Kornimate/medical-research-clean huggingface dataset:
evaluation of safety and efficacy of ave5530 as add-on to ongoing statins in patients with primary hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the present study is assessing the efficacy and safety of ave5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. the main objective is to evaluate the effects of the association ave5530+statin on ldl-c level reduction after 12 weeks of treatment. the effects of ave5530 on other lipid parameters will be assessed as secondary objectives.

the two doses of ave5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. the study will include a screening phase up to 2 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Eligibility criteria:
inclusion criteria: * adults with cholesterol levels not controlled on ongoing stable statin treatment exclusion criteria: * ldl-c levels \> 250 mg/dl (6.48 mmol/l) * triglycerides \>350 mg/dl (3.95 mmol/l) * conditions / situations such as: * presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels * active liver disease * recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or unstable or severe peripheral artery disease * positive test for hepatitis b surface antigen and/or hepatitis c antibody or known to be human immunodeficient virus (hiv) positive * pregnant or breast-feeding women, * women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the investigational product the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: hypercholesterolemia
a phase i dose escalation trial of pr104 given weekly in subjects with solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: the purpose of this study is to determine the side effects and best weekly dose of pr104 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * age 18 years or more * histologically confirmed malignancy for which no effective therapy exists * measurable or evaluable disease * ecog performance status of 0 or 1. see section 15.1 (ecog performance status) for definition of ecog performance status 0 and 1 * ability to read, understand and provide written informed consent * if the subject is on systemic steroids, the dose of steroids must be stable for at least two weeks prior to the first dose of pr-104 exclusion criteria: * licensed or investigational anti-cancer therapy (including radiotherapy) within four weeks of the baseline disease assessment (within six weeks for nitrosoureas and mitomycin c). subjects on androgen deprivation therapy are allowed on study and may continue to receive androgen deprivation therapy while one study * prior radiotherapy to more than 25% of bone marrow; prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplants); or prior receipt of more than three chemotherapy regimens * absolute neutrophil count of \< 1.5 x 109/l * platelet count of \< 100 x 109/l * hemoglobin level of \ 90 g/l) * serum bilirubin greater than the upper limit of normal * alt and ast greater than 2.5 times the upper limit of normal * serum creatinine less than 1.5 times upper limit of normal * prothrombin time (pt-inr) or activated partial thromboplastin time (aptt) greater than 1.1 times the upper limit of normal range * women who are pregnant, breast-feeding or planning to become pregnant during the study * men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose of study medication. see section 5.11 (contraceptives) for definition of effective methods of contraception * evidence of any other significant medical disorder or laboratory finding that in the opinion of the investigator compromises the subject's safety during study participation, including uncontrolled infection or infection requiring a concomitant parenteral antibiotic * plans for concomitant anti-cancer therapy (excluding androgen deprivation therapy) while on study * less than four weeks since major surgery * known to be hiv positive, hepatitis b sag positive or hepatitis c positive with abnormal liver function tests * no known contraindication to single doses of naproxen
quality of life with arcoxia in women with dysmenorrhea (0663-094)

Conditions: Pain

Summary: allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.


Eligibility criteria:
inclusion criteria: * healthy women older than 18 years old and younger than 25 years old * voluntary agreement to participate in the study and signature of informed consent * women with clinical diagnosis of dysmenorrhea exclusion criteria: * diagnosis of secondary dysmenorrhea due to: endometriosis, adenomyosis, malformations of muller's conducts, uterine fibromyomas, ovarian cystic, pelvic varicocoele, inflammatory pelvic disease, adherences, intrauterine devices, cervical channel stenosis, etc. * patients with diagnosis of acute inflammatory abdomen * patients with diagnosis of congestive heart disease, stroke (1 year), unstable angina, and history of myocardial infarction * women auto prescribing rescue medication for dysmenorrheal pain during the study * women with a diagnosis of mild dysmenorrhea
study of systemic impact of trace elements release by implantable medical devices. identification of biomarkers of systemic inflammation

Conditions: Biomarker; Systemic Inflammation

Summary: the main objective of this study is to evaluate the systemic impact of salting out of trace elements (te) by metallic and nonmetallic implantable medical devices (imd) and in particular the immune response of the organism to these trace elements and of their target organs, and to identify circulating protein biomarkers which might indicate an evolution of inflammation caused by an imd.

as secondary objectives, the study aims: * to establish the norms of concentrations of free te and nanoparticles for some forty of elements (in particular chrome, cobalt, nickel, titanium, tantalum, zirconium, tungsten, gold, silver, mercury, molybdenum, strontium ...) in different materials (blood, urine, hair and the viscera), with non-imd holder subjects, before and after mineralization of these materials (dead patients and autopsied non-imd holder subjects and subjects before placement of imd. * to evaluate the distribution of concentrations of metals in the same materials and in peri-prothetic environment with imd holder subjects (dead autopsied patients), more often with no inflammatory sign, with possibility of some probably inflammatory imd. * to evaluate the parameters of distributions of concentrations of metals in same materials (with the exception of the viscera) with living imd holder patients, with inflammatory reaction (during revision surgery). * to define the most suitable material (accessibility, concentrations, absence of contamination) for follow-up and evolution of inflammation in order to determinate norms of studied metals concentration. * to determinate proportion between different forms of circulation: particulate form (analysis after full mineralization) or free form (analysis without mineralization, permitting measurement of free forms), trace elements in organism.

Eligibility criteria:
inclusion criteria: * inpatient subjects for re-intervention of: hip prosthesis made by ceramic-on-ceramic or metal-on-metal, hip prosthesis made by stainless steel ball and knee prosthesis made by polyethylene-on-metal; * autopsied patients with and without imd; * covered by a health insurance. exclusion criteria: * infection caused by prosthesis resumption; * professional exposure to metals; * patient under guardianship.

Keywords: implantable medical devices biomarker systemic inflammation
is there a difference in pulmonary functions and craniovertebral angle among adolescent based on smart phone usage

Conditions: Respiratory Function Tests

Summary: the smartphones have become a necessity for most adolescents as they are used for communication and entertainment and education purposes especially in the period of covid pandemic. they spend most of their time in using smartphones. this could have side effects on their health. while using a smartphone, adolescent usually flex their neck and maintain the head in a forward position for long periods of time, which may affect the craniovertebral angle and pulmonary functions as sustained forward neck posture may lead to respiratory dysfunction.the purpose of the study is to investigate the effect of smart phones and tablets usage time on craniovertebral angle and problems of pulmonary functions among adolescents between 14-18 years' old.

a well-developed adolescents of both genders will participate in this study after signing institutionally approved consent form prior to data collection * they will be recruited from many secondary schools in cairo. their ages range from 14 to 18 years. they will be subdivided into two groups according to smartphone addiction scale-short version (sas-sv) into an addict group who use smart phone not less than 4 hours/day for at least 4 years and non-addict group who used smart phone less than that. * design of the study: cross sectional design will be applied in this study. * smartphone addiction scale-short version (sas-sv) will be used to divide the subjects into two groups addict and non-addict groups * (image j) image processing and analysis in java system will be used to measure the craniovertebral angle for both groups. * micromedical gold standard fully computerized portable auto spirometer will be used to measure pulmonary functions test in the form of forced expiratory volume in one second (fev1), forced vital capacity (fvc)and fev1/fvc for both groups. * all data will be recorded and statistically analysis.

Eligibility criteria:
inclusion criteria: * subjects of late childhood ( adolescence) * age of participants ranged from 14 to 18 years. * subjects with normal development. exclusion criteria: * athletic one. * genetic spinal deformity. * injury to the neck. * history of inflammatory joint disease. * history of surgical intervention at the neck. patients with neuropediatric problem.

Keywords: pulmonary function craniovertebral angle smart phone usage
long-term radiographic and clinic outcomes of ulnar shortening osteotomy in patients with ulnar impaction syndrome and reverse oblique sigmoid notch

Conditions: Distal Radioulnar Joint

Summary: patients with ulnar impingement are often coexisting with patients with distal ulnar and ulnar joints with a type of sigmoid notch, and ulnar shortening surgery is one of the most useful and long-lasting treatments for the treatment of ulnar impingement. some theories point out that if ulnar shortening surgery is performed on patients with distal oblique ulnar incisional ulnar joints, it may lead to accelerated degeneration of distal ulna and ulna articular joints, resulting in worse wrist function. some theories have pointed out this instead, surgery will cause joint remodeling and adaptation, but no long-term studies have confirmed this. therefore, this study plans to evaluate the long-term radiological and clinical outcomes of ulnar shortening surgery performed on patients with preexisting inverted sigmoid notch to determine whether this surgery will cause accelerated distal degeneration of the phalangeal joints or reshaping of joints and clinically corresponding changes in results.


Eligibility criteria:
inclusion criteria: * the distal ulnar joint of the wrist contains a patient with an inverted sigmoid notch of the sacrum, and the ulnar impaction causes ulnar wrist pain. therefore, the ulnar shortening surgery is accepted. exclusion criteria: * patients with diagnosed diseases of immune rheumatism, patients with ischemic necrosis of the carpus, patients with this lesion caused by infection or tumor.

Keywords: osteotomy reverse oblique sigmoid notch ulnar impaction syndrome ulnar shortening
leave safe with doacs

Conditions: Cardiovascular Diseases; Venous Thromboembolism; Atrial Fibrillation; Bleeding; Stroke

Summary: given the risks associated with direct oral anticoagulants (doacs) and the lack of defined pathways for patients prescribed this class of medications, the study intervention has the potential for an enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and adherence with doac therapy.

patients first treated with direct oral anticoagulants (doacs) in an ambulatory setting are at an elevated risk for adverse drug events (ades) or potential ades from medication errors. an intervention that integrates clinical pharmacists, a pharmacy technician, and follows a checklist published by experts at the anticoagulation forum can prevent adverse outcomes. the investigators propose research on the effectiveness, implementation, and dissemination for a care transition intervention that follows the checklist which includes evaluation for appropriateness of doac use, assistance with drug procurement, telephone access to an anticoagulation expert, and other best practice recommendations.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * new prescription of doac within 4 days of consent or continued doac use for a patient with new episode of worsening thromboembolic or bleeding event within 4 days of consent or discharged from the hospital with doac prescription within 4 days of consent * fluency in english, portuguese, or spanish exclusion criteria: * currently hospitalized with inpatient status (as opposed to observation status) * age \< 18 * prisoners * pregnant patients (medications are contraindicated)
long term study of 3 radiofrequency devices

Conditions: Varicose Veins of Lower Limb

Summary: to establish which of the radiofrequency venous ablation modalities studied in the original 3rf study (venefit (closurefast), vs. radiofrequency induced thermal therapy vs. endovenous radiofrequency) is most effective in relieving patients' symptoms and signs from varicose veins disease, and in maintaining absence of reflux in the treated vein segment (of the great saphenous vein (gsv)) 5 years following surgery.

results of randomised trials and meta-analyses have shown that endovenous thermal ablation of the gsv using radiofrequency ablation or laser is associated with improved recovery compared with conventional surgery. furthermore, radiofrequency ablation (using the closurefast device) has been shown to cause less pain and require less analgesic intake than laser treatment. at the time the 3 rf study was conceived there were two other radiofrequency devices that were marketed to have theoretical advantages over the closurefast technique. all three devices were in use in clinical practice (including at worcestershire royal hospital) in 2013. the initial study focused on clinical results (up to 12 months) and anatomical results (up to 6 months) and remains the only clinical trial to date that has directly compared the outcomes of radiofrequency thermal ablation devices. this second (long term) phase of the study aims to assess which of the radiofrequency venous ablation modalities studied in the original 3rf study (venefit (closurefast), vs. radiofrequency induced thermal therapy vs. endovenous radiofrequency) is most effective in relieving patients' symptoms and signs from varicose veins disease, and in maintaining absence of reflux in the treated vein segment (of the great saphenous vein (gsv)) 5 years following surgery.

Eligibility criteria:
inclusion criteria: * patients originally recruited to and studied in the 3rf study (clinicaltrials.gov identifier: nct02441881) who give informed consent to take part in this long term study exclusion criteria: * patients originally recruited to and studied in the 3rf study (clinicaltrials.gov identifier: nct02441881) who do not give informed consent to take part in this long term study
mri compatible and long-term lfp recordable deep brain stimulation on pd patients

Conditions: Idiopathic Parkinson Patients

Summary: deep brain stimulation represents the golden standard for surgical treatment of parkinson's disease (pd), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. therefore,other approaches should be considered. new approaches in mri at 3t and long-term local field potential (lfp) recording are very important to target subthalamic nucleus (stn) and understand mechanisms of dbs on parkinson patients. this study aims at evaluating the safety and effectiveness of 3t mri compatible and lfp recordable deep brain stimulation on pd patients. the chronically lfp recording using g106r is for two goals: 1) evaluate the performance of long-term recordable neural simulation. 2) study long-term clinical and electrophysiology effects of deep brain stimulation on stn.


Eligibility criteria:
inclusion criteria: 1. age ≥18，≤75，idiopathic parkinson's disease，both male and female 2. mmse score ≥24 3. h-y score ≥2.0 on the medicine off situation 4. updrs-iii score≥30 on the medicine off situation 5. the duration of this disease ≥5 years 6. ability to provide informed consent as determined by preoperative neuropsychological assessment 7. history of appropriate response to dopaminergic medication, with at least a 30% improvement in motor updrs with l-dopa by history or in-clinic testing, for the pd patients 8. excellent responsiveness to levodopa 9. ≥6h in medicine off state exclusion criteria: 1. lack of ability to provide informed consent as determined by preoperative neuropsychological assessment 2. otherwise not eligible for dbs surgery, for example known inability to undergo anesthesia 3. hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases 4. patients who are unable to follow verbal instructions 5. other severe pathological chronic condition that might confound treatment effects or interpretation of the data
detecting early myocardial infiltration w/amyloid & light chain deposition disease in multiple myeloma subjects

Conditions: Multiple Myeloma

Summary: the purpose of this study is to see if mri techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. cardiac amyloidosis is a medical disorder that decreases heart function.

the purpose is to investigate the use of multiple newer cmr techniques for early evaluation of cardiac amyloidosis in multiple myeloma.

Eligibility criteria:
inclusion criteria: * all races and ethnic groups * male and female ages 18-80 years of age * history of multiple myeloma * cmr study for evaluation for cardiac amyloidosis exclusion criteria: * pregnant women * subject with a metallic or electronic or other device that could be affected by the magnet

Keywords: cardiac mr (cmr) early myocardial infiltration amyloid light chain deposition disease multiple myeloma
ruxolitinib as add-on therapy in steroid-refractory graft-vs-host disease

Conditions: Steroid Refractory GVHD

Summary: steroid-refractory graft-vs-host disease (sr-gvhd) is a major cause of mortality after allogeneic hematopoietic stem cell transplantation (hsct). we sought to evaluate the effect and safety of ruxolitinib (rux) add-on in the treatment of patients with sr-gvhd.

nowadays, second-line treatment for sr-gvhd differs between centers and depends on the physician's experience. the agents commonly used as second and further lines of therapy include anti-thymocyte globulin, mycophenolate mofetil, calcineurin inhibitor, or extracorporeal photopheresis. however, the response varied. this study highlighted that corticosteroid (cs) is not a panacea for treating gvhd, and some patients with remission still experience further relapse. additionally, the identification of multiple infections adds complexity. hope was supposed to come in 2019 after the food and drug administration (fda) approved rux for the therapy of sr-gvhd in adult and pediatric patients \> 12 years. rux add-on should be withheld as the risks outweigh the benefits, especially for patients who developed scleroderma and bronchiolitis obliterans. rux can be added on as needed for the treatment of gvhd, especially in patients receiving dli as relapse therapy with the conversion from mixed chimerism to complete chimerism. despite some studies showing the efficacy of rux across affected organs, some other data bring the opposite results. thus we conducted this study to reinforce the efficacy of rux as an add-on therapy for sr-gvhd.

Eligibility criteria:
inclusion criteria: * patients diagnosed with hematologic disorder exclusion criteria: * those who are not applicable of receiving ruxolitinib as immunodeficiency-modulation therapy * those who are actively encountering acute infectious illness

Keywords: acute lymphoblastic leukemia hematopoietic stem cell transplantation
rituximab in addition to chemotherapy with autologous stem cell transplantation as treatment diffuse large b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma; POOR PROGNOSIS

Summary: the purpose of this trial was to evaluate efficacy and safety of adding rituximab to dose-dense and high-dose chemotherapy (hdc) with autologous stem cell transplantation (asct) as first line treatment in young patients with dlbcl at intermediate-high and high risk aaipi score


Eligibility criteria:
inclusion criteria: * previously untreated aggressive b-cell lymphoma (diffuse large b-cell, * primary mediastinal, * follicular grade iii b lymphoma); * age 18 to 60; * iii-iv ann arbor stage; * 0-2 eastern cooperative oncology group (ecog) performance status (ps); * intermediate-high (ih) and high (h) risk score according to age-adjusted international prognostic index (ipi). * patients with primary mediastinal lymphoma were included only if they had advanced stage iii or iv disease. exclusion criteria: * hiv, * hepatitis b or c virus seropositivity; * cns involvement at diagnosis; * abnormal renal, pulmonary and hepatic function; * left ventricular ejection fraction less than 45%; * pregnancy.

Keywords: large b-cell lymphoma rituximab asct
the effect of delayed cord clamping and milking on the amount of stem cells in preterm

Conditions: Umbilical Cord; Clamping Time

Summary: stem cell therapies have been promising therapies in neonatal morbidities such as bronchopulmonary dysplasia, intraventricular hemorrhage and hypoxic ischemic encephalopathy. although researchers showed those effects by several mechanisms including paracrine effect, regenerative and restorative effects, there is no obvious recommendations for the type of stem cells, dosage or the route of administration the cells. the usage of exogenous stem cells can be difficult due to technical issues in preterm infants. in the presence of these data, the amount of endogenous stem cells passing through the cord to the infant may show differences in terms of delayed cord clamping and milking. therefore the aim of this prospective randomized study is to determine the quantity of the stem cells according to delayed cord clamping or cord milking. we also aimed to evaluate the association between the number of stem cells and neonatal morbidities.


Eligibility criteria:
inclusion criteria: * infants born under 32 weeks of gestation * accepted to participate with informed consent * history of healthy pregnancy * infants born and will be followed up at the study hospital exclusion criteria: * congenital abnormalities * chromosomal abnormalities * declined to participate