr simulation is an effective way to teach medical students how to manage critically ill children. participants will: * work through three vr cases to practice managing critically ill children in a safe environment. * be tested before and after the vr simulation to assess changes in their skills managing critically ill children. * complete surveys about their experience of the vr simulation, the training sessions, and any cybersickness symptoms they might have.


Eligibility criteria:
inclusion criteria: * eligible participants will be medical students enrolled at medical schools in denmark who are within two years of graduation. exclusion criteria: * lack of informed consent

Keywords: immersive virtual reality virtual reality simulation simulation-based medical education pediatric emergencies debriefing
reconstruction of deficient maxillary ridges using retromolar blocks with and without collagen membrane

Conditions: Bone Augmentation

Summary: is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quantity?

soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. any attempt of bone recontouring and resuturing fails since there is no vascular bed. ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. some types of collagen membrane, contain some degrees of stretchability example geistlich bio-gide or jason membrane botiss.

Eligibility criteria:
inclusion criteria: * patients with maxillary residual alveolar bone height not less than 8 mm. * alveolar bone width from less than or equal 5 mm. * both genders. * at least missing single tooth. * previous failed implants. * previous failed grafting. exclusion criteria: * • heavy smokers more than 20 cigarettes per day. * patients with alcohol abuse * patients with narcotic abuse. * patients with bone disease that may affect normal healing, example; hyperparathyroidism. * patients had radiotherapy and chemotherapy in head and neck. * patients had neoplasms in sites to be grafted. * patients with metabolic diseases uncontrolled diabetic patients, glycated hemoglobin (hb a1c) more than 7 mg\\dl. * pregnant females. * patients with para functional habits, apprehensive and non-cooperative. * bone pathology related to the site to be grafted. * psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations. * intraoral soft and hard tissue pathology. * systemic condition that contraindicate implant placement. * under the age of 18 years.
safety and efficacy of three variants of canaloplasty with phacoemulsification to treat glaucoma and cataract

Conditions: Primary Open Angle Glaucoma, Cataract

Summary: it is a comparative study of safety and efficacy of three variants of canaloplasty: ab-externo, ab-interno and minicanaloplasty. combined with phacoemulsification to treat glaucoma and cataract. it is a randomised, prospective study.


Eligibility criteria:
inclusion criteria: * co-existing glaucoma and cataract * glaucoma types: primary open angle glaucoma, * eye with characteristic glaucoma changes (biomicroscopic,visual field) * iop over 21 mmhg after washout * patients not tolerating antiglaucoma medications, * patients with poor compliance * progression in visual field exclusion criteria: * previous surgical glaucoma procedure * previous cataract surgery * bcva under 0,004 * closed angle glaucoma secondary glaucoma (pseudoexfoliative, pigmentary) * poorly controlled diabetes mellitus * advanced amd * active inflammatory disease * pregnancy * mental disease or emotional instability general steroid therapy

Keywords: open angle glaucoma canaloplasty migs abic
clinical and histological features of head and neck melanoma

Conditions: Melanoma

Summary: the worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. the question whether head and neck melanomas could be a distinct entity has been debated.

aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.

Eligibility criteria:
inclusion criteria: * patients with melanoma * melanoma diagnosed between january 2004 and december 2011 * patients living in champagne-ardenne
functional evaluation with questionnaire in patients investigated for suspected peripheral artery disease

Conditions: Peripheral Artery Disease

Summary: the purpose of this study is to test the routine faisibility of a questionnaire to estimate walking impairment(the welch questionnaire) in patients investigated for suspected pad.

the welch and wiq questionnaires are self completed by the patients and scored by the physician after self-completion.

Eligibility criteria:
inclusion criteria: * sigjned consent for the data treatment as a database exclusion criteria: * non french native language age \< 18 years old

Keywords: peripheral artery disease claudication walking questionnaire
prospective registry of endovascular thrombectomy for extra-large ischemic stroke

Conditions: Stroke, Acute

Summary: since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. recently, five randomized controlled trials (angel-aspect \[endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core\], laste \[large stroke therapy evaluation\], rescue-japan limit \[the recovery by endovascular salvage for cerebral ultra-acute embolism-japan large ischemic core trial\], select 2 \[randomized controlled trial to optimize patient's selection for endovascular treatment in acute ischemic stroke\], and tension \[the efficacy and safety of thrombectomy in stroke with extended lesion and extended time window\]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as alberta stroke program early computed tomography score \[aspects\] ≥3 or infarct core \<100ml). patients with extra-large infarct core (volume greater than 100 ml, aspects score of 2 or less) were excluded from these trials. therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. the xl stroke registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.


Eligibility criteria:
inclusion criteria: clinical inclusion criteria: 1. acute ischemic stroke within 24 hours from onset to enrollment; 2. the patient or patient's representative signs a written informed consent form; imaging inclusion criteria: 3. if the occlusion site is located in the anterior circulation, internal carotid artery, or the middle cerebral artery m1 or m2, or the anterior cerebral artery a1, the baseline aspects is 0 to 2 based on ncct, or cerebral infarction core volume ≥85ml based on ct perfusion. 4. if the occlusion site is located in the vertebrobasilar artery, then the baseline pc-aspects is 0 to 5. exclusion criteria: 1. ct or mr evidence of hemorrhage; 2. evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging; 3. currently pregnancy; 4. previous bleeding disorders, severe heart, liver or kidney disease, or sepsis; 5. any terminal illness with life expectancy less than 6 months.
self-modulation of the sense of agency by means of real-time neurofeedback

Conditions: Psychogenic Seizure; Epilepsy, Temporal Lobe; Health, Subjective

Summary: this study investigates whether the sense of agency is sensitive to self-regulation by means of eeg-based neurofeedback. during neurofeedback, the brain activity in response to a motor task is recorded in real-time and displayed back to the participants. the participants can therefore use this information to adapt their performance on the motor task.


Eligibility criteria:
inclusion criteria (all): * aged \> 18 years old * normal or corrected-to-normal visual acuity * willing to participate in the study (by signing the informed consent form) * neither caffein, nor alcohol intake 48 hours prior to the experiment * regular intake of drugs (except oral contraceptives in women) * employed by, or in a dependent relationship with, the sponsor and / or the investigator(s) * sufficient knowledge of german or english to understand study documents and instructions. inclusion criteria (patients): * a diagnosis of temporal epilepsy (te), documented via video eeg. or * a diagnosis of psychogenic non-epileptic seizure (pnes), according to the diagnostic and statistical manual of mental disorders (dsm-5), and documented via video eeg. exclusion criteria (all): * past surgery in the brain * history of alcohol or drug abuse * incompatibility with eeg recordings, e.g., inability to stay seated for 90 minutes.

Keywords: sense of agency
loteprednol etabonate versus vehicle for the treatment of inflammation and pain following cataract surgery

Conditions: Inflammation; Pain

Summary: this study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility criteria:
inclusion criteria: * subjects who are at least 18 years of age. * subjects who are candidates for routine, uncomplicated cataract surgery. * subjects who, in the investigator's opinion, have potential postoperative pinholed snellen visual acuity (va) of at least 20/200 in the study eye. exclusion criteria: * subjects who have known hypersensitivity or contraindication to the study drug or components. * subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up. * subjects with elevated intraocular pressure (\>/= 21mm hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye. * subjects who are monocular or have pinholed snellen va 20/200 or worse in the non-study eye.
a pilot study of a 14-day modified sequential therapy for helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the purpose of this study is to assess efficacy of a new 14-day sequential therapy for the rescue treatment of refractory helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates. the researchers also want to testify whether a double-dose rabeprazole has equal efficacy to double-dose esomeprazole to provide sufficient acid inhibition.

half of the world's population is infected with helicobacter pylori. strong evidence supports that h.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. however, eradication rates of first-line therapy decreased over years due to the rapidly emerging antibiotic resistance of h. pylori worldwide. an ideal rescue therapeutic regimen to cure refractory h.pylori infection is currently warranted. traditional sequential therapy failed to achieve an ideal eradication rates (over\>95%) as a third line treatment in the region with high antibiotic resistance. this study aims to evaluate the efficacy of 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable. then, this study will also compare the performance of a double-dose esomeprazole with double-dose rabeprazole containing therapy to optimize therapeutic regimen.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 with persistent h. pylori infection. * patients failed at least three different standard eradication therapies before. previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to maastricht v report. exclusion criteria: * patients unable or unwilling to receive gastroscopy. * patients treated with h2-receptor antagonist, ppi, bismuth and antibiotics in the previous 4 weeks. * patients with gastorectomy, acute gi bleeding and advanced gastric cancer. * history of allergy to any of the drugs used in the study. * severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk. * currently pregnant or lactating. * severe neurologic or psychiatric disorders. * alcohol abuse or drug addiction. * patients with compliance lower than 90% in any previous treatment are not included. * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Keywords: sequential therapy rescue treatment