Kornimate/medical-research-clean huggingface dataset:
the deb pilot study

Conditions: Nutritional Physiological Phenomena; Obesity

Summary: the purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.

dose: participants are to consume 1 unit per day of the study product. diet: participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.

Eligibility criteria:
inclusion criteria: * bmi 20 - 40 exclusion criteria: * diabetes (type 1 or 2) * prediabetes * active cancer * serious digestive disorders * other conditions that affect metabolism or body weight * uncontrolled thyroid disorder (controlled = 6 months of medication) * unable to consume study foods * non- weight stable (more than 10 lbs weight gain or loss in last 6 months) * pregnancy * intentions of becoming pregnant in the next 2 months * women who have undergone partial hysterectomy with intact ovary function * current or past alcohol or drug abuse problem * allergy or intolerance to study product ingredients. * any other medical, psychiatric or behavioral factors that in the judgment of the principle investigator that may interfere with study participation or the ability to follow the protocol
a study to evaluate the efficacy, safety, and pharmacokinetics of co-administration of abt-493 and abt-530 with and without rbv in subjects with chronic hepatitis c virus (hcv) genotypes 2, 3, 4, 5 or 6 infection

Conditions: Chronic Hepatitis C; Hepatitis C Virus

Summary: the purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of abt-493 and abt-530 with and without ribavirin (rbv) in chronic hcv genotype 2 (gt2-), genotype 3 (gt3-), genotype 4 (gt4), genotype 5 (gt5-), or genotype 6 (gt6-) infected participants with or without cirrhosis.

the study consisted of four independent parts with treatment and post-treatment periods of enrollment. parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. in parts 1 and 2 of the study, abt-493 and abt-530 were co-administered as separate tablets. however, in parts 3 and 4 of the study, the abt-493/abt-530 co-formulated tablets were administered.

Eligibility criteria:
inclusion criteria: * screening laboratory result indicating hcv genotype 2, 3, 4, 5, or 6 infection. * chronic hcv infection. * participant had to be either hcv treatment-naïve or treatment-experienced. * participant had to be documented as non-cirrhotic or as having compensated cirrhosis (gt3 only). exclusion criteria: * history of severe, life-threatening or other significant sensitivity to any drug. * female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study. * recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. * positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab). * hcv genotype performed during screening indicating co-infection with more than one hcv genotype.

Keywords: hepatitis c virus (hcv) hepatitis c chronic hepatitis c interferon free hepatitis c genotype 2 hepatitis c genotype 3 hepatitis c genotype 4 hepatitis c genotype 5 hepatitis c genotype 6
imaging of osteonecrosis with ferumoxytol-enhanced mri

Conditions: Osteonecrosis

Summary: the goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced mri.

the goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced mri. the investigators approach relies on the fda-approved iron supplement ferumoxytol (feraheme), which is used off label as a contrast agent for mri. ferumoxytol is composed of iron oxide nanoparticles, which provide a strong t1- and t2-signal on magnetic resonance (mr) images and are taken up by cells in bone marrow. 20 patients will undergo mri before and after decompression surgery and transplantation of bone marrow derived cells. 10 patients will receive a single intravenous injection of ferumoxytol prior to their surgery. 10 additional patients will serve as untreated controls. the investigators hypothesize that mr images after intravenous injection of ferumoxytol will improve lesion detection and allow to track transplanted bone marrow cells. mr imaging findings will be correlated with clinical outcomes.

Eligibility criteria:
inclusion criteria: * osteonecrosis * planned decompression surgery with autologous stem cell transplant exclusion criteria: * contraindications for magnetic resonance imaging * hemosiderosis/hemochromatosis ( patients can still be included in the non-ferumoxytol arm)
european perioperative brugada survey

Conditions: Brugada Syndrome

Summary: the aim of this survey is to assess the current perception and clinical practice of resident and board-certified anaesthesiologists and intensivists regarding perioperative care of patients burdened with the brugada syndrome. it is intended to investigate this primarily on national and secondarily on european level.


Eligibility criteria:
inclusion criteria: * all participants must have received an invitation to participate in the survey through the online platform of the european society of anaesthesiology and intensive care. exclusion criteria: * uninvited participation in the survey is not possible.
small bowel length and bariatric surgery outcomes

Conditions: Malnutrition; Obesity; Weight Loss; Micronutrient Deficiency

Summary: the purpose of this study is to determine whether or not the total length of small intestine effects outcomes after bariatric surgery in a cohort of patients preoperatively and up to ten years postoperatively. roux-en-y gastric bypass and vertical sleeve gastrectomy will be the surgical groups in this study. we aim to determine if bowel length has a significant effect on long term weight loss or other nutritional deficiencies in this bariatric cohort.

bariatric surgery (also known as "weight loss surgery") is the most effective treatment for obesity as well as a number of other obesity-related conditions, including type 2 diabetes, hypertension, and hypercholesterolemia. interestingly, not all patients respond with significant weight loss following surgery and some patients even lack much weight loss at all over the long-term. even though variability in treatment response is observed in a variety of diseases, the biological basis for this variability in weight loss after bariatric surgery is poorly understood. recent data from our group as well as others, however, suggest that differences in the total length of the small intestine may significantly contribute to these differences in weight loss over time. for example, roux-en-y gastric bypass is thought to exert its weight loss effect because of a bypass of small intestine that causes a degree of nutrient malabsorption. the bypassed small intestine (\ 1200cm. the total length of small intestine is not routinely measured during any bariatric procedure, as the lengths of the bypass limbs are determined from the portion of the intestines closest to the stomach. the purpose of this study is to determine whether the amount of total small intestine significantly affects weight loss in patients undergoing bariatric surgery - both the roux-en-y gastric bypass (rygb) or the vertical sleeve gastrectomy (vsg). if there is a significant effect of total small intestine length on long-term weight loss in bariatric patients, then it would justify the conduct of a further study to determine whether or not these operations should be performed differently in individuals to account for the differences in small intestine length. this is an observational study that will be looking at body weight (primary endpoint) and other nutritional endpoints (other pre-specified outcome measure) over time up to ten years in this patient cohort. the body weight measurements and any laboratory data will be collected that are part of the routine clinical care of these patients.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic bariatric surgery, either vertical sleeve gastrectomy or roux-en-y gastric bypass * able to give informed consent exclusion criteria: * prior small intestine resection. * inability to safely obtain total small intestinal length measurements in the operating room. * any small bowel tethering due to intestinal adhesions identified in the operating room.

Keywords: obesity bariatric surgery bowel length
comparison of high flow vs standard nasal cannula in children with burns under sedoanalgesia

Conditions: Burns

Summary: the aim of this study is to investigate the positive effects of high-flow oxygen therapy on the reduction of airway adverse events and recovery time compared to conventional nasal oxygen therapy in pediatric burns treated with procedural sedoanalgesia.

high flow nasal cannula oxygenation (hfnco) has gained popularity in pediatric anesthesia practice. the basic mechanism of hfnco involves reducing metabolic cost and work of breathing, decreasing nasopharyngeal resistance, and improving gas conditioning and secretion clearance. heating and humidifying the oxygen administered make it easier for patients to tolerate high flow. the flow rate can be adjusted for all age groups. however, there are no studies in the literature investigating the effectiveness of hfnco during procedural sedation in pediatric burn patients. this randomized prospective study was performed in 50 patients aged 1-14 years in the pediatric burn unit. patients were divided into two groups as group hfo: high flow oxygen (n: 25) and group nc: nasal cannula oxygen (n: 25). age, sex, burn percentage, concomitant diseases, asa score, bmi (body mass index), respiratory and hemodynamic parameters, recovery time and presence of complications during sedoanalgesia were recorded.

Eligibility criteria:
inclusion criteria: * age: 1 and 14 years * asa risk groups 1-3 * second-degree burns covering more than 10% of the total body surface area, or third- and fourth-degree burns covering more than 2% of the total body surface area, burns involving the face, hands, feet, genital area, perineum, or major joints, electrical burns, and chemical burns. exclusion criteria: * under 1 year of age or over 14 years of age * asa score above 3 * having restrictive or obstructive chronic respiratory diseases, active upper or lower respiratory infections, first-degree burns, and burns to the nasal area or respiratory tract.

Keywords: pediatrics burn sedo-analgesia oxygen therapy high flow nasal oxygen hypoxia
extension to a study of the efficacy and safety of vildagliptin in patients with type 2 diabetes with hemoglobin a1c (hba1c) 9-11%

Conditions: Diabetes Mellitus, Type 2

Summary: this study is not being conducted in the united states. this is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. the purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * only patients successfully completing study claf237a2329 are eligible * written informed consent * hba1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units * ability to comply with all study requirements exclusion criteria: * premature discontinuation from study claf237a2329 * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
study of ngx267 oral capsules in patients with xerostomia associated with sjorgren's syndrome

Conditions: Xerostomia; Sjogren's Syndrome

Summary: the purpose of this study is to evaluate the effectiveness of ngx267 in the improvement of decreased salivary flow associated with primary or secondary sjögren's syndrome. for each patient, the study includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient and site discretion. each treatment period includes two overnight stays in the clinic. one dose of study drug is taken during each treatment period


Eligibility criteria:
inclusion criteria: * males and females aged 21 to 55 years, diagnosed with primary or secondary sjögren's syndrome. * patients with a complaint of dry mouth based upon difficulty in speaking, swallowing, a sensation of mouth or throat dryness, lip or tongue dryness, or a level of thirst of sufficient intensity for the patient to seek therapy. * females of childbearing potential must not be at risk for pregnancy during the study. females not of childbearing potential include postmenopausal and women who have been surgically sterilized. * patients must not be in an acute phase of illness. exclusion criteria: * patients who have clinically significant reduction kidney function. cardiovascular abnormalities; lymphoma secondary to sjögren's syndrome; pulmonary disease; the presence of enlarged salivary glands; physical closure of the salivary gland or known surgical procedure on the lacrimal punctum. * patients with diagnoses of a current gastrointestinal (gi) disease that would be exacerbated by the use of cholinomimetics; a current and acute psychiatric disorder, acute iritis, narrow angle glaucoma, or retinal disease as determined by medical history and physical examination. * patients who are otherwise judged inappropriate for inclusion in the study by the investigator * patients who have received any experimental drugs or devices or participated in any clinical trial within 30 days prior to screening including participation in a previous ngx267 clinical trial. * patients who are allergic to compounds that are similar to ngx267.

Keywords: xerostomia sjogren's syndrome
a study to evaluate the efficacy and safety of mlta3698a in combination with a disease-modifying anti-rheumatic drug (dmard) compared with adalimumab in combination with a dmard in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a phase ii, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * diagnosis of ra according to the 1987 revised acr criteria for the classification of ra for at least 6 months prior to screening * positive for rheumatoid factor or anti-cyclic citrullinated peptide (ccp) antibody, or both * active disease, defined as: crp \>= 1.0 mg/dl; swollen joint count \>= 6 (66 joint count); tender joint count \>= 6 (68 joint count) * previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (dmard) consisting of either methotrexate (mtx) or leflunomide (lfu) * for patients currently receiving corticosteroids: treatment at a stable dose during last 4 weeks prior to screening * for patients currently receiving non-steroidal anti-inflammatory drugs (nsaids): treatment at a stable dose during last 4 weeks prior to screening * for patients currently receiving sulfasalazine or anti-malarials: treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose * for patients of reproductive potential (males and females): willing to use a highly effective birth control method for the duration of the study according to local guidelines exclusion criteria: * pregnant, planning to become pregnant during the study, or breastfeeding * clinically significant abnormal laboratory values or abnormal ecg or vital signs * history of anaphylactic reactions * rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra (including but not limited to vasculitis, pulmonary fibrosis, or felty's syndrome), however patients with secondary sjogren's syndrome are eligible for the study * history of or current inflammatory joint disease other than ra (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome) * current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including hiv, hepatitis b or c, tuberculosis * administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study * previous treatment with anti-tnf biologics or other biologic agents, including anti-cd20-directed therapy (e.g. rituximab), anti-il6-directed therapy (e.g. tocilizumab), or t cell-directed therapy (e.g. abatacept)
in-person focus groups in the management of urinary incontinence in women

Conditions: Urinary Incontinence

Summary: the purpose of this study is to investigate how a support group with other individuals who share the condition urinary incontinence (ui) impacts patients experience with management of urinary incontinence.

focus groups in various settings have demonstrated the ability to alleviate psychological and physiological distress in focus group participants. the exploration of focus groups is warranted to measure the potential benefit for patients with urinary incontinence. researchers aimed to assess the feasibility and acceptability of in-person focus groups as a potential intervention for female patients with urinary incontinence from a mixed methods approach. a mixed methods pilot study will be conducted to investigate whether in-person focus group demonstrate meaningful significance in quantitative outcomes measured by validated questionnaires and qualitative outcomes analyzed from focus group transcripts and post-session surveys. this study was an initial assessment to determine whether in-person focus groups for females with ui is strong enough to warrant further research and clinical implementation.

Eligibility criteria:
inclusion criteria: * 18 years or older * english-speaking * have the ability to commute to the meeting facility without institutional assistance exclusion criteria: • those unable to attend all three focus group sessions
social determinants of sleep and obesity

Conditions: Insufficient Sleep; Physical Inactivity; Sedentary Behavior; Obesity

Summary: african american adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. to address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for african american adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. the overall goal of the project is to reduce cancer and obesity-related health disparities among african americans.


Eligibility criteria:
inclusion criteria: * not meeting physical activity guidelines * age range: 21 to 65 years * body mass index range: 25.0 to 40 kg/m2 * average self-reported habitual sleep duration of ≤6 hours * self-identify as black or african american. exclusion criteria: * self-reported organ-related disorder (copd, cardiac arrhythmia, gastro-esophageal disorder) * pregnant or less than 4 months postpartum * infant living in household less than 1 year old
tricuspid regurgitant jet velocity as an independent marker for mortality in sickle cell anemia

Conditions: Sickle Cell Anemia; Pulmonary Hypertension

Summary: the purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. previous studies have shown that an elevated tricuspid jet (tr) regurgitant velocity on echo in this population is a predictor of mortality. this initial data only examined an isolated tr jet velocity. it was presumed that the mortality was related to pulmonary hypertension. it is the aim of this study to retrospectively evaluate patients who have had multiple echocardiograms and to determine if patients who had either a normalization of their tr jet velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart catheterization had a similar mortality rate to those with persistently elevated tr jet velocity.


Eligibility criteria:
to limit bias in this study all patients that with sickle cell anemia and pulmonary hypertension with the pre-specified data required will be included.
remineralizing efficacy of grape seed extract in management of white spot lesion in post orthodontic treated patients.

Conditions: Dental Caries

Summary: this clinical trial will be conducted to compare the efficacy of grape seed extract oil versus sodium fluoride mouth wash in the management of remineralization in adult patients with white spot lesion over six months.

natural products have long been used in traditional medicine and are promising sources for novel therapeutic agents, especially in treating oral diseases such as dental caries. previously, herbs are used in dentistry for prevention and curative purpose of dental caries. the main advantages of using herbal alternatives are easy availability, cost effectiveness, increased shelf life, low toxicity, and lack of microbial resistance. grape seed extract (gse) has been found to be a promising natural remineralizing agent for treatment of the demineralized tooth. grape seed extract (gse), a readily available over the counter supplement, has been noted for its potential dental restorative and caries preventative properties as a potent antioxidant. there are multiple bioactive properties in gse, but in particular, its rich content of proanthocyanidins (pacs) plays a role in its theoretical benefit in caries prevention. pacs have hydrophobic and hydrophilic properties, which enhance their ability to irreversibly bind to a variety of compounds, particularly minerals, proteins, and carbohydrates. the remineralization effect of gse appears to be featured. first, it participates in mineral deposition on the superficial layer of the lesion through forming insoluble complexes and combines with calcium to enhance remineralization. second, gse may interact with the organic portion of enamel through pa-collagen interaction, thereby stabilizing the exposed collagen matrix. proanthocyanidin (pa) has been proved to strengthen collagen-based tissues by increasing collagen cross-links. it is claimed that it can increase collagen synthesis and accelerates the conversion of soluble collagen into insoluble collagen. proanthocyanidin has proved safe in different clinical applications and has been used as dietary supplements as well.

Eligibility criteria:
inclusion criteria: * presence of at least two wsls on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy * age range between 13 and 30years. exclusion criteria: * severe or active periodontal disease. * patients had received therapeutic irradiation to the head and neck region. * patients had participated in a clinical trial within 6 months before commencement of this trial. * patients unable to return for recall appointments * presence of abnormal oral, medical, or mental condition. * presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.