Kornimate/medical-research-clean huggingface dataset:
influence of protein intake on muscle mass and health-related quality of life during and after radiotherapy

Conditions: Malnutrition; Cachexia

Summary: the influence of radiotherapy on the protein intake and muscle mass of patients has not been extensively investigated to date. it is also unclear whether the localization of the tumor disease and thus the radiation field have different effects. therefore, with the pilot study presented here, we would like to record the nutritional uptake of patients before and after radiotherapy. the aim is to determine the amount of energy and protein intake as well as the timing of protein intake. furthermore, the relationship between the timing of protein intake and muscle mass will be investigated.

many studies have shown that cancer patients have a very high prevalence of malnutrition. several large-scale studies have reported that 50-80% of these patients are affected by involuntary weight loss, with the extent of weight loss depending on the tumor location and the type and stage of the disease. it has been widely reported that nutritional interventions are essential in cancer patients. nevertheless, nutritional support is still not universally accessible to all patients. given the prevalence of nutritional risks, the treatment of lean muscle mass loss remains a challenge in clinical practice. for this reason, a multidisciplinary approach with targeted nutritional therapy is crucial to improve the quality of care in oncology. a protein level of 1-1.2 g/kg bw is suggested for the maintenance of muscle mass.however, it has been shown that this amount is not sufficient to support alm in patients with tumor diseases. only an amount above 1.4 g/kg bw has been associated with a positive effect on muscle mass. adequate dietary protein intake is essential for the maintenance of numerous physiological processes, including muscle protein synthesis and muscle function. sufficient energy and protein intake is necessary to support muscle protein synthesis. the scientific literature frequently discusses the relationship between daily protein intake and its distribution over the main meals. the evening meal is particularly important for the maintenance of alm.

Eligibility criteria:
inclusion criteria: * capacity to consent * at least 45 years of age * sufficient knowledge of the german language * indication to undergo radio(chemo)therapy with at least 10 fractions exclusion criteria: * participation in other interventional studies * pregnancy/breastfeeding * previous intake of high-calorie supplementary food or intravenous nutrition * bmi \< 18.5 * when performing the bioimpedance measurement: patients with pacemakers, defibrillators and other implanted automatic devices

Keywords: cancer radiotherapy nutrition sarcopenia inflammation microbiome
two versus four implant-supported fixed full-arch prosthesis

Conditions: Prosthesis Durability

Summary: the aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (ohrqol) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.

* six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department * all patients will be informed about all surgical and prosthodontics procedures that will be done for them. all patients will sign the consent form of the ethical committee in faculty dentistry mansoura university. the patients will be divided into 2 groups 1. control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "all on four concept". 2. study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "all on two concept".

Eligibility criteria:
inclusion criteria: * • eligible patients needed must have sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class i exclusion criteria: * systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.
forxiga tablets specific clinical experience investigation for long-term use

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the investigation is to confirm the following under the post-marketing actual use of forxiga tablets (hereinafter referred to as forxiga) * development of adrs specified as key investigation items and the risk factors * contributing factors possibly having an impact on the safety and efficacy * development of adrs unexpected from the precautions for use and adrs under actual drug use


Eligibility criteria:
inclusion criteria: patients treated with forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug. exclusion criteria: n/a

Keywords: type 2 diabetes mellitus diabetes forxiga long-term use
correlation between endoscopic findings and helicobacter pylori infection in chronic kidney disease patients

Conditions: Chronic Kidney Diseases

Summary: the aim of this study is to 1. evaluate frequency of h. pylori infection in patients with ckd. 2. description the gastroduodenal lesions found in patients with chronic kidney disease and correlate it to h.pylori infection.

cross sectional study to study the relationship between helicobacter pylori infection and gastroduodenal lesions in patients with chronic kidney disease, there have been some debates about the association of helicobacter pylori infection and chronic kidney disease (ckd). pathogenesis of h. pylori infection in patients with ckd is not clearly revealed and there are not enough studies about these two factors. there are several hypothesis which support that kidney disease may reduce h. pylori infection. high level of serum urea nitrogen can contribute to a decreased gastric acid secretion and higher gastric alkalosis which could be the cause of lower prevalence of h. pylori among ckd. inflammatory cytokines are also increased in ckd patients and it can cause gastric mucosal damage, chronic gastritis, and spontaneously eradicate h. pylori. in addition, antibiotics, proton pump inhibitors, or h2 receptor antagonists which are used in patients with ckd for long time might be associated with decreased h. pylori infection. there are other hypothesis that are contrary to above theories. some studies showed that high u rea concentration makes the gastric mucosa more susceptible to h. pylori and infection rate is higher in uremic patients. and, in some articles which have studied about peptic ulcer in ckd, the prevalence of h. pylori infection looked lower compare to ulcer in non-ckd patients but real incidence may not be lower. because the incidence of peptic ulcer is higher in ckd patients with various causes except h. pylori infection. gastrointestinal (gi) disorders are the most prevalent chronic problem in ckd patients, ranking second in frequency only to renal failure itself. gi disorders affect 70 to 80% of patients on hemodialysis (hd); yet, little is known about the impact of hp infection on this multifactorial disorder.

Eligibility criteria:
inclusion criteria: * patients with ckd classified as stages 3 to 5 according kidney disease improving global outcomes classification, on hemodialysis or not. * control group without chronic kidney disease. exclusion criteria: * frail patients with multiple comorbidities or malignant disease. * pregnant ladies. * patients recently on proton pump inhibitors two weeks or less prior to the interview.
relationship of preoperative fasting with tricuspid annular plane systolic excursion

Conditions: The Relationship Between TAPSE Value and Volume

Summary: the aim of our study is to try to establish a relationship between preoperative fasting-related volume changes and tricuspid annular plane systolic excursion (tapse), and to determine whether there are changes in right ventricular functions due to preoperative fasting.

tapse (tricuspid annular plane systolic excursion) is a parameter that easily measures apex-base shortening and provides specific information about global right ventricular (rv) function. it is less dependent on optimal image quality and serves as an easily measurable criterion compared to other rv function measurements. in this study, one day before the operation, transthoracic echocardiography (tte) will be conducted on fasting patients, and if the preoperative fasting duration is appropriate on the day of the surgery, tte measurements will be repeated and recorded. the study aims to evaluate the relationship between tapse and volume and determine whether there are any changes in right ventricular functions due to preoperative fasting.

Eligibility criteria:
inclusion criteria: * asa 1-2-3 * the patient must be between 18 and 75 years old. * perioperative hydration has not been administered. * preoperative sedatives have not been given. * there should be no known heart disease. exclusion criteria: * the patient being pregnant * post-cardiac surgery * severe pulmonary hypertension * severe valve disease * hypertrophic or dilated cardiomyopathy * presence of acute myocardial infarction * non-sinus rhythm

Keywords: tricuspid annular plane systolic excursion preoperative fasting right ventricular functions
efficacy and safety study of magnesium isoglycyrrhizinate injection in subjects with acute drug-induced liver injury

Conditions: Drug-Induced Liver Injury

Summary: the purpose of this study is to investigate the safety, effective dosage and treatment of magnesium isolycyrrhizinate injection to cure the acute drug-induced liver injury compared with the tiopronin injection.

the pharmacology research shows that magnesium isoglycyrrhizinate could significantly decrease the elevation of alt and ast coursed by carbon tetrachloride, d-galactosamine and thioacetamide. it could also significantly reduce the injury on the liver coursed by d-galacosamine and immunologic factors. magnesium isoglycyrrhizinate with strong anti-inflammatory effect could protect the liver cell and improve the liver function.

Eligibility criteria:
inclusion criteria: * racum ≥6 * alts ≥2uln, but tbil is ≤ 3 uln.it may be associated with ast or alp or tbil exceed the upper limit of normal * liver biochemical abnormalities duration of no more than three months * patients need to fully understand and sign the inform consent form. exclusion criteria: * the liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease. * the patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is ≤ 35g/l, prothrombin time is elongated more than 2 seconds compared to its normal range. * the value of the tbil is \> 3uln. * the value of serum creatinine is \> 1.5uln. * patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract. * patients who are taking the drugs that might interfere the trial. * patients who are allergic or intolerant to the study drug. * patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis. * patients who are compliant with protocol. * women who are pregnant, breast-feeding or with childbearing potential. * patients who have attended other clinical trials within 3 months. * not appropriate to be included after assessing by the investigators. uln=upper limited normal

Keywords: drug-induced acute liver injury
magnetic resonance elastography of myofascial pain syndrome

Conditions: Myofascial Pain

Summary: the purpose of this research study is to use a new imaging technique called magnetic resonance (mr) elastography to create new imaging parameters to measure the mechanical properties of myofascial tissues that can be used to assess the impaired myofascial interface in myofascial pain syndrome (mps).

this is observational research that aims to develop an mri-based imaging technique (mre) to quantitatively assess the myofascial tissue properties in healthy subjects and patients with relevant pain conditions. healthy volunteers and patients with mps will be recruited to undergo mri along with mr elastography.

Eligibility criteria:
healthy volunteer inclusion criteria: * absence of a history of chronic pain in the targeted anatomical location (i.e., lower back and low extremities) that had limited activities of daily living or work * a numerical current pain index of less than 0.5 (on a 10-point visual analog scale) * able to understand the goal of the project and give informed consent. healthy volunteer exclusion criteria: * pregnancy or breastfeeding * any contraindication to an mri exam * previous severe/acute back or low extremity injury (including fracture) * previous back or low extremity surgery * back and lower limb deformities * inability to provide consent. myofascial-related pain patient inclusion criteria: * a history of chronic low back or leg pain (the targeted location will be determined based on the findings in aim 1) for at least 3 months. (measured by patient history and physical exam) * a palpable taut band or nodule within the skeletal muscle * hypersensitive tender spot within the taut band * recognition of current pain complaint by pressure on the tender nodule/taut band * painful limit to the full stretch range of motion myofascial-related pain patient exclusion criteria: * pregnancy or breastfeeding * any contraindication to an mri exam * previous therapy in the area to be treated within 6 months * previous severe back or low extremity injury (including fracture) or surgery * any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception * severe osteoarthritis * skin injuries in the area to be treated * inability to provide consent.

Keywords: magnetic resonance imaging (mri) magnetic resonance elastography (mre)
hot water drinking therapy in achalasia

Conditions: Achalasia

Summary: from clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. this study is to observe its efficacy on achalasia symptoms and explore its mechanism.

1. achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup. 2. patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy. 3. if patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation

Eligibility criteria:
inclusion criteria: * achalasia patients diagnosed by endoscopy, barium esophagram and manometry exclusion criteria: * could not drink water * poor compliance * severe comorbidities * esophageal stenosis secondary to erosions and cancer

Keywords: achalasia hot water drinking therapy pneumatic dilation
a study comparing the efficacy and safety between i-chop and r-chop in untreated cd20-positive diffuse large b-cell lymphoma patients

Conditions: Diffuse, Large B-Cell, Lymphoma

Summary: the purpose of this study is to comparing the efficacy and safety between i-chop and r-chop in untreated cd20-positive diffuse large b-cell lymphoma patients.


Eligibility criteria:
inclusion criteria: * untreated cd20-positive dlbcl confirmed by histopathology or cytology. * 18 years to 75 years; male or female patients. * international prognostic index (ipi) score of 0 to 2. * signed an informed consent. * at least one measurable lesions: for nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; for extranodal tumor mass, more than 1.0 cm in the long axis. * eastern cooperative oncology group (ecog) performance status of 0 to 2. * more than 6 months life expectancy. exclusion criteria: * participation in another interventional clinical trial in the past 3 months. * known allergic reactions against monoclonal antibody or rituximab. * contraindication to any component of chop regimen. * previous treatment for dlbcl, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, or surgical treatment (excluding tumor mass biopsies and surgical resection for non-lymphoma lesions), or prior use of any monoclonal antibody within 3 month. * history of cytotoxic drugs treatment or anti-cd20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis). * primary central nervous system (cns) lymphoma, secondary cns involvement, primary testicular lymphoma.
outcome following orthopaedic surgery

Conditions: Osteoarthritis of Knee

Summary: by investigating the long-term functional status of patients who have undergone various types of orthopaedic surgery we will have a basis for devising guidelines for future patients and surgeons.

the purpose of this database is to explore the long term outcome and functional status of patients undergoing various types of orthopaedic surgery. these data will yield a valuable database that can be used to address future research questions. for example, there are three common surgical treatments for medial osteoarthritis of the knee: tibial osteotomy, oxford partial knee replacement, or total knee replacement. no clear guidelines exist regarding which treatment options are optimal for which patients. by gathering functional data from patients who have undergone these treatments, we will have a basis for devising such guidelines.

Eligibility criteria:
inclusion criteria: * all patients who are scheduled to undergo orthopaedic surgery are eligible to be included in the database. exclusion criteria: * those patients who do not meet the above inclusion criteria will be excluded from the study.

Keywords: functional outcome orthopaedic surgery
p200txe diseased eye image collection

Conditions: Retinal Disease

Summary: the primary objective is to collect images on the p200txe device in diseased eyes.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 22 years of age or older who have full legal capacity to subject on the date the informed consent is signed; 2. subjects who can follow the instructions by the clinical staff at the clinical site; 3. subjects who agree to participate; 4. subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve. for glaucoma subjects: a. glaucoma subjects who have a history of visual field loss and rnfl or optic nerve changes. exclusion criteria: 1. subjects unable to tolerate ophthalmic imaging; 2. subjects with ocular media not sufficiently clear to obtain acceptable images.
real world evidence of the effectiveness of paritaprevir/r - ombitasvir, ± dasabuvir, ± ribavirin in participants with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir with or without dasabuvir (abbvie regimen) ± ribavirin (rbv) for the treatment of chronic hepatitis c (chc) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. this observational study is the first effectiveness research examining the abbvie regimen ± rbv, used according to the local label, under real-world conditions in greece in a clinical practice patient population.

this was a prospective, multi-center observational study in participants receiving the interferon-free abbvie regimen ± rbv. the prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. adults chronically infected with hepatitis c virus (hcv), receiving the interferon-free abbvie regimen, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with treatment duration of 24 weeks), end of treatment (eot), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[svr12\] and sustained virologic response 24 weeks after the end of treatment \[svr24\]).

Eligibility criteria:
inclusion criteria: * treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis c (chc), genotype 1 or 4, receiving combination therapy with the interferon-free abbvie regimen ± ribavirin (rbv) according to standard of care and in line with the current local label * if rbv was co-administered with the abbvie regimen, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) * participants had to voluntarily sign and date an informed consent form prior to inclusion into the study * participant must not have participated or intended to participate in a concurrent interventional therapeutic trial exclusion criteria: * none

Keywords: observational study sustained virological response chronic hepatitis c genotype 1 chronic hepatitis c ombitasvir/paritaprevir/ritonavir ± dasabuvir chronic hepatitis c genotype 4
mk-3795 (pt2385) for the treatment of von hippel-lindau disease-associated clear cell renal cell carcinoma (mk-3795-003)

Conditions: VHL Gene Mutation; VHL; VHL Syndrome; VHL Gene Inactivation; Von Hippel; Von Hippel-Lindau Disease; Von Hippel's Disease; Von Hippel-Lindau Syndrome, Modifiers of; Clear Cell Renal Cell Carcinoma; Clear Cell RCC; ccRCC

Summary: the primary objective of this study is to assess the overall response rate (orr) of von hippel-lindau (vhl) disease-associated clear cell renal cell carcinoma (ccrcc) tumors in vhl participants treated with mk-3795.

this open-label phase 2 study will evaluate the efficacy, safety, pk, and pd of mk-3795 in participants with vhl disease who have at least 1 measurable vhl disease-associated ccrcc tumor (as defined by recist 1.1). mk-3795 will be administered orally and treatment will be continuous. changes in vhl disease-associated non-ccrcc tumors will also be evaluated.

Eligibility criteria:
inclusion criteria: * has at least 1 measurable ccrcc tumor and no solid ccrcc tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required); may have vhl disease-associated lesions in other organ systems * has a diagnosis of von hippel lindau disease, based on a germline vhl alteration exclusion criteria: * has had prior radiotherapy or systemic anti cancer therapy for ccrcc (includes anti-vascular endothelial growth factor (vegf) therapy or any systemic investigational anti cancer agent) * has a prior or concomitant non-vhl disease-associated invasive malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the participant has remained disease free for more than 2 years * has any history of metastatic disease * has had radiotherapy to any non-ccrcc site within 4 weeks prior to entering the study or has not recovered from adverse events (ae) * has had any surgical procedure for vhl disease or any major surgical procedure completed within 4 weeks prior to entering the study or has any surgical lesions from recent major surgical procedures that are not well healed