Kornimate/medical-research-clean huggingface dataset:
oxidative stress, inflammation and acute decompensation in urea cycle disorders

Conditions: Urea Cycle Disorders

Summary: the primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in ucd during baseline and decompensated states.

protein turnover is a cyclic process with a net loss of protein in the fasting state and a net gain in the fed state contributing to nitrogen balance. these physiologic processes are impacted during infection; whole-body protein catabolism exceeds protein synthesis, resulting in net loss of whole-body protein. patients with urea cycle disorders suffer episodes of periodic hyperammonemic crisis, often in association with intercurrent infections. the immediate cause of this decompensation is the increase in endogenous protein catabolism that is the endpoint of a cascade triggered by intercurrent illness. this increase in protein catabolism leads to elevations of serum amino acids and ammonia production, which cannot be eliminated by a dysfunctional urea cycle. it is well known that infectious illnesses play a significant role in precipitating metabolic crises in urea cycle defects, presumably by triggering a cascade of events involving the release of inflammatory cytokines that lead to increased protein catabolism. cytokines have also been implicated as distant mediators of oxidative stress. however, the correlation between oxidative stress, cytokine levels, and severity of a crisis is currently unclear. the primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in ucd during baseline and decompensated states. the investigators will undertake measurements of selected markers of oxidative stress and cytokines in serum and urine during baseline and decompensated states in subjects with ucd in order to establish their prognostic value as biomarkers for disease severity and/or predictors of metabolic decompensation.

Eligibility criteria:
inclusion criteria: * confirmed or highly-likely diagnosis of one of the eight ucds as established for the longitudinal study (5101) (see section 4.2 inclusion criteria, table 4 for diagnostic criteria for patients with ucd) * enrolled in longitudinal study of urea cycle disorders (rdcrn ucdc #5101) exclusion criteria: * ucd patients who have undergone orthotopic liver transplantation * significant chronic medical co-morbidity that might confound the analysis as determined by the site investigators. * significant co-morbidities include but are not limited to: * diabetes, liver failure + cirrhosis * renal failure * cardiac disease * chronic inflammatory diseases * asthma requiring daily long-term control medications * significant respiratory disease.

Keywords: urea cycle disorders
vertebroplasty for the treatment of fractures due to osteoporosis

Conditions: Spinal Fractures; Osteoporosis

Summary: vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. this study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis.

spontaneous, atraumatic compression fractures due to osteoporosis occur in more than 700,000 patients per year. pain associated with these fractures may be excruciating, but before the advent of percutaneous vertebroplasty, treatment options were limited. analgesic medications, bed rest, and bracing have been the mainstays of treatment, but each of these therapies has substantial limitations. because of the dearth of viable treatment options for osteoporotic vertebral compression fractures, the practice of percutaneous vertebroplasty, which involves injection of polymethylmethacrylate (medical cement) into the fractured vertebra, has disseminated rapidly. however, evidence for the efficacy of percutaneous vertebroplasty is currently limited to uncontrolled, nonblinded, small case studies. even though high rates of success are reported, with up to 90% of patients achieving substantial pain relief, these case studies have not accounted for numerous important potential biases, including the natural tendency for compression fractures to heal spontaneously, regression toward the mean (wherein patients seek medical attention when pain is maximum), and the placebo effect. this study will examine the clinical efficacy of percutaneous vertebroplasty for treatment of painful osteoporotic vertebral compression fractures. participants in this study will be randomly assigned to receive either percutaneous vertebroplasty or a sham procedure (placebo control group). participants may have up to 2 spinal levels treated. participants will be enrolled in the study for 1 year and will have study visits at entry and months 1 and 12. there will also be phone visits at days 1, 2, 3, and 14 and months 3 and 6. after month 1, crossover from the placebo group to the vertebroplasty group will be allowed.

Eligibility criteria:
inclusion criteria: * confirmed osteoporosis or osteopenia by a referring physician and/or medical history and physical exam or osteopenia on plain film * vertebral compression fracture in vertebrae t4 through l5, of less than 1 year old * pain not responsive to standard medical therapy * current rating for pain intensity of at least 3 on a scale of 0 to 10 exclusion criteria: * evidence or suspicion of malignant tumor or spinal canal compromise * concomitant hip fracture * local or systemic infection * uncorrectable bleeding diatheses * surgery within the previous 60 days * lack of access to telephone * inability to communicate in english * dementia * pregnancy * abnormal renal function or anticipated venography * conscious sedation is contraindicated for subject

Keywords: vertebroplasty crushed vertebrae back pain structurally unstable vertebrae polymethylmethacrylate invest pmma rdq
longitudinal studies of the glycoproteinoses

Conditions: Aspartylglucosaminuria; Fucosidosis; Galactosialidosis; Alpha Mannosidosis; Beta Mannosidosis; Mucolipidosis II; Mucolipidosis III; Schindler Disease; Sialidosis

Summary: the glycoproteinoses are among the most rare and least researched of the lysosomal diseases. the diseases include aspartylglucosaminuria, fucosidosis, galactosialidosis, alpha-mannosidosis, beta-mannosidosis, mucolipidosis ii, mucolipidosis iii, schindler disease, and sialidosis. longitudinal studies of these conditions are needed in order to better define how common the diseases are, identify clinical features which could contribute to early diagnoses, detail progression of the diseases, assess the supportive therapies currently used, and identify potential treatments. laboratory tests will evaluate metabolic and genetic defects found in participants' blood and urine samples.

this is a longitudinal study of 100 individuals diagnosed with any one of the nine glycoproteinoses. because of the small number of individuals diagnosed with these diseases, participants will be strongly encouraged to be evaluated in person at a study site, but inability to travel to a study site will not exclude a person from participating. this non-interventional study will also collect medical information about participants through questionnaire, phone interviews, and review of medical records regarding the person's usual medical care, including lab testing and x-rays or other imaging studies. participants who are evaluated at the study center will have a physical examination performed by a clinical geneticist and neuropsychological studies administered by the study psychologist. neuropsychological studies assess intelligence, learning abilities, language skills, and ability to participate in day to day activities of life. participants seen at the study center will have skeletal x-rays performed to evaluate the impact of the disease on the participant's bones. every participant will complete (or have a care provider complete for them) * a questionnaire about their birth, development, and medical history * an interview with study personnel (in person or via telephone) * follow up interviews on at least an annual basis to update the medical history each participant will be asked to * give a blood sample * give a urine sample * some participants may be asked to give a skin biopsy.

Eligibility criteria:
inclusion criteria: be an individual of any age diagnosed with one of the following conditions * aspartylglucosaminuria * fucosidosis * galactosialidosis * alpha mannosidosis * beta mannosidosis * mucolipidosis ii * mucolipidosis iii * schindler disease * sialidosis exclusion criteria: * not diagnosed with one of the nine glycoproteinoses listed above.

Keywords: glycoprotein storage disease lysosomal storage disease mannosidase deficiency disorders neuraminidase deficiency with beta-galactosidase deficiency mucolipidoses oligosaccharidoses lysosomal disease metabolic disease, inborn aspartylglucosaminuria fucosidosis galactosialidosis alpha mannosidosis beta mannosidosis mucolipidosis ii mucolipidosis iii schindler disease sialidosis
long-term safety study of alogliptin used in combination with thiazolidine in participants with type 2 diabetes in japan

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and thiazolidine administered once daily (qd) for 40 consecutive weeks in participants who completed a phase 2/3 thiazolidine add on study.

both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. takeda is developing syr-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. alogliptin is an inhibitor of the dipeptidyl peptidase iv (dpp-iv) enzyme. dpp-iv is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. it is expected that inhibition of dpp-iv will improve glycemic control in patients with type 2 diabetes. to evaluate the long-term safety and efficacy of alogliptin, participants in the present study were enrolled from a core phase 2/3 thiazolidine add on study (syr-322/cct-004; nct01318070).

Eligibility criteria:
inclusion criteria: 1. had completed the core phase 2/3 thiazolidine add on study. 2. the subject was capable of understanding and complying with protocol requirements. 3. signed a written, informed consent form prior to the initiation of any study procedure. exclusion criteria: 1. with clinical manifestation of hepatic impairment (e.g., an ast or alt value of 2.5 times or more of the upper reference limit at week 8 of the core phase 2/3 thiazolidine add on study). 2. with clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dl or more at week 8 of the core phase 2/3 thiazolidine add on study). 3. with a history or symptoms of cardiac failure.

Keywords: diabetes mellitus - type 2 diabetes mellitus drug therapy
photobiomodulation on the salivary glands of patients with xerostomia induced by the use of benzodiazepines

Conditions: Xerostomia

Summary: depression is the most common mental illness and antidepressants are in the first line of treatment of depressed patients. this therapeutic class is inevitably associated with side effects and adverse reactions, xerostomia being a symptom that seems to be transverse to them all. saliva performs multiple functions and plays a vital role in protecting the health of the soft and hard tissues of the oral cavity. reductions in salivary flow are most often manifested as dry mouth, and this is the subjective complaint called xerostomia. although xerostomia is the most frequent indication of reduced salivary production, it is not invariably associated with hyposalivation. the user of antidepressant drugs has a number of important systemic and oral complications. treatment for salivary changes remains unknown, but low-level laser therapy has been shown to be effective in improving salivary flow in patients with xerostomia due to diabetes, sjogren's syndrome, chemotherapy and radiotherapy for head, neck and lung cancer. this randomized controlled trial aims to evaluate oral symptoms related to salivary gland function and mucosal condition of depressed patients, as well as the effects of photobiomodulation on salivary flow. sixty patients will be included in the protocol, after signing the informed consent form. they will undergo anamnesis, physical evaluation and oral health self-perception questionnaires and symptoms related to salivary gland function and then will be divided into two groups: photobiomodulation (pbm) (n=30); will have their larger salivary glands irradiated with diode laser (808nm, 4j per point, 40s) and placebo (pcb) (n=30), which will be subjected to a simulation, where the application protocol will be repeated, but with the laser off. previous and post treatment sialometries will be performed to compare saliva volume. biochemical analysis, in which total protein and calcium will be measured, will also be performed.


Eligibility criteria:
inclusion criteria: * participants in good general health, but who have depression with regular use of benzodiazepines; * complaints of xerostomia or hyposalivation; * over 18 years of age; * be able to understand and sign the informed consent form. exclusion criteria: * participants who present current acute systemic infectious conditions; * chronic kidney disease; * diabetics; * participants with a history of mental disorders other than depression and anxiety; * participants without conditions for dental treatment in the month of referral to the dental service; * hemodynamic instability; * signs and symptoms related to the cardiovascular systems; * acute systemic infectious processes; * acute cardiovascular disease; * those with any type of photosensitivity; * neoplasms in the region of glands; * under 18 years of age; * pregnant or lactating women; * participants with xerostomia not induced by anxiolytics.
track: validation of the portuguese version

Conditions: Asthma; Respiratory Disease

Summary: the track ("test for respiratory and asthma control in kids") questionnaire is a validated instrument to evaluate the control of respiratory symptoms in young children. the track questionnaire was developed in english and a version in portuguese is not available or validated, purpose of the present project.

the track ("test for respiratory and asthma control in kids") questionnaire is the only instrument developed and validated so far to evaluate the control of respiratory symptoms in young children under five years of age. the track questionnaire consists of five questions, scored from 0 to 20, given to caregivers of children with asthma or recurrent respiratory symptoms, and addresses respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilator medications over the past three months and systemic corticosteroids in the last year. the track questionnaire was developed in english and has already been translated and validated into spanish and arabic. at the moment there is no translation and validation of the track questionnaire for the portuguese language, purpose of the present project.

Eligibility criteria:
inclusion criteria: * native portuguese speakers families * medical diagnosis of asthma or history of at least three episodes of cough and/or wheeze and/or dyspnea (duration longer than 24 hours) and treated with bronchodilators exclusion criteria: * other relevant pulmonary diseases (i.e.: cystic fibrosis, bronchopulmonary dysplasia) * systemic diseases (i.e.: heart diseases, neurologic disorders) * premature birth (under 37 weeks of gestational age) * congenital malformations * illiteracy and/or inability of parents to understand the questionnaire

Keywords: respiratory symptoms children
single-case study on therapeutic change in chronic low back pain

Conditions: Chronic Low Back Pain

Summary: exploration of treatment processes during exposure and cognitive-behavioral therapy in the context of chronic low back pain in a multiple baseline single-case design.

the present study intends to specifically investigate treatment elements during exposure and cognitive-behavioral therapy, which are especially powerful in electing time contingent therapeutic change. hereby, it is the goal to explore further change processes, which play an important role during psychological treatment of individuals with clbp and high levels of fear-avoidance.

Eligibility criteria:
inclusion criteria: * \> 6 months chronic low back pain * sufficient level on fear avoidance scores (pcs \> 35, pass \>20, qbpds \> 30, pdi \> 20 and phoda harm ratings of 13 activities \> 50, including 8 \> 80) * german-speaking * agreeing to participate, verified by completion of informed consent exclusion criteria: * red flags * pregnancy * illiteracy * psychoses * alcohol addiction * surgeries during the last 6 months or planed surgeries * specific medical disorders or cardiovascular diseases preventing participation in physical exercise * participating in another psychotherapy

Keywords: chronic low back pain cognitive-behavioural therapy exposure therapeutic processes single-case study
long-term follow up of mucosal tissue height influence on peri-implant bone levels.

Conditions: Edentulous Alveolar Ridge

Summary: our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. we include 59 people and divide them into three groups based on their gum tissue thickness. some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. we try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run.

the protocol of our study focuses on understanding the impact of gum tissue thickness on the stability of the bone surrounding dental implants over a period of ten years. we enroll 59 participants and categorize them based on their initial gum thickness. the study groups included participants with naturally thin gums, participants whose thin gums were surgically enhanced with an allogenic tissue matrix to increase thickness, and participants with naturally thick gums. we monitore the bone levels around the implants using x-rays at baseline and annually, assessing any changes in bone health and stability. our objective is to determine if and how the thickness of gum tissue influences long-term bone preservation around dental implants, aiming to provide insights into better implant care and outcomes.

Eligibility criteria:
the inclusion criteria for the study were individuals aged 18 years or older, generally healthy with no medical contraindications for implant surgery, missing teeth in the lower jaw posterior area, at least 6 mm bone width, healthy soft tissue, at least 2 mm keratinized gingiva buccally and lingually, no bone augmentation procedures before or during implant placement, and a signed informed consent form. the exclusion criteria included poor oral hygiene, history of uncontrolled periodontitis, smoking, diabetes, alcoholism, and medication influencing healing.

Keywords: dental implant phenotype mucosal tissues mucosal tissue augmentation vertical soft tissue height bone resorption bone remodeling bone formation
the effect of aquacel® ag+ extra dressing on wound biofilms

Conditions: Diabetes; Chronic Foot Wounds

Summary: the purpose of the research is to assess the effects of aquacel ag+ extra dressing on chronic wound bacterial biofilms

background: chronic wounds and wound infections can be costly, resulting in prolonged hospital stays and an increased risk of secondary infection and septicaemia. in the uk the management of chronic venous leg ulcers is estimated to cost £1 billion/year, with surgical site infections requiring approximately 6.5 days additional hospital stay. chronic wounds typically harbour a wide variety of bacteria; heavy bacterial colonisation and subsequent biofilm formation has been cited as a factor which induces a chronic inflammatory state and delays healing times. aquacel®ag+ extra is a soft conformable flat sheet nonwoven fabric dressing, which forms a gel when it becomes wet. its physical characteristics have the potential to increase the speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound bioburden. removing these potential barriers to healing may help towards wound progression. aim: this is a pilot study to investigate the effects of aquacel ag+ extra dressing on chronic wound bacterial biofilms. wound debridement tissue will be assessed for the presence/absence of in situ biofilms which will be monitored over 4 weeks and compared to the baseline (non-treatment) sample. additionally, we will evaluate reductions in wound volume over the treatment period.

Eligibility criteria:
inclusion criteria: * provided written informed consent * be over 18 years of age * must have a chronic foot wound greater than 4 weeks in duration * be willing and able to attend the clinic for the required study visits - exclusion criteria: * subjects with a history of sensitivity to any one of the components of the device being studied * subjects who have any other medical condition which, according to the investigator justifies exclusion from the study * subjects who are currently participating in or have been on a clinical study within the last 4 weeks.

Keywords: chronic wounds biofilms bacteria
effectiveness of a protocol of specific activation.

Conditions: Injuries:Knee Injuries

Summary: in football, knee is the joint that suffers the most severe injuries. sometimes, this is produced by poor pre-activation of the musculature that is responsible for knee stability and central stability. objetive: study the efficacy of specific gluteus medius and core activation protocol in knee stability in youth football players.

a randomized, longitudinal clinical trial with a blinded and prospective evaluator will be carried out, in which the knee stability will be evaluated with the following tests: y-balance test and flamingo balance test. the measurements will be made before and after the intervention. the study will be carried out with patients evaluated by a specialist in traumatology and will be randomly divided by a system of numerical tables through a computer program between the experimental and control groups. the control group will perform a typical warm-up of competitive football; and the experimental one will do this above, added to a specific activation of gluteus medius and core. dynamic stability (y-balance test) and postural and static stability (flamingo balance test) will be measured before and after the intervention.

Eligibility criteria:
inclusion criteria: * perform soccer sports practice, at least 3 times a week at a competitive level. exclusion criteria: * subjects with a knee surgery. * patients who are injured at the time of the study.

Keywords: knee stability. core gluteus medius warm-up football
tyrosine for methamphetamine dependence - 1

Conditions: Amphetamine-Related Disorders

Summary: the purpose of this study is to evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. examine effect of tyrosine on abstinence, retention in treatment, and craving."

evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. examine effect of tyrosine on abstinence, retention in treatment and craving.

Eligibility criteria:
inclusion criteria: 18-65 years of age. able to provide informed consent. desire to reduce/eliminate methamphetamine use. used within the past two weeks. meet dsm criteria for methamphetamine dependence. exclusion criteria: no dependence (within the past 12 months) for other durgs except nicotine. no history or family history of tyrosine intolerance.

Keywords: amphetamine dependence