Kornimate/medical-research-clean huggingface dataset:
effects of pramlintide on endogenous production of very-low-density-lipoprotein (vldl)-triglyceride and glucose in the post prandial state in t2dm

Conditions: Type 2 Diabetes

Summary: diabetes affects almost 21 million people in the united states. in this study we will test a drug called pramlintide(symlin), and see how it works to lower blood sugar and fat levels after a meal. lowering high sugar levels and fat levels after a meal is very important in the prevention of the problems that persons with type 2 diabetes often encounter. hypothesis is that pramlintide will lower blood sugar and fat levels after a meal.

a well recognized and troublesome feature of diabetes management is the exacerbated post prandial glucose elevations following a typical high fat meal. to date the mechanisms driving this increased post prandial glycemia are unclear. pramlintide is believed to affect intermediary metabolism as well as nutrient absorption. the relative contributions from altered absorption and metabolism to the observed post prandial reductions in plasma glucose and tg concentrations remain uncertain, however. combinations of radioactive and stable isotope labeling techniques are able to quantify the relevant fluxes of glucose and lipids in vivo in humans and are therefore able to provide quantitative answers to these questions. aims: 1. to determine the effects of pramlintide on reducing endogenous production of very-low-density-lipoprotein (vldl)-triglycerides(tg) following a high fat breakfast, lunch and dinner in patients with type 2 diabetes mellitus (t2dm). a triple isotope approach will be used to determine rate of appearance of (vldl)-triglycerides following breakfast, lunch and dinner. 2. to compare the relative roles of slowed glucose absorption and reduced endogenous glucose production (glucagonstatic mechanism) in the glucose-lowering effects of pramlintide in the post prandial state in patients with t2dm.

Eligibility criteria:
inclusion criteria: * type 2 dm study participants will be c-peptide positive (levels \> 0.3 nmol/l) * receiving insulin, metformin and/or sulfonylurea/glitinide. * maintained on stable anti-hypertensive medication. * bmi \< 52 kg/m2. * t2dm for at least 3 months with hba1c under 10%. exclusion criteria: * receiving tzds, exenatide, sitagliptin or pramlintide therapy. * receiving medications known to impair gastric emptying, intestinal motility, glucagon release or corticosteroids. * triglyceride levels \> 400 mg/dl. * bmi \> 52 kg/m2.

Keywords: triglycerides endogenous glucose production
effects of virtual reality and cyclic training on balance

Conditions: Stroke, Acute

Summary: stroke is the third leading cause of functional disability and death in the world. it leads to many problems that affect gait, upper extremity function and balance. in stroke patients balance dysfunction leads to impaired postural control and walking. because of poor balance fall rate increases in stroke patients. balance is an important predictor of outcome in stroke rehabilitation. after stroke difficulties in balance control may be caused by multiple factors such as muscle weakness, impaired proprioception, and asymmetry in weight wearing, spasticity and impaired motor control. different means are used to treat stroke, some conventional treatments along with new adjunct therapies are usual practice for the rehabilitation of the stroke. virtual reality is choice of adjunct therapy now a days and can be used in different ways for the rehabilitation. virtual reality or active video gaming proved their role as vital part of the treatment program in pediatric rehabilitation as well as adult rehabilitation program. these programs help the patient to achieve goals for functional and activities of daily living skills.

this study will be a randomized control trial, used to compare the effectiveness of virtual reality and cyclic training on balance in sub-acute stroke patients. subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique. assessment will be done by using berg balance scale (bbs) and time up and go test. subjects in one group will be treated with virtual reality and conventional therapy and in other group cyclic training and conventional therapy.

Eligibility criteria:
inclusion criteria: 1. sub-acute stroke 2. able to stand for 5 minutes 3. the score of mini mental state examination (mmse) \> 19 4. male and females (both genders) 5. verbal instructions can follow exclusion criteria: 1. visual and auditory problem unable to hear and see feedback from the video game and problem of vestibular system 2. spasticity of lower limb 3. any other medical condition that could affect movement and balance 4. use of pacemaker, apraxia, epilepsy 5. psychiatric disorders

Keywords: stroke virtual reality cyclic training active video gaming
breast cancer and kinesiophobia and physical activity

Conditions: Breast Cancer; Kinesiophobia

Summary: breast cancer is the most common type of cancer in women worldwide. a significant number of breast cancer survivors develop many complications. breast cancer and survivors may develop a fear of physical activity avoidance and movement, called kinesiophobia, due to upper extremity pain, numbness, restricted arm/shoulder range of motion, and risk of lymphedema. therefore, in the present study, it is aimed to compare the effect of fear of movement on physical activity, quality of life and psychological states in women who have had breast cancer with healthy people.


Eligibility criteria:
inclusion criteria: * • women diagnosed with stage i-ii-iii breast cancer with surgery as the first treatment * the patient whose first treatment was completed at least three months ago (surgery, radiotherapy and / or chemotherapy) * 18-75 years old woman * does not have a turkish literacy problem exclusion criteria: * • a serious chronic disease (rheumatoid arthritis, multiple sclerosis, amyotrophic lateral sclerosis, kidney disease, heart failure, neurological disorders or diabetes mellitus type i or ii patients) * having severe musculoskeletal pain or disease * serious psychiatric illness * patients with current cancer attack or metastasis * persons with cognitive impairment
efficacy of manual therapy combined with an exercise programme vs combined electrotherapy on football players with adductor tendinopathy

Conditions: Tenopathy; Lower Limb

Summary: background: groin pain associated with adductor tendinopathy is the second cause of muscle pathology in a football player (20%), so a good treatment taking into account both internal and external factors that may influence the pathology of our patient, would be the key to an improvement in the symptoms he may have. material and methods: firstly, the pain threshold is measured by performing the copenhagen compression test, and in a palpation at the proximal level of the adductors, the hip joint range (rom) is measured and the hagos questionnaire is passed. then, a sample of 20 participants (n = 20) is selected and randomly divided into two groups, a control group of 10 participants (n = 10), with a treatment based on electrotherapy combined with an exercise programme; and an experimental group of 10 participants (n = 10) with a treatment based on manual therapy combined with an exercise programme. finally, they performed all measurements.


Eligibility criteria:
inclusion criteria: * age range between 15 and 30 years old. * third division and third year national youth football players. * males. * average of 3 training sessions and 1 match per week. * pain when performing the copenhagen test or squeeze test for 5 seconds (s). * pain on palpation of the proximal insertion of the adductors. exclusion criteria: * players over 30 years of age and under 15 years of age. * players with previous adductor surgery. * players with inguinal hernia. * players with signs or symptoms of urinary or genital pathology. * players unable to attend study treatment sessions. * players on medication during treatment. * players who are undergoing other treatment for groin pathology or have had previous treatment of less than one month. previous treatment of less than one month.

Keywords: manual therapy, electrotherapy, groin pain and adductors.
international registry of patients treated with pressurized intraperitoneal aerosol chemotherapy (pipac)

Conditions: Peritoneum Cancer; Peritoneum Neoplasm; Pleural Cancer; Pleural Effusion; Pleural Mesothelioma; Ovarian Cancer; Gastric Cancer; Appendix Cancer; Pseudomyxoma Peritonei; Colorectal Cancer; Pancreas Cancer; Gallbladder Cancer; Ascites; CUP; Chemotherapeutic Toxicity

Summary: multicentric, international, web-based prospective documentation of the indications and results of pressurized aerosol chemotherapy (so-called pipac or pitac) for treating malignant pleural and peritoneal diseases. indication is decided by the treating physician. there are no predefined inclusion or exclusion criteria.

all data entered into the registry documenting the patient cohort characteristics (disease, demography, therapy) are analyzed using descriptive statistics. survival data are analyzed with kaplan-meier statistics. multivariate cox proportional hazard models are used to identify potential prognostic and predictive factors. in particular, a risk- adjusted comparison of the outcome criteria with a propensity score is planned. the data are stored in a sql-based online database. patient data are pseudoanonymized. the registry has received approval of the data protection officer of the state of northrhine-westphalia. the study steering committee is blinded towards the identity of the participating institutions. each participating institution receives an annual report with own data vs. benchmark. scientific analysis can be proposed by the steering committee, by a participating institution or by other scientists, subjected to the approval of the independent scientific advisory board. an export function has been built in to allow data exchange with the hipec registry of the german society for general and gi surgery (http://www.dgav.de/studoq/studoqhipec.html).

Eligibility criteria:
inclusion criteria: * verified peritoneal metastasis * colorectal cancer * ovarian cancer * gastric cancer * appendical cancer * pseudomyxoma peritonei * malignant mesothelioma * pancreatic cancer * gallbladder cancer * small bowel cancer exclusion criteria - bowel obstruction

Keywords: pressurized intraperitoneal aerosol chemotherapy pipac pressurized intrathoracic aerosol chemotherapy pitac cisplatin oxaliplatin gemcitabine paclitaxel nab-paclitaxel doxorubicine mitomycin
pharmacokinetic comparison of xs003 and tasigna

Conditions: Healthy

Summary: the study will assess bioavailability of xs003 given as a single oral dose compared to tasigna® given as a single oral dose in healthy male subjects.

the study consists of two parts, the first part is composed as a pilot part and compares the bioavailability of single oral doses of xs003 compared to tasigna® given as single oral dose in healthy male subjects. the second part is a food-effect part which assesses the food effect of a single oral dose of xs003 in healthy male subjects either fed or fasted. the study will also evaluate safety and tolerability of xs003 as secondary objectives.

Eligibility criteria:
inclusion criteria: * healthy males * age 18 to 55 years of age * body mass index (bmi) of 18.0 to 29.0 kg/m2 * laboratory parameters in normal range exclusion criteria: * females * current smokers and those who have smoked within the last 12 months. a breath carbon monoxide reading of greater than 10 ppm at screening. * serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients. * history of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator. * subject has a qtcf\>450 ms based on ecg at screening or a history of additional risk factors for torsades de pointe (e.g. hypokalaemia, hypomagnesemia, a family history of long qt syndrome)
a substudy of the effect of acute normovolemic hemodilution in bone tumor surgery

Conditions: Bone Tumor; Acute Normovolemic Hemodilution; Goal-Directed Fluid Therapy

Summary: the prevention of perioperative anemia has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (anh) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. the heal trial will assess whether anh will improve postoperative hemoglobin levels when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.

bone tumor surgery is associated with a significant risk of perioperative blood loss, with blood loss usually in the range of approximately 500-1000 ml. the postoperative anemia caused by blood loss is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients. acute normovolemic hemodilution (anh) is a patient blood management measure. the clinical efficacy of acute normovolemic hemodilution (anh) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. as goal-directed fluid therapy (gdft) is increasingly used in clinical practice, it is of great importance to explore the efficacy of anh in patients undergoing fluid management using gdft. bone tumor surgery is an ideal setting to evaluate anh in gdft, as the procedure is associated with high blood loss and infusion. this trial has been designed as a randomized, controlled trial to determine whether anh will improve postoperative hemoglobin levels when applying gdft in patients undergoing bone tumor surgery.

Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years; 2. undergoing elective bone tumor resection surgery; 3. preoperative hemoglobin ≥11 g/dl; exclusion criteria: 1. using a tourniquet; 2. palliative operation or minimally invasive surgery; 3. bmi\ 30kg/m\^2; 4. international normalized ratio (inr) \>1.5 or platelet count \<100 × 10\^9/l; 5. cardiopulmonary insufficiency; 6. hepatic and renal dysfunction; 7. active infectious disease; 8. allergy to succinyl gelatin; 9. pregnancy; 10. declined participation in the study or declined blood transfusion
colposcopy in detection of oral epithelial dysplasia

Conditions: Intraepithelial Carcinoma

Summary: the aim of this work is to detect the diagnostic accuracy of the intra-oral application of colposcope in diagnosing oral dysplastic lesions in comparison to biopsy taking and histopathological examination.

a- roles and responsibilities: 1. the principle supervisor: dr. mohsen kazem (m.k.), professor of oral \&maxillofacial pathology, cairo university, will examine the taken biopsy histopathologically and determine the definitive diagnosis. 2. the assistant supervisor: dr. heba dahmoush (h.d.), professor of oral \& maxillofacial pathology, cairo university, will examine the taken biopsy histopathologically and determine the definitive diagnosis. 3. the principle investigator: sarah ahmed mohamed mahmoud badawy (s.b.), assistant lecturer of oral \&maxillofacial pathology, cairo university, will read and put a colposcopic score for each participant individually. 4. eman desouky (e.d.) sample size calculation; statistician, faculty of oral and dental medicine, cairo university, egypt. 5. evidence based committee, faculty of dentistry, cairo university: help in reporting study protocol following stard guidelines. 6. ethics committee, faculty of dentistry, cairo university: protocol reviewer of the diagnostic accuracy study in order to protect the right, safety, dignity and well-being of the participants. b- index test: the principle investigator (s.b.) will perform the index test using digital electronic colposcope (kernel, kn-2200, china). before taking up the patients for colposcopic evaluation and giving them a score, the normal colposcopic findings will be standardized based on the colposcopic criteria. colposcopic criteria includes aceto uptake, surface pattern and clarity of demarcation of the mucosal lesions, vascular pattern, lesion size as well as iodine staining. c- reference test:the reference standard; to reach a definitive diagnosis in oral dysplastic lesions, will be a representative biopsy and histopathological examination. m.k. and h.d. will examine the taken biopsy histopathologically, determine the definitive diagnosis and write the diagnosis in the assessor chart. inclusion criteria: * patients seeking for diagnosis of clinically suspected oral dysplastic leukoplakia or erythroplakia * patients seeking for diagnosis of clinically suspected oral carcinoma. exclusion criteria: * patients with secondary infection. * patients having other systemic diseases. * patients undergoing treatment for the lesions.

Eligibility criteria:
inclusion criteria: * patients seeking for diagnosis of clinically suspected oral dysplastic leukoplakia or erythroplakia * patients seeking for diagnosis of clinically suspected oral carcinoma. exclusion criteria: * patients with secondary infection. * patients having other systemic diseases. * patients undergoing treatment for the lesions.

Keywords: colposcopy oral epithelial dysplasia diagnostic accuracy
autologous stem cells in osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will be allocated into two groups: * the control group will receive acetaminophen 750mg orally every 8 hours * the experimental group will receive autologous hematopoietic stem cells from bone marrow (bmasc) signed informed consent is required, as well as answering a questionnaire. patients in experimental group will receive subcutaneous g-csf (10ug/kg/day) for 3 consecutive days and, on the 4th day a bone marrow harvest under general sedation will be performed from posterior iliac crests. the patient will remain in the recovery room while the cells are processed at the hematology service laboratory. finally, bmasc will be infused to the joint under local anesthesia. the procedure is ambulatory.


Eligibility criteria:
inclusion criteria: * patients with knee osteoarthritis grade ii or iii of the kellgren-lawrence radiographic scale * age \> 30 years exclusion criteria: * neurodegenerative, autoimmune, genetic or psychiatric diseases * active infection * recent joint infection * knee surgery history * knee joint fracture history

Keywords: osteoarthritis knee stem cell therapy bone marrow g-csf
a study of mm-111 in patients with advanced, refractory her2 amplified, heregulin positive cancers

Conditions: Her2 Amplified Solid Tumors; Metastatic Breast Cancer

Summary: this study is an open-label phase 1 trial of mm-111.

phase 1: patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of mm-111.

Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed advanced cancer that is: * her2 amplified (ihc 2+ or greater) based on archived tumor evaluation * heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory * patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining * patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists. * patients must be \>= 18 years of age * patients or their legal representatives must be able to understand and sign an informed consent * patients may have measurable or non-measurable tumor(s) * patients should have ecog performance score (ps) 0 or 1 * patients must have adequate bone marrow reserves as evidenced by: * absolute neutrophil count (anc) \>= 1,500/ul and * platelet count \>= 100,000/ul * hemoglobin \>= 9 g/dl * patients must have tumor tissue amenable to biopsy * patients must be willing to undergo biopsy prior to treatment to mm-111 exclusion criteria: * patients for whom potentially curative antineoplastic therapy is available * patients who are pregnant or lactating * patients with an active infection or with an unexplained fever greater than 38.5 c during screening visits or on the first scheduled day of dosing. (at the discretion of the investigator, patients with tumor fever may be enrolled) * patients with untreated and/or symptomatic primary or metastatic cns malignancies (patients with cns metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial * patients with known hypersensitivity to any of the components of mm-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded) * patients with known hiv, hepatitis b or c (if patients have previously been treated for c and have undetectable viral loads, they can be considered eligible for the trial)

Keywords: her2 amplified solid tumors breast cancer her3/erbb3 bispecific antibody