Kornimate/medical-research-clean huggingface dataset:
mirror therapy versus cimt on hand function in cerebral palsy

Conditions: Hemiplegic Cerebral Palsy; Mirror Hands

Summary: the aim is to investigate the effect of mirror therapy on hand functions in children with hemiplegic cerebral palsy.

hemiplegic cerebral palsy (hcp) is a form of paralysis that affects motor performance and muscle tone on one side of the body. spastic hemiplegia cp is the second form of cerebral palsy in premature infants, affecting one side of the body's limbs. hand and upper limb dysfunction cause problems in half of the children with cerebral palsy. mirror therapy is a growingly recognized new treatment option for hemiplegic cerebral palsy. while upper extremity involvement in hemiplegic cp and the residual effects are more severe, there is limited evidence of the efficacy of mirror treatment in children with hemiplegic cp

Eligibility criteria:
inclusion criteria: * spasticity grade 1 or 1+ based on the modified ashworth scale * able to understand and follow instructions exclusion criteria: * cognitive impairment * orthopedic dysfunction * impairment in visual acuity * children who are unable to pay attention during the treatment period

Keywords: mirror therapy hand function grip strength
pinta - prophylactic incisional negative pressure therapy for major amputations

Conditions: Wound Surgical; Wound Infection; Cosmesis

Summary: post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. this study is taking place to investigate if negative pressure wound therapy (npwt) dressings reduces surgical site infections, post surgical complications and improves scar appearance compared to standard dressings.

many factors influence the risk of wound complications. notably, the presence of unreconstructed proximal occlusive arterial disease is a major influence on stump healing. patient factors such as smoking, diabetes, obesity, malnutrition and chronic kidney disease are non-modifiable, particularly in the short-term setting. however, surgical factors may be altered in an effort to reduce the risk of wound complications. one option amenable to alteration is what dressing is applied to the closed incision upon procedure completion. the type of dressing may influence factors such as bacterial access to the wound, the development of collections of blood or fluid in the wound or fluid oozing from the wound. collectively, these wound factors increase the risk of wound infection. therefore, dressings which reduce these factors have the potential to reduce wound breakdown, thereby reducing the burden for patients and healthcare systems. the investigators propose to conduct a multicentre randomised controlled trial comparing prophylactic single-use negative pressure wound therapy with standard dressings in patients with a closed incision following major lower extremity amputation in terms of ssi incidence, wound healing complications and scar appearance, patient quality of life and financial impact on the patient and healthcare system.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older; * patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication; * patients with primary closure of the surgical incision using either interrupted or continuous sutures exclusion criteria: * patients \<18 years; * women who are pregnant and/or breast-feeding; * patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump; * patients with amputations where skin glue is the only means of skin closure * patients with a clinically absent femoral pulse

Keywords: negative pressure wound therapy surgical site infection post-operative complications health economics copaq woundqol
a physical activity program in end-state liver disease

Conditions: End-stage Liver Disease (ESLD); Liver Transplant; Sarcopenia; Poor Physical Fitness; Cirrhosis; Portal Hypertension

Summary: the primary aim of this study is to improve both physical fitness and sarcopenia of patients with esld who are potentially eligible for liver transplantation through a 12-week physical training program. secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. this is a randomized clinical trial including 50 patients, with half allocated to the active group (physical training program) and half to standard of care.


Eligibility criteria:
inclusion criteria: * age 40 to 70. * cirrhosis, any cause, defined as: * biopsy-proven. * two or more of the following: albumin \ 1.3, radiologic or endoscopic evidence of portal hypertension. * creatinine \<2.0 mg/dl. * physiologic model for end stage liver disease (meld) ≥10. * decompensated cirrhosis with active or history of variceal bleeding, ascites, hepatic encephalopathy, or jaundice. * potential transplant candidate as per uams criteria exclusion criteria: * large gastric or esophageal varices with contraindication to use beta-blockers. * persistent hepatic encephalopathy grades 2-4. * prior diagnosis of hepatocellular carcinoma, or hepatic hydrothorax (with prior repeated thoracocentesis). * cirrhotic cardiomyopathy or congestive heart failure, pulmonary vascular complications, known active coronary artery disease, syncope, and cardiac dysrhythmias. * physical impediment to perform a cardiorespiratory fitness test. * use of implantable defibrillator or a pacemaker.
effects of two tear substitutes in patients with dry eye syndrome

Conditions: Dry Eye; Tear Film; Lipid Layer; Liposic; Tears Naturale Forte

Summary: with the potential to address evaporative dry eye, liposic and tears naturale forte have been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. this study compare the effects of liposic and tears naturale forte application on the lipid and stability of the tear film in dry eye patients


Eligibility criteria:
inclusion criteria: * age range from 20 year to 40 years * the value of osdi is over 12 * nbut is less 5 seconds * schirmer 1 test is less 10mm * the basical lipid layer grade is 1-2 exclusion criteria: * any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular infection; photophobia that may cause reflex tearing or difficulty in evaluating the patien 's lipid layer; * known allergic sensitivity to any of the ingredients in liposic or tears naturale forte
effectiveness of school-based cognitive behavioral therapy in preventing depression in young adolescents

Conditions: Depression; Anxiety

Summary: this study will evaluate the effectiveness of the penn resiliency program, a school-based cognitive behavioral depression prevention program for young adolescents.

depression is a serious illness that affects a person's mood, thoughts, and physical well-being. research suggests that approximately one in five children meets criteria for a major depressive episode by the end of high school. these children are at increased risk for a wide range of social, psychological, physical, and achievement-related problems. thus, the potential benefits of effective and highly transportable depression prevention programs are enormous. the penn resiliency program (prp) is a school-based group intervention that teaches cognitive behavioral and social problem-solving skills to young adolescents. this study will examine the effectiveness of prp in preventing symptoms of depression and anxiety among a group of young adolescents. participants in this open label study will be randomly assigned to one of three groups: adolescent only prp, adolescent plus parent prp, or no treatment control. in adolescent prp, students will be taught cognitive and behavioral problem solving skills by school counselors and teachers. parents in prp will be taught to model and reinforce the skills taught in the adolescent program. participants in the adolescent program will attend twelve 90-minute group sessions after school hours. participants in the parent program will attend six 90-minute group sessions. adolescent participants will attend booster sessions twice per year for 2 to 3 years after the initial treatment has ended. parents will attend one booster session per year during the follow-up phase. adolescents' depression and anxiety symptoms will be assessed through questionnaires at baseline, post-treatment, and 6-month intervals for 2 to 3 years following the intervention. adolescents will also complete questionnaires about their coping behaviors, feelings of hopelessness, and several other outcomes related to depression and anxiety in adolescence. data will be collected once per year from parents and teachers. adolescent participants will also be assessed for depression and anxiety disorders each year the child is in the study.

Eligibility criteria:
inclusion criteria: * student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting) exclusion criteria: * not a student in a participating school * not a student in grades six through eight

Keywords: prevention child adolescent parent
effectiveness of endoscopic sleeve gastroplasty in nonalcoholic fatty liver disease/nonalcoholic steatohepatitis

Conditions: Nonalcoholic Fatty Liver Disease

Summary: endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (esg), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. realizing there is a knowledge gap in applying esg to morbidly obese patients with nafld, the investigators propose studying the efficacy of weight control and functional outcomes of esg. this prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than 30 kg/m2, who are eligible for esg * patients scheduled to undergo an endoscopic bariatric weight loss procedure (esg) * patients older than 18 years and younger than 75 years of age at the time of consent * patients able to provide written informed consent on the institutional review board (irb) approved informed consent form * patients willing and able to comply with study requirements for follow-up exclusion criteria: * patients who are treated with intragastric balloons * family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration, * pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline esophagogastroduodenoscopy (egd) * presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia), * known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation * evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy * positivity for hepatitis b virus or hepatitis c virus, current alcohol consumption of more than 20 g/day in females and more than 30 g/day in males on average, use of medications with reported hepato-steatogenic effect (amiodarone, tamoxifen, estrogens), and drug-induced liver disease * type 1 diabetes, prior bariatric surgery, autoimmune liver disease (antinuclear antibody titer \>1/160), wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency, * known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent. * the patient refuses or is unable to provide written informed consent * prior bariatric treatment procedure
system accuracy of the blood glucose monitor for personal use contour care

Conditions: Diabetes

Summary: this study assesses the system accuracy of a blood glucose monitoring system in accordance with din en iso 15197:2015


Eligibility criteria:
inclusion criteria: * male or female patients with hypo-, eu- or hyperglycaemia * the written informed consent had to be signed * the volunteers must be older than 18 years * the volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved exclusion criteria: * pregnancy or lactation * acute or chronic diseases with the risk of aggravation by the measure * a current constitution that does not allow participating in the study * participation in another study or activity with the blood glucose measuring system evaluated in the present study * application of substances listed in appendix a of din en iso 15197:2015
timing of primary surgery for cleft palate

Conditions: Cleft Palate

Summary: this trial is a randomised controlled trial with a parallel design taking place in centres across the uk, scandinavia and brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either: * surgery at age 6 months, or * surgery at age 12 months. the main objective is to determine whether surgery for cleft palate, using a sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. all infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.

infants will be followed up at age 12 months, 3 years and five years. at each visit the following will be assessed: age 12 months * speech development (canonical babbling) * audiological assessments * growth age 3 years * speech development * audiological assessments age 5 years * speech development * audiological assessments * dentofacial development (soft tissue anb and maxillary arch constriction score using modified huddart bodenham scoring)

Eligibility criteria:
inclusion criteria: * infants with isolated cleft palate * medically fit for operation at 6 months, corrected for gestational age * written informed proxy consent * one parent/carer a native language speaker in the country of residence exclusion criteria: * consent not obtained * b. infants with syndromic cleft palate (except van der woude syndrome, which can be included if hearing is not affected) or severe developmental delay * congenital sensorineural hearing loss or middle ear anomalies; * variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the sommerlad technique would be inappropriate; * submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by jensen et al (1988). * where the language spoken at home is not the majority language in the country of residence.

Keywords: cleft palate paediatric pediatric surgery speech velopharyngeal
study of coagulation activation markers and pre eclampsia

Conditions: Pre Eclampsia

Summary: the primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.

100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on gestational age at inclusion and 100 control matched on delivery mode (section). blood and urine samples will be collected at pe diagnosis, delivery and post partum. two axes will be considered: 1. thrombography, or kinetic measurement of thrombin generation, by studying the coagulant profile according to hemker's method in cat system (calibrated automated thrombogram) and by thromboelastogram in rotem technique (delocalized coagulation analyzer), in parallel to specific activation markers (thrombin-antithrombin complex, fibrin monomers). 2. the balance of prostacyclin/thromboxane a2 by using elisa method for urine samples and genotype-phenotype correlation (polymorphism of prostacyclin-synthetase's promoter cyp8a1).

Eligibility criteria:
inclusion criteria: * 18 years old * diagnosis of pre eclampsia exclusion criteria: * multiple pregnancy * less than 18 year old

Keywords: pre eclampsia endogenous thrombin potential
chloroquine phosphate against infection by the novel coronavirus sars-cov-2 (covid-19): the hope open-label, non randomized clinical trial

Conditions: Pneumonia, Viral; Covid-19

Summary: this is an open label clinical study to evaluate the activity of chloroquine phosphate in patients with sars-cov-2 virus infection. the study aims to document possible prevention of pneumonia in patients staying at home and in improving the symptoms of sars-cov-2 pneumonia in patients who will be hospitalised.

humanity has been experiencing a new pandemic of the sars coronavirus-19 virus (sars-cov-2) since december 2019, causing the disease known as covid-19. as of march 23, 2020, there have been 382,341 documented episodes of infection worldwide, of which 16,567 have died. an important limitation in the treatment of the disease is the absence of drugs with known antiviral activity against sars-cov-2. recent data suggest that chloroquine has sufficient in vitro activity against the sars-cov-2 virus by inhibiting virus entry into cells. it has recently been described that hydroxychloroquine significantly reduces the percentage of patients who have positive sputum in the sars-cov-2 virus within 6 days. however, the clinical efficacy of the drug has not been described and it has significant side effects, including more than 10% anorexia, headache, blurred vision, diarrhea or vomiting, and myocardiotoxicity. the frequency of adverse effects of chloroquine in combination with the well-known in vitro activity of chloroquine have led to the design of clinical trials around the world to document the benefits of its use. the present study will evaluate the activity of chloroquine phosphate in patients with sars-cov-2 virus infection.

Eligibility criteria:
inclusion criteria: * age 18 or older * both genders * for women of childbearing age, they should use or be willing to use a double contraceptive method during the study. a urine pregnancy test to exclude pregnancy will be performed prior to study initiation. * written consent after information provided by the patient or the legal representative in the event that the patient cannot consent. * upper respiratory or lower respiratory tract infection, as in annexes ii and iii respectively. * positive respiratory secretion test for sars-cov-2 virus by molecular techniques or positive blood igm titers. exclusion criteria: * under 18 years of age * denial of written consent * any patient case where it has been decided not to rejuvenate * serum ast values greater than 5 times the upper normal range * qtc interval in rest electrocardiogram greater than 500msecs * pregnancy or lactation. urgent pregnancy test to exclude pregnancy before inclusion in the study

Keywords: covid-19 pneumonia chloroquine phosphate sars-cov-2
aortic-stent-register

Conditions: Aortic Dissection

Summary: the aims of the aorta-stent-registry are: • participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:

1. endovascular aorta-stent-graft 2. surgical operation of the distal thoracal aorta * documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine. * documentation of the operational risk (euroscore) * documentation of the technical enforcement of the procedure as well as the result of the intervention * documentation of the hospital lethality and the non-fatal serious complications (spinal cord ischemia, sci, stroke, tia, high blood loss etc.) * documentation of medication at hospital discharge * documentation of long-term lethality and non-fatal serious complications (sci, stroke, tia, major bleeding etc.) as well as hospitalization, re-intervention rates and medicinal drug therapy after 30 days, 1, 3 \& 5 years.

Eligibility criteria:
inclusion criteria: * patients with significant illness of the distal thoracal aorta (distal aortic-dissection; taa; penetrated ulcer; covered perforation; traumatically transection of the distal thoracal aorta) including those that receive an endovascular stent or an open surgical operation. exclusion criteria: * missing signed informed consent

Keywords: aorta aorta-stent-graft surgical operation aortic dissection
paracetamol and endothelial function in patients with stable coronary artery disease

Conditions: Coronary Arteriosclerosis; Endothelial Function

Summary: the purpose of this study is to determine the effect of orally given paracetamol on the vascular function and on 24-hour blood pressure in patients with coronary artery disease

patients with chronic pain diseases (e.g. osteoarthritis) are dependent on effective medication. nsaids are very effective in lowering pain in these patients. recently there has aroused major concern with regard to cardiovascular side effects and safety, especially in selective cyclooxygenase-2 inhibitors (coxibs) but also in "regular" nsaids. at the moment, there is a big confusion, whether these drugs still should be used, especially in patients with known coronary artery disease. physicians now try to switch to high dose paracetamol, despite the weaker efficacy in pain relieve, because this drug is considered generally as not harmful. as there is very few information on the cardiovascular effect of this drug, we plan to perform this study and investigate the impact of paracetamol on endothelial function, an important cardiovascular surrogate marker, on inflammatory markers and on oxidative stress in patients with coronary artery disease on top of standard medication, including aspirin

Eligibility criteria:
inclusion criteria: * age: 30 - 80 years * history of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test) * stable cardiovascular medication for at least 1 month * written obtained informed consent exclusion criteria:- myocardial infarction, unstable angina, stroke within 3 months prior to study entry * coronary intervention/revascularisation procedure within 3 months prior to study entry * left ventricular ejection fraction \<50% * other analgesics (platelet inhibition therapy with aspirin 100mg/d will be continued) * long acting nitrates * smoking * chronic heart failure (\> nyha ii) * ventricular tachyarrhythmias * renal failure (serum creatinine \>200umol) * liver disease (alt or ast \>100 iu), especially acute hepatitis * hyperbilirubinemia * alcohol abuse * oral anticoagulation * concomitant therapy with phenobarbital, phenytoin, carbamazepin, isonicotinic acid, chloramphenicol chlorzoxazone, zidovudine, salicylamide * insulin-dependent diabetes mellitus * drug abuse * anemia (hb\<10 g/dl) * known allergies on paracetamol * pregnancy * malignancy (unless healed or remission \> 5 years) * symptomatic hypotension, hypertension \>160/100 mmhg * disease with systemic inflammation (e.g. rheumatoid arthritis, m. crohn) * participation in another study within the last month