Kornimate/medical-research-clean huggingface dataset:
effect of the chromium nicotinate on type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the role of micronutrients in diabetes is not well understood. studies have demonstrated the relationship between low chromium serum levels and insulin resistance. this study aims to evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients with type 2 diabetes.

insulin is a hormone secreted by cells β of pancreatic islets in response to increased levels of glucose and serum amino acids. insulin resistance means a decrease in the ability of insulin to stimulate glucose utilization because is disabled in the insulin receptor, decrease in concentration of receptors or failure mechanism of cell transit. recently, the discovery of a substance called low molecular weight chromium-binding substance (lmwcr), showed the ability of this substance in amplifying insulin signaling, increasing the sensitivity of insulin receptors in the plasma membrane. this way, the capacity of lmwcr in activating the insulin receptor depends on levels of serum chromium. thus, the hypothesis that the nutritional status of individual poor chromium contributes to the decrease in glucose tolerance and consequently, for type 2 diabetes. thus, it becomes necessary to assess the effect of supplementation of chromium in increased insulin sensitivity in patients with type 2 diabetes. this is a double-blind randomized clinical trial, consisting of a period of three months of nutritional intervention with chromium nicotinate, biochemical and anthropometric evaluation and assessment of food profile and physical activity.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * body mass index \> 25 kg/m2 * increased waist circumference exclusion criteria: * subjects on insulin * pregnancy * patients with chronic complications as heart disease, nephropathy, retinopathy

Keywords: type 2 diabetes chromium insulin resistance
prospective athlete's heart study

Conditions: Athlete Heart

Summary: the pro@heart (prospective athlete's heart) study is an international multicentre long-term prospective trial. the primary objective of the pro@heart study is to investigate the impact of training load (i.e. accurately evaluated in term of type, frequency, duration and intensity) and genotype on the variability of structural, functional and electrical exercise induced cardiac remodeling (eicr) in young competitive endurance athletes. the second objective is to determine how eicr, training load and genotype are associated with physical performance, health benefits and cardiac pathology (e.g. exercise-related cardiomyopathies and arrhythmias) during follow-up over several decades.


Eligibility criteria:
inclusion criteria: 1. males and females aged 14-23 years old 2. athletes competing in endurance sports at national or international level for at least 2 years. sports include: 1. triathlon 2. cycling 3. distance running (≥ 1500 meters) 4. rowing 5. swimming 3. non athletes engaged in \< 3 hours per week of physical activity exclusion criteria: 1. medical history of cardiovascular disease 2. current smoker of past history of smoking 3. diabetes mellitus

Keywords: athlete atrial fibrillation arrhythmias cardiac remodelling cardiomyopathy genetics
the impact of an investment based intervention on weight-loss and beliefs about food in patients post bariatric surgery

Conditions: Obesity

Summary: although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. previous pilot work by the lead researcher shows that successful weight loss is associated with the amount of investment the patient feels that they have made in their operation. for example, those who feel that it has taken more time and effort to organise, has cost more money, has been more disruptive to their family, social and work lives and has caused pain are more likely to lose weight after their operation. therefore, it seems as if the greater the sense of investment, the greater the motivation to make the operation a success. the present study aims to build on these findings by encouraging weight loss surgery patients to focus on the investment they have made, thus making their investment more salient to them. using a trial design, half the patients will be asked to rate and describe the investment they have made in their operation just before surgery (focusing on the time and effort to organise the surgery etc) and 3 months after surgery (focusing on time off work for recovery, disruption of family and friends, pain of surgery, pain of having the stitches removed etc). all patients will record their weight, beliefs about food, intentions to change their behaviour and actual eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. the impact of the investment based intervention will then be assessed to explore whether focusing on the investment involved in having surgery improves patient health outcomes by one year.


Eligibility criteria:
inclusion criteria: * aged 18 or over * having bariatric surgery at university college hospital exclusion criteria: * if the patient does not understand english * if the patient does not consent to take part in the study

Keywords: bariatric surgery health psychology
nutritional supplementation in patients with no signs of malnutrition

Conditions: Primary Neoplasm; Secondary Neoplasm; Abdominal Neoplasm

Summary: the aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition

in previous psychological studies our team found high level psychological stress in over 60% of cancer patients. this may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. in this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications

Eligibility criteria:
inclusion criteria: * primary or secondary resectable gastrointestinal and abdominal malignancy * no signs of malnutrition at qualification for surgery * general performance \>70 karnofsky scale * informed consent exclusion criteria: * history of radio or chemotherapy * signs of mechanical ileus * other major gastrointestinal diseases * type 1 diabetes * autoimmunological diseases requiring systemic steroids * signs of infection * renal and/or liver failure

Keywords: nutritional support gastrointestinal cancer malnutrition
respiratory microbiota and immune response in cvid

Conditions: CVID

Summary: common variable immunodeficiency (cvid) is the most prevalent symptomatic primary immunodeficiency. respiratory ailments are the most frequent complications of cvid, with chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute respiratory infections. this project aims to establish cutting-edge approaches to study pulmonary biology in cvid and apply novel bioinformatics strategies to study complex interactions among microbes and host cells by direct sampling of the respiratory tract. the central hypothesis for this research is that antibody (ab) deficiency in cvid alters respiratory microbiota and host interactions to drive pulmonary disease.


Eligibility criteria:
inclusion criteria: * patients with primary antibody deficiency diagnosed by their treating physician * controls will not have a diagnosis of immunodeficiency of any sort * male and female patients will be enrolled evenly exclusion criteria: * patients who self identify as pregnant * patients with asthma or chronic obstructive pulmonary disease (copd) that are not well controlled clinically

Keywords: impaired antibody response pattern recognition receptor immunoglobulins respiratory microbiota nuclear factor kappa b (nf-κb)-driven cytokines complex microbial-host cell interactions pulmonary biology rnaseq analysis
safety study to assess the potential for adrenal suppression following maximal use treatment with dsxs

Conditions: Psoriasis

Summary: an open label, safety study to assess the potential for adrenal suppression following maximal use treatment with dsxs .

evaluate the potential of dsxs topical product to suppress hpa axis function in patients with moderate to severe scalp psoriasis. evaluate the efficacy parameters and adverse event (ae) profiles of dsxs topical product administered to patients with moderate to severe scalp psoriasis.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating females 18 years of age or older. * ire-approved, signed informed consent form that meets all criteria of current fda regulations. exclusion criteria: * females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
procalcitonin role in influenza patients with regard to morbidity, mortality and antibiotic use

Conditions: Influenza

Summary: the investigators intend to observe the inflammatory marker procalcitonin (pct) in comparison with patient variables on morbidity, mortality and antibiotic treatment. the overall aim is to observe if a low pct value can have potential in reducing unessesary antibiotic use in seasonal influenza patients.

this is an observational study of the clinical utility of early pct measurements in seasonal influenza, with particular attention to pct's predictive value for prognosis and bacterial respiratory superinfection. the aim is to evaluate pct as a supplementary aid in the standard clinical evaluation of influenza patients. patients may be included if a positive influenza test is reported within 48 hours after an initial clinical suspicion of influenza, and the hospital stay is lasting more than one day. the investigators have included 74 patients from the second half of the 2018-19 influenza season and will continue to include patients from the complete 2019-20 season. primary endpoints: mortality (in-hospital and within 30 days post-discharge), bacterial respiratory tract superinfection. secondary endpoints: intensive care unit stay, the proportion of patients on antibiotic use and total antibiotic use in doses and lot ("length-of-treatment").

Eligibility criteria:
inclusion criteria: * patient admitted to the hospital with positive influenza test exclusion criteria: * none

Keywords: procalcitonin
posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients

Conditions: Cholecystitis in Cirrhotic Patients

Summary: to assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients in assuit university hospitals and el rajhi hospital.

cholelithiasis is found in about one third of patients with liver cirrhosis and about twice as much as in the overall population. predisposing factors for that include functional gallbladder alterations (reduced motility and decreased emptying), reduction in bile acidity, increased unconjugated bilirubin secretion, increased levels of estrogen, and increased intravascular haemolysis due to hypersplenism. symptomatic biliary stones in patients with liver cirrhosis are associated with higher morbidity and mortality rates than those in patients with a non-cirrhotic liver. laparoscopic cholecystectomy is the gold standard for the treatment of most of gallbladder problems because of its several advantages over open cholecystectomy including shorter convalescence period and hospital stay. furthermore, considering its safety, it is the gold-standard procedure in selected patients with symptomatic cholelithiasis and hepatic cirrhosis, especially child-pugh score a and b patients. separation of posterior wall of the gallbladder from the liver bed in cirrhotic individuals is difficult and risky during a laparoscopic cholecystectomy surgery because of high-risk gall bladder bed due to fibrosis and tortuous, dilated vessels there so the strategy is leaving the posterior wall intact with the liver and the remnant mucosa was removed either by mucosectomy in patients with acute cholecystitis or by electro fulguration in those with chronic cholecystitis.

Eligibility criteria:
inclusion criteria: * patient age 18 - 60 years old child a and b cirrhotic patients with cholelithiasis patient fit for surgery exclusion criteria: * patient with pervious abdominal surgery
a phase i/iii clinical study of tpx-114 for the treatment of full-thickness rotator cuff tear

Conditions: Rotator Cuff Injuries

Summary: rotator cuff tear is one of the most common shoulder diseases and retears occur frequently after arthroscopic repair. therefore, there is a growing need of new therapy to improve structural outcome. this study evaluates the efficacy and safety of autologous fibroblasts during arthroscopic repair. the primary outcome is the retear rate at 24 weeks after administration of autologous fibroblasts (tpx-114) during arthroscopic repair. secondary outcomes are functional evaluations including range of motion (rom), constant score (cs), american shoulder and elbow surgeons (ases) score and simple shoulder test (sst) at 24 and 52 weeks after administration.


Eligibility criteria:
inclusion criteria: participants must; 1. be 19 years of age or older. 2. require arthroscopic repair for full-thickness rotator cuff tear(\>2cm, ≤5cm) assessed by mri without improvement of symptoms despite more than 3 months of conservative management. 3. consent to undergo skin biopsy to manufacture test product. 4. understand fully the study and voluntarily sign the informed consent for participation in the study. exclusion criteria: participants with any of the following conditions will be excluded unless stated otherwise; 1. unsuitable for skin biopsy. 2. have additional subscapularis tear. 3. have prior medical history of the following at the time of screening. * operation of the affected shoulder * allergies to bovine proteins * anaphylaxis to gentamicin * coagulopathy * genetic disorders affecting fibroblasts or collagen (ex. achondroplasia, osteogenesis imperfecta) * malignant tumors within the last 5 years 4. have been diagnosed with any of the following diseases at the time of screening. * autoimmune disease (including ra) * hiv ab-positive * acute trauma, chronic shoulder dislocation, pyogenic infection on the affected shoulder * scapulohumeral osteoarthritis 5. be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptives suggested in this study. 6. other surgical or nonsurgical procedures on the affected shoulder to be judged more appropriate than arthroscopic repair. 7. have participated in and received investigational agents in other clinical trials within 4 weeks of this study. 8. be deemed inadequate for the study by investigators.
clinical utility of management of patients with pulmonary nodules using the percepta nasal swab classifier

Conditions: Pulmonary Nodule, Solitary; Lung Cancer

Summary: the goal of this observational study is to learn how a physician uses the results of the percepta® nasal swab test to manage people with a newly identified pulmonary nodule. the main questions it aims to answer are: * does the use of the percepta nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign? * does the use of the percepta nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer? participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). researchers will compare management of participants in the two groups.

this is a prospective, multicenter, randomized study to evaluate the clinical utility of the percepta® nasal swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. the study will observe and evaluate how the addition of the percepta nasal swab classifier result impacts current management of newly identified lung nodules. the study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the us. enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer.

Eligibility criteria:
inclusion criteria: * able to tolerate nasal epithelial specimen collection * signed written informed consent obtained * subject clinical history available for review by sponsor and regulatory agencies * new nodule identified on imaging \< 90 days prior to nasal sample collection * ct report available for index nodule * 29 - 85 years of age * current or former smoker (\>100 cigarettes in a lifetime) * pulmonary nodule ≤30 mm detected by ct exclusion criteria: * active cancer (other than non-melanoma skin cancer) * prior primary lung cancer (prior non-lung cancer acceptable) * prior participation in this study (i.e., subjects may not be enrolled more than once) * current active treatment with an investigational device or drug * patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule * concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators
129 xenon mri as a biomarker for diagnosis and response to therapy in pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension; Idiopathic Pulmonary Arterial Hypertension; Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (Disorder); Connective Tissue Diseases

Summary: the overall study objectives outlined in this study are to derive 129xe mri pulmonary vascular biomarker signatures that differentiate common subtypes of pah and to determine the ability of 129xe mri to longitudinally monitor disease progression and response to therapy in pah, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6mwd).

subject enrollment this study will consent and enroll 20 subjects total. • for arm 1, 10 subjects with idiopathic pulmonary arterial hypertension (ipah) will be consented and enrolled. for arm 2, 10 subjects with connective tissue disease associated pulmonary arterial hypertension (pah-ctd) will be consented and enrolled. study design this study will be observational. subjects in both arms of the trial will undergo a 129xe mri/mrs at timepoints of baseline, 3 months, 6 months, and 12 months. in addition to the this, data from standard of care assessments, such as labs, echocardiography, and six-minute walk distance (6mwd), will also collected at these timepoints. primary study endpoints the primary endpoint for this trial will be the change in defect + low percentage of rbc signal on hyperpolarized 129xe mri from baseline to 12 months secondary study endpoints there will be several secondary endpoints for this trial: * change in regional and global rbc oscillation amplitudes on hyperpolarized 129xe mr spectroscopy from baseline to 12 months * change in 6mwd from baseline to 12 months * change in ntprobnp from baseline to 12 months * change in who fc from baseline to 12 months primary safety endpoints there will be several primary safety endpoints for this trial: * frequency of adverse events (ae) and/or serious adverse events (sae) * withdrawals due to adverse event or death * incidence of adverse events of significant interest (aesi): * electrocardiogram and any findings * physical examination and vital signs

Eligibility criteria:
inclusion criteria: arm 1 -ipah * age: 18-75 years * who functional class 2 or 3 * mean pulmonary artery pressures \> 20 mmhg * pulmonary capillary wedge pressure ≤15 mmhg * pulmonary vascular resistance \> 2 wood units (wu) * no other cause identified for pah arm 2 -pah-ctd * age: 18-75 years * who functional class (fc) 2 or 3 * mean pulmonary artery pressures \> 20 mmhg * pulmonary capillary wedge pressure ≤15 mmhg * pulmonary vascular resistance \> 2 wu * diagnosis of connective tissue disease exclusion criteria: * ph other than idiopathic pah or pah associated with ctd; any conditions that prevent the performance of 129xe mri scans will be excluded from the study.
effect of peer support intervention on early recovery outcomes post coronary artery bypass graft surgery

Conditions: Cardiovascular Disease

Summary: recovery from coronary artery bypass graft (cabg) surgery is a complex process involving physical recuperation and psychological adjustment. the high prevalence of postoperative depression in this population may threaten optimal recovery. peer support over the recovery period has promise to mitigate this threat. the purpose of this study was to examine the effect of a professionally-guided telephone peer support intervention on recovery outcomes including depression, social support and health care resource utilization. in a randomized controlled trial, 185 male cabg surgery patients randomly assigned to an intervention (n=61) or usual care (n=124) group. participants in the intervention group received weekly telephone calls from a peer volunteer over 6 weeks post discharge. at hospital discharge and at 6 and 12 weeks follow up, depression was measured using the beck depression scale-ii, social support was measured using the shortened social support scale and health care resource utilization was measured using items in the postoperative self report of recovery questionnaire. participants in the intervention group were also asked questions about their perceptions regarding peer support using the peer support evaluation inventory.


Eligibility criteria:
inclusion criteria: * english speaking * \> 35 years of age * undergoing first-time traditional (sternotomy approach) cabg surgery * an uncomplicated postoperative course * standard length of hospital stay (four to eight days) * had a telephone in the home * able to hear telephone conversation. exclusion criteria: * had cardiac surgery procedures other than cabg surgery * resided in a nursing home or long term care facility * had any neurological or psychiatric disorder that may have impeded ability to self reflect or communicate * had emergent cardiac surgery * had sustained in-hospital post surgical complications of major significance (i.e., stroke, gi bleed, cardiac tamponade, renal failure, cardiac arrest, major sepsis of any origin, deep sternal wound infection, myocardial infarction with significant hemodynamic compromise)

Keywords: depression, peer support, recovery, health services
safety of ngois compared to bss plus in pediatric patients

Conditions: Cataract

Summary: to evaluate the safety of next generation ophthalmic irrigating solution compared to bss plus for use during cataract surgery in pediatric patients.


Eligibility criteria:
inclusion criteria: * cataract present. * other protocol-defined inclusion criteria may apply. exclusion criteria: * as per age requirements. * other protocol-defined exclusion criteria may apply.