Kornimate/medical-research-clean huggingface dataset:
efficacy study of articaine versus lidocaine as supplemental infiltration in inflamed molars

Conditions: Irreversible Pulpitis

Summary: the purpose of this trial is to study the ability of a frequently used dental anesthetic (articaine) to achieve complete numbness of a diseased tooth with the most commonly used injection technique in the lower jaw (inferior alveolar nerve block: ianb). if this technique fails, a commonly used supplemental (sup) technique with one of two possible dental anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of complete numbness between the two anesthetics. standardized administration of anesthesia is provided by controlled delivery using midwest comfort control syringe. the investigators hypothesize that supplemental infiltration anesthesia with articaine will give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular molars with irreversible pulpits. this study consisted of two periods of patient enrollment, treatment and data collection: part i: 101 subjects; part ii: 100 subjects.

the goal of the study is to achieve complete pulpal anesthesia in irreversible pulpitis mandibular molars, either by ianb administration of 4% articaine with 1:100,000 epinephrine (nda 022466), or in case the ianb appeared to be clinically unsuccessful by supplemental infiltration of either articaine or lidocaine. the proposed randomized controlled trial (rct) aims to answer the following questions: 1. what is the success rate of an ianb with articaine using a conventional ianb technique and standardized speed of administration? 2. is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine ianb? 3. is there a difference in first or second molars in achieving complete pulpal anesthesia using supplemental infiltration with either articaine or lidocaine? this study will combine the data from hum00049692- articaine efficacy in inflamed molars to create a larger sample size, giving a total sample size of approximately 200 patients.

Eligibility criteria:
inclusion criteria: * adult patients * irreversible pulpitis in mandibular molar exclusion criteria: * below 18 years

Keywords: articaine lidocaine anesthesia, local endodontics molar dental pulp diseases
clinical significance of heterozygosity for mutations of the slc12a3 gene coding for the thiazide sensitive na-cl cotransporter

Conditions: Heterozygous Carriers of Gitelman Syndrome

Summary: gitelman syndrome is a salt wasting tubulopathy caused by mutations in the slc12a3 gene coding for the thiazide sensitive sodium chloride cotransporter. this disease mimics the chronic treatment with thiazide diuretics and is characterized by renal hypokalemia, low to normal blood pressure, hypocalciuria and hypomagnesemia. the purpose of this study is to determine whether the heterozygous carriers present the metabolic risks and/or the benefits of this disease.

gitelman syndrome (gs), is an autosomal recessive salt wasting tubulopathy caused mainly by loss of function mutations in the slc12a3 gene coding for the thiazide sensitive sodium-chloride cotransporter (ncc). thus, gs mimics a chronic treatment with high doses of thiazide diuretics. ncc is expressed in the distal convoluted tubule, which is responsible for 7% of nacl reabsorption. gs is the more frequent hereditary tubulopathie with estimated prevalence of 1/40000, which implicates that 1% of general population are heterozygous carriers (600 000 in france). previous publications suggest that the apparently asymptomatic heterozygous carriers could present some clinical traits of gs or chronic thiazide treatment. these including: beneficial aspects (low blood pressure, low urinary calcium excretions) or metabolic risks (hypokalemia, insulin resistance). nevertheless, these studies do not evaluate all the aspects and blood pressure was evaluated once in hospital setting. this study aims to compare home monitoring blood pressure; salt balance; potassium, glucose lipid and mineral metabolism and vascular function in 80 heterozygous carriers, 80 gs patients and 80 controls persons (without mutations in slc12a3 gene).

Eligibility criteria:
gitelman syndrome patients, relatives carrying heterozygous mutations and relatives or healthy voluntarees without mutations.

Keywords: gitelman heterozygous slc12a3 mutation blood pressure hypokalemia
effect of milk on the vaccination response

Conditions: Infection

Summary: rationale: oral vaccination is known to induce a systemic immune response as well as an immune response in mucosal tissues, and can therefore serve as a model to study systemic and mucosal immunity. in this study, the oral cholera vaccine dukoral® was chosen as model vaccine. the kinetics of the immune response and the interaction with a raw milk matrix have been evaluated in a previous, pilot study (nl49042.081.14). based on the outcomes of this pilot, in this study oral cholera vaccination will be applied to study the support of immunity by raw milk, compared to heat-treated milk. the study design has been optimised based on previous results: study duration is extended and sample size is based on relevant change and known variation in the primary outcome parameters. infections are an important worldwide cause of death, both in elderly and young children. therefore, support of immunity could help to reduce the incidence of infections. to screen the potential of specific foods or food ingredients to support immunity, oral vaccination can serve as a model. in a previous study, this model was developed using oral cholera vaccination in human adult volunteers. in that study, raw milk was shown to support the immune response to vaccination. in this follow-up study, the effect of raw milk will be compared with pasteurized and ultra-heat treated (uht) milk. objective: to investigate whether pasteurized milk and/or uht milk are able to enhance the immune response as induced by oral cholera vaccination, in comparison to raw milk and to regular vaccination. study design: the study is designed as a single-blind randomized controlled trial of 6 weeks. study population: healthy subjects of 18-50 years of age. interventions: 1) raw milk, obtained from farms that comply to the high quality requirements for production of raw milk, and that has been screened according to the safety criteria for raw milk; 2) commercially available full-fat uht milk; 3) commercially available full-fat pasteurized milk.


Eligibility criteria:
inclusion criteria: * age 18-50 yr * signed informed consent * availability of internet connection * male or female * willing to stop blood donation at the blood bank during the study period exclusion criteria: * currently participating in another clinical trial * previous cholera, salmonella, or e. coli vaccination * tonsillectomy * acute gastroenteritis in the past 2 months * use of antibiotics in the past 2 months * hypersensitivity to the vaccine, to formaldehyde or to any of the excipients (sodium salts) * pregnancy or lactating * not willing to drink raw milk * allergic to milk or lactose-intolerant * disease of gi tract, liver, gall bladder, kidneys, thyroid gland * immune-compromised * use of immunosuppressive drugs * drug abuse, and not willing/able to stop this during the study * excessive alcohol usage (men: \>4 consumptions/day or \>20 consumptions/week; women: \>3 consumptions/day or \>15 consumptions/week)

Keywords: immunity vaccination milk
a safety and efficacy study evaluating ctx130 in subjects with relapsed or refractory t or b cell malignancies (cobalt-lym)

Conditions: T Cell Lymphoma

Summary: this is a single-arm, open-label, multicenter, phase 1 study evaluating the safety and efficacy of ctx130 in subjects with relapsed or refractory t or b cell malignancies.

the study may enroll approximately 45 subjects in total.

Eligibility criteria:
inclusion criteria (abbreviated): 1. age ≥18 years. 2. confirmed diagnosis of a t cell malignancy or diffuse large b-cell lymphoma (dlbcl). 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. adequate renal, liver, cardiac, and pulmonary organ function. 5. female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after ctx130 infusion. exclusion criteria (abbreviated): 1. prior allogeneic stem cell transplant (sct). 2. prior treatment with any anti-cd70 targeting agents. 3. history of certain central nervous system (cns), cardiac or pulmonary conditions. 4. active hiv, hepatitis b virus or hepatitis c virus infection. 5. previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for \>12 months, or any other localized malignancy with low risk of developing into metastatic disease. 6. primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 7. prior solid organ transplantation. 8. pregnant or breastfeeding females.

Keywords: car t allogeneic lymphoma
intra-arterial neuroprotective strategy for ischemic stroke patients with no reperfusion therapy (insist-nrt)

Conditions: Ischemic Stroke; Neuroprotection

Summary: to explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. major neurologic deficits: 6≤nihss≤20; 3. missing recanalization therapy (ivt or evt) or progressive stroke, which was defined as symptoms worsen in 48 hours (an increase in nihss more than 4); 4. premorbid mrs 0 or 1; 5. signed informed consent. exclusion criteria: 1. modified rankin score \>2 caused by a history of prior stroke; 2. patients who underwent intravenous thrombolysis or endovascular treatment; 3. coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<80000/mm3; 4. severe hepatic or renal dysfunction, increase in alt or ast (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; 5. severe hypertension (systolic blood pressure over 200mmhg or diastolic blood pressure over 110 mmhg); 6. unsuitable for this clinical studies assessed by researcher.
efficacy and safety study of blx-028914 in subjects with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: this is a phase ii study in patients with seasonal allergic rhinitis (sar) and will compare the effect versus placebo of two different oral doses of blx-028914 in an allergen challenge model. blx-028914, a selective phosphodiesterase-4 (pde4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by orexo ab, sweden. the aim of this study is to compare the effect, safety and tolerability of 14 days treatment with blx-0289014 in patients with sar in an allergen challenge model versus placebo.


Eligibility criteria:
inclusion criteria: * 18 to 50 years of age (inclusive), male or female * body mass index (bmi) between 18 and 28 kg/m2 (inclusive) * history of pollen-induced seasonal allergic rhinitis but otherwise healthy * positive skin prick test for timothy and/or birch allergen * sufficient reaction to nasally administered allergen at screening * signed informed consent obtained exclusion criteria: * expected symptoms of seasonal allergic rhinitis during the study period * asthma * nasal anatomical deviations, ongoing nasal symptoms, ongoing upper respiratory tract infection * anti-allergy immunotherapy in the previous two years * extensive use of nasal sprays * any medication except for contraceptives, during their last five half- lives prior to the first treatment period except for occasional otc analgesics * ingestion of grapefruit or grapefruit juice or herbal remedies (e.g. st john's-wort) that may effect the enzyme cyp3a4 * smoking within 3 months of first treatment period * clinically significant laboratory findings * pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control * known hypersensitivity to any constituent of the study medication or placebo * participation in any other investigational study in the last three months * subject anticipated not being able to adhere to study plan according to investigator judgement
incline training to personalize motor control interventions after stroke

Conditions: CVA (Cerebrovascular Accident)

Summary: this study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns.

this study seeks to develop a theory-based clinical decision-making framework for the training of walking recovery after stroke based on how different biomechanical patterns of walking illustrate distinct motor control deficits. each participant will complete 12 sessions (three times a week for four weeks) of either incline, decline, or control training. clinical and biomechanical outcome measures will be collected pre- and post-training and after a one-month follow-up period. in addition, the investigators will collect a battery of clinical outcome measures before and after training. spatiotemporal variables (including ssws) will be collected before and after each session. all clinical and biomechanical assessments will be conducted by an evaluator blinded to training group allocation.

Eligibility criteria:
inclusion criteria: * stroke 6 months * residual paresis in the lower extremity (fugl-meyer le motor score \<34) * ability to walk without assistance at speeds ranging from 0.2 - 1.0 m/s (with a support harness for biomechanical testing) * ability to walk on a treadmill without orthotic or assistive device using overhead harness system * provision of informed consent, and 8) written approval from the primary physician (see attached sample of medical approval cover letter). exclusion criteria: * history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during adls * history of copd or oxygen dependence * pre-existing neurological disorders or dementia * history of major head trauma * pp between 0.47 and 0.53 * legal blindness or severe visual impairment * severe arthritis or other problems that limit passive rom * history of dvt or pulmonary embolism within 6 months * severe hypertension with systolic \>200 mmhg and diastolic \>110 mmhg at rest.

Keywords: stroke rehabilitation walking biomechanics
validation of a point-of-care device measuring ferritin with capillary blood

Conditions: Anemia, Iron Deficiency; Iron Overload; Iron-deficiency

Summary: measurement of iron is important for identifying both low and high iron levels in the body. measuring a protein in the blood called ferritin is currently the easiest way to determine a patient's iron status. however, the test requires a blood sample that is be sent to the laboratory for measurement, which can cause delays in obtaining the result. the investigators are testing whether a point of care device that measures ferritin levels using a capillary blood sample is accurate compared to current methods of testing. this could allow measurement of ferritin immediately in the clinic with only a drop of blood, and enable treatment decisions based on these results.


Eligibility criteria:
inclusion criteria: * able to read and understand english (the consent form is in english) * attending ambulatory hematology clinic and/or outpatient medical care exclusion criteria: -
opportunities and limitations of swiss polytrauma registry data for scientific purposes- registry data for scientific purposes

Conditions: Trauma

Summary: the aim of the analysis is an evaluation of the current performance of the swiss trauma registry (str) with respect to providing a reliable basis for (scientific) investigations on the management of trauma patients in switzerland. the current project tries to address this question by considering central aspects of completeness and by exemplifying the use of the registry for research questions. the aim is to identify potential shortcomings of the registry.


Eligibility criteria:
inclusion criteria: * documentation in the str * injury severity score (iss) ≥ 16 exclusion criteria: * none

Keywords: swiss polytrauma registry quality control standardized identification procedures data capture
a safety and efficacy study of talen and crispr/cas9 in the treatment of hpv-related cervical intraepithelial neoplasiaⅰ

Conditions: Human Papillomavirus-Related Malignant Neoplasm

Summary: this is an open-label and triple cohort study of the safety and efficacy of talen and crispr/cas9 to possibly treat hpv persistency and human cervical intraepithelial neoplasiaⅰwithout invasion.

hpv persistent infection is the major causal factor of cervical intraepithelial neoplasia (cin) and cervical cancer. the important roles of e6 and e7 playing in hpv-driven carcinogenesis make them attractive targets for therapeutic interventions. previous evidences showed that using designated talen and crispr/cas9 as genome editing tool could produce disruption of hpv16 and hpv18 e6/e7 dna, significantly decreasing the expression of e6/e7, inducing cell apoptosis and inhibiting cell lines growth. this study will evaluate the safety and efficacy of talen-hpv e6/e7 and crispr/cas9-hpv e6/e7 in treating hpv persistency and hpv-related cervical intraepithelial neoplasiaⅰ

Eligibility criteria:
inclusion criteria: * documented hpv16 or hpv18 infection. * married and fertile, no fertility requirements. * without administration of hormone in the last six months. * subjects must be meet the ethical requirements and have signed informed consent. exclusion criteria: * pregnancy and breast feeding * any bacterial vaginitis * any fungal vaginitis * any sexually transmitted diseases * active drug or alcohol abuse * any hpv medications within the past 12 weeks * allergy to active or non active ingredients in the study of drugs * cardiac insufficiency * liver and renal insufficiency * hypertension and severe complications * serious illness in past 30 days * currently participating in another clinical trial or any prior gene therapy

Keywords: cervical intraepithelial neoplasiaⅰ talen crispr/cas9
a study to evaluate the efficacy and safety of da-6034 and to demonstrate the non-inferiority of da-6034

Conditions: Acute Gastritis; Chronic Gastritis

Summary: this is a multicenter, double-blinded, double-dummy, active-controlled, randomized, phase iii clinical trial to evaluate the efficacy and safety of da-6034 and to demonstrate the non-inferiority of da-6034 compared with rebamipide in patients with acute or chronic gastritis. subjects will receive 45mg, 90mg of da-6034 and 300mg of rebamipide, two tablets, three times a day for two weeks.


Eligibility criteria:
inclusion criteria: * diagnosed with acute gastritis or chronic gastritis * 1 or more erosions found in the gastroscope examination * age should be: 20≤age≤75 exclusion criteria: * a patient with peptic ulcer and a gastroesophageal reflux disease. * received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation * had a surgery regarding gastroesophageal * a patient with zollinger-ellison syndrome * had a medical history of a malignant tumor * a patient who is currently taking anti-thrombotic drugs
clinical comparison of two silicone hydrogel toric lenses in the us

Conditions: Astigmatism

Summary: the purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.


Eligibility criteria:
inclusion criteria: * have a current spectacle prescription, preferably within 6-9 months. * currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear. * be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial. * have acceptable or optimal fit for each eye at the dispense of each pair of study lenses. * other protocol-defined inclusion/exclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks immediately prior to enrollment for this trial. * currently enrolled in any clinical trial. * evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator. * any use of medications for which contact lens wear could be contraindicated as determined by the investigator. * currently wearing soft toric contact lenses as extended wear. * currently wearing either of the products to be worn in the study. * other protocol-defined inclusion/exclusion criteria may apply.
effects of a walking program in people with mental disorders

Conditions: Mental Disorders

Summary: the purpose of this study is to investigate the short- and long-term effects of a 10-week walking program, based on the self-determination theory, in people with mental disorders. the investigators expect positive effects on: * physical fitness * physical activity * well-being (less feelings of anxiety, less feelings of depression) the investigators also expect underlying psychosocial processes to influence these effects.

framework: previous research has shown beneficial health effects of a 10-week walking program in a senior organisation. based upon the self-determination theory, similar results can be expected in people with mental disorders and could be highly relevant, given the fact that these people: * are often less active * have mental problems and often also comorbidities * are often socially isolated participants: psylos tries to recruit a convenience sample of at least 100 participants for an intervention group (which will undertake the walking program) and 80 participants for a control group. all of them have to sign an informed consent. due to attrition, at least 60 participants in the intervention group and 40 in the control group can be expected. a post hoc analysis, with detailed information about the variation in this population, may give additional information about the necessary power to obtain significant results. data analysis: first there will be examined whether the participants in both groups are equal at baseline according to relevant parameters (due to the non-randomisation). second, to test the main effects, the difference scores will be examined between both groups. if certain assumptions are met, by an unpaired t-test; if not, by a non-parametric test. finally (if relevant), the underlying psychosocial processes will be examined by regression analyses.

Eligibility criteria:
inclusion criteria: * at least 18 years old * member of psylos * medically approved by a physician

Keywords: walking program mental disorders physical activity physical fitness anxiety depression self determination