Kornimate/medical-research-clean huggingface dataset:
association between type of ligating brackets and oral health-related quality of life in orthodontic patients

Conditions: Oral Health-related Quality of Life; Orthodontic Treatment

Summary: to evaluate the association of the level of quality of life related to oral health, between treatment with the minitube system and conventional ligation brackets, in adult patients with moderate malocclusion, during the first six months, of orthodontic treatment.

this is an observational cohort study with 1: 1 allocation ratio. the sample will be of 200 participants, divided into two groups. people over 18 years of age will be included; with moderate treatment complexity determined by dental aesthetics index dai. the study interventions are: (1) mini tube system (flow-jac system, bogotá, colombia) and (2) conventional ligating brackets (gemini 3m unitek orthodontic products bracket, calif, usa) with nitinol classic or superelastic (se) archwires 0.014 and 0.016. the outcome variable is oral health-related quality of life (ohrqol) measured with ohip-s14 ortho instrument, which was validated in spanish in patients with orthodontic treatment. consists of 14 questions that address seven dimensions (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap), specifically related to orthodontic treatment. the ohip-s14 ortho score is between 0 to 56. where 0 indicates a positive impact and 56 an unfavorable impact. the questionnaire will be self-administered online during the first 6 months of treatment: t0: prior to cementation, t1: 24 -48 hours after cementation, t2: 1 month after cementation, t3: 3 months after cementation and t4: 6 months after cementation.

Eligibility criteria:
inclusion criteria: * age range from 18 to 35 * moderate treatment complexity determined by dental aesthetics index dai moderate. * orthodontic treatment with mini tube system in upper and lower jaw or mbt conventional ligating pre-set appliances * non- extractions at the start of orthodontic treatment * non- placement of mini-implants at the start of orthodontic treatment exclusion criteria: * craniofacial anomalies * dental caries at the start of orthodontic treatment * periodontal disease at the start of orthodontic treatment * systemic disease * orthognathic surgery indicated * cognitive disorders * non understand the spanish language

Keywords: health-related quality of life oral health impact profile orthodontics, corrective orthodontic appliances
dose-ranging efficacy and pharmacokinetics study of intravenous atorvastatin in hypercholesterolemic patients

Conditions: Hypercholesterolemia; Dyslipidemias

Summary: open-label study will titrate doses of intravenous atorvastatin and monitor respective ldl-c levels in hypercholesterolemic patients previously controlled on oral atorvastatin.


Eligibility criteria:
inclusion criteria: * on stable dose of daily oral atorvastatin for \>= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin) * stable ldl-c confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase. exclusion criteria: * history of myopathy or rhabdomyolysis * liver disease including current biliary disorders * positive for hiv, hepatitis b or hepatitis c virus * abuse of alcohol or non-prescribed drugs * unstable angina or arrhythmias or a cardiac event in the previous three months * hypothyroidism, diabetes, or hypertension that is not under control * pregnant or plans to be pregnant
the impact of simultaneous presence of viral and bacterial pathogens on therapy and course of severe pneumonia

Conditions: Community Acquired Pneumonia; Hospital Acquired Pneumonia; Ventilator Associated Pneumonia

Summary: the purpose of the study is to determine if the clinical course of pneumonia is more severe when both, bacterial and viral pathogens are find as possible causative agent and how does it affect treatment.

basic demographic data of the patients (age, gender), data on concomitant diseases and epidemiological circumstances will be collected severity of illness will be assessed by apache ii (at day 1) and sofa (at day 1,2,3 and 7) scoring system following laboratory tests will be performed at day 1, 2,3 and 7.: * blood count analysis * differential blood count * c- reactive protein, procalcitonin * glucose, urea, potassium, sodium, chloride, magnesium, creatinine, bilirubin, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine transaminase, gamma-glutamyl transpeptidase , alpha-amylase, lipase, creatine kinase, lactate dehydrogenase, myoglobin * arterial blood gas analysis * tests of hemostasis. additional 2 ml of blood will be taken at day 1 and day 21 (or later), due to paired serologic testing to establish the presence of potential pathogens we will perform following microbiological investigations: * cultivation of 2 pairs of blood cultures in all patients * cultivation of sputum or quantitative cultivation of tracheal aspirate in nonintubated patients * quantitative cultivation of tracheal aspirate or bronchoalveolar lavage in intubated patients * testing the presence of soluble legionella antigen in urine in all patients * testing the presence of genetic material of respiratory viruses (influenza a, influenza b, respiratory syncytial virus , adenovirus, bocavirus, coronavirus, metapneumovirus, parainfluenza virus, rhinovirus) by qualitative polymerase chain reaction (pcr) in nasopharyngeal swabs in all patients, in the tracheal aspirate in nonintubated patients and in tracheal aspirate or bronchoalveolar lavage fluid in intubated patients * testing the presence of mycoplasmal, legionella and chlamydial dna by qualitative pcr in nasopharyngeal smears in all patients, in the tracheal aspirate in nonintubated patients and in bronchoalveolar lavage fluid or in tracheal aspirate in intubated patients

Eligibility criteria:
inclusion criteria: diagnosis of * severe community acquired pneumonia or * severe hospital acquired pneumonia or * ventilator--associated pneumonia exclusion criteria: * antibiotic treatment of actual episode of pneumonia for more than 24 hours

Keywords: simultaneous bacterial and viral pneumonia
exclusive enteral nutrition in preterm neonates

Conditions: Premature; Infant, Light-for-dates; Enteral Feeding Intolerance

Summary: to test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.

qualifying participants will be randomly assigned to one of two study groups: 1) exclusive enteral feeds or 2) progressive enteral feeds with supplemental parenteral nutrition. regardless of study group assignment, donor human milk will be offered if the mother's expressed breast milk is not enough to complete the intervention as assigned. intervention group: feeds will be initiated with a target volume of 60-80 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150ml/kg/day is achieved. control group: enteral feeds will be initiated with a target volume of 20-30 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150 ml/kg/day is achieved. if parent agrees, stool "dirty" diapers will be collected 2 times during this study. one time around the time of birth and one time at 28 days or discharge (whichever occurs first).

Eligibility criteria:
inclusion criteria: * gestational age between 28 and 32 weeks of gestation exclusion criteria: * intrauterine growth restriction (birth weight \< 10th percentile) * major congenital or chromosomal anomalies * terminal illness in which decisions to withhold or limit support have been made
convulsions in neonates with congenital heart diseases

Conditions: Neonatal Convulsion

Summary: analyze the etiology, electroencephalographic (eeg) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures during their neonatal intensive care unit admission.

neonatal seizures are a commonly encountered neurologic condition in neonates. they are defined as the occurrence of sudden, paroxysmal, abnormal alteration of electrographic activity at any point from birth to the end of the neonatal period. during this period, the neonatal brain is developmentally immature. thus, neonatal seizures have unique pathophysiology and electrographic findings resulting in clinical manifestations that can be different (and more difficult to identify) when compared to older age groups. neonatal seizures are paroxysmal, repetitive and stereotypical events. they are usually clinically subtle, inconspicuous and difficult to recognize from the normal behaviors of the inter-ictal periods or physiological phenomena. there is no recognizable post-ictal state. the most widely used scheme is of five main types of neonatal seizure. * subtle seizures (50%) * tonic seizures (5%) * clonic seizures (25%) * myoclonic seizures (20%) * non-paroxysmal repetitive behaviors neonates with congenital heart disease have a high risk of cerebral lesions, seizures, and neurological impairment. by congenital heart disease, we refer to the group of congenital malformations present at birth that include cyanotic as well as non-cyanotic cardiac lesions. neonatal seizures are the most common clinical expression of central nervous system dysfunction in newborns and one of the most frequent neurological emergencies during this stage of life. they are usually the first sign of neurological involvement and an indicator of the risk of mortality and/ or neurological sequelae.

Eligibility criteria:
inclusion criteria: * all neonates up to 28 days of age with congenital heart diseases presented with repeated seizures admitted to neonatology unit at assiut university children hospital exclusion criteria: * neonates with normal heart or infants more than 28 days of age.
quantification of the socio-economic multifacet burden of alopecia areata and identification of the associated factors

Conditions: Alopecia Areata

Summary: alopecia areata (aa) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. it typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. many patients with aa are dissatisfied with current medical treatments and use alternative therapies and cosmetics. this study will generate new data on the current situation of psychosocial and financial burden of aa. it will help to identify unmet needs and to understand the disease issues. it will also be the basis for the planification of future supporting measures.

alopecia areata (aa) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. it typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. current medical therapies (topical or systemic) for aa are not reliably effective, particularly for severe disease and there is no robust evidence from high-quality randomized controlled trials. patients with aa experience significant mental health and health related quality of life (hrqol) impairment. furthermore, at the country level, skin conditions such as aa ranged from 2nd to 11th leading cause of years lived with disability. it was shown that aa appears to affect all countries across the world similarly, and the health burden has remained stable despite substantial advances in healthcare and health-related resources. more recently, mesinkovska et al demonstrated that the impact of aa extends beyond cosmetic concerns and carries a considerable psychosocial burden. many patients with aa are dissatisfied with current medical treatments and use alternative therapies and cosmetics. cosmetics and not reimbursed treatments can weigh heavily on patients spending.this study will generate new data on the current situation of psychosocial and financial burden of aa. it will help to identify unmet needs and to understand the disease issues. it will also be the basis for the planification of future supporting measures.

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years). * alopecia areata whose diagnosis has been confirmed by a dermatologist according to the standardized diagnostic criteria. * \< 2 years duration of current episode of scalp hair loss. * severity \> s2 (\> 25% hair loss) as assessed by the alopecia tool (salt). exclusion criteria: * patients under juridical protection. * patients not covered by social security. * patients unable to understand french

Keywords: socio-economic burden alopecia areata out-of-pocket expenditures
adjuvant gvax vaccine therapy in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is an open label, phase ii trial study of adjuvant gvax pancreas vaccine in patients with pancreatic cancer.

eligible participants will receive by intradermal administration the gvax pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (gm-csf) gene. there will be two cohorts of research participants: 1. participants previously vaccinated with gvax pancreas vaccine. these participants will receive booster vaccinations as a continuation of care. vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity. 2. participants who were not previously vaccinated with gvax pancreas vaccine (vaccine naive). these participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months.

Eligibility criteria:
1. inclusion criteria: a. previously vaccinated subjects must receive gvax vaccine previously b. naïve and previously vaccinated subjects must meet the following criteria: * have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas * received the last anti-cancer therapy at least 28 days ago. * provide informed consent. * have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * have adequate hematologic function (hemoglobin ≥ 9 gm/dl, absolute neutrophil count (anc) ≥ 1500 #/cu mm, platelets ≥100,000 k/cu mm) * have adequate renal function (serum creatinine ≤ 2 mg/dl). * have adequate hepatic function (bilirubin ≤ 2.0 mg/dl, unless known gilbert's syndrome; aspartate aminotransferase (ast), alanine transaminase (alt) and amylase ≤ 2x upper limit of normal: alk phosphatase ≤ 5x upper limit of normal.) * agree to use adequate birth control, if of childbearing potential. 2. exclusion criteria: * radiographical evidence of pancreatic cancer disease recurrence * documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis * uncontrolled medical problems * systemic steroid therapy within 28 days before vaccine administration * anticipated need for systemic steroid therapy within 28 days after vaccine administration * evidence of active infections * pregnant

Keywords: stage i pancreatic cancer stage ii pancreatic cancer pancreatic neoplasm adenocarcinoma of the pancreas stage iil pancreatic cancer adjuvant therapy cancer vaccine gvax
immunomonitoring of interventional radiology procedures in the management of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this cohort study compares immune response induced in two groups of small hcc patients treated by ablation (group1 rfa, group 2 mwa). patients will benefit for tumoral and non tumoral biopsies prior to treatment and stepped peripheral blood samples juste before ablation and during the first month after.


Eligibility criteria:
inclusion criteria: * histologically proven hcc for less than 3 months before ablation * decision of ablation treatment in multidisciplinary meeting exclusion criteria: * fibrolamellar hcc * hepatocholangiocarcinoma
study assessing high-frequency chest wall oscillation (hfcwo) in preventing pulmonary exacerbations

Conditions: Cerebral Palsy

Summary: to asssess efficacy of airway clearance provided by vest therapy (hfcwo) in the reduction of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle weakness and restrictive lung disease.

this non-randomized home based pre-post intervention study. the study will compare the efficacy of vest® therapy (hfcwo) for mucus secretion clearance in a population of patients with muscle weakness and restrictive lung disease with frequent pulmonary exacerbations. enrolled subjects with a tracheostomy will be evaluated for microbial load and inflammatory status as a pilot evaluation of microbial load and inflammatory status outcomes. the total number of evaluable subjects to be recruited is estimated at 40. subjects will be considered evaluable if they have completed at least 6 months of follow up.

Eligibility criteria:
inclusion criteria: * subject is at least 18 months old. * subject has a chest circumference of greater than 19 inches. * subject has a diagnosis of muscle weakness and restrictive lung disease. * ability to provide informed consent from legal guardian. * subject has had 2 or more exacerbations requiring either hospitalization or antibiotics (iv or oral) in the past 12 months * if inhaled tobramycin has been prescribed prophylacticly, subjects must discontinue the medication at least 2 weeks prior to study enrollment exclusion criteria: * subject has a diagnosed allergy with a respiratory trigger. * participation in another clinical trial. * unstable head or spinal injury. * unresolved pneumothorax or pneumomediastinum present * unresolved hemorrhage * hypotension requiring vasopressors or positioning * bronchopleural fistula * gross hemoptysis within the past eight hours * pulmonary embolism or history of pulmonary embolism within the past two months * burns, open wounds and skin infections on the thorax * osteomyelitis of the ribs * osteoporosis with history of fractures.

Keywords: high frequency chest wall oscillation cerebral palsy restrictive lung disease
sentinel lymph node mapping in detecting cancer that has spread to lymph nodes in patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: diagnostic procedures such as sentinel lymph node mapping may improve the ability to detect cancer that has spread to the lymph nodes. purpose: this clinical trial is studying how well sentinel lymph node mapping works in detecting cancer that has spread to the lymph nodes in patients who are undergoing surgery for stage i non-small cell lung cancer.

objectives: primary * determine the feasibility and accuracy of intraoperative sentinel lymph node mapping using technetium tc 99 sulfur colloid in patients with stage i non-small cell lung cancer. * determine the percentage of patients in which at least 1 positive sentinel lymph node is identified using this procedure. * determine the percentage of patients undergoing this procedure who are found to have positive sentinel lymph nodes with no metastases in other intrathoracic lymph nodes. secondary * determine the percentage of patients undergoing this procedure whose disease stage is upgraded due to detection of micrometastases in sentinel lymph nodes. * correlate the presence of micrometastases in sentinel lymph nodes with survival in patients undergoing this procedure. * determine the percentage of patients undergoing this procedure with "skip metastases" pattern (nz) sentinel lymph nodes. outline: this is a multicenter study. patients receive an intraoperative intratumoral injection of technetium tc 99 sulfur colloid. at least 10 minutes later, patients undergo sentinel lymph node mapping using a gamma probe. patients then undergo sentinel lymph node dissection and tumor resection. pathology assays are performed using sentinel lymph node tissue, including hematoxylin and eosin staining, serial sections, and immunohistochemistry using the ae1/ae3/pck2b cytokeratin antibody. patients are followed every 6 months for 2 years and then annually thereafter.

Eligibility criteria:
1. patients with clinical stage i lung cancer for whom surgical resection is planned are eligible. histologic confirmation of lung cancer is not required prior to registration or surgical exploration. preoperative mediatinoscopy is allowed but not required in those patients with indications for mediatinoscopy. it is preferred that that mediatinoscopy be done at a different setting (prior to registration), but the procedure may be done at the same setting as the lobectomy. 2. no prior therapy for this diagnosis. 3. no prior treatment with mediastinal radiation therapy. 4. age ≥ 18 years of age. 5. ecog performance status: 0-2.

Keywords: stage i non-small cell lung cancer
prediction of jaundice in term infants

Conditions: Infant, Newborn; Jaundice

Summary: the objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

jaundice occurs in most human neonates during the several days after birth. the objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

Eligibility criteria:
inclusion criteria: * infants born via cesarean delivery (to ensure subjects would still be hospitalized and available for etcoc measurement and blood sampling on day 3 postpartum) * delivery within each center's scheduled recruitment period (to maximize nursing availability and minimize cost) * birth weight \>2500 g * gestational age \>37 weeks exclusion criteria: * any illness that would require admission to the neonatal intensive-care unit (nicu) within 8 hours of birth

Keywords: nichd neonatal research network term infant hyperbilirubinemia
the effect of supplementation of flaxseed, hesperidin, flaxseed and hesperidin together in non-alcoholic fatty liver disease: a randomized, controlled study

Conditions: Non Alcoholic Steatohepatitis

Summary: to study the effects of hesperidin, flaxseed and both together on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with nonalcoholic steatohepatitis (nash), 100 patients who referred to gastrointestinal (gi) clinic with steatosis grade 2 and 3 will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. at the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: * age of 18 to 70 years * body mass index (bmi) between 25-40 * sonographic findings compatible with hepatic steatosis (degree 2 or more) exclusion criteria: diabetes taking any kind of antibiotics two weeks before recruitment history of alcohol consumption pregnancy or lactation professional athletes other liver disease (viral/etc) use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin e a history of hypertension, cardiovascular disease, pulmonary disease, renal disease \& celiac disease; cirrhosis history of upper gi surgery / prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty following program to lose weight in recent 3 mo a history of hypothyroidism or cushing's syndrome