Kornimate/medical-research-clean huggingface dataset:
dose-finding, feasibility study of optison in contrast enhanced u/s for the detection of carotid artery disease

Conditions: Carotid Artery Disease

Summary: the purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 ml, 0.5 ml and 1.5 ml of optison in assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (u/s) by dose group.


Eligibility criteria:
inclusion criteria: * the subject is is greater than or equal to 18 years of age. * the subjects has highly suspected or established carotid artery disease. * the subject has undergone or been referred for either unilateral or bilateral intra-arterial x-ray carotid angiography for the determination of subject management (within 30 days before or after the u/s procedure). * the subject has non-diagnostic u/s of the carotids as defined by institutional standards. exclusion criteria: * the subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study. * the subject has a history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent. * the subject has a known or suspected hypersensitivity to any of the components of optison, blood, blood products, or albumin. * the subject has right to left, bi-directional or transient right to left cardiac shunts.

Keywords: ce-u/s - contrast-enhanced u/s u/s - ultrasound assess effectiveness
real world study on the use of cemiplimab in adult patients in uk

Conditions: Cutaneous Squamous Cell Carcinoma

Summary: the primary objective is to describe the real-world clinical effectiveness of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma (lacscc) or metastatic cutaneous squamous cell carcinoma (mcscc) treated in routine clinical practice.

patients initiating treatment with cemiplimab in the uk between 2nd july 2019 and 30th november 2020, will be followed for a minimum of 12 and a maximum of 36 months from initiation of cemiplimab.

Eligibility criteria:
inclusion criteria: * patients aged \>=18 years at initiation of cemiplimab. * patients treated with \>=1 dose of cemiplimab for lacscc or mcscc who were not suitable for curative surgery or curative radiation according to routine practice. * patients initiating treatment with cemiplimab in the uk between 2nd july 2019 and 30th november 2020. exclusion criteria: * patients who are known to have opted out of participation in any research (as required for compliance with gdpr). * patients participating in any form of investigative study (e.g., clinical trials) during the post-index observation period.
breast cancer education to prisoner women

Conditions: Breast Cancer

Summary: the aim of the study is to determine the effect of breast cancer education given to incarcerated women on breast cancer knowledge and awareness.

breast cancer is the most common cancer among women in the world, accounting for almost a quarter of cancer cases diagnosed among women, with 1.15 million cases diagnosed each year. breast cancer is common in both developed and developing countries. however, in developing countries, these rates are three times higher and the mortality rate is quite high. risk factors include age, low socioeconomic level, early menarche, late menopause, family history of breast disease, long-term use of hormone replacement therapy, breastfeeding status and lifestyle habits. it is reported that breast cancer screening programs such as mammography, breast self-examination (bse) and clinical breast examination (cmm) have an important role in early diagnosis, increasing the survival rate, reducing the death rate and preventing relapse in breast cancer patients. it has been reported that women who perform regular bse are more likely to have early stages of the disease, this is because regular bse gives the woman information about the feel and appearance of the breast. thus, the woman will be able to detect any changes as early as possible. it is reported that the practice of breast self-examination depends on different factors, including women's knowledge, attitude, socio-demographic and sociocultural factors. other reasons for low implementation rates, such as lack of time, forgetfulness, and low education level, have also been reported. breast cancer is the second leading cause of death after cervical cancer among incarcerated women under the age of 40. 27% of women over the age of 40 had breast cancer, and 18% of these women died. it is of great importance to raise awareness, which is considered one of the main elements of secondary prevention in breast cancer.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study, * being between the ages of 18-65, * no history of breast cancer, * to know turkish. exclusion criteria: * those who do not agree to participate in the study, * having a history of breast cancer, * those who do not speak turkish
frequency of hypoglycaemic episodes during treatment with insulin detemir in well controlled subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in africa, europe and oceania. the aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to nph insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * fasting c-peptide below lower limit of normal fasting range * duration of type 1 diabetes for at least 12 months * current treatment: basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections * hba1c maximum 9.0% (using biorad variant method) * able and willing to perform self-monitoring of blood glucose * basal insulin requirement at least 30% of the total daily insulin dose * bmi (body mass index) maximum 35 kg/m\^2 exclusion criteria: * proliferative retinopathy or maculopathy requiring acute treatment * total daily insulin dose above 1.4 iu/kg/day * known unawareness of hypoglycaemia * impaired hepatic function * impaired renal function * cardiac problems * uncontrolled, treated/untreated hypertension * known or suspected allergy to trial product or related products
development and validation of a deep learning model to predict distant metastases in nasopharyngeal carcinoma using whole slide imaging and mri

Conditions: Nasopharyngeal Cancinoma (NPC); Distant Metastasis

Summary: an ai model was developed to predict the likelihood of distant metastasis in patients with nasopharyngeal cancer based on pathology slides and mri scans of the primary tumor. the model was validated using data from multiple centers. it was then applied to patients with advanced stages who were recommended to undergo pet/ct scans based on the nccn or csco guidelines. this ai model can accurately screen patients with high risk of distant metastasis at the time of initial diagnosis to receive pet/ct, avoid excessive examination of patients with low risk of distant metastasis, save medical resources and reduce the economic burden on patients.

an ai model was constructed based on he-stained pathological sections of the primary lesion and mri of the nasopharynx and neck to predict the probability of distant metastasis at the first visit, and the ai model was fully verified by multicenter data; the ai model was applied to t3-4 or n2-3 patients who were recommended to undergo pet/ct examination according to the nccn and csco guidelines, and the threshold of the ai model when the negative predictive value for predicting m0 was not less than 95% was determined, providing theoretical support for patients predicted by ai to be exempted from pet/ct examination.

Eligibility criteria:
inclusion criteria: a. the primary lesion was pathologically confirmed as nasopharyngeal carcinoma (who classification is i, ii and iii); b. the stage was t3-4 or n2-3, and the nasopharynx + neck mri plain scan and enhanced scan were performed to confirm the nasopharyngeal and cervical lymph node lesions, and pet/ct or conventional examination (chest ct plain scan + enhanced scan, upper abdominal ct or mri plain scan + enhanced scan or abdominal color doppler ultrasound or ultrasound angiography, and whole body bone imaging) was performed to screen for distant metastases. exclusion criteria: previous history of other malignant tumors (such as other head and neck squamous cell carcinomas, thyroid cancer, breast cancer, esophageal cancer, etc.).

Keywords: nasopharyngeal cancinoma (npc) distant metastasis pet/ct mri whole slide imaging deep learning model
the applicability of the cumberland ankle instability tool in basketball athletes.

Conditions: Ankle Injuries; Ankle Sprains

Summary: the aim of our study is to evaluate the applicability, validity, and reliability of the cumberland ankle instability tool (cait) in basketball athletes. given that a significant proportion of injuries in basketball occur in the ankle, our study holds importance for instability assessments conducted in this population. if the cumberland ankle instability tool is found to be applicable in basketball athletes, it may be utilized in future research.

the aim of our study is to evaluate the applicability, validity, and reliability of the cumberland ankle instability tool (cait) in basketball athletes. since most injuries in basketball occur in the ankle, our study is significant for assessing instability in this population. if the cumberland ankle instability tool is found to be applicable in basketball athletes, it may be utilized in future research. hypotheses: h₀ (null hypothesis): the cumberland ankle instability tool is not applicable, valid, or reliable in basketball athletes. h₁ (alternative hypothesis): the cumberland ankle instability tool is applicable, valid, and reliable in basketball athletes. the demographic information of the athletes, including height, age, weight, and years of sports experience, will be recorded. the cumberland ankle instability tool (cait) will be created using google forms and distributed to the athletes online. to assess the reliability of the questionnaire, it will be administered twice to the athletes within a 3 to 7-day interval. the following reliability parameters will be calculated: internal consistency, test-retest reliability, standard error of measurement (sem), minimal detectable change (mdc). for validity assessment, the relationship between the cumberland ankle instability tool (cait) and the foot and ankle ability measure (faam) as well as the identification of functional ankle instability (idfai) will be analyzed.

Eligibility criteria:
inclusion criteria: * age between 16 and 45 * history of ankle sprain * participation in basketball training at least once per week exclusion criteria: * participation in basketball training at least once per week

Keywords: ankle instability validity study reliability study
zinc deficiency treatment in celiac disease: supplementation versus diet

Conditions: Celiac Disease; Nutrient Deficiency

Summary: micronutrient deficiencies are common amongst celiac disease (ced) patients due to consumption of a restrictive and nutritionally unbalanced gluten-free diet (gfd) in addition to slow intestinal villi healing. preliminary data of 221 patients attending our celiac disease clinic at mcmaster university show that 64% of patients on a gfd have nutrient deficiencies with zinc (zn) deficiency affecting 48% of treated ced patients. dietary supplements are prescribed to treat zn deficiency and it is unclear whether zn levels can be restored with optimizing zn in diet. this project will evaluate the the feasibility of dietary therapy to treat zn deficiency in ced in comparison to supplementation. additional objectives of this pilot study, are to assess the efficacy of zn optimized gfd compared to zn supplements in 1) normalizing plasma zn levels and 2) improving ced gastrointestinal and extra-intestinal symptoms at 3 and 6 month. subjects will be recruited from mcmaster celiac clinic. this randomized controlled trial aims to recruit 50 ced participants with two treatment groups; zinc optimized diet (guided by dietitian to achieve target of 11 mg/day for females and 14 mg /day for males) or zinc oral supplementation (25 mg zinc gluconate tablet/day; 7 mg elemental zn) with a total study a total study period of 6 months and 4 visits. to be included in the study the investigators require celiac diagnosed patients confirmed through ced serology and duodenal biopsies adhering to a gfd \> 6 months and plasma zn ≤9.3 µmol/l. questionnaires will be used to assess presentation of symptoms, dietary adherence, quality of life, depression and anxiety. the trial would be considered to be feasible if the enrolment fraction (i.e., number of enrolled patients /number of eligible patients) is 60% or above.


Eligibility criteria:
inclusion criteria: * diagnosis of ced based on specific ced serology (elevated anti-tissue transglutaminase iga, deaminated gliadin peptides-immunoglobulin g or anti-endomysial antibodies iga) and confirmed by duodenal biopsies showing villous atrophy (marsh 3a or greater); * adopting a gluten-free diet for at least 6 months; * untreated zn deficiency (zn plasma levels ≤9.3 µmol/l) exclusion criteria: * are already on a zn optimized diet; * treatment with zn supplements or multivitamins containing \>11 mg of zn in the last month; * prior allergic reaction to zn supplements; * treatment with antibiotics or probiotics supplements in the last 30 days; * pregnancy or lactation * current infection in the last 30 days; * intestinal obstruction, short gut (remnant bowel \<180 cm), or any serious illness considered by the investigator that will interfere with the study procedure or results. data including medication and supplementation will be recorded in case report form and zn content added to total zn in the analysis. * untreated pancreatic insufficiency (fecal elastase \<200).

Keywords: zinc deficiency microbiome gastrointestinal and extra-intestinal symptoms supplementation dietary treatment feasibility
evaluation of a probiotic on anxiety and stress in healthy adults sensible to daily stress

Conditions: Anxiety; Stress

Summary: the purpose of the the study is to determine if probiostick® decrease stress and anxiety of people sensible to daily stress.


Eligibility criteria:
inclusion criteria: * caucasian healthy men or women * age 30-60 years * hospital anxiety and depression score equal or below 12 and above 4 * standard safety biology exclusion criteria: * had a results above 12 and below 4 * had d results above 12 * neurologic or psychiatric pathology * consumption of psychotropic * high level of caffeine consumption * any important chronic pathology * drugs wich impairs concentration, anxiety and stress

Keywords: probiostick® probiotic anxiety daily stress
assessment of cod protein as an insulin-sensitizing agent in women with polycystic ovary syndrome.

Conditions: Insulin Sensitivity; Polycystic Ovarian Syndrome

Summary: the objective of our study is to determine the effects of fish protein on insulin sensitivity in pcos women with insulin resistance, and its mechanism of action on glucose and endocrine metabolism. our working hypothesis is that dietary fish protein improves insulin sensitivity, glucose tolerance, and related plasma endocrine and lipid abnormalities in pcos women by restoring secretory β-cell function and insulin signaling to the pi 3-kinase activity/akt pathway. we further hypothesize that fish protein will improve cycle regularity and ovarian function.

women with polycystic ovary syndrome are at high risk of developing diabetes. apart from a primary ovarian defect, up to 10% and 40-50% of those women develop diabetes and insulin resistance (ir) respectively. ir and associated hyperinsulinemia are recognized as important pathogenic factors in determining diabetes in the majority of pcos women, particularly when obesity is present. treating ir might reduce the risk of diabetes and improve ovulation and fertility in pcos women. we recently found that obese, ir men and women consuming a cod protein diet showed a 30% improvement in insulin sensitivity compared with other animal proteins, and also a 24% decrease in high-sensitive c-reactive protein plasma concentration. therefore, dietary fish protein could represent a natural, safe and practical means to improve insulin sensitivity in pcos women with ir, and a new non-pharmaceutical approach for the treatment of the multiple endocrine and metabolic abnormalities of pcos women (see outcome measures for a more extensive description).

Eligibility criteria:
inclusion criteria: * women * 18 to 45 years old * having polycystic ovarian syndrome * overweight (bmi\>27) * insulin resistance based on fasting insulin levels in the upper 95th percentile (\>90pmol/l) * non-diabetic exclusion criteria: * diabetes * hysterectomy * abnormal endometrial biopsy if abnormal bleeding in the last 6 months * clinical evidence of cushing's syndrome * congenital adrenal hyperplasia (17-oh progesterone\>10nmol/l) * excessive androgens suspicious of a tumour * prolactins levels \>50μg/l * previous breast, uterus, ovary or liver neoplasia * use of medication known to affect glucose and lipid metabolisms (e.g. steroid hormones, oral contraceptives, ß-blockers, glitazones, statins, insulin) * depo-medroxyprogesterone acetate injection in the last year * important weight loss or weight gain within the last 6 months * chronic, metabolic (except well controlled chronic hypothyroidism) or acute disease or major surgery within the last 3 months * dietary incompatibility with calcium supplementation and/or fish consumption (allergy, intolerance, dislike)

Keywords: polycystic ovarian syndrome, sex hormones, ovarian function, women, fish protein, insulin sensitivity, glucose tolerance, β-cell function, inflammation
a phase i/ii open-label study of mcs110 in patients with prostate cancer and bone metastases

Conditions: Prostate Cancer; Bone Metastases

Summary: this study will evaluate the safety and efficacy of mcs110 in patients with prostate cancer and bone metastases


Eligibility criteria:
inclusion criteria: * patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment * 18 years old and over exclusion criteria: * plan to be on cytotoxic or biologic therapy during study * active dental problems * active heart complications * active infection * patients with moderate to severe swelling due to fluid other protocol-defined inclusion/exclusion criteria may apply

Keywords: prostate cancer bone metastases anti-m-csf m-csf antibody m-csf prostate cancer with bone metastases
efficacy and safety of oral encochleated amphotericin b (camb) in the treatment of fluconazole-resistant vulvovaginal candidiasis

Conditions: Vulvovaginal Candidiases; Yeast Infection; Vulvovaginitis; Yeast Infection Vaginal; Candidiasis, Vulvovaginal

Summary: this is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of camb dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (vvc).

this is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of camb dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (vvc). approximately 16 women with fluconazole-resistant vvc will be randomized to either 200 mg or 400 mg oral camb for 14 days. the primary objectives of this study are to assess the clinical cure rate, mycology eradication and responder outcome. the secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral camb.

Eligibility criteria:
inclusion criteria: * female 18-65 years * informed consent * clinical diagnosis of fluconazole-resistant vvc * negative pregnancy test * vaginal ph ≤ 4.5 exclusion criteria: * intolerance or hypersensitivity to any amphotericin b (amb) product or to azole antifungal drugs * receiving antifungal therapy unrelated to vvc or has evidence of systemic fungal infections requiring antifungal therapy * received antifungal treatment for vvc within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent * has another cause or suspected cause of vulvovaginitis * has active hpv * has other urogenital infection * has other vaginal or vulvar condition that would confound interpretation of clinical response * has significant laboratory abnormality at screening * has type i diabetes, use of insulin, hba1c\>10 * exposure to any investigational product within 30 days of screening * has other condition that would interfere with subject ability to provide informed consent or put subject at undue risk

Keywords: fluconazole fluconazole-resistant
impact of prehabilitation in oncology via exercise - breast cancer

Conditions: Breast Cancer; Prehabilitation; Physical Activity; Surgery

Summary: the purpose of this study is to determine whether patients are able to participate in a so called prehabilitation program (prior to the beginning of cancer treatment) which includes (1) a supervised and home-based exercise program plus one educational session or (2) just home-based exercise plus one educational session or (3) just one educational session. breast cancer surgery may have potential for several side effects, including functional (e.g. flexibility in the affected arm, lymphedema \[swelling that generally occurs in the arms or legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer treatment\], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue) aspects. evidence shows that exercise is considered to be an effective treatment approach in breast cancer patients during and after treatment with regard to the above mentioned side-effects. also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. however, no experience exits with regard to prehabilitation exercise in breast cancer patients.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy * not metastatic (stage \<4) * females and males ≥18 years of age * fluent in written and spoken english * must be able to provide and understand informed consent * must have an ecog ps of ≤ 2 * scheduled for lump- or mastectomy at penn state cancer institute * ≥ 2 weeks till primary treatment * primary attending surgeon approval exclusion criteria: * receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy * not fluent in written and spoken english * evidence in the medical record of an absolute contraindication (e.g. heart insufficiency \> nyha iii or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (gfr \ 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µl; reduced standing or walking ability) for exercise * pregnant women * engaging in systematic intense exercise training (at least 1h twice per week)

Keywords: prehabilitation exercise breast cancer physical activity surgery