Kornimate/medical-research-clean huggingface dataset:
safety of add on aliskiren to angiotensin converting enzyme inhibitor (acei) and angiotensin i receptor blocker (arb) treatment in type 2 diabetes with nephropathy

Conditions: Type 2 Diabetes With Nephropathy

Summary: activation of renin-angiotensin plays a crucial role diabetic nephropathy. angiotensin converting enzyme inhibitor (acei) and angiotensin i receptor blocker (arb) has been shown renoprotection whether it was used alone or in combination. aliskiren is a direct renin inhibitor (dri) that has shown renal benefits and safety when combined with arb. however, to date, the safety of add on aliskiren to the combination treatment of acei and arb in diabetic nephropathy patients remains to elucidate.


Eligibility criteria:
inclusion criteria: * type2 diabetes patients * age \ * overt proteinuria (urinary protein creatinine ratio \> 200mg/g 2 times or more during past 6 mo) * scr \< 2.5 mg/dl * hba1c \< 7.5 * systolic blood pressure \> 160 mmhg without antihypertensive drugs or \> 140 with antihypertensive drug * no history of previous cardiovascular event (stroke, myocardial infarction, unstable angina, hospitalization, surgical correction pvd or pvd with claudication) * no hospitalization within 1 yr except for elective surgery exclusion criteria: * physical examination found or suspected serious co-morbid (af, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease) * non adherence to protocol * intolerable to acei or arb during run-in * abnormal liver function test at the run-in period * rapid declining renal function (scr increase \> 40%) during run-in * hyperkalemia (serum k \> 5.5 meq/l at randomization) * malignancy detected o * sbp lower than 110 mmhg (at randomization)

Keywords: acei, arb, dn, aliskiren, proteinuria
cardioprotection on chemotherapy-induced cardiotoxicity

Conditions: Cardiotoxicity

Summary: the aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.

the goal of this interventional study is to evaluate the protective impact of angiotensin-converting enzyme (ace) inhibitors versus β-blockers on the cardiotoxicity profile of pediatric patients with acute leukemia. the impact is measured by evaluation of left ventricular ejection fraction (lvef) by 2d echocardiography at baseline and at the end of induction phase (42 days).

Eligibility criteria:
inclusion criteria: * willingness of the legal representative of research participant to participate in the study by giving "informed consent." * ability to take oral medication. * age 2-18 years at the time of diagnosis. exclusion criteria: * documented allergy to cardioprotective medications
trial of cognitive behavioral therapy for schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder; Delusional Disorder

Summary: the following study addresses the hypothesis that cognitive-behavioral interventions will be effective in reducing positive and negative symptoms of schizophrenia under the conditions of the german health care system. it is also hypothesized that interventions designed to reduce delusions will reduce cognitive biases and dysfunctional self-concepts.

background: in spite of the proven effectiveness in a series of randomized controlled studies, cognitive-behavioural interventions for the treatment of symptoms of schizophrenia have been not yet been evaluated under the conditions of the german health care system. additionally, it remains unclear which processes are responsible for reducing positive symptoms using cbt-interventions. hypothesis: the following study addresses the hypothesis that cbt will be effective in reducing positive and negative symptoms of schizophrenia. it is also hypothesized that cbt will reduce cognitive biases and dysfunctional self-concepts. method: 70 patients with a primary diagnosis of schizophrenia will be randomized to a cbt-treatment- and a waiting-list-control-group. cbt involves a formulation-based treatment of approximately 25 sessions by trained and supervised therapists plus standard care (psychiatric medical treatment) in an outpatient setting. participants will be referred from cooperating psychiatrists. patients randomized to the waiting-list condition take part in the assessment phase, then receive standard care alone for 12 weeks and are then offered cbt. the primary outcome measure will be the positive and negative syndrome scale. additionally, depression, dysfunctional self-concepts and cognitive biases will be assessed before and after treatment.

Eligibility criteria:
inclusion criteria: * persons with a primary diagnosis of schizophrenia, schizoaffective disorder, delusional disorder acute or in incomplete remission a value of at least 3 on delusions, p1, p3 or g9 in positive and negative syndrome scale fluent in german language exclusion criteria: * severe organic brain disease

Keywords: cognitive behavioral therapy schizophrenia cognitive biases efficacy
effects of intrauterine flushing with human chorionic gonadotropin on icsi outcome

Conditions: Female Infertility

Summary: a number of infertile women who were prepared for icsi and immediately post ova pick up intrauterine flushing with human chorionic gonadotropin was done to study the effect of this drug on icsi outcome and ultrasound parameter.

ninety infertile women included. written informed consent was obtained before being included in the study. three groups of patients according to type of intervention. assessment of plasma hormone level was done for all. the quantification of serum tnf and il-10 levels was conducted through the application of the enzyme-linked immunosorbent assay (elisa) methodology at a privately-owned laboratory.

Eligibility criteria:
inclusion criteria: 1. the patient\&#39;s consent to participate in the research study is crucial for data collection and analysis. 2. each pair of individuals undergoing ivf/icsi procedures typically possess grade 1 (g1) embryos during the embryo transfer process. 3. the age range of the female participants varied from 18 to 40 years. 4. infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined. 5. male-related factors contributing to infertility were also taken into consideration. 6. the procedure involved the transfer of grade one embryos during a fresh cycle. exclusion criteria: endometrioses, whether clinically suspected or discovered during laparoscopy, are of interest. 2. instances of congenital abnormalities in the reproductive system are being examined. 3. individuals above the age of forty are under consideration. 4. individuals who do not possess g1 embryos are also included. 5. patients with chronic systemic conditions (such as diabetes, hematologic disorders, hypertension, autoimmune disorders of the connective tissue, asthma, thyroid disorders) are a part of the study. 6. the presence of empty follicles is noted in stimulated cycles where no oocytes were obtained during the aspiration procedure. -

Keywords: implantation infertility human chorionic gonadotropin
evaluating the analytical equivalency of serum and whole blood samples run on the memed key® platform (perseverance study)

Conditions: Acute Infection

Summary: this is a prospective, multi-center, sample collection study enrolling pediatric and adult subjects presented to the ed/urgent care, with symptoms consistent with acute bacterial or viral infection will be recruited according to eligibility criteria. the study is designed to measure the memed bv®️ score in whole blood and serum samples and demonstrate the equivalence between the two matrices. patients will be managed according to the current standard of care per standard institutional procedures.


Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained from the patient or his/her legal guardian. for children under 18 years old, written informed consent from the legal guardian must be obtained and assent from the patient may be required depending on the local requirements. 2. over 90 days of age. 3. clinical suspicion of acute bacterial or viral infection. 4. symptoms of acute infectious disease \< 7 days. 5. experienced fever at least once within the last 7 days (self-reported or temperature ≥ 37.8°c (100°f)). exclusion criteria: 1. hiv, hbv, active hcv, or active tuberculosis infection (self-declared or known from medical records). 2. suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis. 3. active inflammatory disease (e.g., ibd, sle, jia, ra, kawasaki, other vasculitis). 4. pregnancy- self reported or medically confirmed. 5. active malignancy. 6. congenital or acquired immune deficiency (cid). 7. a proven or suspected infection on presentation with mycobacterial (e.g., tuberculosis, mac), parasitic or fungal (e.g., candida, histoplasma, aspergillus) pathogen. 8. significant trauma or burns in the last 7 days. 9. patients that have undergone major surgery in the last 7 days. 10. current treatment with immune-suppressive or immune-modulating therapies, including without limitations: 1. administration of p.o.\\iv\\im high dose steroids \>1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids \> 0.25 mg/kg/day in the past 7 days 2. monoclonal antibodies, anti-tnf agents 3. intravenous immunoglobulin (ivig) 4. cyclosporine, cyclophosphamide, tacrolimus, azathioprine, methotrexate 5. g/gm-csf, interferons.
comparing endoscopic based stent strategy versus bypass surgery in non-resectable periampullary cancer

Conditions: Pancreatic Neoplasms; Biliary Tract Neoplasms; Duodenal Neoplasms

Summary: randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. this operation was often associated with a high morbidity. developments in endoscopic treatments allow palliation with lower morbidity. however, stent treatment is not free of problems like stent dysfunction. during the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. a total of 70 patients were randomized to surgery with hepaticojejunostomy on roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Eligibility criteria:
inclusion criteria: * patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction. * the patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable". exclusion criteria: * non consent. * the patients' general condition will not tolerate either treatment (strategy). * previous laparotomy or laparoscopy. * life expectancy \< 3 months. * inability to participate (language, social, etc.)

Keywords: pancreatic cancer periampullay neoplasms biliary duodenal jaundice obstruction pancreas cancer pancreatic cancer
recovery after sugammadex(propofol vs sevoflurane)

Conditions: Anesthesia

Summary: sugammadex is used to reverse of a neuro-muscular block deep. it has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. the goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.


Eligibility criteria:
inclusion criteria: * adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium exclusion criteria: * known drug allergy, * contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex * difficulty to use bispectral index monitor * inability to obtain a proper monitoring of muscle relaxation.
safety and tolerability of lu ag06479 in healthy young men

Conditions: Healthy

Summary: the purpose of this study is to investigate the safety and tolerability of lu ag06479 and what the body does to lu ag06479 after swallowing single doses of the drug.

part a: randomized, sequential part b: open-label, cross-over

Eligibility criteria:
inclusion criteria: * healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (bmi) ≥18.5 kg/m2 and ≤30 kg/m2 at the screening visit. other in- and exclusion criteria may apply
hydrolyzed collagen and undenatured collagen type ii in oa knee

Conditions: Osteo Arthritis Knee

Summary: randomized controlled trial targeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. the groups are divided into two groups: group 1: patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type ii collagen group 2: control patients will take placebo primary outcome : pain level


Eligibility criteria:
inclusion criteria: * age: 50-80 years old * medial compartment knee osteoarthritis * kellgren and lawrence classification stage 2 -3 * able to walk without walking aid exclusion criteria: * history of knee surgery on the study side * history of intra-articular steroid injection within 6 months prior to study entry * systemic arthritis conditions * degenerative neurological and muscular conditions in the lower extremities * chronic kidney disease with crcl \< 30 ml/min (glomerular filtration rate \<60 ml/min/1.73 m2)

Keywords: osteoarthritis collagen supplement
renal denervation using externally focused therapeutic ultrasound

Conditions: Hypertension

Summary: this study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.

this study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. it will be conducted on a maximum of twenty patients who meet the eligibility criteria and have signed the informed consent form. safety is the primary endpoint of this study. safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. clinical utility is a secondary endpoint of this study. clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * average systolic blood pressure at least 160 mmhg * refractory, stable hypertension despite being treated with at least three hypertensive drugs * two functioning kidneys, defined as egfr \>= 45 ml/min * at least one renal artery on each side which is greater than 4 mm. exclusion criteria: * history of nephrectomy or hydronephrosis * renal stenosis \> 50% * renal stent * ambulatory blood pressure monitoring 24 hour average systolic blood pressure \<= 135 mmhg * kidney stones which are symptomatic and/or \> 1 cm * history of abdominal surgery within the past 6 months * heterogeneities in the kidneys (cysts or tumors) * residual pyelonephritis * history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last 6 months * hemodynamically significant valvular heart disease * implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with mri * body weight \> 150 kilograms * target treatment depth \> 14 cm from the skin line * pregnant, nursing or intends to become pregnant during the trial period

Keywords: hypertension
a efficacy and safety study of nasal prongs with proprietary surface coating aiming to reduce bacterial colonization

Conditions: Nosocomial Infections; Pneumonia, Ventilator-Associated

Summary: the study is a first step in establishing the safety and efficacy of the cytacoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units.


Eligibility criteria:
inclusion criteria: 1. legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (icf). 2. subject is between 18 and 65 years of age. 3. subjects that have intact, wound free and scar free skin at the nasal prong target site. 4. subject that have intact, irritation-free nasal mucus membrane. exclusion criteria: 1. pregnant or nursing women. 2. subjects who are active smokers or using snuff. 3. subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea. 4. subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study. 5. subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study. 6. subjects using and/or subjects that have used oral or topical anti-inflammatory drugs within 1 week prior to entering the study. 7. subjects participating in any other clinical study. 8. subjects diagnosed with any type of skin infection (bacterial, viral or fungal) or inflammatory skin disease including psoriasis, eczema or severe acne 9. subjects diagnosed with any type disease affecting mucus membranes. 10. subjects suffering from any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment. 11. subjects who have a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the nasal prong target site 12. any subject that according to the declaration of helsinki is deemed unsuitable for study enrolment.
anterolateral versus direct lateral approach in hemiarthroplasty for hip fracture

Conditions: Hip Fractures

Summary: patients with dislocated hip fractures are randomised to cemented hemiarthroplasty with an anterolateral approach or a direct lateral approach.

dislocated intracapsular hip fractures are usually treated with cemented hemiarthroplasty. in norway, a direct lateral approach is most often used, as recommended in national guidelines. in total hip arthroplasty, however, minimally invasive approaches are also commonly used, and may improve the clinical results, as compared to posterior or direct lateral approaches. the aims of the present study are to evaluate the effect of the minimally invasive anterolateral approach (watson-jones approach) compared to the direct lateral approach (hardinge approach) to the hip joint in hemiarthroplasty after dislocated hip fractures. patients with dislocated hip fractures who are fit for cemented hemiarthroplasty are randomised to surgery with an anterolateral approach or a direct lateral approach.

Eligibility criteria:
inclusion criteria: * dislocated hip fracture. * planned cemented hemiarthroplasty. * able to walk, with or without walking aids, prior to the injury. exclusion criteria: * young and healthy patients with displaced hip fractures who are recommended total hip arthroplasty or open reduction / internal fixation of the fracture. * patients with severe comorbidity and high risk of cement-related complications who are recommended uncemented hemiarthroplasty (some, but not all, patients with asa (american society of anesthesiologists) grade 4). * not able to give informed consent.

Keywords: surgical approach hemiarthroplasty
application of eular recommendations for cardiovascular risk management in patients with rheumatoid arthritis

Conditions: Cardiovascular Check-up in Patients With Rheumatoid Arthritis

Summary: introduction cardiovascular diseases are the first cause of death in rheumatoid arthritis (ra). in 2010, eular standing committee for clinical affairs provides 10 recommendations for cardiovascular risk management in patients with rheumatoid arthritis, including a cardiovascular risk assessment annually. the goal of this study is to evaluate the application of eular recommendations in real life in patients with ra in the french population. inclusion criteria: all patients over 18 years old with rheumatoid arthritis treated with at least one dmards and/or biologic therapy, affiliated to the rsi (regime social des independents which correspond to other branches of the universal healthcare insurance agency). non inclusion criteria: patients declared as rheumatoid arthritis without dmards or biologic therapy or treated with steroids alone. the following analysis will be performed on the whole database of the rsi, without name identification. evaluation criteria: at least once a years the prescription of at least one of the following items use in the evaluation of the cardiovascular risk factors: lipides dosage, glycemia, hba1c, stress test, carotid ultra-sonography, coronary or lower limbs arteriography, heart ultra-sonography, cardiology clinic, endocrinology clinic. this evaluation will be done on the whole national population of rsi for the year 2011 (01/01/2011 - 31/12/2011). on a subgroup of patients from the region "provence alpes côte d'azur", the investigators will analyze the year 2009, and compare to year 2011, to evaluate the impact of theses recommendations.


Eligibility criteria:
inclusion criteria: * patients over 18 years, affiliated to rsi, with rheumatoid arthritis treated with at least one dmards and/or biologic therapy exclusion criteria: * patients under 18 years * patients declared as rheumatoid arthritis without dmards or biologic therapy or treated with steroids alone