Kornimate/medical-research-clean huggingface dataset:
transitional care program for fluid overload in cirrhosis

Conditions: Cirrhosis, Liver

Summary: the goal of this clinical trial is to learn about an intensive monitoring plan (transitional care program) in patients with cirrhosis and excessive swelling that are going to be discharged from the hospital. the main question\[s\] it aims to answer are: * how much time and what resources are needed to run such a program * how well do patients follow up with the phone calls, bloodwork, and doctor appointments? * do the patients enrolled in the program have less need for hospitalization later, less kidney injury, better fluid control, and/or better survival compared to patients that are not in the program? participants will * be given a digital scale and a binder with educational material and a log to monitor their weights after discharge from the hospital * receive a phone call from the study team within 72 hours of discharge and weekly * be given a follow up appointment with hepatology within 4 weeks of discharge researchers will compare participants in this program to patients that receive normal care to see if there are differences in need for hospitalization later, kidney injury, fluid control, and/or survival.


Eligibility criteria:
inclusion criteria: * patients \> 18 years of age. * inpatient at penn state health, milton s. hershey medical center. * diagnosis of cirrhosis. * hospitalized with fluid overload (ascites and/or significant anasarca/edema) requiring diuretic therapy. * english speaking exclusion criteria: * placement of a tips. * ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome. * non-english speaking

Keywords: ascites anasarca edema
a 1-year study of an investigational drug in obese patients (0557-012)(completed)

Conditions: Obesity

Summary: this is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.


Eligibility criteria:
inclusion criteria: * obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study. exclusion criteria: * patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
fluoride retention in the mouth of older adults

Conditions: Hyposalivation

Summary: individuals with dry mouth (a reduction in the production of saliva) suffer from high rates of oral diseases. dry mouth is a common problem among older individuals, because many medications to control chronic conditions (such as blood pressure, bladder-control problems and depression) reduce the flow of saliva. for these individuals, fluoride is used to maintain a good oral health. usually, higher fluoride concentration products, such as prescription toothpastes, are recommended. in this project, the ability to increase fluoride retention in the mouth by using calcium before a conventional fluoride rinse will be tested in older adults with a range of salivary flow rates. this approach was never tested in patients with dry mouth, for whom the treatment with calcium may also be beneficial. a crossover, clinical study with two experimental phases will be conducted, in which patients with a range of saliva flows (from normal to dry mouth) will rinse with a fluoride rinse only (used at over the counter concentration), or a fluoride rinse preceded by a calcium rinse. the concentration of fluoride and calcium in the saliva and dental plaque residues will be determined up to two hours after the rinse(s), to test the effect of the approach to optimize fluoride retention in the mouth of patients with dry mouth.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * good general health as evidenced by medical history * good oral health as evidenced by a clinical oral exam * having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth * having salivary flow rate ranging from normal to hyposalivation according to direct flow rate determination methods * agreement to adhere to the study protocol exclusion criteria: * unable to understand and/or follow study instructions * active periodontitis * oral pain * in need of urgent dental care
does antrum size matter in sleeve gastrectomy?

Conditions: Bariatric Surgery Candidate

Summary: laparoscopic sleeve gastrectomy (lsg) is currently the most frequent primary bariatric procedure performed worldwide. lsg is safe and effective in terms of excess weight loss. it is a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behaviour, glycemic control and intestinal functions. lsg is easier regarding its technical aspects and does not need any intestinal anastomosis, begin limited to the stomach. the most frequent and sometimes dangerous complications are leaking, haemorrhage, splenic injury, sleeve stenosis and gastroesophageal reflux. despite its established efficacy and safety, controversy still exists on optimal operative technique for lsg: bougie size, the distance of resection margin from the pylorus, the shape of the section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing is among the most controversial issues 11\[6\]. in literature, different authors have adopted a resection distance from the pylorus between 2 and 6-7 cm with various reasons 11\[6\]. resections more distant to the pylorus improve gastric emptying, prevent distal stenosis and reduce intraluminal pressure, potentially leading to a lower incidence of fistula and/or reflux. on the other hand, resections close to the pylorus would reduce gastric distensibility and increase intragastric pressure, potentially increasing satiety with less oral intake 11(11,12). the primary aim of this randomized monocentric study is to evaluate %ewl at 1 and 2 years follow-up after lsg in two groups: group a with a gastric resection starting from 2 cm from the pylorus with therefore a wide antrectomy and group b with a gastric resection starting from 6 cm from the pylorus with therefore a small antrectomy.


Eligibility criteria:
inclusion criteria: * informed consent. * morbid obesity defined as body mass index (bmi) 40 kg/m2 exclusion criteria: * previous bariatric surgical procedures, * endocrine disorders causing obesity * pregnancy or lactation * psychiatric illness * inflammatory bowel disease * barrett ́s oesophagus * severe gerd with esophagitis b and c * a large hiatal hernia (\>5 cm) * gerd-hrqlscore \> 25 dietary restriction despite
exercise training in grown-up congenital heart disease

Conditions: Congenital Heart Disease

Summary: rationale: regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. unfortunately, no such data is available on exercise training in adult patients with congenital heart disease. objective: the objective of the extra guch trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum n-terminal prohormone brain natriuretic peptide (nt-probnp) levels. study design: international, multi-centre parallel randomized controlled trial. study population: adult patients with congenital heart disease, who are in new york heart association (nyha) class ii or iii. intervention (if applicable): the intervention group receives a six-month individualized exercise training program, the control group receives usual care. main study parameters/endpoints: the primary outcome is the change in peakvo2 between patients in the sports participation group, and the control group. secondary outcome measures are change in nyha functional class, quality of life, and nt-probnp levels. the primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. the secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.

the investigators intend to submit the trial design of this study for this purpose.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * congenital heart disease of all complexities * nyha class ii or iii exclusion criteria: * inability to give informed consent * inability to participate in an exercise training program * exercise-induced arrhythmia and/or ischemia * cyanosis at rest * pregnancy * major cardiovascular event and/or procedure within three months previous to inclusion. * participation in interventional clinical trial

Keywords: congenital heart disease sport exercise training
non-invasive diagnostics of pulmonary hypertension with dual energy computed tomography

Conditions: Pulmonary Arterial Hypertension

Summary: the aim of the study is to determine relevant hemodynamic parameters for the diagnostics of pulmonary arterial hypertension (pah) by dynamic contrast enhanced dual-energy ct (de-ct). in this prospective study the investigators validate de-ct results of patients against hemodynamic parameters from right heart catheterisation and control the results by other clinical investigations. the investigators expect that using this non-invasive method, parameters relevant for the diagnosis of the patients with pah, like pulmonary blood volume, blood flow and perfusion heterogeneity, can be determined.

pulmonary arterial hypertension (pah) is a rare, life-threatening disease. it is characterized by the elevation of pulmonary arterial pressure and pulmonary vascular resistance. a remodeling of small pulmonary vessels characterized by the proliferation of the adventitia, the hypertrophy of the media and fibrosis of the intima can be observed on the microscopic level. non-invasive techniques for hemodynamic assessment and identification of early pulmonary vascular remodeling and pulmonary hypertension have a marked practical advantage as compared to invasive right heart catheterization, however, their accuracy and reliability is not well established. in the present study the investigators examine patients who are scheduled for a thorax ct with an additional dynamic contrast-enhanced de-ct protocol and derive established parameters for the diagnosis of pah as well as novel parameters from the ct scans. these are compared to results from the right-heart catheterization and other investigations routinely carried out on these patients.

Eligibility criteria:
inclusion criteria: * patients with right heart catheterization data exclusion criteria: * patients with decreased renal function * patients who received ct in the previous six months * intolerance of contrast material * other standard ct contraindications

Keywords: early diagnosis of pulmonary arterial hypertension dynamic dual-energy computed tomography
treatment of keloid scar by autologous platelet rich plasma obtained with rgenkit-bct

Conditions: Keloid

Summary: the aim of this prospective study is to assess the efficacy of autologous platelet rich plasma prepared with regenkit-bct in the prevention and the treatment of keloid scars refractory to conventional treatments. fifteen patients were included and received three prp injection sessions with a one-month interval. the outcomes were assessed at baseline (before treatment), 3, 6, 12 and 24 months after the last injection session. safety was assessed by reported adverse event analysis.

to evaluate the efficacy and the safety of platelet rich plasma in the treatment of keloid scars. this prospective, comparative study (before-after treatment) included 15 patients with keloid scars refractory to conventional treatment (corticoids, surgery, cryotherapy). the primary outcome was the percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment. secondary outcomes were the vancouver scar scale and pruritus severity scored at 3, 6, 12 and 24 months post treatment vs baseline.

Eligibility criteria:
inclusion criteria: * patients with keloid scars refractory to conventional treatments. the indication of prp injection was based on the absence of response to corticosteroids alone or in combination with surgery after 4 sessions of infiltration and/or absence of response to other therapies. exclusion criteria: * patients younger than 18 years * pregnancy or breastfeeding * patients suffering from anemia * patients with active skin disorder infection including active hepatitis or human infection virus infection * auto-immune disease such as hashimoto, rheumatoid arthritis. * malignancy with or without metastatic disease * chemotherapy * anticoagulant therapy

Keywords: keloid scar wound healing platelet-rich plasma regenlab
study of blood and tissue samples from patients with locally advanced, metastatic, or recurrent non-small cell lung cancer treated with bevacizumab, carboplatin, and paclitaxel

Conditions: Lung Cancer

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is looking at blood and tissue samples from patients with locally advanced, metastatic, or recurrent non-small cell lung cancer treated with bevacizumab, carboplatin, and paclitaxel.

objectives: primary * to determine whether germline polymorphisms (dna) of genes involved in dna repair (e.g., xpd, ercc-1, and others) and angiogenesis (e.g., vascular endothelial growth factor \[vegf\], interleukin-8, cxcr2, adrenomedullin, leptin, and others) are associated with toxicity and clinical outcome in patients with non-small cell lung cancer enrolled on protocol ecog-4599. outline: blood samples previously obtained from patients on protocol ecog-4599 are analyzed for the association of germline variations of genes involved in dna repair (xpd and ercc1), angiogenesis (vegf and il-8), and clinical outcome (overall survival, response, progression-free survival, and toxicity). tumor cells are collected from paraffin-embedded tissue using laser-capture microdissection and normal tissue is collected from the specimen. polymorphisms in ercc-1, xrcc-1, xrcc-3, gst-p1, tgf-β, and il-8cxcr are assessed using taqman assays.

Eligibility criteria:
disease characteristics: * available serum or plasma samples from patients with locally advanced, metastatic, or recurrent non-squamous non-small cell lung cancer * stage iiib (with pleural effusion) or stage iv disease * enrolled on protocol ecog-4599 * treated with carboplatin and paclitaxel with or without bevacizumab patient characteristics: * not specified prior concurrent therapy: * see disease characteristics * no prior chemotherapy

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer recurrent non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer
butyric acid supplementation for gut improvement after cardiac surgery in kids

Conditions: Congenital Heart Disease (CHD)

Summary: butyric acid has been shown to promote gut health and improve the microbiome in multiple adult studies. in preliminary studies in older children with inflammatory bowel disease, butyric acid was shown to be safe. however, it's suitability for infants and young children with congenital heart disease (chd) has yet to be determined. this study will examine butyric acid supplementation in infants and children, ages 1 month to 3 years, with chd who require cardiac surgery with cardiopulmonary bypass. study goals include determining the safety and tolerability of butyric acid supplementation before cardiac surgery, and to identify changes in gut microbial communities, metabolic profile, and genetic markers intestinal function. also, the study seeks to establish a reduction in inflammation (inflammatory signaling) after cardiopulmonary bypass (cpb) in participants receiving butyric acid.

the goal of this study is to supplement a liquid form of butyric acid once daily for 3 weeks prior to cardiac surgery for infants and children, ages 1 month to 3 years, with congenital heart disease to improve their pre-operative gut microbiome in efforts to reduce post-operative gut permeability and reduce post-operative inflammatory signaling. up to 35 participants will be enrolled in each of three arms: * 2 ml butyric acid * 4 ml butyric acid * placebo. participants will be asked to: * provide blood and stool samples (baseline, post-supplement-pre-operative, 1-hr post-op, \& post-op days 1-3) * take either 2 ml, 4 ml or placebo once daily for 3 weeks prior to cardiac surgery * complete a daily log to track timing of supplement administration and any side effects or adverse events experienced study aims: * aim 1 safety and tolerability will be measured following baseline complete blood counts, complete metabolic panel to evaluate electrolytes and organ function, along with a daily log of supplementation timing and any experienced adverse events. * aim 2 modulation of gut health will be measured with stool and blood samples. changes will be measured in the gut microbiome and metabolite profiles before and after supplementation, as well as post-operatively. gut health will be determined by measuring plasma markers of gut barrier function before and after supplementation, as well as post-operatively. * aim 3 reduction of post-operative inflammatory signaling will be measured with blood samples. plasma cytokine levels, immune cell profiles, and inflammatory gene activation with an rna hybridization panel will be measured pre-operatively and post-operatively.

Eligibility criteria:
inclusion criteria: * infants and children undergoing cardiac surgery with cardiopulmonary bypass exclusion criteria: * antibiotics, surgery, or chemotherapy within the past 8 weeks * continuous enteral feeds before surgery * gi pathology or intestinal surgery (excluding g-tube) * liver disease with elevated transaminitis or dialysis-dependent renal disease

Keywords: congenital heart disease gut health microbiome gut barrier function inflammation
evaluation of endostapled anastomoses for laparoscopic gastric bypass (eea-lgb)

Conditions: Morbid Obesity

Summary: laparoscopic gastric bypass surgery is a common procedure being performed for the treatment of morbid obesity. the procedure consists of a creation of a small gastric pouch and rerouting the small bowel to bypass the stomach and duodenum. there are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy. potential complications after gastric bypass include gastrointestinal bleeding and leaks. gastrointestinal bleeding can occur at any staple line including the gastrojejunostomy. potential methods for prevention of postoperative gastrointestinal bleeding include oversewing of the anastomosis or the use of a smaller stapler height. we hypothesize that the use of staplers with smaller staple height will significantly result in a lower rate of staple line bleeding and possible leaks.

rationale: 1. gastrointestinal (gi) bleeding can occur in up to 4% of cases. gi bleeding is associated with significant morbidity which may include transfusion and possible re-operation 2. leaks at the gastrojejunostomy can be potentially life threatening and ranged from 1% to 2%. hypotheses: the smaller circular stapler may be associated with a lower rate of intraoperative intraluminal bleeding and postoperative gastrointestinal bleeding than the larger one.

Eligibility criteria:
inclusion criteria: 1. bmi between 40-60 kg/m2 2. bmi of 35 kg/m2 with comorbidities exclusion criteria: 1. large abdominal ventral hernia 2. large hiatal hernia, 3. history of liver cirrhosis 4. history of venous thrombosis or pulmonary embolism, coagulopathy or 5. pregnant women * all physician, hospital, surgery, and laboratory costs will be billed to the subject or their insurance carriers as customary. the 3.5mm circular stapler is an fda approved product and it will also be billed to the subject or insurer in the customary fashion.

Keywords: morbid obesity laparoscopic gastric bypass staple line hemorrhage
effectiveness of buerger allen exercise among type 2 diabetes mellitus patients with foot ulcer

Conditions: Diabetic Foot Ulcers

Summary: this study was conducted to determine the effect of buerger allen exercises on lower extremity perfusion and wound healing in patients with foot ulcer type 2 diabetes. the buerger allen exercise is a specific exercise that aims to improve circulation in the feet and legs. buerger allen exercise is an ideal and noninvasive therapy for diabetic patients with a diabetic foot ulcer as it is an easy-to-learn, repetitive, low-cost, and low-risk physical activity. subjects were randomly allocated to either the control or intervention group. the ulcers and lower extremity perfusion of the patients in both the intervention and control groups were examined and measured.

the purpose of this study was to investigate the effect of buerger allen exercises on lower extremity perfusion and wound healing in type 2 diabetic patients with a diabetic foot ulcer. subjects were recruited by the researcher in the clinics where they received treatment. randomized controlled study design was used in the study. patients in the study were allocated to the control and study intervention groups. the data collection form developed by the researcher was used to collect the data. patients in both groups received standard wound care. subjects in the study intervention group were asked to exercise twice daily for 12 weeks. the ulcers and lower extremity perfusion of the groups were assessed in the beginning, in the 4th week, and the 12th week. the groups will be compared in terms of the ulcer size and lower extremity perfusion.

Eligibility criteria:
inclusion criteria: * 18 years or older, * patients with type 2 diabetes with foot ulcer * receiving oral antidiabetic and/or insulin therapy, * pedis classification stage 1 and 2 * does not have communication and mental problems, * are literate and speak turkish, * patients who volunteered to participate in the study exclusion criteria: * with dementia and mental problems, * those with serious diabetes complications such as kidney failure and hemodialysis, * patients receiving hyperbaric oxygen therapy, negative pressure wound therapy, epidermal growth factor for wound healing.
comparative study of nxl103 versus comparator in adults with community acquired pneumonia

Conditions: Community Acquired Pneumonia

Summary: the purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral nxl103 with oral comparator in the treatment of community acquired pneumonia in adults


Eligibility criteria:
inclusion criteria: * community acquired pneumonia exclusion criteria: * severe cap * respiratory infections attributed to sources other than community acquired bacterial infection * concomitant pulmonary disease * history of hypersensitivity to study medication, macrolide or beta lactam antibiotics

Keywords: cap community acquired pneumonia