Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of zoledronic acid in the treatment of bone metastases-related pain in patients with prostate cancer

Conditions: Pain

Summary: this study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the prostate * bone-scan documented metastases * age \> 18 years * non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion * life expectancy \> 3 months * written informed consent exclusion criteria: * new systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks * radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry * bisphosphonate therapy within 8 weeks before study entry * abnormal renal function (serum creatinine \> 2 x the upper normal limit or creatinine clearance \< 30 ml/min) * corrected serum calcium \> 3 mmol/l or \< 2 mmol/l * clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug * severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain * patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.) other protocol-defined exclusion criteria may apply.

Keywords: prostate cancer bone metastases zoledronic acid bone metastases-related pain prostate cancer
quality of life in patients treated for tongue and/or jaw neoplasia before and after speech therapy

Conditions: Tongue Cancer; Jaw Cancer; Oral Cancer; Intelligibility, Speech

Summary: this study aims to verify the impact of four speech therapy sessions on the quality of life of patients treated for malignant tongue and/or jaw cancer, using as measure specific questionnaires of speech and swallowing. the hypothesis is that after treatment with exercises and speech therapy guidance, patients will present better indicators on quality of life related to speech and swallowing.


Eligibility criteria:
inclusion criteria: * over 18 years * tongue and/or jaw neoplasm * submitted to surgical treatment exclusion criteria: * under 18 years * cognitive impairment or deficits in language comprehension * previous speech therapy intervention * recurrence or active disease * death during the intervention

Keywords: speech therapy dysphagia speech intelligibility quality of life
protocol for coxsackievirus vaccine in healthy voluntteers

Conditions: Viral; Infection, Coxsackie(Virus)

Summary: phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of prv-101, a coxsackie virus b vaccine, in healthy volunteers.

thirty two healthy adult subjects will be enrolled into 2 dose cohorts (low-dose and high-dose cohorts, 16 subjects per cohort) and will be randomized in a double-blind manner to prv-101 or placebo in a 3:1 ratio. each subject will receive up to 3 administrations of the study drug (prv-101 or placebo) at 4-week intervals and will be followed for 24 weeks after the final dose. each cohort will start with a sentinel dosing group (2 subjects). cohort 2 will commence after safety data from the first 2 doses from all cohort 1 participants are reviewed.

Eligibility criteria:
inclusion criteria: * healthy adults, males and females, ages 18 to 45 yrs, with bmi 19 to 30 kg/m2 * women of childbearing potential must have negative pregnancy test and agree to use an acceptable method of highly effective contraceptive * men must either have a vasectomy or agree to use highly effective contraception exclusion criteria: * prior or current clinically significant medical illness or disorder * has celiac disease or type 1 diabetes or related autoantibodies * has active acute or chronic/latent infection, or history of recent serious infection * recent acute illness or recent major illness, hospitalization or surgery * recent history of alcohol or drug abuse * received an experimental antibody or biologic therapy in last 6 months * received live, inactivated or subunit virus vaccine or a bacterial vaccine within last 4 weeks * intolerance or hypersensitivity to vaccines or vaccine components or has a drug or food allergy or allergic disease requiring medication

Keywords: coxsackie virus b, vaccine
assessing visual processing in high anxiety

Conditions: Anxiety

Summary: high trait anxiety, a stable personality trait, is a risk factor for psychiatric disorders. individuals with high trait anxiety have difficulty differentiating safety from threat, including visual information like emotional faces. this study aims to characterize visual system function in high trait anxiety. a portion of this study involves an intervention. for the intervention portion, a subset of participants will be asked to return for a lab visit upon completing the first portion of the study (multimodal magnetic resonance imaging (mri) scan). during this follow up visit, participants will complete a computer task that involves looking at faces and identifying emotions. participants will complete this task either six months or twelve months after their mri scan visit. results from this research have the potential to inform novel therapies that target the visual system in individuals at risk for the development of psychiatric disorders.

the purpose of this study is to understand how people with anxious personalities process emotional facial expressions. the intervention portion of this study is part of a larger study. the first portion of this study consists of a screening visit with questionnaires, and a second visit with a magnetic resonance imaging (mri) scan and short computer tasks. for the intervention portion of this study, a subset of participants will return to the lab for an in-person visit either six or twelve months after their mri scan. this visit will last approximately two hours. participants will be asked to complete a computer task where they will be asked to identify emotional face expressions and receive feedback on their performance. they will also complete questionnaires about their mood and emotions. the primary purpose of this research is to gather scientific information about how people with anxiety process social and emotional information.

Eligibility criteria:
inclusion criteria: * young adults varying continuously in trait anxiety as assessed by the spielberger state trait anxiety inventory (stai). * hta participants with stai trait scores of ≥44 exclusion criteria: * contraindication to mri * history of head trauma or loss of consciousness * major medical or neurological illness * current psychiatric medication usage or use in the last three months * alcohol/substance abuse or dependence and/or illicit substance use (excepting cannabis) in the last three months

Keywords: visual processing
validity and reliability of the turkish version of the head and neck cancer inventory

Conditions: Quality of Life; Head and Neck Cancer

Summary: the primary treatment option of many patients with head and neck cancer is surgery, radiotherapy and chemotherapy. in the literature, functional problems that occur after surgical interventions applied to head and neck cancer patients are frequently mentioned. morbidities resulting from the combined application of radiotherapy and chemotherapy are based on more anecdotal information and critical data on long-term functional outcomes in this patient group are scarce. the aim of this study is to make the validity, reliability and cultural adaptation of the head and neck cancer inventory in turkish.

in the literature, there are general cancer scales developed to evaluate the quality of life of head and neck cancer patients and sub scales associated with head and neck cancers developed in addition to these scales. in addition, scales specific to head and neck cancers have also been developed. however, previous research shows that even general health status scales or cancer-specific scales cannot determine outcomes related to many head and neck cancer patients. in addition, items containing multiple functions and patients' attitudes (behaviors) cannot be analyzed separately in any of the scales specific to head and neck cancer. very few surveys contain items related to patients' attitudes (behaviors), or the number of items related to this topic is small because most of these scales are functional items. unlike its counterparts in the literature, head and neck cancer inventory evaluates the attitudes (behaviors) of patients associated with various functions in daily life. head and neck cancer inventory is the only scale in the literature that contains the basic features of the health conditions declared by the patient and has been developed specifically for head and neck cancer.

Eligibility criteria:
inclusion criteria: * voluntarily accepting to participate in the study * patients whose native language is turkish * patients diagnosed with head and neck cancer exclusion criteria: * patients whose health conditions are too bad to fill the scale * having a serious mental disorder or dementia
a heart disease study of semaglutide in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. the study will last for about 3.5-5 years. participants will have up to 25 clinic visits and 1 phone call with the study doctor. women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female, age equal to or above 50 years at the time of signing informed consent * diagnosed with type 2 diabetes mellitus * hba1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement) * at least one of the below conditions (a-d): a) coronary heart disease defined as at least one of the following: i. prior myocardial infarction ii. prior coronary revascularisation procedure iii. 50% or above stenosis in coronary artery documented by cardiac catheterisation, computerized tomography coronary angiography iv. coronary heart disease with ischaemia documented by stress test with any imaging modality b) cerebrovascular disease defined as at least one of the following: i. prior stroke ii. prior carotid artery revascularisation procedure iii.50% or above stenosis in carotid artery documented by x-ray angiography, magnetic resonance angiography, computerized tomography angiography or doppler ultrasound c) symptomatic peripheral artery disease (pad) defined as at least one of the following: i. intermittent claudication with an ankle-brachial index (abi) below 0.85 at rest ii. intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by x-ray angiography, magnetic resonance angiography, computerized tomography angiography or doppler ultrasound iii. prior peripheral artery (excluding carotid) revascularization procedure iv. lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) d) chronic kidney disease defined as: i. egfr below 60 ml/min/1.73 m\^2 (based on medical records using latest available and no more than 6 months old assessment) exclusion criteria: * any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening * planned coronary, carotid or peripheral artery revascularisation known on the day of screening * heart failure presently classified as being in new york heart association class iv * treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening
metabolic activation with almased for type 2 diabetes patients

Conditions: Type 2 Diabetes Mellitus

Summary: overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. however, in many cases, even a high insulin dosage (\> 100 u per day) does not achieve satisfying metabolic control. a new therapy option is necessary that makes it possible to lower the daily insulin requirement and to improve metabolic control. the aim of this study was to investigate whether a protein-rich meal replacement is suitable to lower the daily insulin requirement and to reduce hba1c and body weight.

the pilot study included patients with type 2 diabetes (n=22), that injected \>100 u insulin daily. during the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (almased) (=1100 kcal per day). during weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. during weeks 5-12, only dinner was replaced. clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. wilcoxon signed rank test was used for the intention-to-treat analysis and mann-whitney test for subgroup analyses.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * bmi \> 27 kg/m2 * age 35-75 years * insulin therapy \>100 u insulin per day exclusion criteria: * contraindication for a calorie reduced diet

Keywords: type 2 diabetes mellitus insulin hba1c body weight
nbi-nearfocus assisted cold snare polypectomy improves the complete resection rate of small colorectal polyps: a prospective single-arm observational study

Conditions: Colon Polyp

Summary: nbi-nearfocus can assist cold snare polypectomy (csp) to remove small colorectal polyps, but its specific efficacy is not clear.the aim of this study was to assess the efficacy of csp with nbi-nearfocus evaluation of polypectomy sites for removal of small colorectal polyps. and then formulate a standard operating procedure for cold snare removal of polyps.


Eligibility criteria:
inclusion criteria: ① outpatient or inpatient patients aged 18-85 years old; ② untamed, subpodial, and flat polyps with a diameter of 5-9mm (paris classification: o-is o-isp、o-iia；jnet classification: typel, type2a); ③ patients who agree to participate in this study. exclusion criteria: * individuals currently taking antiplatelet or anticoagulant drugs, or those with coagulation dysfunction (pt prolongation greater than 3 seconds); * polyp diameter\<5mm or ≥ 10mm, morphology does not conform or jnet classification ≥ type 2b; * individuals with severe heart, lung, liver and kidney dysfunction or severe mental disorders who cannot cooperate with the examination; ④ patients with intestinal obstruction, inflammatory bowel disease, lynch syndrome, and familial adenomatous polyposis diagnosis; * pregnancy; ⑥ those who fail to meet the requirements for bowel cleansing preparation (bbps\<6 points).
acute effects of beetroot juice on isometric knee extension strength, explosive strength and local muscular endurance

Conditions: Healthy Adults

Summary: this is a double-blind placebo-controlled cross-over trial that aims to determine the acute effect of beetroot juice ingestion on isometric knee extension strength, explosive strength and local muscular endurance.

the study aims to determine whether concentrated beetroot juice has an acute effect on isometric strength of the knee muscles and the rate of force development in knee extension, as well as endurance of the same muscle. this will be a cross-over study. 20 subjects will be randomly selected to the experimental group or control group; after 1 week, participants will repeat the measurements in the other condition. subjects will consume 140 ml of beetroot juice extract 2.5 hours before the measurement or placebo (140 ml of blackcurrant juice with added appropriate amount of sugar to equalize the carbohydrate value and lemon juice fort the taste). an isometric dynamometer will be used to measure the isometric strength of the knee extensors. investigators will quantify peak force, rate of force development, endurance of knee extensors at 50 % of the maximal force, and the force recovery after a fatiguing protocol.

Eligibility criteria:
inclusion criteria: * age between 18 and 30 years * physically active and healthy athletes (recreational or professional) exclusion criteria: * cardiovascular, pulmonary, metabolic, neurological diseases and musculoskeletal injuries * smokers * consumption of drugs such as antacids and proton pump inhibitors in the previous 3 months * pregnant or breastfeeding women * beetroot allergic participants

Keywords: isometric strength beetroot nitrates local muscle endurance supplementation
efficacy, safety, and tolerability of multiple dosing regimens of oral atogepant (agn-241689) in episodic migraine prevention

Conditions: Migraine, With or Without Aura

Summary: this study will evaluate the safety and tolerability of the following doses of atogepant (agn-241689): 10 mg once daily (qd), 30 mg qd, 30 mg twice daily (bid), 60 mg qd, and 60 mg bid for the prevention of episodic migraine and will characterize the dose/response relationship.


Eligibility criteria:
inclusion criteria: * has at least a 1-year history of migraine with or without aura * age of the patient at the time of migraine onset \< 50 years * history of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to visit 1 in the investigator's judgment * demonstrated compliance with e-diary exclusion criteria: * has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine * has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy * difficulty distinguishing migraine headache from other headaches * has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption * has a history of hepatitis within previous 6 months * usage of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs \[nsaids\], acetaminophen) ≥ 15 days/month in the 3 months prior to visit 1 * pregnant or nursing females
reducing disparities in diabetes risk through lifestyle changes in community settings

Conditions: Diabetes

Summary: this study aims to design and test the effectiveness of a lifestyle diabetes risk reduction program, live well, be well, in reducing risk of diabetes in persons at risk with a focus on reaching lower-income, minority individuals.

to design and test the effectiveness of a lifestyle diabetes risk reduction program, live well, be well, to increase physical activity, decrease weight, and improve diet, offered in community-based settings to primarily lower income, minority persons aged 25 and older at moderate to high risk of diabetes. the design is a randomized controlled trial with the primary outcome being fasting plasma glucose; secondary outcomes are weight, physical activity, blood pressure, and other physiological risk factors as well as health-related quality of life. this project is a partnership between the university of california san francisco and the city of berkeley division of public health.

Eligibility criteria:
inclusion criteria: * age 25 and older * moderate- to high-risk score on a diabetes risk appraisal (dra) (assessing sedentary behavior, family history of diabetes, race/ethnicity, gestational diabetes, hypertension, and high cholesterol) and a fasting fingerstick glucose level of 95-140 mg/dl (indicating high risk of diabetes). * conversant in english or spanish exclusion criteria: 1. diabetes, assessed by self-report of having ever been told by a physician that they have diabetes (other than gestational) or use of an oral hypoglycemic medication or insulin, or a fingerstick fasting glucose level of \>150 mg/dl; 2. unstable chronic or serious condition that could limit participation in unsupervised light to moderate physical activity (e.g. unstable angina, diagnosed with or hospitalized for chest pain, heart surgery, stroke, or myocardial infarction in the past 6 months); 3. uncontrolled hypertension (systolic \>180 mmhg or diastolic \>105 mmhg); 4. current pregnancy or attempting to conceive; 5. plans to move from the area within 1 year; 6. insufficient cognitive functioning to complete program procedures, 7. implanted defibrillator, 8. a hip or knee replacement in the past 3 months.

Keywords: risk reduction minority diabetes prevention lifestyle program behavior change
tsms in essential tremor

Conditions: Essential Tremor

Summary: this is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. half of the patients will receive tsms of the left hemisphere and the other half of the right hemisphere.


Eligibility criteria:
inclusion criteria: * essential tremor exclusion criteria: * mri-incompatible metal objects in the body (e.g. cardiac pacemakers) * other main neuropsychiatric co-morbidity * pregnancy
biomarker analysis in metastatic colorectal cancer treated with cetuximab

Conditions: Colorectal Cancer

Summary: prometheus's onco dx assay platform provides technological breakthrough for immunoassay by obtaining a level of sensitivity down to single tumor cells without compromising specificity. this allows assessment of multiple tki treatment targets, their activation status, as well as down stream signaling proteins using very tiny amount of tissue that can be obtained by fna or ctcs. we planned this study to explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the prometheus platform. we will also elucidate signal transduction pathway attributable to cetuximab resistance, monitor changes in the rtk activation status during cetuximab treatment using circulating tumor cells and analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed metastatic colorectal cancer * cetuximab-based chemotherapy (monotherapy, combination therapy with cytotoxic chemotherapy such as folfox, xelox, irinotecan, folfiri, xeliri, first-line, second-line or third-line are all eligible) * age \> 18 years. * ecog performance status of 0-2 * adequate bone marrow, liver and renal function * signed and dated informed consent before the start of specific protocol procedures. * fna will be performed in patients with feasible biopsy site; ascites or pleural fluid will be collected in metastatic crc patients with ascites or pleural effusion exclusion criteria: * active clinically serious infections (\> grade 2 ctcae version 3.0) * patients with evidence or history of bleeding diathesis * radiotherapy during study or within 4 weeks of start of study drug. * prior exposure to the study drug. * substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

Keywords: colorectal cancer, cetuximab, biomarker, prometheus