Kornimate/medical-research-clean huggingface dataset:
pilot study to determine efficacy of cyclamen europaeum extract nasal spray in patients with acute sinusitis

Conditions: ACUTE SINUSITIS

Summary: to evaluate the efficacy and safety of cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis


Eligibility criteria:
inclusion criteria: 1. adults age 18-70 2. must be symptomatic on the basis of subject assessments of total sympton score. 3. evidence of mucopurulence on nasal endoscopy 4. evidence of inflammation upon nasal endoscopy 5. ct scan with radiographic signs of acute sinusitis 6. able to complete all study activities or procedures through the end of the study, including all visits and tests, and capable of selfadministration of study medication 7. agree to abide by the study protocol and its restrictions exclusion criteria: 1. known history of hypogammaglobulinemia, immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa, or cystic fibrosis 2. known hypersensitivity to cyclamen, primula, or other primulaceae 3. serious unstable comorbidity such as malignancy (other than squamous or basal cell carcinoma of the skin) or sever renal or hepatic disease. 4. abnormal screening laboratory/imaging test results 5. condition(s) that compromise the ability to either administer the agent or assess the risks/benefits (eg mucocele, choanal polyp, stage 4 polyposis or cyst extending below the inferior turbinate, deviated septum, facial trauma, or birth defect) 6. expansile mass or bony erosion on sinus radiograph 7. females who are pregnant, planning to become pregnant or currently breastfeeding. 8. history of viral upper respiratory infection (uri) in the past 2 weeks 9. temperature greater than 102.5°f 10. facial or periorbital edema 11. local complications including orbital cellulitis; acute abnormalities of extraocular movements; cavernous vein thrombosis; dental or facial abscess 12. altered mental status 13. recent nasal or sinus surgery (within 3 months or less) or planned surgery within the next 3 months 14. use of intranasal antibiotics within the previous 30 days or systemic antibiotics within the previous 15 days 15. use of oral and/or topical nasal decongestants within the previous 7 days 16. had radiation therapy or chemotherapy within the previous 12 months 17. have used an investigational drug or device within 30 days prior to screening 18. have a history of illegal drug or alcohol abuse within the past 5 years 19. have major unstable organ system disease that could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives subjects who have asthma, seasonal and/or perennial allergic rhinitis will be allowed to enter the study.

Keywords: sinusitis cyclamen
natural history of hepatitis c in patients with normal liver tests

Conditions: Chronic Hepatitis C

Summary: the major goals of this project was to assess the natural history of disease in chronic hepatitis c patients with normal alt and to determine the virologic and host factors associated with disease severity.


Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c and persistently normal liver enzymes * able to give consent exclusion criteria: * decompensated liver disease * any prior antiviral or immunosuppressive therapy * other liver disease besides hepatitis c

Keywords: hepatitis c hcv natural history
impact of pomegranate seed oil on postprandial cardiovascular disease risk markers

Conditions: Postmenopausal Women

Summary: dietary fat plays a crucial role as a modifiable risk factor influencing both non-fasting lipaemia and vascular reactivity. notably, the intake of dietary saturated fatty acids (sfas) has been associated with adverse effects on blood lipid profiles, whereas increased consumption of unsaturated fatty acids (ufas) has shown potential to improve lipid health. pomegranate seed oil (pso) stands out due to its high content of conjugated α-linolenic acids (clnas). however, research comparing the impact of these fatty acids on postprandial vascular function, particularly in postmenopausal women, remains limited. a cross-over, single-blind, randomised acute postprandial study will be conducted in 15 healthy postmenopausal women. participants will be assigned to consume the test meals either a placebo (50 g of mixed fat; 4:0.5:0.5 palm oil: rapeseed oil: safflower oil) or pso (40 g of mixed fat and 10g of pso) in random order on 2 separate occasions, with 4-6 weeks between each study visit. the anthropometric, blood pressure, and arterial stiffness, will be taken for each study visit. blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, and whole blood culture. the findings from this study will contribute to the evidence base on how consuming meals rich in pso influence the level of blood lipids as well as other biomarkers for cardiovascular disease.


Eligibility criteria:
inclusion criteria: * postmenopausal women who have been postmenopausal for at least 12 months. * aged 65 and under years * serum tag \< 2.3 mmol/l * body mass index (bmi) between 18-35 kg/m2 * fasting total cholesterol \< 7.5 mmol/l * fasting glucose concentration \<7 mmol/l exclusion criteria: * smokers * medical history of myocardial infarction or stroke in the past 12 months * diabetes (defined as fasting glucose \> 7.0 mmol/l) or other endocrine disorders * kidney, liver, pancreas or gastrointestinal disorder * hypertension (blood pressure \> 140/90 mmhg), cancer, medication for hyperlipidaemia (e.g. statins), hypertension or, inflammation * anaemia (\<115 g/l haemoglobin) * taking any dietary supplements known to influence lipids/gut microbiota (e.g. plant stanols, fish oil, phytochemicals, natural laxatives, probiotics and prebiotics) * drinking in excess of 14 units of alcohol per week * planning on a weight-reducing regime * parallel participation in another dietary intervention study * any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study
combination of capecitabine and gti-2040 in the treatment of renal cell carcinoma

Conditions: Carcinoma, Renal Cell; Metastases, Neoplasm

Summary: this phase ii, 43 patient trial, will evaluate the efficacy of gti-2040, an antisense oligonucleotide complementary to the r2 component of ribonucleotide reductase (rnr) mrna, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. preclinical studies have shown synergy between gti-2040 and capecitabine against renal cell carcinoma.


Eligibility criteria:
* age greater than or equal to 18. * histologically or cytologically confirmed diagnosis of advanced or metastatic renal cell carcinoma for which no effective therapy is available or that is unresponsive to conventional therapy. * measurable disease. to be considered measurable, a lesion must be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral ct scan. * karnofsky performance status of greater than or equal to 70. * be able to have a central venous like access maintained throughout the study. * provide written informed consent prior to the initiation of protocol therapy. * appropriate organ function.

Keywords: metastatic renal cell carcinoma
use of microscopy, cultures and molecular biological methods for diagnosing nosocomial pneumonia

Conditions: Nosocomial Pneumonia

Summary: nosocomial pneumonia in the intensive care unit is often not properly diagnosed mainly due to ongoing antimicrobial therapy. the study investigates the feasibility of more advanced diagnostic technics.

icu patients fulfilling the cdc criteria for nosocomial pneumonia and mechanically ventilated for no more than 24 hours are included in the study. the material for the diagnostic procedure is pulmonal secretion collected by 1. suctioning in the tracheal tube and 2. bronchioalveolar lavage. the diagnostic procedures are culturing, 16s and18s gene pcr and subsequent sequencing. the 3 diagnostic methods will be compared in order of proper diagnosis and the ability to determine a specific antimicrobial treatment.

Eligibility criteria:
inclusion criteria: * patients intubated because of respiratory failure following nosocomial pneumonia exclusion criteria: * terminal patients * patients with lung cancer * intubated for more than 24 hours at the sampling time * not fulfilling the cdc criteria for nosocomial pneumonia

Keywords: nosocomial, pneumonia diagnostics 16s 18s pcr next generation sequencing
optifit-optimal fiber trial for diabetes prevention

Conditions: Diabetes; Nutrition Disorders; Obesity; Overweight; Metabolic Syndrome x; Body Weight; Glucose Metabolism Disorders; Metabolic Diseases

Summary: high intake of insoluble fiber is strongly associated with a reduced incidence of diabetes and cardiovascular events in prospective observation studies. our primary objective is to compare a life style diabetes prevention program(praedias) with and without added insoluble fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with impaired glucose tolerance. subjects with igt not willing to participate in the intervention will be used as independent controls. secondary aims are to identify mechanisms of action with regard to body composition, anti-inflammatory and metabolic effects of fibers. we propose a randomized, prospective intervention study. the results will be of general relevance for guidance of fiber intake in the population and will help the food industry to design healthy high fiber foods. fiber can be added at low cost to numerous foods. increased fiber intake may therefore provide a simple non-cognitive prevention strategy effective at the population level.

the overall objective is to investigate whether insoluble fibers added to standard nutrition can reduce the progression of impairment of glucose metabolism in a high risk population with impaired glucose metabolism. large prospective cohort studies clearly show that mainly insoluble cereal fiber from whole grains is associated with reduced risk of type 2 diabetes and cardiovascular disease. however, there is a lack of evidence from prospective intervention studies targeted to evaluate the potential of dietary fibers to reduce diabetes and cardiovascular disease as recently stated by the cochrane foundation. dietary fiber intake is generally much lower than currently recommended, which may in part be related to side effects of whole grain nutrients and their gustatory properties. intestinally uncomfortable effects are at least partly related to fermentation which is much less induced by insoluble non-fermentable fibers than by soluble fermentable fibers. the prospective demonstration of beneficial effects of insoluble fibers in preventing diabetes type 2 will allow detailed nutritional recommendations. this may serve to support the consumption of metabolically beneficial constituents of fiber-rich diets and help to increase fiber intake by high fiber natural nutrients or everyday nutrients enriched in insoluble natural fibers.

Eligibility criteria:
inclusion criteria: * impaired glucose tolerance * age\>18years old * both gender exclusion criteria: * diabetes type 1 and type 2 * chronic or malignant disease * intake of metabolic influence drugs * food allergies, fiber intolerance

Keywords: nutritional support diet therapy diabetes prevention insoluble fiber healthy life style weight loss
paracetamol metabolism research in postoperative hepatic surgery

Conditions: Paracetamol Causing Adverse Effects in Therapeutic Use; Hepatic Disease

Summary: the main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. the clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable. some patients may be operated on up to four or five times in the liver. moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. it is therefore interesting to evaluate the use of paracetamol in this situation.


Eligibility criteria:
inclusion criteria: * patients requiring surgery for hepatic resection by initiation under chest or laparoscopic without hepatocellular insufficiency, * asa score 1 to 3 (american society of anesthesiologists score ranging from 1 to 5 evaluating the preoperative health status of a patient), * verification of the understanding of the protocol, exclusion criteria: * patients classified asa 4 or 5, * allergy or intolerance to indocyanine green * allergy or intolerance to paracetamol, * taking of paracetamol the week before the intervention, * patient less than 60 kgs (because decrease of doses of paracetamol), * emergency surgery, palliative surgery and surgical recovery, * psychic disorder, * contra-indication to a treatment used during the study, * incapable major, * intellectual incapacity preventing proper understanding of the protocol, * pregnant or nursing woman,
methotrexate and statins with methotrexate alone in the treatment of rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the objective of the study is to compare the efficacy of combination of methotrexate and statins with methotrexate alone in the treatment of rheumatoid arthritis. it is hypothesized that adding statins to methotrexate for treatment of rheumatic arthritis will significantly suppress the disease activity as compared to methotrexate alone.

after approval from board of studies and irb of king edward medical university, all patients fulfilling inclusion and exclusion criteria from out patient department and wards of mayo hospital lahore will be selected and randomized to group a or group b by lottery method (using coin flipping method) with one group receiving combination of methotrexate and simvastatin and other group receiving simvastatin only. all patients will be given adequate dose of analgesics for pain relief. informed consent will be obtained from the patient. demographic information like name, age and sex, will also be obtained. das 28 scoring will be done at the time of presentation and will be noted. patients will be followed at 1 month, 3 month and at 6 month. at each follow up das 28(esr) score will be calculated using das 28 calculator. all this information will be recorded on predesigned proforma (attached).

Eligibility criteria:
inclusion criteria: * all patients between ages 18 years and above * gender- both male and female * fulfilling 2010 acr/eular criteria of rheumatoid arthritis with active inflammatory disease defined by das 28 score \>2.6, * normal serum cholesterol level. exclusion criteria: * already diagnosed patients of diabetes mellitus. * use of steroids greater than 4 weeks of duration or intra articular steroid injection within 4 weeks of study. * statin therapy in last three months. * statin intolerant patient. * elevated creatinine phosphokinase more than twice the upper limit of normal range. * diagnosed case of chronic liver disease or abnormal liver functions (transaminases \> 2 times the upper limit of normal range) before the start of treatment or during follow-up. * high serum creatinine level * pregnancy and breast feeding.

Keywords: methotrexate statins rheumatoid arthritis
a study of guselkumab in pediatric participants with moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with crohn's disease (cd) at the end of maintenance therapy (week 52) among participants who were in clinical response to guselkumab at week 12.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of crohn's disease (cd) or fistulizing cd, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. * participants must have moderately to severely active cd (as defined by a baseline pediatric crohn's disease activity index \[pcdai\] score greater than or equal to \[\>=\] 30) * participants must have endoscopy with evidence of active cd defined as simple endoscopic score for crohn's disease (ses-cd) score greater than or equal to (\>=) 6 (or \>=4 for participants with isolated ileal disease) within 1 month of receiving study intervention at week 0 * participants must have a prior or current cd medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or intravenously (iv) corticosteroids or have received biologic therapy/jak inhibitor for the treatment of cd and have a documented history of inadequate response, loss of response (lor), or intolerance to the biologic therapy/jak inhibitor exclusion criteria: * participants has complications of cd such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery. * participants must not have an abscess * participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline

Keywords: pediatric, inflammatory bowel disease
pilot study of imatinib (gleevec) as treatment for advanced thymic carcinoma

Conditions: Thymic Carcinoma

Summary: this study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or pdgf. if this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.

thymic carcinomas are particularly more concerning due to their aggressive metastatic nature and shorter overall survival, in comparison to their lesser-malignant thymoma counterparts. this necessitates the need for systemic therapy. due to the paucity of thymic carcinoma cases, the ideal regimen for locally advanced or metastatic thymic carcinomas is not defined.to this point, there has not been a study using imatinib in thymic tumors expressing the kit tyrosine kinase protein or pdgf tyrosine kinase protein. this study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or pdgf. if this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.

Eligibility criteria:
inclusion criteria: * histological or cytological proof of advanced c-kit positive or pdgfr positive thymic carcinoma. for protocol purposes, advanced disease is defined as disease * patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy. * no prior imatinib therapy. * age \> 18 years at the time of consent * ecog performance status of 0 or 1 * anc ≥ 1500/mm3,platelet count ≥ 100,000/mm,total bilirubin \< 1.5uln,3.10 serum creatinine ≤ 1.7 mg/dl,alt and ast ≤ 3 x uln exclusion criteria: * clinically significant infections as judged by the treating investigator * clinically significant concurrent illnesses * females of childbearing potential not using birth control or breastfeeding * prior radiation therapy \> 25% of the bone marrow * symptomatic brain metastasis * history of grade iii/iv cardiac problems * history of major surgery within 14 days prior to being registered * treatment with any investigational agent within 30 days prior to being registered for protocol therapy.

Keywords: thymic malignancy thymic carcinoma
topical cosmetic products for hand and foot syndrome

Conditions: Hand Foot Skin Syndrome

Summary: the aim of the study is to evaluate the efficacy of a dermocosmetic protocol in reducing the main cutaneous side effects that occur in palmar-plantar erythrodysesthesia syndrome in subjects with a tumor diagnosis, undergoing chemotherapy and targeted treatments such as target therapy and radiotherapy.

cancer patients undergoing active oncological treatment (chemotherapy, biological therapies, radiotherapy) experience multiple side effects, including skin toxicity, which negatively affects their quality of life, increasing the risk of interrupting cancer therapy. symptomatic therapy is often neglected and prescribed late in the course of the disease. many patients undergoing anti-cancer therapies experience adverse skin reactions such as dry skin, rashes, redness, and itching. dry skin, erythema, and nail lesions are particularly common for those undergoing chemotherapy and targeted treatments such as target therapy and radiotherapy. cleansing must be done by affinity, that is, with an emulsification mechanism and not solubilization, through the use of "sebum-like" fatty substances to remove only the excess lipids on the skin surface and the dirt attached to them. this eudermic cleansing without the use of surfactants does not solubilize the epidermal lipids that are fundamental in the structure of the hydrolipidic film, maintaining the right protection and hydration of the skin. therefore, the main objective of the following study is to evaluate the efficacy of 4 topical cosmetic products specifically formulated for patients undergoing oncological therapy in the management of palmar-plantar erythrodysesthesia syndrome, a skin toxicity typical of oncological treatments, which causes skin alterations such as erythema and/or xerosis and/or mild to moderate nail damage, to ensure an improvement of the skin condition during therapy.

Eligibility criteria:
inclusion criteria: * cancer diagnosis undergoing oncological therapy with chemotherapeutic agents, targeted therapy, immunotherapy hormonal treatments * patients with grade 1 of hand-foot syndrome (hfs) male and female patients 18 age or more * conditions favoring the correct execution of the proposed program * signature of informed consent, privacy and the form for the use of the data exclusion criteria: * pregnancy or breastfeeding in progress * other skin toxixities different from hfs * patients with hfs adverse skin symptoms higher than grade 1 * psychic or other disorderes * patients with preexisting skin disorders thet could interfere with thw study results (like dermatitis, prosriais) * known hypersensitivity or allergy to one of the components of the products

Keywords: hand-foot syndrome skin toxicity cancer treatments quality of life cosmetic products