Kornimate/medical-research-clean huggingface dataset:
glass-ionomer cement containing chlorhexidine for art

Conditions: Dental Caries

Summary: this study evaluated the clinical and microbiological long-term effects of 1.25% chx associated with gic applied in primary molars using atraumatic restorative treatment (art) technique. randomized controlled trial was conducted on 40 children with carious lesions that received art either with gic containing chx or gic only. survival rate of restorations was checked at 3 days, 3 months and 1 year after their placement when the unstimulated saliva samples were collected for microbiological assessment of mutans streptococci (ms) counts. data were analyzed using anova/tukey or kruskal-wallis/mann-whitney tests (p \<0.05).

art treatment and follow-up: carious lesions were prepared by removing infected dentin with hand instruments. no local anesthesia was administered. then, the cavities were filled with the press finger technique with one of the randomly selected materials: (1) gic ketacmolar easymix® containing 1.25% chlorhexidine digluconate (km + chx; n= 41 tooth surfaces) or (2) ketacmolar easymix® as a control group (km; n = 66 tooth surfaces). material excess was removed using carver instrument and the restoration was coated with a layer of petroleum jelly. multiple-surface cavities were filled after placement of plastic bands and wedges. both molars (class i and ii) and incisors were treated in this study and the same gic were used for patients who had more than one carious teeth indicated to art. the children underwent longitudinal clinical follow-up to assess physical condition (partial or complete fractures) of the restoration and the presence of primary or secondary caries at 7 days, 3 months and 1 year, according to art evaluation criteria by frencken et al. children were encouraged and instructed on dental hygiene and received all other necessary oral care. microbiological assays: unstimulated whole saliva was collected after 7 days, 3 months and 1 year after treatment from each subject by direct expectoration into a 50-ml sterile container for 5-10 min. pooled supragingival biofilm samples were collected from all buccal and lingual smooth surfaces, except from the interior of the cavities. in order to standardize plaque amount, a sterile plastic disposable inoculating loop with a circular opening of about 1 µl capacity was used for the collection. collection was stopped when the opening was filled. biofilm samples were placed immediately into a 1-ml centrifuge microtubes containing tris-edta buffer (10 mm tris-hcl, 0.1 mm edta, ph 7.5). collections were performed at least 1 h after feeding. tubes were transported on ice to laboratory and processed within 2 h.

Eligibility criteria:
inclusion criteria: * good general health * at least one cavitated dentin carious lesion in primary molars or incisors that had an opening wide enough for the smallest art excavator access exclusion criteria: * teeth with pulpal exposure or the presence of fistula and history of pain were excluded

Keywords: dental caries glass ionomer cement art
study to evaluate the efficacy and safety of medi9929 (amg 157) in adult subjects with inadequately controlled, severe asthma

Conditions: Asthma

Summary: the primary objective of the study is to evaluate the effect of 3 dose levels of medi9929 (amg 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.


Eligibility criteria:
inclusion criteria: * age 18 through 75 * body mass index (bmi) between 18-40 kg/m2 and weight greater than or equal 40 kg * documented physician-diagnosed asthma - subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose inhaled corticosteroids (ics) plus long acting β2 agonist (laba) -if on asthma controller medications in addition to ics plus laba, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ics, long-acting anti-muscarinics (lama), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -subjects must have a documented history of at least 2 asthma exacerbation events or at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit. exclusion criteria: * diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma. * current smokers or subjects with a smoking history of ≥ 10 pack years * former smokers with \< 10 pack years must have stopped for at least 1 year to be eligible. * any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, churg-strauss syndrome). * evidence of active liver disease. * history of cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -known history of active tuberculosis (tb) * history of anaphylaxis to any biologic therapy * positive medical history for hepatitis b or c * subject with human immunodeficiency virus (hiv) or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.

Keywords: asthma
the effect of photobiomodulation using low-level diode laser therapy on postoperative pain in symptomatic lower molar teeth with irreversible pulpitis and apical periodontitis; a randomized controlled clinical trial

Conditions: Effect of Photobiomodulation Using Diode Laser

Summary: this study aims to assess the effect of photobiomodulation using low-level diode laser therapy on postoperative pain after single-visit root canal treatment of mandibular molars with symptomatic irreversible pulpitis and apical periodontitis.


Eligibility criteria:
inclusion criteria: * . mature multirooted mandibular molar teeth with: i. pre-operative sharp pain marked on the vas scale by reading not less than 6. ii. clinical diagnosis of symptomatic irreversible pulpitis with periapical periodontitis. iii. normal periapical radiographic appearance or slight widening in lamina dura. iv. positive response and pain provoked by percussion. - patients who agree to provide written consent and attend for recall appointments. exclusion criteria: * patients who used nsaids in the 24 hours before treatment. * medically compromised patients having significant systemic disorders. (asa iii or iv). * patients with two or more adjacent teeth requiring endodontic treatment. * pregnant or nursing females. 5. teeth that have: i. periodontal affection (with pocket depth greater than 5mm, associated with swelling orfistulous tract, or greater than grade i mobility). ii. no possible restorability. iii. signs of pulpal necrosis; associated sinus tract or swelling.
the effect of intravenous l-kynurenine (lkyn) on cerebral hemodynamics in healthy volunteers

Conditions: Headache

Summary: to measure the cerebral hemodynamic effect of l-kynurenine.

aim: to investigate the physiological effect of l-kynurenine after intravenous administration to healthy volunteers. hypothesis: l-kynurenine induces vasodilation in the cerebral vessels and trigger headache in healthy individuals. methods: 6 healthy volunteers will receive intravenous infusion of l-kynurenine using the following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500 microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in between. before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital signs, circumferences of middle cerebral artery, superficial temporalis artery and headache intensity and characteristics. the subjects will then have a questionnaire about headache for the following 24 hours.

Eligibility criteria:
inclusion criteria: 1. healthy volunteers of both sexes. 2. 18-60 years. 3. 50-90 kg. 4. women of childbearing potential must use adequate contraception. exclusion criteria: 1. all primary headaches 2. first-degree relative with migraine 3. headache less than 48 hours before the tests start 4. daily consumption of drugs of any kind other than oral contraceptives. 5. pregnant or nursing women. cardiovascular disease of any kind, including cerebrovascular diseases.

Keywords: l-kynurenine cerebral hemodynamic headache mohammad al-mahdi al-karagholi
a dose-escalating study of obinutuzumab in patients with b-lymphocyte antigen (cd20+) malignant disease (gauguin)

Conditions: Lymphoma

Summary: the primary objective for the phase i part of the study is to investigate the safety and tolerability of escalating intravenous (iv) doses of obinutuzumab given as monotherapy in participants with cd20+ (tumor-infiltrating lymphocytic) malignant disease, including b-cell chronic lymphocytic leukemia (cll) and non-hodgkin's lymphoma (nhl). the primary objective for the phase ii part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory cll and nhl that is, in turn, either indolent (inhl) or aggressive (anhl). it is an open label dose escalating study in phase i and open label in phase ii, but the two doses in inhl \& anhl are randomized (to high or low dose of the same open label treatment). cll was not randomized as only one dose level was used. participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a retreatment period.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * phase 1 only: cd20+ malignant disease (b-cell lymphoma or b-cll); * phase 2 only: relapsed or refractory indolent nhl, relapsed or refractory aggressive nhl or relapsed or refractory b-cll * have a clinical indication for treatment as determined by the investigator * eastern cooperative oncology group (ecog) performance status of 0 to 2 * life expectancy \>12 weeks exclusion criteria: * prior use of any investigational antibody therapy or other agent within 6 months of study start; * prior use of any anti-cancer vaccine; * prior use of standard anti-lymphoma/leukemia therapy or radiation therapy within 4 weeks of enrollment; * prior use of mabthera (rituximab) within 8 weeks of study entry; * prior administration of radioimmunotherapy 3 months prior to study entry; * central nervous system (cns) lymphoma.
high-activity natural killer immunotherapy for small metastases of tongue cancer

Conditions: Tongue Cancer

Summary: the aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of tongue cancer.

by enrolling patients with small metastases of tongue cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 2 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: metastatic tongue cancer high-activity natural killer
effect of magnesium administration in subjects with family history of diabetes or metabolic syndrome

Conditions: Family History of Metabolic Syndrome; Family History of Diabetes

Summary: magnesium is the second most abundant ion in human cells and plays fundamental roles in several enzymatic reactions: it is involved in atp production, in the phosphorylation of proteins, in glucose metabolism and in the contraction of cytoskeleton. several epidemiological studies demonstrated that low dietary magnesium intake is inversely associated with diabetes mellitus, hypertension and metabolic syndrome. magnesium could be related to important haemodynamic and metabolic anomalies: at vascular level it acts as an antagonist of calcium, especially in vascular smooth muscle cells, thus its deficit could enhance vascular contraction; with regard to glucose metabolism, magnesium is involved in the physiopathological mechanism of insulin resistance, through a reduction in cellular uptake of glucose. this condition and the subsequent compensatory hyperinsulinemia can ultimately lead to increased synthesis of proinflammatory cytokines and to endothelial dysfunction. thus, magnesium depletion and subsequent alterations can increase the risk of developing vascular disease such as atherosclerosis and has been associated with cardiovascular events. several clinical trials have explored the possible beneficial effect of magnesium supplementation on blood pressure, plasma lipids and insulin resistance but the results are often contradictory. one of the possibilities for these unclear results could be that in some of them the interventions started too late when haemodynamic and metabolic changes are more difficult to revert. the investigators hypothesis is that magnesium supplementation in a population at increased genetic risk of developing metabolic syndrome but without it could improve blood pressure and the other metabolic syndrome related components. thus, the aim of the present study is to evaluate the effect of oral supplementation of magnesium (16.2 mmol/day of magnesium pidolate) on metabolic syndrome's components in a sample of 15 subjects who are at increased risk of developing metabolic syndrome since have a positive familiar history of type ii diabetes mellitus and/or metabolic syndrome(aha/nhlbi criteria).


Eligibility criteria:
inclusion criteria: * positive family history of type ii diabetes mellitus and/or metabolic syndrome(aha/nhlbi criteria). exclusion criteria: * any therapy related to metabolic syndrome (that is antihypertensive, anti diabetic, antilipemic drugs); * age \ 50 years; * previously diagnosed hypertension or immediate need for antihypertensive therapy (bp≥160/100); * diabetes mellitus (ada criteria); * obesity (bmi\>30kg/m2); * continuative use of nsaids, magnesium or vitamin supplements; * hypermagnesaemia; * previous cardio- or cerebrovascular events; * chronic kidney or liver or inflammatory or neoplastic disease; * gastrointestinal dysfunction with hypomotility; * active smoke (\>5 cigarettes per day); * impossibility to give informed consent.

Keywords: magnesium metabolic syndrome diabetes family history
an open label study of gene therapy product (vesemnogene lantuparvovec) in spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: this is an interventional study to evaluate safety and efficacy of aav-hsmn1 in spinal muscular atrophy patients.

study duration per participant is approximately 25 months including an approximately 30-day screening/baseline period, an approximately 24-month study observation period including 1 treatment day, and an approximately 24-month follow-up period. patients will be tested at baseline and return for follow-up visits twice a week through the first month post dose, and followed by visits at months 2, 3, 6 12, 18 and 24 post infusion. unscheduled visits may occur if the investigator determines that they are necessary.

Eligibility criteria:
inclusion criteria: * diagnosis of sma based on gene mutation analysis with bi-allelic survival motor neuron (smn1) mutations (deletion or point mutations). * patients or parent(s)/legal guardian(s) willing and able to complete the informed consent process and comply with study procedures and visit schedule. exclusion criteria: * active viral infection (includes hiv or serology positive for hepatitis b or c). * use of invasive ventilatory support (tracheotomy with positive pressure) or pulse oximetry \<95% saturation. * concomitant illness and any drug that in the opinion of the investigator creates unnecessary risks for gene transfer. * clinically significant abnormal laboratory values. * participation in a recent sma treatment clinical trial that in the opinion of the pi creates unnecessary risks for gene transfer. * patient with signs of aspiration based on a swallowing test and unwilling to use an alternative method to oral feeding.
education and exercise program for adults with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this two phase study is to: 1) develop and 2) assess a program titled: merging yoga, occupational therapy and nutrition education (my-ot-ed) designed for low income adults with type 2 diabetes. half of the participants will participate in the nutrition education, and the other half of the participants will participate in nutrition education plus occupational therapy group and group yoga.

merging yoga, occupational therapy and nutrition education (my-ot-ed) is an interdisciplinary program designed to help low income adults with type 2 diabetes engage fully in life while learning to manage their diabetes. the aim is to empower individuals to embed diabetes self-management into everyday activities and routines while upholding quality of life. currently extension services bring nutrition education to the under-served population in the local communities through the expanded food and nutrition education program (efnep). colorado efnep uses the evidence-based, healthy eating and active living curriculum, eating smart • being active (esba), with adult participants. while efnep may be helpful in the management of some aspects of diabetes care, it is not designed to address the established self-care behaviors and routines essential for effective diabetes self management. therefore, it is critical to merge nutrition education programs such as efnep with other established interventions to best meet the needs of the individual with diabetes. likewise, yoga is an effective form of physical activity to manage some aspects of diabetes care and outcomes. however, yoga is also not enough to address all of the needs of the individual. furthermore, evidence for the success of occupational therapy's role in diabetes self-management is growing as a way to manage some aspects of the complexity of diabetes care or routines in everyday life. our aim in this study is to follow best practice and create and evaluate an interdisciplinary approach to type 2 diabetes self-management by merging together yoga, occupational therapy and nutritional education to improve diabetes related outcomes in our population.

Eligibility criteria:
inclusion criteria: * ability to speak english and answer questions/communicate * self-report diagnosis of type 2 diabetes * self-report of children living at home * self-report of low socioeconomic status or use of food assistance programs exclusion criteria: * pregnant or anticipation of becoming pregnant in the next 6 months * completion of type 2 diabetes self-management or participation in occupational therapy with an emphasis on managing diabetes or other chronic condition in the last year.

Keywords: low income adults feasibility pilot study occupational therapy nutrition education yoga
open label extension study to evaluate the long-term safety of zorblisa (sd-101-6.0) in patients with epidermolysis bullosa

Conditions: Epidermolysis Bullosa

Summary: the study aimed to assess the long-term safety of topical use of zorblisa (sd-101-6.0) in participants with epidermolysis bullosa (eb).

this was an open label, multi-center extension study to assess the long-term safety of topically applied sd-101-6.0 in participants with simplex, recessive dystrophic, and junctional non-herlitz eb. sd-101-6.0 was applied topically once a day to the entire body. the planned duration of treatment with sd-101-6.0 for study sd-006 was up to 48 months, with a safety follow-up period of 30 days; however, the study was terminated early by the sponsor. the maximum study duration completed by at least 1 participant, treatment and safety follow-up, was 37 months. participants who successfully completed study sd-005 had the option to rollover into study sd-006. the screening/baseline visit (visit 1) occurred at visit 5 (approximately 90 days from baseline) of study sd-005. the body surface area (bsa) assessments of lesional skin and wound burden performed at visit 5 (approximately 90 days from baseline) for study sd-005 were utilized as the baseline assessments for study sd-006. participants returned for follow-up visits at month 1 then every 3 months. at each visit, assessments included bsa of lesional skin and wound burden. for target wounds that are not closed by the end of study sd-005, the aranz picture and calculation of target wound area at the final visit for study sd-005 was used as the baseline area size of the target wound for study sd-006. these unhealed target wounds from study sd-005 were assessed via aranz silhouettestar™ at each subsequent scheduled visit until the target wound was documented as closed. closed wounds were assessed for scarring.

Eligibility criteria:
inclusion criteria: * informed consent form signed by the participant or participant's legal representative; if the participant was under the age of 18 but capable of providing assent, signed assent from the participant. * participant (or caretaker) must have been willing to comply with all protocol requirements. * participants who completed the sd-005 study (on study drug at visit 5, approximately 90 days from baseline). exclusion criteria: * participants who did not meet the entry criteria outlined above. * pregnancy or breastfeeding during the study. (a urine pregnancy test was performed at the final visit for study sd-005 for female participants of childbearing potential and repeated at screening/baseline visit of study sd-006 if these visits did not occur on the same day). * female participants of childbearing potential who were not abstinent or not practicing a medically acceptable method of contraception.

Keywords: amicus therapeutics scioderm, inc. simplex recessive dystrophic junctional non-herlitz epidermolysis bullosa sd-101 6% sd-101-6.0 allantoin 6% zorblisa
minimally invasive thoracic surgery intercostal nerve block trial

Conditions: Thoracic Diseases; Postoperative Pain; Opioid Use

Summary: the minimally invasive thoracic surgery intercostal nerve block trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by liposomal bupivacaine versus standard bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.


Eligibility criteria:
inclusion criteria: * robotic or video-assisted lung resection for all indications exclusion criteria: * additional thoracic procedures (beyond lung resection and mediastinal lymphadenectomy) * extra-thoracic procedures * hypersensitivity to amide local analgesia * cardiac conduction abnormalities * hepatic dysfunction * preoperative neuropathic pain and/or preoperative daily opioid usage

Keywords: liposomal bupivacaine intercostal nerve block minimally invasive thoracic surgery