Kornimate/medical-research-clean huggingface dataset:
study of sb681323 and prednisolone on biomarkers in copd (chronic obstructive pulmonary disease) patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study will assess the effects of single oral doses of sb681323 and prednisolone on biomarkers in induced sputum and blood copd patients


Eligibility criteria:
inclusion criteria: * subject is current smoker or ex-smoker with a smoking history of at least 10 pack years (number of pack years = \[number of cigarettes per day/20\] x number of years smoked). * the patient has serum crp ≥ 3 mg/l at screening * subjects able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. exclusion criteria: * any clinically relevant abnormality identified on medical assessment, laboratory examination, or 12-lead ecg which in the opinion of the investigator, will lead to an unacceptable increase in the risk of study participation or will call into question the validity of the outcome measures. * subjects who are obese, defined as having a bmi \> 40 * subject has a diagnosis of asthma that is confirmed by the investigator. * subject has poorly controlled copd, defined as the occurrence of any of the following in the 2 weeks prior to visit 1: acute worsening of copd that is managed by the subject at home by self-treatment with corticosteroids or antibiotics, or that requires treatment by a physician. * subject has active tuberculosis, lung cancer or clinically overt bronchiectasis. * symptoms of "cold or flu" or any respiratory infection/symptoms at the start of the study * subject has cardiac, gastrointestinal, neurological, renal, endocrine or psychiatric disease that is uncontrolled on permitted medication * subject has history of allergic rhinitis. * subjects with a history of any type of malignancy with the exception of successfully treated basal cell cancer of the skin. * subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. inflammatory bowel disease). * subjects with chronic infections such as gingivitis, periodontitis, prostatitis, gastritis, and urinary tract infections. * subjects with history of hepatic disease. * history of increased liver function tests (alt, ast) above upper limit of normal in the past 6 months and/or liver function tests (bilirubin, alt, ast) above upper limit of normal at screening. * history of positive hiv, hepatitis b /c antibody test result, a positive hep b/c result at screen or a risk factor for these diseases. * history of drug or other allergy, which, in the opinion of the investigator precludes participation in the study.

Keywords: copd sb-681323 prednisolone biomarkers
intra-articular dexamethasone to prevent post-traumatic osteoarthritis: a pilot study

Conditions: Distal Radius Fracture; Osteoarthritis

Summary: the primary aim of the study is to see if a single wrist injection (intra-articular) of dexamethasone at the time of treatment will reduce the incidence of early-onset of post traumatic osteoarthritis.

our hypothesis is that the intra-articular administration of dexamethasone soon after joint injury will prevent the subsequent development of ptoa, and restore normal joint homeostasis. we plan to generate the data needed to test this hypothesis in a phase 0 (pilot) clinical trial using patients who have suffered distal radius fractures.

Eligibility criteria:
inclusion criteria: 1. unstable distal radius fracture 2. fracture type ao b1, b2, b3, c1, c2 or c3. 3. 18-65 years old 4. understand and read english 5. community dwelling (not in assisted living or nh) exclusion criteria: 1. open or bilateral drf 2. associated upper extremity carpal fracture or carpal ligament injuries requiring casting or surgical repair at the time of drf fixation. 3. greater than 2 weeks post injury 4. neurologic disorders affecting the hand, wrist or arm. 5. history of permanent dementia, alzheimer's or other neurologic dx 6. substance abuse 7. pathologic fractures 8. known pregnancy 9. radiocarpal joint arthritis

Keywords: drf ptoa dexamethasone
phase 1 dose escalation of artemicoffee

Conditions: Ovarian Cancer

Summary: this is a phase i dose-escalation study of artemisia annua (aa) in patients with advanced ovarian cancer who have completed front-line chemotherapy with carboplatin and paclitaxel. the primary objective of this study is to determine the recommended phase ii dose (rp2d) of artemisia annua.

this is a phase i dose-escalation study of artemisia annua (aa) decaffeinated coffee in patients with advanced ovarian cancer who have completed front-line chemotherapy with carboplatin and paclitaxel. the primary objective of this study is to determine the recommended phase ii dose (rp2d) of aa decaf coffee pods. sequential cohorts of three patients per cohort will have escalating doses of aa, starting with one cup per day (450mg) and with a maximum of 4 cups per day (1800mg). after identifying the rp2d, the study will evaluate an expansion cohort of 6 patients for further tolerability and secondary endpoints. the secondary endpoints include: 1) efficacy as measured by time to tumor progression or recurrence; 2) the ability of aa decaf coffee to influence downstream biomarkers of the nrf2/keap1 signaling pathway; and 3) plasma concentrations of artemisinin and dihydroartemisinin.

Eligibility criteria:
inclusion criteria: * able to understand and willing to sign a written informed consent document. * age ≥ 18 years. * patients diagnosed with stage ii-iv ovarian cancer who have completed initial first-line therapy with carboplatin and paclitaxel and achieved a complete response. * creatinine clearance ≥ 60 ml/min * total bilirubin ≤ 1.5 x uln, and ast and alt ≤ 3.0 x uln * gog performance status ≤ 2. exclusion criteria: * 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 visits, in the opinion of the treating physician. * pregnant women are excluded from this study. * concurrent use of strong inducers of cyp2a6, including phenobarbital and rifampin * women with active gastric ulcers are excluded from this study. * patients who are receiving concurrent maintenance therapy with a parp inhibitor for a known hereditary recombinant deficiency (hrd) mutation. bevacizumab maintenance therapy is allowed. * concurrent use of nevirapine, ritonavir and strong ugt inhibitors or inducers.

Keywords: dose escalation artemicoffee artemisia annua art-coffee herbal
digital mammography: computer-aided breast cancer diagnosis

Conditions: Tumors, Breast

Summary: the purpose of this study is to develop computer programs to assist radiologists in finding breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on direct digital and film mammograms.

to develop a computer-aided diagnosis (cad) system for full field digital mammography (ffdm) using advanced computer vision techniques and to evaluate the effects of cad on interpretation of digital mammograms (dms). this system will assist radiologists with the four most important areas in mammographic interpretation: (1) detection of masses, (2) classification of masses, (3) detection of microcalcifications, (4) classification of microcalcifications. the proposed approach is distinctly different from previous approaches in that image information from two-view and bilateral mammograms will be fused with that from the single-view mammogram to improve lesion detection and characterization.

Eligibility criteria:
inclusion criteria: * females who have been scheduled for mammographic exams. * females who have been recommended for work-up or biopsy due to a suspicious finding on their mammogram. * females who can give informed consent. exclusion criteria: * no subject under 18 years of age
topical 5% minoxidil and potent topical corticosteroid versus intralesional corticosteroid in the treatment of alopecia areata

Conditions: Alopecia Areata

Summary: alopecia areata (aa) presents with circumscribed patches of non-scarring hair loss. it inflects a significant psychological and social burden. many treatment options are used for the treatment of aa. randomized controlled trials comparing intralesional and topical therapy and comparing combinations are few. the aim of this work is to evaluate the efficacy of combined topical 5% minoxidil and potent topical corticosteroid therapy compared to intralesional triamcinolone injection in alopecia areata


Eligibility criteria:
inclusion criteria: * patients presenting with scalp alopecia areata, patchy type, of at least 2 months duration. exclusion criteria: * alopecia totalis and alopecia universalis. * alopecia areata solely affecting the beard. * pregnant and lactating. * patients known to have autoimmune diseases e.g. autoimmune thyroid disease, vitiligo or sle. * patients receiving systemic treatment relevant to alopecia areata within 3 months before enrollment into the study or topical treatment relevant to alopecia areata within 2 months before. * patients with a dermatological condition affecting the scalp other than aa: e.g. psoriasis, eczema. * patients with psychiatric illness or psychological state interfering with compliance or influencing the expectation of the patient.

Keywords: alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, il-23, tgfβ-1
imaging techniques for identifying factors of sudden cardiac death risk

Conditions: Sudden Cardiac Death

Summary: sudden cardiac death is a tragic event that strikes all age groups and is unfortunately increasing in prevalence. because it is difficult to predict those at highest risk, this study is designed to test the hypothesis that new imaging techniques (magnetic resonance imaging \[mri\] and computed tomography \[ct\]) are useful for identifying factors which put people at high risk for sudden death.

some people with heart disease and a weak heart muscle experience abnormal electrical activity of the heart that may predispose them to sudden death. in light of this risk, it has been recommended that such patients undergo implantation of an implantable cardioverter defibrillator (icd). your doctors have determined that you are such a patient and are to undergo implantation of an icd. it is unclear who among the many patients who undergo icd implantation for this reason are at greatest risk of sudden death and therefore require electrical response from their icd. this research is being done to determine whether new imaging tests, such as magnetic resonance imaging (mri) or multi-detector computed tomography (mdct), can be used to predict who is at highest risk of sudden death and require electrical response from their icd.

Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction \<or = 35% * planned implantable cardioverter-defibrillator (icd) implantation for clinical indications (primary prevention) exclusion criteria: * history of sudden death (secondary prevention) * contraindication to undergoing mri (metallic implant, pacemaker, etc.)
psychosocial intervention pilot for partners in brca testing

Conditions: Breast Cancer

Summary: a brief psychosocial intervention for partners of women affected by or at risk for breast cancer and harboring brca genetic alterations.


Eligibility criteria:
inclusion criteria: * age, married/partnered status exclusion criteria: -
improving the impact of calorie labeling policies

Conditions: Obesity; Diet Habit

Summary: increased consumption of fast-food may be a contributing factor to the obesity epidemic. posting calories on menus in fast-food restaurants is an important public health initiative and may help consumers to make lower calorie, healthier choices. this study will develop and test an intervention to improve the impact of calorie labeling policies. further, the study will examine potential barriers to using posted calorie information

by the year 2030, 50% of american adults could be obese. increasingly, americans are consuming more foods away from home and most of these foods are consumed in fast-food restaurants. menu calorie labeling provides calorie information at the point of purchase in fast-food restaurants and is one strategy employed to promote lower calorie, healthier food choices. initial studies of the impact of calorie labeling, however, suggest that posting calories may only affect calories purchased in a minority of consumers. the patient protection and affordable care act (ppaca) mandates that calorie labeling be implemented nationally and fast-food restaurants throughout the u.s. will begin to post calorie information. with an overarching goal of improving the impact of calorie labeling policies; this proposal will develop and pilot test a brief intervention that is complementary to the posted calorie information, and will explore potential barriers to reducing calories among an urban clinic population. the study aims are: (aim 1) to develop the complementary calorie labeling (ccl) intervention, an individual single-session intervention that can be delivered in primary care settings. semi-structured interviews will be conducted among 40 overweight or obese participants to guide development of intervention components and materials. (aim 2) to conduct a pilot randomized controlled trial of the ccl intervention among 188 overweight or obese participants. the ccl intervention will be compared to a control group that receives an educational brochure about calories. the primary outcome will be weekly calories purchased at fast-food restaurants as measured by fast-food receipts and food logs. (aim 3) to examine whether calorie knowledge, health literacy, numeracy, and motivation are barriers to using calorie information and whether these variables moderate intervention efficacy. the proposed study will be conducted in a primarily low-income, minority clinic population in the bronx nyc. nyc was the first major city to implement calorie labeling. preliminary data from nyc suggest that fast-food consumers in the bronx may be less likely to reduce their calories purchased when calorie information is posted, compared to other consumers in nyc. developing interventions that may improve the impact of calorie labeling policies within this population will have important implications as these policies are implemented in urban communities throughout the u.s.

Eligibility criteria:
inclusion criteria: * eats at fast-food restaurant at least once per week bmi\>25 exclusion criteria: * inability to keep food logs or fast-food receipts
histopathological analysis of temporal artery biopsy following dynamic full-field optical coherence tomography, a comparison to conventional histopathological findings in patients with suspected giant cell arteritis (docta)

Conditions: Giant Cell Arteritis; Tomography, Optical Coherence

Summary: giant cell arteritis (gca) is a type of large vessel granulomatous vasculitis responsible for the inflammation of the aorta and the branches of the external carotid, notably temporal arteries. the diagnosis of gca relies upon the identification of vasculitis following histopathological analysis of temporal artery biopsy (tab) showing mononuclear cells infiltration, fragmentation of the internal elastic lamina as well as significant intimal hyperplasia. apart from its lack of sensitivity, one of the weaknesses of tab is the delay in obtaining the result due to the time required to prepare the sample for histological analysis. pursuing the idea to improve tab performances, our group recently demonstrated the use of full-field optical coherence tomography (ff-oct) to visualize structural changes associated with the inflammatory processes of gca. the present work suggests a further use of dynamic ff-oct on tab for a direct visualization of the mononuclear cells infiltration to ensure rapid on-site diagnosis of gca.


Eligibility criteria:
inclusion criteria: * patient \> 50 years of age with suspected giant cell arteritis who received temporal artery biopsy between start study date and primary completion date exclusion criteria: * inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery biopsy

Keywords: giant cell arteritis temporal artery biopsy full-field optical coherence tomography
evaluation of extended wear infusion set with 670g hybrid closed-loop therapy

Conditions: Type 1 Diabetes

Summary: this is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with type 1 diabetes

this study will compare use of a standard infusion set with an extended wear infusion set. subjects will be asked to wear both types of sets twice for up to 7 days, alternating wear of set type over 4 weeks. the order of infusion set wear will be randomized with the first set wear. the investigators aim to see whether there is a benefit to using an extended wear infusion set.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes for more than one year, using an insulin infusion pump for at least 6 months, and using the 670g pump for at least 3 months 2. age ≥18 years 3. using novolog or humalog insulin at time of enrollment 4. for females, not currently known to be pregnant 5. an understanding of and willingness to follow the protocol and sign the informed consent 6. willing to have photographs taken of their infusion sites 7. willing to download their 670g pump every week to a research carelink account 8. willing to submit a brief online questionnaire at the time of any infusion set failure 9. able to understand spoken or written english 10. hemoglobin a1c \<8.5% at the time of enrollment 11. willing to perform three or more fingerstick glucose measurements each day 12. willing to sign a consent for release of medical information at the time of enrollment 13. willing to change their infusion pump insulin reservoirs at least every 6 days exclusion criteria: 1. hypoglycemic seizure or loss of consciousness in the past 6 months 2. severe episode of dka in the 6 months prior to study enrollment that was unrelated to an infusion set failure 3. a known cardiovascular disease 4. active proliferative diabetic retinopathy 5. known tape allergy 6. current treatment for a seizure disorder 7. cystic fibrosis 8. active infection 9. a known medical condition that in the judgment of the investigator might interfere with the completion of the protocol 10. inpatient psychiatric treatment in the past 6 months 11. presence of a known adrenal disorder 12. if on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the last 2 months prior to enrollment in the study 13. abuse of alcohol 14. history of dialysis, renal failure or known egfr \<60 ml/min/1.73m2 15. has received a blood transfusion or required treatment for anemia in the three months prior to enrollment
a study to evaluate the safety and efficacy of vx-121 combination therapy in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of vx-121 combination therapy in subjects with cystic fibrosis (cf).


Eligibility criteria:
key inclusion criteria: * part 1: heterozygous for f508del and an mf mutation (f/mf) * part 2: homozygous for f508del (f/f) * fev1 value ≥40% and ≤90% of the predicted mean for age, sex, and height key exclusion criteria: * history of clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status * history of solid organ or hematological transplantation other protocol-defined inclusion/exclusion criteria may apply
the evaluation of the effectiveness of cam treatments for lumbar and cervical spine pain patients due to spinal disease

Conditions: Lumbar and Cervical Pain

Summary: the purpose of this study is to investigate the effect of cam treatments consisting of herbal medicine, chuna manual therapy, pharmacoacupuncture, acupuncture on lumbar and cervical spine pain patients due to spinal disease.

"the purpose of this study is to investigate the effect of cam treatments on lumbar and cervical spine pain patients due to spinal disease. after subjects selected by screening, who receive cam treatments 1-2times a week for more than 2 months and f/u at 1st, 2nd, 3rd month by meeting and f/u at 6nd, 12nd month by calling. the cam treatments used in this study consists of 120ml of chuna herbal medicine(ostericum koreanum, eucommia ulmoides, acanthopanax sessiliflorus, achyranthes bidentata, psoralea corylifolia, peucedanum japonicum, cibotium barometz, lycium chinense, boschniakia rossica, and cuscuta chinensis) and dried extracts in pill form(cibotium barometz, atractylodes japonica) taken twice a day 30 minutes after meals, chuna manual therapy, intermuscular injections of bee-venom pharmacoacupuncture(select 6 acupoints, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session), acupuncture and allow for nsaid intake during the investigational period. the subject is allowed a maximum of 3 pills/day, taken at a minimum of 8 hrs apart. the number of pills taken will be measured at 4 wks after conclusion of treatment."

Eligibility criteria:
inclusion criteria: * patients suffering from low back pain or neck due to spinal disease agree to the treatment of more than 2 months * age all(if under 18yr, guardian's consent need) * volunteers do not have a problem with my speech as those who have signed the consent exclusion criteria: * diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc. * prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, alzheimer's disease, epilepsy, etc. * progressive neurologic deficit(s) or concurrent severe neurological symptoms unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc. * under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher * experience of gastroenteric complications after taking nsaids or currently undergoing treatment for digestive disorders * during pregnancy or suspected pregnancy * subjects considered unsuitable for clinical trial by the researcher

Keywords: lbp neck pain integrative package cam