Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of topical diclofenac combined with oral diclofenac in the treatment of knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: oral non-steroidal anti-inflammatory drugs (nsaids) are a recommended treatment for the symptoms of osteoarthritis of the knee. however, nsaids may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. a topical nsaid may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral nsaids. the purpose of this study is to determine the safety and effectiveness of a topical nsaid when used alone or when combined with an oral nsaid in the treatment of osteoarthritis of the knee.

during this 12-week study, patients will visit the study clinic 5 times. at the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical examination performed. after washout of all nsaids/other analgesic medication, the patient will return for the baseline visit. during the treatment phase of the study, the patient will apply a topical solution to his/her osteoarthritic knee and take an oral study tablet. the patient may randomly receive active treatment with topical diclofenac, oral diclofenac, both, or neither (placebo). follow-up clinic visits are conducted at 4, 8 and 12 weeks. routine laboratory analyses are done at baseline, 4 and 12 weeks.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis of the knee, verified radiographically * moderate flare of pain in the knee after washout of stable therapy * if female, non-pregnant * ability to swallow moderately-sized tablets exclusion criteria: * secondary osteoarthritis of the knee * major knee surgery at any time, or minor knee surgery in previous year * severe uncontrolled heart, liver or kidney disease * ulcer or bleeding from the stomach * corticosteroid use * fibromyalgia * skin disorder of the knee

Keywords: topical nsaid topical diclofenac
estrogen and diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: diabetes has recently been referred to as "the epidemic of the 21st century". the reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (cvd) compared to men with type 1 diabetes is unknown.the purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.


Eligibility criteria:
inclusion criteria: * both men and premenopausal * normal menstrual cycle interval of 25-35 days for at least 3 previous cycles * all races * clinical diagnosis of insulin-dependent type 1 diabetes (patients only) exclusion criteria: * clinical diagnosis of hepatic, cardiovascular, or renal disease * uncontrolled diabetes (hba1c\>9%) * diabetic complications (i.e. macrovascular, microvascular, or autonomic) * proteinuria * uncontrolled hypertension (\>140/90 mmhg on therapy) * hormonal use of birth control (past 3 months) * pregnancy * oligomenorrhea * direct vasoactive medications (i.e. nitrates) * anti-estrogens (i.e. serms) * plycystic ovarian syndrome (defined by nih guidelines-hyperandrogenic anovulation) * undetectable anti-mullerian hormone (amh) following screening

Keywords: estrogen, diabetes
administration of a lactobacillus gg and vitamins containing mixture is effective in preventing nosocomial infection in children

Conditions: Nosocomial Infection

Summary: nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. in most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as lactobacillus gg. a recent rcct, which provided for the administration of lgg against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with lgg, compared with patients who received placebo. there are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. we thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing lgg, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.


Eligibility criteria:
inclusion criteria: * males and females between the ages of 3 months and 5 years * children admitted to a pediatric ward exclusion criteria: * children with chronic diseases of the respiratory , gastrointestinal , renal system; * children with malformations of the cardiovascular system ; * children with immune deficiencies ; * infants born preterm ( gestational age \< 37 weeks ) ; * children with congenital metabolic diseases ; * children who received probiotics before enrollment ( up to 7 days before hospitalization)

Keywords: lgg probiotics nosocomial infection prevention pediatrics
children immune functions(2)

Conditions: Diarrhea; Upper Respiratory Infections

Summary: to investigate the effect of milk-based formulas on infections and immune functions in healthy children.

particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. in that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, gii and uri. the beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.

Eligibility criteria:
inclusion criteria: * parents written and signed informed consent for participation in the study. * healthy children aged 1 to 3 years that are no more breastfed. * go to a selected nursery and / or pediatrician. * parents must have a phone at home or a cellular phone to call the paediatrician. * no consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period. * parents are able to give their children, twice daily, 2 milk servings on a 5 months period. * children not being intensive consumers of regular yoghurts exclusion criteria: * rotavirus and flu vaccines administration within the last 3 months prior to v1 (baseline visit). * used antibiotics within the last 30 days prior to v1 (baseline visit). * congenital or chronic disease. * any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance. * significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.

Keywords: diarrhea children lactobacilli
quality of life and exercise capacity in copd

Conditions: Copd; Quality of Life; Exercise Capacity

Summary: copd patients will be examined in 4 groups according to their walking distance. patients walking under 150 meters will be determined as group 1, those walking between 150-249 meters will be group 2, those walking between 250-349 meters will be selected as group 3, and patients with copd who walk 350 and above will be determined as group 4. the groups were compared in terms of quality of life, psychological symptoms and dyspnea.

quality of life affects the mortality rate independently in patients with copd. the treatment applied in copd does not stop the decrease in lung function, nor does it prolong the survival time. spirometric evaluations to determine the severity of the disease are not sufficient to explain the perception of patients and their adaptation to their diseases. therefore, evaluating the quality of life has become an important measure of treatment in copd patients. quality of life measurements should be done to minimize the effect of the disease, to help patients better cope with the consequences of an incurable long-term condition, and to determine modifiable factors. identifying modifiable factors; in personalized treatment adopted in airway diseases in recent years; it is important to be able to apply appropriate pharmacological and non-pharmacological treatments our aim is to exercise capacity in copd patients; firstly to investigate the effect on quality of life, then to determine the relationship between emergency admission and hospitalization, dyspnea, psychological symptoms.

Eligibility criteria:
inclusion criteria: * copd patients completed all tests and qustionnaires exclusion criteria: -

Keywords: copd quality of life exercise capacity
the effects of olfactory stimulation on diagnosis and prognosis of doc patients

Conditions: Minimally Conscious State; Vegetative State

Summary: analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; after the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the coma recovery scale-revision (crs-r).

previous studies suggested that olfactory stimulus have some effect on some patients with disorders of consciousness. then, the aim of the present study is to know the prognostic value of olfactory stimulation and the diagnosis for doc patients. doc patients were recruited (standard diagnosis procedure is 5 times crs-r testing within 10 days). the different stimuli were as follows: 1) 1-octene-3-ol, odor. 2) pyridine, odor. 3) water. we presented these stimuli randomly, and we recorded the patient's crs-r scale behavioral response and response to olfactory stimulation. analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; after the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the coma recovery scale-revision (crs-r).

Eligibility criteria:
inclusion criteria: * 18-65 years old; * non-acute phase; * after coma; * no nerve stimulation drugs within 48 hours before the implementation of the study; * no neuromuscular blockers within 24 hours before implementation exclusion criteria: * history of forehead injury; * nasal fractures; * tracheotomy; * developmental mental or neurological diseases leading to recorded dysfunction; * severe fractures of the extremities.

Keywords: disorders of consciousness prognosis prediction minimally conscious state vegetative state olfactory stimulation
continuous monitoring of blood pressure in spontaneous intraparenchimal cerebral haemorrhage

Conditions: Intraparenchimal Cerebral Haemorrhage

Summary: evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral haemorrhage and its consequences to clinical outcome


Eligibility criteria:
inclusion criteria: * hospitalization only for spontaneous intraparenchimal cerebral haemorrhage * age over 18 years exclusion criteria: * cerebral haemorrhage secondary to other causes
concussion prevention in female soccer athletes

Conditions: Concussion, Mild; Concussion, Brain

Summary: the purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of soccer playing athletes wearing the device and compared to a similar population not wearing the device. secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.

this study will investigate the effectiveness of this device in high school athletes playing a non-helmeted sport such as soccer. athletes participating in this study will be randomly assigned to one of two groups: 1) device wearing during the season or 2) non-device wearing during the season. this study will focus on the use and effectiveness of the device solely in females, as male football and hockey players have previously been investigated. all participants will be outfitted with an adhesive patch-like accelerometer (which will be placed behind the ear (xpatch-x2 biosystems http://www.x2biosystems.com/x2_x_patch/) which will measure the magnitude of every impact to the head sustained by the athlete. effectiveness of the device will be determined via differences in longitudinal brain imaging and functional testing following competitive soccer participation. a subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. at each of these time points participants will also undergo various neurocognitive assessments

Eligibility criteria:
inclusion criteria: * female * normal healthy volunteer * able to provide written consent * must be 14 years or older and a participant on a high school soccer team exclusion criteria: * unable to provide written consent * history of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening: * medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis) * glaucoma (narrow angle or normal tension) * hydrocephalus * recent penetrating brain trauma (within 6 months) * known carotid hypersensitivity * known increased intracranial pressure * central vein thrombosis * any known airway obstruction * any known seizure disorder
validation of breath tests in diagnosing small bowel bacterial overgrowth

Conditions: Malabsorption Syndromes

Summary: normally the gastrointestinal tract is only sparsely colonized with bacteria. the normal flora of the duodenal or jejunal aspirate contains no more than 10\^5 bacteria per milliliter. small bowel bacterial overgrowth (sbbo) is defined as a pathologically increased number of bacteria or the presence of colonic flora in the proximal intestine. the reasons for this condition are manifold, ranging from diabetic neuropathy to surgical bypass. sbbo is frequent in elderly people. therapy is targeted at correcting the underlying small bowel abnormalities that predispose to the condition and at providing appropriate antibiotic therapy. the symptoms and signs of sbbo can be reversed with this approach. however, in many patients the conditions predisposing to sbbo persist life-long, once present. this suggests that noninvasive, sensitive diagnostic tools with high specificity are required. bacterial culture of upper intestinal content is considered the diagnostic gold standard. however, since endoscopic harvesting of duodenal or jejunal fluid is difficult and invasive, indirect tests such as breath tests have been advocated as diagnostic tools. hydrogen breath tests are commonly employed since the substrates can be easily obtained and the measurement is simple. hydrogen is formed when carbohydrates are fermented in the intestine. breath hydrogen analysis allows a separation of metabolic activity of the intestinal flora from that of the host, since no known hydrogen production occurs in mammalian tissue. the hydrogen breath test most often used in routine clinical practice uses glucose. however, the utility of this test is mostly limited by its low sensitivity, because there are "nonproducers" in up to 25% of the subjects tested. the investigators have developed a stable isotope breath test using 13c-labeled lactose-ureide. glycosyl-ureides are condensation products of reducing sugars and urea in aqueous acid. lactose-\[13c\]ureide has been used to investigate oro-caecal transit time because it resists digestion by small intestinal enzymes and is hydrolyzed by bacterial enzymes in the large intestine. a number of studies have described the use of this substrate in adults and children. the aim of the present study was to investigate the lactose-\[13c\]ureide breath test in subjects with suspected sbbo and to compare its results with the results of the glucose hydrogen breath test. microbiological analyses of upper intestinal bacterial cultures were used as gold standard to identify sbbo.


Eligibility criteria:
inclusion criteria: * suspected small bowel bacterial overgrowth exclusion criteria: * age \< 18 years * antibiotic therapy

Keywords: small bowel bacterial overgrowth
efficacy and safety of secukinumab in conjunction with surgery in moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa (HS); Hidradenitis Suppurativa (Acne Inversa); Secukinumab

Summary: this study aims to retrospectively analyze the efficacy and safety of secukinumab combined with surgery in treating moderate to severe hs in real-world clinical practice, providing clinical practioners with real-world evidence in hs treatment.

hidradenitis suppurativa (hs) is a chronic, recurrent, and disabling inflammatory disease that occurs in apocrine distribution sites such as the axilla, groin, and perianal region with a worldwide prevalence of approximately 1.5% -4.6%.the pathogenesis is excessive activation of the th17 type immune response mediated by il-17, il-23, resulting in abnormal keratinization of hair follicles, obstruction of sebaceous ducts, and bacterial infection, culminating in abscesses, sinus tracts, and scarring.patients with moderate to severe hs (hurley stage ii-iii) often suffer from a severe decline in their quality of life due to recurrent infections, pain, and dysfunction, and their risk of depression is markedly elevated.traditional treatments such as antibiotics, glucocorticoids, surgical debridement have limited efficacy, and the recurrence rate of surgery alone is as high as 50% -70%.in recent years, the use of biologic agents such as tnf-α inhibitors has dramatically improved hs outcomes, but 30% to 40% of patients still have an inadequate response to tnf-α inhibitors. accumulating evidence suggests that the il-17 pathway plays a key role in hs pathogenesis, that il-17a expression is upregulated in the skin lesions of hs patients and positively correlates with disease severity. the efficacy and safety of secukinumab in combination with surgery remain unclear.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 80 years old with moderate-severe (hurley ii-iii) hs 2. the diagnosis of hs was confirmed by histopathological examination in the department of pathology of our hospital 3. patients with hs who received secukinumab combined with surgery in the department of dermatologic surgery of our hospital 4. patients with complete clinical data followed up for at least 1 year exclusion criteria: 1. patients lost to follow-up 2. patients with less than one year of follow-up 3. patients who received additional adjuvant therapy during the follow-up period
a phase iii study of kct-0809 in dry eye patients with sjögren's syndrome

Conditions: Dry Eye With Sjögren's Syndrome

Summary: the purpose of this study is to investigate the superiority of kct-0809 to placebo, and to evaluate safety in dry eye patients with sjögren's syndrome


Eligibility criteria:
inclusion criteria: * dry eye patients with sjögren's syndrome * corneal and conjunctival damage exclusion criteria: * severe ophthalmic disorder * punctal plugs or surgery for occlusion of the lacrimal puncta

Keywords: dry eye syndromes corneal diseases conjunctival diseases
study to assess the safety and tolerability of increasing single doses of atr-107 (pf-05230900) in healthy people

Conditions: Healthy

Summary: this is a "first in human" study to determine the safety and tolerability of the drug after single doses. nine doses of increasing strength will be injected or infused (given into a vein) to 9 different groups of people. one third of the participants will be given an injection or infusion of placebo (sugar water). all participants will be healthy people.

first in human single dose study. study terminated 12 october 2011. the atr-107 development team reached a recommendation to terminate further development of atr-107 (pf-05230900). this was based on a number of factors, including development of anti-drug antibodies in approximately 70% of subjects in the first-in-human study in healthy volunteers (b2281001). this recommendation is not based on adverse events observed in study b2281001.

Eligibility criteria:
inclusion criteria: * females of non-childbearing potential * body mass index between 17.5 to 30.5 and body weight \> 50 kg exclusion criteria: * history of significant medical illness * positive urine drug screen or alcohol dependance * smoking \> 10 cigarettes per day

Keywords: pharmacokinetics crohn's disease
study of the efficacy of moderate sedation with intra-nasal dexmedetomidine monitored by eeg monitoring

Conditions: Procedural Sedation and Analgesia; Pediatric ALL

Summary: this is a prospective, monocentric diagnostic study aiming to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (eeg), the psi score, could identify patients for whom a 2 μg/kg dose of dex would not be sufficient for the successful performance of cerebral nmri, and who could therefore benefit from a higher dosage of dex (4 μg/kg).

for some children, brain mri is a particularly important examination for etiological assessment or for monitoring the progress of neurological diseases. it can sometimes be complicated to perform, due to the age and/or pathology of the child concerned. impossibility, postponement or the need for a general anaesthetic are constraints that should be avoided as far as possible. procedural sedation with dexmedetomidine (dex) can be administered intra-nasally. this technique offers good results and safety of use. nevertheless, the failure rate is 20% to 30%, and may depend on the dosage of dex used (indicated doses vary from 2 to 4 μg/kg). this study aims to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (eeg), the psi score, could identify patients for whom a 2 μg/kg dose of dex would not be sufficient for the successful performance of cerebral nmri, and who could therefore benefit from a higher dosage of dex (4 μg/kg).

Eligibility criteria:
inclusion criteria: * indication of dex sedation for brain nmri at the chr de metz-thionville * in a patient aged between 12 months and 5 years or * for a patient aged between 5 and 18 whose cooperation during the examination appears compromised (previous failure, autism spectrum disorders, etc.). * membership of a social security scheme * free and informed consent obtained from the patient's legal guardian(s). exclusion criteria: * weight \< 10 kg * patients with contraindications to the use of dex * hypersensitivity to the active ingredient or to any of the excipients listed in the section on "hypersensitivity". * advanced heart block (level 2 or 3), unless pacemaker implanted * uncontrolled hypotension * acute cerebrovascular pathologies * patients with nasal obstruction * parental refusal of dex administration * minors under guardianship * minors under judicial sanction

Keywords: mri dexmedetomidine eeg