Kornimate/medical-research-clean huggingface dataset:
oral versus intravenous dexamethasone

Conditions: Pneumonia

Summary: the purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.


Eligibility criteria:
inclusion criteria: * aged 18 years and older * presenting to the emergency room with suspected pneumonia (to be confirmed within 24 hours from admission) pneumonia is defined as a new or progressive infiltrate on a chest x-ray plus at least two of the following criteria: cough, sputum production, temperature \>38°c or \ 10 g/l, \ 10% rods in leucocyte differentiation), c-reactive protein \>3 times the upper normal limit corticosteroid naive at time of presentation exclusion criteria: * patients needing corticosteroid treatment above study medication * failure to obtain written consent to participate * patients using medication drugs that interact with dexamethasone (i.e. phenytoin, barbiturates, rifampicin, erythromycin, clarithromycin, aprepitant, colchicine, everolimus, itraconazole, ketoconazole, pazopanib, tipranavir, and vinorelbine) * moribund patients (defined as expected to die within 24 hours) * patients with proven or suspected allergy to dexamethasone * patients not capable of taking tablets orally
localization of vasculonervous structures in tibial nerve neuromodulation: a cross-sectional study

Conditions: Tibial Nerve; Healthy Volunteers

Summary: tibial nerve neuromodulation is an effective and widely used technique in various pelvic floor dysfunctions. there are two approaches described in scientific literature to perform this technique: transcutaneous and percutaneous. however, there is no consensus on the execution of these techniques, as the location of the tibial nerve in relation to other anatomical structures like the tibia has not been described. the findings of this research could serve as a basis for the implementation and development of protocols aimed at improving the technique of posterior tibial neuromodulation.

design: a cross-sectional observational study at the physiotherapy unit of the ramón y cajal university hospital. the main objective of this study is to determine the location and size of tibial vasculonervous structures (nerve, artery, and vein) in relation to the tibia and skin using ultrasound in healthy subjects methods: healthy subjects will participate, and sociodemographic data (age, sex, weight, height) will be collected. subsequently, various measurements of the right tibial vasculonervous structures will be obtained through ultrasound a single examiner with over 5 years of experience in ultrasound will perform the measurements. significance of the research: knowledge of the position and size of the tibial vasculonervous bundle could be useful to justify and standardize transcutaneous and percutaneous approaches in tibial nerve neuromodulation. this would improve the safety of the technique, avoiding adverse events resulting from the intervention

Eligibility criteria:
inclusion criteria: * healthy subjects over 18 years of age exclusion criteria: * previous fracture of the distal end of the right tibia * previous vascular pathology of the distal end of the right tibia * previous nervous condition of the distal end of the right tibia * previous surgical intervention of the distal end of the right tibia * ongoing oncological process of the distal end of the right tibia

Keywords: tibial arteries ultrasonography pelvic floor disorders transcutaneous electric nerve stimulation
glycemic and insulinemic response of pasta products in comparison to asian foods

Conditions: Diabetes

Summary: the aim of the study is to determine the glycaemic and insulinaemic index of pasta products and local foods. it is hypothesized that different pasta cuts and wholegrain composition of pasta and local foods have different gi depending on the nature of the carbohydrate content and the food structure within each food.

there will be a total of 9 test sessions and each session will last up to 3.5 hours. the order of sessions will be determined with an online randomizer. at each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations subject will be served the test food and to consume within15 minutes following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.

Eligibility criteria:
inclusion criteria: * healthy asian - indian and chinese ethnicity * age between 21-40 years * body mass index between 18.5 to 25 kg/m2 * normal blood pressure (\<140/90 mmhg) * fasting blood glucose \< 6 mmol/l exclusion criteria: * is a current smoker * is currently pregnant * have any metabolic diseases (such as diabetes, hypertension etc) * have known glucose-6-phosphate dehydrogenase deficiency (g6pd deficiency) * have medical conditions and/or taking medications known to affect glycemia(glucocorticoids, thyroid hormones, thiazide diuretics) * have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug * have any severe food allergy (e.g. anaphylaxis to peanuts) * have any known allergies to any food components of the study protocol * have active tuberculosis (tb) or currently receiving treatment for tb * have any known chronic infection or known to suffer from or have previously suffered from or is a carrier of hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv) * is a study team member or an immediate family of any study team member. immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study. * have partake in sports at the competitive and/or endurance levels * have intentionally restrict food intake
a study of lx211 in active sight threatening, non-infectious intermediate-, anterior and intermediate-, posterior-, or pan-uveitis

Conditions: Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Summary: the objective of this study is to evaluate the safety and efficacy of lx211 as therapy in subjects with active non-infectious uveitis


Eligibility criteria:
inclusion criteria: * documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis * current uveitis therapy must conform to one of the following: 1. prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization 2. have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy 3. receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization 4. receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization 5. subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy * grade of 2+ or higher for vitreous haze at time of enrollment * considered by the investigator to require immunomodulatory therapy. * not planning to undergo elective ocular surgery during the study exclusion criteria: * uveitis of infectious etiology * clinically suspected or confirmed central nervous system or ocular lymphoma * primary diagnosis of anterior uveitis

Keywords: uveitis calcineurin
local application of vancomycin powder in grade i-iiia open fractures

Conditions: Fractures, Open; Surgical Wound Infection

Summary: the purpose of this study is to determine if local administration of vancomycin powder at the site of grade i-iiia open fractures at the time of surgery will be an efficacious method to lower infection rates in open fracture treatment and to elucidate any detrimental effects of applying vancomycin powder at the site of open fractures.

hypothesis: local administration of 1 gram of vancomycin powder at the site of primarily closeable gustilo-anderson grade i-iiia open fractures at the time of surgery, in addition to clinically accepted open fracture management (intravenous antibiotics, surgical irrigation and debridement and stabilization), will significantly decrease the postoperative infection rate in comparison to the current treatment algorithm. methods: study subjects will be randomized to one of two groups prior to surgery (parallel group design): standard treatment (control group) versus vancomycin powder treatment (experimental group). each group will have an equal number of subjects. once randomized, the intervention is then un-blinded to facilitate treatment. post-operatively, all patients will receive intravenous antibiotics, such that all patients receive a total of 24 hours of intravenous antibiotics. the surgical drain will be removed at the patient's bedside approximately 24 hours after the surgical procedure. patients will follow up with their surgeon for routine scheduled visits at approximately 2 weeks, 6 weeks, 12 weeks, and further until aseptic union or resolution of infection. there will be no additional appointments solely for the purpose of research follow-up.

Eligibility criteria:
inclusion criteria: * skeletally mature patients ≥18 years of age * acute gustilo-anderson type i-iiia open fracture * fracture is deemed primarily closable at initial surgery * likely to follow-up with surgeon until fracture is healed * ability to understand and agree to informed consent exclusion criteria: * patients \<18 years of age * gustilo-anderson type iiib and iiic open fractures * open fractures requiring multiple operations (i.e. for repeat surgical debridement or staged bone grafting of critical segmental defects) * delayed presentation of open fracture * pre-existing systemic infection requiring antibiotic therapy * allergy to vancomycin * open fracture at the site of a previous fracture or surgical site * current skin infection, chronic wounds or known systemic infection * unlikely to follow-up until fracture is healed * unable to understand or agree to informed consent

Keywords: vancomycin
recover-sleep: platform protocol, appendix_b (cpsd)

Conditions: Long COVID; Long COVID-19; Sleep Disturbance

Summary: the platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. for example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. this platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for pasc-mediated sleep disturbances. the hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with pasc can be improved by phenotype-targeted interventions. specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex pasc-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).

interventions will be added to the platform protocol as appendices. each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix. after completing baseline assessments, participants will be randomized to an intervention group, which is based on their sleep phenotype, or into a placebo/control group.

Eligibility criteria:
inclusion criteria: • see nct06404086 for recover-sleep: platform protocol level inclusion criteria which applies to this appendix exclusion criteria: • see nct06404086 for recover-sleep: platform protocol level exclusion criteria which applies to this appendix additional appendix b (cpsd) level inclusion criteria: the following additional exclusion criteria are to be considered together for determining eligibility. they are separated here by tl and melatonin only for presentation. reset-pasc presents no additional exclusions. tailored lighting exclusion criteria 1. severe visual impairments affecting sensitivity or ability to respond to light 2. severe photosensitivity dermatitis 3. severe progressive retinal disease, eg, macular degeneration 4. permanently dilated pupil, eg, following certain cataract surgeries 5. unwilling to remove or not wear blue-light-blocking glasses during tl dosing melatonin exclusion criteria 1. sleep medication, if not willing to washout for 4 weeks.

Keywords: pasc sleep disturbances
trabecular microbypass istent in patients with glaucoma

Conditions: Primary Open Angle Glaucoma (POAG); Istent Inject W; Normal Tension Glaucoma (NTG)

Summary: the goal of this clinical trial is to assess the safety and efficacy of phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-istent) versus phacoemulsification alone in a taiwanese population, as well as to investigate any differences in outcomes between patients with primary open angle glaucoma (poag) and those with normal tension glaucoma (ntg). the main question it aims to answer is: • how much do intraocular pressure (iop) and the number of antiglaucoma medications change after istent insertion, with subgroup analyses for poag and ntg? researchers will compare phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-istent) versus phacoemulsification alone to see if iop and the number of antiglaucoma medications decrease. participants will receive their regular phacoemulsification and decided whether to receive istent by themselves.


Eligibility criteria:
inclusion criteria: patients evaluated by a clinician who require cataract surgery or cataract surgery combined with istent implantation due to concomitant glaucoma and cataracts. exclusion criteria: * eyes that have previously undergone vitrectomy or retinal surgery. * patients with ocular surface inflammation (e.g., corneal ulcers, orbital cellulitis, etc.). * patients with hypotony (intraocular pressure \<5 mmhg). * patients with a history of globe rupture.
monoclonal antibody therapy in treating patients with advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase i trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer.

objectives: * determine the toxicity, maximum tolerated dose, and pharmacokinetics of monoclonal antibody hu3s193 in patients with advanced colorectal carcinoma. * determine the immune response in these patients treated with this regimen. outline: this is a dose escalation study. patients receive monoclonal antibody hu3s193 (mab hu3s193) iv over 30 minutes to 4 hours weekly for 8 weeks followed by 2 weeks of rest. patients with stable or responding disease at week 10 receive maintenance mab hu3s193 weekly. courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of mab hu3s193 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities.

Eligibility criteria:
inclusion criteria: * histologically proven stage iv colorectal carcinoma. * failed or refused conventional chemotherapy. * lewis y antigen present on more than 50% of tumor cells. * measurable or evaluable disease. * no central nervous system (cns) tumor involvement. * karnofsky 80-100%. * life expectancy: at least 6 weeks. * granulocyte count greater than 1,500/mm\^3. * platelet count greater than 100,000/mm\^3. * bilirubin no greater than 1.0 mg/dl. * prothrombin time less than 3 times upper limit of normal. * creatinine no greater than 1.4 mg/dl. * female patients of childbearing age and male patients must be asked to use effective contraception during the study. * at least 4 weeks since other prior immunotherapy. exclusion criteria * new york heart association class iii or iv heart disease. * serious infection requiring antibiotics or other serious illness. * pregnancy or nursing. * history of bleeding gastric ulcers or pancreatitis. * diabetes mellitus requiring insulin. * human antimouse antibodies (hama). * no prior mouse monoclonal antibody or antibody fragments. * illness requiring the use of steroids or other anti-inflammatory agents. * positive anti-hu3s193 antibody (haha) titer.

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer
laser ablation versus radiofrequency ablation for thyroid nodules

Conditions: Thyroid Nodule

Summary: the purpose of this study is to prospectively compare percutaneous radiofrequency ablation (rfa) versus percutaneous laser ablation (la) for the treatment of solid thyroid nodules.

nodular thyroid disease is a common clinical problem whose prevalence increases with age and with a more widespread use of thyroid ultrasonography. although most thyroid nodules are benign and need only periodic monitoring, some may require treatment for associated pressure and/or cosmetic symptoms. although thyroid surgery is the main therapeutic approach for compressive thyroid nodules, it may be associated with several drawbacks. long-term levothyroxine suppression treatment in elderly patients with large nodular goiters is unsatisfactory because it is ineffective. furthermore, it is associated with adverse effects on bones and the cardiovascular system. nonsurgical, minimally invasive treatment modalities such as percutaneous laser ablation (la) and radiofrequency ablation (rfa) have been used to treat thyroid nodules. however no studies comparing la and rfa have been published so far. aims of the study 1. to evaluate whether la and rfa cause a reduction ≥50% in the volume of thyroid nodules after 6 months and 1 year follow-up 2. to evaluate whether the features of thyroid nodules as evaluated by thyroid ultrasound, contrast-enhanced ultrasound, power-doppler and core-biopsy influence la and rfa outcomes 3. to evaluate changes in thyroid function and thyroid autoimmunity after la and rfa. 4. to evaluate differences between la and rfa in terms of complications, side effects and tolerability. patients will be recruited, treated and followed at santa maria goretti hospital in latina, italy, by physicians with expertise in la and rfa. the scientific coordinator of this study is dr. silvia manfrini.

Eligibility criteria:
inclusion criteria: * solitary thyroid nodule or dominating nodule which is well-identifiable in multinodular goiter. * compressive and /or cosmetic symptoms caused by thyroid nodule or increase in nodule volume \>20% in 1 year even without symptoms * a nodule volume ≥ 5 ml * solid nodule (uniformly compact or nearly completely solid, with a liquid component not exceeding 30%); * two thyroid biopsies resulted negative for malignancy * calcitonin levels within normal ranges exclusion criteria: * hyperfunctioning lesion as evaluated biochemically and/or by 99mtc scintigraphy * pregnancy

Keywords: thyroid nodule percutaneous radiofrequency ablation (rfa) percutaneous laser ablation (la)
epidemiological study in tuberculosis-endemic urban area in senegal

Conditions: Tuberculosis

Summary: a cross-sectional childhood m. tuberculosis infection survey of age-specific rates (defined by positivity to the test quantiferon-tb gold plus) will be conducted in senegal to collect information on the local tb endemic to inform site selection, sample size, and recruitment strategies for a future efficacy trial of vaccine candidate mtbvac in young children.

mtbvac is a new tb vaccine candidate based on an attenuated clinical isolate of m. tuberculosis. the clinical development consortium of this edctp program is preparing for future years an mtbvac efficacy trial by setting up a network of three african sites in south africa, senegal and madagascar. each site has established an operational clinical research infrastructure. as a first step, senegal site needs to collect crucial epidemiological data on tb in children, to allow a rapid transition to a phase 3 trial in infants. the primary objective is to estimate the prevalence of tb infection by the quantiferon-tb gold plus technique in 500 children splined in 1-year, 2-year, 5-year, and 12-year-old age groups living in the study area (saint louis, senegal). secondary objectives are: * to study the socio-demographic characteristics, the vaccination history of each subject and the possible tuberculous contacts he has. * to map selected populations (from gps residence data) according to the status (infected or uninfected) of each subject. * to ensure the orientation of children found positive by the quantiferon-tb gold plus test for care and follow-up related to the tb diagnosis and treatment at one of the health centers (thc) located in the study areas. * to estimate the number of tuberculosis cases detected in children aged up to 12 years and resident in the study area from thc registries and data from the national tuberculosis control plan (pnb).

Eligibility criteria:
inclusion criteria: * children resident in the study area (st louis city) * obtaining written consent from one of the parents / guardians. * children meeting one the following age criterion: * 1-year old child (12 months -1/+4 months); * 2-year-old child (24 months -1/+4 months); * 5-year old child (60 months +/-6 months); * 12-year old child (12 years old +/-6 months); exclusion criteria: * child resident outside the study area. * participation refusal by one of the parents / guardians. * objection of the child belonging to the 12-year old group. * child with a known chronic pathology (severe asthma, epilepsy, type 1 diabetes, severe immunosuppression ...) * child considered by the principal investigator as medically unfit to participate in the study.

Keywords: tuberculosis quantiferon gold plus test tuberculosis in children senegal mtbvac
dynamic laryngotracheal separation for aspiration

Conditions: Aspiration Pneumonia

Summary: people who aspirate after neurologic insults such as stroke often develop fatal pneumonia. this study examines the effects of dynamic vocal cord closure on swallowing. implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. the patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.

data pending

Eligibility criteria:
inclusion criteria: * aspiration pneumonia after neurological insults (e.g. stroke) * ability to understand the purpose of the research * appropriate hand motor control * inability to improve under standard treatments (speech-language pathologists) * acceptance of a tracheostomy exclusion criteria: * lack of understanding the research * poor hand motor coordination * uncontrolled seizures * pregnancy * refusal to accept a tracheostomy

Keywords: aspiration pneumonia implanted laryngeal stimulator vocal cord closure modified barium swallow