Kornimate/medical-research-clean huggingface dataset:
compare the efficacy of cinacalcet vs traditional vitamin d for secondary hyperparathyroidism (shpt) among subjects undergoing hemodialysis

Conditions: Hyperparathyroidism, Secondary

Summary: the purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin d therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at screening * treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening * informed consent provided by the study candidate * for subjects not receiving cinacalcet and/or vitamin d therapy for shpt within 60 days prior to enrollment: plasma pth levels ≥ 450 pg/ml (50 pmol/l) during screening, as obtained from the central laboratory and, serum corrected total calcium ≥ 8.4 mg/dl (2.1 mmol/l) and \< 10.2 mg/dl (2.55 mmol/l) during screening, as obtained from the central laboratory exclusion criteria: * parathyroidectomy in the 12 weeks before the date of informed consent * history of seizure within 12 weeks prior to randomization * scheduled for kidney transplant * parathyroidectomy anticipated within the next 6 months * liver function tests \> than 2 x the upper limit of normal * prior use of bisphosphonates, or expected to receive bisphosphonates during the trial * subject has previously enrolled in this study * general * other investigational procedures are excluded * currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) * subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment * subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment * subject has known sensitivity or intolerance to any of the protocol required therapies * subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge * subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Keywords: secondary hyperthyroidism hemodialysis parathyroid paradigm
current role of pentafecta outcomes in open and laparoscopic partial nephrectomy for localized renal tumors

Conditions: Pentafecta; Laparoscopic; Partial Nephrectomy; Renal Tumors

Summary: this study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following partial nephrectomy.

partial nephrectomy (pn) is widely considered the preferred treatment for clinical t1 (ct1) renal masses, primarily because it preserves kidney function more effectively than radical nephrectomy. the trifecta metric includes three components: warm ischemia time (wit) of ≤ 25 minutes or cold ischemia time (cit) of ≤ 60 minutes, negative surgical margins, and the absence of perioperative major complications. the pentafecta expands upon these criteria by adding two additional parameters: preservation of ≥ 90% of the estimated glomerular filtration rate (egfr) and no progression in chronic kidney disease (ckd) stage within 12 months postoperatively.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * both sexes. * patients who diagnosed with clinical t1 or t2a n0m0 renal tumors who were suitable candidates for partial nephrectomy exclusion criteria: * severe and irreversible coagulopathy. * anatomically unfavorable tumor location. * extensive encasement of the renal pedicle. * diffuse invasion of the renal vein or central collecting system. * adjacent organ invasion consistent with stage ct4 disease. * regional lymphadenopathy (stage ctxn1), or anticipated retention of less than 20% of total nephron mass.
cubicin(r) for complicated post-surgical wound infections

Conditions: Wound Infections

Summary: the purpose of the study is to describe the clinical efficacy of cubicin therapy in patients with superficial and deep post-surgical gram-positive wound infections

a multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of cubicin therapy in patients with superficial and deep post-surgical gram-positive wound infections. adjunctive treatment with aztreonam and/or metronidazole could be given for gram-negative and/or anaerobic organisms. patients are to be treated for a period of 7-14 days as specified in the package insert. an evaluation is to be performed on the day cubicin treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). a follow-up is required for patients with an investigator response of 'improved' at the end of treatment.

Eligibility criteria:
inclusion criteria: * read and signed informed consent form * female of childbearing potential, negative pregnancy test result * confirmed diagnosis of post-surgical wound infections known or suspected (based on gram stain) to be due to gram-positive organisms obtained within 3 calendar days prior to first dose of study medication * onset of surgical wound infection within 30 days after surgery * at least three clinical signs and symptoms of skin infection exclusion criteria: * previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug * uncomplicated surgical infections (eg, stitch abscesses) * osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection * any type of space infection * conditions requiring surgical removal of wound infection * necrotizing fasciitis, synergistic gangrene, clostridial myonecrosis (gas gangrene), or fournier's gangrene; * foreign material involved in the post-surgical wound infection * known to be allergic or intolerant to study medication * creatinine clearance (clcr) \<30 ml/min * history of neurological disease (eg, guillain-barré, multiple sclerosis)

Keywords: post-surgical wound infection superficial deep surgical
study gsi-136 in healthy young and healthy elderly subjects

Conditions: Alzheimer Disease; Healthy

Summary: this is a first-in-humans study of gsi-136, a drug being developed for the treatment of alzheimer disease. the main purpose of this study is to determine whether gsi-136 is safe and tolerable in healthy young and healthy elderly subjects. the amount of drug in the body and the effects of the drug on the body will also be evaluated at certain timepoints.


Eligibility criteria:
\<inclusion: 1. men or women of nonchildbearing potential (woncbp) aged 18 to 50 years or greater than 65 years, inclusive, at screening. woncbp may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than 1 year (with follicle-stimulating hormone \[fsh\] level greater than 38 miu/ml) and must have a negative pregnancy test result within 48 hours before test article administration. women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration. 2. body mass index (bmi) in the range of 18.0 to 30.0 kg/m2 and body weight greater than 50 kg. 3) the elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, 12-lead ecgs, or clinical laboratory test results that are associated with stable, chronic, and well-controlled medical conditions. exclusion: 1. any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (copd). 2. any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3. presence or history of thyroid disease, symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris, significant cardiac arrhythmia, or seizures.

Keywords: alzheimer disease
quality of postoperative recovery (qor-15t) in patients undergoing video-assisted thoracoscopic surgery (vats)

Conditions: Video-Assisted Thoracic Surgery

Summary: video-assisted thoracoscopic surgery (vats) is a minimally invasive technique that provides faster recovery after thoracic surgery. techniques such as thoracic paravertebral block, erector spina plane expansion (esp block) are accepted as loco-regional techniques for vats. the quality of recovery after anesthesia (qor) is an important information of the early health components of patients after surgery. qor-15 offers a valid, reliable, sensitive and easy-to-use method for recovery after surgery. we aimed to investigate the relationship between qor-15 score and postoperative pain temperature after video-assisted thoracoscopic surgery (vats) esp block and paravertebral spread.

video-assisted thoracoscopic surgery (vats) is a minimally invasive technique that provides faster recovery after thoracic surgery. techniques such as thoracic paravertebral block, erector spina plane expansion (esp block) are accepted as loco-regional techniques for vats. despite the improvement in invasiveness against thoracotomy treatment, postoperative pain after vats was still moderate to severe. in order to accelerate the recovery of patients, a multimodal analgesic should be carefully planned and where it will be beneficial. the quality of recovery after anesthesia (qor) is an important information of the early health components of patients after surgery. the performance of qor-15 has been translated into turkish and validation studies have been conducted on its products. qor-15 offers a valid, reliable, sensitive and easy-to-use method for recovery after surgery. we aimed to investigate the relationship between qor-15 score and postoperative pain temperature after video-assisted thoracoscopic surgery (vats) esp block and paravertebral spread.

Eligibility criteria:
inclusion criteria: * asa1-3 * patient undergoing video assisted thoracoscopic surgery (vats) * over 18 years of age exclusion criteria: * sympathectomy, lobectomy and pneumonectomy surgery using video assisted thoracoscopic surgery (vats) * cases that started with video assisted thoracoscopic surgery (vats) but were converted to thoracotomy, * patients who were uncooperative, * patients who refused to participate in the study, * presence of a neuropsychiatric disorder that could bias qor-15t measurements or emergency surgical intervention, * patients under 18 years of age.

Keywords: video-assisted thoracic surgery perioperative care patient-reported outcome measures pain
effect of conventional therapy and low level laser therapy on pain and function in patients with temporomandibular joint dysfunction

Conditions: Low Level Laser Therapy; Temporomandibular Joint Dysfunction

Summary: this study was to determine the effect of conventional therapy and low level laser therapy on pain and function in patients with temporomandibular joint dysfunction. sixty patients with myofascial pain syndrome of tmj are randomly classified into two groups with thirty patients in each group; group i received traditional exercise. group ii received low level laser therapy in addition to traditional exercise. all outcome measures including pain and function, were evaluated before and after the treatment program.

methodology subjects: this prospective study was conducted on thirty patients of both genders with myofascial pain syndrome of tmj in the department of physical therapy at october 6 university hospital from december 2016 to october 2017. the patients were selected to be enrolled into this study according to the following criteria:

Eligibility criteria:
inclusion criteria: * all patients are diagnosed as myofascial pain syndrome of tmj. exclusion criteria: * presence of systematic musculo-articular pathologies. * pregnant women. * history of facial trauma. * facial palsy. * fractures of the facial bones.

Keywords: conventional therapy
desarda repair compared to lichtenstein repair for the treatment of inguinal hernias

Conditions: Postoperative Pain; Recurrence; Wound Complication

Summary: the lichtenstein technique for hernia repair is safe and simple, but the underlying mesh prosthesis has its setbacks, as it acts as a mechanical barrier5. the mesh does not provide mobile and the physiologically dynamic posterior wall. the most dangerous complication associated with the mesh prosthesis is its migration from the abdominal cavity's primary implantation site. the relatively knew technique developed by dr. desarda does not utilize the synthetic mesh rather it uses a strip of external oblique aponeurosis to strengthen the posterior wall. our study has compared the two methods regarding various aspects.


Eligibility criteria:
inclusion criteria: 1. patients of age between 20 to 70years 2. a primary inguinal hernia 3. consented to participate in the research. exclusion criteria: 1. age below 20, 2. recurrent and pantaloons hernia 3. patients who did not give the informed consent 4. patients who lose the follow-up

Keywords: desarda repair comparison lichtenstein repair randomized controlled trial
ono-4578-06:phase i study of ono-4578 and letrozole plus cdk4 /6 inhibitors in breast cancer

Conditions: Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer

Summary: this is a multicenter, open-label, non-controlled, phase i study to investigate the tolerability and safety of ono-4578 used in combination with standard-of-care letrozole and a cdk4/6 inhibitor (palbociclib or abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, her2-negative breast cancer.


Eligibility criteria:
inclusion criteria: 1. patients with postmenopausal metastatic or recurrent breast cancer 2. patients with ecog performance status 0 to 1 3. er-positive, pgr-positive and her2-negative patients exclusion criteria: 1. patients are unable to swallow oral medications 2. patients with severe complication

Keywords: breast cancer hormone receptor-positive her2-negative metastatic recurrent
feasibility, acceptability, and preliminary efficacy of a novel personalized mobile intervention for suicide - open trial

Conditions: Suicide; Suicide and Self-harm; Suicide, Attempted; Suicidal Ideation

Summary: the primary aim of this grant is to conduct pilot testing on a novel personalized mobile intervention for suicide - mobile application to prevent suicide (maps) - and to establish feasibility, acceptability, safety, and primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).


Eligibility criteria:
inclusion criteria: * suicidal ideation and/or suicidal behavior in the past month verified by the c-ssrs * between the ages of 18 and 26 * english proficiency * comfortable with smartphone technology * deemed by the treatment team to be stable enough to complete study procedures exclusion criteria: * current psychotic or manic symptoms severe enough to interfere with study procedures
behaviour of intravenous solutions in obese patients under general anesthesia

Conditions: Obesity; Obesity, Morbid

Summary: there is no objective evidence of how long intravenous solutions remain inside venous blood vessels after they have been administered, therefore there is no definite guideline of how to administer them in the preoperative setting. besides, obese patients represent a particular group of subjects as they theoretically with-hold a constant inflammatory response and that would modify the way solutions behave intravenously, that is how long they remain inside. having said this, we wish to describe the way colloid solutions behave in this group of patients by taking serial blood samples in 12 obese patients after a colloid infusion, to calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it remains intravascularly. all this in the hope this information will help, in the near future, to establish a more objective way to use these solutions and avoid possible complications due to over-administration.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of obesity (imc \>35kg/m2) that will be treated with gastrojejunal laparoscopic bypass exclusion criteria: * renal failure kdoqi \>3 * cardiac failure nyha iii-iv * sepsis * allergy to tetrastarch * allergy to any of the anesthetic medication that is to be used in the protocol previously established * patients in which vasoactive drugs are used * patients in which the blood samples are completed.

Keywords: general anesthesia volume kinetics
clinical food study to evaluate the effect of kb195 on gut nitrogen metabolism in patients with urea cycle disorders

Conditions: Urea Cycle Disorders

Summary: this clinical food study aims to explore the effect of kb195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (ucds). this will be done using a stable isotope to assess nitrogen metabolism in the blood, urine, and stool. the study will also assess the safety and tolerability of kb195 in patients with ucds.


Eligibility criteria:
inclusion criteria: * confirmed ucd patient at any age ≥ 14 years * parental/legal guardian permission or patient's written informed consent or assent, as applicable * be willing and able to comply with study requirements exclusion criteria: * any medical condition unrelated to the sequelae of ucd * patient has n-acetylglutamate synthase (nags) deficiency * recent hospitalization or risk for metabolic decompensation * liver transplantation * systemic antibiotics, probiotics or prebiotics that do not align with study guidances * change in dose or frequency of any drug or other compound to modulate gi motility * contraindications or known allergy/sensitivity to the use of the study products * use of an investigational drug, product or device within 30 days prior to screening visit, or current enrolment in another investigational drug, product, or device study * considered to be at risk for noncompliance or unlikely for any reason to be able to comply with the study procedures

Keywords: kb195 urea cycle disorders ucd microbiome kaleido ammonia
acute kidney injury biomarkers: diagnosis and application in pre-operative period of liver transplantation

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki), is a common complication of patients undergoing liver transplantation. timing and definition of aki, usually based on serum creatinine, have been inaccurate and inconsistent. we hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to provide information on the risk of progression of aki, the need for rrt and mortality.


Eligibility criteria:
inclusion criteria: * older than 18 years * reception liver transplantation exclusion criteria: * ckd stage 4 / 5 * combined organ transplants * patients receiving dialysis before liver transplant operation

Keywords: patients undergoing the liver transplantation acute kidney injury
isoniazid prophylaxis based on risk factors of tuberculosis in living kidney transplantation recipients

Conditions: Kidney Transplantation; Tuberculosis; Isoniazid Toxicity

Summary: tuberculosis (tb) is a major and severe opportunistic infection among solid organ transplant recipients. chemoprophylaxis is advised for those with latent tuberculosis infection (ltbi). however, the effectiveness of an isoniazid (inh) prophylactic approach based on tb risk factors, without relying on tuberculin skin test (tst) or interferon-gamma release assay (igra), remains uncertain. therefore, the investigators conducted this retrospective study to evaluate the safety and efficacy of a 6-month inh prophylaxis regimen guided by tb risk factors in kidney transplant recipients.


Eligibility criteria:
inclusion criteria: 1. living-donor kidney transplant recipients 2. receiving standard triad immunosuppressive regimen exclusion criteria: 1. active tb infection 2. multiorgan transplantation 3. liver cirrhosis 4. malignancy history in the donor and recipient 5. human immunodeficiency virus infection 6. those who had received a nine-month course of inh.
management of urinary tract infections in primary care facilities.

Conditions: Urinary Tract Infection

Summary: the emergency ward center in oslo has the last two years used a questionnaire to identify patients who qualify for treatment of acute cystitis by the use of a delegation form. the aim of the study is to evaluate this practice, the primary objective being to evaluate if in a selected patient group the treatment outcome after identifying patients with probable acute cystitis by delegation form will be as good or better than the treatment received after a regular doctor's consultation. the planned study will also investigate which symptoms, signs and laboratory findings that coincide with significant bacteruria. the reference standard will be a microbiological culture of every patients urine.


Eligibility criteria:
inclusion criteria: * females 16-55 years * dysuria * increased frequency of urination exclusion criteria: * pregnant * breastfeeding child \< 1 month of age * diabetes * kidney disease * fever * poor general condition * backpain * abdominal pain * increased amount of vaginal secretions * vaginal itching or pain * urinary tract infection in the last four weeks * use of urinary catheter in the last four weeks * symptoms lasting more than seven days * ongoing antibiotic treatment * allergy to penicillin * use of the medicine probecid

Keywords: urinary tract infection cystitis bacteruria