Kornimate/medical-research-clean huggingface dataset:
the study of cm310 in patients with chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of cm310 in patients with crswnp.


Eligibility criteria:
inclusion criteria: * the patient must be able to understand and voluntarily sign an icf. * participated in the clinical study of cm310 in patients with crswnp (study no. of cm310np001) and meet the criterion "a" or "b" as below: 1. patients have completed the treatment as required by the protocol and completed the eos (v12) visit; 2. early withdrawal from the visit due to poor compliance or other objective reasons other than cm310-related ae, and the patient have completed early withdraw visit as per protocol, and, as assessed by the investigator and sponsor, the factors resulting in early termination of main study treatment have disappeared/will not affect the patient's participation in this extension study. * patients must have received incs at a relatively stable dose for at least 4 weeks upon the screening visit. exclusion criteria: * patients who are considered ineligible for continuous cm310 treatment by the investigator and the sponsor due to cm310-related\* sae or discontinuation caused by cm310-related\* ae developed in the main study. * patients who had poor compliance in the main study and are judged unable to complete this study by the investigator. * not enough washing-out period for previous therapy. * presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (hiv) infection, active hepatitis b, hepatitis c or parasitosis, neoplasm malignant, etc. * patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (ast) or alanine aminotransferase (alt) level \> 2 times of upper limit of normal (uln) or serum creatinine level \> uln. * women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
sodium-glucose co-transporter 2 (sglt2) inhibitor risk of below-knee lower extremity amputation: a retrospective cohort study using a large claims database in the united states

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to estimate the incidence of below-knee lower extremity amputation in type 2 diabetes mellitus (t2dm) participants newly exposed to sodium-glucose co-transporter 2 inhibitors (sglt2i)/ non-sglt2i antihyperglycemic agents (aha) overall and in the subgroup with high cardiovascular (cv) risk and to compare the hazards of below-knee lower extremity amputation in canagliflozin new users versus non-sglt2i aha new users.


Eligibility criteria:
inclusion criteria: * first exposure to the particular drug in person's history * for the initial analysis, exposure start is between april 1, 2013 and january 31, 2015. for the ongoing repeat analysis per the protocol amendment, the study period ending date will vary depending on the time of each data extraction and analysis * at least 365 days of observation time prior to index * at least 1 condition occurrence of 'type ii diabetes' any time before or on index * exactly 0 condition occurrences of 'type i diabetes' any time before or on index exclusion criteria: * participants who had amputations prior to the index date were excluded.
better acceptance of single injection apidra added to once daily lantus versus twice daily premixed insulin in real life use setting

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to demonstrate non-inferiority of once daily injection of insulin glargine (lantus) plus one injection of mealtime insulin glulisine (apidra) at the main meal versus twice daily premixed insulin (novomix 30/70) based on the reduction of hba1c percentage from baseline to endpoint. secondary objective: * to determine treatment satisfaction (dtsqs/diabetes treatment questionnaire - status, dtsqc/ diabetes treatment questionnaire - change and itsq/insulin treatment satisfaction questionnaire) * to determine the mean hba1c, fbg (fasting blood glucose), prandial bg (blood glucose) and proportion of patients with a hba1c \<7% * to determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions) * to determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus treated with insulin glargine once daily and oral blood glucose lowering medication * patients with a hba1c \> 7% * patients with a fbg within range (4-7 mmol/l) at baseline, based on the mean of 3 fbg values (measured 5x during the run-in phase, with the highest and lowest value excluded) exclusion criteria: * patients treated with an insulin other than insulin glargine * patients with hypersensitivity to insulin glargine, insulin glulisine, biphasic insulin aspart/insulin aspart protamine 30/70 or any of the excipients * patients with a (pre)proliferative retinopathy (an optic fundus examination should have been performed within the 2 years prior to study entry) * pregnant or lactating women * patients who are unable to fill in the pro (patient reported outcomes) questionnaires the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
cognitive function after treatment of primary cns malignancy

Conditions: CNS Malignancy

Summary: in this study, the investigators propose to evaluate cognitive function and determine the feasibility of neurocognitive assessment using a select cogstate test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent. the investigators will use the cogstate software to quantify changes in verbal learning, memory, and executive function over the initial months and years following radiation treatment. cognitive changes and temporal patterns of function will be compared to baseline performance for each patient. data regarding cognitive function, fatigue, quality of life, and standard patient reported outcomes will be collected to characterize the daily impact of treatment. in addition, observed outcomes will be correlated with dosimetry values, radiation dose volumes, and anatomic dose distribution.


Eligibility criteria:
inclusion criteria: * age ≥ 4 years with primary cns malignancy * able to use computer for assessment battery * receiving photon- or proton-based radiation for primary intracranial malignancy * demonstrates the capacity to sign informed consent exclusion criteria: * patients with who grade iv tumors
liquid biopsy in high-grade gliomas and meningiomas

Conditions: High Grade Glioma; High Grade Meningioma

Summary: the general objective of this project is to evaluate the value of cell-free dna circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas. to this end, we propose to longitudinally collect four samples of plasma at the following time points: * t0: before surgery; * t1: one month after surgery; * t2: one month after the end of radiotherapy; * t3 at the time of radiological progression. the goal is to evaluate whether changes in plasma concentration of circulating cell-free dna can help predict progression-free survival, overall survival, and response to therapies.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * finding, on an mri scan of the brain with gadolinium, of a brain lesion compatible with a primary brain tumor, intra- or extra-axial, suspected for a high-grade glioma or a high-grade meningioma, manifested with new onset neurological symptoms * clinical indication to perform a biopsy or surgical resection of the lesion * karnofsky performance status (kps) ≥ 60 * signature of informed consent exclusion criteria: * absolute contraindications to magnetic resonance imaging or to the administration of gadolinium (e.g. patients with pacemakers or other non-magneto-compatible devices) * known positivity for hiv, hcv or hbv * there are clinical, biological or instrumental data suggesting that the brain lesion is non-neoplastic in nature (e.g., abscess, vascular malformation, inflammatory disease of the central nervous system) * women who are pregnant or breastfeeding
a pilot observational clinical survey: impacts of tahitian noni juice on the quality of life of patients with osteoarthritis

Conditions: Osteoarthritis

Summary: tahitian noni juice (tnj) made from morinda citrifolia (noni) fruits may provide a safe adjunctive treatment for osteoarthritis (oa) due to its anti-inflammatory and analgesic properties. in this study the investigators examined whether tnj was able to improve the symptoms and quality of life (qol) of oa patients. the investigators also sought to evaluate the tolerability and safety of tnj. this was an open label three-month intervention pilot study. data were collected by pre and post intervention survey as well as laboratory testing. inclusion criteria were: adults of both sexes aged 40 to 75, with a diagnosis of oa on the hip or knee by their primary care physician, not on prescription medicine for oa, and who were willing to drink 3 oz of tnj a day.


Eligibility criteria:
inclusion criteria: * adults aged 40 to 75 of both sexes with a physician diagnosis of oa of the hip or knee who were not taking prescription medicine for arthritis and were willing to drink 3 oz of tnj daily for 12 weeks exclusion criteria: * all others

Keywords: osteoarthritis
a pilot study to assess the immunogenicity of candidate psa peptides for a prostate cancer vaccine

Conditions: Prostate Cancer

Summary: to measure antigen-specific interferon-secretion by enzyme-linked immunospot (elispot) assay, which measures antigen-specific interferon-secretion.

the goal of this project is to collect information in regards to the immunogenicity of psa peptides in order to develop a novel therapeutic vaccine. this vaccine will consist of prostate specific antigen (psa) peptide and candida skin test reagent. candida has recently been shown to be a promising new vaccine adjuvant for promoting t-cell responses. it can induce interleukin-12 (promotes t-cell response) secretion by langerhans cells, the main antigen presenting cells in skin. in a phase i clinical trial treating women with biopsy-proven high-grade squamous intraepithelial lesions (hsils), precursors of cervical cancer, a combination of human papillomavirus peptides with candida was demonstrated to be safe, to induce immune responses to human papillomavirus, and to promote t-helper type 1 (th-1) response (promotes cellmediated immunity) in vaccine recipients. for treating prostate cancer, psa is an ideal antigen as it is expressed in prostate cancer but not in any other organs. the characteristics of peptides that can effectively be used in therapeutic vaccines are their solubility in a single solution, immunogenicity in terms of containing large number of t-cell epitopes (so the vaccine can be used for all patients and not just a few that express certain human leukocyte antigen (hla) tissue types), and ability to mature langerhans cells which in turn promotes t-cell activity. in this protocol the investigators focus on the immunogenicity of candidate peptides.

Eligibility criteria:
inclusion criteria: * histological documented diagnosis of prostate cancer * 18 years of age or older * signed informed consent form approved by the university of arkansas for medical sciences (uams) institutional review board (irb) exclusion criteria: * subjects must have no other current malignancies. * subjects with prior history at any time of any basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. * subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration

Keywords: vaccine
long-term outcome of subjects with elevated psa in healthy taiwanese men

Conditions: Prostate Cancer

Summary: to determine the long-term survival outcome of subjects who had various psa levels at screening


Eligibility criteria:
inclusion criteria: * health men who received psa screening at ntuh and cgmh exclusion criteria: * prior history of prostate cancer

Keywords: psa, asian men, survival
evaluation of a procedure for identification and brief intervention of lifestyle advice assisted by application in a care setting

Conditions: Chronic Disease

Summary: chronic diseases share similar risk factors associated with four daily behaviours: unbalanced diet, sedentary lifestyle (physical inactivity and time spent sitting down), smoking and alcohol consumption. these diseases are responsible for 74% of deaths worldwide. despite the frequency with which practitioners witness these bad habits in their patients, little time is devoted to lifestyle advice during medical visits, and even less to using effective techniques to discuss their behaviour. yet medical and paramedical consultations could be an essential educational opportunity to promote a healthy lifestyle. but advice is often limited during medical check-ups, due to a lack of time and suitable tools, and is often focused on a particular risk factor. to date, there is no procedure for screening and behavioural intervention to deal with harmful lifestyle habits in patients.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. treated for a stabilised chronic disease or person treated for localised cancer, after the end of heavy treatment during the follow-up period within 5 years of the date of diagnosis of the cancer. 3. contactable by telephone 4. affiliated to a social security scheme 5. having signed a free, informed and written consent. exclusion criteria: 1. requiring psychiatric assessment 2. suffering from eating disorders 3. undergoing dietetic treatment or therapeutic education for dietetic purposes (at least two consultations at the same facility in the previous year) 4. suffering from a life-threatening condition within 5 years 5. suffering from a disabling condition (reduced activity with major restrictions) 6. unable to read 7. taking part in another psycho-behavioural nutritional intervention study 8. protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declaratory), breast-feeding woman and minor).

Keywords: brief intervention of lifestyle advice
feasibility and safety of ultrasound guided installation central subclavian catheter through supraclavicular way

Conditions: Heart Diseases; Diseases, Metabolic

Summary: our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.


Eligibility criteria:
inclusion criteria: * patient hospitalized in the neonatal intensive care or neonatal intensive care at the university hospital of hautepierre * all infants less than 44 weeks corrected age who require a surgical approach * in the first line if neonate over 34 weeks corrected age requiring dual carriageway catheter * after failure or inability laying ktec for children between 30 and 34 weeks of age corrected and heavy over 1000 exclusion criteria: * nouveau-né de poids \< 1000g * nouveau-né de moins de 30 semaines d'âge corrigé * choix d'une autre voie d'abord plus judicieux (ktvo, ktc broviac) * sortie avant retrait du ktc
study of a pandemic influenza vaccine in children

Conditions: Influenza

Summary: the world health organisation has warned that an influenza pandemic is inevitable. the avian influenza strain h5n1 is one of the leading candidates to cause the next influenza pandemic. children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an h5n1 pandemic influenza vaccine in healthy children.


Eligibility criteria:
inclusion criteria: * healthy children aged greater or equal to 6 months to less than 9 years * normal gestation period exclusion criteria: * history of clinically significant medical conditions * history of guillain barre syndrome or active neurological disease

Keywords: pandemic influenza prevention vaccine prevention of pandemic influenza
laparoscopic transvaginal hybrid cholecystectomy: a prospective data collection.

Conditions: Cholecystolithiasis; Cholecystitis

Summary: transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available notes-procedure for the clinical routine. few authors have demonstrated the feasibility and safety in a selected patient collective. the aim of this prospective data collection is to evaluate the feasibility in the clinical routine in a non select patient collective. therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.


Eligibility criteria:
inclusion criteria: * given informed consent for transvaginal hybrid cholecystectomy exclusion criteria: * pregnancy * malignoma * present choledocholithiasis

Keywords: symptomatic cholecystolithiasis
effect of a lifestyle intervention on nutritional status and prognosis of endometrial cancer survivors

Conditions: Endometrium Cancer; Life Style; Obesity

Summary: the objective of the present study is to implement and evaluate the effect of a counseling program to promote healthy eating and practice of physical activity in the nutritional status, quality of life and prognosis of women type i (endometrioid) endometrial cancer.

endometrial cancer (ec) is the fifth most commonly diagnosed malignant neoplasm among women worldwide. the incidence of ec is higher in high-income countries, but it has been increasing in low- and middle-income countries. the main risk factors for ec include the presence of comorbidities, such as diabetes mellitus and hypertension, as well as conditions associated with prolonged exposure to estrogens. obesity is recognized as a major risk factor for many cancers, including ec. multiple mechanisms related to obesity are probably involved in the carcinogenesis of ec. among obese women in the postmenopausal period, there is an increase of bioavailable circulating estrogens. these estrogens come from the aromatization of androgens in adipose tissue and from increased circulating estrogens secondary to the reduced synthesis of sex hormone binding globulin (shbg) in the liver. insulin resistance, hyperinsulinemia, increased secretion of adipocytokines and pro-inflammatory cytokines may also play a role in the carcinogenesis of ec. although the incidence of ec is remarkable, insufficient data has addressed the impact of obesity on ec outcomes. since about 70% of women diagnosed with endometriod ec are obese, the consequences of obesity-related diseases should be taken into account in order to implement strategies to improve survival outcomes among these women. sedentary lifestyle and physical inactivity also seem to be relevant, and have been identified as predictors of poor prognosis in patients with different types of cancer. however, the role of lifestyle (including eating and social habits and physical activity) on endometrial cancer prognosis has not been assessed prospectively yet. studies assessing nutritional status and lifestyle before and after ec diagnosis may elucidate whether and when these factors influence clinical outcomes, including long-term survival.

Eligibility criteria:
inclusion criteria: * endometrial cancer patients undergoing surgical treatment exclusion criteria: * previous oncologic treatment * cancer stage iv according to the international federation of gynecology and obstetrics (figo) * patients who report physical activity over 150 minutes/week of moderate or vigorous intensity * individuals with decompensated diabetes mellitus or hypertension * patients who have a contraindication to physical activity.

Keywords: lifestyle intervention endometrial cancer survival
analysis of patients treated for chronic granulomatous disease since january 1, 1995

Conditions: Chronic Granulomatous Disease

Summary: this study is a longitudinal and cross-sectional evaluation of patients with chronic granulomatous disease (cgd) who received or are receiving hematopoietic cell transplantation (hct) for their disease under a variety of protocols used by participating institutions compared to a control non-hct group receiving standard care. investigators at multiple centers caring for patients with cgd in north america and 3 centers in europe will participate. patients with cgd will have been treated according to institutional practice and protocols. investigators will enroll these patients as subjects in this protocol. this study will investigate which patients benefit most from hct, and what types of transplants are optimal for patients with cgd, in the context of overall outcomes in cgd patients with and without transplant.

this study is a longitudinal and cross-sectional evaluation of patients with chronic granulomatous disease (cgd) who received or are receiving hematopoietic cell transplantation (hct) for their disease under a variety of protocols used by participating institutions compared to a control non-hct group receiving standard care. investigators at multiple centers caring for patients with cgd in north america and 3 centers in europe will participate. patients with cgd will have been treated according to institutional practice and protocols. investigators will enroll these patients as subjects in this protocol. this study will investigate which patients benefit most from hct, and what types of transplants are optimal for patients with cgd, in the context of overall outcomes in cgd patients with and without transplant.

Eligibility criteria:
* both hct and non-hct subjects must be over the age of 2 and actively enrolled and receiving treatment under a cgd protocol at niaid.

Keywords: rare diseases primary immune deficiency treatment consortium retrospective natural history
effect of home-based exercise program in older adults with sarcopenia

Conditions: Sarcopenia

Summary: in the prospective, randomized, controlled multi-centre study, 100 patients who were clinically diagnosed with sarcopenia were assigned to either a home-based exercise group or the control group. the home-based exercise program was performed three days per week for 12 weeks. before and three months after the exercise program, all the patients were evaluated.

sarcopenia is a complex and multifactorial syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength.the randomized, multicenter study was conducted at the physical medicine and rehabilitation departments of five different centers. one hundred patients met the inclusion and exclusion criteria and were randomly allocated to either a home-based exercise group (n=50) or a control group (n=50). the patients were evaluated before and 3 months after inclusion using the timed up and go test, the berg balance scale, the 6-minute walk test , a numeric rating scale to determine qol, and the number of falls.

Eligibility criteria:
inclusion criteria: community-dwelling older adult diagnosis of sarcopenia according to the clinical examination; and able to walk independently. the physical performance of patients with a sarc-f score ≥4 were tested using a gait speed test and a short physical performance battery (sppb). the diagnosis of sarcopenia was confirmed in cases where the patient's gait speed was ≤0.8 m/s and the sppb score was ≤8 exclusion criteria: having cardiovascular, pulmonary, and/or chronic diseases that may affect participation in the exercise program; impaired cognition; previous diagnosis of a neurological condition that severely affected mobility and balance; malignancy; metastatic cancer; serious vision loss or vestibular impairment