Kornimate/medical-research-clean huggingface dataset:
prasterone (dhea) for the treatment of hypoactive sexual desire disorder (hsdd) - second study

Conditions: Hypoactive Sexual Desire Disorder (HSDD)

Summary: the primary objective is to confirm the efficacy of intravaginal prasterone (dhea) on hypoactive sexual desire disorder (hsdd) in postmenopausal women.


Eligibility criteria:
inclusion criteria (main criteria): * postmenopausal women (hysterectomized or not). * women between 40 and 80 years of age. * being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months. * diagnosis of hsdd confirmed by a qualified clinician. * willing to participate in the study and sign an informed consent. exclusion criteria (main criteria): * chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity. * taking drugs which could be responsible for hsdd. * severe medical condition which can explain the loss of sexual desire. * the administration of any investigational drug within 30 days of screening visit. * clinically significant abnormal serum biochemistry, urinalysis or hematology.

Keywords: prasterone dhea menopause sexual disorder hsdd
efficacy and safety of a new formulation of chondroitin sulfate and glucosamine sulfate to treat knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (cs+gs) compared with placebo in patients with primary osteoarthritis of the knee.

the purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. clinical efficacy at the end of treatment will be evaluated. safety will be evaluated through adverse events recoding during the study period.

Eligibility criteria:
inclusion criteria: * patient \>= 45 years . * primary oa of the knee according to acr criteria. * oa radiological grade ii-iii according to kellgren and lawrence. * patients with moderate-severe pain. exclusion criteria: * patients with clinical significant trauma or surgery in the target knee. * concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia. * pain in other parts of the body greater than the knee pain that could interfere with the evaluation. * subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, hiv positivity) or fungal infections. * clinical diagnosis established of uncontrolled diabetes mellitus. * patients with asthma. * history of hypersensitivity to the active drugs or any excipients of the formulations.
evaluation of conventional antibiotic prophylaxis during a change of hip or knee infected at a time

Conditions: Total Hip Replacement

Summary: infection is a serious complications after undergoing total hip replacement. it occurs in about 1% of cases. the optimal treatment of these infections is discussed. the team validated by international publications change strategy of the infected prosthesis at a time. antibiotic prophylaxis has significantly reduced the infection intraoperative contamination in orthopedic surgery rates. it must be conventionally administered before the surgical incision. in response to infection, it is typically recommended to start this antibiotic after the completion of the deep bacteriological samples, so as not to negate the risk of these samples by the prior administration of antibiotics. this attitude, however, is not formally validated by the scientific literature. in contrast, two recent publications challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in septic interventions. our multidisciplinary team opted for a few months for this new strategy. we wish to evaluate the influence of this new approach results in the treatment of infection in total hip or knee.


Eligibility criteria:
inclusion criteria: * patients operated in service between january 2012 and july 2013 for treatment of an infection of total hip or knee. exclusion criteria: * patients operated in service before january 2012 and after july 2013 for treatment of an infection of total hip or knee.

Keywords: hip replacement knee replacement knee infection hip infection antibiotic prophylaxis
descriptive and evaluation study of the use of pulmonary ultrasound in the initial management of pregnant women in the context of covid-19

Conditions: Pregnant Women Suspected of COVID-19

Summary: cohort prospective study. objectives : primary objective: to describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed covid-19 secondary objectives: * to compare the lung ultrasound lesions with chest computed tomography -scanner (ct-scan) lesions * to evaluate the performances of the lung ultrasound to diagnose covid-19 in pregnant women * to evaluate predictive value of different lung ultrasound lesions for intensive care unit admission of pregnant women with suspected or confirmed covid-19 * to describe the pregnancy issues of the study population course of the study: * inclusion of pregnant suspected of having covid-19 and cared following the service protocol * performing of lung ultrasound at bedside in labor ward or in covid unit primary outcome: lung ultrasound lesions (and corresponding score) at the moment of the initial management of pregnant women suspected or confirmed with covid-19 (having a nasopharyngeal reverse transcription polymerase chain reaction (rt-pcr) sars-cov-2 and a chest ct-scan)


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * gestational age greater than or equal to 22 weeks of gestation * pregnant women suspected of covid-19 : * already having a nasopharyngeal rt-pcr for the sars-cov-2 * and having a chest ct-scan or waiting for this exam * women giving a writing consent to participate exclusion criteria: * women giving an opposition to participate * women not enough fluent in french to benefit from clear and intelligible information
population pharmacokinetics of lassila tazobactam in patients after aortic dissection

Conditions: Aortic Dissection; Lung Infection

Summary: the individualized drug use research on optimizing piperacillin tazobactam for crrt of hospital-acquired pulmonary infection after cardiopulmonary bypass is still in the initial stage at home and abroad, lacking systematic research data. with the help of the population pharmacokinetic model, it can help clinicians to formulate individualized drug administration plans for such patients and provide methodological and data support for precise treatment. the rational use of piperacillin tazobactam will play an important role in reducing the use of carbapenems and curbing the occurrence of drug resistance.

the incidence of acute renal failure after aortic dissection can be as high as 30%. in order to reduce mortality, most patients need continuous renal replacement therapy (crrt). the concentration of antimicrobial drugs in patients receiving crrt is often lower than the treatment level, which leads to treatment failure. the drug clearance rate of critically ill patients may change every day and it is difficult to estimate, especially when the renal function deteriorates and crrt begins. as a time-dependent antimicrobial drug, increasing the% t \> mic of piperacillin tazobactam is closely related to ensuring clinical efficacy. however, the molecular weight of piperacillin tazobactam is less than 2000 d, which can easily pass through the filter membrane. all crrt methods have the same clearance rate. meanwhile, the binding rate of piperacillin and tazobactam to plasma protein is only about 30%, which is easy to clear through crrt. as a result, the curative effect of piperacillin tazobactam in treating hospital-acquired pneumonia after aortic dissection is not good according to the conventional dosage and administration. more and more doctors will consider choosing carbapenems as soon as possible, which is related to national health. therefore, the traditional pharmacokinetic study is no longer applicable, and it can't provide a basis for clinical determination of individualized drug use plan of piperacillin and tazobactam, while the population pharmacokinetic study can effectively solve this problem. the frequency of blood collection from patients is low (usually 2 \~ 4 blood collection points), which is the most advanced method for individualized drug use research in the world at present \[10\]. methods the nonlinear mixed effect model (non-mem) was used to calculate the average and variability of pharmacokinetic parameters in patients, and the synergistic effect of patient factors (such as age and weight) on pharmacokinetic parameters could be evaluated, thus providing a reliable basis for formulating individualized and accurate drug administration plan and improving the success rate of anti-infection.

Eligibility criteria:
inclusion criteria: cardiopulmonary bypass during aortic dissection， lung infection， continuous renal replacement therapy exclusion criteria: intracranial infection, urinary tract infection

Keywords: piperacillin tazobactam crrt
laparoscopic rectopexy for rectal prolapse

Conditions: Rectal Prolapse

Summary: the aim of the present prospective, double-blind, randomized study is to study whether laparoscopic anterior mesh rectopexy is as good as laparoscopic posterior rectopexy with respect to obstructive defecation afterwards.

full-thickness rectal prolapse is defined as a "falling down" of the rectum so that it is outside the body. rectal prolapse can only be treated by surgery. the choice of procedure depends on the patient's general condition and is based on a clinical judgment. usually, elderly, high-risk patients are treated by perineal procedures. all other patients are offered an abdominal rectopexy using open or laparoscopic techniques. the general principle for all abdominal procedures is to induce adhesions between the mobilised, elevated rectum and the presacral fascia. at least 30%-60% develop long-term complications: obstructive defecation, which may be related to peroperative trauma to rectums innervation. sparing of the lateral stalks during the rectal mobilisation results in lower frequency of obstructive defecation afterwards, but also higher recurrence rate. a nerve-sparing laparoscopic technique for rectal prolapse has been developed in belgium: laparoscopic anterior mesh rectopexy. after this procedure, the rate of obstructed defecations afterwards has been reported to less than 10%, that is, much lower than observed after other procedures. the functional results after this nerve-sparing laparoscopic technique should be compared to those after laparoscopic posterior rectopexy, i.e. the conventional laparoscopic method.

Eligibility criteria:
inclusion criteria: * patients with full-thickness rectal prolapse for whom the department otherwise would offer abdominal rectopexy according to the department's recommendation. that is, patient being fit for an abdominal rectopexy procedure. exclusion criteria: * age below 18 years. * pregnancy or breast-feeding. * patients who do not speak or read danish. * dementia or other psychiatric disease, i.e., inability to give informed consent. * recurrence of rectal prolapse.

Keywords: rectal prolapse laparoscopic rectopexy obstructed defecation
the postoperative lidocaine and ketamine effects on morphine requirement in bariatric surgery

Conditions: Pharmacological Action; Post Operative Pain; Opioid Use; Obesity, Morbid; Anesthesia Morbidity

Summary: the goal of this observational study is to evaluate the quality of postoperative analgesia in a group of obese patients schedule to bariatric surgery under tiva opiod-free after to receive lidocaine and ketamine perfusion. the main question it aims to answer are: how lidocaine and ketamine perfusion during recovery period does impact over morphine consumption on the following 48 hours after surgery? all participants will receive total intravenous anesthesia and, at the end of the surgery, they will be divided in two groups, group a: placebo and, group b: with postoperative lidocaine and ketamine perfusion. our hypothesis is ketamine and lidocaine are a good alternative to decrease the use of morphine in obese patients.

the obese patients have more risk for certain side effects and complications with elevated risk of perioperative mortality and morbidity. an effective postoperative pain management is important to prevent pulmonary complications and, it is not recommended continuous infusions of opioids in this kind of patients, because the opioid-induced upper airway obstruction and respiratory depression are more likely to be seen in obese patients with obstructive sleep apnea. we can reduce perioperative opioid using dexmedetomidine, ketamine and lidocaine, however, it is a little know the use and benefits of lidocaine and ketamine inmediately after surgery.

Eligibility criteria:
inclusion criteria: * all patients between 18 y 65 years old. * imc \> 30 kg/m2 * asa ii/iii exclusion criteria: * patients taking high doses of opioids before operation for chronic pain * patients with allergies to any study medication. * pregnancy or breastfeeding. * kidney or heptic failure. * surgical complication
comparative immunogenicity study of two hepatitis a vaccines

Conditions: Hepatitis A

Summary: hepatitis a is the most prevalent hepatitis which account for approximately 45% . the susceptible population is children and adolescence, also the morbidity in adult presented rising trend in recent years. therefore, vaccination of hepatitis a vaccine play an important role in national immunisation program(china). the aim of this experiment is to verify the effects of experimental group non-inferior than control group. the experiment methods is compared the difference of seroconversion rate and antibody geometric mean titer (gmt)between experimental and control hepatitis a vaccines. in addition, evaluating the safety of two hepatitis a vaccines in 18-24 months chinese children.


Eligibility criteria:
inclusion criteria: * the healthy children in mental and physical aged between 18-24 months, and the guardians agree and fully understand the protocol. * no hepatitis a disease and contraindication of vaccination * no history of hepatitis a vaccine * the subjects can follow the requirements of experiment project. * do not vaccinate other vaccine in one months. * axillary's temperature≤37℃ exclusion criteria: * having severe diseases. * allergy to the components in vaccine * immune abnormalities * the people who do not agree with the inclusion criteria * have a serious chronic disease * any conditions which researcher think will influence the results or the subjects.
iron supplement in the prevention of anemia in female breast cancer patients

Conditions: Breast Cancer

Summary: study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.


Eligibility criteria:
inclusion criteria: 1. women older than 18 years 2. patient with operated breast cancer with indication for (neo)adjuvant therapy 3. they must have hemoglobin levels within the normal range (\> 12g/dl), absence of renal and hepatic dysfunction as assessed by serum levels of urea, creatinine, ast, alt. 4. lack of folic acid deficiency and vitamin b12 5. able to provide written informed consent. exclusion criteria: 1. use of any oral supplement containing iron; 2. patients who have iron overload as defined by serum ferritin\> 800 microg / l or transferrin saturation\> 40%; 3. patients who are pregnant or breastfeeding; 4. history of active infection or active bleeding except menstruation; 5. history of hiv or hepatitis b or c - clinically important; -
proof of concept, twice daily applications of leo 124249 ointment in the treatment of chronic hand eczema

Conditions: Hand Eczema

Summary: to compare the efficacy of twice daily applications of leo 124249 ointment with leo 124249 ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic hand eczema with or without atopic etiology/background with a history of not adequately controlled disease activity with cutaneously applied steroid * physician's global assessment of disease severity graded as at least mild at visit 1 * in overall good health including well controlled diseases exclusion criteria: * systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin) or corticosteroids within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used). * puva (psoralen ultraviolet a) or uvb (ultraviolet b) therapy on the hands within 4 weeks prior to randomization * cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization. * use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization * concurrent skin diseases on the hands * current diagnosis of exfoliative dermatitis * significant clinical infection (impetiginized hand eczema) on the hands which requires antibiotic treatment * a marked abnormal ecg at baseline * known hepatic dysfunction or hepatic dysfunction tested at screening * current participation in any other interventional clinical trial
personalized treatment planning in intracranial aneurysm surgeries.

Conditions: Aneurysm Cerebral

Summary: patients who will undergo a intracranial aneurysm (ia) surgery are educated concerning their disease and the surgical procedure.the objective of this study is to explore the advantages of conventional, virtual reality and 3d stereolithographic models for patient and resident education in the treatment of las.

patient understanding of their medical condition and treatment satisfaction has gained increasing attention in medicine. as for neurosurgical conditions however, the treatment plan is often difficult for patients to comprehend, with many of them having an inaccurate understanding of the involved anatomy. novel technologies therefore may play a role in facilitating patient education. in particular, conventional 2d images makes it sometimes difficult for surgeons to inform their patients about the planned intervention and potential complications. this is why new modalities have been developed for patient information and may have further an impact on resident education to better estimate the treatment plan and potential complication. for the latter, given that intracranial aneurysms (las) are increasingly treated via endovascular methods, training opportunities are reduced and understanding of the vascular anatomy can become difficult. the objective of this study is to explore the advantages of conventional, virtual reality and 3d stereolithographic models for patient and resident education in the treatment of las.

Eligibility criteria:
inclusion criteria: * all patients undergoing elective surgery for non-ruptured ia during the study period will be considered for inclusion. patients are included if they are at least 18 years old and are able to give informed consent and signed the informed consent form. exclusion criteria: * patients with ruptured or mycotic ia are not considered. furthermore, patients elected for ia surgery that are younger than 18 years old, as well as patients who are unable to give informed consent (e.g. neurological impairments) will not be included.
myomectomy during cs: a retrospective cohort study

Conditions: Cesarean Section; Uterine Fibroid

Summary: to evaluate the value of myomectomy during delivery by cesarean section (cs) in pregnant women with uterine fibroids.


Eligibility criteria:
inclusion criteria: * women who underwent elective cs with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery exclusion criteria: * antepartum hemorrhage * blood diseases or bleeding tendencies. * medical conditions complicating pregnancy. * performed another surgical procedure at cs other than myomectomy.
intralesional injection of mitomycin c following visual internal urethrotomy for recurrent urethral stricture

Conditions: Urethral Stricture

Summary: to evaluate the effectiveness of administering mitomycin c through intralesional injection after performing visual internal urethrotomy (viu) for the treatment of recurring urethral stricture.

numerous studies have investigated the impact of intralesional administration of antifibrotic drugs on urethral strictures following visual internal urethrotomy (viu). these drugs include mitomycin c, botulinum toxin a, somatostatin analog, and glucocorticoids. mitomycin c (mmc) is known for its potent chemotherapeutic and antibiotic properties. it effectively hinders mitosis and fibroblast proliferation, playing a crucial role in tissue healing and scar formation by reducing the release of matrix proteins through the inhibition of proliferative fibroblasts. with its anti-proliferative and anti-scarring characteristics, mmc proves to be a suitable option for treating recurrent urethral strictures. thus we conduct a randomized controlled trial to evaluate the safety and efficacy of mitomycin in decrease urethral stricture recurrence.

Eligibility criteria:
inclusion criteria: * all adult male patients aged above 18 years with a single bulbar urethral stricture measuring less than ( 1.5 cm), and had failed at least one prior intervention for urethral stricture(urethral dilation \& viu) were included in our study exclusion criteria: * patients with urethral strictures more than (1.5 cm), multiple urethral strictures, complex stricture, complicated by a fistula or abscess, completely occluded urethral strictures and previous urethroplasty were excluded

Keywords: mitomycin c - visual internal urethrotomy - urethral stricture