Kornimate/medical-research-clean huggingface dataset:
efficacy of calcifediol supplementation in asthma control in asthmatic patients with vitamin d deficiency (acvid)

Conditions: Asthma, Bronchial

Summary: introduction: there are many cross-sectional studies in children and adults indicating that low vitamin d levels in asthmatic patients are correlated with poorer asthma control, poorer lung function, decreased response to glucocorticoids and more frequent exacerbations. moreover, as there is a significant group of asthmatic patients having insufficient control of their disease, despite high doses of inhaled corticosteroids, we have investigated new treatment alternatives, which include vitamin objective: to determine the efficacy of vitamin d supplementation in asthmatic patients with vitamin d deficiency in degree of asthma control. materials and methods: a prospective, controlled, randomised, triple-blind study was conducted with a follow-up of 6 months. the patients recruited were over 18 years of age with a medical diagnosis of bronchial asthma and serum 25(oh)d3 levels \ 2 mg/dl), hypercalcaemia (corrected with proteins \> 10.5 mg/dl), a repeat episodes of renal colic, any gastrointestinal disease that might interfere with vitamin d absorption, or severe psychosocial problems, or were pregnant or breast-feeding. the randomisation process assigned patients to one of two groups: a group that received vitamin d (in the form of calcifediol (hidroferol®) in 16,000-iu ampoules taken weekly by the oral route) and another group that received placebo in a presentation with an identical appearance and the same administration regimen. demographic, clinical, spirometry and laboratory endpoints were collected. the primary endpoint was degree of asthma control as determined by the internationally validated asthma control test (act). the secondary endpoints were asthma exacerbations, dose of inhaled corticosteroids and quality of life as measured using the mini-aqlq (asthma quality of life questionnaire).


Eligibility criteria:
inclusion criteria: * medical diagnosis of bronchial asthma * serum 25(oh)d3 levels \< 30 ng/ml. exclusion criteria: * smoking habit ≥ 10 pack-years, * taking vitamin d supplements, * kidney disease (creat. \> 2 mg/dl), * hypercalcaemia (corrected with proteins \> 10.5 mg/dl), * repeat episodes of renal colic, * any gastrointestinal disease that might interfere with vitamin d absorption, * severe psychosocial problems, * pregnant * breast-feeding
a study to evaluate the long-term safety of repeated qutenza administration for treatment of pain caused by nerve damage in diabetic patients

Conditions: Painful Diabetic Peripheral Neuropathy (PDPN)

Summary: the purpose of the study is to assess the safety of repeated applications of qutenza in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.

patients will be divided into 3 groups of approximately equal size. in the first group, patients will receive a qutenza patch applied for 30 minutes to the feet; in the second group, patients will receive a qutenza patch applied for 60 minutes to the feet. in both these groups patients will also continue to receive their normal treatment (standard of care (soc)) for their peripheral neuropathic pain (pnp) and may receive further qutenza patch applications in the same way during the study. the third group will not receive a qutenza patch but will continue to receive their normal treatment for their neuropathic pain (soc). subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.

Eligibility criteria:
inclusion criteria: * diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes * stable glycemic control for at least 6 months prior to screening visit * average numeric pain rating scale (nprs) score over the last 24 hours of \>4 at the screening and the baseline visit exclusion criteria: * primary pain associated with pdpn in the ankles or above * pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of pdpn * significant pain (moderate or above) of an etiology other than pdpn, that may interfere with judging pdpn-related pain * female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study. * hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter \[otc\] capsaicin products), any qutenza excipients, eutectic mixture of local anesthetics( emla) ingredients or adhesives

Keywords: painful diabetic peripheral neuropathy qutenza
physical activity and health outcomes

Conditions: Overweight; Obese

Summary: obesity is common in adults with complex medical problems with ensuing complications afterwards. obese patients suffer higher mortality and impaired functional status often as a result of their obesity. one primary goal to reduce both obesity and improve functional status is exercise. the investigators hypothesize that a simple exercise intervention with limited behavioral goal-setting will reduce weight and increase functional status compared to usual care. as a secondary measure, the investigators hypothesize that using this intervention will reduce hospital admissions and er visits.

we are enrolling up to 150 subjects where half will receive a pedometer and behavioral goal-setting at enrollment and half will receive a pedometer and goal-setting 2 months later. it is a 4 month study. our aims are as follows: primary aim: determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients. second primary aim: to determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients. secondary aim: determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.

Eligibility criteria:
inclusion criteria: 1. patients will be over the age of 18 2. have a bmi over 25.0 kg/m2. 3. have a minnesota medical tiering concerning medical complexity of 3-4. exclusion criteria: 1. patients will be excluded if they have clinically documented dementia. 2. subjects will be community dwelling and patients living in skilled nursing facilities will be excluded. 3. subjects residing within a correctional institution will be excluded. 4. subject is a female patient who is currently pregnant.

Keywords: increased activity weight loss obesity
the research of constructing a risk assessment model for gastric cancer based on machine learning

Conditions: Gastric Cancer; Precancerous Lesion; Mechine Learning

Summary: based on the gastric cancer database established earlier, this project explored the pg standard suitable for chinese people, and further explored the establishment of machine learning model to stratify gastric cancer risk in the population, guide the frequency of gastroscopy screening, and extract important gastric cancer risk factors from it.establish electronic health records of gastric organs, track the development and outcome of gastric diseases through deep learning method, in order to predict the development and outcome of gastric diseases;then, the simulation hypothesis deductive method is used to compare the outcomes that may be caused by different lifestyles with the help of deep learning model, so as to guide patients to develop a better lifestyle and explore the establishment of health management paths for gastric cancer patients and high-risk groups in china.


Eligibility criteria:
inclusion criteria: * 1） intention to undergo gastroscopy during health checkup examination; and 2) 25-75 years of age exclusion criteria: * 1) a history of gastric ulcer, gastric polyp, or gc; 2) a history of gastrectomy; 3) treatment with a proton pump inhibitor in the last month; 4) contraindications to gastroscopy; 5) a history of hp eradication; 6) a history of abdominal pain, abdominal distention, belching, acid reflux, nausea and other digestive tract symptoms within 1 month or 67) incomplete data.
safety and effectiveness study of the solysafe septal occluder

Conditions: Atrial Septal Defects

Summary: prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (asd)


Eligibility criteria:
inclusion criteria: * asd exclusion criteria: * criteria that exclude catheterization (e.g. too small size, dic, high risk of bleeding such as coagulation or clotting disorders)
prevention of ovarian cancer in women participating in mammography

Conditions: Epithelial Ovarian Cancer

Summary: the primary purpose of this study is to evaluate the effect of systematic identification and genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove both fallopian tubes and ovaries) in women having mammograms at swedish medical center in seattle, wa.


Eligibility criteria:
inclusion criteria: * prior mammogram at swedish medical center * willing and able to provide informed consent, primary physician information, and complete study questionnaires * must meet at least one of the following criteria: * personal history of breast cancer diagnosed before age 50 * personal history of bilateral breast cancer at any age * 1 or more first degree relatives with breast cancer diagnosed before age 50 * 3 or more first or second degree relatives with breast cancer at any age * 2 second degree relatives with breast cancer diagnosed before age 50 * a male relative with breast cancer at any age * ashkenazi jewish with any family history of breast or ovarian cancer * 1 first or second degree relative with ovarian cancer and 1 first or second degree relative with breast cancer at any age * 2 first degree relatives with ovarian cancer or 2 second degree relatives with ovarian cancer or 1 first and 1 second degree relative with ovarian cancer. * a first degree relative with both breast and ovarian cancer (2 primaries in the same person) * personal history of positive genetic test result for any of the following genes: brca1, brca2, hnpcc, or p53 * family history of a positive genetic test result for any of the following genes: brca1, brca2 or hnpcc exclusion criteria: * previous diagnosis of ovarian cancer * prior bilateral-salpingo oophorectomy * had a negative genetic test result for a known family genetic mutation

Keywords: ovarian cancer prevention prophylactic surgery risk biomarkers screening symptoms
safety and efficacy of ingap-peptide in patients with type 1 diabetes

Conditions: Diabetes Mellitus, Insulin-Dependent

Summary: insulin is a chemical that the body needs in order to use or store sugar. it is made by a type of cell called a beta cell which resides in an organ known as the pancreas. type 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. sugar levels rise in the blood as a result. ingap-peptide is being tested to attempt to create new beta cells in the pancreas, and to restore the ability to produce insulin in type 1 diabetic patients.


Eligibility criteria:
inclusion criteria * age 18-65 * fasting c-peptide \<0.3 ng/ml. * hba1c \<10% * history of onset of type 1 dm at or before 20 years of age. * otherwise healthy

Keywords: type 1 diabetes
bupropion sr plus counseling for smoking cessation

Conditions: Tobacco Dependence; Smoking

Summary: the purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.


Eligibility criteria:
inclusion criteria: * smoke 10 or more cigarettes per day * expired carbon monoxide (co) level greater than 9 parts per million (ppm) * motivated to quit smoking (score of 3 on 4-point self-report scale) * willing to fulfill study requirements exclusion criteria: * carbon monoxide breath test score below 9 ppm * serious psychopathology (bipolar disorder, psychosis) * center for epidemiologic studies depression scale ces-d)score over 16 * contraindications for use of bupropion * history of seizure disorder * history of eating disorder * current heavy drinking * risk of pregnancy * current breastfeeding

Keywords: smoking cessation medications smoking cessation counseling
efficacy of unirelievertm offloading brace in the management of knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.

osteoarthritis (oa) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of oa. a survey of 2000 french general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee oa. with the increasing importance of non-pharmacological treatment in recommendations for oa, orthoses will increase in use. the use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. it can even delay the need for surgery. the aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the kellgren lawrence system * visual analog scale pain ≥ 40/100 in the last 48 hours * signed informed consent prior to any study-mandated procedure. * affiliated to the general regime of the social security or covered by a similar health insurance system exclusion criteria: * inability to walk or dependance on a wheelchair or use of crutches. * diseases that do not allow participation in the study for a period of six weeks. * concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial oa. * ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial oa. * a body mass index over 35. * successful cortisone injection within the last four weeks before the start of the study. * participation to any other clinical study which has an impact on the different endpoints. * vulnerable patient, adults being the object of a legal protective measure or enable to express their consent. * inability to communicate in german.

Keywords: osteoarthritis knee brace knee functional capacity pain compliance
hydrocodone/acetaminophen for acute pain following bunionectomy

Conditions: Pain

Summary: the primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.

the bunionectomy was performed under regional anesthesia and propofol sedation. perioperative anesthesia was standardized for all participants. upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol. after an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (vas) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 5 treatment arms. in order to maintain the single-blind nature of the study, all participants were dosed with study drug (active and/or placebo) every 6 hours.

Eligibility criteria:
inclusion criteria: - subjects who were in general good health, experiencing moderate to severe pain following bunionectomy surgery and who were willing to remain confined for approximately 4 days following surgery for study procedures. exclusion criteria: * subjects who underwent base wedge osteotomy and/or long-z hart bunionectomy procedures * allergic reaction to study medications * pregnant or breastfeeding females * clinically significant lab abnormalities at screening * positive hepatitis testing at screening * clinically significant or uncontrolled medical disorders or illness at screening * active malignancy or chemotherapy * any history of drug or alcohol abuse/addiction * known or suspected history of human immunodeficiency virus (hiv); requires treatment with monoamine oxidase inhibitors (maois), tricyclic antidepressants (tcas) or butyrophenones * history of major depressive episode or major psychiatric disorder * current systemic corticosteroid therapy * inability to refrain from smoking during or alcohol during stay at investigative site

Keywords: postoperative pain
a study of diagnosis and treatment of depression based on biological evidence of dopamine reward pathway

Conditions: Diagnosis and Treatment of Depression

Summary: this study will recruit depressed patients unresponsive to selective serotonin reuptake inhibitor antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, parkinson's disease with and without depression, and healthy controls. the subjects need to complete the brain positron emission tomography/magnetic resonance examination, stress assessment, genetic testing, clinical evaluation and neuropsychological tests. using the data, this study aimed to identify the abnormalities of reward circuit of depression and its differences with other diseases, and its abnormalities in first-degree relatives of depression. the depressed patients who were ineffective in treatment with selective serotonin reuptake inhibitor antidepressants were then given combined medication with dopamine receptor-mediated drugs, including dopamine transporter inhibitor - bupropion, d2 receptor antagonist - risperidone, or d2 receptor partial agonist - aripiprazole, to examine the regulation of dopamine pathway and its relationship with the therapeutic effect. through the above work, we will provide new evidence for integrating the biological evidence of dopamine reward pathway into the clinical practice of depression.


Eligibility criteria:
inclusion criteria: * patients unresponsive to ssri antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, parkinson's disease with and without depression, and healthy controls exclusion criteria: * major physical illness; other dsm-iv axis i mental illness; personality disorder, mental retardation; drug and/or alcohol dependence; pregnant or lactating women; mri examination contraindications.
orise study: evaluation of novel injecting solution (orise) during endoscopic resection of colorectal polyps.

Conditions: Colorectal Polyp

Summary: is orise gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.

endoscopic resection of large colonic polyps is preferred over surgical resections due to lower morbidity and preservation of the colon and its functions. the use of submucosal injection is essential for a successful resection (emr/ esd). injection of fluid into the submucosa cushions and isolates the tissue just before capture of the target lesion with a snare, thereby reducing thermal injury and the risk of perforation during emr. esd requires a long period of submucosal dissection and that involves multiple injections to maintain the submucosal cushion; without which the risk of perforation increases. a mixture of normal saline solution + epinephrine and blue dye like indigo carmine is the commonly used injecting solution. however, saline dissipates very quickly leading to frequent and multiple injections. this leads to longer procedure time. studies have demonstrated long-lasting effects of colloids when injected in the submucosal space. orise gel is a newly licensed injecting solution which contains a poloxamer agent leading to longer lasting submucosal cushion effect. multicentre prospective observational cohort study primary objective : primary objective to evaluate the technical feasibility, effectiveness \& safety of the orise gel as an injecting solution on its own during endoscopic resection of colorectal polyps (ability to start and finish the resection with orise). secondary objective : to identify polyp resection time (prt) and the amount of orise gel used during resection of large colorectal polyps.

Eligibility criteria:
inclusion criteria: * \> 18 years old at the date of consent * subjects referred for emr for the excision of: treatment naïve, laterally spreading sessile, flat polyps or adenomas of the colon equal to or greater than 20 mm in largest dimension, assessed by the investigator to be suitable for emr or esd. exclusion criteria: * lesions less than 20 mm in largest dimension * subjects with ulcerated depressed lesions (paris type iii-excavated) or biopsy proven invasive carcinoma * scarred polyps * endoscopic appearance of deep invasive malignancy * previous partial resection or attempted resection

Keywords: orise gel emr esd colorectal polyps submucosal injection
safety and immunogenicity of adcovid in healthy adults (covid-19 vaccine study)

Conditions: Healthy Volunteers

Summary: a study to evaluate the immune response and safety of adcovid administered as an intranasal spray in healthy adults.


Eligibility criteria:
inclusion criteria: * men and women ages 18 to 55 years, inclusive * good general health status * screening laboratory results within institutional normal range or grade 1 abnormality if the investigator documents clinical insignificance. grade 2 laboratories may be permissible if considered not clinically significant by the investigator. * for women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test * willingness to practice a highly effective method of contraception * ability and willingness to comply with all aspects of the study, including nasopharyngeal swabs and blood and urine samples, through the entire study period exclusion criteria: * subjects at increased risk of exposure to sars-cov-2, including healthcare workers, emergency response personnel, and those with known contact with covid-19 patients * pregnant or lactating women or planning to conceive a child during the next 3 months * body mass index (bmi) \> 30.0 kg/m2 * acute covid-19, a positive test result for sars-cov2 infection, a positive sars-cov-2 serology for prior sars-cov-2 infection at screening, or exposure within 14 days to an individual with acute covid-19 * an acute respiratory illness * positive result for hiv, hepatitis b virus, or hepatitis c virus at screening * chronic or current cigarette smoking * any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent

Keywords: covid-19 sars-cov-2 intranasal vaccine