Kornimate/medical-research-clean huggingface dataset:
preventive effects of zoledronic acid on bone metastasis in patients with stage iiib and iv lung cancer

Conditions: Lung Cancer

Summary: bone metastases are common in patients with advanced lung cancer and can have devastating consequences. preventing or delaying bone metastases may improve outcomes. bisphosphonates are inhibitors of osteoclast-mediated bone resorption. the current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and paget's disease), the treatment of hypercalcaemia of malignancy (hcm), and the prevention of skeletal-related events(sres）from malignant bone disease. clinical trials also confirm that bisphosphonates, and zoledronic acid（zol) in particular, can prevent bone loss from cancer treatment.there is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. this study will evaluate whether the addition of zol 4 mg every 3 months for up to 1 years in patients with stage iiib/iv lung cancer could reduce the rate of bone metastases ,improve progression-free survival (pfs) and overall survival(os), and delay time to bone metastases .

bone metastases are common in patients with advanced lung cancer and can have devastating consequences. which can lead to pain, decreased mobility and skeletal complications .preventing or delaying bone metastases may improve outcomes. bisphosphonates are inhibitors of osteoclast-mediated bone resorption. the current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and paget's disease), the treatment of hypercalcaemia of malignancy (hcm), and the prevention of sres from malignant bone disease. clinical trials also confirm that bisphosphonates, and zoledronic acid in particular, can prevent bone loss from cancer treatment.there is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. this study will evaluate whether the addition of zol 4 mg every 3 months for up to 1 years in patients with stage iiib/iv lung cancer could reduce the rate of bone metastases ,improve progression-free survival (pfs) and overall survival(os), and delay time to bone metastases .

Eligibility criteria:
inclusion criteria: 1. age between 18 and 70 years of age, male or female 2. histologically or cytologically confirmed stage iiib or iv lung cancer at diagnosis 3. no evidence of bone metastatic lesions was radiographically confirmed by bone scintigraphy 4. life expectancy of ≥6 months 5. adequate renal, hematologic, and hepatic 6. eastern cooperative oncology group(ecog) performance status≤2 7. all patients provided written informed consent exclusion criteria: 1. treatment with other bisphosphonates 2. presence of brain metastases 3. be allergic to zol 4. attending other unlisted drug clinical trials,currently.

Keywords: zol prevention lung cancer
effectiveness and safety of acupuncture for climacteric syndrome in patients with breast cancer

Conditions: Climacteric Syndrome

Summary: the purpose of the investigators study is to create the evidence of effectivness on climacteric syndrome in patients affected by breast cancer, by acupuncture added to the standard care (self care).

the study will be performed under randomized, open, controlled design. the effect of acupuncture and control group will be compared including the following outcomes: greene climacteric scale score, quality of life (menqol italian version), overall improvement in climacteric syndrome, adverse effects from treatment.

Eligibility criteria:
inclusion criteria: * breast cancer * thermoregulation symptoms from at least 6-8 weeks - at least 6 hot flushes a day * climateric simptoms * age from 18 to 65 years * spontaneous or caused by chemotherapy amenorrea * hormone therapy for breast cancer * green climateric scale score = or \> of 15 * performance status eastern cooperative oncology group (ecog) \< or = to 1 * the patient agrees to follow physical exercice * diet and self-help groups exclusion criteria: * hormone substitutive therapy (tos) during the last month * other systemic treatments for climateric syndrome (tibolone, antidepressants, homeopathy) * chemotherapy or radiotherapy * patients who refuses acupuncture

Keywords: climacteric, climacteric syndrome
the effects of caffeinated coffee on intraocular pressure

Conditions: Primary Open Angle Glaucoma

Summary: high intraocular pressure (iop) is a known risk factor for developing primary open-angle glaucoma (poag). there is controversy in the literature regarding the degree to which caffeine influences iop, with some studies reporting minimal changes in iop while others report up to 4 mmhg increases. to date there are no double-masked randomized controlled trials that examine acute caffeinated coffee's effects on iop in patients with or at risk for primary open-angle glaucoma. the investigators aim to better understand the relationship between acute caffeinated coffee (vs decaffeinate coffee) consumption and iop in a double-masked, crossover randomized controlled clinical trial.


Eligibility criteria:
inclusion criteria: * 40-89 yrs * poag for cases or no forms of glaucoma for controls * willingness to drink coffee * consent signed exclusion criteria: * age less than 40 or greater than 89 yrs * all forms of glaucoma other than poag * any condition inappropriate for tonometry (ie corneal disease, lasik) * unable or unwilling to give consent * unable or unwilling to drink coffee * pregnancy
auditory rehabilitation in stroke patients with auditory processing disorders

Conditions: Auditory Processing Disorder, Central; Stroke

Summary: this study aimed to evaluate long term benefits in speech reception in noise, after daily 10 week use of an assisting listening device (personal frequency-modulates systems) , in non-aphasic stroke patients with auditory processing deficits.

stroke can affect all levels of the auditory pathway. approximately one in five stroke survivors report severe difficulties when listening to speech-in-noise, despite normal hearing, attributed to abnormal processing of sounds within the brain, and these individuals are more likely to experience communication difficulties in poor acoustic environments, the patient with significant auditory deficits and functional limitations may require a range of rehabilitation and remediation approaches. several studies conclusively demonstrate substantial improvements in speech recognition in noise when using personal frequency-modulated (fm) systems. these devices are used to improve speech perception in noise in adults with neurological disorders including stroke with good immediate benefits. however, the long-term benefits of fm systems in stroke patients has not been studies. in this research study the investigators aimed to investigate the long term benefits in speech reception in noise in non-aphasic stroke patients and measure the potential improvement in unaided speech in background noise performance after 10 weeks.

Eligibility criteria:
inclusion criteria: * clinical history of ischaemic stroke verified by brain magnetic resonance imaging (mri) * diagnosis of auditory processing disorders * normal pure-tone audiogram exclusion criteria: * severe aphasia * significant psychiatric illnesses
drug sensitivity correlation between patient-derived organoid model and clinical response in nsclc patients

Conditions: NSCLC

Summary: this clinical study aims to evaluate the feasibility to predict clinical response of target therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using patient-derived organoids.

methods - open label single arm observatory comparison experiment 1. enrolled patients (before or after surgery) were treated with chemotherapy or target therapy. the medication regime and treatment cycle were decided based on the clinical guideline and evidence-based medicine. this clinical study will not affect the treatment plan of the patients. 2. the resection tissue or biopsy tissue of nsclc will be collected, and subject to ex vivo 3-d culture to establish patient-derived tumor organoid models, which will be used for drug sensitivity test. 3. the patient-derived organoid-based drug sensitivity test will be compared with clinical treatment data of chemotherapy or target therapy, followed by correlation analysis.

Eligibility criteria:
inclusion criteria: * aged 18 years old or more; * late stage nsclc patients, with tumor invasion confirmed by histopathology analysis. metastasis of axillary lymph nodes and other region lymph nodes are confirmed with histopathologic or cytopathologic analysis; * accessible to biopsy and/or surgery sample of metastasis and/or primitive tumor; * no clinical evidence of other malignancy, unstable complication or uncontrolled infection; * life expectancy \> 12 months. * informed and signed consent by the patient. exclusion criteria: * not accessible to biopsy and/or surgery sample; * patient already enrolled in another clinical trial with another first line of chemotherapy; * unmeasurable locally advanced (incurable) or metastatic lesion(s), according to recist 1.1 criteria; * women who are pregnant, plan to become pregnant or are lactating during the study; * elevation of carcinoembryonic antigen (cea) observed without distal metastases found; * have some kind of contraindications for chemotherapy and targeted therapy: cardiovascular and cerebrovascular diseases; liver and kidney function deficiency; hematological system diseases; clinician consider the patients are not suitable for chemotherapies or target therapies; * have other malignant tumor previously; * have surgical contraindications: anesthesia taboo; surgery unresectable extensive lesions; * state of health can't finish the study; * patient already enrolled in another clinical trial with another anti-cancer therapy or plan to participate in other clinical study. * no self-determination or refuse to participant. * with unlisted exclusion criteria but are considered not suitable for the clinical study by researchers.

Keywords: tumor organoids drug sensitivity nsclc
safety study of ctx-100 inhalation solution (formerly etx-100)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of the study is to evaluate the safety of administering repeated doses of ctx-100 (formerly etx-100) to subjects with smoking-related chronic obstructive pulmonary disease.

the study primarily aims to establish safety and evaluate biochemical activity of ctx-100 (formerly etx-100) with respect to elastin breakdown, but will also concurrently gather data that may point to efficacy. the preliminary efficacy results will be used to assist in the design of subsequent phase 2b clinical studies of longer duration to examine both efficacy and safety of ctx-100 as a therapy for chronic obstructive pulmonary disease.

Eligibility criteria:
inclusion criteria: * able and willing to provide written informed consent and comply with study requirements. * men or women aged 40 through 75 years at the time of consent. * at least 10-pack years (average packs/day x number of years) of cigarette use, and either current smoker or ex-smoker. * diagnosis of copd at screening consistent with national institutes of health guidelines. * evidence of emphysema on chest x-ray. * a ratio of prebronchodilator fev1 to forced vital capacity (fvc) of ≤ 70% at screening. * fev1 ≥ 50% (prebronchodilator) and ≤ 79% (postbronchodilator) of predicted normal at screening. * clinical laboratory tests (complete blood count, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the pi/sponsor at screening. * women of childbearing potential and men who are sexually active must agree to use an adequate method of contraception (oral contraceptives, depot progesterone, condom plus spermicide, or iud) during the study and for 1 month after the final dose of study drug. exclusion criteria: * subjects with a measured dlco of ≤ 50%, or unable to perform a reproducible dlco. * subjects unable to perform 3 reproducible spirometry tests after 5 attempts. * upper or lower respiratory tract infection within 2 weeks prior to screening and baseline (day 1). * presence of clinically relevant abnormality on chest x-ray (other than evidence of emphysema) at screening or within the previous 12 months. * use of supplemental oxygen therapy. * requirement for ventilatory support within the last year. * exacerbation requiring treatment with systemic corticosteroids within the last 3 months. * history of lung transplant. * presence of clinically relevant abnormality on electrocardiogram (ecg). * any medical condition that, in the investigator's judgment, would compromise study participation or the evaluation of the study drug. * women who are pregnant or breastfeeding. * receipt of an investigational drug within 30 days prior to screening (including subjects who participated in the first phase of this study).

Keywords: chronic obstructive pulmonary disease (copd)
retinal care data repository

Conditions: Diabetic Retinopathy; Age Related Macular Degeneration

Summary: the retinal care data repository's primary objective is to make data available for retinal care to develop algorithms that improve the care of people with retinal diseases.

the initial focus is to develop algorithms that prevent, delay the progression, or improve treatment of diabetic retinopathy (dr) and age-related macular degeneration (amd). examples include but are not limited to: describing the incidence, prevalence, and severity distribution of dr and amd in the overall population and subgroups; diagnosing specified severity thresholds for dr and amd; predicting the development and progression of dr and amd for the overall population, subgroups, and individuals; and recommending tests and treatments to prevent or delay the progression of dr and amd for the overall population, subgroups, and individuals. data will be collected retrospectively and prospectively.

Eligibility criteria:
inclusion criteria: * diabetes or age 65 years and older exclusion criteria: * none
microbes and bariatric surgery

Conditions: Obesity; Diabetes; Periodontal Disease

Summary: the investigators will study people who are obese and will be treated by bariatric surgery. the investigators will test the hypothesis that some of the features of obesity are related to the bacteria in the gastro-intestinal tract.


Eligibility criteria:
inclusion criteria: * ages 18-65 * will undergo bariatric surgery for treatment of obesity in syracuse ny * willingness to participate exclusion criteria: * any previous gastrointestinal surgery * use of antibiotics in the previous 3 months

Keywords: obesity diabetes periodontal disease
a drug-drug interaction study with risdiplam multiple dose and midazolam in healthy participants

Conditions: Spinal Muscular Atrophy

Summary: this will be a phase i, 2-part, open-label, non-randomized study to investigate the safety, tolerability, and pharmacokinetics (pk) of a multiple-dosing regimen of risdiplam (part 1) and the effect of risdiplam on the pk of midazolam (part 2) following oral administration in healthy adult male and female participants.


Eligibility criteria:
inclusion criteria: * healthy participants as defined by the investigator * a body mass index (bmi) of 18.0 to 32.0 kg/m2 * use of adequate contraception methods during the treatment period and until 4 months after last study drug administration. males must refrain from donating sperm during this same period * willingness and ability to complete all aspects of the study exclusion criteria: * concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study * history or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs * surgical history of the gi tract affecting gastric motility or altering the gi tract * history or presence of clinically significant ecg abnormalities or cardiovascular disease * history of malignancy in the past 5 years * positive result on human immunodeficiency virus (hiv)-1, hiv-2, hepatitis b virus, or hepatitis c virus * donation of blood or blood products for transfusion * participation in an investigational drug medicinal product or medical device study within 90 days prior to screening * any clinically significant history of hypersensitivity or allergic reactions * history of hypersensitivity to midazolam or any other benzodiazepine or its formulation ingredients for part 2 participants: - history of acute angle glaucoma
suprathreshold pressure pain stimulation in fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to investigate the induced-pain characteristics after suprathreshold pressure stimulation at different intensities in fibromyalgia subjects, compared with healthy volunteers.

fibromyalgia syndrome is a chronic painful, non-inflammatory rheumatic disease with a high negative impact on the quality of life, and is characterized by widespread pain, fatigue and generalised hyperalgesia on examination, symptoms that can be the consequence of central sensitization. despite several methods have successfully addressed this increased responsiveness of nociceptive neurons in the central nervous system, there is a lack of consensus about how to systematically perform them and those that are more appropriated for different syndromes. therefore, investigating appropriate simple methods to assess clinical manifestations of central sensitization is relevant in the assessment of fibromyalgia. the present study aims to investigate the pain response after suprathreshols pressure stimulation in fibromyalgia subjects compared with healthy volunteers.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * fullfilled the american collegue of rheumathology criteria for fibromyalgia. * understanding of spoken and written spanish. exclusion criteria: * diagnosed psychiatric pathology. * rheumatic pathology not medically controlled.

Keywords: reffered pain pain sensitivity fibromyalgia suprathreshold central sensitization
osi-906 with gemcitabine and erlotinib for metastatic ductal adenocarcinoma of the pancreas

Conditions: Pancreatic Cancer, Metastatic

Summary: osi-906 is a new drug that may stop cancer cells from growing abnormally. this drug has been used in other research studies and information from those suggests that osi-906 may help block cell receptors involved in tumor growth. gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. in this research study, the investigators are looking for the highest dose of osi-906 that can be given safely in combination with gemcitabine and erlotinib. this dose will then be given together with gemcitabine and erlotinib to a further group of patients with pancreatic cancer.

this study will be conducted in two parts: a phase i study and a phase ii study. in both instances, a treatment cycle is 28 days (4 weeks). subjects will take osi-906 by mouth, twice a day, every day. subjects will receive gemcitabine through an iv in clinic over 30 minutes on days 1, 8 and 15 of each 28-day cycle. subjects will take erlotinib by mouth, once a day, every day. at every visit subjects will have a physical exam and blood tests. an ekg will be done on days 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. a ct scan will be done every 2 cycles (8 weeks). subjects will complete a daily drug diary and perform glucose monitoring (finger stick) once daily at home.

Eligibility criteria:
inclusion criteria: * metastatic pancreatic ductal adenocarcinoma * measurable disease * life expectancy \> 12 weeks * normal organ and marrow function * fasting blood glucose \</= 150 mg/dl * able to swallow pills exclusion criteria: * prior chemotherapy or radiotherapy for treatment of pancreatic cancer * receiving any other experimental agent * known brain metastases * history of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or osi-906 * impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea) * use of enzyme-inducing anti-epileptic drugs * diabetes mellitus which requires the use of exogenous insulin for glucose control * major surgery within 4 weeks of the start of study treatment * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * use of strong or moderate cyp1a2 inhibitors/inducers * pregnant or breast feeding * history of a different malignancy unless disease-free for at least 3 years * hiv positive

Keywords: metastatic pancreas cancer adenocarcinoma
comparing the stress-reducing effects of a robotic pet and a weighted toy

Conditions: Stress

Summary: the goal of this trial is to learn whether interacting with a robotic pet (paro) or holding a weighted sensory toy can reduce stress in healthy adults after an acute stressful experience. the main questions it aims to answer are: * does interacting with paro or holding a weighted toy lower self-reported stress and anxiety levels? * does interacting with paro or holding a weighted toy lower physiological markers of stress, such as heart rate and blood pressure? researchers will compare interaction with paro (robotic pet), interaction with a weighted sensory toy and a control group with no intervention to see which method is most effective in reducing stress. participants will: 1. complete a stress induction task (trier social stress test); 2. be randomly assigned to interact with paro, hold a weighted toy, or sit quietly without intervention; 3. have their heart rate and blood pressure measured; 4. complete surveys about their stress, anxiety and mood before and after the intervention.

the study investigates the immediate effectiveness of interacting with an interactive robotic pet (paro, a robotic seal) or a weighted sensory modulation toy for reducing acute stress and anxiety. it aims to determine the comparative efficacy of these interventions relative to a control condition involving quiet relaxation. participants will be randomly assigned to one of three experimental conditions: interaction with paro, interaction with a weighted sensory toy, or a control group with no intervention. all participants will first complete baseline measurements, including self-reported anxiety and stress assessments using validated instruments (state-trait anxiety inventory, positive and negative affect schedule, and visual analog scale), as well as physiological indicators of stress (heart rate and blood pressure). subsequently, participants will undergo the trier social stress test (tsst), a validated procedure involving a brief public speaking task and mental arithmetic performed under evaluative conditions designed to induce moderate stress. following the stress induction, participants will repeat stress and anxiety assessments and physiological measurements. they will then engage in their assigned intervention for 15 minutes. post-intervention measurements of stress and anxiety, physiological markers, and perceived enjoyment/ engagement will be collected. participants will also provide qualitative feedback regarding their intervention experiences.

Eligibility criteria:
inclusion criteria: * over 18 years old * fluent in english * free from diagnosed anxiety or stress-related disorders exclusion criteria: * cardiovascular conditions that may affect heart rate and blood pressure measurements * existing anxiety disorders or panic disorders.

Keywords: stress reduction robotic pet paro weighted sensory toy deep pressure stimulation acute stress trier social stress test (tsst) heart rate blood pressure human-robot interaction sensory modulation