Kornimate/medical-research-clean huggingface dataset:
high dose oral 4-aminosalicylic acid (paser®) to control acute flares of mild to moderate crohn's disease in children

Conditions: Crohn's Disease

Summary: the purpose of this 4 week study is to determine whether paser®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal crohn's disease.

eligible pediatric patients with acute flares of ileocecal crohn's disease will be randomized to receive either paser®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, or an identical-appearing placebo preparation. patients will be required to maintain a daily diary and to return at 2 weeks for blood and stool tests. at the four week mark, patients will return for clinical evaluation, global assessment of disease activity and change in disease activity, as well as additional laboratory tests.

Eligibility criteria:
inclusion criteria: * age less than 18 years * crohn's disease predominantly involving the ileum and/or cecum. the diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. the diagnosis must have been confirmed by at least one gastroenterologist. * harvey bradshaw index of at least 7 * the onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. symptoms relating to the flare should not have diminished or started to improve prior to entry. * written informed consent exclusion criteria: * concomitant corticosteroids, budesonide * corticosteroids within 2 months * cyclosporine, mycophenolate mofetil or experimental drugs during the last three months * maintenance infliximab, or infliximab or other biologics in the preceding 3 months * if the severity of the flare has started to decrease spontaneously * coexisting diagnosis of primary sclerosing cholangitis * infectious diarrhea * signs of intestinal obstruction or perforation * new fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare * hypersensitivity to 4-asa or any components of paser® * pregnancy or breast-feeding * failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active * severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a wbc \< 3,000 during the preceding three months

Keywords: crohn's crohn's disease acute flare mild to moderate crohn's disease children pediatrics ileo-cecal pediatric crohn's disease new onset crohn's disease recently diagnosed crohn's disease
effect of da-5515 (circulan® soft cap.) in patients with chronic fatigue symptoms due to impaired blood circulation

Conditions: Fatigue Symptom

Summary: the aim of the present clinical study is to evaluate the efficacy and safety of the da-5515 (circulan soft cap.) in patients with chronic fatigue symptoms due to impaired blood circulation.

this study is conducting to assess the efficacy and safety of the da-5515 (circulan soft cap.), which has been known to have a fatigue recovery effect due to impaired blood circulation.

Eligibility criteria:
inclusion criteria: * rutherford's category 0/0 or ⅰ/1 * abi \<1.0 * cis greater than 76 * hads less than or equal to 10 * subjects who have fatigue symptoms more than 1 month exclusion criteria: * subjects who have diseases that can cause fatigue * subjects who are taking medication that can cause fatigue

Keywords: chronic fatigue symptom blood circulation
observational, retrospective, multicenter study to describe the reasons for the change of the regimen of antiretroviral therapy in hiv patients

Conditions: HIV

Summary: the study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients with hiv * patients in antiretroviral regimen, that have changed the antirretroviral treatment. exclusion criteria: * patients unable to sign the consent form * patients that changing their treatment are going to take the same components in co-formulated * patients that changing their treatment are going to take the same components separately * total or selective interrupts not indicated by the specialist * patients that after changing antiretroviral therapy between january 2011 and july 2012, and during the next year, again suffered another change of treatment
a rct to compare the effects of two wound products on biofilm disruption in dfus

Conditions: Diabetic Foot Ulcer

Summary: this study is a prospective comparative study to determine if an iodine gel (iodosorb◊) is better than standard dressing (solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers. ◊ trademark of smith \& nephew

iodosorb gel is a cadexomer iodine product indicated for use in wet ulcers and wounds. as the use of iodosorb has an anti-microbial effect and removes exudate continuously from the wound, a reduction in pain, odour, oedema, exudate, pus and debris, and microbial load including biofilm can be achieved, hence providing an environment conducive to the normal healing process. while evidence exists to support the use of iodosorb in diabetic foot ulcers (dfus) for the reduction of planktonic bacteria, little evidence exits for the effect of any topical therapy on non-planktonic or biofilm bacteria in-vivo. the aim of this study is to explore the effects of iodosorb on biofilm in the wound, wound healing, and associated factors, such as odour, pain, and reduction of slough.

Eligibility criteria:
inclusion criteria: 1. the patient is able to understand the study and is willing to consent to the study. 2. the patient consents to the ongoing use of their de-identified photos by the sponsor for purposes outside of this study. 3. the patient must be at least 18 years of age. 4. males and females - provided they are not pregnant or lactating and if of reproductive age are using contraception. 5. the patient has presented with a dfu which, according to the clinical judgement of the investigator, has a suspected biofilm 6. the patient has a dfu of grade 1 or 2 according to the meggit-wagner scale. grade 1 - superficial ulcers limited to the dermis grade 2 - ulcers are transdermal with exposed bone or tendon, and without osteomyelitis or abscess formation 7. the patient's ulcer is suitable to be dressed with iodosorb or solosite. 8. the patient has an abpi \>0.49; or toe pressure \>50mmhg. exclusion criteria: 1. patients with a known history of poor compliance with medical treatment. 2. patients who have participated in this study previously and who healed or were withdrawn. 3. patients who are participating in any other clinical study. 4. patients that have received continuous treatment with iodosorb (on any wound) in the past 8 weeks (iodosorb must not be continuously used for more 3 months) or whose reference ulcer has been treated with iodosorb in the past 2 weeks. 5. patients with a history of any thyroid disorders, e.g. hashimoto's thyroiditis, graves disease or non-toxic nodular goitre. 6. patients undergoing treatment with mercurial antiseptics, taurolidine or lithium. 7. patients with a known sensitivity to iodine or any of the other ingredients in iodosorb, solosite or allevyn non-adhesive 8. patients with severe renal impairment 9. patients with an ulcer less than 3cm diameter. 10. patients with an ulcer that is not exuding.
celecoxib japan observational study for the patients with acute pain

Conditions: Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain

Summary: this study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.

patients with traumatic pain, post-surgical and tooth extract pain will be included in this study. patients will receive celecoxib for 2 weeks and the efficacy on pain relief and the safety will be evaluated.

Eligibility criteria:
inclusion criteria: * patients with traumatic pain, post-surgical pain and tooth extract pain exclusion criteria: * hyperreactive to sulfonamide * aspirin asthma patients * peptidic ulcer patients * serious liver disease patients * serious kidney disease patients * serious heart failure patients * end of pregnancy

Keywords: nsaids acute pain
efficacy of hyaluronic-acid and hydrogen-peroxide mouthwash in gingivitis treatment

Conditions: Gingivitis; Bleeding Gum

Summary: a clinical study to evaluate the efficacy and safety of a mouthwash containing hydrogen peroxide, sodium hyaluronate and glycine in the prevention and management of complications associated gingivitis by film forming action.

50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque and/or tartar selected consecutively. subsequently, subjects will be equally divided and randomized into the test group or control group. during the three examinations, the subjects will undergo the collection of bleeding and plaque indices according to silness j \& loe h 3,4. four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.

Eligibility criteria:
inclusion criteria: * subjects aged between 12 and 50 years * presence of gingivitis caused by accumulation of plaque/tartar * acceptance of informed consent exclusion criteria: * subjects suffering from hiv * subjects suffering from hepatitis * serious systemic diseases preventing the use of specific dental therapies * acute and/or chronic infectious diseases * inability to provide consent * use of topical or systemic drugs * inability to follow post-intervention hygiene instructions * smokers

Keywords: gingivitis bleeding plaque tartar
asymmetric dbs for pd : a multicenter, prospective, single arm, open label study

Conditions: Parkinson Disease

Summary: deep brain stimulation (dbs) is an efficacious neurosurgical treatment for moderate-to-late stage parkinson's disease (pd). the subthalamic nucleus (stn) and globus pallidus interna (gpi) are two targets extensively studied and used worldwide in treating pd. although the conventional symmetric bilateral stn and gpi dbs are shown to be effective in controlling motor symptoms such as bradykinesia, tremor, and dyskinesia, each target has its pros and cons in terms of axial symptom control, medication reduction, cognitive decline, and programming. therefore, we speculate that an asymmetric bilateral implantation of dbs leads (i.e., combined unilateral stn and contralateral gpi dbs) may be able to bring the greatest clinical benefits to pd patients by taking advantage of both bilateral stn and gpi dbs at the same time. the preliminary retrospective study containing eight pd patients undergoing asymmetric implantation of dbs demonstrated the safety and efficacy of this treatment strategy during short-term follow-up. this multicenter, single arm, open label study aims to prospectively investigate during the long-term follow-up the safety and efficacy of asymmetric dbs for pd in terms of motor and nonmotor symptoms, medication reduction, cognitive decline, and quality of life.


Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease based on the mds clinical diagnostic criteria for parkinson's disease * aged more than 18 years * levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on mds updrs-iii * the modified hoehn-yahr scale between 2 and 4 under on-medication condition * compliance with written informed consent exclusion criteria: * atypical parkinsonian syndrome * history of stroke, encephalitis, neuroleptic uses, mri scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery * presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent * presence of anatomical abnormalities in the target region * clinically significant medical history or that increases pre-/post-operative complications * other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

Keywords: deep brain stimulation subthalamic nucleus globus pallidus interna asymmetric deep brain stimulation
evaluation of long-term immunogenicity in children and adolescents boosted with a new pediatric tbe vaccine after five years

Conditions: Encephalitis, Tick-Borne

Summary: blood draw five years after booster-immunization with tbe vaccine to investigate immunogenicity in children


Eligibility criteria:
inclusion criteria: * healthy volunteers of both sexes aged \>1 years at the time of enrollment in v48p4 who participated in studies v48p4e1 and v48p4e2, and who/whose parents or legal guardians are willing to sign informed consent.

Keywords: blood draw five years after booster-immunization with tbe vaccine to investigate immunogenicity in children tbe
the validity of peripheral perfusion index to predict fluid responsiveness

Conditions: Septic Shock

Summary: fluid therapy is an essential component of the management of patients with acute circulatory failure. nevertheless, unnecessary administration of fluids in non-responders is harmful. thus, the concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion. the aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock .

the concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion. several methods have been suggested to detect fluid responsiveness. mini fluid challenge with concomitant monitoring of stroke volume is one of the most robust methods for pre-load challenge. the main foreshortening of mini fluid challenge method is the need for a real-time cardiac output monitor, to track the instantaneous change of stroke vole with changing body position. finding a surrogate to cardiac output to trace the effect of mini fluid challenge would make the test more applicable without the need for advanced hemodynamic monitors. there is a growing interest in the use of perfusion indices in assessment of fluid responsiveness. perfusion indices are measures for adequacy of oxygen delivery in peripheral tissues; thus, they were hypothesized to be possible surrogates of cardiac output. peripheral perfusion index represents "the ratio between the pulsatile and non-pulsatile component of the light reaching the pulse oximeter" . peripheral perfusion index has been considered as a numerical non-invasive measure for peripheral perfusion. ppi has the advantage over other perfusion indices that it a non-invasive, user-friendly monitor. the aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock. mini-fluid challenge test will be performed by infusion of 200 ml lactated ringer's solution over 1 minute. velocity time integral will be monitored using transthoracic echocardiography at the left ventricular outflow tract at the apical five-chamber view. cardiac output will be calculated, and the patient will be considered fluid-responder if cardiac output increased by 10% after fluid challenge.

Eligibility criteria:
inclusion criteria: * septic shock patients exclusion criteria: * evident blood loss * peripheral vascular disorders * upper limb injury or burns
oral cancer screening in mumbai, india by primary health care workers

Conditions: Oral Cancer; Precancerous Conditions

Summary: a feasibility study to compare the test characteristics of three different oral cancer screening techniques performed by trained primary health care workers:1)unaided visual inspection, 2)velscope assisted examination, and 3) examination after application of toluidine blue dye.

oral cancer is the most common cancer among men in india mainly due to the habit of using smokeless tobacco. pre-cancerous lesions like leukoplakia, melanoplakia, erythroplakia,oral submucous fibrosis and indolent ulcers can be easily detected by periodic examination of the oral cavity of the at-risk populations. several methods of oral cancer screening have been tried over the past three-four decades with varying success. this study investigates the feasibility of application and compares the test characteristics of three oral cancer screening techniques: unaided visual inspection, velscope assisted examination and examination after application of toluidine blue dye by primary health care workers among tobacco users attending a cancer early detection clinic, in mumbai, india.

Eligibility criteria:
inclusion criteria: * the study participants will be apparently healthy males with tobacco habit ( present tobacco users and those who have quit within past six months), * above 18 years of age, * attending preventive oncology clinic. exclusion criteria: * participants with frank oral cancers will not be recruited in the study.

Keywords: screening oral precancers tobacco users velscope visual inspection toluidine blue
the effect of aerobic endurance training in patients with drug addiction

Conditions: Substance-Related Disorders

Summary: physical health does not have a high priority in today's treatment of patients with substance use disorder (sud) patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the lifestyle that addiction causes. there are today few studies that provide information about sud patients' physical health. one of the project's aims is to document the physical health of sud patients in treatment, using objective measures. after completion of various physical tests, an 8 week period of high intensity aerobic training intervention will follow. it will be investigated if the sud patients are able to engage and participate throughout the whole training intervention, to what degree the participants improve their physical health and the effect of physical health improvement on substance abuse treatment.


Eligibility criteria:
inclusion criteria: * substance use disorder diagnosed icd10 * written informed consent * "residential treatment" exclusion criteria: * not been using drugs the last six months

Keywords: exercise oxygen consumption mental health
effect of cabazitaxel on the qtc interval in cancer patients

Conditions: Neoplasms, Malignant

Summary: primary objective: * to assess the potential effect on qtcf interval (qtc fridericia) of cabazitaxel in cancer patients secondary objectives: * to assess the effects of cabazitaxel on heart rate (hr), qt, qtcb (bazett's correction), and qtcn (population specific correction) intervals * to assess the clinical safety of cabazitaxel * to assess cabazitaxel plasma concentrations at cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)

the main period of the study consists of a maximum of 21-day screening phase, then first 2 treatment cycles with cabazitaxel. end of main period will be cycle 3 or 30 days after last dose if patient discontinues study after 1 or 2 treatment cycles. the duration for a patient for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles). after cycle 2, patients will have the option to continue to receive cabazitaxel and should be followed for safety reporting until 30 days after the last dose of cabazitaxel.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered. exclusion criteria: * conditions with screening ecg repolarization difficult to interpret, or showing significant abnormalities. this includes, but is not limited to: high degree av block, pace-maker, atrial fibrillation or flutter * qtcf \>480 msec on screening electrocardiogram (ecg) * significant hypokalemia at screening (serum potassium \<3.5 mmol/l) * significant hypomagnesemia at screening (serum magnesium \<0.7 mmol/l) (note: patient may be enrolled after correction of these laboratory abnormalities) * patient receives (and cannot discontinue), or is scheduled to receive a qt-prolonging drug the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
alveogyl and gelatin sponge in the management of pain after epithelialized free gingival graft harvesting

Conditions: Pain, Procedural

Summary: clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.


Eligibility criteria:
inclusion criteria: 1. patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting 2. systemically healthy exclusion criteria: 1. severe gagging reflex 2. smokers 3. occlusal trauma at site of graft 4. pregnancy 5. psychiatric disorder 6. patients allergic to the used agents

Keywords: alveogyl, gelatin sponge, free gingival graft, palate, pain
epidemiological, observational and post marketing study of rotarix™ in children with severe gastroenteritis in belgium

Conditions: Infections, Rotavirus

Summary: the main aim of this study is to investigate cases of rotavirus gastroenteritis in belgian children with opportunity to receive rotarix™ to monitor the potential occurrence of genetic drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts (re-assortments) between vaccine and naturally circulating wild-type strains in belgium population after the introduction of rotarix™. the study will also detect if there is any alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine strain is still efficacious in preventing rotavirus gastroenteritis.

this study is conducted in two phases: phase i and phase ii. phase i will be retrospective and consist of re-using the data collected in rotabel (epi-rota-111426) study. phase ii will be prospective and consist of maintaining the active surveillance system to identify rotavirus cases in several hospitals in belgium.

Eligibility criteria:
inclusion criteria: phase i: • vaccinated and unvaccinated confirmed g1 and/or p\[8\] rotavirus gastroenteritis cases from the rotabel study. phase ii: * a male or a female, born after 1 october 2006 and aged between 14 weeks and \< 5 years at the time of hospital admission. * child admitted at the study hospital for severe gastroenteritis during the study period. * onset of severe gastroenteritis ≤14 days prior to admission. * child whose stool sample was tested positive for rotavirus by a hospital routine test. * written informed consent obtained from the parent or guardian of the child. exclusion criteria: • child in care.

Keywords: observational rotarix™ post-marketing