Kornimate/medical-research-clean huggingface dataset:
acupuncture for diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: gastroparesis is a common complication of prolonged diabetes mellitus, both with type 1 and type 2 forms. treatment of diabetic gastroparesis ranges from changing dietary habits to medications and invasive procedures, all of which offer only partial and transient relief, with some options having potentially harmful effects. acupuncture is an ancient treatment which has been found to be beneficial for many ailments, including those involving the gastrointestinal tract. we propose to evaluate whether acupuncture is an effective and safe treatment for diabetic gastroparesis using a randomized, double-blind, placebo/sham-controlled crossover trial. because symptoms of gastroparesis do not correlate well with objective tests of gastric emptying (i.e., scintigraphy or 13c breath tests), our primary outcome value will be the gastroparesis cardinal symptom index (gcsi), a reliable and validated instrument for quantifying symptoms in these patients. as a secondary outcome we will measure gastric emptying using a c13-acetate breath test, as well as the sf-12 short form health survey. blinding of the participants will be evaluated using a validation of blinding questionnaire at the end of the treatment period. diabetic patients suffering from moderate gastroparesis (total gcsi score \> 2.50) who fulfill the inclusion criteria (and none of the exclusion criteria) will be eligible to participate in the study. on induction, participants will fill out the gcsi questionnaire and sf-36 survey, and will undergo a c13-acetate breath test. they will then be randomly assigned to either true acupuncture treatment or placebo/sham acupuncture treatment. each participant will undergo 8 treatments twice-weekly, for a period of 4 weeks. at the end of the eighth treatment session, each participant will again fill out a gcsi questionnaire and sf-12 form, as well as repeating the c13-acetate breath. following a 4-week washout period, patients will be crossed over to either placebo/sham or true acupuncture treatment, again 8 twice-weekly treatments, for a period of 4 weeks. at the end of the second treatment regimen all participants will again fill out a gcsi questionnaire and sf-12 form, and undergo a c13-acetate breath test. at the end of the second treatment regimen participants will again fill out a validation of blinding questionnaire.


Eligibility criteria:
inclusion criteria: * age 18 years and older; * controlled diabetes (\<250 mg/dl); * moderate gastroparesis (gcsi \> 2.50); * ability to comply with study protocol exclusion criteria: * past experience with acupuncture; * history of gastric surgery, intrapyloric botulinum toxin, gastric pacemaker; * uncontrolled diabetes or evidence of diabetic ketoacidosis; * malabsorptive syndrome, liver or pulmonary disease; * pregnancy or fertility treatments; * overt psychopathology.

Keywords: diabetes gastroparesis acupuncture symptoms gastric emptying
evaluation of retinal and vascular features in radiation maculopathy after intravitreal injections of ranibizumab

Conditions: Radiation Maculopathy

Summary: this study evaluates the retinal and vascular features in patients with radiation maculopathy under the effects of ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.

the radiation maculopathy is a consequence of radiotherapy for treatment of choroidal melanoma. the radiation maculopathy is characterized by the compromission of the macular microvasculature that can lead to the leakage, lipid exudates, hemorrhages, teleangiectasie, macular edema, non perfusion areas with consequent significant impaiment of visual acuity. ranibizumab is a vascular endothelial growth factor antagonist and it represents an efficacy treatment acting on vascular hyperpermeability. the optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. the study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after intravitreal injections of ranibizumab at the last follow up to one year in patients affected by radiation maculopathy.

Eligibility criteria:
inclusion criteria: * age older than 40 years * diagnosis of radiation maculopathy * treatment-naïve with ranibizumab * absence of other vitreoretinal and vascular retinal diseases exclusion criteria: * age younger than 40 years * no diagnosis of radiation maculopathy * previous treatments with ranibizumab * presence of vitreoretinal and vascular retinal diseases
kn046 in patients with recurrent or metastatic esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this is an open-label, phase ii study of kn046 combined with chemotherapy and palliative radiotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma to evaluate the safety, efficacy and tolerance.


Eligibility criteria:
inclusion criteria: * signed inform consent form(icf) * age ≥ 18 years and ≤ 75 years, male or female * histologically or cytologically documented recurrent or metastatic esophageal squamous cell carcinoma, with indications of radiotherapy and without prior systemic treatment * at least one measurable lesion according to response evaluation criteria in solid tumors（recisit） v 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ function * female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). contraception should be continued for a period of 24 weeks after dosing has been completed. * ability to comply with treatment, procedures and pharmacokinetics (pk) sample collection and the required study follow-up procedures exclusion criteria: * known brain metastasis or another central nervous system (cns) metastasis that is either symptomatic or untreated. * patients who are participating or have participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment. * patients who have received immune checkpoint proteins/antibody/medicine for treatment. * patients who have interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. * subjects with active autoimmune diseases or history of autoimmune diseases should be excluded * active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. * known hiv infection or known history of acquired immune deficient syndrome (aids) * any unresolved the common terminology criteria for adverse events (ctcae) grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia * patients who have serious hypersensitive reaction to monoclonal antibodies and have history of uncontrolled allergic asthma
signs and symptoms of genetic abnormalities linked to inherited heart disease

Conditions: Cardiomyopathy, Hypertrophic, Familial

Summary: genetically inherited heart diseases (familial cardiomyopathies) are conditions affecting the heart passed on to family members through abnormalities in genetic information. these conditions are responsible for many heart related deaths and illnesses. in this study researchers hope to determine the signs and symptoms (clinical correlation) associated with specific genetic abnormalities causing inherited heart diseases. in order to do this, researchers plan to evaluate patients and family members of patients diagnosed with inherited heart disease. patients participating in the study will undergo several tests including blood tests, electrocardiograms (ekg), and echocardiograms. patients may also be asked to undergo an mri of the heart to provide a clearer picture of it. patients participating in this study may not be directly benefited by it. however, information gathered from the study may contribute to the medical care, treatment, and prevention of problems for others in the future.

familial cardiomyopathy (fc) often demonstrates both non-allelic and allelic genetic heterogeneity. we propose to determine the clinical correlates of specific genetic defects which cause fc by identifying and expanding a set of kindreds with identical and distinct molecular defects.

Eligibility criteria:
individuals with cardiomyopathy referred for evaluation to the nih.

Keywords: cardiac hypertrophy genetics phenotypes hypertrophic cardiomyopathy
effects of uri on diabetic subjects utilizing technosphere insulin after a meal challenge

Conditions: Diabetes Mellitus; Upper Respiratory Infection

Summary: effect of upper respiratory infection (uri) on diabetic subjects with a meal challenge


Eligibility criteria:
inclusion criteria: * subjects will have met the same inclusion criteria as mkc-ti-030 * clinical diagnosis of uri with in 24 hrs prior to clinic visit and/or day of clinic visit * at least 3 uri symptoms exclusion criteria: * prior participation in mkc-ti-112 * medhist, pe or lab findings of acute bacterial infection including but not limited to sputum prod., nasal/eye discharge, chest exam abnormalities, cxr findings of pneumonia.
dexamethasone for non-urgent thoracic surgery

Conditions: Thoracic Surgery; Anesthesiology; Corticosteroids; Respiratory Complication

Summary: thoracic surgery is at high risk of respiratory complications. despite the improvement of surgical procedures such as video-thoracoscopy, respiratory complications appear in 15 to -20% of procedures. thoracic surgery induces local pulmonary inflammation which is involved in the occurrence of post-operative respiratory failure. similarly to the example of the acute respiratory distress syndrome, corticosteroids could reduce lung injury secondary to immunological stress. in addition, recent studies suggest that dexamethasone could lead to a reduction of respiratory complications after major non cardiothoracic surgery. since dexamethasone is recommended to prevent postoperative nausea and vomiting, around one in two patients receive dexamethasone during anesthetic induction. by retrospective analysis with compensation of bias by propensity score, the investigators aim to assess the effect of dexamethasone to prevent respiratory complications


Eligibility criteria:
inclusion criteria: * age : minimum 18 years old * patients who underwent scheduled lung resection surgery exclusion criteria: * absence of patient's consent * age under 18 years * pregnant women

Keywords: thoracic surgery anesthesiology corticosteroids respiratory complication
effects of polyphenolic-rich dark chocolate/cocoa and almonds on cardiovascular disease risk factors

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to investigate the individual and combined effects of dark chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation, phenolic acids, inflammatory status, blood pressure and arterial health. it is hypothesized that dark chocolate/cocoa and/or almonds will favorably affect lipids, lipoproteins, antioxidants, inflammatory status, blood pressure and arterial health compared to a healthy american control diet; however, the effects will be greater when dark chocolate/cocoa and almonds are consumed together versus consumption of each food individually.


Eligibility criteria:
inclusion criteria: * overweight and obese (bmi ≥25, ≤40 kg/m2) * moderately elevated ldl-c between the 25-95th percentile from nhanes: 105-194 mg/dl for males; 98-190 mg/dl for females. exclusion criteria: * tobacco use * systolic blood pressure ≥159 mm hg * diastolic blood pressure ≥ 99 mm hg * a history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on meds) * blood pressure or cholesterol-lowering medication use * refusal to discontinue intake of putative cholesterol-lowering supplements (e.g. psyllium, fish oil, soy lecithin, niacin, fiber, flax, stanols/sterols) * vegetarianism or dietary practices that are inconsistent with the test diets * nut allergies * refusal to discontinue nutritional supplements, herbs, or vitamins * history of inflammatory gastrointestinal disease
efficacy of jianpi qushi huatan decoction in the treatment of polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a common reproductive disease associated with endocrine and metabolic disorders. some studies have shown that chinese herbal medicine is beneficial for pcos, but the efficacy of chinese herbal medicine in the treatment of pcos is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of chinese herbal medicine (jianpi qushi huatan decoction) in women with pcos.


Eligibility criteria:
inclusion criteria: 1. the diagnosis of pcos is based on the rotterdam criteria. 2. meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness in tcm theory. 3. women aged 18-40 years without fertility requirements. 4. a willingness to undergo this treatment plan. exclusion criteria: 1. hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart). 2. diminished ovarian reserve, fsh (follicle-stimulating hormone) level more than 10 iu/l. 3. abnormal thyroid function, tsh (thyroid stimulating hormone) level less than 0.2 miu/ml or more than 5.5 miu/ml. 4. suspected cushing's syndrome. 5. adrenal or ovarian tumors secreting androgen. 6. poorly controlled type ii diabetes. 7. pregnancy or lactation. 8. hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmhg or a diastolic blood pressure more than 100 mmhg). 9. those who had taken hormones or other drugs during the previous 3 months. 10. acute heart, liver, kidney or blood diseases.
effect of recombinant human bone morphogenetic protein-2 with an absorbable collagen sponge on stability of dental implant: (split mouth randomized clinical trial study.

Conditions: Hypertension; Diabetes Mellitus; Blood Disease

Summary: effect of recombinant human bone morphogenetic protein-2 with an absorbable collagen sponge on stability of dental implant: (split mouth randomized clinical trial study.

the primary outcome will be measuring the effect of rhbmp- 2/acs in improving the secondary stability of dental implant by using rfa in comparison to control group. secondary outcome association of the effect of other factors (ridge dimension, bone density) on dental implant stability.

Eligibility criteria:
inclusion criteria: * patients have good oral hygiene. * systemic healthy individuals ,age more than18 years. * healed edentulous area for at least 6 months after tooth extraction (delayed implant protocol). * patients have at least two missing teeth in the jaw (canine to 1st molar area) indicated for the dental implant. exclusion criteria: * presence of systemic diseases preventing implantation. * previous implantation or augmentation of the same region. * the need for additional bone augmentation procedures (such as maxillary sinus augmentation) * partial or total edentulous ridge associated with a severe knife-edge ridge . * acute infection or any pathological lesion a the implant site. * allergy to one of the materials to be used during operation. * pregnancy. * radiation therapy, bisphosphonate drugs , osteoradionecrosis.
patient pathway pharmacist - optimal drug-related care

Conditions: Hip Fractures; Aging; Patient Fall

Summary: medication errors represent the most common cause of patient injury and one of the most frequently reported health related deviation in norway. the addition of a dedicated clinical pharmacist throughout the hip fracture patient pathway (patient pathway pharmacist) is believed to improve patient safety and ensure optimal drug-related patient care. the pharmacist will perform medication reconciliation at admission to hospital, medication review after surgery and assist physicians with discharge summary. six weeks after discharge the patient pathway pharmacist will perform a second drug reconciliation and medication review. this study will assess the pharmacists' place and specific tasks in the patient pathway, describe areas where the pharmacist contribute to increased quality of care and assess the benefits and/or disadvantages experienced with introducing a patient pathway pharmacist. the estimated number of patients included is 60. current practice will be determined by investigating the last 50 patients' medical record and a questionnaire to health care professionals involved in treatment of hip fracture patients. data from medication reconciliation and drug review will be collected and compared to current practice. after the inclusion period, focus group surveys and/or semi-structured interviews will be executed to describe the perceived improvement in the quality of care. primary endpoints are: 1) medication reconciliation score at admission 2) number of inappropriate drugs for elderly 3) discharge summary score 4) discharge summaries following procedure. secondary endpoints are readmissions and mortality after 30 and 90 days. qualitative endpoints: 1) health care professionals experience of current drug-related practice 2) experienced advantages and disadvantages of a patient pathway pharmacist.


Eligibility criteria:
inclusion criteria: * hip fracture patients in vestfold county, norway exclusion criteria: * patients under 18 years * terminally ill * hip fracture patients who do not follow the standardized patient pathway at vestfold regional hospital * patients who do not consent to be included in the study

Keywords: medicine review patient handoff patient hand over intertrochanteric fractures trochanteric fractures subtrochanteric fractures hospital readmission hospital readmissions injuries, hip hospitalization hospitalisation hip fracture femoral fractures femoral neck fractures medication errors medication review medication reconciliation
tolerability of slit with lais® mites allergoid tablets

Conditions: Allergic Rhinitis

Summary: to expand knowledge on the application and tolerability of immunotherapy with lais® mites allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual therapy in special consideration of the chosen titration schedule in everyday practice.

until now, results from controlled studies with their specific requirements (patient selection, defined inclusion and exclusion criteria, close patient management and monitoring, randomisation) are available for lais® mites allergoid tablets only for a small patient population. in addition, an open-label, controlled study and an observational study have been carried out investigating the clinical efficacy and tolerability of the preparation. owing to the differences in the study designs, the allergen dose administered and the frequency with which the preparation was applied varied among the individual studies, making it necessary to gather further data on the safety and tolerability of the preparation in a larger patient population. the observation schedule of this nis (nis in accordance with article 67 paragraph 6 of the german medicinal products act (amg)), which takes into account the recommendations made by the german federal institute for drugs and medical devices (bfarm) and by the paul ehrlich institute for planning, implementing and evaluating an nis, is geared to the routine procedure carried out for patients with allergies to tree pollen. the aim of this observational study is to observe and document the tolerability and improvement of symptoms after treatment with lais® mites allergoid tablets under normal application conditions and in consideration of the chosen titration schedule in therapeutic practice - in accordance with the patient information leaflet - in a large patient population: retrospective survey of rhinitis/rhinoconjunctivitis symptoms induced by tree pollen overall symptomatology documentation of restrictions caused by allergy/asthma tolerability of the treatment by means of ae documentation patient compliance additional requirements extending beyond the specifications listed in the patient information leaflet on product use, patient groups, dosage, contraindications, etc., will not be made.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older having allergies within the scope of specifications stated in the patient information leaflet exclusion criteria: * contraindications according to the patient information leaflet

Keywords: non interventional study nis sublingual immunotherapy allergen mites
maternal key nutritional factors and offspring's atopic dermatitis (mknfoad)

Conditions: Atopic Dermatitis

Summary: the study is a prospective birth cohort study and the purpose is to describe the status of maternal key nutrients(eg. folate and vitamin d) supplementation among pregnancies at early gestation in shanghai, to find out the association between the level of serum key nutrients and atopic dermatitis (ad) in offsprings during 6 months.

this study based on shanghai pregnancy population is a prospective birth cohort. the investigators obtain the data of participants' folic acid and vitamin d supplement intake through the questionnaire at 12-14 gestational weeks. and the investigators collect participants' blood samples during gestation to directly detect the biological exposure levels of folate and vitamin d. in the follow-up, skin barrier function is evaluated at time of infant 24-48 hours, 42 days and 6 months. during 6 months from birth, the incidence of ad is investigated on offsprings. this cohort study is aimed to (1) clarify the association between prenatal key nutrients with offspring ad; (2) assess the role of maternal key nutrients in the skin barrier of offsprings. it will be a good evidence for the ad prevention and a meaningful protocol to reduce the incidence of ad by its unique design.univariate and multivariate association analyses will be performed to identify risk factors to ad by using multivariate logistic regression model.

Eligibility criteria:
inclusion criteria: * mother plans to proceed prenatal care and delivery in minhang maternal and children health care hospital * offspring plans to stay in shanghai until 6 months and proceed follow-up in children's hospital of fudan university exclusion criteria: * none

Keywords: birth cohort prenatal skin barrier atopic dermatitis key nutritional factors