Kornimate/medical-research-clean huggingface dataset:
intramyocardial injection of autologous umbilical cord blood derived mononuclear cells during surgical repair of hypoplastic left heart syndrome

Conditions: Hypoplastic Left Heart Syndrome

Summary: researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the stage ii palliative surgery for single ventricle patients with hypoplastic left heart syndrome (hlhs) or hlhs variant. researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.

this is a phase iib trial to determine if the delivery of the autologous ucb-mnc product into the myocardium of the right ventricle of the heart at the time of stage ii surgical repair will provide an improvement in cardiac function, reaching growth and developmental milestones, and quality of life, while also providing a reduction in the cumulative days of hospitalization following stage ii surgical repair. long-term improvement in cardiac function, reaching growth and developmental milestones, reaching stage iii surgical repair pre-op work-up, prolonging time to cardiac transplantation or death, and improving quality of life will also be determined.

Eligibility criteria:
inclusion criteria: * diagnosis of hlhs or hlhs variant with single right ventricular dependent chd having undergone stage i surgical repair and undergoing stage ii surgical repair. * less than 13 months of age at time of stage ii surgical repair * previous participation in the ucb collection protocol with autologous ucb-mnc product that is acceptable for use (treatment arm only) exclusion criteria: * history of dmso reaction (treatment arm only). * parent(s) and/or legal guardian(s) unwilling to have their child participate or unwilling to follow the study procedures. * severe chronic diseases at the discretion of the treating physician. * extensive extra-cardiac syndromic features. * known history of cancer. * any of the following complications of his/her congenital heart disease: 1. any condition requiring urgent, or unplanned interventional procedure within 15 days prior to stage ii surgical repair, unless complete and full cardiac recovery is documented by site investigator 2. severe pulmonary hypertension (reported in the medical record as \>70% systemic pressure) 3. other clinical concerns as documented by a site investigator that would predict (more likely to happen than not to happen) a risk of severe complications or very poor outcome, not directly related to the stem cell product or its injection procedure, during or after stage ii surgical repair.

Keywords: hypoplastic left heart syndrome hlhs congenital heart disease umbilical cord blood ucb cord blood stem cells regenerative therapy stage ii glenn glenn surgery single ventricle
a study to evaluate the safety, tolerability and pharmacokinetics of multiple subcutaneous injections of abt-981 in patients with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: to assess the safety, tolerability and pharmacokinetics of abt-981 in patients with osteoarthritis of the knee.

this is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. thirty-six patients with osteoarthritis of the knee will be selected to participate. patients will be randomized to receive either abt-981 or placebo. abt-981 or placebo will be administered as subcutaneous (under the skin) injections in four dosing groups. subjects will be administered subcutaneous injections of abt-981 for up to 8 weeks.

Eligibility criteria:
inclusion criteria: * adult male or female, 40 to 70 years of age, inclusive. * history of symptomatic osteoarthritis (oa) of the knee joint for at least 3 months, with typical osteoarthritis (oa) symptoms * radiographic osteoarthritis (oa) of kellgren-lawrence (k-l) grade 1, 2 or 3 * patients assessment of osteoarthritis (oa) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm vas scale * other than osteoarthritis (oa) of the study joint, patient should be in general good health exclusion criteria: * radiographic oa of kellgren-lawrence grade 4 or chronic opioid user due to severe knee oa * history of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent * significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint * diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than osteoarthritis (oa) of the knee. * any uncontrolled medical illness including unstable treatment or therapy.

Keywords: immunogenicity safety tolerability osteoarthritis pharmacokinetics
cardio-pulmonary exercise testing in healthy population

Conditions: Healthy Obesity, Metabolically

Summary: introduction: cardiopulmonary exercise test (cpet) is a helpful tool for evaluation of aerobic exercise capacity and tolerance for variety of population. the test progression include an incremental stepwise or ramp control protocol to exhaustion there are different methods used in various clinical setting. cpet involves the measurement of respiratory gas exchange i.e. oxygen uptake, carbon dioxide, minute ventilation, other variables while monitoring ecg, blood pressure, pulse oximetry and exertion perceived (borg scale) during an incremental test on a cycle-ergo meter or treadmill. this test allow to assess an integrative exercise responses to submaximal and maximal effort. aim: to compere exercise responses and achieved criteria for maximal exercise testing with different exercise protocol methods: healthy volunteers (normal and overweight ) will be recruited to participants in the study. demographics (age, sex), anthropometric (height, weight, abdominal circumference), will be measured. by using questionnaire, physical activity behavior and motivation toward engage in physical activity will be filled by the participants. each participants will conducted an exercise test on treadmill (using modified bruce protocol) and cycle ergometer. quark cpet metabolic cart (cosmed, rome, italy) will be used to collect and analysis gas exchange. 10 minute after the graded exercise test supra maximal exercise test (smt) will be done for 2 minutes one stage (treadmill protocol) or 10% at cycle protocol higher than highest load achieved in the incremental test. all exercise parameter done on the different ergometer will be compared


Eligibility criteria:
inclusion criteria: * healthy 18-55 exclusion criteria: * physical activity limitation due to orthopedic , neurological and cognition deficit pregnancy children

Keywords: exercise maximal exercise test exercise protocol metabolic
magnetic resonance imaging (mri) muscle phenotyping in mitochondrial disease

Conditions: Mitochondrial Disease

Summary: the purpose of the study is to use a new research imaging technique, a kind of magnetic resonance imaging (mri), to measure important metabolic features of muscle, including mitochondrial function, in people with mitochondrial disease and in healthy individuals. (mitochondria are tiny organelles that generate energy for the body.) it is hoped that this new strategy will help physicians to understand better the health problems of people with mitochondrial disease. eventually, this could lead to better diagnostic and treatment approaches.

there are two study-related visits. the first visit is a "screening" visit to ensure eligibility. this includes fasting blood tests. the second visit is an mri scanning session. this also takes around 2 - 3 hours, with no more than 1.5 hours spent in the actual mri machine. it may be possible to complete these two visits on the same day. otherwise, the mri session should occur within 3 months of the screening visit. in addition, an optional physical capacity visit will occur on the same day as the mri session.

Eligibility criteria:
group 1) mitochondrial disease: inclusion criteria: * genetic diagnosis of mitochondrial disease * be able to perform sub-maximal leg exercise for several minutes * be able to provide written, informed consent * cognitively and medically stable and able to comply with study procedures * able to fast for 4 hours prior to blood draw and/or mri scanning * be willing to stop taking any over-the-counter vitamins and supplements that are neither prescribed nor recommend by their physician for 2 weeks prior to mri scanning exclusion criteria: * diabetes * alcohol/substance abuse * smoking * use of any investigational agents within 4 weeks of enrollment * any contraindication to mri scanning group 2) healthy individuals: inclusion criteria: * be able to perform sub-maximal leg exercise for several minutes * be able to provide written, informed consent * cognitively and medically stable and able to comply with study procedures * able to fast for 4 hours prior to blood draw and/or mri scanning * be willing to stop taking any over-the-counter vitamins and supplements that are neither prescribed nor recommend by their physician for 2 weeks prior to mri scanning exclusion criteria: * carry a diagnosis of mitochondrial disease * have a first-degree relative with a diagnosis of mitochondrial disease * diabetes * alcohol/substance abuse * smoking * use of any investigational agents within 4 weeks of enrollment * any contraindication to mri scanning

Keywords: mitochondrial disease magnetic resonance imaging magnetic resonance spectroscopy creatine phosphocreatine
the clinical application of 68ga-nota-exendin-4 pet/ct in detecting insulinoma

Conditions: Insulinoma

Summary: the small insulinoma can not be detected by the ct or mri. we use 68ga-nota-exendin-4 positron emission tomography/computed tomography (pet/ct) to detect the insulinoma for the patient diagnosed with endogenous hyperinsulinemic hypoglycaemia. and the diagnostic value will be performed. a single dose of 37-111 mega-becquerel (mbq) 68ga-nota-exendin-4 will be injected intravenously. visual and semiquantitative method will be used to assess the pet/ct images.

the glucagon-like peptide-1 receptor (glp-1r) is an emerging target due to its high expression in benign insulinomas. 68ga-nota-exendin-4 is an optimal probe targeting glp-1r. the clinical use of 68ga-nota-exendin-4 pet/ct in detecting insulinomas will be evaluated. and the comparation between pet diagnostic value and ct / mri will be done.

Eligibility criteria:
inclusion criteria: * 1.age ≥6 years old 2.patients with hypoglycaemia 3.endogenous hyperinsulinemic hypoglycaemia 4.enhanced ct or mri within 1 month 5.signed written consent exclusion criteria: * 1. breast feeding 2.pregnancy or the wish to become pregnant within 6 months 3.renal function: serum creatinine during 41-73umol/l 4.any medical condition may significantly interfere with study compliance; 5.known allergy
idiopathic pulmonary fibrosis registry for future studies

Conditions: Lung Disease, Interstitial; Idiopathic Pulmonary Fibrosis

Summary: to establish a registry of patients for future studies of inflammation in interstitial lung disease/idiopathic pulmonary fibrosis.

to establish a framework in which biologic samples and physiologic measures from patients with ipf can be longitudinally collected and evaluated. having a bank of samples that are correlated with physiologic measures that follow patients through their course will allow the following proposed studies as well as future investigations to be efficiently carried out.

Eligibility criteria:
inclusion criteria: * any patient referred to the interstitial lund disease clinic who is undergoing evaluation and or treatment for a new diagnosis of ild. this can include patients referred for presumed pulmonary fibrosis/interstitial pneumonitis (ipf, uip, nsip), sarcoidosis, hypersensitivity pneumonitis, cryptogenic organising pneumonia, drug-induced, or other idiopathic ilds. exclusion criteria: * pregnancy * inability to follow study requirements

Keywords: ipf
a comparative study between regional anesthesia in thoracoscopes and the conventional general anesthesia

Conditions: Pleural Effusion, Malignant; Pleural Mesothelioma; Pleural Empyema; Pulmonary Diseases or Conditions; Pleural Neoplasms; Pulmonary Atelectasis; Pleural Diseases; Pericardial Effusion; Mediastinal Lymphadenopathy; Pneumothorax and Air Leak; Hemothorax; Pyopneumothorax

Summary: video-assisted thoracic surgery (vats) is usually performed with general anesthesia and single lung ventilation. however, performing thoracic surgery under awake regional anesthesia has several potential advantages including avoidance of airway trauma and ventilator dependence associated with endotracheal intubation, besides promoting enhanced recovery after surgery and shorter mean hospital stay.

the aim of this study is to investigate the feasibility and the effect of thoracic epidural anaesthesia for awake thoracic surgery to speed up recovery in patients as well as avoiding the complications accompanying general anesthesia with one lung ventilation. type of study: prospective randomized clinical study. study setting: this study will be conducted in ain shams university hospitals.. study period: expected for two years starting from 2019. sampling method: randomized sampling by a computer generated random numbers table. sample size: 40 patients. sample size was calculated using pass 11 program for sample size calculation and according to the (pompeo et al., 2004) study, the mean pao2 perioperatively in the awake group = -3±1.5 mmhg and in the second group = -6.5±1.83 mmhg. sample size of 40 cases per group (total 40) can detect this difference with power 100% and α-error 0.05.

Eligibility criteria:
inclusion criteria: * asa less than or equal ii. * the procedure expected to be completed within 2 hours. exclusion criteria: * patients with expected difficult airway management. * hemodynamically unstable patients. * persistent cough or high airway secretions. * severe emphysema or clinical signs of active infectious disease. * hypoxemia (pao2 \&lt;60 mmhg) or hypercarbia (pco2 \&gt;50 mmhg) * coagulopathy (inr \&gt;1.5). * obesity (bmi \&gt;30 kg/m 2 ). * infection at the injection site, allergy to local anesthetics. * neurological disorders: seizures, intracranial mass or brain edema.

Keywords: thoracocentesis, pleural, biopsy, wash, effusion, ventilation thoracic epidural non intubated vats, pericardiocenthesis
effects of the adjunctive use of hyaluronic acid-based gel in the surgical periodontal treatment of periodontitis

Conditions: Periodontitis (Stage 3)

Summary: this study aimed to assess the effect of hyaluronic acid-based gel as an adjunctive chemotherapeutic agent in surgical periodontal treatment on clinical parameters and cytokine levels (il-6, il-8, il-10, il-17a, tos, and tas) in gingival crevicular fluid (gcf) among periodontitis patients.

the aim of this study is to evaluate the effects of adjunctive hyaluronic acid-based gel (ha) application in the surgical treatment of patients with moderate to severe stage iii periodontitis (grade b or c) on clinical parameters, as well as on il-6, il-8, il-10, il-17, tas, and tos levels in gingival crevicular fluid (gcf) to determine its anti-inflammatory and antioxidant efficacy. this split-mouth study included 18 patients (mean age 43.44±8.12 years) diagnosed with stage iii grade b or c periodontitis. quadrants were randomly assigned to two groups: group 1 (control: open flap debridement \[ofd\], n=18) and group 2 (test: ofd + 0.8% ha gel, n=18). baseline (t0) assessments included plaque index (pi), gingival index (gi), bleeding on probing index (bpi), probing pocket depth (ppd), clinical attachment level (cal), and gcf collection. following non-surgical treatment, patients underwent ofd; ha gel was applied to defect sites in the test group and saline in the control. clinical parameters and gcf sampling were repeated pre-surgery (ts-1), and at 1 month (ts-2) and 6 months (ts-3) post-surgery.

Eligibility criteria:
inclusion criteria: * stage iii grade b or c periodotitis * over 18 years old * signed the informed consent exclusion criteria: * pregnancy, or lactation, * systemic problems that would contraindicate for periodontal surgery, * prosthetic restorations in the test or control teeth, * taking medications that affect wound healing (corticosteroids, anticancer agents, etc), * using nonsteroidal anti-inflammatory drugs, using any antibiotics and anti-inflammatory drugs in the last 6 months, * alcohol abuse and smoking use
the effect of combination therapy of oral mb and prp-fg in patients with non-healing diabetic foot ulcer

Conditions: Diabetic Foot Ulcers; Diabetic Wound

Summary: the aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.

the current study assesses the effects of methylene blue along with the use of platelet-rich plasma-fibrin glue on wound healing in patients with nonhealing diabetic foot ulcers (non-healing dfu). this randomized controlled trial is performed on 20 patients with non-healing dfu. patients were treated with prp-fg dressing plus 200 ml of oral methylene blue dissolved in milk(intervention group) or prp-fg dressing plus placebo (200 ml of milk) (control group) for 4 weeks.

Eligibility criteria:
inclusion criteria: * having a diabetic ulcer grade ii and iv based on wagner's classification on the sole, medial, or lateral part of the foot (including all surfaces of the toes) * having a single ulcer on the feet and extremities (toes, soles, heels) with no significant reduction in ulcer size (\<20%) despite the use of best treatment methods for at least four weeks * if there is more than one non-healing wound, choose the largest wound * the size of the wound surface (length × width) between 2 cm2 and 20 cm2 * no smoking, alcohol, and drug addiction based on the patient's self-report * not taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressants, and cytotoxic agents * not having a concurrent chronic disease that may cause problems in wound healing, such as cancers, vasculitis, no history of known severe kidney, liver, and heart disease, such as liver cirrhosis, active hepatitis, dialysis, etc. * not taking antidepressants * insensitivity to milk lactose * not having glucose 6-phosphate dehydrogenase (g6pd) deficiency * confirmed, informed, signed consent form * ankle brachial index (abi) higher than or equal to 0.7 exclusion criteria: * do not be treated with methylene blue * the confirmed presence of osteomyelitis, or if there is suspicion of osteomyelitis * the subject is pregnant or intends to become pregnant during the test period * the patient is known to have mental, developmental, physical, and emotional disorders * the occurrence of certain medical conditions * the presence of a wound with a clear and severe infection, which is characterized by significant purulent secretions or extensive cellulitis, or gangrene requiring amputation * evidence of venous, ischemic, neurotrophic ulcers (numbness, tingling, lack of achilles tendon reflex) and traumatic wounds in the patient * failure to refer the patient more than two times to the mentioned center for follow-up and dressing change * hypersensitivity reaction to methylene blue * platelet count less than 100,000 * the patient's lack of consent to continue cooperation

Keywords: platelet-rich plasma-fibrin glue dfu methylene blue non-healing diabetic foot ulcers
virtual reality on pain and range of motion on burn

Conditions: Burns

Summary: the purpose of the study is to determine the effect of virtual reality exercise on pain and shoulder range of motion in pediatrics with 2nd-degree anterior shoulder burn injuries.

burns are an important cause of injury to young children, being the third most frequent cause of injury resulting in death behind motor vehicle accidents and drowning. burn injuries account for the greatest length of stay of all hospital admissions for injuries and costs associated with care are substantial. the majority of burn injuries in children are scald injuries resulting from hot liquids, occurring most commonly in children aged 0-4 years. other types of burns include electrical, chemical and intentional injury. mechanisms of injury are often unique to children and involve exploratory behavior without the requisite comprehension of the dangers in their environment. immersive virtual reality (vr) is a new form of cognitive distraction and has been found to be an effective adjunctive, nonpharmacologic analgesic for postburn physical therapy. the vr gives the individual the illusion of "going into" the 3-dimensional computer generated environment, as if it were a place in which they are actually physically present. the strength of the presence is thought to reflect the amount of attention that is drawn into the virtual world. because vr is a highly attention-grabbing experience, it can be an effective psychological pain control technique. less attention to pain can result in reductions in pain intensity, unpleasantness, and the amount of time patients spend thinking about their pain.

Eligibility criteria:
inclusion criteria: * age range between 9-16 years. * both sexes will participate in the study. * patients who suffered from anterior shoulder burns with involvement of axillary fold. * patient who suffered from second degree burns. * all patients are acute cases . exclusion criteria: * injuries to the face or head * injuries in hands * cognitive impairment * a history of severe motion sickness * mental health problems.

Keywords: burn injuries
discontinuation of magnesium sulfate after delivery in women with severe preeclampsia. a randomized controlled trial

Conditions: Preeclampsia Severe

Summary: all women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate iv followed by the maintenance dose of 1 g/h infusion till the delivery. after delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two groups: group i ( 50 cases) no magnesium sulfate received postpartum and group ii ( 50 cases)-magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour

all women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate iv followed by the maintenance dose of 1 g/h infusion till the delivery. after delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two equal groups: group i is the study group: no post partum magnesium sulfate doses were given. group ii is the control group where magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour

Eligibility criteria:
inclusion criteria: * women with severe preeclampsia * severe features of preeclampsia include any of the following findings: systolic blood pressure of 160 mmhg or higher, or diastolic blood pressure of 110 mmhg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before that time),thrombocytopenia, impaired liver function, progressive renal insufficiency, pulmonary edema or new onset cerebral or visual disturbances exclusion criteria: - severe preeclampsia with serum creatinine\[1.2 mg/dl 2. previous history of eclampsia 3. associated maternal medical diseases: pre-existing diabetes mellitus, epilepsy, renal disease. 4. renal insufficiency. 5. anuric or oliguric urinary out-put under 25 ml/hour. 6. contraindication to the use of magnesium sulfate such as known hypersensitivity to the drug 7. those with evident hemolysis, elevated liver enzymes, and low platelet count (hellp) syndrome

Keywords: preeclampsia magnisium sulfate