Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of risedronate in the treatment of osteogenesis imperfecta in children

Conditions: Osteogenesis Imperfecta

Summary: children with osteogenesis imperfecta (oi) have bone pain, low bone mass and fractures. there are no approved drugs for the treatment of oi in children, even though some intravenous (iv) bisphosphonates are used off-label in some countries. in a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with oi. this three year study will test the safety and efficacy of risedronate in the treatment of children with oi. for the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. for the second and third years of the study, all patients will receive risedronate.


Eligibility criteria:
inclusion criteria: * oi diagnosis * increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (bmd) or has very low bmd with or without a history of fractures. exclusion criteria: * any bisphosphonate use within one year of enrollment

Keywords: primary disease: osteogenesis imperfecta
cardec-pel: comparison of two methods of caries risk assessment in children

Conditions: Caries,Dental

Summary: the aim of the study was to compare dental caries treatment and follow-up based on an elaborate and individualized assessment of caries risk in children, to a simpler risk assessment strategy by means of a double-blind randomized clinical trial of two years monitoring. participants will be children from 7 to 11 years old, who pass through the screening of the children's clinic of the faculty of dentistry of the federal university of pelotas and fulfill the inclusion criteria. a randomized, stratified sample of approximately 250 children will be included in the study, one group will be composed of children undergoing dental caries-related treatment and maintenance, guided by an individualized and multivariate risk assessment, and another group of children treated based on dental caries experience alone in the deciduous and / or permanent dentition. recruitment will begin at the beginning of 2019, and participants will be followed up for 24 months. parents will respond to an anamnesis, 24-hour dietary recall, food frequency questionnaire, and oral and general health-related quality of life questionnaire, children will undergo a clinical examination to assess caries, according to the international caries detection and assessment system (icdas) in its simplified form and evaluation of caries activity. dental treatments and return intervals will be designated according to the individual risk of the patient detected in the initial approach according to the group. the study evaluations consist of baseline, 12 months and 24 months, data will be transferred to spreadsheets after the different phases of the study. primary outcomes (number of dental surfaces requiring operative intervention) and secondary outcomes will be analyzed by student's t test, quality of life and quality of life related to oral health, will be assessed at the beginning of the study and at the end of treatment, and compared between the groups.


Eligibility criteria:
inclusion criteria: * individuals aged 7 years months to 11 years; * children seeking dental treatment at the pediatric dentistry university clinic in pelotas (ufpel) exclusion criteria: * medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child
correlation between q-value changes and progression of pediatric keratoconus.

Conditions: Keratoconus; Collagen Diseases; Corneal Disease

Summary: keratoconus is a progressive corneal disease characterized by asymmetric corneal thinning and structural changes in corneal collagen which leads to decrease in visual acuity due to myopic shift, irregular astigmatism or corneal scarring. early detection of the disease in children aids in halting the progression and improve their quality of life. there is no consensus regarding the progression criteria of the disease, we aimed to assess the changes in corneal asphericity in children after corneal collagen crosslinking and investigate any possible correlation with progression criteria widely used.

the keratoconus progression is defined as increasing by 1.0 diopter (d) or more in the maximum keratometry (kmax), progressive deterioration in minimal corneal thickness is also associated with kc progression, other methods have been investigated to confirm kc progression such as changes in manifest refraction, unaided visual acuity (uava), bcva, posterior keratometric data and higher order aberrations (hoa) which are altered in kc and can aid to confirm disease progression. q-value (a coefficient of corneal asphericity) reflects the shape of the cornea, its refractive power, and spherical aberration. the mean q-value in normal cornea is -0.26 ± 0.18, the severity of kc and the q-value are inversely related. mean q-value in kc at 8mm zone is -0.84 and -1.10 for anterior and posterior corneal surfaces, respectively. until now, no precise criteria of kc progression especially in cases had undergone previous trans-epithelial corneal collagen cross-linking (te-cxl) to halt the progression of the disease. in the present study we aimed to analyze the correlation between the changes in q-value and progression of the kc in children had undergone bilateral te-cxl.

Eligibility criteria:
inclusion criteria: children that were diagnosed as bilateral progressive kc (stage i-iii, according to amsler classification, kmax change \>1d between 2 scanning with at least 2 months apart), and their age were less than 16 years old at time of te-cxl, topographic parameters were kmax 47-60d and mct more than 400μm. exclusion criteria: eyes with central corneal scarring, amblyopic eyes, and other corneal pathologies that may alter pentacam scanning.

Keywords: corneal asphericity corneal collagen cross-linking q-value pediatric keratoconus trans-epithelial
integrative study of vestibular pathology

Conditions: Dizziness; Syndrome

Summary: exploratory posturological, neurosensory, cognitive, emotional, personality and general evaluations (quality of life). the investigators will characterize a sensory profile quantified by one or more scores from a multi-parameter baysian approach. each parameter and these scores will be correlated to the type of vestibular damage and its recovery in order to establish diagnostic, prognostic and therapeutic follow-up markers.

this is an exploratory neurophysiological work that aims to identify diagnostic, prognostic and therapeutic markers in vestibular pathology. theinvestigators wish to characterize the neurosensory profile of individuals using new exploration paradigms provided by a new posturology platform coupled with virtual reality scenarios and by proposing a complete transversal approach in terms of evaluation of the subjects: personality, cognition, emotion including the depressive state, sensory strategy, general data. baysian statistical approaches and linear mixed model will be used to determine markers of sensory profile correlated to the vestibular damage for diagnostic, prognostic and therapeutic follow-up. the investigators aim to be able to better characterize the cognitive-emotional and sensory deficits expressed by the vertiginous and unstable patients, to integrate it into the evaluation of the vestibular pathology, to use these markers to better discriminate the underlying physiopathological mechanisms, and to improve at the same time the diagnosis of the functional attack and the rehabilitation follow-up of the patients.

Eligibility criteria:
inclusion criteria: * male or female patient (18-80 years old) * patient with an acute or chronic vestibular pathology according to ent diagnostic criteria exclusion criteria: * subjects under 18 years of age * pregnant or breastfeeding women, * persons in an emergency situation or unable to give their consent, including adults under guardianship * person under legal protection * patient presenting a vertigo or postural disorders of non vestibular etiology * persons deprived of liberty, minors, protected adults, * patients with an intercurrent neurological pathology including cerebellar pathology * inclusion of the subject in another interventional research protocol with pharmacological aim during the present study

Keywords: posture vertigo cognition emotion physiotherapist vestibular system balance
novel use of an enhanced fluoroscopic imaging device to reduce radiation exposure and operative time during intramedullary nailing of hip fractures

Conditions: Radiation Exposure

Summary: the purpose of this study is to evaluate the effectiveness of a novel digital image enhancement (die) technology in reducing the radiation exposure to both the patient and surgical staff during standard intramedullary nail placement for treatment of hip fractures. secondarily, to evaluate whether the image quality and reproducibility of desired images can be improved with use of the die technology. finally, to evaluate whether die technology reduces total operative time.


Eligibility criteria:
inclusion criteria: * closed hip fracture requiring intramedullary nailing exclusion criteria: * age \<18 years
antiviral prophylaxis in a burn population

Conditions: Herpes Simplex

Summary: a prospective, randomized trial to calculate incidence of herpes simplex virus in an in-patient burn population and determine efficacy of prophylactic antiviral therapy to prevent viral infection and/or reactivation. hypothesis is that antiviral prophylaxis will be effective in reducing hsv infection/reactivation.

a prospective, randomized trial of antiviral prophylaxis of at risk individuals has yet to be performed. we anticipate that the disease burden in our population of burn patients will be large, especially in patients who exhibit high risk characteristics, and hypothesize that antiviral prophylaxis will significantly reduce the incidence of herpes simplex virus in the burn population. this study will have a profound impact on the treatment of burn patients both at our own institution and throughout the country. prophylactic treatment using acyclovir in burn patients would decrease patient morbidity, pain and suffering and would likely positively impact scarring, wound healing, and, ultimately, patient satisfaction and quality of life. reducing the incidence of hsv infections will decrease the length of hospital stays for many patients, saving both health care expenses and resources. if prophylactic acyclovir becomes standard of care treatment for burn patients, this treatment plan would be a tremendous public health breakthrough for preventing hsv outbreaks and could be extrapolated to researching similar protocols for other health conditions.

Eligibility criteria:
inclusion criteria: * patients presenting to memorial medical center's regional burn unit, both transfers and direct admissions * patients aged 24 months to 110 years old * patients presenting with thermal, flame, flash, chemical, grease or electrical burns * patients with second degree or higher burn to the face or burn to any part of the body of 20% tbsa or greater * patients, power of attorney or legally authorized representative cognitively competent to give consent. exclusion criteria: * patients who do not wish to consent to all facets of the study * patients younger than 24 months * patients older than 110 years of age * patients with mechanical skin injury (ie, road rash, crush injury) * patients who are pregnant or become pregnant during the treatment phase of the study * patients with a documented allergy to acyclovir, famcyclovir or valacyclovir * patients already taking acyclovir, famcyclovir or valacyclovir * patients who have or develop thrombotic thrombocytopenic purpura * patients have or develop hemolytic uremic syndrome * patients concurrently taking tizanidine, phenytoin, valproic acid, fosphenytoin, meperidine, micophenolic acid, tenofovir disoproxil fumarate, or zidovudine * patients whom the investigator feels would be inappropriate.

Keywords: antiviral herpes simplex virus herpes burn patients hsv acyclovir
heterotaxy syndrome and intestinal rotation abnormalities - a prospective study

Conditions: Heterotaxy Syndrome

Summary: infants with heterotaxy syndrome (hs) are born with an abnormal arrangement of organs along the right-left body axis. abnormalities of intestinal rotation and fixation are commonly associated with hs. malrotation is the most worrisome intestinal rotation abnormality (ira). advances in cardiac surgery have improved hs mortality such that there is increasing attention to ira and their management. the objective of this research project is to prospectively observe a cohort of infants with hs and ira and evaluate their long term outcomes. specifically, the investigators would like to determine what is the natural history of asymptomatic ira in patients with hs and what is the morbidity and mortality secondary to an elective ladd procedure for asymptomatic ira in a population with hs? the investigators plan a prospective, multi-center, observational study to follow this complicated group of patients. this will be a web-based database collected from major cardiac tertiary care centers in both canada and the united states. patients with hs will be recruited by their primary site and clinical data will be collected by their primary site prospectively throughout childhood until they are at least five years of age. this patient population will be followed by their own clinical care givers; this is not an interventional study. no additional clinic visits will be required and the patients will not have to be contacted. patient medical records will be accessed by a member of the study team at the primary site at least once per year or more frequently if interventions are required or complications develop.


Eligibility criteria:
inclusion criteria: * all infants less than or equal to six months of age with a new diagnosis of heterotaxy syndrome exclusion criteria:

Keywords: pediatrics congenital heart disease heterotaxy syndrome intestinal malrotation
duration of antibiotic treatment in community-acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: international and national clinical guidelines recommend short antibiotic regimens in patients with non-severe community-acquired pneumonia (cap) who have reached clinical stability. however, adherence to these recommendations remains unclear. the goals of this quasi-experimental trial are: 1) to assess adherence to clinical guidelines in relation to the duration of antibiotic treatment in patients hospitalized for non-severe cap who have reached clinical stability; 2) increase adherence to clinical guidelines and reduce the use of antibiotics in patients hospitalized for non-severe cap who have achieved clinical stability after at least 5 days of antibiotic treatment. to this end, a multicenter prospective study will be carried out over 2 years and divided into 2 phases: i) during the first year (observational phase), patients with cap hospitalized in the participating centers will be recorded to assess objective 1; ii) to achieve objective 2, at the beginning of the second year (quasi-experimental trial) the centers will be randomized into 2 groups of hospitals, one of them a control group and the other an intervention group. the intervention will consist in automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability.


Eligibility criteria:
inclusion criteria: * patients \>18 years hospitalized for community-acquired pneumonia with a new infiltrate on chest x-ray and/or computerized tomography. * at least one compatible sign or symptom (fever, cough, expectoration, dyspnea, chest pain or crackles on auscultation) * correctly treated with ≥ 3 days of antibiotic exclusion criteria: * intensive care unit admission during the first 5 days since hospital admission * abscess or necrotizing pneumonia * empyema or pleural effusion requiring drainage tube * bronchiectasis * cystic fibrosis * active tuberculosis * postobstructive pneumonia * suspected bronchial aspiration * sars-cov-2 infection * immunosuppression (congenital immunodeficiencies, hiv infection, solid organ transplantation, functional or anatomical asplenia, immunosuppressive treatment, active solid or haematological neoplasia \[active treatment in the last 12 months\], etc.) * hospital acquired pneumonia * concomitant extrapulmonary infection that requires antibiotic treatment for more than 5 days (eg myocarditis) * confirmed diagnosis alternative to pneumonia (eg, lung cancer)

Keywords: pneumonia antibiotic treatment duration clinical stability adherence
study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of ibi346#cibi346y001#

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: an open label, single-arm clinical study evaluating the safety and efficacy of ibi346 infusion in relapsed/refractory multiple myeloma


Eligibility criteria:
inclusion criteria: 1. according to the multiple myeloma diagnostic criteria of the international myeloma working group (imwg), there is the initial diagnosis of multiple myeloma. 2. subjects must have previously received at least 3 anti-myeloma regimens. subjects must have documented disease progression (according to imwg criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (pi) and immunomodulatory drug (imid). 3. measurable disease as defined by the protocol 4. ecog score is 0 or 1. 5. expected survival time ≥12 weeks. exclusion criteria: 1. patients suffering from graft-versus-host disease (gvhd) or requiring immunosuppressants drugs. 2. patients who received autologous hematopoietic stem cell transplantation (asct) or prior allogeneic hematopoietic stem cell transplantation (allo-hsct) within 12 weeks prior to mononuclear cell collection. 3. no unmobilized mononuclear cells can be collected for car t cell production. 4. screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses \< 10mg/ day). 5. patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmhg).
phase i trial of an intervention to increase condom use by hiv-discordant couples

Conditions: HIV Infections

Summary: to assess the acceptability of and participation in a group counseling intervention, including an assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate. to evaluate the profile of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing and attempts to initiate condom use within a stable hiv serodiscordant partnership. to assess the potential for the intervention to result in increased condom use among stable sexual partners. there is a significant risk of hiv transmission to hiv-uninfected partners in hiv-discordant couples. while condom use has been a major component of most aids prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. the most effective way to promote condom use among discordant couples remains largely unknown.

there is a significant risk of hiv transmission to hiv-uninfected partners in hiv-discordant couples. while condom use has been a major component of most aids prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. the most effective way to promote condom use among discordant couples remains largely unknown. a pilot study to assess the acceptability of intervention precedes the main study. the phase i study recruits 15 hiv-infected men and 15 hiv-infected women and their partners at each of three sites (india, thailand, and uganda). volunteers participate in a multi-session group-based condom promotion program for approximately 12 months. couples are organized into small groups consisting of 4 to 6 couples per group. each group meets for a total of 4 sessions within a 2- to 4-week period. follow-up interviews are conducted at months 1 and 3 following completion of the intervention.

Eligibility criteria:
inclusion criteria volunteers must be: * hiv-positive through hivnet testing or hiv-seronegative by eia. * presently in a sexual relationship of at least 6 months duration with the intention to remain with this partner for the duration of the study. * willing to identify and recruit this sexual partner to which he/she has disclosed or will disclose hiv serostatus. * willing to receive counseling and hiv testing (hiv-seronegative partners only). * willing to agree to be interviewed with their partner and individually. * willing to continue engaging in sex with their partner. * willing to participate in a couples-based condom promotion intervention. * willing and able to attend each scheduled intervention/follow-up study visit. exclusion criteria volunteers with the following are excluded: * history of domestic violence. * current consistent condom use.

Keywords: sexual partners condoms counseling
esophageal hypersensitivity study in patients with gastroesophageal reflux disease (gerd)

Conditions: Sensitivity in Esophagus

Summary: the purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.


Eligibility criteria:
inclusion criteria: * provision of signed informed consent form * bmi 18.5-35.0, inclusive * continuous ppi treatment for gerd during the last 4 weeks exclusion criteria: * patients that have not experienced any gerd symptoms improvement at all after ppi treatment * unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides gerd * prior surgery of the upper gi tract

Keywords: gerd patient esophagus pain
gliflozin in elderly diabetic patients: a pragmatic intraclass evaluation trial

Conditions: Diabetes Mellitus, Type 2

Summary: three sglt2i were commercially available in italy at the time the trial was designed: canagliflozin, dapagliflozin, and empagliflozin. preliminary evidence suggests that the higher dose canagliflozin (300 mg/day) might exert a stronger glucose-lowering effect than dapagliflozin or empagliflozin. the clinical relevance of this putative difference is however unknown. on the other side, the use of canagliflozin, but not empagliflozin and dapagliflozin, has been associated with an increased risk of some adverse events, namely bone fractures and lower limb amputations. currently, the available information on the efficacy and safety of sglt2i in elderly (70+ years) patients with type 2 diabetes are is very scant. thus, a compelling need now exists of comparing efficacy and safety of the commercially available sglt2i in a population of frail patients at high risk of cardiovascular and renal diseases.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * age 70+ years * male or female * prevalent cardiovascular disease (symptomatic or asymptomatic) or egfr \<90 ml/min/1.73 m2 and above the lower limit for initiation of sglt2i according to label (currently egfr \<60 ml/min/1.73 m2) * hba1c above individualized target * indication to add sglt2i exclusion criteria: * age \>90 years * estimated life expectancy \<1 year * very high risk of genitourinary tract infections (\>2 events in the last 6 months) * recent weight loss (\>5% in \<6 months) * inability to provide informed consent